Abstract Background Biological therapy has revolutionized the treatment of inflammatory bowel disease (IBD); however, a subset of patients still requires therapy optimization to achieve therapeutic goals. This study aimed to identify patients who underwent biological therapy optimization (TO) and compare their characteristics with those who did not require such adjustments. Methods A retrospective study was conducted using data from the national patient registry of GEDIIB (Brazilian Crohn's and Colitis Organization). A total of 1,660 patients with Crohn's disease (CD) and 530 patients with ulcerative colitis (UC) undergoing biological therapy were included. The need for TO was determined based on clinical or endoscopic criteria specific to each participating center. Statistical analyses included association tests and Poisson regression. Results The need for TO was more frequent among patients with CD(33.3%) compared to those with UC (26.2%) (p=0.003). In CD, optimization was associated with younger age (p=0.016), stenosing (p=0.03) or penetrating behavior (p=0.015), perianal disease (p<0.001), presence of fistula (p=0.019), and prior surgery (p=0.044). Table 1 displays the adjusted frequency ratio (FR) for TO in CD patients. After adjusting for confounding factors, the most significant predictors for optimization in CD were younger age, perianal disease, and prior surgery. In UC, optimization was associated with younger age (p=0.013), pancolitis extent (p<0.001), previous surgery (p=0.037), hospitalization (p=0.025), and chronic liver disease (p=0.024). Table 2 presents the adjusted FR for therapy optimization in UC patients. After adjustment, the factors most strongly associated with optimization in UC were prior surgery and chronic liver disease. Conclusion Approximately 30% of patients required optimization of biological therapy. This need was associated with younger age, a more severe disease profile, and the presence of complications, such as perianal disease in CD, as well as a history of surgery and hospitalization in UC. References Papamichael K, Cheifetz AS, Melmed GY, Irving PM, Vande Casteele N, Kozuch PL, Raffals LE, Baidoo L, Bressler B, Devlin SM, Jones J, Kaplan GG, Sparrow MP, Velayos FS, Ullman T, Siegel CA. Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1655-1668.e3. doi: 10.1016/j.cgh.2019.03.037. Fróes RSB, Andrade AR, Faria MAG, de Souza HSP, Parra RS, Zaltman C, Dos Santos CHM, Bafutto M, Quaresma AB, Santana GO, Luporini RL, de Lima Junior SF, Miszputen SJ, de Souza MM, Herrerias GSP, Junior RLK, do Nascimento CR, Féres O, de Barros JR, Sassaki LY, Saad-Hossne R. Clinical factors associated with severity in patients with inflammatory bowel disease in Brazil based on 2-year national registry data from GEDIIB. Sci Rep. 2024 Feb 21;14(1):4314. doi: 10.1038/s41598-024-54332-1.
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