Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials

Objective Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). Design We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. Results 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change...
Source: Gut - Category: Gastroenterology Authors: Tags: Open access Inflammatory bowel disease Source Type: research

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ConclusionUsing the obstruction protocol in patients with bowel obstruction reduced emergency surgery and postoperative morbidity and mortality in this pilot study. This protocol seems to be a viable and efficient alternative to emergency surgery.
Source: European Journal of Surgical Oncology (EJSO) - Category: Surgery Source Type: research
Conclusions: VDZ is associated with mucosal healing in pediatric IBD. Anti-TNF exposure significantly impacted endoscopic remission, but not histologic remission in children on VDZ.
Source: Journal of Pediatric Gastroenterology and Nutrition - Category: Gastroenterology Tags: Original Articles: Gastroenterology: Inflammatory Bowel Disease Source Type: research
Objective: Infliximab (IFX) is a frequent therapeutic option for Crohn disease (CD) patients. Early detection of responders to IFX is critical for the management of CD in order to avoid long-term exposure to the drug without benefit. This retrospective study aimed at analysing which early parameters recorded during the induction period are able to predict response to IFX during the maintenance period in pediatric CD. Patients and Methods: Medical records of all CD patients ages from 2 to 18 years who received IFX at a tertiary IBD center were retrospectively analyzed. Children were classified in 3 groups according to ...
Source: Journal of Pediatric Gastroenterology and Nutrition - Category: Gastroenterology Tags: Original Articles: Gastroenterology: Inflammatory Bowel Disease Source Type: research
Conclusions: The present study explores the prevalence and presentation of perfectionism in a sample of adolescents with IBD. Results suggest dimensions of perfectionism are differentially associated with psychosocial and disease management outcomes, suggesting further evidence of the relationship between perfectionism, maladaptive coping, and subsequent influences on health outcomes in the context of pediatric chronic illness.
Source: Journal of Pediatric Gastroenterology and Nutrition - Category: Gastroenterology Tags: Original Articles: Gastroenterology: Inflammatory Bowel Disease Source Type: research
Authors: Yue Ying C, Jun S, Yu Fan W, Hua RZ Abstract Introduction: Anemia is a common extraintestinal complication of Crohn's disease (CD) mainly caused by iron deficiency and, affects the quality of life of CD patients. In recent years, the etiology and pathology of iron-deficiency anemia (IDA) and anemia of chronic diseases have been elucidated. However, common biochemical parameters of iron status for the assessment of patients with anemia and CD are insufficient. Thus, novel iron indices are required for accurate assessment in CD patients with IDA. Oral iron supplementation as IDA treatment is common and assoc...
Source: Expert Review of Gastroenterology and Hepatology - Category: Gastroenterology Tags: Expert Rev Gastroenterol Hepatol Source Type: research
Hello all! This is my second post on SDN. I am a biomedical engineering pre-med who is currently in my sophomore year. I am currently in the worst semester I have ever taken in my college career. It was going well at first, but then, and I know it's really stupid, but I heard that the coronavirus was in my University, and since I have a low immune system due to Crohn's and Remicade, I began to skip a lot of classes and now I'm playing catchup. Most likely I will get a a low GPA this... Deathly worried about my future as a pre-med!
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pre-Medical - MD Source Type: forums
Epidemiological investigations have shown that smoking ameliorates ulcerative colitis (UC) but exacerbates Crohn's disease (CD), diseases that feature a Th2-mediated and Th1-mediated response, respectively. Cigarette extracts, especially nicotine, affect the Th1/Th2 balance. We previously reported that nicotine protects against mouse DSS colitis (similar to UC) by enhancing microRNA-124 (miR-124) expression. Intriguingly, elevation of miR-124 in CD is reported to aggravate the disease. Here we investigate the dual regulation of miR-124 in inflammatory bowel diseases (IBDs), which may explain the similar bidirectional regul...
Source: Frontiers in Immunology - Category: Allergy & Immunology Source Type: research
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Source: Molecular Biology Reports - Category: Molecular Biology Authors: Tags: Mol Biol Rep Source Type: research
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Source: Neuromodulation: Technology at the Neural Interface - Category: Biotechnology Authors: Tags: Clinical Research Source Type: research
Conditions:   Crohn's Disease;   Vitamin D Deficiency;   Vitamin D Supplement Intervention:   Drug: Caltrate Pill Sponsor:   Second Affiliated Hospital of Wenzhou Medical University Not yet recruiting
Source: - Category: Research Source Type: clinical trials
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