Mean change from baseline in efficacy variables
| Change from baseline to week 12 | Change from baseline to week 24 | ||||
|---|---|---|---|---|---|
| Variable, mean (SD) | Placebo (N=115) | Adalimumab (N=229) | p Value* | Placebo to adalimumab (N=113†) | Continuous adalimumab (N=224†) |
| BASDAI total score, cm | −1.4 (1.9) | −2.8 (1.9) | <0.0001 | −3.6 (2.1) | −3.7 (2.0) |
| ASDAS total score | −0.6 (0.8) | −2.0 (1.1) | <0.0001 | −2.3 (1.2) | −2.3 (1.1) |
| PGA (0–10 VAS), cm | −1.8 (1.7) | −3.1 (1.6) | <0.0001 | −4.4 (1.4) | −4.4 (1.7) |
| PTGA (0–10 VAS), cm | −1.2 (2.2) | −2.9 (2.4) | <0.0001 | −3.6 (2.5) | −3.8 (2.5) |
| Total back pain (0–10 VAS), cm | −1.4 (2.3) | −3.2 (2.4) | <0.0001 | −3.8 (2.4) | −4.2 (2.3) |
| BASFI score | −4.7 (16.4) | −17.5 (20.2) | <0.0001 | −20.9 (21.5) | −23.2 (21.0) |
| Inflammation/morning stiffness,‡ cm | −1.5 (2.2) | −2.9 (2.0) | <0.0001 | −3.6 (2.2) | −3.6 (2.2) |
| MASES | −0.8 (1.7) | −1.2 (2.1) | 0.030 | −1.4 (2.0) | −1.5 (2.3) |
| hs-CRP, mg/dl | −4.2 (21.2) | −17.8 (23.8) | <0.0001 | −20.1 (30.6) | −18.2 (24.3) |
| Chest expansion, cm | 0.3 (1.1) | 0.4 (1.3) | 0.923 | 0.7 (1.2) | 0.5 (1.3) |
| BASMIlin | −0.2 (0.7) | −0.5 (0.6) | <0.0001 | −0.5 (0.6) | −0.6 (0.7) |
| Nocturnal pain (0–10 VAS), cm | −1.2 (2.1) | −3.0 (2.5) | <0.001 | −3.5 (2.4) | −4.0 (2.5) |
| Patient's global assessment of pain (0–10 VAS), cm | −1.1 (2.2) | −3.0 (2.4) | <0.001 | −3.7 (2.3) | −3.9 (2.3) |
| Swollen joint count (44 joints) | −0.1 (0.8) | −0.2 (0.7) | 0.019 | −0.2 (0.7) | −0.2 (0.8) |
| Tender joint count (46 joints) | −0.7 (1.8) | −1.2 (3.0) | 0.004 | −1.2 (2.1) | −1.3 (2.8) |
| BAS-G | −9.2 (17.7) | −24.3 (22.3) | <0.0001 | −30.1 (23.0) | −34.0 (23.7) |
| HAQ-S | −0.2 (0.4) | −0.3 (0.5) | <0.0001 | −0.4 (0.4) | −0.4 (0.5) |
| SF-36 physical component score | 4.0 (6.3) | 6.6 (6.4) | <0.0001 | 9.2 (7.3) | 8.6 (7.4) |
| SF-36 mental component score | 2.8 (9.4) | 5.1 (9.9) | 0.002 | 6.6 (10.2) | 5.7 (9.9) |
| WPAI-SHP activity impairment | −10.1 (20.3) | −21.1 (24.1) | <0.001 | −25.7 (24.3) | −28.1 (25.0) |
| WPAI-SHP overall work impairment | −12.3 (21.1)§ | −18.8 (23.7)§ | 0.009 | −29.6 (22.1)¶ | 26.3 (28.4)¶ |
*Based on an analysis of covariance model adjusting for baseline.
‡Mean of questions 5 and 6 of the BASDAI.
†N represents all randomised subjects who completed week 12 and had ≥1 dose of study drug during the open-label period.
§Placebo, N=60; adalimumab, N=140.
¶Placebo to adalimumab, N=53; adalimumab, N=127.
AS, Ankylosing spondylitis; ASDAS, AS Disease Activity Score; BASDAI, Bath AS Disease Activity Index; BASFI, Bath AS Functional Index; BAS-G, Bath AS Patient Global Score; BASMIlin, Bath AS Metrology Index linear; HAQ-S, Health Assessment Questionnaire modified for spondyloarthropathies; hs-CRP, high-sensitivity C-reactive protein; MASES, Maastricht AS Enthesitis Score; PGA, Physician Global Assessment of Disease Activity; PTGA, Patient Global Assessment of Disease Activity; SF-36, 36-Item Short Form Health Survey; VAS, visual analogue scale; WPAI-SHP, Work Productivity and Activity Impairment-Specific Health Problem.