Safety and Efficacy of Biological Therapy in Chronic Antibiotic Refractory Pouchitis

Abstract

Background: Pouchitis is the most common long-term complication after ileal pouch-anal anastomosis in patients with ulcerative colitis. Those with ≥3 episodes of pouchitis/year and symptoms despite antibiotics are considered to have chronic antibiotic refractory pouchitis (CARP). While several agents including probiotics, steroids and immunomodulators have been used, treatment of CARP remains challenging. We conducted a systematic review and meta-analysis evaluating the safety and efficacy of various biological agents in treatment of CARP. Methods: Multiple databases were searched through June 2020 for studies that reported the efficacy and safety of biological therapy including antitumor necrosis factor-alpha agents [infliximab (IFX) and adalimumab (ADA)], vedolizumab (VDZ), and ustekinumab in CARP. We excluded studies on Crohn’s like and/or other inflammatory complications of the pouch. Meta-analysis was performed to calculate pooled rates of clinical as well as endoscopic improvement and remission. Results: We included 15 studies with 311 patients in our final analysis. Ninety-two patients were treated with IFX, 42 with ADA, 144 with VDZ and 33 with ustekinumab. Pooled rate of clinical improvement was 71.4%, 58.2%, 47.9% and clinical remission was 65.7%, 31%, 47.4% with IFX, ADA, and VDZ, respectively. Pooled rate of endoscopic improvement was achieved in 61.2% patients treated with VDZ while endoscopic remission was achieved in 70.3% patients treated with IFX. Adverse events were reported in 3.9% patients. Conclusion: Biologic therapy is safe and effective in the treatment of CARP.

Effectiveness and safety of azathioprine for inflammatory pouch disorders: results from the RESERVO study of GETECCU

“…Biological therapy is a good therapeutic option in patients with chronic refractory pouchitis and CD of the pouch. 25 – 29 , 33 , 36 , 38 One meta-analysis reported that clinical remission after induction of anti-TNF agents was more common in CD than in chronic pouchitis (64% versus 10%). 27 Nonetheless, our data show that they would be a useful alternative long-term option, especially for patients with previous exposure to steroids who develop dependence (85% versus 15%, p = 0.01).…”

Systematic review and meta-analysis: analysis of variables influencing the interpretation of clinical trial results in NAFLD

“…First, the interpretation of some results could be challenging because of the different mechanisms of action of included drugs. However, this kind of approach has been done for other therapeutic areas (e.g., biologics in ulcerative colitis [ 49 ]) and could be interesting to provide additional data to guide the NAFLD drug pipeline properly. Second, studies reporting cirrhotic-related outcomes were scarce, precluding making robust analysis.…”

Guidelines for the management of ulcerative colitis. Recommendations of the Polish Society of Gastroenterology and the Polish National Consultant in Gastroenterology

“…Other targeted agents, notably infliximab, adalimumab and ustekinumab, have also been shown to be effective, and benefits of tofacitinib have been reported. Their use can be considered on a case-by-case basis, taking into account the benefits and risks of therapy [ 114 , 119 , 123 , 131 – 136 ].…”