SynthesisPharmacology2026
Tocilizumab Biosimilars versus Reference Tocilizumab in Rheumatoid Arthritis: A Meta-Analysis of Pharmacokinetic Biosimilarity, Efficacy, Safety, and Immunogenicity.
Synthesis in Pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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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Abstract
<p>Introduction: The aim of the study was to systematically evaluate the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of tocilizumab biosimilars compared to reference tocilizumab (r-TCZ) in patients with rheumatoid arthritis (RA) and healthy volunteers.
methodsWe searched PubMed, Embase, and Cochrane CENTRAL for phase I and III randomized controlled trials (RCTs) comparing tocilizumab biosimilars vs. r-TCZ. Primary outcomes included change from baseline in DAS28-ESR, ACR20/50/70 response rates, adverse events (AEs), serious AEs (SAEs), anti-drug antibody (ADA) positivity, and PK parameters (AUC
resultsEight studies met the inclusion criteria, comprising 3 phase III RCTs (n = 1,696 RA patients) and 5 phase I RCTs (n = 1,363 healthy volunteers), for a total of 3,059 participants. In RA patients, biosimilars demonstrated equivalent efficacy to r-TCZ at week 24, with no significant differences in DAS28-ESR change (MD -0.06; 95% CI: -0.19 to 0.06; I2 = 0%) or ACR20 response rates (RR 1.03; 95% CI: 0.96-1.10; I2 = 0). Results for ACR50 and ACR70 were similarly balanced. Safety profiles were comparable (any AE: RR 1.01; 95% CI: 0.94-1.08), as was immunogenicity (ADA positivity: RR 1.28; 95% CI: 0.99-1.65). In healthy volunteers, PK biosimilarity was confirmed across intravenous and subcutaneous routes with pooled GMRs (90% CI) of 104.5% (101.2-107.9%) for AUC
conclusionTocilizumab biosimilars exhibit therapeutic similarity in RA patients and pharmacokinetic biosimilarity in healthy volunteers compared to r-TCZ, with comparable safety and immunogenicity, supporting their use as credible, cost-effective alternatives in clinical practice. </p>.
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