In a pre-specified subgroup analysis of the phase3b EXCEED trial, patients with psoriatic arthritis achieved higher responses with secukinumab compared with adalimumab in simultaneous improvement of joint and skin disease (i.e. combined ACR50 and PASI 100 response) and in skin specific endpoints (i.e. PASI 100 and PASI score ≤3) at week 52 [1].
In a previous head-to-head trial versus etanercept, secukinumab has shown to achieve significantly greater PASI 75/100 responses in patients with moderate-to-severe plaque psoriasis [2]. In the EXCEED study, researchers aimed to investigate whether secukinumab is superior to adalimumab as monotherapy in biologic-naïve patients with psoriatic arthritis with active plaque psoriasis, which was defined as having at least 1 psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis [1].
The study presented by Prof. Alice Gottlieb (Mount Sinai Hospital, New York, USA) reported the pre-specified skin outcomes from the EXCEED study in the subset of patients with at least 3% body surface area (BSA) affected with psoriasis at baseline. This was a head-to-head, phase-3b, randomised, double-blind, active-controlled, multicentre, parallel-group trial. The primary endpoint of the study was superiority of secukinumab versus adalimumab on ACR20 response at week 52. Pre-specified outcomes included the proportion of patients who achieved a combined ACR50 and PASI 100 response, PASI 100 response, and absolute PASI score ≤3. Participants (n=853) were randomised to receive secukinumab 300 mg subcutaneous in week 1-4, followed by dosing every 4 weeks until week 48 (n=426) or adalimumab 40 mg subcutaneous every 2 weeks until week 50 (n=427). At baseline, 215 patients in the secukinumab group and 202 patients in the adalimumab group had at least 3% BSA affected with psoriasis.
The results showed that 30.7% of patients who were treated with secukinumab achieved simultaneous improvement in ACR50 and PASI 100 response versus 19.2% of patients who received adalimumab (P=0.0087). Higher efficacy was demonstrated for secukinumab compared with adalimumab for PASI 100 responses and for the proportion of patients who achieved absolute PASI score ≤3.
Sources:
1. Gottlieb AB, et al. Comparison of secukinumab versus adalimumab efficacy on skin outcomes in psoriatic arthritis: 52-week results from the EXCEED study. Abstract 0340. EULAR E-Congress, 3-6 June 2020.
2. Langley RG, et al. Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials N Engl J Med. 2014;371:326-38.