Here with you with results in all key clinical manifestations of psoriatic arthritis (PsA) for up to 2 years1-5
Please see clinical trial primary end points, key data, and study designs
In FUTURE 5, ACR50, dactylitis, enthesitis, mNAPSI, and PASI 90 were prespecified exploratory end points at 2 years, and PASI 100 was a post hoc analysis based on PASI 90. In MAXIMISE, ASAS20 at 1 year was a prespecified exploratory end point. No clinical or statistical conclusions can be drawn.1-3,5,6
Data from the MAXIMISE trial, whose study design, patient population, and dosing regimen are consistent with those of FUTURE 2. In FUTURE 2, 20% of patients had spondylitis with peripheral arthritis. MAXIMISE primary end point: 63% experienced relief on COSENTYX 300 mg at Week 12 vs 31% with placebo, as measured by ASAS20 (P<0.0001) (n=164) (MI).2
Nail data in PsA from FUTURE 5 at Week 16 (mixed population) were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).7
At baseline in FUTURE 5 (mixed population), mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.6
A robust safety profilem
Convenient once-a-month maintenance dosing (every 4 weeks)m
Support to help offices help patients
Here for your community
Novartis commitment to rheumatology is ongoing:
-
6 years of treating rheumatology patients—and counting8*
*FDA approved for active PsA and AS in 2016.
Hear what matters to patients
A patient's experience:
"I was talking to my doctor about treatment options, and before he could finish his sentence, we both said COSENTYX."
Meet Darren
Darren, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.
COSENTYX clinical trial end points
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders9
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)9,10
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)9,10
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI9,10
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 2410
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders6
JOINT6
ACR20 response rates (NRI) (primary end point) were:
-
63% for COSENTYX 300 mg (n=222) (P<0.0001)
-
56% for COSENTYX 150 mg (n=220) (P<0.0001)
-
27% for placebo (n=332)
ENTHESITIS6
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
-
56% for COSENTYX 300 mg (n=140)
-
55% for COSENTYX 150 mg (n=141)
-
35% for placebo (n=192)
DACTYLITIS6
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
-
66% for COSENTYX 300 mg (n=82)
-
57% for COSENTYX 150 mg (n=80)
-
32% for placebo (n=124)
SKIN6
Patients who achieved PASI 90 (NRI):
-
54% for COSENTYX 300 mg (n=110)
-
37% for COSENTYX 150 mg (n=125)
-
9% for placebo (n=162)
NAIL6*
Reduction in nail disease (mNAPSI as observed) response rates were†:
-
51% for COSENTYX 300 mg (n=125)
-
53% for COSENTYX 150 mg (n=128)
-
11% for placebo (n=203)
MAXIMISE
MAXIMISE studied biologic-naive patients with PsA11
-
The primary end point (ASAS20 responses at Week 12) was achieved by 63% of patients on COSENTYX 300 mg (n=164) compared with 31% for placebo (n=164) (MI; P<0.0001)11
-
The key secondary end point, ASAS20 responses at Week 12 in patients on COSENTYX 150 mg, was achieved by 66% (n=157) (MI; P<0.0001)11
TRANSFIGURE
TRANSFIGURE studied patients with nail psoriasis7,12
-
The primary end point, improvement from baseline NAPSI at Week 16 (repeated measures analysis), was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001)7,12
*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).7
†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.6
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.9,10,13
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).6,14
MAXIMISE study design
MAXIMISE was a randomized, double-blind, placebo-controlled, multicenter, 52-week study that evaluated 498 patients with active PsA and axial skeleton involvement (defined by BASDAI score ≥4, spinal pain VAS ≥40 [0 to 100 mm scale]) who had inadequate response to at least 2 NSAIDs for at least 4 weeks. Patients were randomized to receive subcutaneous COSENTYX 150 mg (n=165), COSENTYX 300 mg (n=167), or placebo (n=166) at Weeks 0, 1, 2, 3, 4, and 8. Primary end point was the proportion of patients with ASAS20 response at Week 12. After Week 12, patients who were placed in the placebo group at baseline were rerandomized to active treatment with COSENTYX 150 mg or 300 mg, administered every 4 weeks from Week 12 to Week 52 (last dose on Week 48) but remained blinded to dose.11
TRANSFIGURE study design
TRANSFIGURE was a double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe nail PsO. Patients were randomized to COSENTYX 300 mg (n=66), COSENTYX 150 mg (n=67), or placebo (n=65). All patients were adults with moderate to severe PsO (PASI score ≥12 and BSA ≥10%) and significant nail involvement (fingernail NAPSI score of ≥16 and ≥4 fingernails involved), who were candidates for systemic therapy. Primary end point: NAPSI assessment at Week 16. Secondary end points included NAPSI response over time up to Week 132.12
ACR, American College of Rheumatology; ASAS, Assessment of SpondyloArthritis international Society criteria; BASDAI, Bath Ankylosing Spondylitis Activity Index; BSA, body surface area; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MI, multiple imputation; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor; VAS, visual analog scale.
Definitions
ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society criteria; FDA, US Food and Drug Administration; MI, multiple imputation; mNAPSI, modified Nail Psoriasis Severity Index; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis.
References
1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
2. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
3. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
4. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 100 Tender/Swollen Joints Pain Biologic-Naive. Novartis Pharmaceuticals Corp; April 2020.
5. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
6. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
7. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
8. Data on file. Novartis press release. Novartis Pharmaceuticals Corp; January 2016.
9. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
10. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
11. Data on file. CAIN457F3302 (MAXIMISE) Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016.
12. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2017.
13. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
14. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Here with you because relief can’t come soon enough
In FUTURE 5
Fast relief of joint symptoms as early as Week 21
ACR20 response at Week 2 in a mixed population1
-
31% for COSENTYX 300 mg (n=222)
-
26% for COSENTYX 150 mg (n=220)
-
15% for placebo (n=332)
In FUTURE 5, ACR20 was a prespecified exploratory end point at Week 2. No clinical or statistical conclusions can be drawn.1
Relief for your biologic-naive patients with PsA
In FUTURE 5, ACR50 was a prespecified exploratory end point at Week 16 in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.1
COSENTYX clinical trial end points
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders2
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)2,3
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)2,3
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI2,3
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 243
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders1
JOINT1
ACR20 response rates (NRI) (primary end point) were:
-
63% for COSENTYX 300 mg (n=222) (P<0.0001)
-
56% for COSENTYX 150 mg (n=220) (P<0.0001)
-
27% for placebo (n=332)
ENTHESITIS1
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
-
56% for COSENTYX 300 mg (n=140)
-
55% for COSENTYX 150 mg (n=141)
-
35% for placebo (n=192)
DACTYLITIS1
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
-
66% for COSENTYX 300 mg (n=82)
-
57% for COSENTYX 150 mg (n=80)
-
32% for placebo (n=124)
SKIN1
Patients who achieved PASI 90 (NRI):
-
54% for COSENTYX 300 mg (n=110)
-
37% for COSENTYX 150 mg (n=125)
-
9% for placebo (n=162)
NAIL1*
Reduction in nail disease (mNAPSI as observed) response rates were†:
-
51% for COSENTYX 300 mg (n=125)
-
53% for COSENTYX 150 mg (n=128)
-
11% for placebo (n=203)
*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).4
†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.1
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.2,3,5
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).1,6
ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.
Definitions
ACR, American College of Rheumatology; PsA, psoriatic arthritis.
References
1. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
2. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
4. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
5. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
6. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Here with you for the long term
In FUTURE 2, as observed in biologic-naive patients with psoriatic arthritis (PsA)
Lasting joint results at 5 years1
*73% and 76% completed the extension treatment period in the 300 mg arm and 150 mg arm, respectively.1
As with other uncontrolled studies, this phase of the study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, n=67 and n=63 were biologic-naive in the 300 mg and 150 mg arms, respectively.2
In the mixed population: 74% of patients in the 300 mg arm and the 150 mg arm achieved an ACR20 response; 48% of patients in the 300 mg arm and 42% in the 150 mg arm achieved an ACR50 response; 28% of patients in the 300 mg arm and 29% in the 150 mg arm achieved an ACR70 response.
Up to76%
retention rate of biologic-naive patients at Year 51*
In FUTURE 2, ACR20, ACR50, and ACR70 were prespecified exploratory end points from baseline through 5 years in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.2
Hear what matters to patients
A patient’s experience:
"When the disease is managed well, I can do most things I need to do. I can’t think of anything it has prevented me from doing."
Meet Mike
Mike, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders2
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)2,3
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)2,3
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI2,3
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 243
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.2-4
ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.
Definitions
ACR, American College of Rheumatology; PsA, psoriatic arthritis; TNF, tumor necrosis factor.
References
1. Data on file. CAIN457F2312 (FUTURE 2): 5-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
2. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
4. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Tried and tested specifically for axial symptoms of PsA
In MAXIMISE, as observed in biologic-naive patients with PsA
Demonstrated improvement in axial symptoms1,2
FIRSTAND ONLY
dedicated biologic study with significant results in axial PsA manifestations3
ASAS20 responses at Week 12 (MI) were1:
-
63%, 66%, and 31% for COSENTYX 300 mg (primary end point; n=164), COSENTYX 150 mg (key secondary end point; n=157), and placebo (n=164), respectively (P<0.0001)
In MAXIMISE, ASAS20 and ASAS40 were prespecified exploratory end points at 1 year. No clinical or statistical conclusions can be drawn.2
ASAS components are relevant to your patients with PsA and include4:
Data from the MAXIMISE trial, whose study design, patient population, and dosing regimen were consistent with those of FUTURE 2. In FUTURE 2, 20% of patients had spondylitis with peripheral arthritis.
*85% and 90% of patients completed the trial in the 300 mg and 150 mg arms, respectively.2
MAXIMISE
MAXIMISE studied biologic-naive patients with PsA1
-
The primary end point (ASAS20 responses at Week 12) was achieved by 63% of patients on COSENTYX 300 mg (n=164) compared with 31% for placebo (n=164) (MI; P<0.0001)1
-
The key secondary end point, ASAS20 responses at Week 12 in patients on COSENTYX 150 mg, was achieved by 66% (n=157) (MI; P<0.0001)1
MAXIMISE study design
MAXIMISE was a randomized, double-blind, placebo-controlled, multicenter, 52-week study that evaluated 498 patients with active PsA and axial skeleton involvement (defined by BASDAI score ≥4, spinal pain VAS ≥40 [0 to 100 mm scale]) who had inadequate response to at least 2 NSAIDs for at least 4 weeks. Patients were randomized to receive subcutaneous COSENTYX 150 mg (n=165), COSENTYX 300 mg (n=167), or placebo (n=166) at Weeks 0, 1, 2, 3, 4, and 8. Primary end point was the proportion of patients with ASAS20 response at Week 12. After Week 12, patients who were placed in the placebo group at baseline were rerandomized to active treatment with COSENTYX 150 mg or 300 mg, administered every 4 weeks from Week 12 to Week 52 (last dose on Week 48) but remained blinded to dose.1
ASAS, Assessment of SpondyloArthritis international Society criteria; BASDAI, Bath Ankylosing Spondylitis Activity Index; MI, multiple imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PsA, psoriatic arthritis; VAS, visual analog scale.
Definitions
ASAS, Assessment of SpondyloArthritis international Society criteria; BASFI, Bath Ankylosing Spondylitis Functional Index; MI, multiple imputation; PsA, psoriatic arthritis.
References
1. Data on file. CAIN457F3302 (MAXIMISE) Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016.
2. Data on file. CAIN457F3302 (MAXIMISE): 1-Year Clinical Study Report. Novartis Pharmaceuticals Corp; August 2020.
3. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
4. Data on file. CAIN457F2310 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Here with you to reduce the burden of enthesitis
In FUTURE 5, as observed in biologic-naive patients
Complete resolution of enthesitis1
*Patients with no enthesitis are defined as having an LEI score of 0 among patients with a score of 1 or more at baseline.3
†91% of patients completed the study in both the 300 mg and 150 mg arms.1
-
Complete resolution of enthesitis at Week 16 in a mixed population (prespecified secondary end point) using NRI analysis: 56% for COSENTYX 300 mg (n=140) and 55% for COSENTYX 150 mg (n=141) vs 35% for placebo (n=192)2
-
82% of patients achieved complete resolution of enthesitis at 2 years in the 150 mg arm1
-
Among patients with enthesitis, 40% of biologic-naive patients in the COSENTYX 150 mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion1
In FUTURE 5, complete resolution of enthesitis was a prespecified exploratory end point at 2 years in a subgroup of biologic-naive patients with LEI >0 at baseline. No clinical or statistical conclusions can be drawn.3
As with other uncontrolled studies, this phase of the FUTURE 5 study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, 97 patients and 93 patients in FUTURE 5 had enthesitis in the 300 mg and 150 mg arms, respectively (biologic-naive).3
COSENTYX clinical trial end points
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders4
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)4,5
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)4,5
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI4,5
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 245
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders3
JOINT3
ACR20 response rates (NRI) (primary end point) were:
-
63% for COSENTYX 300 mg (n=222) (P<0.0001)
-
56% for COSENTYX 150 mg (n=220) (P<0.0001)
-
27% for placebo (n=332)
ENTHESITIS3
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
-
56% for COSENTYX 300 mg (n=140)
-
55% for COSENTYX 150 mg (n=141)
-
35% for placebo (n=192)
DACTYLITIS3
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
-
66% for COSENTYX 300 mg (n=82)
-
57% for COSENTYX 150 mg (n=80)
-
32% for placebo (n=124)
SKIN3
Patients who achieved PASI 90 (NRI):
-
54% for COSENTYX 300 mg (n=110)
-
37% for COSENTYX 150 mg (n=125)
-
9% for placebo (n=162)
NAIL3*
Reduction in nail disease (mNAPSI as observed) response rates were†:
-
51% for COSENTYX 300 mg (n=125)
-
53% for COSENTYX 150 mg (n=128)
-
11% for placebo (n=203)
*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).6
†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.3
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.4,5,7
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).2,3
ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.
Definitions
LEI, Leeds Enthesitis Index; NRI, nonresponder imputation.
References
1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
2. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
3. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
4. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
5. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
6. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
7. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Here with you to help your patients with “sausage digits”
In FUTURE 5, as observed in biologic-naive patients
Complete resolution of dactylitis1
*Patients with no dactylitis are defined as having a LDI score of 0 among patients with a score of 1 or more at baseline.
†87% and 84% of patients completed the study in the 300 mg and 150 mg arms, respectively.1
-
Complete resolution of dactylitis at Week 16 in a mixed population (prespecified secondary end point) using NRI analysis: 66% for COSENTYX 300 mg (n=82) and 57% for COSENTYX 150 mg (n=80) vs 32% for placebo (n=124)2
-
86% of patients achieved complete resolution of dactylitis at 2 years in the 150 mg arm1
-
Among patients with dactylitis, 56% of biologic-naive patients in the COSENTYX 150 mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion1
In FUTURE 5, complete resolution of dactylitis was a prespecified exploratory end point at 2 years in a subgroup of biologic-naive patients with LDI >0 at baseline. No clinical or statistical conclusions can be drawn.2
As with other uncontrolled studies, this phase of the FUTURE 5 study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, 55 patients and 52 patients had dactylitis in the 300 mg and 150 mg arms, respectively (biologic-naive).2
COSENTYX clinical trial end points
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders3
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)3,4
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)3,4
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI3,4
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 244
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders2
JOINT2
ACR20 response rates (NRI) (primary end point) were:
-
63% for COSENTYX 300 mg (n=222) (P<0.0001)
-
56% for COSENTYX 150 mg (n=220) (P<0.0001)
-
27% for placebo (n=332)
ENTHESITIS2
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
-
56% for COSENTYX 300 mg (n=140)
-
55% for COSENTYX 150 mg (n=141)
-
35% for placebo (n=192)
DACTYLITIS2
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
-
66% for COSENTYX 300 mg (n=82)
-
57% for COSENTYX 150 mg (n=80)
-
32% for placebo (n=124)
SKIN2
Patients who achieved PASI 90 (NRI):
-
54% for COSENTYX 300 mg (n=110)
-
37% for COSENTYX 150 mg (n=125)
-
9% for placebo (n=162)
NAIL2*
Reduction in nail disease (mNAPSI as observed) response rates were†:
-
51% for COSENTYX 300 mg (n=125)
-
53% for COSENTYX 150 mg (n=128)
-
11% for placebo (n=203)
*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).5
†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.2
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.3,4,6
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).2,7
ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.
Definitions
LDI, Leeds Dactylitis Index; NRI, nonresponder imputation.
References
1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
2. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
3. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
4. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
5. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
6. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
7. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Here with you to help clear their skin
Real treatment success with COSENTYX
Skin clearance through 2 years
Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.
In FUTURE 5, as observed in biologic-naive patients
Your patients with PsA can achieve clearer skin1
*91% and 90% of patients completed the two-year clinical trial in the 300 mg and 150 mg arms, respectively.1
*91% and 90% of patients completed the two-year clinical trial in the 300 mg and 150 mg arms, respectively.1
In FUTURE 5, PASI 100 is a post hoc analysis in a subgroup of biologic-naive patients with PsA and PsO based on PASI 75 and PASI 90 as prespecified exploratory end points at 2 years. No clinical or statistical conclusions can be drawn.2
71%
PASI 90 response at 2 years (as observed), 300 mg (n=68)3
-
66% PASI 90 response, 150 mg (n=84)3
-
38% of patients with PsA and PsO in the COSENTYX 150 mg arm were up-titrated to 300 mg starting at Week 52, at the investigator's discretion1
In FUTURE 5, PASI 90 was a prespecified exploratory end point at 2 years. Results were as observed in a subgroup of biologic-naive patients with PsA and plaque psoriasis. No clinical or statistical conclusions can be drawn.
Hear what matters to patients
COSENTYX clinical trial end points
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders4
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)4,5
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)4,5
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI4,5
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 245
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders2
JOINT2
ACR20 response rates (NRI) (primary end point) were:
-
63% for COSENTYX 300 mg (n=222) (P<0.0001)
-
56% for COSENTYX 150 mg (n=220) (P<0.0001)
-
27% for placebo (n=332)
ENTHESITIS2
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
-
56% for COSENTYX 300 mg (n=140)
-
55% for COSENTYX 150 mg (n=141)
-
35% for placebo (n=192)
DACTYLITIS2
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
-
66% for COSENTYX 300 mg (n=82)
-
57% for COSENTYX 150 mg (n=80)
-
32% for placebo (n=124)
SKIN2
Patients who achieved PASI 90 (NRI):
-
54% for COSENTYX 300 mg (n=110)
-
37% for COSENTYX 150 mg (n=125)
-
9% for placebo (n=162)
NAIL2*
Reduction in nail disease (mNAPSI as observed) response rates were†:
-
51% for COSENTYX 300 mg (n=125)
-
53% for COSENTYX 150 mg (n=128)
-
11% for placebo (n=203)
*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).6
†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.2
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.4,5,7
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).2,8
ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.
Definitions
PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis.
References
1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 100 Tender/Swollen Joints Pain Biologic-Naive. Novartis Pharmaceuticals Corp; April 2020.
2. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
3. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
4. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
5. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
6. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
7. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
8. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p, Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.
Here with you for relief of stubborn nail symptoms
Real treatment success with COSENTYX
Patient photos taken from a dedicated nail PsO trial
Baseline
Week 16
Week 32
Week 80
Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.
Look between the cuticle and the new nail to see treatment success. It can take on average about 24 weeks to 1 year for the nail to grow out.1
In FUTURE 5, as observed in biologic-naive patients
Nail clearance through 2 years2
*79% and 83% of patients completed the trial in the 300 mg and 150 mg arms, respectively.2
-
46% of patients with nail psoriasis were up-titrated from 150 mg to 300 mg starting at Week 12, at the investigator’s discretion2
In FUTURE 5, mNAPSI, a measure used to assess psoriatic nail involvement, was a prespecified exploratory end point in a subgroup of biologic-naive patients with PsA and nail psoriasis. No clinical or statistical conclusions can be drawn.3
Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).4
At baseline, 66% and 61% of biologic-naive patients had nail psoriasis in the 300 mg and 150 mg arms, respectively. Mean baseline and 2-year mNAPSI values were 19.2 and 3.1, and 19.7 and 2.2, in the 300 mg and 150 mg arms, respectively.2,3
Look deeper—help inhibit progression of joint structural damageb
A robust safety profilem
Support to help offices help patients
COSENTYX clinical trial end points
FUTURE 2
FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders5
-
ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)5,6
-
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)5,6
-
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI5,6
-
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 246
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders3
JOINT3
ACR20 response rates (NRI) (primary end point) were:
-
63% for COSENTYX 300 mg (n=222) (P<0.0001)
-
56% for COSENTYX 150 mg (n=220) (P<0.0001)
-
27% for placebo (n=332)
ENTHESITIS3
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
-
56% for COSENTYX 300 mg (n=140)
-
55% for COSENTYX 150 mg (n=141)
-
35% for placebo (n=192)
DACTYLITIS3
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
-
66% for COSENTYX 300 mg (n=82)
-
57% for COSENTYX 150 mg (n=80)
-
32% for placebo (n=124)
SKIN3
Patients who achieved PASI 90 (NRI):
-
54% for COSENTYX 300 mg (n=110)
-
37% for COSENTYX 150 mg (n=125)
-
9% for placebo (n=162)
NAIL3*
Reduction in nail disease (mNAPSI as observed) response rates were†:
-
51% for COSENTYX 300 mg (n=125)
-
53% for COSENTYX 150 mg (n=128)
-
11% for placebo (n=203)
*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).4
†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300 mg and 150 mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300 mg and 150 mg arms, respectively.3
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.5-7
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).3,8
ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.
Definitions
mNAPSI, modified Nail Psoriasis Severity Index; NAPSI, Nail Psoriasis Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis.
References
1. National Psoriasis Foundation. Managing nail psoriasis. https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails/managing-nail-psoriasis. Accessed January 8, 2020.
2. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
3. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
4. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
5. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
6. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
7. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
8. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.
b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.
f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.
j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.
k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.
m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.
o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.
p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.
q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.
s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.
t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.