Saint Peter's University Hospital / Rutgers Robert Wood Johnson Medical School New Brunswick, NJ
Archit Garg, MD1, Vishali Moond, MD1, Mehak Bassi, MD1, Sahil Raval, MD1, Aadhithyaraman Santharaman, MD1, Aashi Garg, MD2, Umesh Bhagat, MD3, Abhishek Chouthai, MD1, Marcella Pimpinelli, MD1, Louisa Recinos-Arenas, MD1, Arkady Broder, MD, FACG1 1Saint Peter's University Hospital / Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ; 2Boston University School of Public Health, Boston, MA; 3Cleveland Clinic Foundation, Cleveland, OH Introduction: Tofacitinib, a Janus kinase inhibitor has been used for induction and maintenance of remission in patients with moderate to severe ulcerative colitis. However, recent studies have shown promising results in management of chronic pouchitis (CP) with tofacitinib. We performed a pooled analysis of the efficacy and safety of tofacitinib for CP in patients with inflammatory bowel disease. Methods: We searched multiple databases from inception through November 2024 for articles reporting outcomes of tofacitinib in patients with CP. Standard meta-analysis methods were employed using the random-effects model, and heterogeneity was studied by I2 statistics. Results: We analyzed 8 studies including 3 prospective and 5 retrospective studies involving 99 subjects (55.56% males and mean age of 37.46 years). The mean duration of reassessment after initiating tofacitinib was 2.5 months.
The pooled clinical response rate with tofacitinib was 47.7% [Cl 33.3-62.6%; I2= 40%]. The endoscopic response rate and endoscopic remission rate were 51.7% [Cl 37.4-65.7%; I2=34%] and 41.2% [Cl 26.6-57.6%; I2= 0%] respectively. Clinical PDAI (Pouchitis Disease Activity Index) score improved markedly post-tofacitinib (Pre: 3.35 [Cl 2.9-3.7; I2 = 68%] vs Post: 2.0 [Cl 1.59-2.4; Cl = 0%] with SD 0.80 ± 0.19 and p-value < 0.001). There was a significant reduction in endoscopic PDAI score with treatment (Pre: 4.5 [Cl 3.7-5.2; I2 = 84%] vs Post: 2.5 [Cl 1.7-3.3; Cl = 64%] with SD 0.99 ± 0.25 and p-value < 0.001). Total PDAI scores also showed significant improvement with tofacitinib (Pre: 7.4 [Cl 5.3-9.6; I2 = 96%] vs Post: 4.3 [Cl 2.8-5.9; Cl = 84%] with SD 1.30 ± 0.37 and p-value < 0.001).
The pooled adverse events were 30.9% [Cl 17.5-48.5; I2=24%]. The pooled rate of lack of symptomatic improvement was 47% [Cl 28.8-66.0%; I2=32%] and worsening of pouchitis was 56.6% [Cl 7-95.8%; I2=82%]. The discontinuation rate of tofacitinib was 43% [Cl 25-63.1; I2=40%]. Discussion: Based on this meta-analysis, tofacitinib caused statistically significant changes in clinical, endoscopic and total PDAI scores with favorable response and remission rates. Although there are significant rates of adverse events, worsening of symptoms and discontinuation, this is similar to other biologic therapies and in some instances less frequent. Future studies are required to evaluate the long-term safety profile of tofacitinib before considering it as an effective alternative for the treatment of CP.
Figure: Table 1: Changes in clinical, endoscopic and total PDAI (pouchitis disease activity index) scores with tofacitinib as treatment for chronic pouchitis
Figure: Table 2: Pooled outcomes of tofacitinib as treatment for chronic pouchitis
Disclosures: Archit Garg indicated no relevant financial relationships. Vishali Moond indicated no relevant financial relationships. Mehak Bassi indicated no relevant financial relationships. Sahil Raval indicated no relevant financial relationships. Aadhithyaraman Santharaman indicated no relevant financial relationships. Aashi Garg indicated no relevant financial relationships. Umesh Bhagat indicated no relevant financial relationships. Abhishek Chouthai indicated no relevant financial relationships. Marcella Pimpinelli indicated no relevant financial relationships. Louisa Recinos-Arenas indicated no relevant financial relationships. Arkady Broder indicated no relevant financial relationships.
Archit Garg, MD1, Vishali Moond, MD1, Mehak Bassi, MD1, Sahil Raval, MD1, Aadhithyaraman Santharaman, MD1, Aashi Garg, MD2, Umesh Bhagat, MD3, Abhishek Chouthai, MD1, Marcella Pimpinelli, MD1, Louisa Recinos-Arenas, MD1, Arkady Broder, MD, FACG1. P1036 - Exploring the Role of Tofacitinib in Managing Chronic Pouchitis: A Systematic Review and Meta-Analysis, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.