Response to Foslevodopa/Foscarbidopa by Sex: Post Hoc Analyses of 2 Phase 3 Clinical Studies
Okeanis Vaou1, Drew Kern2, Irene Malaty3, Per Odin4, Tove Henriksen5, Lars Bergmann6, Marie O'Meara6, Resmi Gupta6, Megha Shah6, Manon Bouchard7
1University of Texas Health Science Center at San Antonio, 2Departments of Neurology and Neurosurgery, University of Colorado School of Medicine, 3University of Florida, 4Lund University, 5Movement Disorder Clinic, University of Bispebjerg Hospital, 6AbbVie Inc, 7Clinique Neuro-Lévis and Centre de Recherche St-Louis
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.
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