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Abstract Details

Response to Foslevodopa/Foscarbidopa by Sex: Post Hoc Analyses of 2 Phase 3 Clinical Studies
Movement Disorders
P11 - Poster Session 11 (8:00 AM-9:00 AM)
5-013

Evaluate the sex-specific outcomes of people with Parkinson’s disease (PD) treated with foslevodopa/foscarbidopa(LDp/CDp). 

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

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.
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.

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.
Authors/Disclosures
Okeanis Vaou, MD, FAAN (UT San Antonio)
PRESENTER 		Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ABBVIE. Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Vaou has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic . Dr. Vaou has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for medtronic. An immediate family member of Dr. Vaou has stock in SAGE. The institution of Dr. Vaou has received research support from Medtronic.
Drew S. Kern, MD, FAAN (University of Colorado) Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. The institution of Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. The institution of Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Kern has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. The institution of Dr. Kern has received research support from Boston Scientific. The institution of Dr. Kern has received research support from AbbVie Pharmaceticals. Dr. Kern has received research support from Medtronic.
Irene Malaty, MD, FAAN (University of Florida) Dr. Malaty has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Malaty has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aevum. The institution of Dr. Malaty has received research support from Abbvie. The institution of Dr. Malaty has received research support from Revance. The institution of Dr. Malaty has received research support from Parkinson Foundation. The institution of Dr. Malaty has received research support from SAGE. The institution of Dr. Malaty has received research support from Emalex. The institution of Dr. Malaty has received research support from Acadia. Dr. Malaty has received publishing royalties from a publication relating to health care. Dr. Malaty has received personal compensation in the range of $500-$4,999 for serving as a Speaker & Center of Excellence Director with Parkinson Foundation. Dr. Malaty has a non-compensated relationship as a MAB member & Center of Excellence Directory with Tourette Association of America that is relevant to AAN interests or activities.
Per Odin Per Odin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for Britannia. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for Convatec. Per Odin has received personal compensation in the range of $0-$499 for serving as a Consultant for UCB.
Tove Henriksen, MD (Bispebjerg Hospital) Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nordic infucare. Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Britannia. Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck . Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for convatec. Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie. Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Nordic Infucare. Dr. Henriksen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Britannia.
Lars Bergmann, MD (Abbvie GmbH & Co) Lars Bergmann has received personal compensation for serving as an employee of Abbvie. Lars Bergmann has stock in Abbvie.
Marie Omeara, Pharmacist Ms. Omeara has nothing to disclose.
Resmi Gupta (Abbvie Inc) Resmi Gupta has nothing to disclose.
Megha Shah Megha Shah has received personal compensation for serving as an employee of AbbVie. Megha Shah has stock in AbbVIe .
Manon Bouchard, MD (Clinique Neuro Levis) Dr. Bouchard has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Bouchard has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Bouchard has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Es Therapeutics. Dr. Bouchard has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Bouchard has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. The institution of Dr. Bouchard has received research support from FRQS. Dr. Bouchard has received publishing royalties from a publication relating to health care.