Fendrix vs Engerix-B for Primo-Vaccination Against Hepatitis B Infection in Patients With Inflammatory Bowel Disease: A Randomized Clinical Trial.

Autor:	Chaparro M; Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain., Gordillo J; Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain., Domènech E; Gastroenterology Unit, Hospital Universitari Germans Trias i Pujol, CIBERehd, Badalona, Spain., Esteve M; Gastroenterology Unit, Hospital Universitari Mutua Terrassa, CIBERehd, Terrassa, Spain., Barreiro-de Acosta M; Gastroenterology Unit, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain., Villoria A; Gastroenterology Unit, Hospital de Sabadell, CIBERehd, Sabadell, Spain., Iglesias-Flores E; Gastroenterology Unit, Hospital Universitario Reina Sofía, IMIBIC Universidad de Córdoba, Córdoba, Spain., Blasi M; Gastroenterology Unit, Hospital Santa Creu i Sant Pau, Barcelona, Spain., Naves JE; Gastroenterology Unit, Hospital Universitari Germans Trias i Pujol, CIBERehd, Badalona, Spain., Benítez O; Gastroenterology Unit, Hospital Universitari Mutua Terrassa, CIBERehd, Terrassa, Spain., Nieto L; Gastroenterology Unit, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain., Calvet X; Gastroenterology Unit, Hospital de Sabadell, CIBERehd, Sabadell, Spain., García-Sánchez V; Gastroenterology Unit, Hospital Universitario Reina Sofía, IMIBIC Universidad de Córdoba, Córdoba, Spain., Villagrasa JR; Preventive Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain., Marin AC; Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain., Donday MG; Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain., Abad-Santos F; Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Facultad de Medicina, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), CIBERehd, Madrid, Spain.; UICEC Hospital Universitario de La Princesa, Plataforma SCReN (Spanish Clinical Research Network), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain., Gisbert JP; Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
Jazyk:	angličtina
Zdroj:	The American journal of gastroenterology [Am J Gastroenterol] 2020 Nov; Vol. 115 (11), pp. 1802-1811.
DOI:	10.14309/ajg.0000000000000926
Abstrakt:	Introduction: To compare Engerix-B and Fendrix hepatitis B virus for primo vaccination in inflammatory bowel disease (IBD). Methods: Patients with IBD were randomized 1:1 to receive Engerix-B double dose or Fendrix single dose at months 0, 1, 2, and 6. Anti-HBs titers were measured 2 months after the third and fourth doses. Response to vaccination was defined as anti-HBs ≥100 UI/L. Anti-HBs titers were measured 2 months after the third and fourth doses and again at 6 and 12 months after the fourth dose. Results: A total of 173 patients were randomized (54% received Engerix-B and 46% Fendrix). Overall, 45% of patients responded (anti-HBs ≥100 IU/L) after 3 doses and 71% after the fourth dose. The response rate after the fourth dose was 75% with Fendrix vs 68% with Engerix-B (P = 0.3). Older age and treatment with steroids, immunomodulators, or anti-tumor necrosis factor were associated with a lower probability of response. However, the type of vaccine was not associated with the response. Anti-HBs titer negativization occurred in 13% of patients after 6 months and 20% after 12 months. Anti-HBs ≥100 IU/L after vaccination was the only factor associated with maintaining anti-HBs titers during follow-up. Discussion: We could not demonstrate a higher response rate of Fendrix (single dose) over Engerix-B (double dose). A 4-dose schedule is more effective than a 3-dose regimen. Older age and treatment with immunomodulators or anti-tumor necrosis factors impaired the success. A high proportion of IBD patients with protective anti-HBs titers after vaccination loose them over time. The risk of losing protective anti-HBs titers is increased in patients achieving anti-HBs <100 IU/L after the vaccination.
Databáze:	MEDLINE
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