Table 1.
Patient demographics and disease characteristics
| Adalimumab 40 mg q2w (n=185) |
Sarilumab 200 mg q2w (n=184) |
|
|---|---|---|
| Demographics | ||
| Age, mean±SD, year | 53.6±11.9 | 50.9±12.6 |
| Female, n (%) | 150 (81.1) | 157 (85.3) |
| Race, white, n (%) | 164 (88.6) | 171 (92.9) |
| Weight, mean±SD, kg | 71.8±17.8 | 72.3±16.5 |
| BMI, mean±SD, kg/m2 | 27.3±6.5 | 27.1±5.6 |
| Geographical region, n (%)* | ||
| Region 1 | 62 (33.5) | 61 (33.2) |
| Region 2 | 35 (18.9) | 36 (19.6) |
| Region 3 | 88 (47.6) | 87 (47.3) |
| Disease and treatment history | ||
| Duration of RA, mean±SD, year | 6.6±7.8 | 8.1±8.1 |
| Rheumatoid factor positive, n (%)† | 116 (64.8) | 119 (66.9) |
| Anti-CCP autoantibody positive, n (%)‡ | 138 (76.7) | 134 (75.3) |
| No. of prior csDMARDs, n (%) | ||
| None | 0 | 0 |
| 1 | 88 (47.6) | 83 (45.1) |
| 2 | 58 (31.4) | 57 (31.0) |
| ≥3 | 39 (21.1) | 44 (23.9) |
| Prior csDMARDs other than MTX, n (%)§ | ||
| Sulfasalazine | 44 (23.8) | 59 (32.1) |
| Leflunomide | 45 (24.3) | 42 (22.8) |
| Hydroxychloroquine | 43 (23.2) | 41 (22.3) |
| Prior csDMARDS in combination with MTX, n (%) | 44 (23.8) | 35 (19.0) |
| Reason for stopping MTX, n (%)¶ | ||
| Inadequate responder | 103 (55.7) | 97 (52.7) |
| Intolerant | 81 (43.8) | 87 (47.3) |
| Inappropriate for continued treatment | 1 (0.5) | 0 |
| Concomitant oral corticosteroids, n (%) | 104 (56.2) | 98 (53.3) |
| Disease activity, mean±SD | ||
| DAS28-ESR** | 6.8±0.8 | 6.8±0.8 |
| DAS28-CRP** | 6.0±0.9 | 6.0±0.9 |
| Swollen joint count (66 assessed)** | 17.5±10.3 | 18.6±10.7 |
| Tender joint count (68 assessed)** | 26.7±13.6 | 28.0±13.2 |
| CDAI score** | 42.4±12.0 | 43.6±12.1 |
| ESR, mm/h** | 47.5±23.2 | 46.5±21.8 |
| CRP, mg/L** | 24.1±31.0 | 17.4±21.3 |
| HAQ-DI score (0–3)** | 1.6±0.6 | 1.6±0.6 |
| SF-36 physical component score (0–100)†† | 31.5±6.5 | 30.8±6.1 |
| FACIT-Fatigue score (0–52)†† | 24.4±10.3 | 23.6±8.9 |
| SF-36 mental component score (0–100)†† | 36.9±11.6 | 36.4±10.4 |
*Region 1 (Western countries): Czech Republic, Germany, Hungary, Israel, Spain and USA. Region 2 (South America): Chile and Peru. Region 3 (rest of world): Poland, South Africa, South Korea, Romania, Russia and Ukraine.
†Adalimumab group, n=179; sarilumab group, n=178.
‡Adalimumab group, n=180; sarilumab group, n=178.
§Included if used in >5% of the population.
¶MTX intolerance or inappropriate to continue status was primarily based on clinical judgement of the investigator.
**Higher scores represent more severe disease.
††Lower scores represent more severe disease.
BMI, body mass index; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP, 28-joint disease activity score using CRP; DAS28-ESR, DAS28 using erythrocyte sedimentation rate; ESR, erythrocyte sedimentation rate; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; q2w, every 2 weeks; RA, rheumatoid arthritis; SF-36, Medical Outcomes Short Form 36 Health Survey.