medwireNews: The efficacy and safety profiles of disease activity-guided dose reduction of tumor necrosis factor (TNF) inhibitors are maintained for up to 3 years in patients with rheumatoid arthritis (RA), follow-up results of the DRESS study suggest.
Although TNF inhibitors provide “benefits for symptoms, functioning, quality of life and inhibition of joint damage,” their use is associated with a dose-dependent increased risk for infection and skin cancer, in addition to high costs and burden of self-injection, say Chantal Bouman (Sint Maartenskliniek, Nijmegen, the Netherlands) and study co-authors.
Previous findings from the intervention phase of the DRESS study demonstrated that a dose reduction strategy for adalimumab and etanercept is “feasible and non-inferior to usual care with regard to prolonged flaring,” they add.
Patients in the dose reduction group underwent 3-monthly stepwise increases in the injection time interval until flare or discontinuation alongside standardized tight control treatment to maintain a Disease Activity Score at 28 joints based on C-reactive protein (DAS28-CRP) score below 3.2 points, whereas those in the usual care group received standardized tight control treatment only. After month 18, patients originally assigned to the usual care group were allowed to undergo dose reduction at their rheumatologist’s discretion.
From month 18 to 36, 10% of 115 patients in the dose reduction group experienced major flare – defined as a flare lasting for more than 12 weeks – compared with 12% of 57 participants in the usual care group.
The difference between groups was –2%, and the upper limit of the 95% confidence intervals (CI), at 15%, was less than the noninferiority margin of 20%, “compatible with non-inferiority” of the dose-reduction versus usual care strategy, report the researchers in the Annals of the Rheumatic Diseases.
The cumulative incidence of major flare over the whole 3-year study period was 17% for patients in the dose reduction group and 14% in the usual care group.
From baseline to the 18-month follow-up, 20% of patients in the dose reduction group successfully discontinued their biologic treatment from baseline to month 18, with 17% remaining biologic-free until the 36-month follow-up. The majority (86%) of patients in the usual care group did not undergo dose reduction in the first part of the study, but 65% attempted the strategy from month 18 to 36, with 14% of these participants discontinuing treatment by month 36.
Although patients in the dose reduction group experienced “a large reduction in TNF [inhibitor] use” over the extension phase of the study, the researchers note that “other benefits of tapering, including less [adverse events], were not observed.”
Indeed, a comparable proportion of patients in the dose reduction and usual care groups experienced adverse events from month 18 to 36, at 34% versus 39%.
Together, these findings suggest that “a disease activity-guided [dose reduction] strategy of [TNF inhibitors] in patients with RA doing well seems a reasonable long-term approach in RA treatment,” write Bouman and colleagues.
And they conclude: “Further optimisation of this strategy could consist of identification of predictors for successful [dose reduction] or discontinuation.”
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