Main efficacy results at M12 (N=577)
| MONO group N=228 | COMBO group N=349 | All patients N=577 | |
|---|---|---|---|
| Disease activity indices and efficacy responses at M12 (missing data not taken into account for analyses) | |||
| DAS28-ESR, n/N (%) | |||
| LDA (≤3.2) | 94/125 (75.2) | 155/199 (77.9) | 249/324 (76.9) |
| Remission (<2.6) | 79/125 (63.2) | 124/199 (62.3) | 203/324 (62.7) |
| CDAI, n/N (%) | |||
| LDA (≤10) | 71/104 (68.3) | 82/139 (59.0) | 153/243 (63.0) |
| Remission (≤2.8) | 22/104 (21.2) | 30/139 (21.6) | 52/243 (21.4) |
| SDAI, n/N (%) | |||
| LDA (≤11) | 70/101 (69.3) | 81/136 (59.6) | 151/237 (63.7) |
| Remission (≤3.3) | 23/101 (22.8) | 34/136 (25.0) | 57/237 (24.1) |
| HAQ-DI Questionnaire, mean±SD | |||
| Standard Score | (n=86) | (n=132) | (n=218) |
| 1.06±0.78 | 1.02±0.69 | 1.03±0.73 | |
| Change between D0 and M12 | (n=74) | (n=106) | (n=180) |
| −0.47±0.68 | −0.45±0.62 | −0.46±0.65 | |
| Disease activity indices and efficacy responses at M12 (missing data considered as failure) | (n=228) | (n=349) | (n=577) |
| DAS28-ESR, n (%) | |||
| LDA (≤3.2) at M12 | 94 (41.2) | 155 (44.4) | 249 (43.2) |
| Remission (<2.6) at M12 | 79 (34.6) | 124 (35.5) | 203 (35.2) |
| CDAI, n/N (%) | |||
| LDA (≤10) at M12 | 71 (31.1) | 82 (23.5) | 153 (26.5) |
| Remission (≤2.8) at M12 | 22 (9.6) | 30 (8.6) | 52 (9.0) |
| SDAI, n/N (%) | |||
| LDA (≤11) at M12 | 70 (30.7) | 81 (23.2) | 151 (26.2) |
| Remission (≤3.3) at M12 | 23 (10.1) | 34 (9.7) | 57 (9.9) |
| ACR20/50/70 responses, n (%) | |||
| ACR20 responders | 74 (32.5) | 92 (26.4) | 166 (28.8) |
| ACR50 responders | 50 (21.9) | 59 (16.9) | 109 (18.9) |
| ACR70 responders | 22 (9.6) | 34 (9.7) | 56 (9.7) |
| EULAR responses, n (%) | |||
| Good or moderate | 114 (50.0) | 173 (49.6) | 287 (49.7) |
| Patients’ quality of life at M12 | |||
| RAID Score | |||
| Score, mean±SD | (n=87) | (n=134) | (n=221) |
| 3.70±2.17 | 3.63±2.14 | 3.66±2.15 | |
| Change between D0 and M12, mean±SD | (n=72) | (n=108) | (n=180) |
| −2.42±2.29 | −2.15±2.34 | −2.26±2.32 | |
| PASS Questionnaire | (n=84) | (n=132) | (n=216) |
| Acceptable condition—n (%) | 71 (84.5) | 105 (79.5) | 176 (81.5) |
ACR, American College of Rheumatology; CDAI, clinical disease activity index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; COMBO, tocilizumab in combination with csDMARD at inclusion; DAS28, Disease Activity Score 28 joints; ESR, Erythrocyte Sedimentation Rate; EULAR, European League Against Rheumatism; HAQ-DI, health assessment—disease index questionnaire; MONO, tocilizumab as monotherapy at inclusion; PASS, patient acceptable symptom state; RAID, rheumatoid arthritis impact of disease; SDAI, simplified disease activity index.