Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial.
J Intern Med
; 292(3): 477-491, 2022 09.
Article
en En
| MEDLINE
| ID: mdl-35411981
ABSTRACT
BACKGROUND:
Anti-drug antibodies (ADAb) frequently form early in the treatment course of infliximab and other tumour necrosis factor (TNF) inhibitors, leading to treatment failure and adverse events.OBJECTIVE:
To identify risk factors for ADAb in the early phase of infliximab treatment.METHODS:
Patients (n = 410) with immune-mediated inflammatory diseases who initiated infliximab treatment were included in the 38-week Norwegian Drug Monitoring Trial (NOR-DRUM) A and randomised 11 to therapeutic drug monitoring (TDM) or standard therapy. Serum levels of infliximab and ADAb were measured at each infusion. Possible risk factors for ADAb formation were assessed using logistic regression, adjusting for potential confounders.RESULTS:
ADAb were detected in 78 (19%) patients. A diagnosis of rheumatoid arthritis (RA) (odds ratio [OR], 1.9 [95% confidence interval [CI] 1.0-3.6]) and lifetime smoking (OR, 2.0 [CI 1.1-3.6]) were baseline risk factors, while baseline use of concomitant immunosuppressors (OR, 0.4 [CI 0.2-0.8]) and a diagnosis of spondyloarthritis (SpA) (OR, 0.4 [CI 0.2-0.8]) reduced the risk of ADAb. Higher disease activity during follow-up (OR, 1.1 [CI 1.0-1.1]) and "drug holidays" of more than 11 weeks (OR, 4.1 [CI 1.2-13.8]) increased the risk of ADAb, whereas higher infliximab doses (OR, 0.1 [CI 0.0-0.3) and higher serum infliximab concentrations (OR, 0.7 [CI 0.6-0.8]) reduced the risk of immunogenicity.CONCLUSION:
Several risk factors for ADAb formation during early-phase infliximab treatment were identified. This knowledge provides a basis for treatment strategies to mitigate the formation of ADAb and identify patients in whom these measures are of particular importance.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Artritis Reumatoide
/
Antirreumáticos
/
Infliximab
/
Anticuerpos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
J Intern Med
Asunto de la revista:
MEDICINA INTERNA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Noruega