Variables | Placebo → GOL, 2 mg/kg | GOL, 2 mg/kg |
---|---|---|
Patients randomized, n | 103 | 105 |
Clinical efficacy | ||
ASAS20 | 67 (65.0) | 73 (69.5) |
ASAS40 | 53 (51.5) | 59 (56.2) |
ASAS partial remission | 25 (24.3) | 26 (24.8) |
ASAS 5/6 response | 56 (54.4) | 69 (65.7) |
BASDAI50 | 57 (55.3) | 59 (56.2) |
BASDAI70 | 36 (35.0) | 35 (33.3) |
ASDAS inactive disease | 27 (26.2) | 27 (25.7) |
ASDAS major improvement | 46 (45.1) | 48 (46.6) |
ASDAS clinically important improvement from baseline | 73 (71.6) | 79 (76.0) |
BASMI, change from baseline | −0.4 ± 0.7 | −0.4 ± 0.6 |
BASFI, change from baseline | −2.6 ± 2.5 | −2.7 ± 2.5 |
Enthesitisb | ||
n | 85 | 87 |
Change from baseline | −3.6 ± 4.0 | −3.8 ± 5.0 |
HRQOL | ||
Patients, n | 102 | 104 |
Change from baseline | ||
ASQoL | −5.4 ± 5.3 | −5.5 ± 5.3 |
SF-36 PCS | 9.7 ± 8.1 | 9.5 ± 8.8 |
SF-36 MCS | 5.1 ± 11.9 | 7.3 ± 10.6 |
Data are presented as mean ± SD or n (%) unless otherwise specified.
↵a Missing data were imputed using last observation carried forward. For dichotomous composite endpoints with all components missing, nonresponder imputation was used through Week 52.
↵b Among patients with enthesitis at baseline. GOL: golimumab; ASAS20/40: ≥ 20%/40% improvement in Assessment of SpondyloArthritis international Society criteria; ASDAS: Ankylosing Spondylitis Disease Activity Score; ASQoL: Ankylosing Spondylitis Quality of Life; BASDAI50/70: 50%/70% improvement in Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; BASMI: Bath Ankylosing Spondylitis Metrology Index; HRQOL: health-related quality of life; SF-36: 36-item Medical Outcomes Study Short Form; PCS: physical summary score; MCS: mental summary score.