Real-World Experience with Tofacitinib in IBD at a Tertiary Center

• Published in: Digestive diseases and sciences 2019-07, Vol.64 (7), p.1945-1951
• Main Authors: Weisshof, Roni, Aharoni Golan, Maya, Sossenheimer, Philip H., El Jurdi, Katia, Ollech, Jacob E., Pekow, Joel, Cohen, Russel D., Sakuraba, Atsushi, Dalal, Sushila, Rubin, David T.
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adult; Adults; Biochemistry; Care and treatment; Clinical trials; Colitis - diagnosis; Colitis - drug therapy; Colitis - enzymology; Colitis - immunology; Colitis, Ulcerative - diagnosis; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - enzymology; Colitis, Ulcerative - immunology; Cytokines; Drug Administration Schedule; Endoscopy; Family medical history; FDA approval; Female; Gastroenterology; Health aspects; Hepatology; Humans; Infections; Inflammatory bowel disease; Janus Kinase Inhibitors - adverse effects; Janus Kinase Inhibitors - therapeutic use; Male; Medical records; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Pathogenesis; Patients; Pharmaceuticals; Piperidines - administration & dosage; Piperidines - adverse effects; Pouchitis - diagnosis; Pouchitis - drug therapy; Pouchitis - enzymology; Pouchitis - immunology; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Pyrroles - administration & dosage; Pyrroles - adverse effects; Remission Induction; Retrospective Studies; Rheumatoid arthritis; Systematic review; Tertiary Care Centers; Time Factors; Tofacitinib; Transplant Surgery; Treatment Outcome; Tumor necrosis factor-TNF; Ulcerative colitis; Work experience
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-019-05492-y

Background and Aims Many inflammatory bowel disease (IBD) patients do not respond to medical therapy. Tofacitinib is a first-in-class, partially selective inhibitor of Janus kinase, recently approved for treating patients with ulcerative colitis (UC). We describe our experience with the use of tofacitinib for treatment of patients with moderate-to-severe IBD. Methods This is a retrospective, observational study of the use of tofacitinib in IBD. Patients with medically resistant IBD were treated orally with 5 mg or 10 mg twice daily. Clinical response and adverse events were assessed at 8, 26, and 52 weeks. Objective response was assessed endoscopically, radiologically, and biochemically. Results 58 patients (53 UC, 4 Crohn’s, 1 pouchitis) completed at least 8 weeks of treatment with tofacitinib. 93% of the patients previously failed treatment with anti-TNF. At 8 weeks of treatment, 21 patients (36%) achieved a clinical response, and 19 (33%) achieved clinical remission. Steroid-free remission at 8 weeks was achieved in 15 patients (26%). Of the 48 patients followed for 26 weeks, 21% had clinical, steroid-free remission. Of the 26 patients followed for 12 months, 27% were in clinical, steroid-free remission. Twelve episodes of systemic infections were noted, mostly while on concomitant steroids. One episode of herpes zoster infection was noted during follow-up. Conclusions In this cohort of patients with moderate-to-severe, anti-TNF resistant IBD, tofacitinib induced clinical response in 69% of the patients. 27% were in clinical, steroid-free remission by 1 year of treatment. Tofacitinib is an effective therapeutic option for this challenging patient population.