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

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.

Keywords: IL-17A; biological therapy; psoriatic arthritis; radiography; secukinumab.

Conflict of interest statement

Competing interests: PJM has received research grants from AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN, and UCB; consulting fees from AbbVie, Amgen, BMS, Celgene, Covagen, Crescendo, Janssen, LEO, Lilly, Merck, Novartis, Pfizer, SUN and UCB; and speakers’ bureau fees for AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Pfizer and UCB. AK served as consultant for Novartis. AR has received research grants from Janssen, Novartis, Pfizer and AbbVie; and consulting fees from Lilly. HT served as consultant or participation in advisory boards for AbbVie, Novartis, Pfizer, UCB, Eli-Lilly, Janssen Education Grants, Novartis and Pfizer. JR received speaker fees from AbbVie, AstraZeneca, Biogen, BMS, Celgene, Chugai, GSK, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi Aventis and UCB; consulting fees from AbbVie, AstraZeneca, Biogen, BMS, Chugai, MSD, Novartis, Pfizer, Roche, Sanofi Aventis and UCB. PG participated in clinical studies, advisory boards, received speaker’s fees from Abbott, Amgen, BMS, Lilly, MSD, Novartis, Pfizer, Roche, UCB and Will-Pharma. PP is an employee of Novartis with Novartis stock. EMD is an employee of Novartis. SM is an employee of Novartis, with Novartis stock. LP is an employee of Novartis with Novartis stock.

Figures

Figure 1

Patient disposition up to week 156. FAS, full analysis set; n, number of patients; SC, subcutaneous.

Figure 2

(A) ACR20/ACR50 response rates through week 156 in all patients originally randomised to secukinumab. (B) ACR20 response rates through week 156 in anti-TNF-nave and anti-TNF-experienced patients. Multiple imputation applied to missing variables through week 156. ACR, American College of Rheumatology; IV, intravenous; n, number of patients; SC, subcutaneous; TNF, tumour necrosis factor.