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LOS ANGELES – Two studies of real-world use of pimavanserin after its approval in March 2016 for the treatment of Parkinson’s disease–associated psychosis indicate its effectiveness, tolerability, and safety in line with clinical trial results, according to reports presented at the annual meeting of the American Academy of Neurology.
In the first study, 102 patients were prescribed pimavanserin (Nuplazid) during May 2016-March 2018. Of the 88 patients who actually took the drug, 83% had Parkinson’s, and 78% were men. Participants’ mean age was 79 years. Nearly a third had deep brain stimulation.
About two-thirds of the patients started taking pimavanserin after failing prior antipsychotic therapy, whereas the other third had not previously taken an antipsychotic. Quetiapine had been used by 91% of previous antipsychotic users, and another 20% had taken clozapine. Other antipsychotics were less commonly used.
There was no consistent strategy implemented for starting pimavanserin: 17 stopped or were advised to stop their other antipsychotic before starting pimavanserin, 15 were told to taper off their other antipsychotic for 1 week or for up to 3 months, and 22 were told to keep taking their other antipsychotic after starting pimavanserin.
The mean treatment duration has been nearly 11 months for the two-thirds of patients who remain on pimavanserin, including 38 who take it alone and another 20 who take it with another antipsychotic.
A total of 10 patients were unable to tolerate pimavanserin because of adverse events, 5 of whom had generalized weakness/gait instability. This adverse event was the only difference in adverse events that was seen from the clinical trials, said lead author Jessie Sellers, a nurse practitioner at Vanderbilt University Medical Center in Nashville, Tenn.
“But overall the drug was really well tolerated and was effective,” she said.
There also was no increase in mortality detected in users, providing evidence against an association with mortality in older people with dementia-related psychosis that previously led to a boxed warning for atypical antipsychotics, noted senior author Daniel O. Claassen, MD. A total of 6 of the 88 patients died, compared with 5 of the 14 patients who never started the drug.
Patients who stopped pimavanserin and started another antipsychotic had only limited success. Of 11 patients who stopped pimavanserin and started another antipsychotic, only 5 were successful. Another six who stopped pimavanserin did not take another antipsychotic drug, primarily because of the resolution of their symptoms.
The pimavanserin status was unknown for four patients, and another three patients who stopped the drug had not returned for follow-up.
Abhimanyu Mahajan, MD, and other researchers from Henry Ford Hospital in Detroit reported similar results with pimavanserin at the AAN annual meeting in a separate, smaller, retrospective chart review of 16 patients with Parkinson’s disease–associated psychosis and 1 with Lewy body dementia.
These patients had a mean duration of parkinsonism of nearly 12 years and more than 2 years of psychotic symptoms, which consisted of daily or continuous hallucinations in all but one patient.
Telephone interviews with patients and caregivers revealed that 10 of 14 had improvement in hallucinations, and 3 had stopped taking it because of either no benefit or remission. Of six patients who took pimavanserin monotherapy, half improved from severe to mild hallucination severity (less than one episode per week), two had no change, and one improved from severe to moderate. For the other eight patients who took pimavanserin with another antipsychotic, two had no change in hallucination severity, two went from severe to mild, three improved from severe to moderate, and one went from moderate to mild. The patients reported no major adverse events.
Ms. Sellers and another author had no disclosures. Dr. Claassen disclosed personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with several companies, including Acadia, which markets pimavanserin.
Two of the authors of Dr. Mahajan’s study reported financial ties to Acadia and other companies.
SOURCE: Sellers J et al. AAN 2018, abstract P1.040 and Mahajan A et al. AAN 2018, abstract P5.065
LOS ANGELES – Two studies of real-world use of pimavanserin after its approval in March 2016 for the treatment of Parkinson’s disease–associated psychosis indicate its effectiveness, tolerability, and safety in line with clinical trial results, according to reports presented at the annual meeting of the American Academy of Neurology.
In the first study, 102 patients were prescribed pimavanserin (Nuplazid) during May 2016-March 2018. Of the 88 patients who actually took the drug, 83% had Parkinson’s, and 78% were men. Participants’ mean age was 79 years. Nearly a third had deep brain stimulation.
About two-thirds of the patients started taking pimavanserin after failing prior antipsychotic therapy, whereas the other third had not previously taken an antipsychotic. Quetiapine had been used by 91% of previous antipsychotic users, and another 20% had taken clozapine. Other antipsychotics were less commonly used.
There was no consistent strategy implemented for starting pimavanserin: 17 stopped or were advised to stop their other antipsychotic before starting pimavanserin, 15 were told to taper off their other antipsychotic for 1 week or for up to 3 months, and 22 were told to keep taking their other antipsychotic after starting pimavanserin.
The mean treatment duration has been nearly 11 months for the two-thirds of patients who remain on pimavanserin, including 38 who take it alone and another 20 who take it with another antipsychotic.
A total of 10 patients were unable to tolerate pimavanserin because of adverse events, 5 of whom had generalized weakness/gait instability. This adverse event was the only difference in adverse events that was seen from the clinical trials, said lead author Jessie Sellers, a nurse practitioner at Vanderbilt University Medical Center in Nashville, Tenn.
“But overall the drug was really well tolerated and was effective,” she said.
There also was no increase in mortality detected in users, providing evidence against an association with mortality in older people with dementia-related psychosis that previously led to a boxed warning for atypical antipsychotics, noted senior author Daniel O. Claassen, MD. A total of 6 of the 88 patients died, compared with 5 of the 14 patients who never started the drug.
Patients who stopped pimavanserin and started another antipsychotic had only limited success. Of 11 patients who stopped pimavanserin and started another antipsychotic, only 5 were successful. Another six who stopped pimavanserin did not take another antipsychotic drug, primarily because of the resolution of their symptoms.
The pimavanserin status was unknown for four patients, and another three patients who stopped the drug had not returned for follow-up.
Abhimanyu Mahajan, MD, and other researchers from Henry Ford Hospital in Detroit reported similar results with pimavanserin at the AAN annual meeting in a separate, smaller, retrospective chart review of 16 patients with Parkinson’s disease–associated psychosis and 1 with Lewy body dementia.
These patients had a mean duration of parkinsonism of nearly 12 years and more than 2 years of psychotic symptoms, which consisted of daily or continuous hallucinations in all but one patient.
Telephone interviews with patients and caregivers revealed that 10 of 14 had improvement in hallucinations, and 3 had stopped taking it because of either no benefit or remission. Of six patients who took pimavanserin monotherapy, half improved from severe to mild hallucination severity (less than one episode per week), two had no change, and one improved from severe to moderate. For the other eight patients who took pimavanserin with another antipsychotic, two had no change in hallucination severity, two went from severe to mild, three improved from severe to moderate, and one went from moderate to mild. The patients reported no major adverse events.
Ms. Sellers and another author had no disclosures. Dr. Claassen disclosed personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with several companies, including Acadia, which markets pimavanserin.
Two of the authors of Dr. Mahajan’s study reported financial ties to Acadia and other companies.
SOURCE: Sellers J et al. AAN 2018, abstract P1.040 and Mahajan A et al. AAN 2018, abstract P5.065
LOS ANGELES – Two studies of real-world use of pimavanserin after its approval in March 2016 for the treatment of Parkinson’s disease–associated psychosis indicate its effectiveness, tolerability, and safety in line with clinical trial results, according to reports presented at the annual meeting of the American Academy of Neurology.
In the first study, 102 patients were prescribed pimavanserin (Nuplazid) during May 2016-March 2018. Of the 88 patients who actually took the drug, 83% had Parkinson’s, and 78% were men. Participants’ mean age was 79 years. Nearly a third had deep brain stimulation.
About two-thirds of the patients started taking pimavanserin after failing prior antipsychotic therapy, whereas the other third had not previously taken an antipsychotic. Quetiapine had been used by 91% of previous antipsychotic users, and another 20% had taken clozapine. Other antipsychotics were less commonly used.
There was no consistent strategy implemented for starting pimavanserin: 17 stopped or were advised to stop their other antipsychotic before starting pimavanserin, 15 were told to taper off their other antipsychotic for 1 week or for up to 3 months, and 22 were told to keep taking their other antipsychotic after starting pimavanserin.
The mean treatment duration has been nearly 11 months for the two-thirds of patients who remain on pimavanserin, including 38 who take it alone and another 20 who take it with another antipsychotic.
A total of 10 patients were unable to tolerate pimavanserin because of adverse events, 5 of whom had generalized weakness/gait instability. This adverse event was the only difference in adverse events that was seen from the clinical trials, said lead author Jessie Sellers, a nurse practitioner at Vanderbilt University Medical Center in Nashville, Tenn.
“But overall the drug was really well tolerated and was effective,” she said.
There also was no increase in mortality detected in users, providing evidence against an association with mortality in older people with dementia-related psychosis that previously led to a boxed warning for atypical antipsychotics, noted senior author Daniel O. Claassen, MD. A total of 6 of the 88 patients died, compared with 5 of the 14 patients who never started the drug.
Patients who stopped pimavanserin and started another antipsychotic had only limited success. Of 11 patients who stopped pimavanserin and started another antipsychotic, only 5 were successful. Another six who stopped pimavanserin did not take another antipsychotic drug, primarily because of the resolution of their symptoms.
The pimavanserin status was unknown for four patients, and another three patients who stopped the drug had not returned for follow-up.
Abhimanyu Mahajan, MD, and other researchers from Henry Ford Hospital in Detroit reported similar results with pimavanserin at the AAN annual meeting in a separate, smaller, retrospective chart review of 16 patients with Parkinson’s disease–associated psychosis and 1 with Lewy body dementia.
These patients had a mean duration of parkinsonism of nearly 12 years and more than 2 years of psychotic symptoms, which consisted of daily or continuous hallucinations in all but one patient.
Telephone interviews with patients and caregivers revealed that 10 of 14 had improvement in hallucinations, and 3 had stopped taking it because of either no benefit or remission. Of six patients who took pimavanserin monotherapy, half improved from severe to mild hallucination severity (less than one episode per week), two had no change, and one improved from severe to moderate. For the other eight patients who took pimavanserin with another antipsychotic, two had no change in hallucination severity, two went from severe to mild, three improved from severe to moderate, and one went from moderate to mild. The patients reported no major adverse events.
Ms. Sellers and another author had no disclosures. Dr. Claassen disclosed personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with several companies, including Acadia, which markets pimavanserin.
Two of the authors of Dr. Mahajan’s study reported financial ties to Acadia and other companies.
SOURCE: Sellers J et al. AAN 2018, abstract P1.040 and Mahajan A et al. AAN 2018, abstract P5.065
REPORTING FROM AAN 2018
Key clinical point:
Major finding: Psychotic symptoms improved in 71%-88% of patients taking pimavanserin.
Study details: Two retrospective chart reviews totaling 105 patients who took pimavanserin.
Disclosures: One or more authors in each study reported financial ties to Acadia, which markets pimavanserin.
Source: Sellers J et al. AAN 2018, abstract P1.040, and Mahajan A et al. AAN 2018, abstract P5.065.