BACKGROUND: Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disorder. Multiple randomized controlled trials (RCTs) have verified the efficacy of adalimumab for axSpA. Nevertheless, few integrated analyses explore its time-varying efficacy across different disease subtypes and age groups, and the optimal treatment time point and full respiratory disorders remain unclear. METHODS: We searched four electronic databases for eligible RCTs up to September 1, 2022. Two researchers independently screened literature and extracted data. Methodological bias was assessed using the Cochrane risk-of-bias tool, and Stata 15.0 was adopted for quantitative meta-analysis. RESULTS: Nine studies involving 1113 patients were included. At week 12, adalimumab significantly increased ASAS20 [RR = 2.36, 95% CI (1.94, 2.87)], ASAS40 [RR = 3.16, 95% CI (2.46, 4.06)], ASAS5/6 [RR = 4.07, 95% CI (3.09, 5.37)] and ASAS partial remission [RR = 5.29, 95% CI (3.02, 9.26)] response rates. Disease activity indicators, including ASDAS [SMD = -1.31, 95% CI (-1.52, -1.09)] and BASDAI [SMD = -0.81, 95% CI (-0.99, -0.63)], were significantly lower, while CRP [SMD = -0.52, 95% CI (-0.70, -0.35)], total back pain [SMD = -0.68, 95% CI (-0.86, -0.49)], nighttime back pain [SMD = -0.69, 95% CI (-0.88, -0.50)], BASMI [SMD = -0.39, 95% CI (-0.58, -0.20)] and BASFI [SMD = -0.60, 95% CI (-0.77, -0.42)] were also markedly reduced. No significant between-group difference was detected in the incidence of adverse events. DISCUSSION: Adalimumab achieves peak efficacy at week 12, with comparable efficacy in radiographic and non-radiographic axSpA, and works effectively in adolescents aged ≥ 12 years. Despite possible infections, respiratory disorders and liver dysfunction, adalimumab possesses a favorable safety profile. These results underpin its standardized clinical use for axSpA.
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