Baseline characteristics and therapeutic response to 12-month tofacitinib treatment in previous bDMARD-failure patients
| bDMARD-failure patients (n=154) | |||
| 1-class failure (n=78) | 2-class or 3-class failure (n=76) | P value* | |
| Baseline characteristics | |||
| Age, years, mean (SD) | 66.4 (11.7) | 67.1 (11.4) | 0.67 |
| Male sex, number (%) | 16 (20.5) | 17 (22.4) | 0.85 |
| RA duration, years, mean (SD) | 14.1 (9.9) | 13.8 (9.4) | 0.82 |
| Advanced stage†, number (%) | 48 (61.5) | 49 (64.5) | 0.74 |
| Anti-CCP-positive, number (%) | 63 (80.8) | 72 (94.7) | 0.013 |
| RF-positive, number (%) | 63 (80.8) | 65 (85.5) | 0.52 |
| CDAI, mean (SD) | 21.2 (8.9) | 25.0 (11.1) | 0.019 |
| High CDAI (>22), number (%) | 34 (43.6) | 42 (55.3) | 0.20 |
| Concurrent MTX use, number (%) | 45 (57.7) | 39 (51.3) | 0.52 |
| Concurrent PSL use, number (%) | 19 (24.4) | 23 (30.3) | 0.47 |
| Therapeutic outcomes at 12 months | |||
| CDAI, mean (SD)‡ | 11.4 (10.7) | 13.9 (11.9) | 0.17 |
| Dropout, number (%) | 21 (26.9) | 23 (30.3) | 0.51 |
| Lack or loss of efficacy | 14 (17.9) | 13 (17.1) | 1.00 |
| Adverse events | 6 (7.7) | 9 (11.8) | 0.43 |
| Lost to follow-up | 1 (1.3) | 1 (1.3) | 1.00 |
| Remission (CDAI≤2.8), number (%) | 14 (17.9) | 10 (13.2) | 0.51 |
| Low CDAI (>2.8 and ≤10), number (%) | 35 (44.9) | 25 (32.9) | 0.14 |
| Remission or low CDAI, number (%) | 49 (62.8) | 35 (46.1) | 0.052 |
| High or moderate, number (%) | 8 (10.3) | 18 (23.7) | 0.032 |
| Improvements at 12 months, number (%)§ | |||
| CDAI85 (major response) | 16 (20.5) | 13 (17.1) | 0.68 |
| CDAI70 (moderate response) | 32 (41.0) | 24 (31.6) | 0.24 |
| CDAI50 (minor response) | 42 (53.8) | 40 (52.6) | 1.00 |
| MCID-based CDAI improvement | 47 (60.3) | 41 (53.9) | 0.52 |
*Comparisons of baseline characteristics or CDAI-based improvement measures between patients with one-class failure and those with one-class or two-class failure, using the independent-measures t-test for continuous variables and the χ2 test for categorical variables.
†Advanced stage was defined as Steinbrocker radiological stages III and IV.
‡To calculate mean CDAI values at 12 months, missing data on dropout patients were imputed using baseline observation carried forward.
§For classification of patients at 12 months, non-responder imputation was used for missing data on patients who had withdrawn from the study because of lack or loss of efficacy, adverse events and lost to follow-up.
anti-CCP, anti-cyclic citrullinated peptide antibodies; bDMARD, biological disease-modifying antirheumatic drug; CDAI, clinical disease activity index; MTX, methotrexate; PSL, prednisolone; RA, rheumatoid arthritis; RF, rheumatoid factor.;