Self-administration of subcutaneous secukinumab by autoinjector resulted in sustained improvements at 52 weeks across multiple clinical domains in patients with active psoriatic arthritis (PsA), according to the randomized, placebo-controlled FUTURE 3 study (ClinicalTrials.gov identifier: NCT01989468), published in Arthritis Research & Therapy.
Peter Nash, MD, associate professor in the Department of Medicine, University of Queensland, Brisbane, Australia, and colleagues conducted a 52-week efficacy and safety study of secukinumab administered by autoinjector in 414 patients with active PsA.
Patients were randomly assigned to receive subcutaneous secukinumab 300 mg, 150 mg, or placebo at baseline; at 1, 2, 3, and 4 weeks; and every 4 weeks thereafter. Placebo-treated patients were re-randomized to receive subcutaneous secukinumab 300 or 150 mg at 16 weeks for nonresponders or at 24 weeks for responders. Participants were stratified at randomization by prior anti-tumor necrosis factor therapy. The primary endpoint was the proportion of patients achieving at least a 20% improvement in American College of Rheumatology response criteria (ACR20) at 24 weeks. Autoinjector usability was evaluated by the Self-Injection Assessment Questionnaire (SIAQ).
Most of the patients completed 24 weeks of therapy, including 92.1% of the 300-mg secukinumab group, 91.3% of the 150-mg group, and 93.4% of the placebo group, whereas 84.9% and 79.7% of the 300- and 150-mg secukinumab groups, respectively, completed 52 weeks of therapy. In the overall population, ACR20 response rate at 24 weeks was significantly higher in the secukinumab groups compared with the placebo groups. Participants receiving 300 mg had an ACR20 response rate of 48.2% (P <.0001), whereas those receiving 150 mg had a response rate of 42% (P <.0001) compared with a response rate of 16.1% in the placebo group. Response was sustained through 52 weeks. Results from the SIAQ showed that 93% of patients were satisfied or very satisfied with autoinjector usage.
The authors note that the study was not designed to detect differences between the doses. Another limitation was that the long-term efficacy and safety of secukinumab compared with placebo could not be determined, as patients receiving placebo had to be given rescue medication after a short period. Secukinumab was well tolerated, and the safety profile was consistent with previous reports.
Nash P, Mease PJ, McInnes IB, et al. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3) [published online March 15, 2018]. Arthritis Res Ther. doi: 10.1186/s13075-018-1551-x