Table 2.
Mean clinical end point changes from baseline in patients achieving/not achieving MIC at week 12
| Change in | Tofacitinib | Tofacitinib | Tofacitinib | Pooled tofacitinib | Placebo |
|---|---|---|---|---|---|
| disease outcome | 2 mg BID | 5 mg BID | 10 mg BID | 5 and 10 mg BID | |
| ΔASDAS, mean (s.d.) | |||||
| SI joint ≥MIC (2.5) | −1.7 (1.2) | −1.6 (0.8) | −1.6 (1.2) | −1.6 (1.0) | −1.0 (0.7) |
| n | 12 | 17 | 13 | 30 | 4 |
| SI joint <MIC (2.5) | −1.1 (0.9) | −1.4 (0.8) | −1.4 (0.7) | −1.4 (0.8) | −0.7 (0.9) |
| n | 30 | 26 | 31 | 57 | 28 |
| Spine ≥MIC (5) | −1.9 (0.8) | −1.6 (0.8) | −1.8 (0.7) | −1.7 (0.8) | −1.3 (1.8) |
| n | 12 | 15 | 18 | 33 | 4 |
| Spine <MIC (5) | −1.1 (1.0) | −1.4 (0.9) | −1.3 (0.9) | −1.4 (0.9) | −0.6 (0.7) |
| n | 29 | 2.8 | 26 | 54 | 28 |
| ΔBASDAI, mean ( s.d.) | |||||
| SI joint ≥MIC (2.5) | −4.0 (2.6) | −3.3 (1.8) | −3.8 (2.0) | −3.5 (1.9) | −2.5 (1.7) |
| n | 12 | 17 | 13 | 30* | 4 |
| SI joint <MIC (2.5) | −2.5 (2.1) | −2.8 (1.6) | −2.6 (1.7) | −2.7 (1.6) | −1.8 (2.1) |
| n | 30 | 26 | 31 | 57 | 29 |
| Spine ≥MIC (5) | −4.2 (1.9) | −3.2 (2.1) | −2.7 (1.9) | −3.0 (2.0) | −3.8 (3.0) |
| n | 12 | 15 | 18 | 33 | 4 |
| Spine <MIC (5) | −2.4 (2.3) | −2.9 (1.5) | −3.1 (1.8) | −3.0 (1.6) | −1.6 (1.8) |
| n | 29 | 28 | 26 | 54 | 29 |
| ΔBASFI, mean ( s.d.) | |||||
| SI joint ≥MIC (2.5) | −2.8 (2.1) | −2.9 (1.8) | −2.4 (2.4) | −2.7 (2.0) | −0.8 (0.9) |
| n | 12 | 17 | 13 | 30 | 4 |
| SI joint <MIC (2.5) | −1.7 (1.9) | −2.4 (1.9) | −2.4 (2.0) | −2.4 (1.9) | −1.4 (1.8) |
| n | 30 | 26 | 31 | 57 | 29 |
| Spine ≥MIC (5) | −3.0 (1.9) | −3.0 (2.2) | −2.8 (2.0) | −2.9 (2.1) | −3.0 (2.7) |
| n | 12 | 15 | 18 | 33 | 4 |
| Spine <MIC (5) | −1.7 (1.9) | −2.4 (1.6) | −2.1 (2.1) | −2.2 (2.1) | −1.1 (1.5) |
| n | 29 | 28 | 26 | 54 | 29 |
| ΔTotal back pain, mean ( s.d.) | |||||
| SI joint ≥MIC (2.5) | −4.0 (2.8) | −3.8 (2.5) | −3.4 (3.3) | −3.6 (2.8) | −2.0 (1.8) |
| n | 12 | 17 | 13 | 30 | 4 |
| SI joint <MIC (2.5) | −2.6 (2.6) | −3.1 (1.9) | −2.6 (2.2) | −2.8 (2.1) | −1.8 (2.4) |
| N | 29 | 25 | 31 | 56 | 29 |
| Spine ≥MIC (5) | −4.6 (2.0) | −3.6 (2.1) | −3.5 (2.3) | −3.5 (2.1) | −4.3 (3.1) |
| n | 12 | 14 | 18 | 32 | 4 |
| Spine <MIC (5) | −2.4 (2.7) | −3.3 (2.3) | −2.4 (2.7) | −2.9 (2.5) | −1.5 (2.0) |
| n | 28 | 28 | 26 | 54 | 29 |
P < 0.05 vs patients not achieving the MIC using two-sample t test SI joint ≥MIC (2.5): patients achieving the MIC for SPARCC SI joint score (≥2.5-point decrease); SI joint <MIC (2.5): patients not achieving the MIC for SPARCC SI joint score (<2.5-point decrease) Spine ≥MIC (5): patients achieving the MIC for SPARCC spine score (≥5-point decrease); Spine <MIC (5): patients not achieving the MIC for SPARCC spine score (<5-point decrease). Δ: change from baseline; ASDAS: Ankylosing Spondylitis Disease Activity Score; BID: twice daily; MIC: minimally important change; SI joint: sacroiliac joint; SPARCC: SPondyloArthritis Research Consortium of Canada.