In Brazil, IBD frequently causes disability for prolonged periods and contributes to early retirement. Reduction trends may reflect improvements in access to health care and medication. Vocational rehabilitation programs may positively impact social security and the patients' quality of life.

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.

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Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients, as public reimbursement is relatively recent. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian UC patients, and evaluate possible factors associated with remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was carried out including patients with moderate-to-severe UC treated with anti-TNF therapy. Disease activity was categorized using Mayo score at baseline, weeks 8, 26 and 52. Clinical remission was defined as a partial Mayo score ≤ 2. Endoscopic remission was defined as a Mayo endoscopic subscore ≤ 1. Patients were allocated in 2 groups (ADA and IFX) and a comparative efficacy study was performed. Statistical analysis: logistic regression model was used to study effects of predictor variables on categorical outcomes, such as presence or absence of remission at week 52. Statistical significance was assumed if p <0.05. Results Overall, 393 patients were included (111 ADA and 282 IFX). The mean age was 41.86 ± 13.60 y, 61.58% women, most patients had extensive colitis (62.40%) and 19.39% previous exposure to biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65 %, p <0.0001) and 52 (65.24% vs. 51.35%, p <0.0001) – figure 1. Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the two groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). The variables associated with clinical remission after 1 year of treatment were age, non-prior exposure to biological therapy, use of IFX, endoscopic remission at week 26 and no need for optimization (table 1). The variables associated with endoscopic remission after 1 year were non-prior exposure to biological therapy, clinical and endoscopic remission at week 26 and no need for optimization. Conclusion In this national multicentric study, overall efficacy of anti-TNF therapy was similar to real world data with IFX and ADA. IFX treatment was associated with higher rates of clinical remission after 1 year in comparison to ADA. Patients naive to biological therapy presented higher rates of clinical and endoscopic remission. This is the first real world national study analyzing efficacy of anti-TNF agents in UC in Brazil.

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Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. Results Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan–Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. Conclusions IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.

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