Transcript
CAPLYTA's short- and long-term clinical safety profile
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Spotlight on Short- and Long-Term Clinical Safety: CAPLYTA in Adults With Bipolar I or II Disorder (Bipolar Depression)
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Heather Luing, MD
Medical Director
Florida Center for TMS
Medical Director, Mental Health Unit
Flagler Hospital
St Augustine, Florida
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Please see Important Safety Information, including Boxed Warnings regarding increased mortality in elderly patients with dementia-related psychosis at the end of this video.
[CAPLYTA logo with 42 mg dosage appears on the right]
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Intra-Cellular Therapies, Inc. is sponsoring this video presentation. The speaker is presenting on behalf of the company and has received compensation for these services. The speaker is presenting information that is consistent with FDA guidelines.
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Please see Important Safety Information, including Boxed Warnings, and full Prescribing Information via the link adjacent to this video player.
(Dr. Heather Luing)
Hello, everyone. Thank you for joining us today to discuss the clinical safety profile of CAPLYTA in patients with bipolar depression. I am Dr. Heather Luing, Medical Director, Mental Health Unit at Flagler Hospital in St Augustine, Florida.
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Heather Luing, MD
Medical Director
Florida Center for TMS
Medical Director, Mental Health Unit
Flagler Hospital
St Augustine, Florida
(Dr. Heather Luing)
CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder, or bipolar depression, as monotherapy and as adjunctive therapy with lithium or valproate. Like other antipsychotic drugs, CAPLYTA has a boxed warning that elderly patients with dementia-related psychosis are at an increased risk of death. CAPLYTA is not approved for these patients. There is also a boxed warning regarding the increased risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Patients must be closely monitored for clinical worsening and for emergence of suicidal thoughts and behaviors when treated with antipsychotics.
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Indications and Boxed Warnings
CAPLYTA is indicated in adults for the treatment of
- Schizophrenia
- Depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.
Caplyta. Prescribing information. Intra-Cellular Therapies; 2022.
(Dr. Heather Luing)
You can see here that CAPLYTA has been approved for a wide range of patients. In fact, looking at this chart, we see the medications that have been evaluated in clinical studies, in adults with bipolar depression. CAPLYTA is the first and only treatment indicated for depressive episodes associated with bipolar I and bipolar II depression, in adults as monotherapy and adjunctive therapy with lithium or valproate. Note that this does not include all indications for each product listed and there are no head-to-head clinical studies comparing the safety and efficacy of these products.
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| Clinical studies evaluating adults with a depressive episode associated with bipolar disorder (bipolar depression)1-6 | Monotherapy | Adjunctive (with lithium or valproate) | ||
| Bipolar I | Bipolar II | Bipolar I | Bipolar II | |
| CAPLYTA | ✔️ | ✔️ | ✔️ | ✔️ |
| Quetiapine/ Quetiapine XR | ✔️ | ✔️ | ||
| Olanzapine/ Fluoxetine | ✔️ | |||
| Lurasidone | ✔️ | ✔️ | ||
| Cariprazine | ✔️ | |||
The FIRST AND ONLY treatment indicated for depressive episodes associated with bipolar I and bipolar II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate
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There are no head-to-head clinical studies comparing the safety and efficacy of these products. This chart is descriptive of the FDA-approved indications in adults with bipolar depression and does not represent all approved indications for each product.
1. Caplyta. Prescribing information. Intra-Cellular Therapies; 2022. 2. Quetiapine. Prescribing information. BluePoint Laboratories; 2021. 3. Seroquel XR. Prescribing information. AstraZeneca; 2020. 4. Olanzapine/fluoxetine. Prescribing information. Teva Pharmaceuticals USA, Inc; 2021. 5. Latuda. Prescribing information. Sunovion Pharmaceuticals Inc; 2019. 6. Vraylar. Prescribing information. RemedyRepack Inc; 2019.
(Dr. Heather Luing)
Before we dive into the safety data, let's take a brief look at the efficacy and dosing of CAPLYTA. CAPLYTA has proven antidepressant efficacy when used as monotherapy or as adjunctive therapy with lithium or valproate, demonstrating an improvement in depressive symptoms and disease severity in adult patients with bipolar I and bipolar II.
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CAPLYTA has proven efficacy when used as monotherapy or as adjunctive therapy with lithium or valproate1-3
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1. Caplyta. Prescribing information. Intra-Cellular Therapies; 2022. 2. Data on File. Intra-Cellular Therapies. 3. Calabrese JR et al. Am J Psychiatry. 2021;178(12):1098-1106.
(Dr. Heather Luing)
This efficacy was achieved at the therapeutic dose of 42 mg once daily, with no titration required. CAPLYTA can be administered at any time of day, with or without food. For patients with moderate or severe hepatic impairment and those taking certain CYP3A4 inhibitors, dose strengths of 21 mg and 10.5 mg are available for dose adjustment.
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42 mg therapeutic dose (CAPLYTA pill) Not actual size.
Once-daily (24-hour icon)
Titration-free (calendar and pill icon)
Taken orally with or without food (knife and fork icon)
Reduce dose for:
- Concomitant use with moderate CYP3A4 inhibitors (21 mg) or with strong CYP3A4 inhibitors (10.5 mg)
- Patients with moderate or severe hepatic impairment (21 mg)
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Caplyta. Prescribing information. Intra-Cellular Therapies; 2022.
(Dr. Heather Luing)
Now, let's explore the short- and long-term safety data. Overall the safety and tolerability of CAPLYTA was evaluated in 2664 adult patients with schizophrenia or bipolar depression who were exposed to one or more doses across the placebo-controlled trials. The most common adverse reactions in the 6-week bipolar depression trials were somnolence or sedation, dizziness, nausea, and dry mouth. And of note, there was no single adverse reaction leading to discontinuation that occurred at a rate greater than 2% of patients treated with CAPLYTA.
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CAPLYTA Had a Consistent Safety and Tolerability Profile Across Clinical Trials
| Most common adverse reactions in 6-week bipolar depression trials, proportion of patients (%): | Monotherapya | Adjunctive with lithium or valproatea | ||
| CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) | |
| Somnolence/ Sedation | 13% | 3% | 13% | 3% |
| Dizzinessb | 8% | 4% | 11% | 2% |
| Nausea | 8% | 3% | 9% | 4% |
| Dry mouth | 5% | 1% | 5% | 1% |
There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in patients treated with CAPLYTA
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a≥5% of patients exposed to CAPLYTA and greater than twice the rate of placebo.
bDizziness, dizziness postural.
Caplyta. Prescribing information. Intra-Cellular Therapies; 2022.
(Dr. Heather Luing)
Let's review the extrapyramidal symptoms or EPS and akathisia profile of CAPLYTA. Shown here is the proportion of patients with EPS and akathisia and movement scores. The left side of the table shows the monotherapy trial data. And the right side shows the adjunctive therapy trial data. Overall the EPS and akathisia profile of CAPLYTA in the bipolar depression trials was similar to placebo. In addition to the spontaneously reported adverse events of EPS and akathisia, objective measures were also used. The Barnes Akathisia Rating Scale and the Abnormal Involuntary Movement Scale were used to measure dyskinesias and the Simpson-Angus Scale was used to measure EPS. So, we can see that in both the spontaneous adverse events and objective scales recorded, EPS and akathisia were similar between CAPLYTA and placebo. I want to note that antipsychotic drugs have been reported to cause tardive dyskinesia or TD, a syndrome of potentially irreversible dyskinetic and involuntary movements, which may increase as the duration of treatment and total cumulative dose increase. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of TD and, if needed, discontinue CAPLYTA if clinically appropriate.
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The EPS and Akathisia Profile of CAPLYTA Was Similar to Placebo
| Incidence of EPSa and akathisia in clinical trials at 6 weeks1,2 | Monotherapy | Adjunctive with lithium or valproate | ||
| CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) | |
| Proportion of patients (%) | ||||
| EPS (including akathisia) | 1.3% | 1.1% | 4.0% | 2.3% |
| Akathisia | 0.0% | 0.3% | 0.6% | 0.0% |
| Movement scores | ||||
| BARSb | -0.1 | -0.1 | 0.0 | -0.1 |
| AIMSc | 0.0 | 0.0 | 0.0 | 0.0 |
| SASd | 0.0 | 0.0 | 0.0 | 0.0 |
Antipsychotic drugs have been reported to cause tardive dyskinesia (TD), which may increase as the duration of treatment and cumulative dose increases, and can develop after brief treatment periods or after discontinuation.
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AIMS, Abnormal Involuntary Movement Scale; BARS, Barnes Akathisia Rating Scale; EPS, extrapyramidal symptoms; SAS, Simpson-Angus Scale.
aEPS include akathisia, extrapyramidal disorder, muscle spasms, restlessness, dyskinesia, tremor, movement disorder, and gait disturbance.
bBARS ranges from 0 to 14.
cThe AIMS for dyskinesia (total score ranges from 0 to 28).
dThe SAS for EPS (total score ranges from 0 to 40).
1. Caplyta. Prescribing information. Intra-Cellular Therapies; 2022. 2. Data on File. Intra-Cellular Therapies.
(Dr. Heather Luing)
Generally, body weight changes can be a concern for both patients and providers. Here we see the effect of CAPLYTA on body weight over the course of 6 weeks in the bipolar depression trials. First, consider the mean change in body weight from baseline in the left set of graphs. Now, let's look at the proportion of patients with clinically significant weight gain, defined as an increase in body weight greater than or equal to 7% from baseline in the right set of graphs. Overall, we can see that the effects of CAPLYTA on weight were similar to placebo. In fact, 99% of participants receiving CAPLYTA did not experience clinically significant weight gain.
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Previous table and copy fade out, and new graphs and copy fade in. Dr. Luing also fades out but appears as voiceover for on screen content. The graph on the left outlines the mean change in body weight from baseline at 6 weeks for patients taking CAPLYTA. The graph on the right showcases the proportion of patients with an increase in body weight greater than or equal to 7% from baseline for patients taking CAPLYTA. The respective graph enlarges when it is spoken about by Dr. Luing. "Please see" copy and CAPLYTA logo remain on screen.
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Weight Change on CAPLYTA Was Similar to Placebo in Short-Term Bipolar Depression Trials at 6 Weeks
Mean Change in Body Weight From Baseline
Study 1: Monotherapy
Study 2: Adjunctive Therapy
Proportion of Patients With an Increase in Body Weight ≥7% From Baseline
Study 1: Monotherapy
Study 2: Adjunctive Therapy
99% of participants receiving CAPLYTA did not experience clinically significanta weight gain
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Antipsychotic drugs have been reported to cause metabolic changes, including weight gain. Measure weight when initiating CAPLYTA and monitor periodically during long-term treatment.
aDefined as ≥7% increase in body weight.
Data on File. Intra-Cellular Therapies.
(Dr. Heather Luing)
It may also be reassuring that CAPLYTA has a favorable metabolic profile, characterized by an effect that was similar to placebo at 6 weeks. These effects were seen across levels of glucose, insulin, cholesterol, and triglycerides. In addition, mean changes from baseline and the proportion of patients with shifts to higher levels of glucose and insulin, total cholesterol, and triglycerides in patients treated with CAPLYTA was similar to those in patients treated with placebo. I want to remind everyone that antipsychotic drugs have been reported to cause hyperglycemia, diabetes, dyslipidemia, and weight gain. So it is important to measure weight and assess fasting, plasma glucose, and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
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Previous graphs and copy fade out, and the new table and copy fade in. Dr. Luing also reappears to the right of the screen and is facing the camera. The table outlines how the levels of glucose, insulin, cholesterol, and triglycerides with CAPLYTA were similar to placebo at 6 weeks. "Please see" copy and CAPLYTA logo remain on screen.
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Levels of Glucose, Insulin, Cholesterol, and Triglycerides With CAPLYTA Were Similar to Placebo at 6 Weeks1,2
| Metabolic parameters | Monotherapy | Adjunctive with lithium or valproate | ||
| CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) | |
| Glucose (mg/dL) | 0.1 | 0.0 | 1.2 | 0.8 |
| Insulin (mIU/mL) | -0.8 | 0.6 | 3.5 | 0.4 |
| Total cholesterol (mg/dL) | -0.6 | -1.1 | -6.5 | -0.7 |
| LDL cholesterol (mg/dL) | -0.7 | -0.6 | -5.9 | -0.6 |
| Triglycerides (mg/dL) | -1.4 | -4.0 | -1.6 | -1.2 |
The proportion of patients with shifts to higher levels of these metabolic parameters was similar between CAPLYTA and placebo1
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Antipsychotic drugs have been reported to cause hyperglycemia, diabetes, dyslipidemia, and weight gain.
Blood glucose, weight, and lipids should be monitored periodically during long-term treatment.
1. Caplyta. Prescribing information. Intra-Cellular Therapies; 2022. 2. Data on File. Intra-Cellular Therapies.
(Dr. Heather Luing)
The effect of CAPLYTA on prolactin was also evaluated. Prolactin was measured as change from baseline, percentage of patients experiencing prolactin-related treatment-emergent adverse events, and percentage of patients experiencing clinically significant elevations in prolactin. All three measures were similar to placebo at week 6. CAPLYTA also demonstrated low grades of adverse reactions related to sexual function at 6 weeks.
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Impact of CAPLYTA on Prolactin Levels at 6 Weeks
Prolactin Levels Were Similar to Placebo
| Prolactin | Monotherapy | Adjunctive with lithium or valproate | ||
| CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=164) | Placebo (n=170) | |
| Mean change from baseline (μg/L) | -0.2 | 1.1 | 0.63 | 1.78 |
| Prolactin-related TEAEs | CAPLYTA (n=372) | Placebo (n=374) | CAPLYTA (n=177) | Placebo (n=175) |
| Blood prolactin increased | 1.3% | 0.3% | 2.3% | 0.0% |
| Hyperprolactinemia | 0.3% | 0.8% | 0.6% | 3.4% |
| Clinically significant elevations | CAPLYTA (n=335) | Placebo (n=355) | CAPLYTA (n=162) | Placebo (n=170) |
| Prolactin (≥5x upper limit of normal) | 0.3% | 0.6% | 1.2% | 1.2% |
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Data on File. Intra-Cellular Therapies.
(Dr. Heather Luing)
Continuing our discussion of findings from the 6-month trial, CAPLYTA also had a favorable weight, metabolic, and prolactin profile. Shown here are the mean changes from baseline in metabolic and prolactin parameters. We can see that the mean change in body weight with CAPLYTA was -0.02 lbs at 6 months. Also shown here is the impact on fasting glucose, insulin, cholesterol-related parameters, and prolactin.
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Previous table and copy fade out, and new table and copy fade in. The new table outlines how CAPLYTA had a favorable weight, metabolic, and prolactin profile at 6 months. Dr. Luing remains on screen. "Please see" copy and CAPLYTA logo remain on screen.
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CAPLYTA Had a Favorable Weight, Metabolic, and Prolactin Profile at 6 Months
Mean change from baseline in metabolic and prolactin parameters in an open-label, long-term trial
| Body weight (lb) | 6 months |
|---|---|
| Body weight | -0.02 (n=116) |
| Blood glucose | 6 months |
|---|---|
| Glucose (mg/dL) | +2.1 (n=112) |
| Insulin (mIU/mL) | +0.7 (n=111) |
| Hemoglobin A1c (%) | 0.0 (n=96) |
| Prolactin (μg/L) | 6 months |
|---|---|
| Prolactin | +1.09 (n=115) |
| Cholesterol (mg/dL) | 6 months |
|---|---|
| LDL | -5.1 (n=117) |
| HDL | +0.9 (n=117) |
| Total cholesterol | -2.4 (n=117) |
| Triglycerides | +2.3 (n=112) |
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Antipsychotic drugs have been reported to cause hyperglycemia, diabetes, dyslipidemia, and weight gain.
Blood glucose, weight, and lipids should be monitored periodically during long-term treatment.
Data on File. Intra-Cellular Therapies.
(Dr. Heather Luing)
In conclusion, we learned today that in addition to proven efficacy in adult patients with bipolar I and bipolar II depression, when used as monotherapy and as adjunctive therapy with lithium or valproate, CAPLYTA also had a consistent safety and tolerability profile across clinical trials. Specifically, CAPLYTA had a favorable EPS and akathisia profile, as well as a favorable weight and metabolic profile over the short- and long-term. Please stay tuned for important safety information on CAPLYTA.
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✔ Consistent safety and tolerability across clinical trials1
✔ Favorable EPS and akathisia profile1,2
✔ Favorable weight and metabolic profile over the short and long term1,2
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LEARN MORE
Comorbidities →
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Antipsychotic drugs have been reported to cause tardive dyskinesia (TD), which may increase as the duration of treatment and cumulative dose increases, and can develop after brief treatment periods or after discontinuation.
Antipsychotic drugs have been reported to cause hyperglycemia, diabetes, dyslipidemia, and weight gain.
Blood glucose, weight, and lipids should be monitored periodically during long-term treatment.
1. Caplyta. Prescribing information. Intra-Cellular Therapies; 2022. 2. Data on File. Intra-Cellular Therapies.
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CAPLYTA is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy and as adjunctive therapy with lithium or valproate.
Important Safety Information
Boxed Warnings:
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome, which is a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation of CAPLYTA and provide intensive symptomatic treatment and monitoring.
- Tardive Dyskinesia (TD), a syndrome of potentially irreversible, dyskinetic, and involuntary movements which may increase as the duration of treatment and total cumulative dose increases. The syndrome can develop after a relatively brief treatment period, even at low doses, or after treatment discontinuation. Given these considerations, CAPLYTA should be prescribed in a manner most likely to reduce the risk of TD. Discontinue CAPLYTA if clinically appropriate.
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Perform complete blood counts in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Discontinue CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors.
- Orthostatic Hypotension and Syncope. Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
- Falls. CAPLYTA may cause somnolence, postural hypotension, and motor and/or sensory instability, which may lead to falls and, consequently, fractures and other injuries. Assess patients for risk when using CAPLYTA.
- Seizures. Use CAPLYTA cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Potential for Cognitive and Motor Impairment. Advise patients to use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. Use CAPLYTA with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. Use CAPLYTA with caution in patients at risk for aspiration.
Special Populations: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Reduce dose for patients with moderate or severe hepatic impairment (21 mg).
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs placebo were:
- Schizophrenia: somnolence/sedation (24% vs 10%) and dry mouth (6% vs 2%).
- Bipolar Depression (Monotherapy, Adjunctive therapy): somnolence/sedation (13% vs 3%, 13% vs 3%), dizziness (8% vs 4%, 11% vs 2%), nausea (8% vs 3%, 9% vs 4%), and dry mouth (5% vs 1%, 5% vs 1%).
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CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.
© 2022 Intra-Cellular Therapies, Inc. All rights reserved.
US-CAP-2200202 06/2022