Tofacitinib Is Safe and Effective for Treatment of Severe Ulcerative Colitis

Ulcerative colitis
ulcerative colitis, inflammatory bowel disease, IBD, UC
Researchers analyzed the effectiveness of tofacitinib for the treatment of moderate to severe ulcerative colitis.

A systematic review and meta-analysis found that tofacitinib was effective for the treatment of moderate to severe ulcerative colitis (UC). These findings were published in Inflammatory Bowel Disorders.

Researchers from the Hospital Clinico San Carlos in Madrid, Spain, searched publication databases for studies of UC and tofacitinib therapy from June 2015 through June 2020. They included a total of 17 publications involving 1162 patients with UC in this analysis.

A total of 34.7% (95% CI, 24.4-45.1; I2 =87%) of patients achieved remission by week 8 while undergoing tofacitinib therapy, and by week 16 nearly half of patients did (47% [95% CI, 40.3-53.6]; I2 =59%). Clinical response at 8 weeks was reported in 62.1% (95% CI, 55-69.1; I2 =73%) of patients, in 64.2% (95% CI, 56.3-73.2; I2 =82%) by week 16, and in 50.8% (95% CI, 42.1-59.5; I2 =60%) at 6 months.

Between weeks 12 and 16, 44.3% (95% CI, 32%-56.5%; I2 =76%) of patients were in corticosteroid-free clinical remission and 35.1% (95% CI, 11.5-58.7) had mucosal healing.

Prolonged induction (10 mg of tofacitinib up to 16 weeks) was required among 43.2% (95% CI, 37.2-49.2) of patients, and 46.3% (95% CI, 35.8-56.9) required dose escalation to 10 mg twice daily. Colectomy was performed in 9% (95% CI, 6.4-11.6) of patients.

Stratified by prior exposure to biologics, 83% (95% CI, 56.5-99.2) of patients who were naive responded to treatment, compared with 58.1% (95% CI, 49.3-66.7) of patients who were experienced.

Nearly half (46.6%) of the 15 patients who had steroid-refractory acute severe UC achieved corticosteroid-free remission with tofacitinib.

Outbreaks of herpes zoster occurred among 32 patients (3.4% [95% CI, 2.2-4.5]). A total of 35 (4.4% [95% CI, 2.9-5.9) severe adverse events were reported. No incidence of major adverse cardiovascular events or thromboembolic complications were observed.

This review was limited by the high heterogeneity between studies, likely because of differences in study design or population.

The study authors concluded that these real-world data confirmed the effectiveness of tofacitinib for the treatment of active moderate to severe UC with an acceptable safety profile.

Disclosures: Multiple authors declared industry affiliations. Please refer to the original article for a full list of disclosures.


Taxonera C, Olivares D, Alba C. Real-world effectiveness and safety of tofacitinib in patients with ulcerative colitis: systematic review with meta-analysis. Inflamm Bowel Dis. Published online February 15, 2021. doi: 10.1093/ibd/izab011