Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial

Autor: Joseph Sexton, Daniel Aletaha, Eirik Klami Kristianslund, Espen Andre Haavardsholm, Nils Bolstad, Johanna Elin Gehin, Silje Watterdal Syversen, David John Warren, Guro Løvik Goll, Ingrid Jyssum, Rolf Anton Klaasen
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: RMD Open, Vol 10, Iss 4 (2024)
Druh dokumentu: article
ISSN: 2056-5933
DOI: 10.1136/rmdopen-2024-004888
Popis: Objectives The objectives of this study are to identify a therapeutic serum level for adalimumab associated with remission and low disease activity in patients with rheumatoid arthritis.Methods Associations between serum adalimumab trough levels and disease activity were examined using longitudinal data from a 48-week randomised phase III trial including patients with tumour necrosis factor inhibitor-naïve rheumatoid arthritis with active disease starting adalimumab treatment. Disease activity was classified according to 28-joint Disease Activity Score (DAS28)-erythrocyte sedimentation rate and C reactive protein (CRP) levels.Results Adalimumab trough levels were recorded longitudinally for 336, 330 and 302 patients at weeks 12, 24 and 48, respectively. All patients received concomitant methotrexate. Median adalimumab trough levels were 6.4 mg/L (IQR 3.4–9.5) at week 12, 7.5 mg/L (IQR 3.5–10.9) at week 24 and 7.6 mg/L (IQR 3.6–12.0) at week 48. In serial serum samples from weeks 12, 24 and 48, trough levels ≥3.9 mg/L were associated with DAS28 remission (OR 3.88 (95% CI 1.80, 8.38), p
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