Table 1.
Baseline values and LSM changes from baseline, percentage of patients with improvement ≥MCID, and NNT at month 3 for PRO measures (full analysis set, no imputation), for patients receiving tofacitinib 5 mg or 10 mg twice daily, or placeboa
| Baseline | Change from baseline at month 3 | Patients reporting improvements ≥MCID at month 3 | NNT to achieve MCID | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| PRO measure | 5 mg (n = 312)b | 10 mg (n = 315)b | placebo (n = 158) | 5 mg (n = 294)b | 10 mg (n = 292)b | placebo (n = 147) | 5 mg (n = 294)b | 10 mg (n = 292)b | placebo (n = 148) | 5 mg (n = 294)b | 10 mg (n = 292)b |
| PtGA | 59.0 ± 22.9 (n = 311) | 60.2 ± 22.5 | 57.9 ± 23.3 | −24.8 ± 1.2 (n = 293)c | −28.2 ± 1.3c | −12.5 ± 1.7 (n = 148) | 68.6 (n = 293)c | 72.6c | 49.3 | 5.2 (n = 293) | 4.3 |
| Pain | 57.1 ± 23.8 (n = 311) | 58.6 ± 22.2 | 57.1 ± 22.8 | −24.2 ± 1.2 (n = 293)c | −26.8 ± 1.3c | −11.4 ± 1.7 (n = 148) | 67.9 (n = 293)c | 69.5c | 46.0 | 4.6 (n = 293) | 4.2 |
| HAQ DI | 1.44 ± 0.69 (n = 311) | 1.43 ± 0.68 | 1.35 ± 0.66 (n = 157) | −0.46 ± 0.03 (n = 292)c | −0.56 ± 0.03c | −0.21 ± 0.04 | 66.1 (n = 292)c | 70.2c | 44.9 (n = 147) | 4.7 (n = 292) | 4.0 |
| HRQOL (SF‐36) | |||||||||||
| PCS | 32.4 ± 7.8 | 32.0 ± 7.5 | 32.7 ± 7.6 | 5.9 ± 0.4 (n = 293)c | 7.5 ± 0.4 (n = 290)c | 2.4 ± 0.6 (n = 146) | 64.5 (n = 293)d | 74.1 (n = 290)c | 47.3 (n = 146) | 5.8 (n = 293) | 3.7 (n = 290) |
| MCS | 40.9 ± 12.6 | 41.6 ± 11.1 | 41.7 ± 11.6 | 4.4 ± 0.5 (n = 293)e | 4.4 ± 0.5 (n = 290)e | 1.6 ± 0.7 (n = 146) | 58.4 (n = 293)d | 53.8 (n = 290)e | 41.8 (n = 146) | 6.0 (n = 293) | 8.3 (n = 290) |
| PF | 32.5 ± 9.6 | 31.7 ± 9.6 | 32.8 ± 9.6 | 4.5 ± 0.5d | 6.4 ± 0.5 (n = 291)c | 1.7 ± 0.7 | 42.5e | 53.3 (n = 291)c | 32.0 | 9.5 | 4.7 (n = 291) |
| RP | 33.7 ± 9.7 | 33.2 ± 9.4 | 33.9 ± 9.6 | 5.7 ± 0.5d | 7.4 ± 0.5c | 2.6 ± 0.7 | 45.9e | 54.1c | 30.6 (n = 147) | 6.5 | 4.3 |
| BP | 33.4 ± 7.3 | 33.9 ± 7.3 | 34.2 ± 7.5 | 7.3 ± 0.4c | 8.7 ± 0.5c | 3.9 ± 0.6 | 47.6c | 52.7c | 28.6 (n = 147) | 5.3 | 4.1 |
| GH | 34.0 ± 9.1 | 34.3 ± 8.6 | 34.7 ± 8.3 | 5.3 ± 0.4c | 5.6 ± 0.4 (n = 291)c | 1.3 ± 0.6 | 46.6c | 46.1 (n = 291)c | 22.5 (n = 147) | 4.1 | 4.2 (n = 291) |
| VT | 40.8 ± 10.3 | 40.9 ± 8.9 | 41.3 ± 9.4 | 6.3 ± 0.5c | 6.5 ± 0.5c | 2.6 ± 0.7 | 55.4c | 57.2c | 34.7 (n = 147) | 4.8 | 4.4 |
| SF | 36.2 ± 11.2 | 37.0 ± 10.3 | 36.9 ± 11.6 | 5.2 ± 0.5c | 5.9 ± 0.5c | 1.7 ± 0.7 | 55.8e | 60.3d | 42.9 (n = 147) | 7.7 | 5.7 |
| RE | 35.5 ± 13.7 | 34.9 ± 13.0 | 35.4 ± 13.0 | 3.9 ± 0.6 (n = 293) | 5.3 ± 0.6 (n = 291)e | 2.3 ± 0.9 (n = 146) | 39.3 (n = 293) | 47.1 (n = 291)e | 34.3 (n = 146) | 20.0 (n = 293) | 7.8 (n = 291) |
| MH | 39.9 ± 12.5 | 41.1 ± 10.5 | 41.5 ± 11.4 | 4.8 ± 0.5c | 4.7 ± 0.5d | 1.5 ± 0.7 | 50.3c | 52.1c | 29.3 (n = 147) | 4.7 | 4.4 |
| FACIT‐F | 29.0 ± 11.1 | 28.7 ± 9.5 (n = 314) | 29.7 ± 9.0 | 5.8 ± 0.5c | 6.9 ± 0.5 (n = 291)c | 2.1 ± 0.6 | 53.7e | 63.6 (n = 291)c | 40.8 (n = 147) | 7.7 | 4.4 (n = 291) |
| MOS Sleep | 41.1 ± 20.7 | 40.9 ± 18.5 (n = 313) | 39.8 ± 18.3 | −6.2 ± 0.8 (n = 292)d | −7.4 ± 0.8 (n = 290)c | −1.6 ± 1.1 (n = 146) | NA | NA | NA | NA | NA |
Values are: mean ± SD (baseline), LSM ± SE (month 3), % (patients reporting improvements). LSM = least squares mean; MCID = minimum clinically important difference; NNT = number needed to treat; PRO = patient‐reported outcome; PtGA = patient global assessment of arthritis; Pain = patient assessment of arthritis pain; HAQ DI = Health Assessment Questionnaire disability index; HRQOL = health‐related quality of life; SF‐36 = Short Form 36 health survey; PCS = physical component score; MCS = mental component score; PF = physical functioning; RP = role‐physical; BP = bodily pain; GH = general health; VT = vitality; SF = social functioning; RE = role‐emotional; MH = mental health; FACIT‐F = Functional Assessment of Chronic Illness Therapy–Fatigue; MOS = Medical Outcomes Study; NA = not available.
Tofacitinib twice daily.
P < 0.0001 versus placebo.
P < 0.001.
P < 0.05.