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TNF Dose Reduction Safe, Effective, and Less Costly for Some RA Patients
Boston—Tumor necrosis factor (TNF) inhibitors are often used for the treatment of rheumatoid arthritis (RA); however, they are associated with side effects, and they are costly medications. The DRESS [Dose Reduction Strategies of Subcutaneous TNF Inhibitors] study sought to examine a dose-reduction strategy for TNF inhibitors related to safety and efficacy in RA patients. The results of this randomized, controlled, noninferiority study were presented at the ACR/ARHP meeting.
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The study’s primary goal was to assess noninferiority with regard to persistent disease flare between a TNF inhibitor dose reduction strategy and usual care in daily clinical practice.
The study included 180 RA patients who had low disease activity and were using either adalimumab or etanercept for treatment. Patients were randomized to a dose reduction strategy or usual care, both in a tight control setting. The TNF inhibitor dose reduction strategy consisted of a stepwise increase of the interval between injections every 3 months until flare or discontinuation. If the patient experienced a flare, the dose was either restarted or escalated and no further dose optimization attempts were made.
A flare was defined as a Disease Activity Score 28 using C-reactive protein (DAS28-CRP) increase >1.2 or DAS28-CRP increase >0.6 and current DAS28-CRP ≥3.2 compared to baseline. A persistent flare was defined as a flare lasting ≥12 weeks.
The patients were followed for 18 months and data were collected on DAS28-CRP scores, physical function, health-related quality of life, RA medication use, and costs, including work loss, outpatient visits, and travel costs.
The researchers found that in the dose reduction group, TNF inhibitors could be successfully stopped in 20% of the patients. They also found that the interval could be successfully increased in 43% of the patients. However, in 37% of patients included in the study, no dose reduction was possible. The researchers also found that costs were significantly lower in the dose reduction group, with a mean difference per patient estimated at $11,480 during the 18-month study period.
Adverse events reported were similar among the dose reduction and usual care groups, according to the researchers.
“As the yearly revenues for adalimumab and etanercept alone exceed $20 billion, implementation of the DRESS findings could result in improved cost-effectiveness of the use of these biologics,” said the study’s lead author, Noortje van Herwaarden, MD, Sint Maartenskliniek, Netherlands, in a press release.
The study’s authors concluded that a tight control TNF inhibitor dose reduction is noninferior to usual care in maintaining disease control, function, and quality of life in RA patients with low disease activity. This strategy may also help reduce healthcare costs in this population, according to the study’s authors.—Kerri Fitzgerald