National analysis investigates the effect of COVID-19 on vedolizumab dispensing for IBD in Brazil, suggesting policy implications.
Background The COVID-19 pandemic disrupted chronic-care pathways and pharmaceutical logistics worldwide, significantly impacting access to biological therapies for inflammatory bowel disease (IBD) (1,2). In Brazil, vedolizumab—a selective anti-integrin agent—has progressively expanded its role in Crohn’s disease and ulcerative colitis. Understanding how pandemic-related disruptions affected its use is essential for guiding policy and ensuring equitable access. This study examined national and regional dispensing trends after the major pandemic waves. Methods Vedolizumab dispensing data from DATASUS (3) between 2021 and 2024 were analysed nationally and by Brazil’s five macro-regions. Metrics included annual totals, year-on-year (YoY) variation, compound annual growth rate (CAGR), regional composition, and concentration indices (Herfindahl–Hirschman Index [HHI], Gini). National counts were modelled as Poisson distributions with normal-approximation 95% confidence intervals (CIs). Yearly changes were summarised as Poisson rate ratios (RRs) with log-transformed 95% CIs. Analyses were performed in Python (pandas, matplotlib) with figures standardised for publication quality (300 dpi, grayscale, labelled axes, colour heatmaps). Results Total dispensations rose from 1 743 in 2021 to 23 483 in 2024 (CAGR 137.9%). YoY RRs were 6.01 (95% CI 5.71–6.32) for 2022 vs 2021, 1.61 (95% CI 1.57–1.65) for 2023 vs 2022, and 1.39 (95% CI 1.37–1.42) for 2024 vs 2023. In 2024, the Southeast region accounted for 58.6% of dispensations, followed by the South (19.7%), Northeast (13.6%), Centre-West (6.8%), and North (1.4%). Regional concentration remained high (HHI 4052; Gini 0.51). Conclusion The steep increase after 2021 indicates recovery from pandemic backlogs and reinstatement of elective IBD care (1,2). The 2022 surge (RR > 1) reflects catch-up initiations delayed during COVID-19 peaks, while continued growth through 2024 suggests systemic consolidation rather than temporary rebound (1). The Southeast’s dominance likely mirrors its higher specialist density and referral-centre capacity. Persistent HHI and Gini values underscore structural inequalities in biologic access across macro-regions. Limitations include the administrative nature of the dataset and absence of clinical variables such as disease activity and treatment persistence. Nevertheless, consistent effect-size estimates and concentration indices support a robust post-pandemic expansion in vedolizumab use in Brazil. Ongoing surveillance linking dispensing data to clinical outcomes is warranted to reduce regional disparities and improve care continuity (2,3). References: 1. Kennedy NA, Jones G-R, Lamb CA, Appleby R, Arnott I, Beattie RM, et al. 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ECCO position paper on biological treatment cycles in inflammatory bowel disease. J Crohns Colitis. 2020;14(12):1609–1623. 7. Fiorino G, Allocca M, Danese S. COVID-19 in patients with inflammatory bowel disease: Management and clinical outcomes. Nat Rev Gastroenterol Hepatol. 2020;17(10):577–579. 8. Ungaro RC, Brenner EJ, Gearry RB, Kaplan GG, Kissous-Hunt M, Lewis JD, et al. Effect of IBD medications on COVID-19 outcomes: Results from an international registry. Gastroenterology. 2022;162(2):316–319. 9. Bezzio C, Saibeni S, Variola A, Allocca M, Massari A, Gerardi V, et al. Outcomes of COVID-19 in patients with inflammatory bowel disease treated with biologics. Aliment Pharmacol Ther. 2020;52(11–12):1410–1418. 10. D’Amico F, Peyrin-Biroulet L, Danese S. Inflammatory bowel disease management during the COVID-19 outbreak: A survey among gastroenterologists. United European Gastroenterol J. 2020;8(7):775–781. 11. Agrawal M, Brenner EJ, Zhang X, Colombel JF, Kappelman MD. Characteristics and outcomes of IBD patients with COVID-19 on biologics: Insights from SECURE-IBD registry. Gut. 2021;70(4):725–732. 12. Macaluso FS, Orlando A, Cottone M. The role of vedolizumab in ulcerative colitis treatment: Current evidence and future perspectives. Ther Adv Gastroenterol. 2020;13:1–15. 13. Baumgart DC, Misery L, Naegeli AN, Ferrante M, Hanauer S, Peyrin-Biroulet L. Biological therapy for Crohn’s disease and ulcerative colitis: Results, risks and perspectives. Nat Rev Gastroenterol Hepatol. 2021;18(10):601–612. 14. Feagan BG, Panaccione R, Sandborn WJ, D’Haens GR, et al. Clinical trial endpoints for therapeutic studies in IBD: Recommendations from the IOIBD. Gastroenterology. 2020;159(2):422–429. 15. D’Amico F, Danese S, Peyrin-Biroulet L. Systematic review on COVID-19 and inflammatory bowel disease: Lessons for future preparedness. J Crohns Colitis. 2022;16(7):1019–1032. 16. World Health Organization. The impact of COVID-19 on health systems: Policy brief. Geneva: WHO; 2021. 17. Brazilian Ministry of Health. Política Nacional de Assistência Farmacêutica: Componentes e diretrizes. Brasília: Ministério da Saúde; 2023. 18. Peyrin-Biroulet L, Oussalah A, Williet N, Roblin X. Impact of immunosuppressants and biologics on COVID-19 outcomes in IBD: A systematic review. Gut. 2021;70(4):725–732. 19. Ungaro R, Colombel JF. Vedolizumab: A gut-selective integrin blocker for the treatment of IBD. Clin Gastroenterol Hepatol. 2017;15(4):584–594. 20. Panaccione R, Danese S. Targeted therapies in inflammatory bowel disease: Future perspectives beyond anti-TNF agents. Gastroenterology. 2022;163(5):1275–1290. Conflict of interest: Da Silva Cornelio, Thiago: No conflict of interest Caroline de Almeida, Erica: No conflict of interest Fernandes Notaro, Daniela: No conflict of interest
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