BAT2306 shows comparable efficacy and safety to secukinumab in moderate-to-severe plaque psoriasisTrial shows BAT2306 performs similarly to secukinumab for plaque psoriasis

BACKGROUND: Secukinumab is licensed for the treatment of moderate-to-severe plaque psoriasis in adults. BAT2306 is a proposed biosimilar to reference secukinumab. We aimed to compare the safety, efficacy, pharmacokinetics, and immunogenicity of BAT2306 with secukinumab in patients with moderate-to-severe plaque psoriasis. METHODS: We did a multicentre, double-blind, randomised, active-controlled, phase 3 trial at 49 sites in four countries. Eligible patients were 18 years or older with a diagnosis of moderate-to-severe plaque-type psoriasis. Patients were randomly assigned (1:1) to receive either 300 mg BAT2306 or secukinumab subcutaneously at weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks up to week 40. After the initial 24-week treatment period (ie, treatment period one) eligible patients in the BAT2306 group continued with BAT2306 (BAT2306-BAT2306 group) in the second 28-week treatment period (ie, treatment period two), whereas eligible patients in the secukinumab group were re-randomly assigned (1:1) to receive either secukinumab (secukinumab-secukinumab group) or BAT2306 (secukinumab-BAT2306 group) during treatment period two. The primary endpoint was to determine equivalent efficacy of BAT2306 and secukinumab by measuring the percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score to week 8 (as per the European Medicines Agency [EMA] requirements) or to week 12 (as per the US Food and Drug Administration [FDA] and the China National Medical Products Administration [NMPA] requirements) using prespecified equivalence margins (95% CI -13 to 13 [EMA and NMPA] and 90% CI -12 to 10 [FDA]). The safety endpoints were assessed from baseline to week 52. Individuals with lived experience were not involved in the design of this study. This study is registered with ClinicalTrials.gov, NCT05377944, and is completed. FINDINGS: Between Oct 13, 2022, and May 24, 2024, a total of 502 patients were randomly allocated: 252 (50%) to the BAT2306 group and 250 (50%) to the secukinumab group in treatment period one. Of 474 patients entering treatment period two, 118 (25%) patients were assigned to the secukinumab-secukinumab group, 113 (24%) to the secukinumab-BAT2306 group, and 243 (51%) to the BAT2306-BAT2306 group. Mean age was 44·5 years (SD 13·8), 359 (72%) of 502 patients were male, 143 (28%) were female, and 325 (65%) were Asian. The primary endpoint of the study was met. The percentage change from baseline in PASI scores was similar across the BAT2306 and secukinumab groups with a least square mean difference of 1·549 (95% CI of -0·954 to 4·051) at week 8, and -0·349 (90% CI of -2·221 to 1·523 and 95% CI -2·579 to 1·881) at week 12, which were within the equivalence margins set by EMA, FDA, and NMPA, respectively. Comparable safety, pharmacokinetic and immunogenicity profiles were observed for BAT2306 and secukinumab. 375 (75%) of 502 patients had 1452 treatment-emergent adverse events during the study. The most common treatment-emergent adverse events were upper respiratory tract infections and nasopharyngitis. INTERPRETATION: BAT2306 showed comparable efficacy and safety profiles to those of secukinumab. Switching from secukinumab to BAT2306 did not affect outcomes, supporting BAT2306 as a biosimilar option to improve treatment accessibility. FUNDING: Bio-Thera Solutions.