Primary and major secondary efficacy endpoints at Week 24.*
| Belimumab | |||||
|---|---|---|---|---|---|
| Measure | Placebo, n = 69 | 1 mg/kg, n = 72 | 4 mg/kg, n = 71 | 10 mg/kg, n = 71 | All, n = 214 |
| ACR20, % responders | 15.9 | 34.7, p = 0.010 | 25.4, p = 0.167 | 28.2, p = 0.080 | 29.4, p = 0.021 |
| ACR50, % responders | 4.3 | 9.7, p = 0.207 | 8.5, p = 0.318 | 14.1, p = 0.042 | 10.7, p = 0.085 |
| ACR70, % responders | 2.9 | 5.6, p = 0.430 | 1.4, p = 0.539 | 2.8, p = 0.977 | 3.3, p = 0.877 |
| Mean change in DAS28 score† | −0.9 | −1.3, p = 0.096 | −0.9, p = 0.786 | −1.5, p = 0.005 | −1.2, p = 0.059 |
| DAS28 good/moderate improvement, % | 40.6 | 50.0, p = 0.261 | 42.3, p = 0.841 | 60.6, p = 0.018 | 50.9, p = 0.133 |
| DAS28 good improvement, % | 4.3 | 11.1, p = 0.209 | 7.0, p = 0.719 | 11.3, p = 0.208 | 9.8, p = 0.215 |
| Mean change in total Sharp score‡ | 0.7 | 0.3, p = 0.194 | 0.3, p = 0.256 | 0.6, p = 0.871 | 0.4, p = 0.288 |
↵* P values for comparisons between each belimumab group and the placebo group for ACR20/50/70 and DAS28 good/moderate responses were obtained with likelihood ratio chi-square test, for DAS28 good responses with Fisher’s exact test, and for change from baseline in DAS28 and modified Sharp scores with 2-sample t test.
↵† n = 70 and 213 in the belimumab 10-mg/kg and all-belimumab groups, respectively.
↵‡ n = 67, 70, 66, 68, and 204 in the placebo, belimumab 1-mg/kg, 4-mg/kg, and 10-mg/kg and all-belimumab groups, respectively. ACR: American College of Rheumatology; DAS28: Disease Activity Score 28-joint count.