Abstract
Objective:
The objective of the study is to analyze the pharmacology, efficacy, and safety of ustekinumab-ttwe in the treatment of moderate-to-severe plaque psoriasis.
Data Sources:
PubMed, Embase, and ClinicalTrials.gov were searched using the following search terms: ustekinumab, biosimilar, ustekinumab-ttwe, Pyzchiva, SB17, and psoriasis.
Study Selection and Data Extraction:
Articles published in English between January 9, 2015, and June 21, 2025, related to the pharmacology, pharmacokinetics, efficacy, safety, immunogenicity, and clinical trials were reviewed.
Data Synthesis:
Search results from PubMed and EMBASE yielded 259 articles, and 12 studies from Clinicaltrials.gov. Only 2 clinical trials of ustekinumb-ttwe’s use in psoriasis were identified and were included in analysis. The pharmacokinetic parameters of ustekinumab-ttwe (SB17), European Union-sourced ustekinumab (EU-UST) and United States-sourced ustekinumab (US-UST) were similar in its phase I trial. In addition, a phase III trial comparing the efficacy of ustekinumab-ttwe to ustekinumab showed that the difference of percent change from baseline of the Psoriasis Area and Severity Index (PASI) score between the 2 groups was comparable with a change of 85.7% for ustekinumab-ttwe (95% confidence interval [CI] = [–3.78, 2,58]) and 86.4% for ustekinumab (90% CI = [–3.34, 1.93]).
Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:
The pharmacology, pharmacokinetics, efficacy, safety, and immunogenicity of ustekinumab-ttwe and reference ustekinumab were equivalent, demonstrating its role as a biosimilar. There are no current clinical trials directly comparing ustekinumab-ttwe with ustekinumab’s other biosimilars.
Conclusion:
Ustekinumab-ttwe’s equivalence to its reference biologic ustekinumab creates another treatment option for patients with moderate- to- severe plaque psoriasis.
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