*ULTIMATE: non-responder imputation data in biologic-naïve patients originally randomly assigned to Cosentyx (n=83). Patients taking Cosentyx received 150 mg if their body surface area (BSA) was ≤10%, or 300 mg if their BSA was >10% (as assessed by PASI score). The primary endpoint (Global OMERACT-EULAR Synovitis Score [GLOESS] mean change from baseline at Week 12) was met (p=0.004).
†MATURE: non-responder imputation data for the 300 mg treatment group of patients with moderate to severe plaque PsO at baseline (n=41). The co-primary endpoint (PASI 75 and Investigator’s Global Assessment [IGA] 0/1 at Week 12) was met (p<0.0001).
‡TRANSFIGURE: observed data in patients with moderate to severe nail PsO in the 300 mg treatment group (n=66); in the respective 150 mg treatment group (n=67), there was a mean NAPSI improvement of -63.6%. The primary endpoint (percentage change from baseline in mean NAPSI score at Week 16) was met (p<0.0001). Actual photos taken of a Cosentyx patient by investigators during clinical trials. Individual patient responses may vary.
§MAXIMISE: observed data in biologic-naïve patients in the 300 mg treatment group (n=139); in the respective 150 mg treatment group, 65% achieved ASAS40 at Year 1 (n=141). The primary endpoint (ASAS20 response rate at Week 12) was met (p<0.0001).
¶FUTURE 2: observed data for the 300 mg treatment group of biologic-naïve patients with this symptom at baseline, including those originally randomly assigned to Cosentyx and placebo-switchers (n=51); 75% in the respective 150 mg group maintained complete resolution of enthesitis through Year 5 (n=64). The primary endpoint (the proportion of patients with ACR20 response at Week 24) was met (p<0.0001).
‖FUTURE 2: observed data for the 300 mg treatment group of biologic-naïve patients with this symptom at baseline, including those originally randomly assigned to Cosentyx and placebo-switchers (n=40); 82% in the respective 150 mg group maintained complete resolution of dactylitis through Year 5 (n=28). The primary endpoint (the proportion of patients with ACR20 response at Week 24) was met (p<0.0001).
**SERENA is an ongoing, longitudinal, non-interventional study across 438 sites in patients with moderate to severe, chronic PsO, active PsA or active AS who were treated with Cosentyx for ≥16 weeks at registration. The primary objective of this 2-year interim analysis was to assess long-term retention of Cosentyx in patients with PsA or AS.
ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis international Society; axSpA, axial spondyloarthritis; BSA, body surface area; BSR, British Society for Rheumatology; CI, confidence interval; DMARD, disease modifying anti-rheumatic drug; !!ERA, enthesitis-related arthritis; EULAR, European Alliance of Associations for Rheumatology; GLOESS, Global OMERACT-EULAR synovitis score; GRAPPA, Group for Research and Assessement of Psoriasis and Psoriatic Arthritis; HS, hidradenitis suppurativa; IGA, investigator’s global assessment; IL, interleukin; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; MDA, minimal disease activity; MTX, methotrexate; NAPSI, nail psoriasis severity index; nr-axSpA, non-radiographic axial spondyloarthritis; OMERACT, outcome measures in rheumatology; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, psoriasis; SC, subcutaneous; SmPC, Summary of Product Characteristics; TNFi, tumour necrosis factor inhibitor; TNFi-IR, tumour necrosis factor inhibitor-inadequate responder.
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