Table 1.
Summary of phase III clinical trials of sarilumab in rheumatoid arthritis.
| Study | Population | Sarilumab | Comparator | Primary endpoints | p value | Pertinent secondary endpoints | p value |
|---|---|---|---|---|---|---|---|
| MOBILITY11 | MTX-IR | 150 mg SC q2w + background weekly MTX 200 mg SC q2w + background weekly MTX |
Placebo + background weekly MTX | ACR20 at week 24 | ACR70 at week 24 | ||
| 150 mg versus placebo: 58% versus 33.4% |
p < 0.0001 | 150 mg versus placebo: 12.8% versus 3% |
p < 0.0001 | ||||
| 200 mg versus placebo: 66.4% versus 33.4% |
p < 0.0001 | 200 mg versus placebo: 14.8% versus 3% |
p < 0.0001 | ||||
| HAQ-DI at week 16 | DAS28-CRP < 2.6 at week 24 | ||||||
| 150 mg versus placebo: –0.53 versus –0.29 |
p < 0.0001 | 150 mg versus placebo: 27.8% versus 10.1% |
p < 0.0001 | ||||
| 200 mg versus placebo: –0.55 versus –0.29 |
p < 0.0001 | 200 mg versus placebo: 34.1% versus 10.1% |
p < 0.0001 | ||||
| SHS at week 24 | CDAI ⩽ 2.8 at week 24 | ||||||
| 150 mg versus placebo: 0.90 versus 2.78 |
p < 0.0001 | 150 mg versus placebo: 10.3% versus 5% |
p < 0.0001 | ||||
| 200 mg versus placebo: 0.25 versus 2.78 |
p < 0.0001 | 200 mg versus placebo: 13.8% versus 5% |
p < 0.0001 | ||||
| TARGET12 | anti-TNF- IR | 150 mg SC q2w + background cDMARDs 200 mg SC q2w + background cDMARDs |
Placebo + background cDMARDs | ACR20 at week 24 | ACR50 at week 24 | ||
| 150 mg versus placebo: 55.8% versus 33.7% |
p < 0.0001 | 150 mg versus placebo: 37% versus 18.2% |
p < 0.0001 | ||||
| 200 mg versus placebo: 60.9% versus 33.7% |
p < 0.0001 | 200 mg versus placebo: 40.8% versus 18.2% |
p < 0.0001 | ||||
| HAQ-DI at week 12 | ACR70 at week 24 | ||||||
| 150 mg versus placebo: –0.5 versus –0.3 |
p < 0.01 | 150 mg versus placebo: 19.9% versus 7.2% |
p < 0.001 | ||||
| 200 mg versus placebo: –0.6 versus -0.3 |
p < 0.001 | 200 mg versus placebo: 16.3% versus 7.2% |
p < 0.01 | ||||
| DAS28-CRP < 2.6 at week 24 | |||||||
| 150 mg versus placebo: 24.9% versus 7.2% |
p < 0.0001 | ||||||
| 200 mg versus placebo: 28.8% versus 7.2% |
p < 0.0001 | ||||||
| MONARCH13 | MTX-IR | 200 mg SC q2w monotherapy | Adalimumab 40 mg SC q2w | DAS28-ESR at week 24 | DAS28-ESR < 2.6 at week 24 | ||
| Sarilumab versus adalimumab: 3.5 versus 4.5 |
p < 0.0001 | Sarilumab versus adalimumab: 26.6% versus 7% |
p < 0.0001 | ||||
| HAQ-DI at week 24 | |||||||
| Sarilumab versus adalimumab: 1 versus 1.2 |
p = 0.0037 | ||||||
| ACR20 at week 24 | |||||||
| Sarilumab versus adalimumab: 71.4% versus 58.4% |
p = 0.0074 | ||||||
| ACR50 at week 24 | |||||||
| Sarilumab versus adalimumab: 45.7% versus 29.7% |
p = 0.0017 | ||||||
| ACR70 at week 24 | |||||||
| Sarilumab versus adalimumab: 23.4% versus 11.9% |
p = 0.0036 |
MTX, methothrexate; IR, inadequate response; SC, subcutaneous; q2w, every 2 weeks; ACR20/50/70, American College of Rheumatology 20%/50%/70% response rate; HAQ-DI, Health Assessment Questionnaire Disability Index; DAS28-CRP, 28-Joint Disease Activity Score using C-reactive protein; SHS, modified Sharp/van der Heijde Score; CDAI, Clinical Disease Activity Index; anti-TNF, antitumor necrosis factor; cDMARDs, conventional disease-modifying antirheumatic drugs; DAS28-ESR, 28-Joint Disease Activity Score using erythrocyte sedimentation rate.