ArticleAlimentary pharmacology & therapeutics2021
The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme.
Article in Alimentary pharmacology & therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Systematic Review: The Impact and Importance of Body Composition in Inflammatory Bowel Disease.Journal of Crohn's & colitis · 2022Pooled it
- Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme.Journal of Crohn's & colitis · 2023Trial
- Trial
- Impact of baseline body mass index on the efficacy and safety of tofacitinib in patients with psoriatic arthritis.RMD open · 2021Trial
- Body mass index and baricitinib treatment effect in hospitalized adults with COVID-19: A secondary analysis of ACTT-2.Heart & lung : the journal of critical careTrial
- Metabolic Disorders and Inflammatory Bowel Diseases: Unraveling Shared Pathways and Clinical Interactions.Metabolites · 2026Review
- JAK Inhibitors in Atopic Dermatitis: Does Weight Matter? A Real-World, Nationwide Retrospective Study: IL-AD (Italian Landscape Atopic Dermatitis).Dermatology and therapy · 2025Article
- Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials.Rheumatology and therapy · 2025Article
- Obesity and Chronic Inflammation: Implications for Rheumatoid Arthritis, Spondyloarthritis, and Ulcerative Colitis.Immunity, inflammation and disease · 2025Review
- Clinical and Endoscopic Outcomes Through 78 Weeks of Tofacitinib Therapy for Ulcerative Colitis in a US Cohort.Inflammatory bowel diseases · 2024Article
- Impact of Obesity and Metabolic Syndrome on IBD Outcomes.Digestive diseases and sciences · 2024Review
- Assessing anorectal function in patients with recurrent ulcerative colitis.International journal of colorectal disease · 2024Article
- Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting.Inflammatory bowel diseases · 2023Article
- Iranian Consensus Guideline for Pharmacotherapy with Biologics and Small Molecules Drugs in Adults with Inflammatory Bowel Diseases.Middle East journal of digestive diseases · 2023Article
- Obesity and novel management of inflammatory bowel disease.World journal of gastroenterology · 2023Review
- Article
- The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme.Alimentary pharmacology & therapeutics · 2021Article
- Tools for managing IBD in obese patients: Get JAK in the box!Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology AssociationArticle
Corrections and comments
- Commented on by
Authors and funding
8 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundObesity may affect efficacy and safety of biologic treatments for ulcerative colitis (UC). Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of UC.
aimsTo assess efficacy and safety of tofacitinib in patients with UC, by baseline body mass index (BMI).
methodsThis post hoc analysis evaluated patients with UC receiving placebo or tofacitinib from the 8-week OCTAVE Induction 1 and 2 (NCT01465763, NCT01458951) and 52-week OCTAVE Sustain (NCT01458574) studies. Patients were stratified by BMI at OCTAVE Induction 1 and 2 baseline (<25, 25 to <30 and ≥30 kg/m
resultsAt Week 8 of OCTAVE Induction 1 and 2, and Week 52 of OCTAVE Sustain, higher proportions of patients receiving tofacitinib 5 or 10 mg twice daily (b.d.) achieved clinical response vs placebo, regardless of baseline BMI subgroup (all P < 0.05). Proportions of patients achieving efficacy endpoints were generally similar across BMI subgroups; in univariate and multivariate regression analyses, BMI was not a significant predictor (all P ≥ 0.05; univariate BMI [continuous] odds ratio for remission: 0.98 [95% confidence interval 0.95, 1.02]). There was no consistent trend between BMI and adverse events. Among patients receiving tofacitinib 10 mg b.d. in OCTAVE Induction 1 and 2, serious infections were numerically greater in the BMI ≥30 subgroup (3.2%) vs other subgroups (0.4%). Limitations included small patient numbers in the BMI ≥30 subgroup.
conclusionsEfficacy and safety of tofacitinib were similar in patients with UC regardless of baseline BMI.
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What OpenQuestion holds
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 OpenQuestion graph.