gms | German Medical Science

Background: Secukinumab (IL-17A-inhibitor) provided improvements in multiple clinical domains of PsA through 52 weeks (wks) in the Phase 3 FUTURE 1 study [1].

Objectives: To assess the long-term efficacy and safety of secukinumab in pts with PsA treated for up to 104 wks.

Methods: 606 adults with active PsA were randomised to secukinumab or PBO. Secukinumab pts received a 10 mg/kg i.v. loading dose at BL, Wks 2 and 4, followed by 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-randomised to receive secukinumab 150 or 75 mg s.c. from either Wk 16 (non-responders) or Wk 24 (responders). Clinical assessments at Wk 104 included: ACR 20/50/70, PASI 75/90, DAS28-CRP, SF-36 PCS, HAQ-DI, mTSS, dactylitis, and enthesitis.

Results: 476 pts (78.5%) completed 104 wks of study (167 [82.7%] pts in IV→150 mg group; 155 [76.7%] in IV→75 mg group). ACR 20/50/70 response rates were 66.8/39.0/22.4% with IV→150 mg and 58.6/29.7/17.6% with IV→75 mg, respectively. Sustained clinical improvements with secukinumab were observed across other clinically important domains of PsA. Responses were sustained 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 in anti-TNF-naïve pts were 75.2% and 63.7% with IV→150 mg and IV→75 mg; corresponding rates in anti-TNF-IR pts were 48.0% and 46.9%. No radiographic disease progression was observed in 84.6% of x-ray completers in the IV→150 mg and 83.9% in the IV→75 mg groups. Overall (mean exposure to secukinumab of 627.1 days) the type, incidence and severity of AEs were consistent with that reported previously. Infections and infestations were the most common AEs observed (67.9 per 100 pt-years). Malignant/unspecified tumours and major adverse cardiac events occurred at a rate of 0.6 and 0.7 per 100 pt-years, respectively.

Table 1 [Tab. 1]

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.