Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil

摘要

BACKGROUND Crohn’s disease(CD)and ulcerative colitis(UC)are inflammatory bowel diseases(IBDs)with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden,especially in patients with moderate-to-severe disease.The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil(RISE BR)study was a noninterventional study designed to evaluate disease control,treatment patterns,disease burden and health-related quality of life in patients with moderate-to-severe active IBD.We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD.AIM To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil.METHODS This was a prospective,noninterventional study of adult patients with active Crohn’s disease(CD:Harvey-Bradshaw Index≥8,CD Activity Index≥220),inadequate CD control(i.e.,calprotectin>200μg/g or colonoscopy previous results),or active ulcerative colitis(UC:Partial Mayo score≥5).Enrollment occurred in 14 centers from October 2016 to February 2017.The proportion of active IBD patients after 9-12 mo of follow-up,Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation,discontinuation and dose changes were examined.RESULTS The study included 118 CD and 36 UC patients,with mean±SD ages of 43.3±12.6 and 44.9±16.5 years,respectively.The most frequent drug classes at index were biologics for CD(62.7%)and 5-aminosalicylate derivates for UC patients(91.7%).During follow-up,65.3%of CD and 86.1%of UC patients initiated a new treatment at least once.Discontinuations/dose changes occurred in 68.1%of CD patients[median 2.0(IQR:2-5)]and 94.3%of UC patients[median 4.0(IQR:3-7)].On average,CD and UC patients had 4.4±2.6 and 5.0±3.3 outpatient visits,respectively.The median time to first mild or no activity was 319(IQR:239-358)d for CD and 320(IQR:288-358)d for UC patients.At 9-12 mo,22.0%of CD and 20.0%of UC patients had active disease.CONCLUSION Although a marked proportion of active IBD patients achieved disease control within one year,the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting.