Table 4.
Disease activity and patient-reported outcome measures.
| Tofacitinib (n = 20) | Placebo (n = 10) | Difference in change (tofacitinib vs. placebo) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Outcome variable | Day 1 | Day 56 | Day 84 | Day 1 | Day 56 | Day 84 | Day 1 | Day 56* | Day 84** |
| mean ± SD | mean ± SD | mean ± SD | mean ± SD | mean ± SD | mean ± SD | P value |
P value difference (95% CI) |
P value difference (95% CI) |
|
| SF-36 total | 110.3 ± 9.6 | 113.3 ± 9.5 | 111.9 ± 9.3 | 107.6 ± 8.4 | 111.5 ± 8.1 | 108 ± 9.8 | 0.46 | 0.91, −0.20 (−3.69, 3.29) | 0.31, 2.92 (−2.84, 8.69) |
| MD-Fatigue average | 1.6 ± 1.7 | 1.9 ± 2.2 | 2.1 ± 2.2 | 4.4 ± 2.7 | 2.2 ± 1.6 | 2.3 ± 2.2 | 0.001 | 0.016, 1.47 (0.30, 2.65) | 0.04, 1.71 (0.04, 3.36) |
| SLEDAI-2K | 5.1 ± 2.2 | 4.2 ± 2.3 | 3.9 ± 1.9 | 5.5 ± 3.7 | 4.5 ± 2.4 | 4.9 ± 2.9 | 0.68 | 0.95, 0.04 (−1.04, 1.11) | 0.25, −0.72 (−1.98, 0.53) |
| PGA | 0.8 ± 0.8 | 0.8 ± 0.9 | 0.9 ± 0.7 | 1.2 ± 0.9 | 0.9 ± 0.8 | 0.8 ± 0.8 | 0.21 | 0.43, 0.18 (−0.28, 0.64) | 0.38, 0.23 (−0.30, 0.76) |
| DAS-28-ESR | 2.7 ± 1.3 | 2.5 ± 1.2 | 2.5 ± 0.9 | 3.2 ± 2 | 2.9 ± 1.6 | 2.8 ± 1.3 | 0.44 | 0.73, −0.09 (−0.61, 0.43) | 0.81, 0.05 (−0.40, 0.51) |
| CLASI total activity | 2.6 ± 1.9 | 1.9 ± 1.7 | 2.1 ± 1.8 | 2.4 ± 1.7 | 2.1 ± 1.7 | 2.2 ± 1.5 | 0.83 | 0.35, −0.31 (−1.03, 0.42) | 0.54, −0.26 (−1.12, 0.60) |
| CLASI total damage*** | 1 ± 2.1 | 1.1 ± 2.2 | 1.1 ± 2.2 | 1 ± 2.2 | 0.9 ± 2.2 | 0.9 ± 2.2 | 1 | 0.46 | 0.46 |
| BILAG 2004† | 7.6 ± 4.6 | 6.2 ± 4.8 | 5.5 ± 3.9 | 9.3 ± 4.3 | 8.1 ± 5.5 | 7.9 ± 4.4 | 0.32 | 0.36, 1.56 (−1.86, 4.98) | 0.16, −2.04 (−4.96, 0.89) |
SF 36 Short Form Health Survey, MD-Fatigue Multidimensional Assessment of Fatigue Questionnaire, SLEDAI 2 K Systemic Lupus Erythematosus Disease Activity Index 2000, PGA Physician Global Assessment, DAS 28-ESR Disease Activity Score of the 28 joints with erythrocyte sedimentation rate, CLASI Cutaneous Lupus Erythematosus Disease Area and Severity Index, BILAG 2004 British Isles Lupus Assessment Group Disease Activity Index.
*To calculate the P value and the estimated difference (95% confidence interval) in change from baseline (tofacitinib vs. placebo), the linear mixed-effects models were used to include all the other time points between baseline and day 56.
**To calculate the P value and the estimated difference (95% confidence interval) in change from baseline (tofacitinib vs. placebo), the analysis of covariance (ANCOVA) test was used to analyze data on day 84 only.
***Due to the violation of the normality assumption, the Wilcoxon ranked-sum test was used to assess the baseline data and to compare the change scores for day 56 and day 84 separately. The 95% confidence intervals were not provided.
†BILAG 2004 numerical scoring method: A = 12, B = 8, C = 1, D = 0, and E = 0.
Two-tailed tests were used where appropriate.
No adjustments were made for multiple comparisons.