SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026
Ustekinumab Biosimilars versus Reference Ustekinumab for Moderate-to-Severe Plaque Psoriasis: A Pre-switch Systematic Review and Meta-analysis.
Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
9 authors.
Funding
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Abstract
backgroundUstekinumab biosimilars have expanded treatment options for moderate-to-severe plaque psoriasis, but pooled evidence is needed to determine whether they achieve therapeutic equivalence to reference ustekinumab during the initial randomized comparative period before protocol-defined switching.
objectivesThe aim of this systematic review was to assess the therapeutic equivalence of ustekinumab biosimilars versus reference ustekinumab during the pre-switch period in adults with moderate-to-severe plaque psoriasis.
methodsWe searched PubMed, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and trial registries from inception to 15 October 2025 for phase III randomized clinical trials comparing ustekinumab biosimilars or follow-on biologics with reference ustekinumab and reporting comparative data before switching. Data were extracted independently by two reviewers. Risk of bias was assessed using the Risk of Bias 2 (RoB 2) tool, and certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Random-effects meta-analysis with Hartung-Knapp-Sidik-Jonkman 95% confidence intervals (CIs) was performed. The primary outcome was 75% improvement in Psoriasis Area and Severity Index (PASI 75) response at week 12, analyzed using risk differences with a prespecified equivalence margin of ± 10%.
resultsNine randomized trials including 4532 participants were analyzed. At week 12, the pooled risk difference for PASI 75 was 0.02 (95% CI -0.02 to 0.05), meeting the prespecified ± 10% equivalence criterion, with low between-study heterogeneity (I
conclusionsDuring the initial randomized comparative period, ustekinumab biosimilars met prespecified therapeutic equivalence criteria for PASI 75 and showed equivalence-consistent results for PASI 90 and PASI 100, with comparable short-term safety versus reference ustekinumab. These findings provide pooled reassurance across standard and stringent skin-clearance outcomes during a clinically relevant early treatment window. REGISTRATION: PROSPERO (CRD420251166323). Registered October 12, 2025.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.