NO radiographic progression of further joint damage in PsA¹

Please see clinical trial and primary end points, key data, and study designs

No approved IL-23 inhibitor has been shown to stop further joint damage at 2 years.

In FUTURE 5*

Cosentyx 300 mg (n=139): 84% of biologic-naive patients had no radiographic progression at 2 years.

Artist’s representation of early radiographic damage.

150 mg at 2 years: 71% of patients had no radiographic progression (n=137).¹

Baseline mTSS in the 300-mg and 150-mg treatment arms was 11.5 and 9.6, respectively.^1†

39% of biologic-naive patients in the COSENTYX^® 150-mg arm were up-titrated to 300 mg starting at Week 52, at the investigator's discretion.¹

In FUTURE 5, mTSS was a prespecified exploratory end point at Year 2. Results were analyzed using a linear mixed-effects model in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.^1,4

No radiographic progression is defined as a change from baseline in mTSS ≤0.0.¹
Key secondary end point: In the mixed population, mean change from baseline at 24 weeks in mTSS was 0.03 for COSENTYX 300 mg (n=217), 0.14 for COSENTYX 150 mg (n=213), and 0.51 for placebo (n=296). Patients in the placebo group who were rescued at Week 16 had their value imputed using linear extrapolation. 77%, 71%, and 68% of patients had no radiographic progression at 6 months in the 300-mg, 150-mg, and placebo groups, respectively.^4,5
mTSS measures radiographic progression in the hands and feet and is expressed as the sum of erosion score and joint-space narrowing. Higher scores indicate more articular damage.⁶

*Trial used SC administration.
^†As measured by mTSS in biologic-naive patients (analysis is based on patients with evaluable x-ray at baseline and Year 2).¹

See PsA safety >

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points in PsA

FUTURE 2*
(Two-thirds biologic-naive and one-third anti–TNF-α inadequate responders)⁷

ACR20 responses at Week 16 (NRI) were^5,7:

57% for COSENTYX 300 mg (n=100) (P<0.0001)
60% for COSENTYX 150 mg (n=100) (P<0.0001)
18% for placebo (n=98)

ACR20 responses at Week 24 (primary end point) (NRI) were^5,7:

54% for COSENTYX 300 mg (n=100) (P<0.0001)
51% for COSENTYX 150 mg (n=100) (P<0.0001)
15% for placebo (n=98)
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^5,7
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24⁷

FUTURE 5*
(Two-thirds biologic-naive and one-third anti–TNF-α inadequate responders)⁴
Results at Week 16⁴

JOINT
FUTURE 5 primary end point
ACR20 response rates (NRI) 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)

ENTHESITIS
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)

DACTYLITIS
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)

SKIN
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)

NAIL^†
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)

Study designs

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: two-thirds of patients were biologic-naive and one-third were anti–TNF-⍺ inadequate responders.^5,7,8

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 two-thirds of patients were biologic-naive and less than one-third were anti–TNF-⍺ inadequate responders (individual patients could have been exposed to up to 3 TNF-⍺ inhibitors).^4,6

*All trials used SC administration.
^†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) (MMRM) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).⁹ 
^‡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

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MMRM, mixed-effect model repeated measure; 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; SC, subcutaneous; TNF, tumor necrosis factor.

Definitions and references

Definitions

IL, interleukin; mTSS, modified Total Sharp Score; PsA, psoriatic arthritis; SC, subcutaneous.

References

1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
2. Clinicaltrials.gov. Absence of radiographic progression data at 2 years for IL-23 inhibitors in PsA. Completed March 24, 2025.
3. Clinicaltrials.gov. A study of guselkumab in participants with active psoriatic arthritis (APEX). NCT04882098. Accessed March 24, 2025. https://clinicaltrials.gov/study/NCT04882098
4. Data on file. CAIN457F2342 (FUTURE 5): Clinical Study Report. Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
5. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
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.
7. Data on file. CAIN457F2312 (FUTURE 2): Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
8. Data on file. CAIN457F2312 (FUTURE 2): Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
9. Data on file. CAIN457A2313 (TRANSFIGURE): Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

NO radiographic progression of further joint damage in PsA¹

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

Important Safety Information

Indications

NO radiographic progression of further joint damage in PsA1

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

NO radiographic progression of further joint damage in PsA¹