Your browser doesn't support javascript.
loading
Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study.
Gehin, Johanna Elin; Goll, Guro Løvik; Warren, David John; Syversen, Silje Watterdal; Sexton, Joseph; Strand, Eldri Kveine; Kvien, Tore Kristian; Bolstad, Nils; Lie, Elisabeth.
Afiliação
  • Gehin JE; Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Nydalen, Box 4953, 0424, Oslo, Norway. johgeh@ous-hf.no.
  • Goll GL; Faculty of Medicine, University of Oslo, Oslo, Norway. johgeh@ous-hf.no.
  • Warren DJ; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
  • Syversen SW; Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Nydalen, Box 4953, 0424, Oslo, Norway.
  • Sexton J; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
  • Strand EK; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
  • Kvien TK; Lillehammer Hospital for Rheumatic Diseases, Lillehammer, Norway.
  • Bolstad N; Faculty of Medicine, University of Oslo, Oslo, Norway.
  • Lie E; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
Arthritis Res Ther ; 21(1): 256, 2019 11 29.
Article em En | MEDLINE | ID: mdl-31783773
OBJECTIVES: To identify a therapeutic target interval for certolizumab pegol drug levels and examine the influence of anti-drug antibodies in patients with inflammatory joint diseases. METHODS: Certolizumab pegol and anti-drug antibody levels were measured in serum samples collected after 3 months of certolizumab pegol treatment in 268 patients with inflammatory joint diseases (116 axial spondyloarthritis, 91 rheumatoid arthritis and 61 psoriatic arthritis) in the NOR-DMARD study. Treatment response was defined by Ankylosing Spondylitis Disease Activity Score Clinically important improvement in axial spondyloarthritis, European League Against Rheumatism good/moderate response in rheumatoid arthritis, and improvement in 28-joint Disease Activity Score of ≥ 0.6 in PsA. Serum drug levels and anti-drug antibodies were analysed using automated in-house assays. RESULTS: Certolizumab pegol serum levels varied considerably between individuals (median (IQR) 32.9 (17.3-43.9) mg/L). Certolizumab pegol level ≥ 20 mg/L was associated with treatment response for the total inflammatory joint disease population, with odds ratio (OR) 2.3 (95% CI 1.2-4.5, P = 0.01) and OR 1.9 (95% CI 1.0-3.5, P = 0.05) after 3 and 6 months of treatment, respectively. For individual diagnoses, this association was most consistent for axial spondyloarthritis, with OR 3.4 (95% CI 1.0-11.1, P < 0.05) and OR 3.3 (95% CI 1.0-10.8, P < 0.05), respectively. Certolizumab pegol level > 40 mg/L was not associated with any additional benefit for any of the diagnoses. Anti-drug antibodies were detected in 6.1% (19/310) of samples and were associated with low certolizumab pegol levels (P < 0.01). CONCLUSIONS: Serum certolizumab pegol levels 20-40 mg/L were associated with treatment response in inflammatory joint diseases. Our study is the first to show this association in axial spondyloarthritis and psoriatic arthritis patients. The results suggest a possible benefit of therapeutic drug monitoring in patients with inflammatory joint disease on certolizumab pegol treatment. TRIAL REGISTRATION: NCT01581294, April 2012.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Artrite Reumatoide / Espondilite Anquilosante / Artrite Psoriásica / Espondilartrite / Certolizumab Pegol Tipo de estudo: Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Arthritis Res Ther Assunto da revista: REUMATOLOGIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Noruega País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Artrite Reumatoide / Espondilite Anquilosante / Artrite Psoriásica / Espondilartrite / Certolizumab Pegol Tipo de estudo: Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Arthritis Res Ther Assunto da revista: REUMATOLOGIA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Noruega País de publicação: Reino Unido