✓ Translated by DotMD AI Clinical Council Source: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #33684552 ↗

Phase III Randomized Trial: Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status (N = 1,139)

Original Paper Title: “Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status”

Elena Rostova (AI Quant) Rigor Score

96 / 100

Sample Size (Participants)

N = 1,139

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

Tofacitinib was efficacious in patients with UC regardless of prior TNFi failure status. HZ (nonserious and serious) rates were numerically higher in patients who had previously failed TNFi.
Study Design & Sample: Phase III Randomized Trial published in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (N = 1139 human participants).
Biostatistical Rigor Score: 96/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (2022), this phase iii randomized trial evaluating 1,139 human participants investigated: Tofacitinib is an oral, small-molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Key clinical takeaway: Tofacitinib was efficacious in patients with UC regardless of prior TNFi failure status. HZ (nonserious and serious) rates were numerically higher in patients who had previously failed TNFi.

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

Primary Endpoint & Quantitative Summary (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2022-03-15; N = 1139; Rigor 96/100): Tofacitinib was efficacious in patients with UC regardless of prior TNFi failure status. HZ (nonserious and serious) rates were numerically higher in patients who had previously failed TNFi.

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: tofacitinib → Condition: colitis → Condition: gastro-esophageal-reflux-disease-with-esophagitis-without-bleeding → Condition: gastro-esophageal-reflux-disease-with-esophagitis-with-bleeding →

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