Congratulations to Dr. Irene Malaty on the publication of “Response to Foslevodopa/Foscarbidopa by Sex: Post Hoc Analyses of 2 Phase 3 Clinical Studies, ” which appears in the April 8th issue of Neurology.
Abstract
Objective:
Evaluate the sex-specific outcomes of people with Parkinson’s disease (PD) treated with foslevodopa/foscarbidopa(LDp/CDp).
Background:
Sex-specific differences have been reported in PD incidence and response to therapy. LDp/CDp 24-h/day continuous subcutaneous infusion improved motor fluctuations with a favorable adverse effect profile in a 12-week randomized control trial (RCT; NCT04380142) and 52-week open-label trial (NCT03781167). Post hoc analyses compared LDp/CDp treatment outcomes in women and men
Design/Methods:
Data were pooled to week 12 (n=122 women, n=196 men); only open-label trial data were included from weeks 13–52 (n=98 women, n=146 men). Descriptive statistics (mean[SD]) were provided, and changes from baseline (CFB) between women and men were compared using a 2-sample t-test.
Results:
Baseline characteristics in the pooled 12-week sample were similar among the sexes, except women were slightly older (65.9[8.8] vs 63.6[9.4]years). The open-label trial showed similar differences. At week 12, women (n=60) and men (n=101) showed similar improvements in “Off” time (CFB −2.8[4.1] vs −2.7[3.5]hours, P=.844) and “On” time without troublesome dyskinesia (CFB 3.1[3.7] vs 3.0[3.4]hours, P=.924). Significantly greater improvements in PDSS-2 total scores at week 12 were seen in women compared with men (CFB −10.0[11.2] and −6.2[8.4], P<.01). Similar proportions of women and men experienced any adverse event (AE) at week 12. Although limited by small sample size at week 52, women(n=43) compared with men (n=73) showed greater improvements in “Off” time (CFB −4.5[3.0] vs −2.9[3.1]hours, P≤.01) and “On” time without troublesome dyskinesia (CFB 4.9[3.5] vs 3.1[3.0]hours, P≤.01). From weeks 13–52, adverse effects included hallucinations in 10 (10.2%) women and 7 (4.8%) men, infusion site cellulitis in 6 (6.1%) women and 20 (13.7%) men, and infusion site infection in 1(1%) woman and 12(8.2%) men.
Conclusions:
LDp/CDp improved motor fluctuations in both sexes, with potential differences warranting further investigation. AEs were mixed between the sexes. Real-world studies will be performed to evaluate potential sex differences further.