COSENTYX is the ONLY IL inhibitor with clinical trial persistence data through 5 years in PsA11
Lasting retention through 5 years in biologic-naive patients with PsA in FUTURE 212
Year 1: 88% and 94% in the 300-mg group (n=59) and the 150-mg group (n=59), respectively.12
Year 2: 84% in the 300-mg group (n=56) and the 150-mg group (n=53), respectively.12
Year 3: 81% in the 300-mg group (n=54) and the 150-mg group (n=51), respectively.12
Year 4: 79% and 81% in the 300-mg group (n=53) and the 150-mg group (n=51), respectively.12
Year 5: 73% and 76% in the 300-mg group (n=49) and the 150-mg group (n=48), respectively.12
No clinical or statistical conclusions can be drawn from persistence data.
COSENTYX is the ONLY IL inhibitor with real-world persistence data through 9 years13-15
Retention in a mixed population of patients with PsA, AS, or PsO through 9 years in a real-world analysis (N=332)15
Real-world analyses can only evaluate association, not causation. Efficacy outcomes reported from clinical trials and those collected in a real-world setting are not directly comparable. Clinical trials use prespecified, validated end points, while real-world studies are observational in nature and use data from routine clinical practice. Real-world data may be based on a small sample size and may not reflect outcomes for all patients. Patients are not randomized, and therefore real-world data are not suitable for direct comparison with clinical trial results. The source and type of real-world data may limit the ability to characterize results in relation to end points from clinical trials due to data availability and varying evaluable approaches. While prescribed dosing was consistent with approved labeling, results are pooled across patients prescribed either 300 mg or 150 mg, as determined by their treating rheumatologist.
†The effectiveness and safety of COSENTYX IV formulation are based on the pharmacokinetic exposure and extrapolation of the established effectiveness and safety of SC COSENTYX in adult patients with active PsA, AS, or nr-axSpA.10
‡For SC privately insured patients and IV Medicare Part B FFS patients.
§COSENTYX for SC use is present on formularies as either a first-, second-, third-, fourth-, or fifth-line biologic. Novartis does not guarantee payments or coverage for any product or service. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Coverage information is subject to change by the relevant payer.
||Based on the total number of covered lives across all health plans combined.
¶Based on first-, second-, third-, fourth-, and fifth-line IV coverage of COSENTYX as of March 2026.
#Medicare Part B FFS typically covers outpatient prescription drugs that are administered incident to a physician service and that are not usually self-administered. For drugs that are available in both oral and injectable forms, the MACs are responsible for determining whether the drug and the route of administration are both medically necessary. Novartis does not guarantee payment or coverage for any product or service. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Coverage information is subject to change by the relevant payer.
**No step therapy or prior authorizations are required.
COSENTYX clinical trial end points
FUTURE 2* (PsA)
(Two-thirds biologic-naive and one-third anti–TNF-α inadequate responders)18
ACR20 responses at Week 16 (NRI) were10,18:
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) were10,18:
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 PASI10,18
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 2418
FUTURE 5* (PsA)
(Two-thirds biologic-naive and one-third anti–TNF-α inadequate responders)19
Results at Week 1619
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)
MAXIMISE*§ (PsA)
ASAS20 responses at Week 12 (MI) in biologic-naive patients with PsA were1:
63% for COSENTYX 300 mg (n=164) (primary end point) (P<0.0001)
66% for COSENTYX 150 mg (n=157) (key secondary end point) (P<0.0001)
31% for placebo (n=164)
MATURE* (PsO)
Coprimary end points in patients with moderate to severe PsO20
PASI 75 response at Week 12 (LRM) was:
95% for COSENTYX 300-mg UnoReady® pen (n=41) (P<0.0001)
10% for placebo (n=40)
IGA mod 2011 0/1 response at Week 12 (LRM) was:
76% for COSENTYX 300-mg UnoReady pen (n=41) (P<0.0001)
8% for placebo (n=40)
MEASURE 2* (AS)
61% of patients achieved ASAS20 in a mixed population at Week 16 on COSENTYX 150 mg (n=72) vs 28% on placebo (n=74) (NRI; P=0.0001) (primary end point)10,21
PREVENT* (nr-axSpA)
40% of biologic-naive patients achieved ASAS40 at 1 year on COSENTYX 150 mg no load (n=166) vs 20% on placebo (n=171) (NRI; P<0.05) (primary end point)22
TRANSFIGURE* (nail PsO)
NAPSI improvement at Week 16 in patients with moderate to severe nail PsO (primary end point) (MMRM)5,23:
46% NAPSI improvement for COSENTYX 300 mg (n=63) (P<0.0001)
38% for COSENTYX 150 mg (n=64) (P<0.0001)
12% for placebo (n=56)
*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).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.19
§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.10
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.10,18,24
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).19,25
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.26
MATURE was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel group study of the efficacy, safety, and tolerability of the 300-mg COSENTYX UnoReady pen in 122 adult patients with moderate to severe PsO. After screening, for Treatment Period 1 (randomization through Week 12 predose), patients were randomized 2:2:1:1 to either COSENTYX 300-mg (2 mL) UnoReady pen, COSENTYX 300-mg 2 × 150-mg (2 × 1 mL) prefilled syringes (PFS), placebo UnoReady pen (2 mL), or placebo (2 × 1 mL) PFS. For Treatment Period 2 (Week 12 through Week 52), PASI 90 nonresponders were rerandomized to the respective COSENTYX 300-mg autoinjector or COSENTYX 300-mg 2 x 1 mL PFS group. All arms started with 4 once-weekly loading doses, followed by dosing every 4 weeks. Patients switched from placebo to active drug repeated the loading doses. Primary end point was the efficacy of the COSENTYX 300-mg UnoReady pen vs placebo, with respect to both PASI 75 and IGA mod 2011 0 or 1 response (coprimary end point) at Week 12.27
MEASURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 219 adult patients with active AS who received COSENTYX 75 mg, 150 mg, or placebo subcutaneous treatment at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks. At Week 16, patients who received placebo were rerandomized to either COSENTYX 75 mg or 150 mg every 4 weeks. After 16 weeks, patients knew they were taking active medication, but were blinded to the dose. After 1 year, patients continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years, then every 12 weeks through 5 years. The primary end point was the percentage of patients who achieved ASAS20 response at Week 16.7,10,21
PREVENT was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating 555 adult patients with active nr-axSpA who met the ASAS classification criteria for axSpA and had abnormal hsCRP and/or evidence of sacroiliitis on MRI. Participants were randomized to receive 1 of 3 treatments subcutaneously: COSENTYX 150 mg load, COSENTYX 150 mg no load, or placebo. Patients were treated with COSENTYX 150 mg with load or placebo (Weeks 0, 1, 2, 3, and 4) or COSENTYX 150 mg without load (Weeks 0 and 4), followed by the same dose every 4 weeks thereafter. Starting at Week 16, dose adjustment or addition of concomitant NSAIDs and DMARDs was permitted. Starting at Week 20, patients were allowed to switch to open-label COSENTYX 150 mg monthly or local standard of care if the patient was considered an inadequate responder for 2 consecutive visits by the discretion of the investigator and patient. The primary end point was the percentage of biologic-naive patients who achieved ASAS40 response at Week 52 in the no-load arm. The core phase of the trial ran through Week 104, with an extension phase through Week 208. Most patients (90%) were biologic-naive in this study.9,10,22
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 132.23
Real-world data study designs
Persistence data are sourced from an analysis by Ippoliti E et al., a bicentric observational study evaluating a cohort of 332 patients with PsO, PsA, or AS who were observed over a 9-year period between 2015 and 2023. The study was conducted within university hospitals in Rome, Italy, and involved the dermatology and rheumatology units of the Fondazione Policlinico Universitario Agostino Gemelli and the Department of Dermatology at Centro Hospitalar Universitário do Porto In Porto, Portugal. Patients were treated with SC COSENTYX at the dose approved for each indication. Retention to treatment was defined as the duration for which a patient remained on treatment, from beginning until cessation for any reason (ie, loss of efficacy, safety concerns, switching to a different treatment, loss at follow-up, remission, or patient's decision). Data were recorded from baseline every 6 months for the first year and yearly for the treatment period of up to 9 years, and data from medical records were analyzed retrospectively to evaluate the recurrence of AEs.15
Real-world data can supplement data from clinical trials13,28,29
Randomized controlled trials | Real-world studies |
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ACR, American College of Rheumatology; AE, adverse event; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis International Society criteria; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; DMARDs, disease-modifying antirheumatic drugs; FDA, US Food and Drug Administration; hsCRP, high-sensitivity C-reactive protein; IGA mod 2011, Investigator’s Global Assessment modified 2011; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LRM, logistic regression model; MI, multiple imputation; MMRM, mixed model for repeated measures; mNAPSI, modified Nail Psoriasis Severity Index; MRI, magnetic resonance imaging; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; nr-axSpA, non-radiographic spondyloarthritis; 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; VAS, visual analog scale.
Definitions
AS, ankylosing spondylitis; FFS, fee-for-service; IL, interleukin; IV, intravenous; MAC, Medicare administrative contractor; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous.
References
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