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Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis
William J Sandborn1, Chinyu Su1, Bruce E Sands1
1From the Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla (W.J.S.); Pfizer, Collegeville, PA (C.S., W.N., G.F., N.L., D.Y., D.W., H.Z.); Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York (B.E.S.); the Department of Gastroenterology, Academic Medical Center, Amsterdam (G.R.D.); the Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium (S.V.); Department of Internal Medicine I, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (S.S.); the Inflammatory Bowel Disease Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan (S.D.); Robarts Clinical Trials, Robarts Research Institute, Western University, London (B.G.F.), and McMaster University, Hamilton (W.R.) - both in Ontario, Canada; Pfizer, Groton, CT (A.M., P.H.); and the Networking Biomedical Research Center on Hepatic and Digestive Diseases (CIBERehd), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Hospital Clínic de Barcelona, Barcelona (J.P.).
Tofacitinib demonstrated superior efficacy for both induction and maintenance therapy in ulcerative colitis patients compared to placebo. This Janus kinase inhibitor offers a new treatment option for moderate to severe disease.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Ulcerative colitis (UC) is a chronic inflammatory bowel disease.
- Tofacitinib is an oral small-molecule Janus kinase (JAK) inhibitor.
- Previous phase 2 trials suggested tofacitinib's potential for UC induction therapy.
Purpose of the Study:
- To evaluate the efficacy of tofacitinib as both induction and maintenance therapy for ulcerative colitis.
- To compare tofacitinib versus placebo in adult patients with moderately to severely active UC.
Main Methods:
- Three randomized, double-blind, placebo-controlled phase 3 trials (OCTAVE Induction 1, 2, and Sustain) were conducted.
- Patients with active UC received tofacitinib (10 mg twice daily) or placebo for 8-week induction.
- Responders received 5 mg or 10 mg tofacitinib twice daily or placebo for 52-week maintenance.
Main Results:
- Tofacitinib significantly increased remission rates at 8 weeks (18.5% vs 8.2% and 16.6% vs 3.6%) and 52 weeks (34.3% and 40.6% vs 11.1%).
- Higher rates of overall and serious infections were observed with tofacitinib during induction.
- Increased risks of overall infection, herpes zoster, cardiovascular events, and nonmelanoma skin cancer were noted with tofacitinib during maintenance, alongside elevated lipid levels.
Conclusions:
- Tofacitinib is more effective than placebo for induction and maintenance therapy in patients with moderately to severely active ulcerative colitis.
- The study highlights the efficacy of tofacitinib but also notes an increased risk of infections and other adverse events.
- Further risk-benefit assessments are crucial for clinical decision-making regarding tofacitinib use in UC.
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