Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial
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...
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BMJ Publishing Group
2024-11-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/10/4/e004888.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Joseph Sexton |
| collection | DOAJ |
| description | 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<0.001) and lower CRP levels (p<0.001). Week 12 trough levels ≥3.5 mg/L were associated with DAS28 low disease activity at week 24 (OR 2.62 (1.50, 4.56), p<0.001) and remission at week 48 (OR 1.99 (1.02, 3.88), p=0.04), as well as lower CRP levels at both time points (p<0.001).Conclusion Adalimumab trough levels above 4.0 mg/L were associated with remission/low disease activity throughout the first year of adalimumab therapy and can be considered a lower target level for therapeutic drug monitoring of adalimumab therapy. |
| format | Article |
| id | doaj-art-f7d775b33b4a44a5b570036de9438788 |
| institution | Kabale University |
| issn | 2056-5933 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
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| series | RMD Open |
| spelling | doaj-art-f7d775b33b4a44a5b570036de94387882024-11-14T05:50:07ZengBMJ Publishing GroupRMD Open2056-59332024-11-0110410.1136/rmdopen-2024-004888Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trialJoseph Sexton0Daniel Aletaha1Eirik Klami Kristianslund2Espen Andre Haavardsholm3Nils Bolstad4Johanna Elin Gehin5Silje Watterdal Syversen6David John Warren7Guro Løvik Goll8Ingrid Jyssum9Rolf Anton Klaasen10Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, NorwayDivision of Rheumatology, Medical University of Vienna, Vienna, AustriaCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, NorwayCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, NorwayDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, NorwayDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, NorwayCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, NorwayDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, NorwayCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, NorwayCenter for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, NorwayDepartment of Medical Biochemistry, Oslo University Hospital, Oslo, NorwayObjectives 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<0.001) and lower CRP levels (p<0.001). Week 12 trough levels ≥3.5 mg/L were associated with DAS28 low disease activity at week 24 (OR 2.62 (1.50, 4.56), p<0.001) and remission at week 48 (OR 1.99 (1.02, 3.88), p=0.04), as well as lower CRP levels at both time points (p<0.001).Conclusion Adalimumab trough levels above 4.0 mg/L were associated with remission/low disease activity throughout the first year of adalimumab therapy and can be considered a lower target level for therapeutic drug monitoring of adalimumab therapy.https://rmdopen.bmj.com/content/10/4/e004888.full |
| spellingShingle | 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 Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial RMD Open |
| title | Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial |
| title_full | Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial |
| title_fullStr | Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial |
| title_full_unstemmed | Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial |
| title_short | Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial |
| title_sort | therapeutic serum level for adalimumab in rheumatoid arthritis explorative analyses of data from a randomised phase iii trial |
| url | https://rmdopen.bmj.com/content/10/4/e004888.full |
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