Trial reportAlimentary pharmacology & therapeutics2019
Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study.
Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01470599 (A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease), which is not on this map. Cited by 21 papers.
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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 Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease
Who cites it
21 citing papers in PubMed.
- Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study.Alimentary pharmacology & therapeutics · 2019Trial
- Review
- The JAK-STAT pathway: from structural biology to cytokine engineering.Signal transduction and targeted therapy · 2024Review
- The Complex Relationship between Mechanisms Underlying Inflammatory Bowel Disease, Its Treatment, and the Risk of Lymphomas: A Comprehensive Review.International journal of molecular sciences · 2024Review
- Are All Janus Kinase Inhibitors for Inflammatory Bowel Disease the Same?Gastroenterology & hepatology · 2023Article
- Graves Disease and Inflammatory Bowel Disease: A Bidirectional Mendelian Randomization.The Journal of clinical endocrinology and metabolism · 2023Article
- JAK inhibitors: A new dawn for oral therapies in inflammatory bowel diseases.Frontiers in medicine · 2023Review
- Causal association between inflammatory bowel disease and hidradenitis suppurativa: A two-sample bidirectional Mendelian randomization study.Frontiers in immunology · 2023Article
- Mechanisms of mucosal healing: treating inflammatory bowel disease without immunosuppression?Nature reviews. Gastroenterology & hepatology · 2022Review
- Tofacitinib and newer JAK inhibitors in inflammatory bowel disease-where we are and where we are going.Drugs in context · 2022Review
- Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease.Gastroenterology & hepatology · 2022Article
- Treatment of Crohn's Disease and Concomitant Alopecia Areata With Tofacitinib.ACG case reports journal · 2021Article
- The Era of Janus Kinase Inhibitors for Inflammatory Bowel Disease Treatment.International journal of molecular sciences · 2021Review
- Real-World Effectiveness and Safety of Tofacitinib in Crohn's Disease and IBD-U: A Multicenter Study From the TROPIC Consortium.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021Article
- Small Molecule Drugs in Inflammatory Bowel Diseases.Pharmaceuticals (Basel, Switzerland) · 2021Review
- An IFN-STAT Axis Augments Tissue Damage and Inflammation in a Mouse Model of Crohn's Disease.Frontiers in medicine · 2021Article
- Differential regulation of JAK/STAT-signaling in patients with ulcerative colitis and Crohn's disease.World journal of gastroenterology · 2020Review
- JAK-STAT pathway targeting for the treatment of inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2020Review
- JAK inhibitors and infections risk: focus on herpes zoster.Therapeutic advances in musculoskeletal disease · 2020Article
- Safety of P28GST, a Protein Derived from a Schistosome Helminth Parasite, in Patients with Crohn's Disease: A Pilot Study (ACROHNEM).Journal of clinical medicine · 2019Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
backgroundTofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for inflammatory bowel disease.
aimsThis 48-week open-label extension study primarily investigated long-term safety of tofacitinib 5 and 10 mg b.d. and secondarily investigated efficacy as maintenance therapy in patients with Crohn's disease.
methodsPatients who had completed the phase 2b maintenance study, or withdrawn due to treatment failure, were enrolled. Patients in remission (Crohn's disease activity index <150) at baseline received tofacitinib 5 mg b.d.; all others received 10 mg b.d. A single dose adjustment was allowed after 8 weeks' fixed, open-label treatment.
resultsSixty-two patients received tofacitinib 5 mg b.d.; 88 received 10 mg b.d. Both groups had similar rates of adverse events and serious infections. Crohn's disease worsening was the most frequent adverse event for tofacitinib 5 (33.9%) and 10 mg b.d. (19.3%). Patients not in remission at baseline, receiving 10 mg b.d., had higher rates of serious adverse events (19.3%) and discontinuation attributed to insufficient clinical response (30.7%) vs 5 mg b.d. (8.1% and 9.7%, respectively). At week 48, of patients with baseline remission receiving 5 mg b.d., 87.9% maintained remission and 75.0% sustained remission as observed (46.8% and 38.7%, respectively, by non-responder imputation). Study design prevented between-dose efficacy comparisons.
conclusionsNo new safety signals emerged. Although both doses showed generally similar safety outcomes for overall adverse events, serious adverse events were more frequent for tofacitinib 10 than 5 mg b.d. Discontinuation due to insufficient clinical response was lower among patients in remission at baseline. ClinicalTrials.gov: NCT01470599.
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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.