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Effectiveness of Break-Off Versus Regular Nonsteroidal Anti-Inflammatory Drugs Therapy on 24-Week Flare-Free Rate for Patients with Remission from Axial Spondyloarthritis: A Multicenter Randomised Controlled Trial
34 Pages Posted: 28 Mar 2023
More...Abstract
Background: Long-term and full-dose use of nonsteroidal anti-inflammatory drugs (NSAIDs) for axial spondyloarthritis (axSpA ) is in debating in consideration of it’s benefits and side effects. We aimed to compare effectiveness between the break-off versus the regular NSAIDs therapy on the 24-week flare-free rate among axSpA patients with remission at baseline.
Methods: It was a multicenter, randomized, parallel-controlled, open-label trial. Patients with axSpA with remission after a 4-week washout period were screened in 5 hospitals in southern China from 2018 to 2022. The primary outcome was the 24-week flare-free rate. Intention to treat (ITT) population were applied to primary analyses and safety analyses. This trial was registered with ClinicalTrials.gov, number NCT03425812.
Findings: A total of 92 patients were randomly assigned to receive break-off (n=45) or regular (n=47) NSAIDs therapy. During 24 weeks of follow-up, 67 patients (32 in the break-off and 35 in the regular NSAIDs therapy groups) kept flare-free, and the cumulative probability of flare-free rate in the break-off group was not significantly different from that of the regular group (71·1±6·8% vs. 74·5±6·4%, respectively, p-value=0·690). And the break-off group showedsignificantly higher CRP levels, but not other clinical parameters of disease activity indices, than the regular group. Four and seven patients reported gastrointestinal events in the break-off and regular therapy groups, respectively, with no significant difference.
Interpretation: For patients with remission from axSpA, the break-off NSAIDs therapy was non-inferoir to the regular one on the cumulative probability of 24-week flare-free rate, which supported short-term break-off NSAIDs therapy for them.
Trial Registration: The trial was registered with ClinicalTrial.gov (Identified ID: NCT03425812).
Funding: This study was supported by National Natural Science Foundation of China [grant number U1605223, 81971536, 81701556] and Xiamen Medical and Health Key Projects [grant number 3502Z20209004].
Declaration of Interest: The authors report no conflict of interest to declare.
Ethical Approval: The First Affiliated Hospital of Xiamen University (ethics committee reference number: KYH2018- 006), The First Affiliated Hospital of Fujian Medical University (ethics committee reference number: MRCTA, ECFAHof FMU [2018]198), Quanzhou Orthopedics-Traumatological Hospital (ethics committee reference number: [2018]12), Peking University Shenzhen Hospital (ethics committee reference number: [2018]034), and Fujian Medical University Union Hospital (ethics committee reference number: 2018YF032-01). The study was conducted in accordance with the principle of good clinical practice and the Declaration of Helsinki, and approved by the Institutional Review Boards of each participating center.
Keywords: break-off NSAIDs therapy, regular NSAIDs therapy, axial spondyloarthritis, randomized controlled trial, flare-free rate, remission
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