The efficacy and safety of adalimumab in treating axial spondyloarthritis: a systematic review and meta-analysis

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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Journal
BMC Musculoskeletal Disorders
Published
2026-07-22
DOI
https://doi.org/10.1186/s12891-026-10251-y
Primary Topic
Spondyloarthritis Studies and Treatments
Type
article
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article

The efficacy and safety of adalimumab in treating axial spondyloarthritis: a systematic review and meta-analysis

Ani Ma, Bo Dong, Weidong Yue
BMC Musculoskeletal Disorders
Spondyloarthritis Studies and Treatments
article

The efficacy and safety of adalimumab in treating axial spondyloarthritis: a systematic review and meta-analysis

Ani Ma, Bo Dong, Weidong Yue
article en

Abstract

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.

BMC Musculoskeletal Disorders
Xi'an Honghui Hospital (CN), Qi2 (US), Affiliated Hospital of Shaanxi University of Chinese Medicine (CN), Baoji City Central Hospital (CN)
Zero hunger
Openalex Percentile: Top 8%
Spondyloarthritis Studies and Treatments
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