A multicenter cohort study of 104 patients found that ustekinumab was more effective and durable than vedolizumab in treating Crohn’s disease of the pouch, a complication that can develop after surgery for ulcerative colitis.
The study included adults who had previously undergone colectomy followed by ileal pouch-anal anastomosis and were later diagnosed with Crohn’s disease of the pouch. Diagnosis was based on clinical, endoscopic, or histologic features such as inflammation resistant to antibiotics, strictures, fistulas, or granulomas on biopsy. Patients received either ustekinumab or vedolizumab and were followed for a median of 2.5 years (ustekinumab) and 3.1 years (vedolizumab).
At 3 months, 62% of patients treated with ustekinumab had a clinical response, compared with 53% of those on vedolizumab. At 6 months, response rates were 56% and 46%, respectively. In multivariable models adjusting for age, smoking status, disease duration, corticosteroid use, and antibiotic use, patients on ustekinumab were statistically more likely to respond at 3 months and 6 months.
Clinical remission, defined as return to baseline bowel function with no bleeding or fistula drainage, occurred in 32% of ustekinumab patients and 18% of vedolizumab patients at 3 months, and in 29% and 21% at 6 months. These differences were not statistically significant.
Endoscopic response at 1 year was observed in 41% of ustekinumab patients and 27% of vedolizumab patients. Histologic response was achieved in 46% and 26%, respectively. Endoscopic and histologic remission rates were similar between groups.
During the 3-year follow-up, 5% of patients treated with ustekinumab and 3% treated with vedolizumab were hospitalized for inflammatory bowel disease-related complications. Pouch failure surgery occurred in 9% of ustekinumab patients and 5% of vedolizumab patients.
Treatment durability, defined as the ability to remain on the same therapy long-term, was significantly greater with ustekinumab.
Both treatments were well tolerated. Reported adverse events were infrequent and mild. In the ustekinumab group, these included arthralgia, hair loss, syncope, and upper respiratory infection. In the vedolizumab group, wrist edema and elevated transaminases were reported.
Most patients had prior exposure to biologic therapy before starting ustekinumab or vedolizumab. A subset of vedolizumab-treated patients had previously received ustekinumab, suggesting more treatment-refractory disease.
The authors reported no conflicts of interest.
Source: Inflammatory Bowel Diseases