Biological therapies in inflammatory bowel diseases

levels of evidence and methodological challenges

Authors

  • Letícia Isadora Alves da Silva Lima
  • Erica Nascimento Paranhos do Vale
  • Maria Eduarda Lima Reis
  • Rafaela Oliveira Ribeiro
  • Rossana Vanessa Dantas de Almeida Marques

Keywords:

Biological Therapy; Crohn Disease; Evidence-Based Medicine; Inflammatory Bowel Diseases; Ulcerative Colitis

Abstract

Introduction: Inflammatory Bowel Diseases (IBD), such as Crohn’s disease and Ulcerative Colitis, cause recurrent inflammation and functional impairment. Biological therapies improved management, but methodological variations reduce the strength of evidence. Objective: To critically evaluate and discuss the level of evidence in scientific production on the use of biological therapies for IBD, addressing methodological quality. Methods: Observational, quantitative, descriptive, and analytical study. Articles from PubMed (2020–2025) were assessed with the GRADE methodology. Data were extracted by calibrated reviewers and analyzed with JAMOVI 2.5 software. Literature Review: A total of 140 articles were analyzed. Most showed high-level evidence, while 40% were low quality. Meta-analyses and observational studies predominated. Adverse events were reported in 70% of studies, more frequent in long-term designs. Conclusion: Biological therapies are effective for IBD, but require greater methodological rigor, standardized outcomes, and long-term monitoring to ensure safety and effectiveness.

References

Fabián O, Kamaradová K. Morphology of inflammatory bowel diseases (IBD). Morfologie zánětlivých střevních onemocnění (IBD). Cesk Patol. 2022;58(1):27-37.

Jarmakiewicz-Czaja S, Zielińska M, Sokal A, Filip R. Genetic and Epigenetic Etiology of Inflammatory Bowel Disease: An Update. Genes (Basel). 2022;13(12):2388. Published 2022 Dec 16. doi:10.3390/genes13122388

Singh N, Bernstein CN. Environmental risk factors for inflammatory bowel disease. United European Gastroenterol J. 2022;10(10):1047-1053. doi:10.1002/ueg2.12319

Agrawal M, Spencer EA, Colombel JF, Ungaro RC. Approach to the Management of Recently Diagnosed Inflammatory Bowel Disease Patients: A User's Guide for Adult and Pediatric Gastroenterologists. Gastroenterology. 2021;161(1):47-65. doi:10.1053/j.gastro.2021.04.063

Selinger CP, Rosiou K, Lenti MV. Biological therapy for inflammatory bowel disease: cyclical rather than lifelong treatment?. BMJ Open Gastroenterol. 2024;11(1):e001225. Published 2024 Feb 10. doi:10.1136/bmjgast-2023-001225

LINHARES, M. R. et al. Terapias Imunológicas no Tratamento de Doenças Inflamatórias Intestinais: Impacto dos Novos Agentes Biológicos em Pacientes com Doença De Crohn e Colite Ulcerativa. Revista Brasileira Medicina de Excelência, v. 2, n. 4, p. 678–692, 2024.

Núñez P, Quera R, Yarur AJ. Safety of Janus Kinase Inhibitors in Inflammatory Bowel Diseases. Drugs. 2023;83(4):299-314. doi:10.1007/s40265-023-01840-5

Faria L, Oliveira-Lima JA, Almeida-Filho N. Evidence-based medicine: a brief historical analysis of conceptual landmarks and practical goals for care. Medicina baseada em evidências: breve aporte histórico sobre marcos conceituais e objetivos práticos do cuidado. Hist Cienc Saude Manguinhos. 2021;28(1):59-78. doi:10.1590/S0104-59702021000100004

SOUZA, ACS. Níveis de evidência e níveis de periódicos: análise de impacto de artigos na área de Ortopedia e Traumatologia. 2018. 151 f. Dissertação (Mestrado em Ciência da Informação) - Escola de Comunicações e Artes, Universidade de São Paulo, São Paulo, 2018.345rtg

Schünemann H, Brożek J, Guyatt G, Oxman A, editores. GRADE handbook [Internet]. 4. ed. 2013 [citado 14 jan. 2025]. Disponível em: https://gdt.gradepro.org/app/handbook/handbook.html

Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-1461. doi:10.1053/j.gastro.2020.01.006

Lamb CA, Kennedy NA, Raine T, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults [published correction appears in Gut. 2021 Apr;70(4):1. doi: 10.1136/gutjnl-2019-318484corr1.]. Gut. 2019;68(Suppl 3):s1-s106. doi:10.1136/gutjnl-2019-318484

Mendonça CM, Correa NETO IJF, Rolim A de S, Robles L. INFLAMMATORY BOWEL DISEASES: CHARACTERISTICS, EVOLUTION, AND QUALITY OF LIFE. ABCD Arquivos Brasileiros de Cirurgia Digestiva (São Paulo) [Internet]. 2022 Jun 17;35. doi:10.1590/0102-672020210002e1653

SANDBORN, W. J. et al. Risankizumab as induction and maintenance therapy for Crohn's disease: a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet, v. 396, n. 10262, p. 1732-1744, 2020. DOI: 10.1016/S0140-6736(20)32388-8.

Miola AC, Espósito ACC, Miot HA. Techniques for randomization and allocation for clinical trials. J Vasc Bras. 2025;23:e20240046. Published 2025 Jan 13. doi:10.1590/1677-5449.202400462

Luchini C, Veronese N, Nottegar A, et al. Assessing the quality of studies in meta-research: Review/guidelines on the most important quality assessment tools. Pharm Stat. 2021;20(1):185-195. doi:10.1002/pst.2068

Wang X, Ji X. Sample Size Estimation in Clinical Research: From Randomized Controlled Trials to Observational Studies. Chest. 2020;158(1S):S12-S20. doi:10.1016/j.chest.2020.03.010

Published

2026-03-24

How to Cite

Lima, L. I. A. da S., Vale, E. N. P. do, Reis, M. E. L., Ribeiro, R. O., & Marques, R. V. D. de A. (2026). Biological therapies in inflammatory bowel diseases: levels of evidence and methodological challenges. Revista De Divulgação Científica Sena Aires, 15(Esp. 4), 68–75. Retrieved from https://rdcsa.emnuvens.com.br/revista/article/view/1145