L. Spelman,, P.H. Pinto, R. Rivera, A. Blauvelt, D. Thaci, J.O. Vigueras
Introduction: Obesity is a frequent comorbidity in patients with psoriasis. In the CLEAR study, secukinumab, an antiIL-17A monoclonal antibody, demonstrated superior PASI90, PASI75, PASI100 and IGA mod 2011 responses at 16 weeks when compared to ustekinumab, in patients with moderate to severe plaque psoriasis. Here we present an analysis of these responses in the subgroup of patients with a body weight >100 kg.
Materials and Methods: A total of 676 patients were randomized to either secukinumab 300 mg or ustekinumab 45 or 90 mg (45 mg in patients ≤100 kg and 90 mg in patients >100 kg). The randomization was stratiﬁed by body weight (≤100 or >100 kg). PASI90 (primary endpoint), PASI75, PASI100 and IGA mod2011 (IGA) were analyzed in the ﬁrst 16 weeks of the study for the >100 kg subgroup. Missing values were assigned as non-responders for all patients included in this pre-planned analysis.
Results: Patients with a body weight >100 kg at baseline (n = 78 for secukinumab and n = 83 for ustekinumab), had PASI90, PASI75, PASI100 and IGA responses at week 16 of 64.1%, 84.6%, 30.8% and 73.1% with secukinumab 300 mg and 48.2%, 80.7%, 14.5% and 60.2% with ustekinumab 90 mg, respectively. In this subgroup, secukinumab 300 mg demonstrated a signiﬁcantly higher PASI90 response at week 16 compared with ustekinumab 90 mg (p = 0.042). Secukinumab also demonstrated a statistically signiﬁcantly higher PASI75 and IGA response at week4 (p = 0.021 and p = 0.003) and PASI100 at week16 (p = 0.013).
Conclusion: Secukinumab 300 mg demonstrated a clinically and statistically signiﬁcantly higher efﬁcacy (PASI90 at week16) than ustekinumab 90 mg in patients with a body weight over 100 kg.