Introduction: The effectiveness of tofacitinib for pouch-related disorders after total proctocolectomy (TPC) with ileal pouch anal anastomosis (IPAA) is poorly understood. We conducted a retrospective case series of patients receiving tofacitinib for the treatment of pouch-related disorders.
Methods: This was a retrospective case series of adults prescribed tofacitinib for chronic pouchitis (CP), cuffitis, or Crohn’s-like disease of the pouch (CLDP) at a large academic medical center after 1/1/2015. Patients treated primarily for non-IBD indications were excluded. Electronic health records were manually reviewed for demographics, inflammatory bowel disease (IBD) medication history, pouchoscopy reports, laboratory data, and clinical assessments. The primary outcome was clinical response determined by provider assessment at first clinical follow-up after tofacitinib initiation. Additional outcomes included endoscopic response (determined by endoscopist assessment), tofacitinib discontinuation, need for oral antibiotics or corticosteroids, change in bowel frequency, resolution of rectal bleeding and urgency, IBD hospitalization, need for bowel surgery or ileostomy, and adverse events (AEs).
Results: There were 6 patients who initiated tofacitinib for CP (n=3), cuffitis (n=2), or CLDP (n=1) after IPAA. 5 patients underwent TPC for inflammation and 1 was for dysplasia. All but 1 patient had prior biologic exposures. 3 patients were using antibiotics and 2 were using oral corticosteroids at the time of tofacitinib initiation. Other baseline characteristics are presented in Table 1. Clinical follow-up occurred at a median of 109 days (IQR 49-171 days) after tofacitinib initiation. 1/6 (CP) patients had clinical response. 2/3 patients with post-tofacitinib endoscopic assessments (1/2 CP and 1/1 cuffitis) had endoscopic response at a median of 191 days (IQR 113.5-229 days). All patients ultimately discontinued tofacitinib after a median of 133 days (IQR 95-254 days). Reasons for discontinuation were lack of efficacy (n=3: 1 CP, 2 cuffitis), AEs (n=2: 1 CP, 1 CLDP), and self-discontinuation out of safety concerns (n=1: CP). AEs occurred in 4/6 patients and included infections (C. difficile, pneumonia, candida esophagitis, cytomegalovirus cuffitis, perianal abscess) and dizziness and headaches. Other outcomes are presented in Table 1.
Discussion: The results of this case series do not support the use of tofacitinib for pouch-related disorders. Larger studies are needed to confirm these findings.