- Tofacitinib was clinically effective and well-tolerated for the treatment of refractory moderate to severe ulcerative colitis (UC).
Why this matters
- Real-world experience of tofacitinib in UC is limited and the factors associated with primary non-response remain poorly defined.
- Findings support treatment algorithms that include tofacitinib as a treatment choice in patients with UC who have failed conventional therapies.
- A retrospective observational cohort study of patients with UC treated with tofacitinib across 4 UK centres from October 2018 to October 2019 (n=134; 64% male; median age 37 years; 83% patients had previously received at least one biologic).
- Disease activity was evaluated using the Simple Clinical Colitis Activity Index (SCCAI) or Partial Mayo Score (PMS).
- Clinical response and remission were defined as a reduction in SCCAI or PMS ≥3 and SCCAI ≤2 or a PMS ≤1, respectively.
- Funding: None.
- At week 8, clinical response and remission rates were 74% and 57%, respectively; corticosteroid-free remission was reported in 48% of patients at week 26.
- Primary non-response was independently associated with younger age (OR, 1.04; 95% CI, 1.01-1.07; P=.014) and higher C-reactive protein levels at baseline (OR, 0.29; 95% CI, 0.12-0.66; P=.004) at week 8.
- Primary non-response was reported in 26% of patients at week 8; only 3 of the 13 patients who continued tofacitinib were in steroid-free remission at week 26.
- Previous biologic exposure did not influence response or remission rates.
- After a median of 41 (interquartile range, 26-91) days, 32% (24/74; 95% CI, 22-44%) of patients had a recurrence of symptoms after dose reduction and dose re-escalation successfully recaptured response in 47% (9/19; 95% CI, 25-71%) of patients.
- Dyslipidaemia was reported in 20% (27/134; 95% CI, 14-28%) of patients but adverse events resulting in drug withdrawal were uncommon and no venous thromboembolic events were reported.
- Retrospective design.
- Risk of bias.