Real-world Safety and Efficacy of Tofacitinib in Moderate to Severe Ulcerative Colitis

Pavankumar Kamat


January 13, 2022


Why this matters

  • Findings suggest that long-term follow-up data on safety and efficacy of tofacitinib in UC may provide additional information regarding non-response, effectiveness in special populations (pregnancy, children, elderly), and adverse events (AEs).

Study design

  • UK researchers conducted a meta-analysis of 9 studies (7 retrospective and 2 prospective) including a total of 830 patients with UC.

  • Pooled induction (8-14 weeks) and maintenance (16-26 weeks) clinical response, remission rates, and AEs were evaluated.

  • Funding: Institutional Strategic Support Fund Wellcome Trust clinical lecturer bridging award and others.

Key results

  • Overall, 81% (674/830) of patients with UC were previously treated with anti-tumour necrosis factor and 57% (473/830) with vedolizumab.

  • After a median follow-up of 8 weeks, clinical response and clinical remission were achieved in 51% (262/496; 95% CI, 41 to 60%) and 37% (187/496; 95% CI, 30 to 45%) of patients with UC, respectively.

  • At the end of a median follow-up of 24 weeks, clinical response and clinical remission were achieved in 40% (213/532; 95% CI, 31 to 50%) and 29% (145/496; 95% CI, 23 to 36%) of patients with UC, respectively.

  • The most common AEs were mild infection (13% [47/830]) and worsening of UC requiring colectomy (13% [77/651]).

  • Other AEs included dyslipidaemia (9% [42/373]), serious infection leading to hospitalisation (5% [27/687]), and herpes zoster infection (3% [23/830]).

  • One third of the patients (35%) discontinued tofacitinib, commonly due to primary non-response (51%).


  • Heterogeneity among studies.

Lucaciu LA, Constantine-Cooke N, Plevris N, Siakavellas S, Derikx LAAP, Jones GR, Lees CW. Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis. Therap Adv Gastroenterol. 2021;14:17562848211064004. doi: 10.1177/17562848211064004. PMID: 34987608 View Full Text.


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