Azathioprine or Tofacitinib as Maintenance Therapy in Corticosteroid-Responsive Acute Severe Ulcerative Colitis

The optimal maintenance therapy for patients with acute severe ulcerative colitis (ASUC) remains unclear.

To evaluate the efficacy of azathioprine and tofacitinib in maintaining remission in patients with ASUC who respond to intravenous corticosteroids.

This propensity score-matched, retrospective cohort study evaluated the effectiveness and safety of azathioprine and tofacitinib as maintenance therapies in adult patients with ASUC responding to intravenous corticosteroids. We recorded rehospitalisation, corticosteroid reuse, therapeutic escalation, and colectomy. The primary endpoint was cumulative event-free survival at 1 year. Adverse events were documented in both treatment arms.

We included 115 patients in the final analysis (median age: 38 years [IQR: 28-49]; 54 females [46.95%]; 65 on azathioprine, 50 on tofacitinib). The cumulative probability of event-free survival at 1 year was 44.0% with azathioprine and 75.0% with tofacitinib (log-rank p = 0.01). Rates of rehospitalisation (15.4% v. 0%; p = 0.003) and therapeutic escalation (13.8% v. 2.0%; p = 0.02) were significantly greater in the azathioprine group. More patients receiving tofacitinib achieved symptomatic remission (40.0% v. 23.1%; p = 0.05), and combined symptomatic and biomarker remission (22.0% v. 16.9%; p = 0.49) at 1 year than those receiving azathioprine. Adverse events were reported in 55 patients (47.8%). No patients in either group required discontinuation of therapy due to adverse events.

Tofacitinib is more effective than azathioprine as maintenance therapy for steroid-responsive ASUC at 1 year.