Table 1.
Baseline demographics and disease characteristics
| Monotherapy (N = 223) | Combination therapy (N = 372) | All treated (N = 595) | |
|---|---|---|---|
| Age, mean (SD), years | 57.9 (12.6) | 57.5 (11.4) | 57.6 (11.8) |
| Female, n (%) | 178 (79.8) | 270 (72.6) | 448 (75.3) |
| Caucasians, n (%) | 198 (88.8) | 305 (82.0) | 503 (84.5) |
| N = 212 | N = 353 | N = 565 | |
| Weight, mean (SD), kg | 77.7 (19.3) | 81.6 (18.6) | 80.1 (18.9) |
| N = 205 | N = 343 | N = 548 | |
| BMI, mean (SD), kg/m2 | 27.9 (6.4) | 29.2 (6.8) | 28.7 (6.7) |
| BMI group (kg/m2) | |||
| < 25, n (%) | 70 (34.1) | 107 (31.2) | 177 (32.3) |
| ≥ 25 and < 30, n (%) | 69 (33.7) | 104 (30.3) | 173 (31.6) |
| ≥ 30, n (%) | 66 (32.2) | 132 (38.5) | 198 (36.1) |
| Missing, n (%) | 18 | 29 | 47 |
| N = 218 | N = 367 | N = 585 | |
| Duration of RA, mean (SD), years | 11.2 (10.6) | 9.3 (8.6) | 10.0 (9.4) |
| RA severity (at study start)a | N = 222 | N = 372 | N = 594 |
| Moderate, n (%) | 157 (70.7) | 259 (69.6) | 416 (70.0) |
| Severe, n (%) | 65 (29.3) | 113 (30.4) | 178 (30.0) |
| CDAI, mean (SD) | N = 201 | N = 332 | N = 533 |
| 26.0 (13.0) | 27.2 (13.6) | 26.7 (13.4) | |
| SDAI, mean (SD) | N = 164 | N = 292 | N = 456 |
| 27.4 (13.8) | 28.2 (13.7) | 27.9 (13.7) | |
| SJC (28), mean (SD) | N = 218 | N = 365 | N = 583 |
| 5.9 (5.3) | 6.6 (5.8) | 6.3 (5.6) | |
| TJC (28), mean (SD) | N = 218 | N = 365 | N = 583 |
| 8.8 (7.0) | 9.2 (7.1) | 9.1 (7.1) | |
| PtGA (mm), mean (SD) | N = 207 | N = 343 | N = 550 |
| 60.4 (23.6) | 57.0 (24.9) | 58.3 (24.5) | |
| HAQ-DI score (0–3), mean (SD) | N = 208 | N = 346 | N = 554 |
| 1.5 (0.7) | 1.4 (0.7) | 1.4 (0.7) | |
| DAS28-CRP, mean (SD) | N = 168 | N = 297 | N = 465 |
| 4.6 (1.3) | 4.7 (1.2) | 4.7 (1.2) | |
| DAS28-ESR, mean (SD) | N = 149 | N = 252 | N = 401 |
| 4.8 (1.5) | 4.9 (1.3) | 4.9 (1.4) | |
| Medications | |||
| Prior RA medicationsb, n (%) | 217 (97.3) | 371 (99.7) | 588 (98.8) |
| csDMARDs, n (%) | 178 (79.8) | 369 (99.2) | 547 (91.9) |
| bDMARDs, n (%) | 133 (59.6) | 198 (53.2) | 331 (55.6) |
| tsDMARDs, n (%) | 48 (21.5) | 47 (12.6) | 95 (16.0) |
| Number of prior b/ts DMARDs | |||
| 0, n (%) | 81 (36.3) | 168 (45.2) | 249 (41.8) |
| 1, n (%) | 46 (20.6) | 84 (22.6) | 130 (21.8) |
| 2, n (%) | 43 (19.3) | 62 (16.7) | 105 (17.6) |
| ≥ 3, n (%) | 53 (23.8) | 58 (15.6) | 111 (18.7) |
| Prior RA medications ongoing at baseline and continuedc, n (%) | 127 (57.0) | 368 (98.9) | 495 (83.2) |
| csDMARDs, n (%) | 0 (0) | 365 (98.1) | 365 (61.3) |
| Methotrexate, n (%) | 0 (0) | 279 (75.0) | 279 (46.9) |
| NSAIDs, n (%) | 52 (23.3) | 118 (31.7) | 170 (28.6) |
| Others, n (%) | 43 (19.3) | 133 (35.8) | 176 (29.6) |
| Prednisone equivalent daily dose at baseline, mgd | |||
| n (%) | 73 (32.7) | 154 (41.4) | 227 (38.2) |
| Mean (SD) | 9.0 (6.9) | 8.5 (9.9) | 8.6 (9.0) |
| Concomitant RA medications started after sarilumab initiation, n (%) | 61 (27.4) | 123 (33.1) | 184 (30.9) |
| csDMARDs, n (%) | 10 (4.5) | 54 (14.5) | 64 (10.8) |
| NSAIDs, n (%) | 10 (4.5) | 18 (4.8) | 28 (4.7) |
| Corticosteroids, n (%) | 51 (22.9) | 86 (23.1) | 137 (23.0) |
| Others, n (%) | 9 (4.0) | 16 (4.3) | 25 (4.2) |
bDMARDs biologic DMARD, BMI body mass index, CDAI Clinical Disease Activity Index, CRP C-reactive protein, csDMARDs conventional synthetic DMARD, DAS28 disease activity score in 28 joints, DMARD disease-modifying anti-rheumatic drug, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire—Disability Index, N number of patients, n number of patients, NSAID nonsteroidal anti-inflammatory drug, PtGA Patient Global Assessment, RA rheumatoid arthritis, SD standard deviation, SDAI Simplified Disease Activity Index, SJC swollen joint count, TJC tender joint count, tsDMARD targeted synthetic DMARD, VAS visual analog scale
aAs per the investigator’s judgement
bPrior RA medications that had been discontinued before sarilumab initiation or were ongoing at the time of sarilumab initiation
cPrior RA medications that were ongoing at baseline and continued after sarilumab initiation
dPrednisone equivalent daily dose at baseline = (total prednisone equivalent doses in 4 weeks prior to sarilumab initiation [mg, not including the date of sarilumab initiation])/28