In:
Annals of the Rheumatic Diseases, BMJ, Vol. 77, No. 4 ( 2018-04), p. 484-487
Abstract:
High adalimumab serum concentrations do not result in better response in patients with rheumatoid arthritis (RA), suggesting overexposure. We investigated whether patients with adalimumab concentrations 〉 8 µg/mL can prolong their dosing interval by 50% without a clinically relevant change in disease activity. Methods Consecutive patients with RA, treated with adalimumab 40 mg every other week for at least 28 weeks, were approached for this randomised, open-label, non-inferiority trial. Patients with adalimumab trough concentrations 〉 8 µg/mL were randomly (1:1) assigned to dose-interval prolongation of once every 3 weeks or continuation of every other week. Primary outcome was the change in disease activity score of 28 joints (ΔDAS28-ESR) after 28 weeks, with a non-inferiority margin of 0.6 points. Results In total, 147 patients were screened. Fifty-five patients had concentrations 〉 8 µg/mL and were randomised. Mean ΔDAS28 after 28 weeks was –0.14±SD 0.61 in the prolongation group and 0.30±0.52 in the continuation group. Mean difference was significantly in favour of the prolongation group: 0.44 (95% CI 0.12 to 0.76, p=0.01). Conclusions Adalimumab-treated patients with RA with trough concentrations 〉 8 µg/mL can prolong their standard dosing interval to once every 3 weeks without loss of disease control. Trial registration number NTR3509; Results.
Type of Medium:
Online Resource
ISSN:
0003-4967
,
1468-2060
DOI:
10.1136/annrheumdis-2017-211781
DOI:
10.1136/annrheumdis-2017-211781.supp2
DOI:
10.1136/annrheumdis-2017-211781.supp1
Language:
English
Publisher:
BMJ
Publication Date:
2018
detail.hit.zdb_id:
1481557-6
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