Summary of patient demographics and baseline characteristics
| Parameter | Tofacitinib 10 mg twice daily + MTX (N=36) | Tofacitinib 10 mg twice daily monotherapy (N=36) | MTX monotherapy (N=37) |
|---|---|---|---|
| Age, mean (SD) | 47.8 (12.3) | 50.8 (12.8) | 47.8 (11.6) |
| Females, % | 86.1 | 83.3 | 78.4 |
| Mean duration of disease, years (range) | 0.8 (0.1–2.2) | 0.8 (0.1–8.5) | 0.6 (0.1–1.9) |
| Positive for rheumatoid factor, n/N (%) | 26/34 (76.5) | 27/35 (77.1) | 27/37 (73.0) |
| Anti-CCP positive, n/N (%) | 27/34 (79.4) | 27/35 (77.1) | 30/37 (81.8) |
| Swollen joint count, mean (range) | 13.4 (0.0–32.0) | 15.3 (4.0–46.0) | 14.4 (6.0–39.0) |
| Tender joint count, mean (range) | 20.6 (0.0–57.0) | 20.9 (4.0–53.0) | 20.5 (9.0–52.0) |
| DAS28-4(ESR), mean (SD)* | 6.3 (0.9) | 6.5 (0.8) | 6.4 (0.8) |
| HAQ-DI score, mean (SD)* | 1.5 (0.8) | 1.5 (0.6) | 1.5 (0.7) |
| RAMRIS, mean (SD)† | |||
| BME | 1.9 (3.7) | 2.6 (3.7) | 2.2 (5.1) |
| Synovitis | 5.8 (3.8) | 5.7 (3.5) | 5.3 (3.9) |
| Bone erosions | 9.4 (10.8) | 7.5 (7.6) | 12.2 (14.9) |
| RAMRIQ, mean (SD)* | |||
| BME | 1.4 (2.8) | 1.1 (2.7) | 1.4 (2.7) |
| Synovitis | 7750.4 (5432.8) | 7971.8 (5510.1) | 6980.7 (6304.8) |
| Bone erosions | 1.6 (0.9) | 1.6 (0.8) | 1.9 (1.3) |
| DCE MRI NVox, mean (SD)‡ | 3013.6 (3605.6) | 2767.6 (2140.2) | 3079.8 (3704.9) |
| Radiographic evaluations, mean (SD)† | |||
| van der Heijde mTSS | 13.0 (21.7) | 12.6 (26.0) | 13.7 (26.0) |
| JSN component score | 6.9 (13.3) | 5.7 (15.0) | 6.1 (12.7) |
| Erosion component score | 6.1 (9.3) | 6.9 (11.8) | 7.6 (14.3) |
| Prior MTX, n (%)§ | 0 (0.0) | 2 (5.6) | 4 (10.8) |
| Prior/concomitant systemic corticosteroids, n (%) | 20 (55.6) | 16 (44.4) | 21 (56.8) |
*Evaluable set: tofacitinib with MTX (N=36), tofacitinib monotherapy (N=36), MTX monotherapy (N=37).
†Evaluable set: tofacitinib with MTX (N=34), tofacitinib monotherapy (N=36), MTX monotherapy (N=37).
‡Evaluable set: tofacitinib with MTX (N=34), tofacitinib monotherapy (N=32), MTX monotherapy (N=32).
§Patients who had received <3 weekly doses of MTX were permitted to participate following a 4-week washout of MTX unless MTX had been stopped due to a related adverse event.
BME, bone marrow Oedema; CCP, cyclic-citrullinated peptide; DAS28-4(ESR), Disease Activity Score in 28 joints with 4 variables including erythrocyte sedimentation rate; DCE MRI, dynamic contrast-enhanced MRI; HAQ-DI, Health Assessment Questionnaire-Disability Index; JSN, joint space narrowing; MTX, methotrexate; mTSS, van der Heijde modification of the total Sharp score; NVox, number of enhancing voxels; RAMRIQ, quantitative rheumatoid arthritis MRI score; RAMRIS, rheumatoid arthritis MRI score.