One-Year Real-World Outcomes of Biologic and Small-Molecule Therapy in Patients with Inflammatory Bowel Disease: A Single Healthcare System Experience from Bahrain
Ali Hussein, Salman Kaladari, Weqar Naser, Aysha Albusaiteeni, Nader Khawaja, Naila Ahmed, Amal Mohamed Almutawa, Dana Alsharqi, Omar Sharif, Faisal AbubakerBackground: Biologic and small-molecule therapies have transformed inflammatory bowel disease (IBD) management, yet real-world evidence from the Gulf region remains limited. This study evaluated 12-month clinical, biochemical, and endoscopic outcomes among adults with moderate-to-severe Crohn’s disease (CD) or ulcerative colitis (UC) receiving advanced therapy in Bahrain. Material and Methods: This retrospective observational cohort included 122 patients who remained on the same biologic or small-molecule therapy for 12 months and underwent baseline and follow-up endoscopy. The primary outcome was clinical remission; secondary outcomes included corticosteroid-free status, endoscopic outcomes, IBD-related hospitalization and surgery, and biochemical changes. Results: Of the 122 patients, 95 (77.9%) had CD and 27 (22.1%) had UC. At 12 months, 49.2% achieved clinical remission, 60.7% were corticosteroid-free, and endoscopic response and remission were achieved in 62.3% and 49.2%, respectively. Significant improvements were observed in C-reactive protein, serum albumin, and fecal calprotectin (all p < 0.001). In exploratory, unadjusted analyses, clinical remission and corticosteroid-free status were more frequent with anti-TNF than with non-anti-TNF therapy, whereas endoscopic outcomes did not differ significantly. IBD-related hospitalization (40.2%) and surgery (28.7%) remained substantial. Conclusions: Among patients with moderate-to-severe IBD who remained on biologic or small-molecule therapy for 12 months, treatment was associated with meaningful clinical, biochemical, and endoscopic improvement. However, hospitalization and surgery remained substantial, and the treatment-completer design may have overestimated effectiveness relative to the broader population initiating therapy. These findings add real-world evidence from Bahrain and support larger prospective, multicenter studies with standardized outcomes and longer follow-up.