Table 3.
Change from baseline at week 52 in the subpopulations of participants taking MAO-B inhibitors at baseline and those who were treatment-naive at baseline
| Placebo | Prasinezumab pooled | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| MAO-B (n = 38) | Treatment-naive (n = 67) | All (n = 105) | MAO-B (n = 77) | Treatment-naive (n = 134) | |||||
| Adjusted mean (s.e.) | Adjusted mean (s.e.) | Adjusted mean (s.e.) | Difference in adjusted means (s.e.) | 80% CI | % RR | Difference in adjusted means (s.e.) | 80% CI | % RR | |
| MDS-UPDRS Part III | |||||||||
| Hypothetical strategya | 6.82 (1.371) n = 28 | 5.04 (1.163) n = 48 | 5.57 (0.897) n = 76 | −2.66 (1.713) n = 55 | −4.87, −0.45 | −39.0 | −0.87 (1.411) n = 92 | −2.69, 0.94 | −17.3 |
| Treatment policy OFFb | 4.79 (1.214) n = 36 | 3.10 (1.048) n = 65 | 3.56 (0.800) n = 101 | −2.60 (1.476) n = 76 | −4.51, −0.70 | −54.3 | 0.53 (1.267) n = 125 | −1.10, 2.16 | +17.1 |
| Treatment policy ONb | 4.18 (1.248) n = 38 | 2.01 (1.109) n = 67 | 2.66 (0.840) n = 105 | −2.60 (1.532) n = 76 | −4.57, −0.63 | −62.2 | 0.32 (1.340) n = 130 | −1.40, 2.04 | +15.9 |
| MDS-UPDRS Part II | |||||||||
| Hypothetical strategya | 2.40 (0.635) n = 28 | 2.89 (0.467) n = 48 | 2.75 (0.373) n = 76 | 0.20 (0.773) n = 55 | −0.80, 1.20 | +8.3 | 0.10 (0.567) n = 92 | −0.63, 0.83 | +3.5 |
| Treatment policyb | 1.21 (0.592) n = 38 | 1.63 (0.438) n = 67 | 1.47 (0.353) n = 105 | 0.22 (0.721) n = 76 | −0.71, 1.15 | +18.2 | 0.25 (0.531) n = 129 | −0.43, 0.93 | +15.3 |
| MDS-UPDRS Part I | |||||||||
| Hypothetical strategya | 1.28 (0.466) n = 28 | 0.38 (0.371) n = 48 | 0.77 (0.295) n = 76 | −0.44 (0.567) n = 55 | −1.17, 0.29 | −34.4 | 0.30 (0.447) n = 92 | −0.27, 0.88 | +78.9 |
| Treatment policyb | 0.50 (0.452) n = 37 | 0.10 (0.375) n = 67 | 0.20 (0.292) n = 104 | 0.03 (0.549) n = 76 | −0.68, 0.73 | +6.0 | 0.65 (0.453) n = 125 | 0.06, 1.23 | +650.0 |
a‘Hypothetical strategy’ assumes a scenario in which the events of start of symptomatic therapy or change in MAO-B inhibitor dose did not occur (performed for the mITT population).
b‘Treatment policy strategy’ in which the treatment effect is estimated irrespective of symptomatic treatment start or changes in MAO-B inhibitor treatment (performed for the intention-to-treat population). CI, confidence interval; MAO-B, monoamine oxidase-B; MDS-UPDRS, Movement Disorder Society-Unified Parkinson’s Disease Rating Scale; mITT, modified intention-to-treat; %RR, percent relative reduction; s.e., standard error.