Secukinumab in the treatment of psoriatic arthritis: Efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial

Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Mpofu S, Pricop L (2018)

Publication Type: Journal article

Publication year: 2018

Journal

RMD Open BMJ Publishing Group

Book Volume: 4

Article Number: e000723

Journal Issue: 2

DOI: 10.1136/rmdopen-2018-000723

Abstract

Objective To assess the long-term (3 year) efficacy and safety of secukinumab in patients with active psoriatic arthritis (PsA) in the extension phase of the FUTURE 1 study (NCT01892436). Methods Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab 150 or 75 mg entered a 3-year extension phase. Results are presented for key efficacy and safety endpoints at week 156. Results In total, 460 patients entered the extension study; 308 patients originally randomised to secukinumab were assessed for efficacy. Sustained improvements in all efficacy endpoints were achieved with secukinumab through week 156. Overall, 76.8%/54.9% (secukinumab 150 mg) and 65.2%/39.0% (secukinumab 75 mg) of patients achieved an American College of Rheumatology (ACR) 20/50 response (multiple imputation data); ACR20 responses were sustained irrespective of previous anti-tumour necrosis factor exposure. Improvements in quality of life and physical function were also sustained through week 156. Radiographic results (observed data; van der Heijde modified total Sharp score (mTSS)) showed that 78.1% (secukinumab 150 mg) and 74.8% (secukinumab 75 mg) of patients had no radiographic progression (≤0.5 increase in mTSS) through week 156. Exposure-adjusted incidence rates for selected adverse events per 100 patient-years (secukinumab 150/75 mg) were serious infections (1.7/1.6), Candida infections (1.4/0.7), Crohn's disease (0/0.3), ulcerative colitis (0/0.3) and major adverse cardiac events (0.3/0.8). Conclusion Subcutaneous secukinumab provided sustained improvements in the signs and symptoms, quality of life and physical function of patients with active PsA with low rate of radiographic disease progression through 3 years. Secukinumab was well tolerated with no new safety signals.

Authors with CRIS profile

Hans Jürgen Rech Department of Medicine 3 – Rheumatology and Immunology

Involved external institutions

Monash University AU Australia (AU) Novartis AG CH Switzerland (CH) Hasselt University / Universiteit Hasselt BE Belgium (BE) Dallas VA Medical Center US United States (USA) (US) Swedish Medical Center US United States (USA) (US) Barts Health NHS Trust GB United Kingdom (GB) University of California, San Diego US United States (USA) (US)

How to cite

APA:

Mease, P.J., Kavanaugh, A., Reimold, A., Tahir, H., Rech, J., Hall, S.,... Pricop, L. (2018). Secukinumab in the treatment of psoriatic arthritis: Efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial. RMD Open, 4(2). https://doi.org/10.1136/rmdopen-2018-000723

MLA:

Mease, Philip J., et al. "Secukinumab in the treatment of psoriatic arthritis: Efficacy and safety results through 3 years from the year 1 extension of the randomised phase III FUTURE 1 trial." RMD Open 4.2 (2018).

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