PB0655 - Minor surgical procedures and the outcome of immunotolerance induction: an analysis of the BrazIT Study

Monday, July 11, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Ricardo M. Camelo, MD, MSc, MBA

Physician
Faculty of Pharmacy, Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil

Co-Author(s)

Maíse M. Dias

Researcher
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, São Paulo, Brazil
Ribeirão Preto, Sao Paulo, Brazil
Ld

Laura Peixoto de Magalhães

Physician
Department of Clinics, Faculty of Medicine, Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Letícia Lemos Jardim, PhD

Researcher
Instituto René Rachou (Fiocruz Minas), Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Ad

Andrea G. de Oliveira

Researcher
Fundação Centro de Hematologia e Hemoterapia de Minas Gerais (Hemominas), Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
RR

Rosângela A. Ribeiro

Researcher
Centro de Hematologia e Hemoterapia do Ceará (Hemoce), Ceará, Brazil
Fortaleza, Ceara, Brazil
VF

Vivian K B Franco

Researcher
Centro de Hematologia e Hemoterapia de Santa Catarina (Hemosc), Santa Catarina, Brazil
Florianópolis, Santa Catarina, Brazil
MR

Maria do Rosário F. Roberti

Researcher
Centro de Hematologia e Hemoterapia de Goiás (Hemogo), Goiás, Brazil
Goiânia, Goias, Brazil
FC

Fábia M R A Callado

Researcher
Fundação de Hematologia e Hemoterapia de Pernambuco (Hemope), Pernambuco, Brazil
Recife, Pernambuco, Brazil
LE

Leina Y. Etto

Researcher
Centro de Hematologia e Hemoterapia da Paraíba (Hemoíba), Paraíba, Brazil
João Pessoa, Paraiba, Brazil
MC

Maria Aline F. Cerqueira

Researcher
Centro de Hematologia e Hemoterapia do Piauí (Hemopi), Piauí, Brazil
Teresina, Piaui, Brazil
MC

Mônica H. Cerqueira

Researcher
Instituto de Hematologia do Estado do Rio de Janeiro (Hemorio), Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
CS

Claudia Santos Lorenzato

Haematologist
Centro de Hematologia e Hemoterapia do Paraná (HEMEPAR),
Curitiba, Parana, Brazil
IP

Ieda S. Pinto

Researcher
Fundação Centro de Hematologia e Hemoterapia do Pará (Hemopa), Pará, Brazil
Belém, Para, Brazil
�S

Édvis Santos Soares Serafim

Physician
Centro de Hematologia e Hemoterapia do Rio Grande do Norte (HEMONORTE)
Natal, Rio Grande do Norte, Brazil
AA

Andrea Aparecida Garcia

Researcher
Faculdade Regional de Medicina de São José do Rio Preto, Brazil
São José do Rio Preto,, Sao Paulo, Brazil
TA

Tânia H. Anegawa

Researcher
Centro Regional de Hematologia e Hemoterapia de Londrina, Paraná, Brazil
Londrina, Parana, Brazil
DC

Daniele Campos Fontes Neves

Researcher
Fundação Hemocentro de Rondônia (FHEMERON)
Porto Velho, Rondonia, Brazil
DT

Doralice Marvulle Tan

Physician
Department of Pediatric Onco-hematology, Faculdade de Medicina de Marília
Marília, Sao Paulo, Brazil
SR

Suely M. Rezende

Researcher
Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil

Background: Inhibitors against factor VIII (FVIII) are associated with increased bleeding episodes, worse musculoskeletal outcomes, lower quality of life, and higher mortality in people with hemophilia A (PwHA). Immune tolerance induction (ITI) is the treatment of choice to eradicate inhibitors and recover the hemostatic activity of FVIII. Surgeries may induce immunological imbalances, perpetuating the stimuli to inhibitor maintenance.

Aims: Herein, we performed an analysis of the Brazilian Immunotolerance (BrazIT) Study to evaluate the impact of surgical procedures during ITI on its outcome.

Methods: PwHA on ITI (n = 207) were enrolled in 15 Brazilian hemophilia treatment centers. PwHA were treated according to the Brazilian ITI Protocol, which consists of starting with a low dose of FVIII (50 international units [IU]/kg 3x/week). High-dose ITI (100 IU/kg/day) was started if inhibitor titers did not reduce at least 20% of peak levels after 6 months. ITI outcomes were defined as (i) complete success: negative inhibitor titer ( < 0.6 BU/mL) and a normal FVIII pharmacokinetics (recovery ≥66% of expected values, and half-life ≥6 h) (ii) partial success: inhibitor titer ≤2 BU/mL and/or abnormal FVIII pharmacokinetics; and (iii) failure: success criteria was not achieved after 33 months of ITI. Clinical, laboratory, and therapeutic data were collected from medical files using a standardized form.

Results: A total of 161 (77.8%) of PwHA who completed ITI provided information on surgical procedures. The overall success rate of ITI was 68.9%. Forty-nine surgical procedures were reported for 31 (19.3%) PwHA during ITI. All the described procedures were minor surgeries. Central line insertion/removal was the most frequent (34.7%). The success rates were similar between PwHA who were submitted to surgeries during ITI (71.0%) and those who were not (68.5%; p >0.05).

Conclusion(s): We conclude that minor surgical procedures during ITI do not alter its outcome.