Background

Obesity is a common comorbidity of psoriasis and can attenuate response to biologic treatment.

Objectives

To investigate the efficacy, safety and tolerability of secukinumab 300 mg every 2 weeks (Q2W) vs. secukinumab 300 mg every 4 weeks (Q4W) in patients with a higher body weight.

Methods

In this multicentre, double-blind, parallel-group trial, 331 patients with moderate-to-severe chronic plaque psoriasis weighing ≥90 kg were randomised to receive secukinumab 300 mg Q2W or secukinumab 300 mg Q4W. Patients who did not achieve PASI90 at Week 16 on the Q4W regimen were reallocated to remain on the Q4W regimen or up-titrate to Q2W.

Results

At Week 16, Q2W dosing (N=165) led to significantly higher PASI90 responses vs. Q4W [N=166; 73.2% vs. 55.5%, one-sided p-value=0.0003, odds ratio estimate (95% confidence intervals): 2.3 (1.4, 3.8). At Week 52, higher efficacy responses were maintained in the Q2W arm (N=165) vs. Q4W (N=83); PASI75: 88.9% vs. 74.8%; PASI90: 76.4% vs. 52.4%, PASI100: 46.7% vs. 27.3%; IGA 0/1: 75.9% vs. 55.6% and DLQI 0/1: 66.1% vs. 48.8%. PASI90 non-responders at Week 16 who up-titrated to Q2W (N=31) showed higher efficacy responses at Week 32 (16 weeks post-up-titration, PASI90: 38.7% vs. 16.5%) vs. those who remained on Q4W (N=40). Safety results were comparable across treatment arms and consistent with the established secukinumab safety profile.

Conclusions

Secukinumab 300 mg Q2W demonstrated superior and sustained efficacy compared with Q4W in moderate-to-severe plaque psoriasis patients weighing ≥90 kg. PASI90 non-responders derived additional benefits from up-titration to a Q2W regimen. (NCT03504852)