Time between inhibitor detection and start of immune tolerance induction: Association with outcome in the BrazIT study.
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Camelo Ricardo Mesquita, Dias Maíse Moreira, Caram-Deelder Camila, Gouw Samantha, de Magalhães Laura Peixoto, Zuccherato Luciana Werneck, Jardim Letícia Lemos, de Oliveira Andrea Gonçalves, de Albuquerque Ribeiro Rosângela, Franco Vivian Karla Brognoli, do Rosário Ferraz Roberti Maria, de Araújo Callado Fábia Michelle Rodrigues, Etto Leina Yukari, de Cerqueira Maria Aline Ferreira, Cerqueira Mônica Hermida, Lorenzato Cláudia Santos, de Souza Ieda Solange, Serafim Édvis Santos Soares, Garcia Andrea Aparecida, Anegawa Tânia Hissa, Neves Daniele Campos Fontes, Tan Doralice Marvulle, van der Bom Johanna, Rezende Suely Meireles, Brazilian Immune Tolerance (BrazIT) Study group
Аннотация
OBJECTIVE: The aim of this study was to evaluate this association among a large cohort of severe PwHA-HRi.
METHODS: Severe (factor VIII activity level <1%) PwHA-HRi on ITI (n = 142) were enrolled in 15 hemophilia treatment centers. PwHA-HRi were treated according to the Brazilian ITI Protocol. ITI outcomes were defined as success (i.e., recovered responsiveness to exogenous FVIII) and failure (i.e., no responsiveness to exogenous FVIII and requirement of bypassing agents to control bleeding).
RESULTS: Median ages at inhibitor detection and at ITI start were 3.2 years (interquartile range [IQR], 1.6-8.1) and 6.9 years [IQR, 2.6-20.1), respectively. PwHA-HRi were stratified according to ∆tinhi-ITI quartiles: first (0.0-0.6 year), second (>0.6-1.7 year), third (>1.7-9.2 years), and fourth quartile (>9.2-24.5 years). The overall success rate was 65.5% (93/142), with no difference among first, second, third, and fourth quartiles (62.9%, 69.4%, 58.3%, and 71.4%, respectively) even after adjusting the analyses for potential confounders.
CONCLUSION: In conclusion, delayed ITI start is not associated with failure of ITI in PwHA-HRi. Therefore, ITI should be offered for these patients, regardless of the time elapsed between the detection of inhibitor and the ITI start.