✓ Translated by DotMD AI Clinical Council Source: Journal of the American Academy of Dermatology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39592058 ↗

Phase III Randomized Trial: A randomized phase III study to compare efficacy and safety of BAT2206 (proposed ustekinumab biosimilar) with reference ustekinumab in patients with moderate to severe plaque psoriasis (N = 278)

Original Paper Title: “A randomized phase III study to compare efficacy and safety of BAT2206 (proposed ustekinumab biosimilar) with reference ustekinumab in patients with moderate to severe plaque psoriasis”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 278
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • BAT2206 and UST were comparable in terms of efficacy, safety, pharmacokinetics, and immunogenicity.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of the American Academy of Dermatology (N = 278 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of the American Academy of Dermatology (2025), this phase iii randomized trial evaluating 278 human participants investigated: BAT2206 is a proposed biosimilar to reference ustekinumab (UST; Stelara). Key clinical takeaway: BAT2206 and UST were comparable in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of the American Academy of Dermatology, 2025-04-15; N = 278; Rigor 93/100): BAT2206 and UST were comparable in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: ustekinumab → Rx: severe-congestion-and-cough-max-dextromethorphan-hbr-guaifenesin → Rx: night-time-severe-cold-and-cough-relief-acetaminophen-diphenhydramine → Condition: dietary-proteins → Condition: fifth-disease →
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