Table 1.
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.