A phase 3, randomized, double-blind, active-controlled clinical study to compare BAT2206, a ustekinumab biosimilar, with ustekinumab reference product in patients with moderate-to-severe psoriasis: Treatment period 2 results (post Week 28 to Week 52) - 19/11/25
Abstract |
Background |
BAT2206 is being developed as a ustekinumab (UST) biosimilar.
Objectives |
Equivalent efficacy and comparable safety results of BAT2206 and UST in patients with moderate-to-severe psoriasis up to Week 28 (treatment period [TP] 1) have been reported previously. TP2 (post Week 28 to 52) results are presented here.
Methods |
Patients achieving Psoriasis Area and Severity Index response (≥75) at Week 28 entered TP2. Qualified patients of the UST group in TP1 were re-randomized 1:1 into UST-BAT2206 or UST-UST groups, while qualified patients of the BAT2206 group continued with BAT2206 (BAT2206-BAT2206 group). In TP2, secondary efficacy endpoints, pharmacokinetics, safety, and immunogenicity were assessed at Week 32, 40, 44, and 52.
Results |
A total of 528 patients entered TP2, of which 133, 131, and 264 were assigned to UST-UST, UST-BAT2206, and BAT2206-BAT2206 groups, respectively. The secondary efficacy endpoints and the adverse events showed no obvious differences across all 3 groups. There were no notable differences in the UST serum concentrations. Immunogenicity was comparable, and the switching from UST to BAT2206 did not lead to an increased immunogenicity.
Limitations |
No data collected after Week 52.
Conclusion |
Outcomes were comparable among the groups in TP2, with no impact from the UST-to-BAT2206 switch.
Il testo completo di questo articolo è disponibile in PDF.Key words : biosimilar, psoriasis, randomized, treatment switching, ustekinumab
Abbreviations used : ADA, AE, BSA, CfB, DLQI, IL, NAb, PASI, PK, SAF2, sPGA, TEAE, TP, UST
Mappa
| Funding sources: None. |
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| Patient consent: All patients provided written informed consent before the study was initiated. |
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| IRB approval status: Ethics approval was received from each national central or local ethical committee or institutional review board. |
Vol 93 - N° 6
P. 1448-1455 - dicembre 2025 Ritorno al numero
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