Background 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
Objectives 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-naive). The primary endpoint was American College of Rheumatology 20 (ACR20) response at Wk 24. Secondary endpoints were Psoriasis Area-and-Severity Index (PASI) 75/90 response, 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 35% of pts enrolled were anti-TNF-IR and 65% were anti-TNF-naive. 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 (Table). 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-naive pts. Greatest improvements in the anti-TNF-IR group were generally observed with secukinumab 300 mg (Table).
Conclusions Efficacy was demonstrated with secukinumab 300 mg and 150 mg in both anti-TNF-naive and anti-TNF-IR pts, with secukinumab 300 mg being associated with the highest responses in anti-TNF-IR pts.
McInnes IB, et al. Presented at ACR 2014; L1
Acknowledgements Medical writing support was provided by Rachel Mason at Seren Communications (Tytherington, UK), and was funded by Novartis.
Disclosure of Interest A. Kavanaugh Consultant for: Novartis, I. McInnes Consultant for: Novartis, Amgen, Janssen, BMS, Pfizer, UCB, Abbvie, Celgene, and Lilly, S. Hall: None declared, H. Chinoy Grant/research support from: Novartis, Janssen, Pfizer, UCB, Abbvie, Celgene, Servier, Roche, MSD, and aTyr, Consultant for: Novartis, Janssen, Pfizer, UCB, Abbvie, Celgene, Servier, Roche, MSD, and aTyr, A. Kivitz Grant/research support from: Novartis, S. Kandala Employee of: Novartis, M. Patekar Employee of: Novartis, S. Mpofu Shareholder of: Novartis, Employee of: Novartis