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ABSTRACT BACKGROUND: Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars. OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the drug discontinuation rate in the IBD population who switched from originator to biosimilars in real-world switching studies and address potential nocebo effects as reasons for drug discontinuation. METHODS: Medline (via PubMed), EMBASE, Cochrane Library, and abstract databases of selected congresses were screened for reports of monoclonal antibody (mAb) switching with a minimum post-switch follow-up of >6 months or three infusions. All available information on discontinuation rates was assessed. RESULTS: A total of 30 observational studies were included, involving 3,594 patients with IBD. Twenty-six studies reported a switch from infliximab to CT-P13, two studies involved a switch to SB2, and switching information was not available in two studies. The discontinuation rates were 8%, 14%, and 21% at 6, 12, and 24 months, respectively. The main reasons for drug discontinuation and their respective risks were: disease worsening (2%), remission (4%), loss of adherence (4%), adverse events (5%), and loss of response (7%). The quality of the evidence ranged from low to very low depending on the outcome analyzed. Subjective symptoms leading to drug discontinuation were infrequently reported, and the nocebo effect was clearly assessed in just one of the included papers. CONCLUSION: Discontinuation rates following a switch to a biosimilar in patients with IBD increase over time. However, it was not possible to confirm the nocebo effect as a reason for discontinuation. Therefore, long-term studies evaluating the use of biosimilars to monitor adverse events and potential nocebo effects in post-marketing surveillance are still needed.

Abstract Background The epidemiology of inflammatory bowel disease (IBD) varies in different countries. This study aimed to assess phenotype, medications, prevalence and incidence of IBD in the State of Espírito Santo, Brazil. Methods Patients with IBD who utilized the Public Medication-Dispensing System of the Department of Health of Espírito Santo, between August 2012 and July 2014. Of 1484 active patients, 1048 were analyzed, which included patients of all ages. Results The prevalence of IBD was 38.2 per 100,000 inhabitants, with ulcerative colitis (UC) being 24.1 per 100,000 and Crohn’s disease (CD), 14.1 per 100,000. The incidence of IBD was 7.7 per 100,000 inhabitants/year (UC – 5.3/100,000 inhabitants/year and CD – 2.4/100,000 inhabitants/year). Out of the 1048 patients analyzed, 669 had UC (63.84%), 357 had CD (34.06%), and 22 had unclassified inflammatory bowel disease (UIBD; 2.10%). There were 48/1048 (4.5%) pediatric patients (16 years of age or younger). On the UC phenotype (n = 654), we observed left-sided colitis in 247 (37.7%), pancolitis in 209 (31.9%), and proctitis in 198 patients (30.2%). Pancolitis was more frequent in pediatric patients (p = 0.007). CD showed a homogeneous distribution between ileitis (L1), colitis (L2), and ileocolitis (L3). Regarding the CD behavior (n = 352) observed the inflammatory type (B1) in 176 (50%); fistulizing (B3) in 75 (21.2%), isolated type (B3) in 29 (8.2%), and perianal fistulizing type (B3p) in 46 (13.1%). Biologic therapies were used in 154/357 (43.3%). Conclusion The prevalence of the IBD in the state of Espírito Santo, Brazil was higher than in two other brazilian studies. There was high utilization of biologic therapies in patients with CD.