A randomized, double-blind, phase III study assessing clinical similarity of SB17 (proposed ustekinumab biosimilar) to reference ustekinumab in subjects with moderate-to-severe plaque psoriasis - 20/08/24
, Joanna Narbutt, MD b, Giampiero Girolomoni, MD c, Jan Brzezicki, MD, PhD d, Nataliya Reznichenko, MD, PhD e, Maria Agnieszka Zegadło-Mylik, MD f, Grazyna Pulka, MD, PhD g, Magdalena Dmowska-Stecewicz, MD h, Elżbieta Kłujszo, MD i, Dmytro Rekalov, MD j, Lidia Rajzer, MD, PhD k, Jiyoon Lee, MS l, Minkyung Lee, MS l, Young Hee Rho, MD, PhD, MPH lAbstract |
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.
Il testo completo di questo articolo è disponibile in PDF.Key words : biologics, biosimilar, psoriasis, randomized clinical trial, ustekinumab
Abbreviations used : ADA, CI, DLQI, FAS, IP, PASI, PGA, PK, PPS, TEAE, TNF, UST
Mappa
| Funding sources: This study was funded by Samsung Bioepis, Co Ltd. |
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| A portion of this manuscript has been previously presented at EADV 2023 (Abstract #1320), Berlin, Germany, October 11-14, 2023. |
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| Patient consent: Consent for the publication of recognizable patient photographs or other identifiable material was obtained by the authors and included at the time of article submission to the journal stating that all patients gave consent with the understanding that this information may be publicly available. |
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| IRB approval status: Ethics approval was received from each national central or local ethical committee or institutional review board. |
Vol 91 - N° 3
P. 440-447 - settembre 2024 Ritorno al numero
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