Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease.
Expert Opin Biol Ther
; 24(7): 691-708, 2024 Jul.
Article
em En
| MEDLINE
| ID: mdl-38979696
ABSTRACT
INTRODUCTION:
Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and safety of originator-to-biosimilar switching. This systematic literature review evaluated safety and effectiveness of switching between IFX products in patients with IBD, including multiple switchers.METHODS:
Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012-2022) including patients with IBD who switched between approved IFX products. Effectivenessoutcomes:
disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safetyoutcomes:
incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %) anti-drug antibodies; patients receiving concomitant immunomodulatory medication.RESULTS:
Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.CONCLUSIONS:
Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches. PROTOCOL REGISTRATION www.crd.york.ac.uk/prospero identifier is CRD42021289144.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fármacos Gastrointestinais
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Doenças Inflamatórias Intestinais
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Substituição de Medicamentos
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Medicamentos Biossimilares
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Infliximab
Limite:
Humans
Idioma:
En
Revista:
Expert Opin Biol Ther
Ano de publicação:
2024
Tipo de documento:
Article