dc.contributor.author | Gehin, Johanna E | |
dc.contributor.author | Goll, Guro L | |
dc.contributor.author | Warren, David J | |
dc.contributor.author | Syversen, Silje W | |
dc.contributor.author | Sexton, Joseph | |
dc.contributor.author | Strand, Eldri K | |
dc.contributor.author | Kvien, Tore K | |
dc.contributor.author | Bolstad, Nils | |
dc.contributor.author | Lie, Elisabeth | |
dc.date.accessioned | 2019-12-03T17:02:22Z | |
dc.date.available | 2019-12-03T17:02:22Z | |
dc.date.issued | 2019 | |
dc.identifier.citation | Arthritis Research & Therapy. 2019 Nov 29;21(1):256 | |
dc.identifier.uri | http://hdl.handle.net/10852/71124 | |
dc.description.abstract | 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. | |
dc.language.iso | eng | |
dc.rights | The Author(s). | |
dc.rights | Attribution 4.0 International | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.title | Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study | |
dc.type | Journal article | |
dc.date.updated | 2019-12-03T17:02:23Z | |
dc.creator.author | Gehin, Johanna E | |
dc.creator.author | Goll, Guro L | |
dc.creator.author | Warren, David J | |
dc.creator.author | Syversen, Silje W | |
dc.creator.author | Sexton, Joseph | |
dc.creator.author | Strand, Eldri K | |
dc.creator.author | Kvien, Tore K | |
dc.creator.author | Bolstad, Nils | |
dc.creator.author | Lie, Elisabeth | |
dc.identifier.cristin | 1760534 | |
dc.identifier.doi | https://doi.org/10.1186/s13075-019-2009-5 | |
dc.identifier.urn | URN:NBN:no-74258 | |
dc.type.document | Tidsskriftartikkel | |
dc.type.peerreviewed | Peer reviewed | |
dc.identifier.fulltext | Fulltext https://www.duo.uio.no/bitstream/handle/10852/71124/1/13075_2019_Article_2009.pdf | |
dc.type.version | PublishedVersion | |
cristin.articleid | 256 | |