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Combination olanzapine/samidorphan (LYBALVI) was associated with maintained long-term efficacy and consistent safety outcomes including managed weight gain and metabolic function in patients with 

 who were treated for ≥4 years, according to new findings.

In new phase 3 data presented at the American Psychiatric Association (APA) 2024 Annual Meeting in New York, NY, this weekend, a team of Alkermes-sponsored investigators reported that the fixed-dose, atypical antipsychotic-opioid antagonist combination drug was linked to efficacy and safety outcomes similar to short-term results in patients with either schizophrenia or bipolar I disorder (BD-I).

Investigators led by Rene S. Kahn, MD, PhD, system chair of psychiatry at Icahn School of Medicine of Mount Sinai conducted a long-term evaluation of the safety, tolerability, and durability of clinical effect associated with a 4-year regimen of olanzapine/samidorphan. They sought outcomes including characterization of weight gain and metabolic profiles over the duration of treatment.

“The…combination is approved for the treatment of patients with schizophrenia or BD-I and provides the established antipsychotic efficacy of olanzapine while mitigating olanzapine-associated weight gain,” the team noted.

Kahn and colleagues conducted a 48-month, multicenter, open-label extension assessment involving patients from 1 of 3 relevant completed phase 3 trials, including a pair of 52-week open-label studies assessing patients with schizophrenia, as well as a 12-week randomized controlled trial comparing the combination therapy to lone olanzapine in young adults with recent-onset schizophrenia or BD-1.

Investigators had patients continue their daily dose of 5 - 20 mg olanzapine plus 10 mg samidorphan for an additional 4 years; they adjusted patient doses as warranted during assessment. Long-term safety assessments included incidence of adverse events and change from baseline in body weight and waist circumference. Long-term efficacy endpoints included change in high-density lipoprotein (HDL), low-density lipoprotein (LDL) and total cholesterol triglycerides.

The team additionally sought long-term outcomes for glycemic control based on glucose and glycosylated hemoglobin levels, as well as antipsychotic efficacy per Clinical Global Impressions-Severity (CGI-S) scale.

The patient population included 524 enrolled participants, of whom 523 received ≥1 dose of olanzapine/samidorphan and 188 (35.9%) completed the full 4-year treatment period. Mean duration of exposure was 652 days. Mean patient age was 35.1 years old; they were predominately male (61.6%) and White (72.7%).

Adverse events occurred in 60% of all treated patients; the most common included weight gain (9.8%), headache (7.1%), anxiety (6.1%) and insomnia. Mean body weight change was just 1.47 kg following 4 years of olanzapine/samidorphan. Mean change in waist circumference was 0.61 cm from baseline to 4 years. Investigators additionally observed generally stable lipid and glycemic parameters during the treatment duration.

Disease symptoms remained stable in treated patients over the long period; mean change in CGI from baseline was 0.28 points per patient.

The team concluded their findings showed olanzapine/samidoprhan resulted in consistent safety outcomes per both body weight and lipid/glycemic outcomes during the 4-year open-label extension study.

“Similarly, olanzapine/samidorphan maintained symptom control during long-term treatment,” investigators wrote. “Based on these results olanzapine/samidoprhan maintained long-term antipsychotic efficacy while mitigating the weight gain and metabolic dysfunction associated with olanzapine.”

Kahn R et al. Long-term Safety and Efficacy of Olanzapine/Samidorphan: Results of a 4-Year Open-Label Study. Paper presented at: American Psychiatric Association (APA) 2024 Annual Meeting. New York, NY. May 4-8, 2024.

Alicia J. FDA Approves Olanzapine and Samidorphan for Schizophrenia, Bipolar I Disorder. 

Published June 1, 2021. https://www.hcplive.com/view/fda-approves-olanzapine-samidorphan-schizophrenia-bipolar-disorder

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Four-year, phase 3 data from APA 2024 show olanzapine/samidorphan provided consistent antipsychotic efficacy and weight-related safety in patients with either schizophrenia or bipolar I disorder. 

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Olanzapine/Samidorphan Maintains Mood Disorder Efficacy, Weight and Glycemic Tolerability at 4 Years

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

 was shown to significantly impair a patient’s health-related quality of life (HRQoL) regarding both physical and psychosocial functioning, according to a study published in 

Additionally, as a strong correlation between clinical activity and HRQoL scores was observed, investigators believe the Five-Level EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) may be the best generic assessment for measuring HRQoL among this patient population.

HRQoL is used to determine a patient’s overall perception of the impact of an illness as well as its treatment. This measurement can be used to support patient-centered care and shared decision-making.

“Despite the growing recognition of the importance of HRQoL as an outcome measure, further research is needed to determine whether the existing HRQoL instruments effectively reflect and address the most salient issues of this RA patient community,” wrote a team of international investigators.

In the cross-sectional, observational, non-interventional study, conducted at the Department of Rheumatology and Immunology at Qilu Hospital, Shandong University, investigators evaluated HRQoL and the link between clinical activity measures and HRQoL measurements. They also determined the extent to which different aspects of quality of life—such as social, physical, and psychological—were most affected by RA.

A total of 340 patients with RA were invited to participate in a survey designed to assess HRQoL between December 2019 and October 2020. The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), Assessment of Quality of Life (AQoL)-4D, Short Form 12-item Health Survey (SF-12), and EQ-5D-5L were used to evaluate quality of life. Clinical activity was assessed using the Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR).

Eligible patients met the 2010 RA classification criteria, were aged ≥ 18 years, and had no mental disorders or severe cognitive impairment.

A multivariable linear regression model was employed to compare HRQoL across varying activity levels, while Spearman’s rank correlation coefficient (rs) assessed any link between HRQoL and doctor-reported clinical activity. Patients in clinical remission were used as a reference group.

In total, 314 patients completed the study. The mean age of participants was 52.50 (standard deviation [SD]: 14.73) years, 75% were female, 80% had a high school education or less, and more than half resided in rural areas. Results revealed age, residence, occupation, and annual family income significantly affected disease activity.

Among patients, the mean HAQ-DI score was .87 (SD: .91). Patients in the moderate and high disease activity cohorts reported significantly reduced health state utility values and HRQoL scores compared with the reference cohort (

<.05). Additionally, there was an increase in HAQ-DI scores—indicating more impairment—among these groups (

Scores showed a moderate to strong correlation with RA activity (rs = .50—.65). Although all measurements tended to differentiate disease activity, the disease-specific instrument exhibited the highest correlation.

Investigators noted limitations including missing data on body mass index, smoking status, and comorbidities. Additionally, the AQoL-4D was based on Australian preferences; however, previous research has shown using country-specific scoring algorithms does not significantly affect outcomes. As data was collected at a single hospital, results may not be generalizable to the entire Chinese patient population. Lastly, the cross-sectional study design hindered the possibility of making causal inferences about correlations among variables.

Despite these limitations, strengths included using physician-assessed disease activity in combination with patient-reported HRQoL and the use of multiple generic instruments across RA activity.

“Given the strong correlation between clinical activity and HRQoL scores, and the fact that HRQoL serves as an important clinical supplement, incorporating HRQoL assessment into routine clinical evaluations is crucial for patients,” investigators concluded.

Feng J, Yu L, Fang Y, Zhang X, Li S, Dou L. Correlation between disease activity and patient-reported health-related quality of life in rheumatoid arthritis: a cross-sectional study. 

. 2024;14(5):e082020. Published 2024 May 2. doi:10.1136/bmjopen-2023-082020

Efficace F , Gaidano G , Lo-Coco F . Patient-reported outcomes in hematology: is it time to focus more on them in clinical trials and hematology practice Blood 2017;130:859–66. doi:10.1182/blood-2017-03-737403

Patients in the moderate and high disease activity cohorts reported significantly reduced health state utility values and HRQoL scores compared with the reference cohort. 

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RA Significantly Impairs Physical, Psychosocial Functioning 

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Extended follow-up of an open-label, phase 1/2 trial revealed an escalation of hydroxyurea to the maximum tolerated dose (MTD) significantly improved clinical response and treatment outcomes, without increasing toxicities, in children with 

The non-randomized REACH study, conducted among ≥600 children in sub-Saharan Africa, showed a protocol-directed MTD strategy decreased the rate of important clinical events, including vaso-occlusive pain, acute chest syndrome (ACS), and death, compared with fixed-dose hydroxyurea.

“With non-communicable diseases now recognized as a key contributor to the global burden of disease, it is imperative that children with sickle cell anemia in low-resource settings have access to safe, effective, and affordable hydroxyurea at optimal doses,” wrote the investigative team, led by Banu Aygun, MD, a professor in the division of hematology, oncology, and cellular therapy, Cohen Children’s Medical Center.

Sickle cell anemia is a frequent and severe hemoglobinopathy worldwide–in the US, universal screening has identified 1000 to 2000 newborns each year with the condition, with more than 93% reaching adulthood.

 Globally, the burden of sickle cell involves millions of patients, with nearly 300,000 newborns born annually in sub-Saharan Africa with the condition.

Hydroxyurea is a disease-modifying therapy approved by medicines agencies, including the US Food and Drug Administration (FDA), for children and adults with sickle cell anemia.

 Recent guidelines recommend starting hydroxyurea at 9 months, making it the standard of care for affected patients.

In the REACH trial, eligible children between 1 and 10 years old with documented hemoglobin SS or hemoglobin Sβ zero thalassemia were recruited from four clinical sites in sub-Saharan Africa.

 These patients received fixed-dose hydroxyurea of 17.5 mg/kg per day for 6 months, followed by 6 months of dose-escalation as tolerated, up to 20–35 mg/kg per day. Initial safety and feasibility results at 3 years of hydroxyurea with escalation to MTD in REACH reported fewer painful VOEs and ACS.

This analysis compared results on treatment responses, clinical events, and toxicity rates across the fixed-dose and MTD phases for up to 8 years.

 Between July 2014 and November 2016, 635 children were enrolled in REACH, 606 initiated hydroxyurea, and 522 remained in the trial. As of October 2023, patients received treatment for a median of 93 months, representing 4340 patient-years of treatment.

With dose optimization, by that time point, the mean hydroxyurea dose was 28.2 mg/kg per day and responses were sustained during extended treatment. Mean hemoglobin concentration increased from 7.3 g/dL at baseline to 8.4 g/dL at MTD and the mean fetal hemoglobin level was raised from 10.9% at baseline to 24.1% at MTD and 23.3% at the last measurement. The average absolute neutrophil count (ANC) decreased from 6.8 x 109 cells per L at baseline to 3.6 x 109 cells per L at the last measurement.

Aygun and colleagues noted the clinical event rates over time and across dosing phases suggested significant improvements at higher doses of hydroxyurea, with extended treatment. Substantial reductions in incidence rate ratios (IRRs) were observed between MTD and fixed-dose hydroxyurea in clinical events, including:

ACS events (IRR, 0.21; 95% CI, 0.13 – 0.33; 

Recurrent stroke events (IRR, 0.27; 95% CI, 0.07 - 1.06; 

Malaria infections (IRR, 0.58; 95% CI, 0.46 - 0.72; 

Non-malarial infections (IRR, 0.52; 95% CI, 0.46 - 0.58; 

Serious adverse events (IRR, 0.42; 95% CI, 0.27 - 0.67; 

Dose-limiting toxicity rates were similar between the fixed-dose and MTD phases (24.1 vs 23.2 per 100 patient-years; IRR, 0.97; 95% CI, 0.70 - 1.35; 

 = .86), including numerically higher rates of neutropenia and reticulocytopenia and lower rates of anemia.

In an accompanying editorial, Julie Kanter, division of hematology and oncology, University of Alabama, Birmingham School of Medicine, described key issues accompanying the use of hydroxyurea at MTD in the context of clinical practice, particularly in sub-Saharan Africa.

Kanter highlighted concerns about the key barriers to hydroxyurea use in the region, including poverty and lack of insurance, the low number of clinicians trained in the disease space, and costs, including frequent laboratory surveillance and medication expenses. The editorial also pointed to the potential for long-term increased risk of malignancy, requiring close monitoring of patients with long-term exposure to hydroxyurea therapy to investigate the association.

“As more people survive into adulthood, there needs to be a plan to manage a large population of adults with sickle cell anemia in low-resource regions and to ensure that these adults have a high quality of life as well as longevity,” she wrote.

Aygun B Lane A Smart LR et al. Hydroxyurea dose optimisation for children with sickle cell anaemia in sub-Saharan Africa (REACH): extended follow-up of a multicentre, open-label, phase 1/2 trial. Lancet Haematol. 2024; (published online April 30.) https://doi.org/10.1016/S2352-3026(24)00078-4

Quinn CT, Rogers ZR, McCavit TL, Buchanan GR. Improved survival of children and adolescents with sickle cell disease. 

. 2010;115(17):3447-3452. doi:10.1182/blood-2009-07-233700

Yawn BP, Buchanan GR, Afenyi-Annan AN, et al. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members [published correction appears in JAMA. 2014 Nov 12;312(18):1932] [published correction appears in JAMA. 2015 Feb 17;313(7):729]. 

. 2014;312(10):1033-1048. doi:10.1001/jama.2014.10517

John CC, Opoka RO, Latham TS, et al. Hydroxyurea Dose Escalation for Sickle Cell Anemia in Sub-Saharan Africa. 

. 2020;382(26):2524-2533. doi:10.1056/NEJMoa2000146

Galadanci NA, Kanter J. Long-term data from the REACH study testing hydroxyurea to treat sickle cell anaemia in children in sub-Saharan Africa. The Lancet Hematology. April 30, 2024. Accessed May 3, 2024. https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00096-6/fulltext?dgcid=raven_jbs_aip_email#%20.

Extended follow-up of a phase 1/2 trial finds hydroxyurea dose optimization significantly improves clinical responses in children in sub-Saharan Africa with sickle cell.

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Hydroxyurea Dose Escalation Effective for Children with Sickle Cell Anemia

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

Despite the lack of a statistically significant correlation between 

central centrifugal cicatricial alopecia (CCCA)

 severity, according to recent findings, African American female patients’ subjective views of hair loss severity are strongly linked to quality of life (QoL) impacts regardless of clinical severity.

This research letter was led by M. Agner of Wake Forest School of Medicine in North Carolina, with the investigators conducting their work due to address the psychosocial effects of hair loss which are known to impact morbidity and diminish quality of life. Additionally, CCCA is known to be the most common scarring alopecia type to impact women of African ancestry.

“In particular, scarring types of alopecia like CCCA are associated with higher Dermatology Life Quality Index scores, Hospital Anxiety and Depression Scale scores, and UCLA loneliness scale scores than non-scarring alopecia,” Agner and colleagues wrote.

Agner et al. also noted prior research which highlighted quality of life and disease burden of those with CCCA, though they added that such factors had not been correlated with patients’ disease severity.

The investigators carried out their work through a survey of 50 African American female patients who had been given a diagnosis of CCCA and had their condition diagnosed in-clinic. The investigators' inquiries included participants’ views on impacts on quality of life, subjective symptoms, and their condition’s financial implications.

The research team assessed subjects’ disease severity through their utilization of clinical photographs as well as the Central Scalp Scale (CSS). The survey inquiries were adapted from prior research on alopecia areata life quality.

The team had participants assess themselves regarding their disease severity level, using a scale of 1 - 3, and their survey layout was stratified into 5 sections for the purposes of analysis: impacts on one’s daily life, quality of life, adjustments made, psychological effects, and general financial strain. They also used linear regression to evaluate associations and statistical significance, though qualitative responses by subjects were separated into various themes and their frequency evaluated.

A significant correlation could not be identified between participants’ CSS scores and their scores connected to any of the aforementioned categories, though the research team did find a substantial correlation between subjective scores on severity and all of the factors outside of financial strain.

A notable 74% of study subjects concealed their hair loss and 80% reported that they had implemented alterations to their appearance in general. Despite this, the team found that 78% reported that activities could still be enjoyed and not feeling insecure during gatherings, with most subjects reporting little impact on basic daily activities or personal relationships for the most part.

In terms of psychological impact, many of the participants were noted as feeling anxious, burdened emotionally, and having recurrent thoughts regarding their skin condition. In terms of financial strain, the team found that 72% of subjects reported buying wigs or hair patches, with an average cost of $904.84 each year.

Following the investigators’ open-ended questions regarding participants' experiences noted during the worst points of their disease, they found that participants’ own perceptions of hair loss severity were linked to greater impact on various aspects of their life quality, suggesting limitations to clinical severity assessments.

“The main study limitation is the relatively small sample,” they wrote. “Patients' concerns for their hair loss and its impact on (quality of life) should always be considered, despite the clinical appearance of their disease.”

Agner M, Obeime I, Larrondo J, McMichael A. Severity of hair loss and quality of life for patients with central centrifugal cicatricial alopecia. J Eur Acad Dermatol Venereol. 2024 Apr 18. doi: 10.1111/jdv.20036. Epub ahead of print. PMID: 38634726.

Akintilo L, Hahn EA, Yu JMA, Patterson SSL. Health care barriers and quality of life in central centrifugal cicatricial alopecia patients. Cutis. 2018; 102(6): 427–432.

These data shed light on several important findings related to perceptions of hair loss severity among specific groups with central centrifugal cicatricial alopecia and their QoL measures.


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Central Centrifugal Cicatricial Alopecia: Perceptions of Severity Among Black Female Patients

Clinicians and a pharmacist discuss how they are managing access and assistance with copay assistance program in their practices.

Copay Assistance Programs for Adalimumab Biosimilars

This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.

The conversation delves into the experience with copay assistance programs for biosimilars, highlighting the need for effective patient support to ensure broad uptake and continued adherence. Participants note the familiarity with existing programs for originator drugs and stress the importance of replicating similar support systems for biosimilars to maintain patient confidence.

Concerns arise regarding gaps in education and communication from biosimilar manufacturers, emphasizing the necessity of comprehensive support programs and clear communication channels. Patient access to biosimilars is seen as crucial, with biosimilar adoption programs needing to address various factors such as coverage, support systems, and pharmacoeconomic considerations.

The discussion underscores the significance of accessible and efficient support systems, both for insured and uninsured patients, to facilitate biosimilar adoption. Additionally, effective communication among healthcare providers, specialty pharmacists, and patients is highlighted as essential for navigating access to these programs and ensuring optimal patient care.

Video synopsis is AI-generated and reviewed by HCPLive editorial staff.

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This month's review focuses on digital technology use in ophthalmology, the association between vision impairment and mental health, and public health impacts in eye care.

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Ophthalmology Month in Review: April 2024

These survey results indicate that young adults tended to embrace misconceptions regarding sun protection and positive views of tanning.

Young Adults More Likely to Believe Myths Related to Tanning, Sun Protection, Skin Cancer

Patients often rely on opioids a year before and a year after a diagnosis of ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis.

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Patients with new AS, PSA, RA Diagnosis Have High Reliance on Opioids

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She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Findings suggest metformin and statins have a potective effect against HCC in patients with HCV who fail antiviral therapy.

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Metformin, Statins May Reduce Hepatocellular Carcinoma Risk After HCV Treatment Failure

Our April month in review for hematology breaks down the latest updates to the pipeline, mortality risk in people with sickle cell disease, and our newest multimedia offerings.

Anemia

Hematology Month in Review: April 2024

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

The April 2024 cardiology month in review spotlights FDA news and top updates from the American College of Cardiology 2024 Scientific Session.

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Cardiology Month in Review: April 2024

At 6 months, patients treated with ReNu exhibited significant reductions in assessed knee pain and maintained patient function compared with controls.

Osteoarthritis

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ReNu Achieves Primary Endpoint in Phase 3 Trial for Knee Osteoarthritis

These data suggest vaping poses potential threats to the development of the brain and organs, with teenagers being a predominant target due to surges in use.

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Vaping Frequency in Teen Years Connected to Risk of Exposure to Toxic Lead, Uranium

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Experts discuss treating dry eye with procedural therapies, focusing on common in-office and at-home treatments.

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A new study found specific sociodemographic factors were linked to 76.4% lower odds of adhering to topical therapy for psoriasis.

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Olanzapine/Samidorphan Maintains Mood Disorder Efficacy, Weight and Glycemic Tolerability at 4 Years

RA Significantly Impairs Physical, Psychosocial Functioning

Hydroxyurea Dose Escalation Effective for Children with Sickle Cell Anemia

Central Centrifugal Cicatricial Alopecia: Perceptions of Severity Among Black Female Patients

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