Vedolizumab in Mild-to-Moderate Crohn's Disease Patients Naïve to Biological Therapy: A Multicentric Observational Study.

Autor:	Dotti AZ; Hospital de Clínicas das UFPR, Curitiba, Brazil., Magro DO; Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil., Vilela EG; Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Chebli JMF; Universidade Federal de Juiz de Fora, Brazil., Chebli LA; Universidade Federal de Juiz de Fora, Brazil., Steinwurz F; Hospital Israelita Albert Einstein, São Paulo, Brazil., Argollo M; Hospital São Luiz (Rede D'or), São Paulo, Brazil., Carvalho NS; Hospital São Luiz (Rede D'or), São Paulo, Brazil., Parente JML; Universidade Federal do Piauí, Teresina, Brazil., Lima MM; Universidade Federal do Piauí, Teresina, Brazil., Parra RS; Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Brazil., Perin RL; Universidade de Passo Fundo (UPF), Passo Fundo, Brazil., Flores C; Instituto do Aparelho Digestivo (IAD), Porto Alegre, Brazil., Morsoletto EM; Hospital São Vicente, Curitiba, Brazil., da Costa Ferreira S; Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Brazil., Ludvig JC; Clínica LUDVIG/ ESADI, Blumenau, Brazil., Kaiser Junior RL; Kaiser Clínica, São José do Rio Preto, Brazil., Faria MAG; Kaiser Clínica, São José do Rio Preto, Brazil., Nicollelli GM; Hospital de Clínicas das UFPR, Curitiba, Brazil., Andrade AR; Universidade Estadual da Bahia (UNEB), Salvador, Brazil., Queiroz NSF; Hospital Santa Cruz, Curitiba, Brazil., Kotze PG; Pontificia Universidade Católica do Paraná (PUCPR), Curitiba, Brazil.
Jazyk:	angličtina
Zdroj:	Crohn's & colitis 360 [Crohns Colitis 360] 2023 Sep 22; Vol. 5 (4), pp. otad053. Date of Electronic Publication: 2023 Sep 22 (Print Publication: 2023).
DOI:	10.1093/crocol/otad053
Abstrakt:	Background: In real-world experience, the number of patients using vedolizumab as first-line biological therapy was low. We aimed to evaluate the effectiveness and safety of vedolizumab in mild-to-moderate Crohn's disease (CD) biologic-naïve patients. Methods: We performed a retrospective multicentric cohort study with patients who had clinical activity scores (Harvey-Bradshaw Index [HBI]) measured at baseline and weeks 12, 26, 52, as well as at the last follow-up. Clinical response was defined as a reduction ≥3 in HBI, whereas clinical remission as HBI ≤4. Mucosal healing was defined as the complete absence of ulcers in control colonoscopies. Kaplan-Meier survival analysis was used to assess the persistence with vedolizumab. Results: From a total of 66 patients, 53% (35/66) reached clinical remission at week 12. This percentage increased to 69.7% (46/66) at week 26, and 78.8% (52/66) at week 52. Mucosal healing was achieved in 62.3% (33/53) of patients. Vedolizumab was well tolerated, and most adverse events were minor. During vedolizumab treatment, 3/66 patients underwent surgery. Conclusions: This study demonstrates the effectiveness and safety of vedolizumab as a first-line biological agent in patients with mild-to-moderate CD. Competing Interests: P.G.K. and N.S.F.Q. hold the position of Associate Editor for Crohn’s & Colitis 360 and has been recused from reviewing or making decisions for the manuscript. A.Z.D. received a funding to a Master’s Degree scholarship for 2 years. D.O.M., E.G.V., M.M.L., R.L.P., R.L.K.J., and M.A.G.F. have nothing to declare. J.M.F.C. served as speaker for Abbott, Abbvie, Janssen and Takeda. LAC e ARA served as speaker for Janssen, Takeda, Abbvie. F.S. served as Advisory board member of Eurofarma, Janssen, Pfizer, Takeda, and speaker for AbbVie, Amgen, Ferring, Janssen, Pfizer, Sandoz, and Takeda. M.A. served as speaker from Janssen, Takeda, Abbvie, and Pfizer. NSC served as speaker from Janssen, Abbvie, and Sandoz. J.M.L.P. and J.C.L. served as speaker for Takeda. R.S.P. received lecture fee[s] from AbbVie, Janssen, Takeda, Pfizer; is an advisory committee member for Janssen and AbbVie; and he also does clinical research for Janssen and Abbvie. C.F. served as speaker from Takeda, Abbvie, Janssen, Sandoz, Pfizer. E.M.M. served as speaker from Takeda, Janssen, and Ferring. S.C.F. and G.M.N. served as speaker for Takeda and Janssen. N.S.F.Q. served a speaker and advisory board member for Janssen, Takeda, and Abbvie. P.G.K. served as speaker and consultancy for Janssen, Takeda, Abbvie, and Pfizer. (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)
Databáze:	MEDLINE
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