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

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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.

Original languageEnglish (US)
Article numbere000723
JournalRMD Open
Volume4
Issue number2
DOIs
StatePublished - Aug 1 2018

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Keywords

  • biological therapy
  • IL-17A
  • psoriatic arthritis
  • radiography
  • secukinumab

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Mease, P. J., Kavanaugh, A., Reimold, A., Tahir, H., Rech, J., Hall, S., Geusens, P., Pellet, P., Delicha, E. M., Mpofu, 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), [e000723]. https://doi.org/10.1136/rmdopen-2018-000723