Secukinumab demonstrates a consistent safety profile with up to 5 years’ treatment in patients with psoriatic arthritis and moderate-to-severe plaque psoriasis: updated pooled safety analyses

Abstract

Background: Pooled safety data from secukinumab (SEC) studies in psoriasis and psoriatic arthritis (PsA) have been reported previously. Objectives: To report updated longer-term safety data with up to 5 years of SEC treatment from psoriasis and PsA studies.

Methods: The moderate-to-severe plaque psoriasis and active PsA data pool consisted of 15 Phase 2 and 3 Phase 3 studies. Different SEC doses in the studies included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75-300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were rerandomised to SEC at 12-24 weeks depending on study design. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIR) per 100 patientyears and analyses included all patients who received ≥1 dose of SEC.

Results: A total of 5,181 and 1,380 patients from psoriasis and PsA studies representing an exposure of 10,416.9 and 3,866.9 patient-years, respectively, were included in this study. The most frequently reported AE was viral upper respiratory tract infection (Table 1). EAIRs for serious infections, Candida infections, inflammatory bowel disease and major adverse cardiac events were low and similar in both psoriasis and PsA indications (Table 1). No cases of tuberculosis were reported.

Conclusion: SEC demonstrated a favourable safety profile during long-term treatment (up to 5 years) in patients with moderate-to-severe plaque psoriasis or PsA, hence, supporting long-term use. The safety profile of SEC was consistent with previous reports and comparable across psoriasis and PsA patients.