Munique Kurtz de Mello

Background: Biologics improve outcomes in inflammatory bowel disease, but high costs restrict access and strain healthcare resources. Biosimilars lower costs, expand access, and support sustainable IBD care. Objective: Provide clear, evidence-based answers on biosimilar use in IBD across clinical, therapeutic, and economic domains to guide safe implementation and informed decision-making. Methods: GEDIIB conducted a PICO-structured systematic review across multiple databases and trial registries. We extracted clinically relevant outcomes and performed systematic review. We assessed risk of bias with RoB 2.0 and ROBINS-I and graded certainty using GRADE. A structured Delphi process with two voting rounds and external validation finalized recommendations, with consensus predefined at 85 percent or higher. Results: Anti-TNF biosimilars and originator biologics have similar efficacy, safety, immunogenicity, treatment persistence, and mucosal healing in biologic-naive patients and after switching, with no clinically meaningful differences in adverse events, loss of response, or discontinuation. Data on multiple switches do not indicate harm, though evidence remains limited. Pediatric studies suggest similar profiles, with lower precision. Economic evaluations show substantial cost savings and improved access, supporting the sustainability of the health system. Conclusion: Biosimilars represent a viable, safe, and cost-effective option for IBD management. We recommend structured switching strategies, clear communication with patients, and continuous clinical monitoring. Additional robust studies should strengthen evidence in specific populations and clinical scenarios.

To assess the real-life, long-term effectiveness and safety of tofacitinib in a large cohort of patients with refractory or difficult-to-treat ulcerative colitis (UC). This multicenter, retrospective, observational cohort study included patients with moderately to severely active UC who received tofacitinib for at least 8 weeks. Clinical remission and response, endoscopic response and remission, biochemical response and remission, steroid-free clinical remission, primary and secondary loss of response, drug discontinuation, the need for dose optimization, the need for colectomy, and adverse events were evaluated over up to 30 months. We included 127 patients with UC, with a mean age of 40.3 ± 14.2 years; 58.2% were male, 75.6% had pancolitis, and 79.5% had previously failed at least one biological therapy, predominantly anti-TNF agents (70.1%). Clinical remission was observed in 31.5% of patients at weeks 12-16, 46.5% at 26 ± 4 weeks, and 37.0% at 1 year. Steroid-free clinical remission was achieved in 28.6%, 44.8%, and 37.1% of patients at the same time points, respectively. Biochemical remission was achieved in 33.6% of patients at 26 ± 4 weeks and 29.3% at 1 year. Endoscopic response and endoscopic remission within 1 year were observed in 46.0% and 15.3% of patients, respectively. Ten patients (7.9%) required colectomy, and 13 patients (10.2%) required hospitalization, all of whom had been previously exposed to biologics. The colectomy rate was significantly greater in patients with serum albumin levels ≤ 3.5 g/dL (21.4% vs. 4.1%, p = 0.013). In this large, long-term real-world study involving patients with predominantly biologically refractory UC, tofacitinib effectively induced clinical remission and endoscopic improvement and prevented colectomy for more than 30 months, with a favorable safety profile. Notably, baseline hypoalbuminemia was associated with higher colectomy rates.

Background: Microscopic colitis (MC) is a chronic inflammatory condition of the colon, primarily characterized by watery diarrhea, with normal or near-normal endoscopic findings. It encompasses two main subtypes: lymphocytic colitis and collagenous colitis.