Clinical responses at Week 12. The comparison is between each brodalumab dose group and placebo. Nonresponder imputation is used for the missing data.
| Response | Placebo, n = 63 | Brodalumab | ||
|---|---|---|---|---|
| 70 mg, n = 63 | 140 mg, n = 63 | 210 mg, n = 63 | ||
| ACR50 | ||||
| Response rate, n/N1 (%) | 8/63 (13) | 10/63 (16) | 10/63 (16) | 6/63 (10) |
| Difference in response rate, % | 3.2 | 3.2 | −3.2 | |
| 95% CI of difference | −9.0–15.4 | −9.0–15.4 | −14.1−7.9 | |
| p* | 0.598 | 0.635 | 0.572 | |
| ACR20 | ||||
| Response rate, n/N1 (%) | 27/60 (45) | 25/60 (42) | 23/58 (40) | 29/61 (48) |
| Difference in response rate, % | −3.3 | −5.3 | 2.5 | |
| 95% CI of difference | −21.1−14.4 | 23.1−12.5 | −15.2–20.3 | |
| p* | 0.727 | 0.539 | 0.794 | |
| ACR70 | ||||
| Response rate, n/N1 (%) | 2/63 (3) | 2/63 (3) | 2/63 (3) | 0/63 (0) |
| Difference in response rate, % | 0.0 | 0.0 | −3.2 | |
| 95% CI of difference | −6.1−6.1 | −6.1−6.1 | −7.5−1.2 | |
| p* | 0.984 | 0.993 | 0.159 | |
| DAS28 change from baseline | ||||
| Mean (SD) | −1.3 (1.2) | −1.4 (1.3) | −1.3 (1.2) | −1.3 (1.2) |
| p** | 0.459 | 0.906 | 0.849 | |
↵* P value is nominal p value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.
↵** P value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score. ACR50: American College of Rheumatology 50% response; ACR20: ACR 20% response; ACR70: ACR 70% response; DAS28: Disease Activity Score at 28 joints.