Background/Purpose: In the Phase 3, randomized, double-blind, placebo (PBO)-controlled, FUTURE 1 study (NCT01392326), the anti–interleukin-17A monoclonal antibody secukinumab provided rapid and significant improvements in key clinical domains of psoriatic arthritis (PsA), including signs and symptoms, joint structural damage, physical function and quality of life.¹Here, we present the long-term efficacy and safety of secukinumab in patients (pts) enrolled in FUTURE 1 and treated for up to 104 weeks (wks).

Methods: A total of 606 adults with active PsA were randomized to receive secukinumab or PBO. Secukinumab pts received a 10 mg/kg i.v. loading dose at baseline (BL), Wks 2 and 4, and then either 150 mg s.c. (IV→150 mg) or 75 mg s.c. (IV→75 mg) every 4 wks from Wk 8. PBO was given on the same dosing schedule. At Wk 16, PBO-treated pts were re-randomized to receive secukinumab 150 or 75 mg s.c. from either Wk 16 or Wk 24, based on clinical response. Assessments of clinical efficacy at Wk 104 included: ACR 20/50/70; PASI 75/90; DAS28-CRP; SF-36 PCS; HAQ-DI; mTSS. Efficacy variables are presented from those pts originally randomized to secukinumab. Wk 104 data are as observed.

Results: 476 pts (78.5%) completed 104 wks of study (167 [82.7%] pts in the IV→150 mg group and 155 [76.7%] in the IV→75 mg group). At Wk 104, ACR 20/50/70 response rates were 73.9/46.4/28.1% with IV→150 mg and 68.8/35.5/22.5% with IV→75 mg (observed data). Sustained clinical improvements with secukinumab through Wk 104 were observed across several other clinically important domains of PsA (Table). Responses were sustained through Wk 104 in pts naïve to anti-TNF therapy and in those with an inadequate response or intolerance to these agents (anti-TNF-IR). ACR20 response rates (observed data) at Wk 104 in anti-TNF-naïve pts were 80.0% and 72.9% with IV→150 mg and IV→75 mg, respectively; corresponding rates in anti-TNF-IR pts were 55.3% and 54.8%.  Between BL and Wk 104, 84.6% of x-ray completers in the IV→150 mg group and 83.9% in the IV→75 mg group, had no radiographic disease progression (≤0.5 change in mTSS).  Over the entire study period (mean exposure to secukinumab of 627.1 days) the type, incidence and severity of AEs was consistent with that reported previously. Infections and infestations were the most common AE observed with secukinumab (67.9 per 100 pt-years). No cases of TB were reported. Malignant or unspecified tumors were reported at a rate of 0.3 per 100-pt years. Major adverse cardiac event rates with secukinumab were 0.7 per 100 pt-years. No suicides were recorded in secukinumab-treated patients.

Conclusion: Secukinumab provided sustained improvements in signs and symptoms and multiple clinical domains of active PsA in pts who completed 2 years of therapy. Secukinumab was well tolerated with a safety profile consistent with that previously reported.

Reference:

1. Mease P, et al. Arthritis Rheumatol. 2014;66:S423–4.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-provides-sustained-improvements-in-psoriatic-arthritis-2-year-efficacy-and-safety-results-from-a-phase-3-randomized-double-blind-placebo-controlled-trial/