Source/Disclosures
Disclosures: Kane reports grants from Lundbeck and Otsuka; personal fees from Alkermes, Allergan, Intracellular Therapies, Janssen, Lundbeck, Merck, Neurocrine, Newron, Otsuka, Pierre Fabre, Reviva, Roche, Sumitomo Dainippon, Sunovion and Teva and being a shareholder of LB Pharma; and being a shareholder of Vanguard Research Group outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.
July 17, 2020
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LAI antipsychotic use may delay time to hospitalization for early-phase schizophrenia

Source/Disclosures
Disclosures: Kane reports grants from Lundbeck and Otsuka; personal fees from Alkermes, Allergan, Intracellular Therapies, Janssen, Lundbeck, Merck, Neurocrine, Newron, Otsuka, Pierre Fabre, Reviva, Roche, Sumitomo Dainippon, Sunovion and Teva and being a shareholder of LB Pharma; and being a shareholder of Vanguard Research Group outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.
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Long-acting injectable antipsychotic use among patients with early-phase schizophrenia appeared to significantly delay time to hospitalization, according to results of a randomized clinical trial published in JAMA Psychiatry.

John Kane

“Clinicians are often reluctant to consider a long-acting injectable (LAI) formulation if the patient has yet to experience a relapse due to poor medication adherence,” John Kane, MD, chairman of the department of psychiatry at Zucker Hillside Hospital in New York, told Healio Psychiatry. “Given very high rates of non-adherence, it seems unfortunate to wait for such a deleterious event before considering a more convenient and effective strategy.”

Prior studies suggested that antipsychotic medications reduce relapse risk compared with placebo with a number to treat of three. Epidemiological studies showed substantial reductions in all-cause mortality regarding antipsychotic use compared with no use, and LAIs have proved superior to oral counterparts to this end.

Although LAIs may enhance medication adherence and thus reduce hospitalization risk, clinicians rare consideration of their use for early-phase schizophrenia prompted Kane and colleagues to aim to determine whether using them as such would delay the time to first hospitalization among patients with early-phase illness compared with usual care. The current cluster randomized study, the Prevention of Relapse in Schizophrenia trial, was conducted between December 2014 and March 2019 and included follow-up data across 2 years. Participants were drawn from 39 mental health centers in 19 U.S. states. The researchers randomly assigned 19 clinics to encourage treatment with long-acting aripiprazole monohydrate — the aripiprazole once-monthly (AOM) group — and 20 to offer treatment as usual for the clinician’s choice (CC) group. Schizophrenia diagnosis according to a structured clinical interview, fewer than 5 years of lifetime antipsychotic use and ages 18 to 35 years served as participant eligibility criteria. Investigators enrolled 234 participants at the AOM sites and 255 at the CC sites, for a total of 489 participants.

The only restriction on treatment at CC sites or at AOM sites was that aripiprazole monohydrate had to be prescribed according to FDA-approved guidelines. Time to first psychiatric hospitalization according to participants interviews every 2 months, the service use resource form administered every 4 months and other sources, such as health records, as available served as the primary outcome measures. An independent committee masked to treatment assignment adjudicated potential events.

The participants had a mean age of 25.2 years and had 1 year or less of lifetime antipsychotic use. 52 AOM (22%) and 91 CC (36%) participants had one or more hospitalizations. Results showed a mean survival time until first hospitalization of 613.7 days (95%CI, 582.3-645.1) among AOM participants and 530.6 days (95% CI, 497.3-563.9) among CC participants. The hazard ratio for time to first hospitalization was 0.56 (95% CI, 0.34-0.92), which favored the AOM group. The AOM group had a survival probability of 0.73 (95% CI, 0.65-0.83) and the CC group of 0.58 (95% CI, 0.5-0.67). The number needed to treat to prevent one additional hospitalization was seven participants treated with AOM compared with CC, according to the researchers.

“Our data suggest that using LAIs earlier in the course of illness is acceptable to young patients and can reduce the risk for relapse,” Kane told Healio Psychiatry. “We hope that clinicians will consider the use of long-acting formulations of antipsychotic medications earlier in the course of illness so that we can avoid as many preventable hospitalizations as possible.”