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Line Uhrenholt, MD, discusses the results of her randomized, open-label, equivalence trial study evaluating disease activity-guided tapering of biologics in patients with inflammatory arthritis.
Rheumatology Network interviewed Line Uhrenholt, MD, to discuss her European Alliance of Associations for Rheumatology (EULAR) 2022 conference presentation “Disease activity-guided tapering of biologics in patients with inflammatory arthritis: A randomised, open-label, equivalence trial.” Uhrenholt is associated with the Department of Rheumatology at Aalborg University Hospital.
Rheumatology Network:What sparked your team's interest in evaluating disease activity-guided tapering in this patient population?
Line Uhrenholt, MD: There have been new studies emerging in the rheumatology field evaluating this topic and we wanted to conduct a trial to explore the disease activity-guided tapering of various biological drugs in patients, not only in rheumatoid arthritis (RA), where the most clinical trials has been performed, but also an axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), to see if we could create 1 tapering algorithm that could be implemented for all 3 diagnoses.
RN: Can you tell me a bit more about this study design?
LU: BIODOPTwas a randomized, open-label, controlled trial. We included patients (N = 142) with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis who were in sustained remission or low disease activity on their biological drugs for 12 months or more. They also had to be on a stable dosage of their biological drugs at 12 months and could not be on prednisone or have had a course of prednisone during the last year. We then randomized patients 2:1 so there were more patients in the tapering group compared to the continuation group to have more data on the tapering group.
RN: What were the key findings of your study?
LU: At 18 months, we assessed how many patients in the tapering group had tapered their biologic dose compared with their baseline dose. In the tapering group, 37% of the patients had tapered their medication by ≥50%, compared with only 2% in the continuation group, ultimately leading to a statistically significant group difference of 35%.
What was also interesting was that when looking at the disease activity at 18 months, there was equivalent disease activity between the 2 trial groups within the pre-specified margin for disease activity. Even though the tapering group received significantly less biological drug doses, the disease activity between both groups were comparable.
RN: What is the clinical significance of these results?
LU: The clinical significance is that for patients with RA, PsA, and axSpA, based on the data from our study, you can implement disease activity-guided tapering and receive significant reduction in the biologic dose for approximately 1/3 of patients. Further, while many patients in the tapering group experienced a flare due to lowering their biological dose, the flares were managed with rescue therapy, including biologic dose escalation, prednisone, or nonsteroidal anti-inflammatory drugs (NSAIDs).
RN: Does your team plan on doing any further research on this topic?
LU: We are looking into if we can identify possible predictors for achieving a successful biological tapering by evaluating baseline characteristics, such as sex, age, and other variables, and putting that data into a model to see if we can predict who will be able to taper their biological therapy more easily. We also plan to investigate an analysis of blood samples taken during the trial to examine drug levels and possible anti-drug antibodies development.