Abstract Background Interleukin 12/23 pathway blockade is an important therapeutic strategy in moderate to severe inflammatory bowel disease. Pivotal trials in Crohn’s disease and ulcerative colitis have shown significant induction and maintenance efficacy, including in biologic experienced patients. Real world prospective data from India, especially in consecutive biologic naive and biologic experienced cohorts managed in routine practice, remain limited. Evaluating clinical, endoscopic, and biomarker outcomes, including fecal calprotectin, is essential for understanding treatment effectiveness in this setting. This study assessed the clinical utility of ustekinumab in consecutive patients with Crohn’s disease and ulcerative colitis treated in inpatient and outpatient care. Methods This prospective cross sectional observational study included 32 consecutive patients with moderate to severe inflammatory bowel disease treated with ustekinumab, comprising 14 with Crohn’s disease and 18 with ulcerative colitis. Both biologic naive and biologic experienced patients were included. Clinical response was evaluated using symptom assessment and physician global impression. Endoscopic outcomes were assessed through follow up sigmoidoscopy or colonoscopy. Laboratory markers such as hemoglobin, C reactive protein, erythrocyte sedimentation rate, and fecal calprotectin (when available) were recorded before and after treatment. Results Clinical response occurred in 72 to 75 percent of patients, with clinical remission in 48 to 50 percent. Endoscopic response was seen in 52 to 56 percent and endoscopic remission in 28 to 32 percent. Substantial biochemical improvement was observed, with C reactive protein reduction in 70 to 75 percent, erythrocyte sedimentation rate reduction in 65 to 70 percent, and hemoglobin improvement or stabilization in 68 percent. Fecal calprotectin decreased meaningfully, with biomarker response in 60 to 65 percent and normalization in 25 to 30 percent of those tested. Biologic naive patients demonstrated higher response rates, while biologic experienced patients also achieved meaningful clinical and biochemical improvement. Steroid free clinical response was observed in nearly half of the cohort. Conclusion Ustekinumab demonstrated significant clinical, endoscopic, and biochemical effectiveness in consecutive ulcerative colitis and Crohn’s disease patients treated in real world practice. Benefits were seen across biologic naive and biologic experienced groups, including those with prior treatment failure. These findings provide valuable prospective evidence from the Indian setting and support the integration of ustekinumab into routine management pathways for moderate to severe inflammatory bowel disease. Reference: Feagan BG et al. N Engl J Med. 2016;375:1946–60. Sandborn WJ et al. Clin Gastroenterol Hepatol. 2022;20:578–90.e4. Sands BE et al. N Engl J Med. 2019;381:1201–14. Ma C et al. Inflamm Bowel Dis. 2017;23:833–9. Battat R et al. Clin Gastroenterol Hepatol. 2017;15:1427–34.e2 Conflict of interest: Dr. Vats, Ankit: No conflict of interest
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