P412 Drug persistence and endoscopic, histologic and biochemical remission rates among patients following ileal pouch-anal anastomosis treated with biologic therapy: Results from a prospective patient cohort.
Ollech, J.(1);Yanai, H.(1);Avni-Biron, I.(1);Snir, Y.(1);Banai, H.(1);Broitman, Y.(1);Goren, I.(1);Wasserberg, N.(2);White, I.(2);Dotan, I.(1);
(1)Rabin Medical Center- Petah-Tikva- Israel- Sackler Faculty of Medicine- Tel Aviv University- Tel Aviv- Israel, Gastroenterology, Petach Tikva, Israel;(2)Rabin Medical Center- Petah-Tikva- Israel- Sackler Faculty of Medicine- Tel Aviv University- Tel Aviv- Israel, Surgery, Petach Tikva, Israel;
Background
Patients with ulcerative colitis (UC) after total proctocolectomy and ileal pouch-anal anastomosis (IPAA) may develop chronic pouchitis or Crohn’s like disease of the pouch (CLDP). These patients may need treatment with biologic therapies. Data regarding treatment persistence as well as clinical, biochemical, endoscopic, and histologic remission rates are lacking
Methods
Patients after IPAA were followed prospectively at a dedicated pouch clinic. Patients with CP or CLDP who were antibiotic/steroid-refractory or dependent, had antibiotics/steroids side effects or had extraintestinal manifestations were treated with biologics. Clinical, endoscopic, histologic, and laboratory data were extracted from medical records at the last follow-up. Patient’s quality of life (QoL) was assessed by visual analog scale (VAS), with scores of 0-100 ( higher=better QoL) . Time to biologic therapy discontinuation was measured for all patients; patients were censored if still on biologic therapy at the time of the last follow-up. Biochemical remission was defined as C-reactive protein (CRP)< 0.5 mg/dl and a fecal calprotectin (FC)< 150 ug/dl with a normal albumin level. Endoscopic and histologic remission was defined by the pouchitis disease activity index (PDAI) as an endoscopic subscore ≤2 and a histologic subscore 0 or 1, respectively.
Results
The prospective cohort constituted 130 patients. Females: 73 (56%). Before IPAA, most (70%) patients had pancolitis, 95% received steroids and mesalamine, and 37% - biologic therapies. Median follow-up after ileostomy closure: 16 years. Biologic therapy was started in 28 patients (22%) due to CP or CLDP. The first line biologic for all 28 patients was anti-TNF’s and 9 patients received more than one line of biologics. Median time to commencing biologics: 130 months. Median first-line biologic drug persistence: 222 weeks. Among patients treated with biologic therapy, at the last clinic visit, median CRP was 0.58 mg/dl, median FC: 255ug/g, median HB: 12.46 mg/dl, and median albumin was 4.5 mg/dl .Median PDAI endoscopic and histologic scores were 2; median VAS rating was 80. Biologic remission criteria were fulfilled by 43% of patients (N-12). An additional 43% (N-12) were also in endoscopic remission with an endoscopic PDAI subscore of 2 or below, and an additional 29% of patients (N-8) were in histologic remission with a histologic PDAI score of 0 or 1.
Conclusion
Biologics reintroduction after IPAA was relatively common, albeit after a very long interval. Biologic therapy was effective, with a sizable proportion of patients in biochemical, endoscopic, and histologic remission. Likewise, drug persistence was long. We suggest that early initiation of biologic therapy in certain patients may be prudent.