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THU0411 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)
  1. A. Kavanaugh1,
  2. I.B. McInnes2,
  3. S. Hall3,
  4. H. Chinoy4,
  5. A. Kivitz5,
  6. S. Kandala6,
  7. M. Patekar6,
  8. S. Mpofu7
  1. 1University of California, San Diego School of Medicine, La Jolla, United States
  2. 2University of Glasgow, Glasgow, United Kingdom
  3. 3Monash University, CabriniHealth, Melbourne, Australia
  4. 4Manchester University, Manchester, United Kingdom
  5. 5Altoona Clinical Research Center, Duncansville, United States
  6. 6Novartis Healthcare Pvt Ltd, Hyderabad, India
  7. 7Novartis Pharma AG, Basel, Switzerland

Abstract

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.

References

  1. 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

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