Table 3.
Changes in Efficacy Measures (ITT Population)
| Placebo Q2W (n = 14) |
Nipocalimab | ||||
| 5 mg/kg Q4W (n = 14) | 30 mg/kg Q4W (n = 13) | 60 mg/kg single dose (n = 13) | 60 mg/kg Q2W (n = 14) | ||
| MG-ADL scores | |||||
| Baseline, mean (SD) | 7.3 (2.79) | 8.0 (2.75) | 8.0 (2.61) | 7.9 (2.78) | 8.1 (3.25) |
| Day 57, mean (SD) | 5.2 (3.09) | 5.5 (3.32) | 4.0 (2.63) | 6.5 (3.84) | 4.3 (2.95) |
| Change from baseline, mean (SD) | −1.8 (3.22) | −2.5 (2.41) | −3.9 (3.00) | −1.5 (2.82) | −3.9 (3.66) |
| LS mean values (SE)a | −2.4 (0.9) | −2.4 (0.9) | −3.7 (0.9) | −1.4 (1.0) | −3.7 (0.9) |
| Difference in LS mean values (nipocalimab vs placebo)a | −0.0 (1.1) | −1.3 (1.1) | 1.0 (1.1) | −1.3 (1.1) | |
| 95% CI | −2.1 to 2.1 | −3.5 to 0.9 | −1.2 to 3.1 | −3.4 to 0.8 | |
| p Value | 0.99 | 0.24 | 0.36 | 0.22 | |
| p Value of linear trend test of change from baselineb | 0.03 | ||||
| p Value of linear trend test based on the rank of change from baselinec | 0.004 | ||||
| QMG scores | |||||
| Baseline, mean (SD) | 17.6 (4.20) | 15.9 (2.93) | 17.1 (4.23) | 16.1 (4.07) | 16.9 (2.79) |
| Day 57, mean (SD) | 13.2 (4.92) | 12.2 (4.62) | 13.1 (2.64) | 14.0 (4.56) | 11.3 (4.40) |
| Change from baseline, mean (SD) | −3.7 (2.94) | −3.5 (4.10) | −4.1 (3.45) | −1.5 (2.54) | −5.9 (5.30) |
| LS mean values (SE)a | −3.4 (1.2) | −3.5 (1.1) | −3.9 (1.2) | −1.3 (1.2) | −5.2 (1.1) |
| Difference in LS mean values (nipocalimab vs placebo)a | −0.1 (1.5) | −0.5 (1.6) | 2.1 (1.6) | −1.8 (1.5) | |
| 95% CI | −3.1 to 2.9 | −3.6 to 2.6 | −1.0 to 5.2 | −4.8 to 1.2 | |
| p Value | 0.93 | 0.73 | 0.18 | 0.23 | |
| MG-QoL-15r total scores | |||||
| Baseline, mean (SD) | 17.4 (5.24) | 15.4 (6.26) | 15.6 (7.83) | 17.8 (5.87) | 15.7 (6.82) |
| Day 57, mean (SD) | 15.6 (7.03) | 13.6 (7.49) | 9.1 (7.88) | 16.7 (5.54) | 12.0 (8.53) |
| Change from baseline, mean (SD) | −2.0 (4.58) | −1.7 (4.16) | −6.8 (5.73) | −1.2 (1.91) | −3.7 (5.37) |
| LS mean values (SE)a | −1.9 (1.4) | −2.1 (1.3) | −6.9 (1.4) | −1.3 (1.4) | −4.0 (1.3) |
| Difference in LS mean values (nipocalimab vs placebo)a | −0.2 (1.7) | −5.1 (1.8) | 0.6 (1.8) | −2.2 (1.7) | |
| 95% CI | −3.7 to 3.2 | −8.6 to −1.5 | −3.0 to 4.1 | −5.6 to 1.3 | |
| p Value | 0.90 | 0.005 | 0.754 | 0.21 | |
Abbreviations: ITT = intent-to-treat; LS mean = least squares mean; MG-ADL = Myasthenia Gravis - Activities of Daily Living Total Score; MG-QoL-15r = Revised Myasthenia Gravis Quality of Life -15; QMG = Quantitative Myasthenia Gravis; Q2W = every 2 wk; Q4W = every 4 wk; SE = standard error.
LS mean values, CIs, and p values are from a Mixed-effect Model Repeated Measures (MMRM) at day 57 with treatment group, visit, treatment group by visit interaction, and autoantibody type as fixed effects and the baseline score as a covariate. Compound symmetry covariance structure is used.
Linear trend test is based on the change from baseline at day 57. The 60 mg/kg nipocalimab single-dose treatment group was not included in this analysis, and the coefficients for testing linear trend used were −3, −1, 1, 3 for the placebo, 5 mg/kg nipocalimab Q4W, 30 mg/kg nipocalimab Q4W, and 60 mg/kg nipocalimab Q2W groups, respectively.
Linear trend test is based on the rank of the change from baseline at day 57. Patients without a day 57 result were assigned the largest rank based on the rest of the patients' results. The 60 mg/kg nipocalimab single-dose treatment group was not included in this analysis, and the coefficients for testing linear trend used were −3, −1, 1, 3 for the placebo, 5 mg/kg nipocalimab Q4W, 30 mg/kg nipocalimab Q4W, and 60 mg/kg nipocalimab Q2W groups, respectively.