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Introduction: SB17 is a biosimilar to reference ustekinumab (UST). We compared the efficacy, safety, and immunogenicity of SB17 to UST up to Week 52, including switching from UST to SB17., Methods: Subjects were randomized to receive 45 mg of SB17 or UST subcutaneously up to Week 40. At Week 28, subjects from the UST treatment group were re-randomized to either switch to SB17 or continue UST. Efficacy, safety, and immunogenicity were assessed up to Week 52., Results: Among baseline randomized 503 subjects, 481 subjects were re-randomized at Week 28; continuing SB17 (SB17 + SB17, n  = 237), switching from UST to SB17 (UST+SB17, n  = 122) or continuing UST (UST+UST, n  = 122). The percent change from baseline in Psoriasis Area and Severity Index (PASI) was comparable between treatment groups up to Week 52 (SB17 + SB17: 95.8%, UST+SB17: 95.6%, UST+UST: 94.5% at Week 52). Other efficacy endpoints were also comparable. The incidence of treatment-emergent adverse events (SB17 + SB17: 16.5%, UST+SB17: 13.9%, UST+UST: 23.8%) and the overall incidence of anti-drug antibodies occurring after transition were comparable between treatment groups (SB17 + SB17: 5.6%, UST+SB17: 5.1%, and UST+UST: 6.7%)., Conclusion: SB17 demonstrated clinical biosimilarity to UST after switching from UST, and maintained long-term comparable efficacy and safety with UST up to Week 52.

Background: Ustekinumab (UST) is a safe and effective treatment for moderate-to-severe psoriasis., Objectives: To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed UST biosimilar SB17 with reference UST in subjects with moderate-to-severe plaque psoriasis., Methods: In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at week 0, 4, and every 12 weeks. The primary endpoint was the percent change from baseline in Psoriasis Area and Severity Index at week 12 with an equivalence margin of [-15%, 15%]. Other secondary efficacy, safety, PK, and immunogenicity endpoints were measured through week 28., Results: Two hundred forty-nine subjects were randomized to SB17, 254 to UST. Adjusted difference of Psoriasis Area and Severity Index change from baseline at week 12 of -0.6% (95% confidence interval; -3.780, 2.579) was within the equivalence margin. Physician's Global Assessment and Dermatology Life Quality Index were also comparable. Overall treatment-emergent adverse events were comparable (SB17: 48.2%, UST: 48.8%). The overall incidence of antidrug antibodies up to Week 28 was 13.3% with SB17 and 39.4% with UST., Limitations: Data were only through week 28., Conclusion: SB17 was clinically biosimilar to UST up to week 28., Competing Interests: Conflicts of interest Dr Feldman has received research, speaking, and/or consulting support from Eli Lilly and Company, GlaxoSmithKline/Stiefel, AbbVie, Janssen, Alovtech, vTv Therapeutics, Bristol-Myers Squibb, Samsung Bioepis, Pfizer, Boehringer Ingelheim, Amgen, Dermavant, Arcutis, Novartis, Novan, UCB, Helsinn, Sun Pharma, Almirall, Galderma, Leo Pharma, Mylan, Celgene, Ortho Dermatology, Menlo, Merck & Co, Qurient, Forte, Arena, Biocon, Accordant, Argenx, Sanofi, Regeneron, the National Biological Corporation, Caremark, Teladoc, BMS, Ono, Micreos, Eurofins, Informa, UpToDate, and the National Psoriasis Foundation. Dr Feldman is founder and part owner of Causa Research and holds stock in Sensal Health. Dr Narbutt is an investigator and/or lecturer for Novartis, Eli Lilly, Almirall, AbbVie, Celltrion, Pfizer, Leo Pharma, Janssen, and UCB and participated in SB17-3001 study as an investigator and received investigational grant from Samsung Bioepis. Dr Girolomoni has received personal fees from AbbVie, Abiogen, Almirall, Amgen, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Leo Pharma, Merck Serono, Novartis, Pfizer, Samsung Bioepis, and Sanofi. Drs Brzezicki, Reznichenko, Zegadlo-Myłik, Pulka, Dmowska-Stecewicz, Klujszo, Rekalov, and Rajzer participated in SB17-3001 study as an investigator and received investigator grants from Samsung Bioepis. Authors J. Lee, M. Lee, and Dr Rho are employees of Samsung Bioepis Co, Ltd and owns stocks of Samsung Biologics., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)