Fig. 4 | npj Parkinson's Disease

Fig. 4

From: Evaluation of the safety and immunomodulatory effects of sargramostim in a randomized, double-blind phase 1 clinical Parkinson’s disease trial

Fig. 4

PD patients were randomized to receive placebo or sargramostim. a UPDRS III scores of each individual patient were assessed at 0, 4, and 8 weeks (visits 1–3) before treatment (Pre-Treatment); at 2, 4, 6, and 8 weeks (visits 4–7) during treatment (Placebo or Sargramostim); and at 4 weeks (visit 8) after cessation (Placebo or Sargramostim Post-Treatment). Higher scores represent more severe motor symptoms. b Changes from baseline UPDRS III scores were determined at each visit for placebo-treated and sargramostim-treated patients using the mean scores of visits 1–3 for each patient as baseline from which to normalize. Changes in scores from each randomized treatment group were normally distributed and homoscedastic by Levene’s test (P > 0.05). Factorial ANOVA showed an effect of randomized treatment group (P = 0.05) and marginal effects of visit (P = 0.07) and treatment-by-time (P = 0.05). Fisher’s least significant difference post hoc tests were used to determine pairwise differences between placebo and sargramostim treatment at each visit. UPDRS III scores for placebo group diminished at start of treatment, which may reflect a placebo effect, but returned to baseline during the study course. c MEG assessment of beta ERD in PD patients. Paired sample t-test comparison of beta ERD activity at baseline (pre-treatment) and during treatment for the group of PD patients receiving sargramostim. Significant increases in beta ERD amplitudes are noted for the pre-treated patient composite in the left and right precentral gyri, right premotor cortex, and SMA (top panel). Increases in beta ERD activity from pre-treatment to sargramostim-treatment are shown for individual patients. Compared with pre-treatment, the left precentral gyrus showed a significant effect of visit [F(2, 9) = 8.869, P = 0.007] and visit-by-group interaction [F(2, 9) = 6.04, P = 0.022], which was quadratic [F(1, 10) = 10.772, P = 0.008]. The right precentral gyrus also showed a visit-by-group interaction [F(2, 9) = 3.321, P = 0.06], which also was quadratic [F(1, 10) = 5.447, P = 0.04]. The right premotor cortex showed a marginal effect of visit [F(2, 9) = 3.050, P = 0.07] and the effect was quadratic [F(1, 10) = 6.124, P = 0.03]. Quadratic interactions were explained as beta ERD amplitudes that increase from pretreatment baseline while on sargramostim and return to baseline levels after termination of treatment

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