Objective: Infliximab and tacrolimus are effective for the treatment of patients with moderate or severe corticosteroid-dependent/refractory ulcerative colitis. However, regarding treatment for these patients, whether tacrolimus therapy should precede infliximab as a second-line therapy remains controversial. To address this issue, we retrospectively investigated the efficacy of infliximab salvage therapy for patients with severe or moderate ulcerative colitis who failed to respond to tacrolimus.
Methods: We assessed clinical backgrounds and therapeutic outcomes at baseline, 8, and 30 weeks for 13 patients receiving infliximab for severe or moderate ulcerative colitis who showed refractoriness or loss of response to tacrolimus, or no tolerance.
Results: Mean partial Mayo score was significantly decreased (P<0.05) to 5.69, 3.07, and 2.77 at baseline, 8, and 30 weeks, respectively. Six of 13 patients (46.2%) showed clinical remission at 8 weeks and four (30.8%) showed clinical remission at 30 weeks. Two patients who did not respond to infliximab finally underwent colectomy. Rates of clinical remission at 8 and 30 weeks were 60.0 and 40.0% in tacrolimus responders, and good remission rates of 37.5 and 25.0%, respectively, were also obtained in tacrolimus nonresponders. No serious adverse events were encountered.
Conclusion: Infliximab salvage therapy following tacrolimus tended to appear more efficacious in tacrolimus responders (loss of response or no tolerance) than in nonresponders (refractoriness), although nonresponders also achieved satisfactory results. Sequential therapy may thus prove useful and well tolerated. In addition, we should avoid missing the proper timing of colectomy, and care is warranted regarding adverse events.