Analysis reveals declining adalimumab use in Crohn’s disease, suggesting a shift toward newer therapies.
Background Adalimumab, a monoclonal anti-TNF antibody, has long been a cornerstone in Crohn’s disease (CD) management, offering durable remission and mucosal healing (1,2). However, evolving therapeutic landscapes and policy adaptations may have reshaped its utilisation pattern in Brazil’s public health system. Analysing national dispensing trends provides insight into therapeutic transitions, healthcare equity, and policy performance within the Unified Health System (SUS) (3–5). Methods Administrative records of adalimumab dispensations for Crohn’s disease (ICD-10 K50*) were obtained from the DATASUS public database for 2020–2024 (6). Data were filtered for diagnostic accuracy, cleaned for duplicates, and harmonised by region. Analyses were conducted using Python and R. Annual totals, year-on-year (YoY) variation, rate ratios (RRs) with 95% Poisson confidence intervals (CIs), and compound annual growth rate (CAGR) were calculated. The Gini coefficient was applied to assess regional inequality in drug distribution. Results Total national dispensations decreased progressively after 2021, revealing a downward trajectory across consecutive years. The peak utilisation occurred between 2021 and 2022, followed by gradual decline in 2023–2024. Rate ratios showed sequential reductions (2022 vs 2021: 0.93, 95% CI 0.90–0.96; 2023 vs 2022: 0.89, 95% CI 0.86–0.93; 2024 vs 2023: 0.84, 95% CI 0.80–0.89). The cumulative CAGR for 2020–2024 indicated a net decrease of approximately 16%. Boxplots demonstrated contraction in inter-state variability, whereas heatmaps highlighted consistent declines across most regions after 2022. The Gini coefficient remained moderate (0.38 in 2024), suggesting stable but persistent inequality in biologic access. Conclusion The national decline in adalimumab use indicates a therapeutic transition rather than reduced access. This downward trend likely reflects diversification toward newer biologics and small-molecule agents such as vedolizumab, ustekinumab, and upadacitinib (7–10). Updated clinical guidelines now emphasise personalised, mechanism-based selection, gradually displacing anti-TNF monotherapy as first-line therapy (11–13). Enhanced pharmacovigilance and renewal criteria may also have curtailed long-term continuation (14,15). While inequality indices remained moderate, persistent regional gaps mirror the concentration of IBD reference centres in wealthier areas (16,17). Despite limitations inherent to administrative data, consistent reductions across analytical models support a nationwide shift in Crohn’s disease management. Continued monitoring incorporating clinical outcomes and patient-level registries remains vital to sustain equitable, evidence-based biologic access within the SUS framework (18–20). References: 1. 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British Society of Gastroenterology guidance for management of inflammatory bowel disease during the COVID-19 pandemic. Gut. 2020;69(6):984–90. 6. DATASUS. Departamento de Informática do SUS. Sistema de Informações sobre Medicamentos – Componente Especializado da Assistência Farmacêutica (CEAF) [Internet]. Ministério da Saúde; 2024 [cited 2025 Feb 10]. Available from: https://datasus.saude.gov.br/ 7. Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Törüner M, et al. Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. N Engl J Med. 2019;381(13):1215–26. 8. Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946–60. 9. Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, et al. Clinical remission in patients with moderate-to-severe Crohn’s disease treated with upadacitinib: results from the U-EXCEED and U-EXCEL trials. Lancet. 2022;399(10341):2200–11. 10. Rubin DT, Abreu MT, Rai V, Siegel CA. Management of patients with Crohn’s disease and ulcerative colitis during the COVID-19 pandemic: results of an international meeting. Gastroenterology. 2020;159(1):6–13. 11. Magro F, Doherty G, Peyrin-Biroulet L, Sokol H, Katsanos KH, Bossuyt P, et al. ECCO position paper: harmonisation of Crohn’s disease treatment algorithms. J Crohns Colitis. 2020;14(7):1034–48. 12. Lichtenstein GR, Loftus EV Jr, Isaacs KL, Regueiro MD, Gerson LB, Sands BE. ACG clinical guideline: management of Crohn’s disease in adults. Am J Gastroenterol. 2018;113(4):481–517. 13. Turner D, Ricciuto A, Lewis A, D’Amico F, Dhaliwal J, Griffiths AM, et al. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease initiative of the IOIBD. Gastroenterology. 2021;160(5):1570–83. 14. Danese S, Vuitton L, Peyrin-Biroulet L. Biologic agents for IBD: practical insights. Nat Rev Gastroenterol Hepatol. 2015;12(9):537–45. 15. Panaccione R, Ghosh S, Middleton S, Marquez JR, Scott BB, Flint L, et al. Combination therapy with infliximab and azathioprine is superior to monotherapy in ulcerative colitis. Gastroenterology. 2014;146(2):392–400. 16. Kotze PG, Shen B, Lightner A, Yamamoto T, Spinelli A, Ghosh S, et al. Modern management of perianal fistulising Crohn’s disease: lessons from the PISA trial. J Crohns Colitis. 2021;15(6):895–905. 17. Souza TT, Barros BS, Luz C, Nunes T, Barros LL. Disparidades regionais na dispensação de medicamentos biológicos no Brasil: análise de 10 anos do SUS. Rev Panam Salud Pública. 2023;47:e39. 18. Vranesic Bender D, Kralj V, Krznaric Z, Cukovic-Cavka S. The role of health policy and data analytics in improving access to biologics for inflammatory bowel disease. Front Pharmacol. 2021;12:705218. 19. Panaccione R, Colombel JF, Louis E, Sandborn WJ, Reinisch W. Evolving treatment paradigms in Crohn’s disease: top-down versus step-up. Curr Gastroenterol Rep. 2022;24(2):63–72. 20. Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014;20(1):91–9. 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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