Article
Secukinumab Efficacy in Anti-TNF-Naive and Anti-TNF-IR Patients With Psoriatic Arthritis: Results of a Phase 3 Multicenter, Double-Blind, Placebo-Controlled Study (FUTURE 2)
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Authors
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Jürgen Braun
- Rheumazentrum Ruhrgebiet, Herne
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Arthur Kavanaugh
- UCSD, Division of Rheumatology, Allergy and Immunology, La Jolla, United States of America
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Iain McInnes
- University of Glasgow, Glasgow, England
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Stephen Hall
- Monash University, Melbourne, Australia, Melbourne, Australia
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Hector Chinoy
- University of Manchester, Manchester, UK
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Alan Kivitz
- Altoona Center for Clinical Research, Duncansville, United States of America
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Sekhar Kandala
- Novartis Healthcare, Hyderabad, India
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Manmath Patekar
- Novartis Healthcare Pvt. Ltd. Hyderabad, Hyderabad, India
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Shephard Mpofu
- Novartis Pharma AG, Basel, Switzerland
| Published: | September 1, 2015 |
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Outline
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Introduction: Secukinumab, a human anti–IL-17A monoclonal antibody, demonstrated significant efficacy in the randomized, double-blind, placebo (PBO)-controlled phase 3 FUTURE 2 study (NCT01752634) [1].
The objective is to evaluate secukinumab efficacy by prior tumor necrosis factor inhibitor (anti-TNF) therapy status.
Methods: 397 adults with active PsA were randomized to subcutaneous (s.c.) secukinumab (300, 150 or 75 mg) or PBO at baseline, Week (Wk) 1, 2, 3, 4 and every 4 wks thereafter. Pts were stratified according to inadequate response or intolerance to prior anti-TNF therapy (anti-TNF-IR), or no prior exposure (anti-TNF-naïve). The primary endpoint was American College of Rheumatology 20 (ACR20) response at Wk 24. Secondary endpoints were PASI 75/90, Disease Activity Score 28 using C-reactive protein (DAS28-CRP), Short Form-36 Physical Component Summary (SF-36 PCS), Health Assessment Questionnaire-Disability Index (HAQ-DI), ACR50, dactylitis and enthesitis.
Results: Randomisation resulted in 35% anti-TNF-IR and 65% anti-TNF-naïve patients. At Wk 24, ACR20 responses were greater with secukinumab vs PBO regardless of anti-TNF status. The highest responses were generally observed among anti-TNF-naive pts. Improvements were observed with secukinumab vs PBO for secondary endpoints of ACR50, PASI 75/90, DAS28-CRP, dactylitis, enthesitis, SF-36 PCS and HAQ-DI in both anti-TNF-IR and anti-TNF-naïve pts. Greatest improvements in the anti-TNF-IR group were generally observed with secukinumab 300 mg.
Conclusion: Efficacy was demonstrated with secukinumab 300 mg and 150 mg in both anti-TNF-naive and anti-TNF-IR pts, with secukinumab 300 mg associated with the highest responses in anti-TNF-IR pts.
