Analysis of AS end points stratified by the presence/history or absence of chronic peripheral arthritis
| Peripheral arthritis | Treatment | No | Baseline Mean (SD) | Change from baseline LS Mean (95% CI) | Difference (95% CI) |
|---|---|---|---|---|---|
| *Difference from placebo is significant at p<0.05. | |||||
| Patient assessment of spine pain (VAS) | |||||
| Treatment by strata interaction test, p = 0.005 | |||||
| Present | Placebo | 37 | 78.7 (17.3) | −17.5 (−24.7 to −10.3) | |
| Present | Active | 117 | 77.6 (15.4) | −34.5 (−38.6 to −30.4) | −17.0* (−25.3 to −8.7) |
| Absent | Placebo | 56 | 76.2 (13.8) | −10.0 (−15.9 to −4.1) | |
| Absent | Active | 175 | 77.7 (14.5) | −42.5 (−45.8 to −39.2) | −32.5* (−39.2 to −25.7) |
| Patient assessment of peripheral pain—BASDAI question No 3 (VAS) | |||||
| Treatment by strata interaction test, p = 0.45 | |||||
| Present | Placebo | 37 | 61.8 (27.0) | 0.9 (−5.9 to 7.6) | |
| Present | Active | 117 | 61.2 (27.5) | −16.4 (−20.3 to −12.6) | −17.3* (−25.0 to −9.6) |
| Absent | Placebo | 56 | 45.4 (31.9) | −5.5 (−11.0 to −0.1) | |
| Absent | Active | 175 | 43.5 (31.5) | −26.6 (−29.7 to −23.5) | −21.1* (−27.4 to −14.8) |
| Patient assessment of enthesopathy—BASDAI question No 4 (VAS) | |||||
| Treatment by strata interaction test, p = 0.29 | |||||
| Present | Placebo | 37 | 59.9 (27.9) | −6.5 (−13.3 to 0.4) | |
| Present | Active | 117 | 59.1 (27.2) | −21.3 (−25.2 to −17.5) | −14.9* (−22.7 to −7.0) |
| Absent | Placebo | 56 | 51.8 (28.3) | −7.3 (−12.9 to −1.8) | |
| Absent | Active | 175 | 51.7 (29.1) | −27.6 (−30.8 to −24.5) | −20.3* (−26.7 to −13.9) |
| Patient global assessment of disease activity (VAS) | |||||
| Treatment by strata interaction test, p = 0.32 | |||||
| Present | Placebo | 37 | 66.5 (21.8) | −3.3 (−10.0 to 3.5) | |
| Present | Active | 117 | 64.8 (23.3) | −22.0 (−25.7 to −18.2) | −18.7* (−26.4 to −10.9) |
| Absent | Placebo | 56 | 62.8 (20.5) | −4.3 (−9.7 to 1.2) | |
| Absent | Active | 175 | 63.4 (20.3) | −28.0 (−31.1 to −24.9) | −23.7* (−30.0 to −17.5) |
| Bath Ankylosing Spondylitis Functional Index (VAS) | |||||
| Treatment by strata interaction test, p = 0.39 | |||||
| Present | Placebo | 37 | 55.2 (29.8) | −3.5 (−9.2 to 2.3) | |
| Present | Active | 117 | 58.3 (23.8) | −14.9 (−18.2 to −11.7) | −11.4* (−18.0 to −4.8) |
| Absent | Placebo | 56 | 53.4 (25.2) | −5.1 (−9.8 to −0.4) | |
| Absent | Active | 175 | 53.7 (23.3) | −20.3 (−22.9 to −17.6) | −15.2* (−20.6 to −9.8) |
| Morning stiffness—mean of BASDAI questions 4 and 5 (VAS) | |||||
| Treatment by strata interaction test, p = 0.45 | |||||
| Present | Placebo | 37 | 61.8 (26.0) | −5.7 (−12.4 to 1.0) | |
| Present | Active | 117 | 61.8 (25.4) | −24.4 (−28.1 to −20.6) | −18.7* (−26.4 to −11.0) |
| Absent | Placebo | 56 | 65.0 (21.4) | −6.2 (−11.6 to −0.7) | |
| Absent | Active | 175 | 62.6 (23.7) | −28.7 (−31.8 to −25.6) | −22.5* (−28.8 to −16.2) |