Patient and disease characteristics at baseline–efficacy population (N=407)
| MONO group N=228 | COMBO group N=349 | All patients N=577 | |
|---|---|---|---|
| Patients' characteristics | |||
| Age (years)* | 59.1±12.7 | 55.3±12.5 | 56.8±12.7 |
| Women, n (%) | 180 (78.9) | 274 (78.5) | 454 (78.7) |
| BMI (kg/m²) | (n=217) 25.7±5.5 | (n=338) 25.8±5.8 | (n=555) 25.8±5.6 |
| Patients with ≥1 comorbidity, n (%) | 173 (75.9) | 236 (67.6) | 409 (70.9) |
| RA history | |||
| RA duration (years) | 12.1±10.2 | 10.2±8.2 | 10.9±9.1 |
| Positive RF or ACPA, n (%) | (n=223) 197 (88.3) | (n=336) 281 (83.6) | (n=559) 478 (85.5) |
| Erosive RA, n (%) | (n=225) 174 (77.3) | (n=340) 261 (76.8) | (n=565) 435 (77.0) |
| Structural damage | (n=210) | (n=307) | (n=517) |
| Worsening†, n (%) | 108 (51.4) | 143 (46.6) | 251 (48.5) |
| Previous/ongoing treatment of RA | |||
| Previous/current DMARDs | (n=225) | (n=349) | (n=574) |
| Naive, n (%) | 2 (0.9) | 0 | 2 (0.3) |
| Only csDMARDs, n (%) | 47 (20.9) | 91 (26.1) | 138 (24.0) |
| Only biologics, n (%) | 4 (1.8) | 0 | 4 (0.7) |
| Biologics + csDMARDs, n (%) | 172 (76.4) | 258 (73.9) | 430 (74.9) |
| csDMARDs | |||
| Number of different previous or ongoing csDMARDs | (n=219) 1.7±0.6 | (n=349) 1.5±0.6 | (n=568) 1.6±0.6 |
| Previous/ongoing MTX, n (%) | (n=225) 210 (93.3) | (n=349) 333 (95.4) | (n=574) 543 (94.6) |
| Main reasons for MTX discontinuation, n (%) | (n=202) | (n=55) | (n=257) |
| Intolerance | 146 (72.3) | 45 (81.8) | 191 (74.3) |
| Therapeutic escape | 26 (12.9) | 4 (7.3) | 30 (11.7) |
| bDMARDs | |||
| Number of previous biologics | (n=176) 1.9±1.0 | (n=258) 1.9±1.0 | (n=434) 1.9±1.0 |
| Anti-TNF agent‡, n (%) | 171 (97.2) | 238 (92.2) | 409 (94.2) |
| Oral glucocorticoids at baseline, n (%) | (n=227) | (n=349) | (n=576) |
| Yes, n (%) | 152 (67.0) | 229 (65.6) | 381 (66.1) |
| Daily dose (mg equivalent prednisone), n (%) | (n=226) | (n=348) | (n=574) |
| 0 | 75 (33.2) | 120 (34.5) | 195 (34.0) |
| [0–5] | 44 (19.5) | 65 (18.7) | 109 (19.0) |
| [5–7.5] | 16 (7.1) | 47 (13.5) | 63 (11.0) |
| [7.5–10] | 49 (21.7) | 71 (20.4) | 120 (20.9) |
| >10 | 42 (18.6) | 45 (12.9) | 87 (15.2) |
| RA characteristics at inclusion | |||
| HAQ-DI standard score | (n=167) 1.66±0.63 | (n=247) 1.49±0.64 | (n=414) 1.56±0.64 |
| DAS28-ESR | (n=220) 5.38±1.32 | (n=335) 5.03±1.20 | (n=555) 5.17±1.26 |
| CDAI | (n=205) 29.29±13.72 | (n=314) 25.69±11.38 | (n=519) 27.11±12.47 |
| SDAI | (n=200) 31.92±14.93 | (n=303) 27.21±12.05 | (n=503) 29.08±13.45 |
| Patients’ quality of life | |||
| RAID Score | (n=170) 6.5±2.0 | (n=252) 5.9±1.9 | (n=422) 6.1±1.9 |
| PASS questionnaire—acceptable state, n (%) | (n=168) 43 (25.6) | (n=246) 84 (34.1) | (n=414) 127 (30.7) |
*Data are presented as mean±SD unless stated otherwise.
†Worsening of joint structural damage at X-ray over the past 2 years.
‡Adalimumab or infliximab or etanercept or certolizumab or golimumab.
ACPA, anti-citrullinated protein antibody; BMI, body mass index; CDAI, clinical disease activity index; cs/bDMARD, conventional synthetic/biologic disease-modifying antirheumatic drug; COMBO, tocilizumab in combination with csDMARD at inclusion; DAS28-ESR, Disease Activity Score 28 joints-Erythrocyte Sedimentation Rate; ESR, Erythrocyte Sedimentation Rate; HAQ-DI, health assessment questionnaire-disease index; MONO, tocilizumab as monotherapy at inclusion; PASS, patient acceptable symptom state; RA, rheumatoid arthritis; RAID, rheumatoid arthritis impact of disease; RF, rheumatoid factor; SDAI, simple disease activity index; SJC, swollen joint count; TNF, tumour necrosis factor.