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Switching from originator recombinant growth hormone (Genotropin™) to biosimilar (CRISCY™): Results from a 6-month, multicentric, non-inferiority, extension trial.
Czepielewski, M A; Garret, Q; Vencio, S A C; Rassi, N; Faria, M S; Senn, C C P; Bronstein, M D; Cerqueira, M J A G; Neves, A C L; Spinola-Castro, A M; Cunha, M P R; Leite, N R; Wassermann, G E; Alegria, M C; Toffoletto, O; Afiune, J; Baradelli, R; Rodrigues, D G; Scharf, M.
Afiliação
  • Czepielewski MA; Serviço de Endocrinologia, Hospital de Clínicas de Porto Alegre, UFRGS, Porto Alegre, RS, Brazil. Electronic address: maurocze@terra.com.br.
  • Garret Q; CEDOES, Vitória, ES, Brazil.
  • Vencio SAC; ICF - Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda, Aparecida de Goiânia, GO, Brazil.
  • Rassi N; Hospital Alberto Rassi - HGG, Goiânia, GO, Brazil.
  • Faria MS; Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA, São Luis, MA, Brazil.
  • Senn CCP; Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.
  • Bronstein MD; CPQUALI Pesquisa Clínica Ltda, São Paulo, SP, Brazil.
  • Cerqueira MJAG; Instituto de Ensino e Pesquisa Clínica do Ceará, Fortaleza, CE, Brazil.
  • Neves ACL; Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, PE, Brazil.
  • Spinola-Castro AM; Universidade Federal de São Paulo - UNIFESP/EPM, São Paulo, SP, Brazil.
  • Cunha MPR; CAEP - Centro Avançado de Estudos e Pesquisas Ltda, Campinas, SP, Brazil.
  • Leite NR; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Wassermann GE; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Alegria MC; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Toffoletto O; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Afiune J; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Baradelli R; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Rodrigues DG; Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.
  • Scharf M; Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.
Growth Horm IGF Res ; 56: 101372, 2021 02.
Article em En | MEDLINE | ID: mdl-33260063
ABSTRACT

OBJECTIVE:

A previous 12-month comparative trial with Criscy™ (r-hGH Cristália), a biosimilar recombinant growth hormone, demonstrated equivalent efficacy and safety to Genotropin™. This extension trial evaluated the effects of switching patients treated with Genotropin™ to the biosimilar Criscy™ over an additional 6-month treatment period, comparing efficacy, safety, and immunogenicity parameters with patients remaining in the Criscy™ arm.

DESIGN:

This extension study included 11 research centers and 81 patients who participated in the CERES study (Czepielewski et al., 2019 [1]). Participants from the Genotropinarm (n = 39) had the drug replaced by Criscy™ and the remaining participants were kept in the Criscy™ arm (n = 42) for an additional 6-month period to evaluate immunogenicity, efficacy (growth rate, height SDS), and safety (laboratory tests, and adverse events).

RESULTS:

Before the switch, both Criscy™ and Genotropin groups were similar concerning demographics, and auxological

measures:

age, sex, height, height SDS, weight, and BMI. Height velocity (HV) after 18 months of treatment was 8.7 ± 1.56 cm/year for Criscy™ group and 8.9 ± 1.36 cm/year for Genotropin™ group in the ITT population (p = 0.43). The auxological parameters and IGF-1 and IGFBP-3 SDS were comparable between both groups of patients. No participants were excluded from the study due to adverse events. There were no clinical or statistical relevant differences between the treatment groups concerning frequency, distribution, intensity, and AEs outcome. Similarly, no new anti-r-hGH (ADA) cases among patients that switched from Genotropin™ to Criscy™ were reported. No neutralizing antibody (nAb) was detected in either group.

CONCLUSIONS:

This trial showed that switching from originator recombinant human growth hormone to Criscy™ had no impact on efficacy, safety, nor immunogenicity as compared to continued treatment with Criscy™. Growth rates and ADA incidence remained the same as seen before the switch.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Hormônio do Crescimento Humano / Medicamentos Biossimilares Tipo de estudo: Clinical_trials Limite: Child / Female / Humans / Male Idioma: En Revista: Growth Horm IGF Res Assunto da revista: ENDOCRINOLOGIA Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Hormônio do Crescimento Humano / Medicamentos Biossimilares Tipo de estudo: Clinical_trials Limite: Child / Female / Humans / Male Idioma: En Revista: Growth Horm IGF Res Assunto da revista: ENDOCRINOLOGIA Ano de publicação: 2021 Tipo de documento: Article