Efficacy results of pimavanserin from a multi-center, open-label extension study in Parkinson's disease psychosis patients
Isaacson, SH; Ballard, CG; Kreitzman, DL; et al.Coate, B; Norton, JC; Fernandez, HH; Ilic, TV; Azulay, J-P; Ferreira, JJ; Abler, V; Stankovic, S
Date: 27 April 2021
Journal
Parkinsonism and Related Disorders
Publisher
Elsevier / World Federation of Neurology Research Group on Parkinsonism and Related Disorders
Publisher DOI
Abstract
Introduction: Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, was
approved for hallucinations and delusions associated with Parkinson’s disease psychosis
(PDP). We present durability of response with pimavanserin in patients with PDP for an
additional 4 weeks of treatment.
Methods: This was an open-label extension (OLE) ...
Introduction: Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, was
approved for hallucinations and delusions associated with Parkinson’s disease psychosis
(PDP). We present durability of response with pimavanserin in patients with PDP for an
additional 4 weeks of treatment.
Methods: This was an open-label extension (OLE) study in patients previously
completing one of three double-blind, placebo-controlled (Core) studies. All patients
received pimavanserin 34 mg once daily. Efficacy assessments included the Scale for the
Assessment of Positive Symptoms (SAPS) PD and H+D scales, Clinical Global
Impression (CGI) Improvement and Severity scales and Caregiver Burden Scale (CBS),
through 4 weeks in the OLE. Safety assessments were conducted at each visit.
Results: Of 459 patients, 424 (92.4%) had a Week 4 efficacy assessment. At Week 4 (10
weeks total treatment), SAPS-PD mean (standard deviation) change from OLE baseline
was -1.8 (5.5) and for SAPS-H+D was -2.1 (6.2) with pimavanserin 34 mg. Patients
receiving placebo during the Core studies had greater improvements (SAPS-PD -2.9
[5.6]; SAPS-H+D -3.5 [6.3]) during the OLE. For participants treated with pimavanserin
8.5 or 17 mg during the Core studies, further improvement was observed during the OLE
with pimavanserin 34 mg. The mean change from Core Study baseline for SAPS-PD
score was similar among prior pimavanserin 34 mg and prior placebo-treated participants
(-7.1 vs. -7.0). The CGI-I response rate (score of 1 or 2) at Week 4 was 51.4%. Adverse
events were reported by 215 (46.8%) patients during the first 4 weeks of OLE. The most
common AEs were fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%),
insomnia (2.4%), and peripheral edema (2.2%)
4
Conclusions: Patients previously on pimavanserin 34 mg during three blinded core
studies had durability of efficacy during the subsequent 4 week OLE SAPS-PD
assessment. Patients previously on blinded placebo improved after 4 weeks of OL
pimavanserin treatment. These results in over 400 patients from 14 countries support the
efficacy of pimavanserin for treating PDP.
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Except where otherwise noted, this item's licence is described as © 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license