McInnes IB, et al. – The long–term efficacy, safety, and tolerability of secukinumab were examined up to 104 weeks in patients with active psoriatic arthritis (PsA). Outcomes confirmed that in these patients, secukinumab offered sustained improvements in signs and symptom. Moreover, this therapy was well tolerated, with a consistent safety profile as reported previously.

Methods

• In this study, patients with PsA (n = 397) were randomized to s.c. secukinumab 300, 150 or 75 mg or placebo at baseline, weeks 1, 2, 3 and 4 and every 4 weeks thereafter.
• Placebo–treated patients were re–randomized to receive secukinumab 300 or 150 mg s.c. from week 16 (placebo non–responders) or week 24 (placebo responders).
• Exploratory endpoints at week 104 included 20, 50 and 70% improvement in ACR criteria (ACR20, 50, 70); 75 and 90% improvement in the Psoriasis Area Severity Index, 28–joint DAS with CRP, presence of dactylitis and enthesitis and other patient–reported outcomes.
• For binary variables, missing values were imputed.
• By a mixed–effects model for repeated measures, continuous variables were analyzed.

Results

• A total of 86/100 (86%), 76/100 (76%) and 65/99 (66%) patients in the secukinumab 300, 150 and 75 mg groups, respectively, completed 104 weeks.
• ACR20 response rates after multiple imputation in the 300, 150 and 75 mg groups were 69.4, 64.4 and 50.3%, respectively, at week 104.
• Sustained clinical improvements were observed through week 104 with secukinumab across other clinically important domains of PsA.
• Regardless of prior anti–TNF–α use, responses were sustained through week 104.
• Over the entire treatment period the incidence, type and severity of adverse events were consistent with those reported previously.