Table 2.
Baseline RA Characteristics and Month-6 Outcomes of Patients who Received Tofacitinib Therapy, Stratified by Previous Use of Biological Agents.
| Total (n=113) |
Biologic-naïve patients (n=36) |
Biologic-experienced patients (n=77) |
p* | |
|---|---|---|---|---|
| Baseline characteristics of RA | ||||
| Age, years, mean (95% CI) | 63.7 (61.4-66.0) | 61.0 (56.3-65.8) | 65.0 (62.4, 67.6) | 0.11 |
| Male/female | 26/87 | 6/30 | 20/57 | 0.34 |
| RA duration, years, mean (95% CI) | 11.7 (9.8-12.9) | 9.6 (5.3-13.8) | 12.8 (10.9-14.8) | 0.004 |
| Anti-CCP (+), patient number (%) | 99 (87.6) | 30 (83.3) | 69 (89.6) | 0.37 |
| Stage III/IV, patient number (%) | 58 (51.3) | 7 (19.4) | 51 (66.2) | <0.001 |
| CDAI, mean (95% CI) | 24.5 (22.5-26.6) | 26.5 (22.1-30.9) | 23.6 (21.4-25.9) | 0.20 |
| High CDAI (>22), patient number (%) | 49 (43.4) | 16 (44.4) | 33 (42.9) | 1.00 |
| Concomitant MTX use, patient number (%) | 82 (72.6) | 36 (100) | 46 (59.7) | <0.001 |
| Concomitant PSL use, patient number (%) | 34 (30.1) | 8 (22.2) | 26 (33.8) | 0.27 |
| Therapeutic outcomes at month 6 | ||||
| CDAI, mean (95% CI)† | 9.3 (7.5-11.1) | 4.8 (2.4-7.2) | 11.4 (9.1-17.7) | 0.001 |
| Dropout, patient number (%) | 32 (28.3) | 5 (13.9) | 27 (35.1) | 0.025 |
| Adverse events | 4 (3.5) | 2 (5.6) | 2 (2.6) | 0.59 |
| Lack or loss of efficacy | 17 (15.0) | 1 (2.8) | 16 (20.8) | 0.011 |
| Loss to follow-up | 11 (9.7) | 2 (5.6) | 9 (11.7) | 0.50 |
| Remission (CDAI≤2.8), patient number (%) | 24 (21.2) | 15 (41.7) | 9 (11.7) | 0.001 |
| Low CDAI (<2.8 and ≤10), patient number (%) | 40 (35.4) | 13 (36.2) | 27 (35.1) | 1.00 |
| Moderate CDAI (>10 and ≤22), patient number (%) | 14 (12.4) | 3 (8.3) | 11 (14.3) | 0.55 |
| High CDAI (>22), patient number (%) | 3 (2.7) | 0 | 3 (3.9) | 0.55 |
| Improvement rates of CDAI at month 6 | ||||
| CDAI improvement‡, patient number (%) | 69 (61.1) | 30 (83.3) | 39 (50.6) | 0.001 |
| CDAI50§ (minor response), patient number (%) | 65 (57.5) | 29 (80.6) | 36 (46.8) | 0.001 |
| CDAI70§ (moderate response), patient number (%) | 49 (43.4) | 25 (69.4) | 24 (31.2) | <0.001 |
| CDAI85§ (major response), patient number (%) | 36 (31.9) | 19 (52.8) | 17 (22.1) | 0.002 |
*Compared between biologic-naïve patients and biologic-experienced patients.
†For dropout patients, missing data were replaced by the last observed values.
‡Defined as MCID-based CDAI improvement, i.e., CDAI reduction >12 for patients starting with a high CDAI and >6 for those starting with a moderate CDAI.
§Defined as achieving and maintaining ≥50% improvement of CDAI (CDAI50), ≥70% (CDAI70), and ≥85% (CDAI85) during the 6-month tofacitinib therapy.
RA: rheumatoid arthritis, IR: inadequate response, anti-CCP: anti-citrullinated peptide antibodies, CDAI: clinical disease activity index, MCID: minimally clinically important difference, MTX: methotrexate, PSL: prednisolone, CI: confidence interval