Secondary outcome measures at randomization and followup. Secondary outcome measures include the following self-report instruments: ASAS20, 40, 5 of 6, and partial remission; BASMI, BASFI, ASQoL, ASDAS, EASi-QoL, EQ-5D, patient GDA, patient night pain, physician GDA. CRP levels and proportions of patients discontinuing therapy for different reasons (classified as “lack of efficacy,” “toxicity,” “both,” and “other reasons”). Values are mean (SD) median unless otherwise specified.
| Outcome Measure | Randomization, 6 Mos | Followup, 6 Mos Postrandomization | ||
|---|---|---|---|---|
| 25 mg, n = 23 | 50 mg, n = 24 | 25 mg, n = 23 | 50 mg, n = 24 | |
| ASAS20, n (%) | 18/22 (81.8) | 19/21 (90.5) | 14/22 (63.6) | 20/22 (90.0) |
| ASAS40, n (%) | 12/22 (54.5) | 18/21 (85.7)* | 10/22 (45.5) | 18/22 (81.8)* |
| ASAS5 of 6, n (%) | 12/15 (80.0) | 14/18 (77.8) | 9/16 (56.2) | 16/17 (94.1)* |
| ASAS partial remission, n (%) | 2/23 (8.7) | 4/24 (16.7) | 1/23 (4.3) | 7/24 (29.2)* |
| BASMI | 3.17 (2.50) 2.00 | 2.54 (2.52) 2.00 | 3.43 (2.15) 3.00 | 2.21 (1.98)* 2.00 |
| BASFI | 4.20 (2.21) 3.90 | 2.51 (1.80)** 2.15 | 4.54 (2.19) 4.00 | 2.60 (2.17)** 2.13 |
| ASQoL | 6.63 (5.13) 5.00 | 4.33 (4.33) 3.50 | 7.27 (5.29) 6.00 | 4.96 (4.98) 3.00 |
| ASDAS | 2.15 (1.02) 1.85 | 1.70 (0.70) 1.49 | 2.18 (0.94) 2.02 | 1.60 (0.79)* 1.33 |
| EASi-QoL | ||||
| Physical function | 6.29 (3.47) 6.00 | 4.75 (3.22)* 3.50 | 6.83 (3.11) 6.00 | 5.21 (4.32)* 4.00 |
| Disease activity | 5.39 (2.55) 5.00 | 4.75 (3.22) 3.50 | 6.17 (2.90) 6.00 | 5.13 (3.70) 5.00 |
| Emotional well-being | 5.22 (4.31) 5.00 | 4.13 (3.88) 4.00 | 6.22 (5.11) 5.00 | 4.61 (4.21) 3.00 |
| Social participation | 5.78 (3.84) 6.00 | 4.65 (3.82) 5.00 | 6.45 (4.07) 5.50 | 5.61 (4.51) 5.00 |
| EQ-5D VAS | 7.09 (1.95) 8.00 | 7.55 (1.47) 7.10 | 5.94 (2.08) 6.50 | 7.04 (1.82) 7.20 |
| Patient night pain | 2.97 (2.18) 3.00 | 1.99 (1.66) 2.00 | 3.43 (2.66) 3.00 | 2.06 (2.19) 1.80 |
| Patient GDA | 3.33 (2.26) 3.00 | 3.14 (2.13) 2.75 | 4.24 (2.42) 3.00 | 2.84 (2.28)* 2.60 |
| Physician GDA | 2.60 (1.87) 2.10 | 2.11 (1.86) 2.10 | 2.85 (1.65) 2.60 | 1.87 (1.39)* 1.50 |
| CRP, mg/l | 3.51 (2.73) 2.99 | 2.95 (2.28) 2.99 | 4.82 (7.84) 2.00 | 6.21 (9.34) 2.99 |
| Discontinuation of therapy, n*** | 0 | 0 | 4 | 0 |
↵* p < 0.05.
↵** p < 0.01 on Fisher’s exact test (categorical data) or Mann-Whitney U test (continuous data).
↵*** To be randomized, participants had to meet response criteria; 4 participants in the stepdown arm had their 50-mg dosage reinstated. ASAS: Assessment of Spondyloarthritis international Society; BASMI: Bath Ankylosing Spondylitis Metrology Index; BASFI: Bath Ankylosing Spondylitis Functional Index; ASQoL: Ankylosing Spondylitis Quality of Life score; ASDAS: Ankylosing Spondylitis Disease Activity Score; EASi-QoL: Evaluating Ankylosing Spondylitis Quality of Life; VAS: visual analog scale; GDA: global disease activity; CRP: C-reactive protein.