Trial results back TNF inhibitor dose-reduction strategy in ankylosing spondylitis patients
medwireNews: A dose-reduction strategy may be feasible for ankylosing spondylitis (AS) patients in sustained clinical remission with tumor necrosis factor (TNF) inhibitor treatment, findings from the open-label REDES-TNF trial suggest.
Caridad Pontes (Universitat Autònoma de Barcelona, Spain) and co-researchers demonstrated that the proportion of patients with low disease activity (LDA; BASDAI score <4, plus physician global assessment, patient global assessment, and nocturnal axial pain scores all <4 on a visual analog scale) after 1 year was comparable among the 58 participants who were randomly assigned to receive a reduced dose of their TNF inhibitor and the 55 patients who continued to receive the full recommended TNF inhibitor dose, at rates of 81.3% versus 83.8%.
The adjusted difference between 1-year LDA rates, at 2.5%, met the prespecified criteria for noninferiority of the dose-reduction strategy, report the investigators in Arthritis Research & Therapy.
All patients were in persistent clinical remission at the time of trial entry, defined as a BASDAI score of no higher than 2 points, no clinically active arthritis or enthesitis, and C-reactive protein levels below the upper limit of normal for at least 6 months.
The researchers say that a “conservative TNF [inhibitor] reduction schedule was applied in this study,” with participants in the dose-reduction group given approximately 50% of the standard dose. For instance, the 44 patients treated with adalimumab received a dose of 40 mg every 3 weeks (dose-reduction group) or 40 mg every 2 weeks (control group), and the respective doses were 50 mg every 10 days or 25 mg every 3 days/50 mg every 7 days for the 38 etanercept-treated patients.
Pontes and coworkers describe lower rates of overall (27.9 vs 35.5%), treatment-related (8.2 vs 12.9%), and severe (18.0 vs 22.6%) adverse events among patients receiving the reduced- versus the standard-dose regimen. Rates of infection were also lower among patients given reduced doses (4.9 vs 17.7%).
“This suggests low TNF [inhibitor] doses might have a better safety profile, but confirmation is needed, since the size and duration of our study were insufficient to draw conclusions,” write the study authors.
Nonetheless, they say that “the differences [in adverse event rates] might be relevant, especially since these are long-term treatments for often-fragile patients.”
And the team concludes that “[i]n spite of a number of limitations, this is the first randomized trial to support the non-inferiority of reduced-dose TNF [inhibitor] doses compared with full doses” in AS patients in stable clinical remission.
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