Given this, l’Ami and colleagues undertook the open-label, randomized controlled trial to test the hypothesis that prolonging the dosing interval of adalimumab to 40 mg every three weeks in RA patients with trough concentration of >8 µg/mL would not increase disease activity in these patients.
The study found that being female & having longer disease duration were associated with increased risk of flare.
The study included 54 patients randomized to dose-interval prolongation (adalimumab 40 mg every three weeks) (n=27) or standard dosing (40 mg every two weeks) (n=27). All patients in the trial had received adalimumab treatment for RA for at least 28 weeks and had a trough adalimumab level of >8 µg/mL.
At the 26-week follow-up, no clinically relevant change was found in the primary outcome of the study, DAS28, in patients who received the dose-interval prolongation treatment compared with standard dosing.
“We have one important message,” said Ms. l’Ami. “Many patients are overtreated with standard dose of adalimumab. By measuring the adalimumab concentration after 28 weeks of adalimumab treatment, you can identify patients who are overtreated and prolong the dose-interval to every three weeks without a change in disease activity.”
Mary Beth Nierengarten is a freelance medical journalist based in Minneapolis.
References
- den Broeder AA, van Herwaarden N, van der Maas A, et al. Dose Reduction strategy of subcutaneous TNF inhibitors in rheumatoid arthritis: Design of a pragmatic randomized noninferiority trial, the DRESS study. BMC Musculoskelet Disord. 2013 Oct 24;14:299.
- den Broeder AA, Bouman CAM, van den Hoogen FHJ, et al. Long-term outcomes after disease activity guided tapering of tumor necrosis factor inhibition in rheumatoid arthritis: 3 year data of a randomized controlled pragmatic non inferiority strategy study [abstract 3011]. Arthritis Rheumatol. 2016;68(suppl 10).
- Brahe CH, Krabbe S, Østergaard M, et al. Dose reduction or discontinuation of biological therapy in patients with rheumatoid arthritis in remission—1-year results of a guideline-directed longitudinal cohort study [abstract 3013]. Arthritis Rheumatol. 2016;68(suppl 10).
- Ghiti Moghadam M, Vonkeman HE, ten Klooster PM, et al. Clinical predictors of TNF-inhibitor free disease control in patients with rheumatoid arthritis after stopping TNFi treatment: Results from a Dutch multicentre pragmatic open-label randomized controlled trial [abstract 3012]. Arthritis Rheumatol. 2016;68(suppl 10).
- Ghiti Moghadam M, Vonkeman HE, ten Klooster PM, et al. Stopping tumor necrosis factor inhibitor treatment in patients with established rheumatoid arthritis in remission or with stable low disease activity: A pragmatic multicenter, open-label randomized controlled trial. Arthritis Rheumatol. 2016;68(8):1810–1817.
- l’Ami MJ, Marsman AF, Krieckaert CL, et al. Tapering of adalimumab based on therapeutic drug monitoring in rheumatoid arthritis [abstract 3014]. Arthritis Rheumatol. 2016;68(suppl 10).
- Pou MF, Krieckaert CL, Nurmohamed MT, et al. Key findings towards optimising adalimumab treatment: The concentration-effect curve. Ann Rheum Dis. 2015 Mar;74(3):513–518.
- Center for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Review(s). Food and Drug Administration. 2002; pp. 51–54.
