Efficacy and Safety of CT-P43, a Candidate Ustekinumab Biosimilar, in Moderate-to-Severe Plaque Psoriasis: 52-Week Results From a Randomised, Active-Controlled, Double-Blind, Phase III Study

Abstract

Equivalent efficacy—mean per cent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week (W) 12 (primary endpoint)—was demonstrated between CT-P43, a candidate ustekinumab biosimilar, and reference ustekinumab. This study further evaluated the efficacy, pharmacokinetics, safety and immunogenicity of CT-P43 vs. reference ustekinumab, including after switching to CT-P43 from reference ustekinumab, in patients with moderate-to-severe plaque psoriasis. In this double-blind Phase III trial, patients were randomised (1:1) to treatment with subcutaneous CT-P43 or reference ustekinumab (45/90 mg [baseline body weight ≤ 100/> 100 kg]). At W16, patients receiving reference ustekinumab were re-randomised (1:1) to either continue this treatment or switch to CT-P43; CT-P43-treated patients continued CT-P43. Study medication was administered at W16 (after re-randomisation), W28 and W40. Secondary efficacy endpoints, pharmacokinetics, safety and immunogenicity were evaluated until W52. At W16, 502 patients were re-randomised (n = 253 continued receiving CT-P43; n = 125 continued receiving reference ustekinumab; n = 124 switched to CT-P43). Mean (standard deviation) PASI scores at W52 were similar across groups (continuing CT-P43: 1.44 [2.921]; continuing reference ustekinumab: 1.33 [3.070]; switched: 1.93 [2.966]). At W52, similar proportions of patients continuing CT-P43, continuing reference ustekinumab and switching achieved ≥ 75% improvement in PASI score (n = 226 [89.3%], 116 [92.8%] and 111 [89.5%]), static Physician’s Global Assessment score of 0/1 (n = 215 [85.0%], 110 [88.0%] and 96 [77.4%]) and Dermatology Life Quality Index score of 0/1 (n = 150 [59.3%], 67 [53.6%] and 78 [62.9%]). Serum ustekinumab concentrations were comparable across groups. Proportions of patients experiencing treatment-emergent adverse events (TEAEs) were similar across groups; study medication–related TEAEs occurred in 14 (5.5%), 8 (6.4%) and 12 (9.7%) patients continuing CT-P43, continuing reference ustekinumab and switching, respectively. Switching did not increase antidrug antibody positivity. Results support the comparability of CT-P43 to reference ustekinumab. Efficacy was maintained after switching to CT-P43 from reference ustekinumab, without notable safety or immunogenicity findings.

Trial Registration: ClinicalTrials.gov identifier: NCT04673786