Comparisons of therapeutic response at 12 months between tofacitinib-treated and tocilizumab-treated patients with RA after propensity score matching
| bDMARD-naïve patients (n=186) | Previous bDMARD-failure patients (n=160) | |||||
| Tofacitinib (n=93) | Tocilizumab (n=93) | P value* | Tofacitinib (n=80) | Tocilizumab (n=80) | P value* | |
| Therapeutic outcomes at 12 months | ||||||
| CDAI, mean (SD)† | 6.9 (9.9) | 9.9 (10.6) | 0.030 | 13.7 (11.7) | 14.8 (9.9) | 0.55 |
| Dropout, number (%) | 17 (18.3) | 20 (21.5) | 0.69 | 22 (27.5) | 33 (41.3) | 0.13 |
| Lack or loss of efficacy | 9 (9.7) | 13 (14.0) | 0.48 | 17 (21.3) | 26 (32.5) | 0.19 |
| Adverse events | 7 (7.5) | 6 (6.5) | 1.00 | 4 (5.0) | 6 (7.5) | 0.75 |
| Lost to follow-up | 1 (1.1) | 1 (1.1) | 1.00 | 1 (1.3) | 1 (1.3) | 1.00 |
| Remission (CDAI ≤2.8), number (%) | 53 (57.0) | 25 (26.9) | <0.001 | 10 (12.5) | 12 (15.0) | 0.83 |
| Low CDAI (>2.8 and ≤10), number (%) | 20 (21.5) | 37 (39.8) | 0.015 | 35 (43.8) | 18 (22.5) | 0.007 |
| Remission or low CDAI (≤10), number (%) | 73 (78.5) | 62 (66.7) | 0.082 | 45 (56.3) | 30 (37.5) | 0.046 |
| Moderate or high CDAI (>10), number (%) | 3 (3.2) | 11 (11.8) | 0.039 | 13 (16.3) | 17 (21.3) | 0.54 |
| Improvements at 12 months, number (%)‡ | ||||||
| CDAI85§ (major response) | 59 (63.4) | 28 (30.1) | <0.001 | 13 (16.3) | 17 (21.3) | 0.58 |
| CDAI70§ (moderate response) | 69 (74.2) | 45 (48.4) | 0.001 | 26 (32.5) | 25 (31.3) | 1.00 |
| CDAI50§ (minor response) | 71 (76.3) | 62 (66.7) | 0.18 | 39 (48.8) | 31 (38.8) | 0.29 |
| MCID-based CDAI improvement¶ | 72 (77.4) | 63 (67.7) | 0.18 | 44 (55.0) | 32 (40.0) | 0.11 |
*Comparisons of CDAI-based improvement measures at 12 months between tofacitinib and tocilizumab therapy after propensity score matching, separately in bDMARD-naïve patients and bDMARD-failure patients, using bootstrapping for continuous variables (bootstrapped paired sample t-test) and the McNemar test for categorical variables. The same p values were also obtained with Wilcoxon signed-rank tests for continuous variables.
†To calculate mean CDAI values at 12 months, missing data on dropout patients were imputed using baseline observation carried forward.
‡For classification at 12 months, non-responder imputation was used for missing data on patients who had withdrawn from the study (dropout patients) because of lack or loss of efficacy, adverse events and lost to follow-up.
§Defined as achieving and maintaining ≥50% improvement of CDAI (CDAI50),≥70% (CDAI70) and ≥85% (CDAI85) during the 12-month treatment.
¶Defined as CDAI reduction >12 for patients starting with a high CDAI and CDAI reduction >6 for those starting with a moderate CDAI at 12 months of treatment.
bDMARD, biological disease-modifying antirheumatic drug; CDAI, clinical disease activity index; MCID, minimal clinically important difference; RA, rheumatoid arthritis.