Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study
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...
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| creator | Gehin, Johanna E Goll, Guro L Warren, David J Syversen, Silje W Sexton, Joseph Strand, Eldri K Kvien, Tore K Bolstad, Nils Lie, Elisabeth |
| description | 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 |
| format | Article |
| fullrecord | <record><control><sourceid>cristin_3HK</sourceid><recordid>TN_cdi_cristin_nora_10852_71124</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>10852_71124</sourcerecordid><originalsourceid>FETCH-cristin_nora_10852_711243</originalsourceid><addsrcrecordid>eNqFjEFKA0EQRWeThSSewTpABpyoKO6CMbhRIbgfaqZrkpLurqGqJiHeyTvaiHtX__F4_Ivqe20mPaOzZIOO_ESUoSd1ifw1JexgpL1EMNIpQaQjRVsCZuc66LT_pU4CkxUM4EroibKDko3lk4AzjOW_OIMT-6GIIWJK6KJn-BQucWAjNLJHCOgIg0oCPxC8ve_qzet6twHzKZwX1WzAaHT5t_Pqavv88fRS98rmnNssim1z_XC3au-bZnV783_xA0QHWRk</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><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</title><source>NORA - Norwegian Open Research Archives</source><creator>Gehin, Johanna E ; Goll, Guro L ; Warren, David J ; Syversen, Silje W ; Sexton, Joseph ; Strand, Eldri K ; Kvien, Tore K ; Bolstad, Nils ; Lie, Elisabeth</creator><creatorcontrib>Gehin, Johanna E ; Goll, Guro L ; Warren, David J ; Syversen, Silje W ; Sexton, Joseph ; Strand, Eldri K ; Kvien, Tore K ; Bolstad, Nils ; Lie, Elisabeth</creatorcontrib><description>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.</description><language>eng</language><creationdate>2019</creationdate><rights>info:eu-repo/semantics/openAccess</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,776,881,26544</link.rule.ids><linktorsrc>$$Uhttp://hdl.handle.net/10852/71124$$EView_record_in_NORA$$FView_record_in_$$GNORA$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>Gehin, Johanna E</creatorcontrib><creatorcontrib>Goll, Guro L</creatorcontrib><creatorcontrib>Warren, David J</creatorcontrib><creatorcontrib>Syversen, Silje W</creatorcontrib><creatorcontrib>Sexton, Joseph</creatorcontrib><creatorcontrib>Strand, Eldri K</creatorcontrib><creatorcontrib>Kvien, Tore K</creatorcontrib><creatorcontrib>Bolstad, Nils</creatorcontrib><creatorcontrib>Lie, Elisabeth</creatorcontrib><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</title><description>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.</description><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>3HK</sourceid><recordid>eNqFjEFKA0EQRWeThSSewTpABpyoKO6CMbhRIbgfaqZrkpLurqGqJiHeyTvaiHtX__F4_Ivqe20mPaOzZIOO_ESUoSd1ifw1JexgpL1EMNIpQaQjRVsCZuc66LT_pU4CkxUM4EroibKDko3lk4AzjOW_OIMT-6GIIWJK6KJn-BQucWAjNLJHCOgIg0oCPxC8ve_qzet6twHzKZwX1WzAaHT5t_Pqavv88fRS98rmnNssim1z_XC3au-bZnV783_xA0QHWRk</recordid><startdate>2019</startdate><enddate>2019</enddate><creator>Gehin, Johanna E</creator><creator>Goll, Guro L</creator><creator>Warren, David J</creator><creator>Syversen, Silje W</creator><creator>Sexton, Joseph</creator><creator>Strand, Eldri K</creator><creator>Kvien, Tore K</creator><creator>Bolstad, Nils</creator><creator>Lie, Elisabeth</creator><scope>3HK</scope></search><sort><creationdate>2019</creationdate><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</title><author>Gehin, Johanna E ; Goll, Guro L ; Warren, David J ; Syversen, Silje W ; Sexton, Joseph ; Strand, Eldri K ; Kvien, Tore K ; Bolstad, Nils ; Lie, Elisabeth</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-cristin_nora_10852_711243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><toplevel>online_resources</toplevel><creatorcontrib>Gehin, Johanna E</creatorcontrib><creatorcontrib>Goll, Guro L</creatorcontrib><creatorcontrib>Warren, David J</creatorcontrib><creatorcontrib>Syversen, Silje W</creatorcontrib><creatorcontrib>Sexton, Joseph</creatorcontrib><creatorcontrib>Strand, Eldri K</creatorcontrib><creatorcontrib>Kvien, Tore K</creatorcontrib><creatorcontrib>Bolstad, Nils</creatorcontrib><creatorcontrib>Lie, Elisabeth</creatorcontrib><collection>NORA - Norwegian Open Research Archives</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Gehin, Johanna E</au><au>Goll, Guro L</au><au>Warren, David J</au><au>Syversen, Silje W</au><au>Sexton, Joseph</au><au>Strand, Eldri K</au><au>Kvien, Tore K</au><au>Bolstad, Nils</au><au>Lie, Elisabeth</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study</atitle><date>2019</date><risdate>2019</risdate><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.</abstract><oa>free_for_read</oa></addata></record> |
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| 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 |
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