- A meta-analysis shows that the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) is safe and effective in patients with moderate-to-severe ulcerative colitis (UC).
Why this matters
- Results may contribute to FDA approval for UC as a new indication, considering that tofacitinib is already approved for rheumatoid arthritis.
- Meta-analysis of 3 randomized controlled trials (n=1220) that met eligibility criteria after a search that included MEDLINE, EMBASE, and Cochrane Library.
- Funding: None disclosed.
- Tofacitinib was more effective than placebo on these outcomes:
- clinical remission (OR, 3.84; 95% CI, 2.29-6.44);
- clinical response (OR, 2.95; 95% CI, 2.21-3.95);
- mucosal healing (OR, 2.70; 95% CI, 1.87-4.16);
- QoL by Inflammatory Bowel Disease Questionnaire (IBDQ) response (OR, 2.06; 95% CI, 1.56-2.72); and
- QoL by IBDQ remission (OR, 2.66; 95% CI, 1.94-3.65).
- In subgroup analysis, tofacitinib (vs placebo) showed clinical response in both anti-TNF-drug-naive patients (OR, 2.32; 95% CI, 1.57-3.43) and -experienced patients (OR, 3.43; 95% CI, 2.25-5.22).
- Tofacitinib (vs placebo) had increased risk for infections (OR, 1.51; 95% CI, 1.05-2.19) but not serious infections.
- Tofacitinib (vs placebo) had no increased risk for any or serious adverse events.
- Small number of trials.