Session Type: Abstract Submissions (ACR)
Background/Purpose: We performed a Cochrane systematic review to determine the benefits and harms of non-steroidal anti-inflammatory drugs (NSAIDs) in axial spondyloarthritis (axSpA).
Methods: We included all published randomised controlled trials (RCTs) of NSAIDs versus any comparator in adult patients with axial SpA identified by searches in MEDLINE, EMBASE and CENTRAL (until April 2014). The comparisons investigated were traditional NSAIDs versus placebo, COX-2 NSAIDs versus placebo, traditional NSAIDs versus COX-2 NSAIDs, NSAIDs in low versus high dose and NSAIDs versus NSAIDs. Main efficacy outcomes were pain, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI) and radiographic progression. Main safety outcomes were number of withdrawals due to adverse events and number of serious adverse events. Risk of bias of included studies was assessed according to the Cochrane risk of bias tool.
Results: Forty-one trials (n=6073) with a median duration of 12 weeks (range 1 week to 2 years) met inclusion criteria. Thirty-one studies (n=5317) with a median duration of 12 weeks (range 2 to 26 weeks) could be included in quantitative data-analysis. Most studies were at unclear risk of selection bias, although blinding was adequate in most trials and many trials had low risk of attrition and reporting bias.
In 5 RCTs (n=1165), comparing conventional NSAIDs versus placebo (duration 2 to 12 weeks), there was a consistent significant effect in all efficacy variables favouring NSAIDs, for example pain on VAS: mean difference (MD) -16.5 (95% CI -20.8 to -12.2) in 4 trials (n=850). There were no significantly more (serious or any) adverse events or withdrawals due to adverse events, except for more gastrointestinal adverse events in patients taking NSAIDs (RR 1.92 (95% CI 1.41 to 2.61), 5 trials, n=1289). We found similar results in the comparison COX-2 versus placebo (3 studies, n=669). When comparing conventional NSAIDs to COX-2 we found no difference in either efficacy or safety (4 studies, n=995). In general we found no clear dose-effect on efficacy or safety. When comparing different NSAIDs to each other, no important difference in efficacy could be determined. However, 11 studies (n=1135) showed that indomethacin resulted in more adverse events than other NSAIDs (RR 1.25 (95% CI 1.06 to 1.49)), in particular neurological adverse events like headache and dizziness (RR 1.96 (95% CI 1.06 to 3.57), 9 trials, n=963), although there were not more withdrawals due to adverse events.
Conclusion: In patients with axial SpA, overall high quality trials indicate that traditional and COX-2 NSAIDs are consistently more efficacious than placebo, without a significant difference between the two NSAIDs classes. Various NSAIDs do not differ in efficacy in low to moderate quality trials, although indomethacin seems to result in more, mainly neurological, adverse events, even though this did not lead to more withdrawals. Results of this review support current recommendations for treatment of axial Spa with NSAIDs.
L. van der Burg,
D. van der Heijde,
« Back to 2014 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/non-steroidal-anti-inflammatory-drugs-in-axial-spondyloarthritis-a-cochrane-review/