Pimavanserin Reduces Delusions and Relapse Risk in Dementia-Related Psychosis

Analysis of the HARMONY trial was conducted to evaluate the prevention of relapse in patients with dementia-related psychosis who have been treated with pimavanserin.
(HealthDay News) — A day after his inauguration, President Joe Biden plans to unveil a new, far-reaching pandemic response plan. He will also issue executive orders that aim to ramp up the production and distribution of COVID-19 tests and vaccines, make schools and travel safer, and help states fight the spread of COVID-19.

Biden has repeatedly promised to get 100 million COVID-19 shots into the arms of the American people by his 100th day in office; he has already directed the Federal Emergency Management Agency to begin constructing federally supported community vaccination centers, with the goal of having 100 centers in operation within the next month.

On Wednesday, Biden signed three executive orders relating to the COVID-19 pandemic shortly after taking office, The New York Times reported. They require mask wearing and social distancing on federal property and under other limited circumstances; halting the Trump administration’s withdrawal from the World Health Organization; and recreating a White House unit on global health security and biodefense that was disbanded a few years ago, the newspaper said.

For travel, the president plans to sign an executive order requiring masks to be worn in airports and international travelers to show proof of a negative COVID-19 test before boarding planes to the United States, The Times said.

The New York Times Article

Treatment with pimavanserin in patients with dementia-related psychosis was found to be associated with significant reductions in relapse risk and treatment discontinuation compared with treatment with placebo, according to results from the HARMONY study presented at Psych Congress 2020, held virtually from September 10 to 13, 2020.

The HARMONY trial (ClinicalTrials.gov Identifier: NCT03325556) was a phase 3, relapse-prevention study of pimavanserin in patients with dementia-related psychosis. In this analysis of the HARMONY trial, open-label pimavanserin was administered to patients with moderate to severe psychosis associated with Parkinson disease, dementia with Lewy bodies, possible or probable Alzheimer disease, frontotemporal degeneration spectrum disorders, or vascular dementia.

A total of 217 eligible patients experienced a sustained response to therapy at weeks 8 and 12 and were randomly assigned to continue with pimavanserin (n=105) or placebo (n=112) for up to 26 weeks in the double-blind portion. The primary end point included time from randomization to relapse during the double-blind period.

Interim analysis found that pimavanserin was associated with a >2.8-fold reduction in risk of relapse compared with placebo (hazard ratio [HR], 0.353; 95% CI, 0.172-0.727; P =.0023), which resulted in early termination of the trial for superior efficacy. Treatment with pimavanserin was also associated with a 2.2-fold greater reduction in the risk of all-cause discontinuation compared with placebo (HR, 0.452; 95% CI, 0.261-0.785; P =.0024).

During the open-label period, approximately 36.2% of patients experienced adverse events; rates of adverse events were fairly similar between treatment and placebo groups in the randomized portion of the study (41.0% vs 36.6%, respectively). The HARMONY investigators did not observe any negative trends for worsening motor function or cognition as assessed by the Extrapyramidal Symptoms Rating Scale-A and the Mini-Mental State Examination, respectively.

Disclosure: This study was supported by Acadia Pharmaceuticals, Inc. Please see the original reference for a full list of authors’ disclosures.

(HealthDay News) — For patients with symptomatic, radiographically confirmed osteolysis undergoing revision total hip arthroplasty surgery, a single dose of denosumab results in a reduction in osteoclast numbers, according to a study published online Jan. 11 in The Lancet Rheumatology.

Mohit M. Mahatma, from the University of Sheffield in the United Kingdom, and colleagues conducted a phase 2 randomized, proof-of-concept superiority trial involving patients aged 30 years or older and scheduled for revision total hip arthroplasty surgery for symptomatic, radiographically confirmed osteolysis. Participants were randomly assigned to either subcutaneous denosumab or placebo. The between-group difference in osteoclast number per millimeter of bone surface of biopsies taken from the osteolytic membrane-bone interface at surgery eight weeks later was assessed as the primary outcome.

Ten patients in the denosumab group and 12 in the placebo group were assessed for the primary outcome. The researchers found that compared with the placebo group, in the denosumab group, there were 83 percent fewer osteoclasts at the osteolysis membrane-bone interface (median, 0.05 versus 0.30 per mm). There were no deaths or treatment-related serious adverse events reported.

“The results of this proof-of-concept clinical trial indicate that denosumab is effective at reducing bone resorption activity within osteolytic lesion tissue and is well tolerated within the limitations of the single dose used here,” the authors write.

The study was funded by Amgen. Amgen provided denosumab and placebo free of charge.

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Foff E, Cummings J, Soto-Martin M, et al. Pimavanserin significantly reduces risk of relapse of dementia-related psychosis: Results from the double-blind phase of the HARMONY study. Presented at: Psych Congress 2020 Virtual Experience; September 10-13, 2020. Poster 187.

This article originally appeared on Psychiatry Advisor