Table 1

Patient demographics and disease characteristics

Adalimumab 40 mg
q2w
(n=185)
Sarilumab 200 mg
q2w
(n=184)
Demographics
Age, mean±SD, year53.6±11.950.9±12.6
Female, n (%)150 (81.1)157 (85.3)
Race, white, n (%)164 (88.6)171 (92.9)
Weight, mean±SD, kg71.8±17.872.3±16.5
BMI, mean±SD, kg/m227.3±6.527.1±5.6
Geographical region, n (%)*
 Region 162 (33.5)61 (33.2)
 Region 235 (18.9)36 (19.6)
 Region 388 (47.6)87 (47.3)
Disease and treatment history
Duration of RA, mean±SD, year6.6±7.88.1±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 (%)
 None00
 188 (47.6)83 (45.1)
 258 (31.4)57 (31.0)
 ≥339 (21.1)44 (23.9)
Prior csDMARDs other than MTX, n (%)§
 Sulfasalazine44 (23.8)59 (32.1)
 Leflunomide45 (24.3)42 (22.8)
 Hydroxychloroquine43 (23.2)41 (22.3)
Prior csDMARDS in combination with MTX, n (%)44 (23.8)35 (19.0)
Reason for stopping MTX, n (%)¶
 Inadequate responder103 (55.7)97 (52.7)
 Intolerant81 (43.8)87 (47.3)
 Inappropriate for continued treatment1 (0.5)0
Concomitant oral corticosteroids, n (%)104 (56.2)98 (53.3)
Disease activity, mean±SD
DAS28-ESR**6.8±0.86.8±0.8
DAS28-CRP**6.0±0.96.0±0.9
Swollen joint count (66 assessed)**17.5±10.318.6±10.7
Tender joint count (68 assessed)**26.7±13.628.0±13.2
CDAI score**42.4±12.043.6±12.1
ESR, mm/h**47.5±23.246.5±21.8
CRP, mg/L**24.1±31.017.4±21.3
HAQ-DI score (0–3)**1.6±0.61.6±0.6
SF-36 physical component score (0–100)††31.5±6.530.8±6.1
FACIT-Fatigue score (0–52)††24.4±10.323.6±8.9
SF-36 mental component score (0–100)††36.9±11.636.4±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.