Secukinumab versus adalimumab head-to-head comparison in biologic-naive patients with active psoriatic arthritis through 52-weeks (exceed): a randomised, double-blind, phase-3B study

Abstract

Background: Secukinumab (SEC), an interleukin-17A inhibitor, has demonstrated improvements on multiple domains of psoriatic arthritis (PsA).1 Adalimumab (ADA), a TNF inhibitor, is widely used as a first–line biologic in PsA.

Objectives: To report efficacy and safety outcomes from the head-to-head EXCEED trial (NCT02745080) that compares SEC vs. ADA as first–line biologic monotherapy through 52-weeks (wks), with a musculoskeletal primary endpoint in pts with active PsA.

Methods: Head-to-head, phase-3b, randomised, double-blind trial: biologic naïve active PsA pts were randomised to receive SEC 300mg subcutaneous at baseline, Wk1-4, and then every 4wks (q4w) until Wk48 or ADA 40mg subcutaneous at baseline and then q2w until Wk50. The primary endpoint was superiority of SEC vs. ADA on ACR20 response at Wk52. Binary and continuous variables were analysed using logistic-regression model and MMRM, respectively. Safety analysis included patients who received ≥1 dose of study-drug.

Results: 853 pts were randomised to receive SEC (n=426) or ADA (n=427). Baseline demographics and disease characteristics were comparable between treatment-groups except higher proportion of female pts and pts without enthesitis in the SEC group. ACR20 response at Wk52 for SEC vs. ADA were 67·4% vs. 61·5%, respectively (p=0·0719) (Figure). Higher clinical responses were observed with SEC vs. ADA for a range of musculoskeletal, skin, and higher-hurdle outcomes (Table). A higher retention rate was observed for SEC (85.7%) vs. ADA (76.3%). Safety profiles of SEC and ADA were consistent with previous reports.2,3

Conclusion: Results suggest that SEC is at least as efficacious as ADA on musculoskeletal endpoints whilst providing higher responses on skin endpoints, and is associated with a higher retention rate. No new safety signals were reported.