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. 2024 Feb 26;20(5):501–513. doi: 10.2174/0115733971289295240223095751

Table 1.

Characteristics of the main randomized controlled trials.

Clinical Trial Number Gender Age Intervention Treatment Duration Primary Outcomes Adverse Events
Revicki et al. [1] A: 208 A: M 157; F 51 A: 41.7 Adalimumab40 mgs.c. eow 24 ASAS20, ASAS40, BASDAI, SF-36 NA
P: 107 P: M 79; F 28 P: 43.4
Huang et al. [55] A: 229 A: M 185; F 44 A: 30.1 As above 12 ASAS20, ASAS40, BASDAI50, CRP, HAQ-S, SF-36 AE, serious AE, drug discontinuation, infection, serious infections
P: 115 P: M 95; F 20 P: 29.6
Sieper et al. [60] A: 91 A: M 44; F 47 A: 37 As above 12 ASAS20, ASDAS,BASDAI, BASDAI50,SF-36, HAQ-S AE, serious AE, drug discontinuation, infection, serious infections
P: 94 P: M 40; F 54 P: 38.4
Davis et al. [91] A: 208 A: M 157; F 51 A: 41.7 As above 24 ASAS20, ASAS40, BASDAI, ASQoL, SF-36 NA
P: 107 P: M 79; F 28 P: 43.4
Hu et al. [91] A: 26 A: M 24; F 2 A: 28.2 As above 24 BASDAI, BASFI, CRP, ASDAS NA
P: 20 P: M 20; F 0 P: 27.4
van der Heijde et al. [91] A: 208 A: M 236; F 79 A: 42.2 As above 12/24 rescue BASFI, BASDAI, SF-36, ASQoL AE, serious AE, drug discontinuation, infection, serious infections
P: 107 P: M 219; F 69 P: 42.4

Abbreviations: A, adalimumab group; P, placebo group; M, male; F, female; s.c., subcutaneously; eow, every other week; ASAS, Assessment in AS International Working Group; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C-reactive protein; SF-36, Short Form 36; BASFI, Bath Ankylosing Spondylitis Functional Index; HAQ-S, Health Assessment Questionnaire modified for Spondyloarthropathies; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASQoL, Ankylosing Spondylitis Quality of Life questionnaire; AE, adverse events; NA, not applicable.