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 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 

Visual and anatomic outcomes were relatively better in eyes with 

 treated with an intensive intravitreal vascular endothelial growth factor (VEGF) inhibitor regimen in the first year of treatment, according to new findings.

Results from a 12-month analysis of eyes with DME identified modest visual acuity (VA) gains, regardless of the number of visits where intravitreal therapy was delivered but showed a slight benefit in favor of the more intensive group, with more injections given at fewer visits.

“These results indicate that for DME, a proactive treat-and-extend protocol yields superior results with fewer visits compared with less intensive treatment regimens in the first year of treatment,” wrote the investigative team, led by Pierre-Henry Gabrielle, MD, PhD, department of ophthalmology, Dijon University Hospital.

Randomized controlled trials have proven the benefit of fixed monthly or every-other-month interval regimens of VEGF inhibitors for visual acuity outcomes.

 Still, real-world data have been unable to replicate these findings, stemming from challenges in the burden of appointments for patients, who may have health or mobility issues in coming for a visit.

A movement toward the personalization of healthcare delivery has led to individualized regimens for the treatment of DME, including pro re nata (PRN), where patients are treated only when their disease is active, or a treat-and-extend regimen when the interval between treatments is extended until disease activity is re-identified.

Clinical trial data of individualized treat-and-extend dosing for DME have shown similar long-term visual and anatomical outcomes to fixed or PRN dosing, with fewer visits and a greater number of injections.

 However, the potential beneficial effect of treat-and-extend in managing DME in routine practice is not well understood.

In the current analysis, Gabrielle and colleagues sought to compare the one-year treatment outcomes of eyes with DME treated in routine practice with VEGF inhibition, based on the number of visits where treatments were delivered. The cohort study used data from the prospective Fight Retinal Blindness! (FRB) registry, collecting information on visual acuity outcomes, type of treatment given, and central subfield thickness (CST).

All eyes receiving aflibercept 2 mg, bevacizumab 1.25 mg, or ranibizumab 0.5 mg for DME between October 2015 and October 2021 were eligible for study inclusion, to allow for ≥12 months of follow-up after starting treatment. Ultimately, 2288 treatment-naive eyes with DME starting intravitreal VEGF inhibitor therapy during the study period were included in the analysis.

Eyes were separated into two groups according to the median number of injections per visit (median, 67%): Group A (n = 1172) had fewer than the median injections per visit and Group B (n = 1116) had more than the median. Patients had a mean VA and CST at baseline of 64.6 letters and 404 µm, respectively.

Upon analysis, Group B demonstrated moderately greater visual improvement than Group A (mean change, 5.2 letters vs. 3.6 letters; 

 = .005), as well as a moderately greater reduction in CST (mean change, –85 vs. –69; 

 = .002) after 12 months. Group B also received significantly more injections (7 vs. 4; 

 <.001), with a lower interval from the last injection to the final 12-month visit (mean, 24 vs. 125 days; 

Gabrielle and colleagues identified a moderate, positive correlation between the number of injections received over 12 months of treatment and the change in VA (

 <.001). Eyes with thicker CST at baseline generally received more injections during the study period.

After adjusting for relevant clinical characteristics, the team found eyes with DME receiving more injections over 12 months exhibited moderately greater mean VA improvement (

 = .010) and moderately greater reduction in CST (

Gabrielle and colleagues indicated the primary advantage of proactive treat-and-extend regimens centers around reducing clinical visits, ultimately lessening the appointment burden and ensuring treatment will be delivered at most visits.

“The main disadvantage of proactive treat-and-extend regimens relates to the marginally higher number of intravitreal injections required, although this appears to translate to improved visual outcomes in the first year of therapy in routine clinical practice,” they wrote.

Mehta H, Gabrielle PH, Hashimoto Y, et al. One-year anti-VEGF therapy outcomes in diabetic macular edema based on treatment intensity: Data from the FRB! registry. Ophthalmol Retina. Published online April 12, 2024. doi:10.1016/j.oret.2024.04.008

Mehta H, Nguyen V, Barthelmes D, et al. Outcomes of Over 40,000 Eyes Treated for Diabetic Macula Edema in Routine Clinical Practice: A Systematic Review and Meta-analysis. 

. 2022;39(12):5376-5390. doi:10.1007/s12325-022-02326-8

Chaudhary V; Chair, Retina Evidence Trials InterNational Alliance (R.E.T.I.N.A.) Study Group. Treat & extend in neovascular age-related macular degeneration: how we got here and where do we go next?. 

. 2023;37(4):581-583. doi:10.1038/s41433-022-02221-0

Arnold JJ, Campain A, Barthelmes D, et al. Two-year outcomes of "treat and extend" intravitreal therapy for neovascular age-related macular degeneration. 

. 2015;122(6):1212-1219. doi:10.1016/j.ophtha.2015.02.009

Articles

A proactive treat-and-extend protocol yields superior results with fewer visits than a less intensive regimen in the first year of treatment for DME.

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Treat-and-Extend Regimen Superior in First Year of DME Treatment

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.

Erik Stroes, MD, PhD
Credit: European Society of Cardiology

A phase 3 trial of olezarsen suggests the APOC3 inhibitor could prove useful in the management of 

Results of the trial, called the BALANCE study, the olezarsen 80 mg monthly dose met the primary endpoint of significantly reducing triglycerides in patients with genetically validated FCS at 6 months, with further analysis demonstrating use was associated with a reduced incidence of acute pancreatitis events over 12 months relative to placebo.

"As a physician who has seen first-hand the struggles of people living with FCS and its serious complications, there is significant need for an effective therapy to lower triglycerides and reduce acute pancreatitis events," said lead investigator Erik Stroes, MD, professor of medicine, Amsterdam University Medical Centers.

"Olezarsen represents a potentially life-changing new medicine for these patients who experience debilitating chronic symptoms, including abdominal pain and cognitive symptoms, as well as hospitalizations associated with potentially fatal acute pancreatitis events."

Presented at the American College of Cardiology 2024 (ACC.24) Annual Scientific Session and simultaneously published in the 

, the BALANCE trial was a phase 3, double-blind, placebo-controlled trial launched to assess the effects of olezarsen at a dose of 80 mg or 50 mg against placebo therapy in patients with genetically identified FCS over the course of 53 weeks. The trial enrolled and randomized 66 patients, with 21, 22, and 23 individuals randomized to olezarsen 80 mg, olezarsen 50 mg, and placebo once monthly through the duration of the trial.

The cohort who underwent randomization had a mean triglyceride level of 2630 (Standard Deviation, 1315) mg/dL, the majority were female, were White, and had a normal BMI. Investigators pointed out 83% of the cohort had biallelic pathogenic variants in 

, 17% had other causative genotypes, 71% had a recorded history of acute pancreatitis within the previous 10 years, and 39% had previously received volanesorsen.

The study had 2 primary outcomes of interest, which were the difference between the 80-mg olezarsen group and the placebo group in the percent change in the fasting triglyceride level from baseline to 6 months and the difference between the 50-mg olezarsen group and the placebo group. Of note, the difference between the 50 mg olezarsen group and placebo group occurred first to determine if it was significant. The trial also included multiple secondary endpoints, such as mean percent change from baseline in the APOC3 level and an independently adjudicated episode of acute pancreatitis.

Upon analysis, results revealed a significant reduction in triglyceride levels at 12 months with olezarsen 80 mg (−43.5%; 95% confidence interval [CI], −69.1 to −17.9; 

<.001) relative to placebo therapy. However, this difference failed to achieve statistical significance when comparing the olezarsen 50 mg group against placebo therapy (−22.4%; 95% CI, −47.2 to 2.5; 

Analysis of secondary endpoints indicated use of olezarsen 80 mg was associated with a 73.7% reduction in mean APOC3 level from baseline to 6 months relative to placebo therapy (−73.7%; 95% CI, −94.6 to −52.8). With olezarsen 50 mg, use was associated with a 65.5% reduction in APOC3 relative to placebo at 6 months (−65.5%; 95% CI, −82.6 to −48.3). Investigators highlighted a single episode of acute pancreatitis was observed in each olezarsen group compared to 11 episodes of acute pancreatitis among the placebo (rate ratio [pooled olezarsen groups vs. placebo], 0.12; 95% CI, 0.02 to 0.66).

Safety analyses from the trial demonstrated the most common adverse events were coronavirus disease 2019, abdominal pain, and diarrhea, none of which occurred more frequently among the patients who received either dose of olezarsen than among those who received placebo. Further analysis indicated serious adverse events were reported among 14% of patients treated with olezarsen 80 mg, 19% treated with olezarsen 50 mg, and 39% treated with placebo. In their release, Ionis Pharmaceuticals called attention to an 84% reduction in all-cause hospitalizations from baseline to 12 months among olezarsen-treated patients.

"Balance is the first clinical study to validate the association of reduced triglyceride levels with reduced incidence of acute pancreatitis events in patients with severely elevated triglycerides. This important finding supports the potential for olezarsen to be the standard of care for patients with FCS, if approved. These data further strengthen our confidence for a successful outcome in the ongoing Phase 3 CORE studies evaluating olezarsen in the much more prevalent severe hypertriglyceridemia patient population," said Brett P. Monia, PhD, chief executive officer of Ionis Pharmaceuticals.

Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al. Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome. 

. Published online April 7, 2024. doi:10.1056/NEJMoa2400201

Ionis Pharmaceuticals, Inc. Ionis presents positive results from phase 3 balance study of Olezarsen for familial chylomicronemia syndrome. Ionis Pharmaceuticals, Inc. April 7, 2024. Accessed April 16, 2024. https://ir.ionispharma.com/news-releases/news-release-details/ionis-presents-positive-results-phase-3-balance-study-olezarsen.

Olezarsen shows promise in managing familial chylomicronemia syndrome, reducing triglycerides and acute pancreatitis events.

Dyslipidemia

Conference

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Olezarsen Shows Ability to Reduce Triglycerides for Patients with FCS in BALANCE Trial

experience abrupt transitions between neutral and negative emotional states, with the magnitude of this shift escalating depending on the severity of the emotional numbing symptoms, a new study found.

“These preliminary results provide valuable insights into the complex association between emotional processing and PTSD symptoms,” wrote investigators, led by Nachshon Korem, PhD, from the department of psychiatry at Yale University School of Medicine.

PTSD is characterized as experiencing contrasting symptoms of hyperemotional reactivity (neutral state) and emotional numbing (negative state). Although emotional numbing is considered to restrict positive emotions, it is also suggested to limit negative emotions, too.

 Alongside emotional numbing, many symptoms of PTSD are associated with hyperactivity to emotional stimuli.

In their cross-sectional study, investigators sought to explore whether individuals grappling with PTSD encountered a significant shift from neutral to negative emotional states and how the emotional numbing severity influences the transition.

From January 17 to March 8, 2023, the team recruited trauma-exposed individuals who either witnessed or experienced a life-threatening incident, violent assault, or someone being killed. Participants completed the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5). They were considered to have PTSD if they had a PCL-5 score of ≥ 33 and had ≥ 1 intrusion symptom, 1 avoidance symptom, 2 negative alterations in cognition and mood symptoms, and 2 alterations in arousal and reactivity symptoms.

The study included 1440 trauma-exposed individuals who either were probable PTSD (n = 445) or trauma-exposed controls. The PTSD group leaned younger with a mean age of 36.1 years than the controls with a mean age of 41.5 years (

The sample was made up of mostly White participants (75.3%, followed by African American or Black (7.4%), Multiracial (5.5%), Asian (4.6%), other race (1.6%), preferred not to say (0.7%), and American Indian or Alaska Native (0.6 %). The study included 47.6% of females, and the groups had similar sex distributions, with 230 women in the PTSD group and 427 in the control group (

Investigators analyzed PTSD emotions using hierarchical Bayesian modeling in the logistic regression to analyze the valence ratings of 40 images. The images included stimuli, featuring faces, people, and animals. The team aimed to compare the curve’s slope between groups and explore the association between the slope and the severity of emotional numbing symptoms.

The primary outcome was the slope parameter derived from the logistic curve fitted to the valence rating. The slope parameter represented the rate at which emotional response intensity alters with stimulus valence, indicating the transition speed between neutral and negative valence states.

Overall, the PTSD group demonstrated a steeper slope than the controls (mean slope difference, -0.255; 89% highest posterior density [HPD], -0.340 to -0.171), indicating a sharper transition. Investigators observed a strong association between the slope and emotional numbing severity (mean additive value, 0.100; 89% HPD, 0.051 – 0.15). After controlling for age, emotional numbing was still associated with transition sharpness (additive value, 0.108; 89% HPD, 0.056 – 0.159) without an age-related association (additive value, 0.031; 89% HPD, -0.022 to 0.083).

The team outlined several limitations including potential data manipulation of lower data quality due to using online studies, the age differences between the 2 groups, not collecting data on index trauma, trauma load, childhood trauma, and time since trauma, and using non-trauma-specific images.

“This study advances our understanding of emotional processing in PTSD by focusing on the transitional dynamics between neutral and negative emotional states, a facet often overlooked in traditional research,” investigators concluded. “These transitional dynamics’ robust association with the severity of emotional numbing symptoms extends the prevailing understanding of emotional experiences in PTSD beyond intensity metrics. The steeper slope in emotional transitions holds notable clinical implications, directing attention toward developing targeted interventions that focus on emotion regulation.”

Korem, N, Duek, O, Spiller, T. Emotional State Transitions in Trauma-Exposed Individuals With and Without Posttraumatic Stress Disorder. 

 2024;7(4):e246813. doi:10.1001/jamanetworkopen.2024.6813 (Reprinted)

https://www.ptsduk.org/emotional-numbness/

A new study found individuals with PTSD face rapid transitions between neutral and negative emotional states.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

PTSD

PTSD Emotional Numbing Impacts Intensity of Neutral to Negative State Shifts

Experts discuss the practice of loading doses for newer agents and when they would consider this suitable for patients.

Perspectives on Loading Dose Recommendations for New Therapies

In this segment, the experts discuss the practice of loading doses when switching patients to aflibercept 8 mg. David Eichenbaum, MD inquires whether the experts recommend loading when transitioning patients, especially those who are already on a different treatment cadence. Kenny Fan, MD expresses hesitation in convincing patients to undergo loading when switching from a less frequent dosing schedule to aflibercept 8 mg. He highlights the challenge of persuading patients to undergo a more intensive treatment schedule, especially if they are already satisfied with their current regimen. Seenu Hariprasad, MD suggests that the decision to load depends on the specific scenario. For patients who have been on a stable regimen for an extended period, he may not opt for loading. However, for those with persistent disease activity, he considers taking advantage of loading doses for a more aggressive approach. Diana Do, MD notes that she typically reserves loading for treatment-naive patients. However, if there is substantial disease activity, she supports being aggressive with loading doses to provide patients with the best chance for vision improvement.

This summary was AI-generated and edited for clarity.

Videos

Abigail Brooks is an assistant editor for 

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.

Barratt discusses subgroup analyses of the phase 3 PROTECT trial and what they add to previous findings about the use of sparsentan versus irbesartan in IgAN.

Jonathan Barratt, MD: Sparsentan’s Benefit Across Baseline Proteinuria Groups in PROTECT

Subgroup analyses of the phase 3 PROTECT trial highlight sparsentan’s clinically meaningful benefit over irbesartan for long-term kidney preservation, absolute change in estimated glomerular filtration rate (eGFR), and rate of eGFR change in adult patients with primary 

 across baseline proteinuria subgroups over 2 years.

Findings were presented at the World Congress of Nephrology in Buenos Aires, Argentina, on April 15, 2024, complementing initial 2-year findings presented last year in a late-breaking oral presentation at the American Society of Nephrology Kidney Week 2023, which provided evidence suggesting use of sparsentan was associated with a more significant antiproteinuric effect at 110 weeks, confirmed by chronic and total eGFR slope, relative to use of irbesartan in patients with IgAN.

“The data is very much more looking at subgroup analyses. It doesn't detract. In fact, it reinforces the value of sparsentan with dual ARB ERA blockade in managing IgA nephropathy, so it's supportive data,” Jonathan Barratt, MD, Mayer Professor of Renal Medicine at the University of Leicester, said in an interview with HCPLive. “We've had the headline data already, so it's not going to change that in any way.”

A dual endothelin type A and angiotensin II type 1 receptor antagonist, sparsentan received accelerated approval for reducing proteinuria in adults with primary IgAN in February 2023, making it the first and only non-immunosuppressive treatment targeting glomerular injury in the kidney to reduce proteinuria in this patient population at risk of rapid disease progression. On March 11, 2024, Travere Therapeutics submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for conversion of the existing accelerated approval to full approval, based on 2-year confirmatory results from PROTECT in which sparsentan demonstrated long-term kidney function preservation and achieved a significant reduction in proteinuria and a clinically meaningful difference in eGFR slope versus an active comparator, irbesartan.

“The bottom line is, if we're talking about sparsentan and irbesartan, they are completely complimentary and they do completely different things. In where we are heading in terms of IgA therapeutics, those are drugs I would be wanting to think about using together alongside a drug that targets pathogenic IgA production,” Barratt explained.

Findings presented at the World Congress of Nephrology showed sparsentan outperformed irbesartan for complete proteinuria remission, defined as urine protein excretion < 0.3 g/day, (31% vs 11%; RR, 2.5; 95% CI, 1.6 to 4.1), as well as for change in eGFR mL/min/1.73m2 (-5.8 vs -9.5; 95% CI, 1.5 to 6.0). Results also showed sparsentan (17.4 years) had a greater potential long–term impact of improved eGFR slope on time to dialysis, besting both irbesartan (12.4 years) and renin-angiotensin system inhibitor standard of care (8.9 years).

Serious treatment-emergent adverse events were comparable between the groups (37% vs 35%), with no drug-induced liver injury in the sparsentan group. Additional subgroup analyses by urine protein-to-creatinine ratio revealed sparsentan was favored across all subgroups for absolute change in eGFR by baseline proteinuria.

Barratt J, et al. Sparsentan vs Irbesartan in Patients with IgAN: Subgroup Analyses of 2-Year Results from the Pivotal Phase 3 PROTECT Trial. Presented at: World Congress of Nephrology (WCN) 2024 Annual Scientific Session. April 13 – 16, 2024. Buenos Aires, Argentina.

Campbell P. PROTECT: Sparsentan Outperforms Irbesartan in IgA Nephropathy 

. November 3, 2023. Accessed April 16, 2024. 

https://www.hcplive.com/view/protect-sparsentan-outperforms-irbesartan-in-iga-nephropathy

Travere Therapuetics. Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN). March 11, 2024. Accessed April 16, 2023. 

https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-submits-supplemental-new-drug-application

Barratt discusses results from subgroup analyses of the phase 3 PROTECT trial based on baseline proteinuria and what they add to previous findings.

Nephrology

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IgA Nephropathy

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Jonathan Barratt, MD: PROTECT Subgroup Analyses Continue to Favor Sparsentan for IgAN

An ACC.24 analysis found a decline in TTM use post-2013 TTM trial, which investigators suggest indicates a potential misinterpretation of trial findings.

Cardiology

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Trends in Targeted Temperature Management Before and After 2013, with José López, MD

Experts discuss the importance of fluid management, presenting a range of perspectives on managing complex cases. 

Perspectives on Retinal Fluid Management

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 

In this analysis, the study investigators highlighted the impact of smoking cigarettes on PASI 75 achievement.


Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Psoriasis Severity Index Scores Impacted by Tobacco Smoking in Current, Former Smokers

A new study explored increased health care utilization of children among several specific sleep disorders, race, and age.

Sleep

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Children with Sleep Disorders Have Double the Odds of Increased Health Care Usage

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.

EULAR’s fibromyalgia guidelines provide comprehensive recommendations for managing active fibromyalgia to assist clinicians in making informed decisions. Test your knowledge with this quiz.

Fibromyalgia

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Clinical Quiz: EULAR Guidelines for the Treatment of Fibromyalgia 

Counting down the most impactful news at major medical meetings, it’s the HCPLive Five! This edition focuses on 5 updates from the American College of Cardiology 2024 (ACC.24) Annual Scientific Sessions.

HCPLive Five at ACC 2024

Barratt discusses the potential of targeting the alternative pathway for controlling inflammation and the significance of the new APPLAUSE-IgAN data.

Jonathan Barratt, MD: Targeting the Alternative Complement Pathway in IgAN with Iptacopan

S Louis Bridges Jr, MD, PhD, explores the role of artificial intelligence in managing rheumatoid arthritis. 

Rheumatoid Arthritis

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S Louis Bridges Jr, MD, PhD: Integrating AI into RA Management

A recent multi-center study identified risk factors linked to premature mortality in sickle cell disease, including male gender and hematologic and biochemical parameters.

Hematology

Sickle Cell

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Patients with SCD Face Early Death Despite Improved Survival Rates 

Laura Ross, PA-C, sits down for a Q&A on the HeartBeet Clinic and the role of reimbursable group visits in cardiovascular disease management and education. 

Latest News

Treat-and-Extend Regimen Superior in First Year of DME Treatment

Olezarsen Shows Ability to Reduce Triglycerides for Patients with FCS in BALANCE Trial

PTSD Emotional Numbing Impacts Intensity of Neutral to Negative State Shifts

Perspectives on Loading Dose Recommendations for New Therapies

Jonathan Barratt, MD: PROTECT Subgroup Analyses Continue to Favor Sparsentan for IgAN