Sarilumab | |||
---|---|---|---|
Variable | Placebo +csDMARDs (n=181) | 150 mg q2w+csDMARDs (n=181) | 200 mg q2w+csDMARDs (n=184) |
Age, years | 51.9±12.4 | 54.0±11.7 | 52.9±12.9 |
Female, n (%) | 154 (85.1) | 142 (78.5) | 151 (82.1) |
Race, n (%) | |||
White | 124 (68.5) | 134 (74.0) | 130 (70.7) |
Black | 7 (3.9) | 8 (4.4) | 5 (2.7) |
Asian | 1 (0.6) | 3 (1.7) | 1 (0.5) |
Other | 49 (27.1) | 36 (19.9) | 48 (26.1) |
Geographic region, n (%)† | |||
Region 1 | 77 (42.5) | 77 (42.5) | 79 (42.9) |
Region 2 | 74 (40.9) | 74 (40.9) | 74 (40.2) |
Region 3 | 30 (16.6) | 30 (16.6) | 31 (16.8) |
Duration of RA, years | 12.0±10.0 | 11.6±8.6 | 12.7±9.6 |
Prior anti-TNF exposure, n (%) | 181 (100) | 181 (100) | 184 (100) |
1 | 135 (74.6) | 143 (79.4) | 140 (76.5) |
>1 | 46 (25.4) | 37 (20.6) | 43 (23.5) |
Reason for anti-TNF failure, n (%) | |||
Inadequate response | 174 (96.1) | 163 (90.1) | 167 (90.8) |
Intolerance | 6 (3.3) | 17 (9.4) | 15 (8.2) |
Other | 1 (0.6) | 1 (0.6) | 2 (1.1) |
Rheumatoid factor positive, n (%) | 142 (78.9) | 135 (74.6) | 132 (72.9) |
Anti-CCP antibody positive, n (%) | 150 (83.3) | 135 (75.0) | 137 (76.1) |
DAS28-CRP | 6.2±0.9 | 6.1±0.9 | 6.3±1.0 |
Tender joint count (of 68 joints) | 29.4±14.5 | 27.7±15.6 | 29.6±15.5 |
Swollen joint count (of 66 joints) | 20.2±11.3 | 19.6±11.2 | 20.0±11.9 |
PtGA VAS‡ | 68.8±18.1 | 67.7±17.5 | 70.9±17.4 |
Pain VAS‡ | 71.6±18.2 | 71.0±19.3 | 74.9±18.4 |
HAQ-DI§ | 1.8±0.6 | 1.7±0.6 | 1.8±0.6 |
FACIT-F¶ | 23.7±10.8 | 23.5±10.6 | 23.1±10.8 |
SF-36 PCS** | 29.7±7.8 | 30.3±6.7 | 29.4±6.7 |
SF-36 MCS** | 38.5±12.6 | 38.6±11.4 | 39.1±11.4 |
RAID score†† | 6.6±2.0 | 6.5±2.0 | 6.8±1.8 |
Morning stiffness VAS‡ | 66.8±24.1 | 69.9±21.6 | 71.2±22.6 |
WPS-RA (n)‡‡ | |||
Work days missed due to arthritis | 4.1±6.7 (32) | 3.3±6.1 (43) | 4.0±7.1 (45) |
Days with work productivity reduced by ≥50% due to arthritis | 6.7±8.1 (32) | 6.4±9.2 (43) | 6.9±8.5 (45) |
Rate of arthritis interference with work productivity§§ | 5.0±2.9 (32) | 4.9±2.8 (42) | 5.1±3.4 (45) |
House work days missed due to arthritis | 8.6±9.2 (101) | 9.5±9.7 (126) | 9.9±10.5 (133) |
Days with household work productivity reduced by ≥50% due to arthritis | 10.0±10.1 (101) | 9.1±8.9 (125) | 9.4±9.0 (133) |
Rate of arthritis interference with household work productivity§§ | 5.7±3.2 (100) | 6.2±2.8 (126) | 6.5±2.8 (132) |
Days with outside help hired due to arthritis | 4.9±9.5 (101) | 5.2±9.1 (126) | 6.7±11.3 (133) |
Days with family, social or leisure activities missed due to arthritis | 5.2±8.5 (101) | 5.3±8.0 (127) | 5.6±8.9 (133) |
*Values are the mean±SD unless indicated otherwise.
†Region 1: Australia, Canada, Czech Republic, Germany, Greece, Hungary, Israel, Italy, New Zealand, Portugal, Spain, USA. Region 2: Argentina, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Peru. Region 3: Lithuania, Poland, Russia, South Korea, Taiwan, Thailand, Turkey, Ukraine.
‡Scale range, 0–100; lower scores indicate better outcomes.
§Scale range, 0–3; lower scores represent less difficulty with physical functioning.
¶Scale range, 0–52; higher scores represent less fatigue.
**Scale range, 0–100; higher scores represent less impaired physical/mental health status.
††Scale range, 0–10; higher scores indicate a greater (negative) impact of RA.
‡‡Number of patients with assessment at baseline and week 24.
§§Scale of 0=no interference to 10=complete interference.
Anti-CCP, anti–cyclic citrullinated peptide; anti-TNF, anti-tumour necrosis factor inhibitor; csDMARDs, conventional synthetic disease-modifying anti-rheumatic drugs; DAS28-CRP, 28-joint disease activity using C reactive protein; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue scale; HAQ-DI, Health Assessment Questionnaire Disability Index; MCS, mental component summary; PCS, physical component summary; PtGA, patient global assessment of disease activity; q2w, every 2 weeks; RA, rheumatoid arthritis; RAID, Rheumatoid Arthritis Impact of Disease; SF-36, Short Form 36 Health Survey V.2; VAS, visual analogue scale.