Can weight-loss surgery help prevent pancreatic cancer in people with obesity?

Obesity and type 2 diabetes are risk factors for various malignancies, including pancreatic cancer, which has a high death rate. A new analysis in Diabetes/Metabolism Research and Reviews suggests that weight-loss surgery-also called metabolic-bariatric surgery-may lower the risk of developing pancreatic cancer in people with obesity, especially in those who also have type 2 diabetes.

In the systematic review and meta-analysis, investigators identified 12 relevant studies that explored the effects of metabolic-bariatric surgery on pancreatic cancer incidence, with a total of 3,711,243 adults with obesity. Surgery was associated with a 44% reduction in pancreatic cancer risk among individuals with obesity but without type 2 diabetes and a 79% risk reduction in those with both obesity and type 2 diabetes.

“Metabolic-bariatric surgery not only has beneficial effects on obesity and type 2 diabetes but also may play a crucial role in reducing the risk of pancreatic cancer in these individuals,” said corresponding author Angeliki M. Angelidi, PhD, of the Broad Institute of MIT and Harvard. “These findings underscore the need for further research to elucidate the underlying mechanisms and understand the full spectrum of health benefits of metabolic-bariatric surgery beyond weight loss.”

Reference:

Metabolic–Bariatric Surgery Reduces Pancreatic Cancer Risk: A Meta-Analysis of Over 3.7 Million Adults, Independent of Type 2 Diabetes Status, Diabetes/Metabolism Research and Reviews (2024). DOI: 10.1002/dmrr.3844. 

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Mental health app may help prevent depression in high risk young people, reveals research

A cognitive behavioural therapy (CBT) app has been found to significantly prevent increases in depression in young people who are at high risk – and could be implemented as a cost effective public mental health measure.

Globally, concern is growing about the high and steadily increasing rates of anxiety and depression in young people. Effective and scalable ways of preventing poor mental health in this group are needed, and digital tools such as mobile apps have been proposed as part of the solution.

Whilst there is emerging evidence for mental health apps being effective in treating anxiety and depression, this project led by the University of Exeter is the first to rigorously test a mental health app on such a large scale across four countries. Two linked papers published in Lancet Digital Health report the results of the ECoWeB-PREVENT and ECoWeB-PROMOTE trials, which ran concurrently in the four-year study funded by Horizon 2020. Critically, these studies found that a CBT self-help app can protect vulnerable young people against depression.

Professor Ed Watkins from the University of Exeter led the project and said: “For young people with elevated risk, our findings suggest the CBT app does have a preventative effect on depression and could have a public health benefit. Participants’ quality-of-life measures were better, and their reported work and social functioning was better.

“However, we also found that it’s hard to make improvements in young people who are basically doing okay. Our findings add to the evidence that prevention for depression works best when we identify and select individuals who are more at risk, rather than take a more universal approach. This identification could be done by an online self-screening process or through professional referral.”

The aim of the £3.3-million project was to test the effects of mobile apps in preventing depression and promoting mental well-being for young people aged 16 to 22. In one of the largest studies of its kind, 3,700 young people took part across the UK, Germany, Belgium, and Spain and were allocated into two trials based on their emotional competence abilities at the start of the study. That resulted in 1,200 young people with reduced emotional competency scores that confer increased risk for depression such as increased worry and overthinking going into one trial focused on prevention, whilst 2,500 without such risk went into the other trial focused on wellbeing promotion.

Those two groups were then randomised in equal numbers to three different apps developed by the study. There was a self-monitoring app where people can report their emotions every day, a self-help app that provided personalised training in emotional competence skills, and a self-help app based on CBT principles. Participants were then followed up at three months and 12 months to see how their wellbeing and depression symptoms changed.

The trials found the CBT app prevented an increase in depression, relative to self-monitoring in the higher risk sample, but that there was no difference between any of the interventions in their effects for the lower risk sample.

Professor Ed Watkins said: “Our results suggest that even when young people used the self-help app just a few times, there was a small but meaningful benefit. Because the app is scalable to large numbers of people in a cost-effective way, these effects have potential value as a public health intervention, within a broader portfolio of digital and in-person services and interventions. Next steps are to identify the active ingredients of the app that were beneficial and to improve engagement and ongoing use of these elements.”

The project involved 13 different partners, including two commercial companies – German voice analysis company audEERING and Danish app creator Monsenso. The University of Exeter (UK), LMU Munich (Germany), Ghent University (Belgium), and Universitat Jaume I (Spain), were the main treatment development and trial sites. Meanwhile, the University of Oxford led on the qualitative analysis.

Reference:

Watkins, Edward R et al., Emotional competenceAJself-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial, The Lancet Digital Health, DOI:10.1016/S2589-7500(24)00148-1.

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Use of elderberry as herbal supplement may exacerbate dermatomyositis and cutaneous lupus erythematosus: Study

Researchers found that among those patients affected by autoimmune skin diseases such as dermatomyositis (DM) and cutaneous lupus erythematosus (CLE), the use of herbal supplements is widespread. A recent study, performed in the rheumatologic-dermatology clinic at the University of Pennsylvania, highlights the need to enhance patient and provider education regarding the risks of herbal supplements in autoimmune disorders. The study was published in ACR Open Rheumatology by Daniella and colleagues.

In recent studies, there is a growing trend to undergo herbal remedies; patients have gradually accepted alternate or additive therapies for chronic diseases. However, some supplements can stimulate the immune system, which may worsen the condition by causing immunological derangement. The present study focused on the use of herbal supplements in autoimmune skin disease and aspires to define some patterns and risk involved in them.

A retrospective analysis was conducted on the cohort of 673 adult patients with validated cases of dermatomyositis or cutaneous lupus erythematosus treated at the University of Pennsylvania’s rheumatologic-dermatology clinic between January 2007 and February 2024. Data collected include demographic data, as well as those regarding disease characteristics, and detailed data regarding herbal supplement use. Predictors of supplement treatment were evaluated through chi-square tests, and results are reported in odds ratios to outline significant patterns and risks.

Key Findings

32% of patients reported using herbal supplements. Patterns of use were associated with marked variability based on age and ethnicity:

  • 44% of patients aged 18–29 years used herbal supplements, compared to 29% of patients aged 50–64 years (P = 0.02) and 23% of patients aged 65 years and older (P = 0.003).

  • Herbal supplement use was significantly more common among Hispanic/Latino patients at 58% compared with White patients at 31%, P = 0.009.

  • Sex and race did not differ in supplement use (33% of women patients vs 29% of men patients, P = 0.49) or race (31% of Whites, 31% of African Americans, P = 1.0; 38% of Asians, P = 0.55). No differences occurred between patients with DM (30%) and those with CLE (36%, P = 0.12).

However, the study did reveal some important information regarding the risk of herbal supplements.

  • Among DM patients, 31% reported onset or worsening of disease after initiation of herbal therapy, compared with 10% of CLE patients.

  • Among these herbal supplements, elderberry appears to be the most commonly linked with exacerbation in both DM and CLE patients, with symptoms worsening in 62% of DM and 50% of CLE.

In conclusion, the prevalence of supplement use was high in autoimmune skin disease patients. Of these supplements, elderberry posed the greatest risk to patients’ conditions, particularly for dermatomyositis sufferers. Healthcare providers need to be vigilant in terms of screening and advising patients against using risky supplements so that patients are protected from immune dysregulation and worsening of conditions.

Reference:

Faden, D. F., Stone, C. J., Xie, L., Lopes Almeida Gomes, L., & Werth, V. P. (2024). Prevalence and risk of immunostimulatory herbal supplement treatment among autoimmune dermatology patients. ACR Open Rheumatology. https://doi.org/10.1002/acr2.11735

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ASSIST II study evaluated Feasibility, Safety, and Efficacy of the OdonAssist Device for Assisted Vaginal Births

Recent study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial for assisted vaginal births. The study involved 104 participants who received the OdonAssist intervention, as well as a nested cohort of participants who consented but did not receive the intervention.

Primary and Secondary Outcomes

The primary outcome was the proportion of births successfully assisted with the OdonAssist device. Secondary outcomes included clinical, patient-reported, operator-reported, device, and health care utilization measures, as well as maternal and neonatal outcomes. The study found that the success rate of the OdonAssist device was 66% (69/104), meeting the threshold for a future randomized controlled trial. There were no serious device-related maternal or neonatal adverse reactions, and potential advantages were observed for neonatal outcomes, with only 4% of the successful OdonAssist group experiencing any device-related adverse effects in the form of neonatal soft tissue bruising, compared to 20% in the unsuccessful OdonAssist group and 23% in the nested cohort.

Factors Affecting OdonAssist Success

Factors associated with higher OdonAssist success rates included shorter total second stage duration, lower station at birth, and more operator experience. Participants reported high birth perception scores, and all practitioners found the device easy to use.

Feasibility, Recruitment, and Future Trial Implications

The study demonstrated that recruitment to an interventional study of a new device for assisted vaginal birth is feasible, with 64% of eligible participants willing to participate. The results provide important data to inform the design of a future randomized controlled trial to compare the OdonAssist with current standard practice for assisted vaginal births.

Key Points

1. The study aimed to determine the feasibility, safety, and efficacy of the OdonAssist device for assisted vaginal births, involving 104 participants who received the intervention and a nested cohort who did not.

2. The primary outcome was the success rate of the OdonAssist device, which was 66%, meeting the threshold for a future randomized controlled trial. There were no serious device-related adverse reactions, and potential advantages were observed for neonatal outcomes.

3. Factors associated with higher OdonAssist success rates included shorter total second stage duration, lower station at birth, and more operator experience. Participants reported high birth perception scores, and practitioners found the device easy to use.

4. The study demonstrated that recruitment to an interventional study of a new device for assisted vaginal birth is feasible, with 64% of eligible participants willing to participate.

5. The results provide important data to inform the design of a future randomized controlled trial to compare the OdonAssist with current standard practice for assisted vaginal births.

6. Overall, the study suggests that the feasibility, safety, and efficacy of the OdonAssist device are sufficient to justify conducting a future randomized controlled trial for assisted vaginal births.

Reference –

Hotton EJ, Bale N, Rose C, White P, Wade J, Mottet N, Loose AJ, Elhodaiby M, Lenguerrand E, Draycott TJ, Crofts JF; ASSIST II Study Group. The OdonAssist inflatable device for assisted vaginal birth-the ASSIST II study (United Kingdom). Am J Obstet Gynecol. 2024 Mar;230(3S):S932-S946.e3. doi: 10.1016/j.ajog.2023.05.018. Epub 2023 Jul 30. PMID: 38462264.

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Extra Virgin Olive Oil Preserves Cognitive Function in Down Syndrome, suggests study

Researchers working with the Alzheimer’s Center at Temple (ACT) recently investigated the effect of extra virgin olive oil (EVOO) on brain health and memory to determine if consumption of extra virgin olive oil, the main component of the Mediterranean diet, can delay cognitive decline in people with Down Syndrome (DS). DS is the most common genetically induced form of physical and intellectual disability, and while modern medical advances have helped to prolong life expectancy from around 40 years to an average of 60, the development of Alzheimer’s disease (AD) in DS patients has become more common than ever before. Individuals with Down syndrome develop age dependent cognitive decline and synaptic dysfunction.

Studies have shown that by the age of 40, about 50% of people with DS manifest significant learning and memory problems which are associated with the presence of Alzheimer’s-like impairment.

The paper, “Extra virgin olive oil beneficial effects on memory, synaptic function, and neuroinflammation in a mouse model of Down syndrome,” describes the results of the study in the Journal of Alzheimer’s Disease. 

Using a mouse model of DS, researchers administered EVOO for 5 months in their diet, after which they were tested for learning and memory impairment. Synaptic function was then measured, and brain tissues were assessed for inflammatory biomarkers. Researchers found that mice receiving EVOO had a significant improvement in learning and spatial memory. Additionally, treated mice had an improvement in synaptic function, and EVOO decreased levels of several inflammatory biomarkers.

“Administration of EVOO to a mouse model of Down syndrome has beneficial effects on memory impairments, synaptic function deficits and neuroinflammation,” says senior author Domenico Praticò, MD, the Scott Richards North Star Foundation Chair for Alzheimer’s Research, Professor of Neural Sciences and Founding Director of the Alzheimer’s Center at Temple (ACT), at the Lewis Katz School of Medicine at Temple University (LKSOM). “Our findings provide additional support for the potential therapeutic effects of EVOO also in individuals with Down syndrome.” 

Reference:

Li J-G, Leone A, Servili M, Praticò D. Extra virgin olive oil beneficial effects on memory, synaptic function, and neuroinflammation in a mouse model of Down syndrome. Journal of Alzheimer’s Disease. 2024;0(0). doi:10.1177/13872877241283675.

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Xanthelasma Palpebrarum Not Linked to Increased Cardiovascular or Dyslipidemia Risk: Study

Research has established that xanthelasma palpebrarum (XP), which is associated with yellowish cholesterol deposits on the eyelids, does not significantly contribute to the incidence of dyslipidemia and cardiovascular disease (CVD). A recent study was published in the journal Ophthalmology conducted by Lustig-Barzelay and colleagues..

This study was designed to establish a hypothesis to identify an association between xanthelasma palpebrarum and dyslipidemia, cardiovascular disease, and other systemic conditions within a large population.

Case-control study was carried out at a single tertiary care center in the medical records of 2001 to 2020. Available records were reviewed on the grounds of ophthalmic evaluations, results from blood tests, and diagnoses for systemic conditions. The study group consisted of patients diagnosed with XP in at least one eye, while a control group without XP was established and matched by age and sex at a ratio of 10:1 for the purposes of robust statistical comparisons between the two groups. The main outcome measures were associations of XP with dyslipidemia and cardiovascular disease with an emphasis on comparing lipid profiles and use of medications between the groups.

  • The database consisted of 35,452 individuals with an average age of 52.2 ± 12.2 years. Of the total number, 24,287 patients (69%) were males.

  • Of these, 203 patients had a diagnosis of XP, while there were 2,030 matched controls included in the study population.

  • The prevalence of dyslipidemia was not significantly different between groups, 42% in XP compared with 46% in controls (P = 0.29).

  • The use of lipid-lowering agents, that is, statins and fibrates, was nearly the same for both study groups ( P = 0.88).

  • Lipid profiles, including total cholesterol, HDL, LDL, and triglyceride levels, were similar in XP patients compared with controls. As an example, median total cholesterol was 192 (XP) vs. 187 (controls) (P = 0.093); LDL was 125 (XP) vs. 120 (controls) (P = 0.17).

  • The rates of CVDs were similar between the groups, though 8.9% of XP patients had a history of CVD as compared to 10% controls (P = 0.56).

  • Other systemic conditions were also similar between the groups and include hypertension, with 23% of XP and 24% controls. Diabetes mellitus was found in 10% XP as opposed to 14% controls, and cerebrovascular accidents with 1% XP versus 1.3% controls (P>0.05).

XP in itself is not an indicator of an increased incidence of dyslipidemia and cardiovascular disease, as was observed in this large population study. However, based on the present results, the presence of XP should by itself not be used as a marker for heightened cardiovascular or lipid-related risk. This study points out the necessity for further research with respect to systemic relevance and supports a more conservative interpretation of its clinical significance in cardiovascular and lipid health.

Reference:

Lustig-Barzelay, Y., Kapelushnik, N., Goldshtein, I., Leshno, A., Segev, S., Ben-Simon, G. J., & Landau-Prat, D. (2024). Association between xanthelasma palpebrarum with cardiovascular risk and dyslipidemia. Ophthalmology. https://doi.org/10.1016/j.ophtha.2024.07.033

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Menstrual cycle luteal phase lengths are not ‘fixed’ at 13-14 days, claims study

The current expectation is that every ovulatory menstrual cycle will have a luteal phase (the time from egg released until the next flow) that lasts approximately 14 days. It is simple, ovulation covers half of the expected, classical 28-day menstrual cycle. That fits with another current concept, “All regular month-apart menstrual cycles are ovulatory.”

“We discovered a wide variety of luteal phase lengths, even in healthy premenopausal women who needed two cycles in a row that were both of normal cycle length and ovulatory in order to join the original study,” said this study’s first author, Sarah Henry, BSc (hons), MD, now in her University of British Columbia family practice residency who did this research as a medical student. “Although the luteal phase was not predictable in length, it was usually less variable than the follicular phase.”

The findings, just published in Human Reproduction, show that the luteal phase is quite variable. It was documented using the validated Quantitative Basal Temperature© (QBT©) method. By QBT©, a normal luteal phase length is ≥10 days; short luteal cycles are <10 days.

“This year-long study is a rare one examining within-woman follicular phase and luteal length variabilities,” said Sonia Shirin MD, MHSc, CeMCOR research associate and co-author who worked with Dr. Henry on statistical analyses. “We studied 53 healthy women’s cycles over about a year; all had at least 8, and an average of 13 menstrual cycles.”

“An amazing thing is that, despite rigorous screening, only 6 of 53 women (11%) had normally ovulatory cycles the whole year,” said Azita Goshtasebi, MD, MPH, PhD, CCFP, co-author and family physician as well as woman’s public reproductive health expert. “Fifty-five percent of women across the study year had more than one short luteal phase in an ovulatory cycle.”

Does it matter if the luteal phase is short?

Yes. A meta-analysis CeMCOR published in 2014 (Li D, Epidemiol Rev) showed there was bone loss in those with more short luteal phase ovulatory and anovulatory cycles compared with those having more normally ovulatory cycles over a year, even if all cycles remained month-apart. It is also likely that short luteal phase cycles, as well as those without ovulation, are related to trouble becoming pregnant.

“I wish I had known that my perfectly regular, month-apart menstrual periods might have hidden silent ovulatory disturbances that could make fertility difficult for me,” said Sophia Park, MD, FRCPC, MBA, associate clinical professor in Pathology and Laboratory Medicine at the University of British Columbia with the lived experience of infertility.

“It is important to know about our own ovulation and luteal phase lengths. Why? Because increasing evidence says that estrogen, a powerful growth stimulator, needs to be counterbalanced. Progesterone decreases proliferation while encouraging cells to become more well-developed and specialized,” reported senior author, Jerilynn C. Prior, BA, MD, FRCPC, professor of endocrinology at the University of British Columbia.

The researchers say this new information about the variability of the luteal phase lengths is important for two reasons:

1. We cannot assume month-apart menstrual cycles mean ovulation or normal-length luteal phases

2. Women need to know about ovulation both for health and fertility. 

Reference:

Sarah Henry, Sonia Shirin, Azita Goshtasebi, Jerilynn C Prior, Prospective 1-year assessment of within-woman variability of follicular and luteal phase lengths in healthy women prescreened to have normal menstrual cycle and luteal phase lengths, Human Reproduction, 2024;, deae215, https://doi.org/10.1093/humrep/deae215.

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Study Recommends Double-J Stent for Enhanced Outcomes in Staghorn Stone Treatment via Percutaneous Nephrolithotomy

Iran: A recent study published in BMC Urology has raised important questions about the necessity of using a double-J stent (DJ stent) after complete supine percutaneous nephrolithotomy (csPCNL) in adult patients with staghorn renal stones. Staghorn stones are large, branched calculi that can significantly impair kidney function and lead to severe complications if not treated effectively. 

The researchers suggest that while omitting a double-J stent after csPCNL can yield acceptable outcomes, the higher residual stone rates associated with staghorn stones lead to increased incidences of renal colic, longer hospital stays, and extended recovery periods. Therefore, they recommend the insertion of a DJ stent.

The research highlights that while csPCNL has become a popular minimally invasive technique for managing these complex stones, postoperative management remains a critical discussion topic. Traditionally, placing a DJ stent following the procedure has been standard practice. The stent maintains urinary drainage, reduces the risk of complications, and adds to patient discomfort and recovery time.

Against the above background, Samira Kazemi, Guilan University of Medical Sciences, Rasht, Iran, and colleagues compared the outcomes of ureteral catheters versus double-J stents in tubeless complete supine PCNL for staghorn stone treatment.

For this purpose, the researchers conducted an analytical cross-sectional study from May 2008 to August 2022, assessing 123 patients who underwent tubeless csPCNL. The patients were categorized into two groups: those who received a double-J (DJ) stent (Group I; n = 23) and those who had a totally tubeless approach using only a perioperative ureteral stent (Group II; n = 100). The study compared demographic characteristics, stone-related factors, and perioperative and postoperative parameters between the two groups.

The following were the key findings of the study:

  • Baseline characteristics were similar across both groups. However, the operative time for Group I was significantly longer than for Group II (68.26 versus 55.25 minutes).
  • In contrast, the duration of hospitalization was shorter for Group I (1.81 versus 2.37 days).
  • The stone-free rate was higher in Group I (90.5% versus 79.8%), although this difference was not statistically significant.
  • There were no major complications between the groups.
  • Patients in Group II experienced a significantly shorter time to return to normal activities (6.48 versus 7.91 days).
  • Multivariable linear regression analysis indicated that preoperative creatinine levels and stone size significantly affect operative time. However, the number of stones and underlying health conditions influenced the length of hospital stay.

“While the necessity of a DJ stent in PCNL for staghorn stones remains debated, its use is advised for these patients due to benefits such as shorter hospital stays, quicker recovery times, and improved success rates,” the researchers concluded.

Reference:

Falahatkar, S., Esmaeili, S., Kazemi, S. et al. Is double-J stent mandatory in complete supine percutaneous nephrolithotomy for adult patients with staghorn renal stones? BMC Urol 24, 216 (2024). https://doi.org/10.1186/s12894-024-01610-9

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Cycling may improve physical function and reduce hospital stays among critically ill patients, finds study

A new systematic review led by researchers in Hamilton, Canada has shown that specialized in-bed cycling therapy, when used in the intensive care unit with critically ill patients, leads to better physical function and a one-day shorter length of stay in the ICU.

The review showed on average, patients who cycled spent one day less in the ICU compared to those who didn’t, and 1.5 days less in the hospital overall, freeing up an important bed sooner. , the average costs per patient can be up to $7,300 per ICU day and $1,500 per hospital day.

Traditionally, ICU rehabilitation studies have been inconclusive or lacked clear results. With this systematic review, a clearer picture is emerging around the safety and benefits of cycling as a rehabilitation intervention in the ICU.

The research – published in NEJM Evidence and simultaneously announced at the European Society of Intensive Care Medicine Congress in Spain – was led by researchers with McMaster University’s School of Rehabilitation Science and St. Joseph’s Healthcare Hamilton. The review analyzed data from 33 rehabilitation clinical trials in 13 countries and included nearly 3,300 patients.

“This research is a major win for patients and their families,” said Heather O’Grady, lead author and recent PhD graduate from Rehabilitation Science at McMaster. “This analysis shows that cycling as part of rehabilitation in the ICU can decrease ICU and overall hospital length of stay, is safe and perhaps most importantly for patients, leads to better physical function post-ICU discharge.”

The review builds off previous research conducted by senior author Michelle Kho, a professor with McMaster’s School of Rehabilitation Science, that first highlighted the potential benefits of cycling by patients in the ICU.

In addition to the main findings, the review showed that adverse events during cycling are uncommon, occurring in less than one per cent of patients. Importantly, patients who received cycling in the ICU did not have higher mortality than those in the comparison groups.

The researchers say the findings provide a distinct research pathway for future study because the model of rehabilitation uses clear-cut equipment, is reproducible and easily standardized.

Reference:

 Heather K. O’Grady, Hibaa Hasan, Bram Rochwerg, Deborah J. Cook, Alyson Takaoka, Rucha Utgikar, Julie C. Reid, and Michelle E. Leg Cycle Ergometry in Critically Ill Patients-An Updated Systematic Review and Meta-Analysis, NEJM Evidence, doi/full/10.1056/EVIDoa2400194.

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Twice-Yearly Depemokimab Effectively Lowers Exacerbation Rates in Severe Eosinophilic Asthma: Study Reveals

USA: A recent study published in the New England Journal of Medicine highlights the effectiveness of Depemokimab, an innovative monoclonal antibody, in managing severe asthma among patients with an eosinophilic phenotype.

The findings reveal that administering Depemokimab twice yearly significantly lowers the annualized rate of asthma exacerbations, offering hope for better disease management.

Eosinophilic asthma, characterized by elevated eosinophil levels in the airways, often leads to more severe symptoms and frequent exacerbations compared to other asthma phenotypes. Traditional treatments may not always provide adequate relief, prompting the need for targeted therapies like Depemokimab, which specifically aims to reduce inflammation associated with eosinophils. Depemokimab is a long-acting biologic therapy with improved binding affinity for interleukin-5, potentially allowing for effective dosing every six months.

In this context, David J. Jackson, the King’s College London, London, and colleagues assessed the efficacy and safety of depemokimab in patients with severe asthma characterized by an eosinophilic phenotype. This phenotype was defined by a high eosinophil count (≥300 cells per microliter in the past 12 months or ≥150 cells per microliter at screening) and a history of exacerbations despite receiving medium- or high-dose inhaled glucocorticoids. The evaluation was conducted through phase 3A, randomized, placebo-controlled trials known as SWIFT-1 and SWIFT-2.

Patients were randomly assigned in a 2:1 ratio to receive either 100 mg of depemokimab administered subcutaneously or placebo at weeks 0 and 26, along with standard care. The primary endpoint was the annualized rate of exacerbations at 52 weeks. Secondary endpoints, analyzed hierarchically to account for multiple comparisons, included changes from baseline in the St. George’s Respiratory Questionnaire (SGRQ) scores, forced expiratory volume in one second (FEV1), and reports of asthma symptoms at 52 weeks.

The researchers reported the following findings:

  • Across the two trials, 792 patients were randomized, with 762 included in the full analysis—502 received depemokimab and 260 received placebo.
  • In the SWIFT-1 trial, the annualized rate of exacerbations was 0.46 for the depemokimab group compared to 1.11 for the placebo group, resulting in a rate ratio of 0.42.
  • In SWIFT-2, the annualized rates were 0.56 for depemokimab and 1.08 for placebo, yielding a rate ratio of 0.52.
  • No significant differences in the change from baseline in SGRQ scores were found in either trial, precluding statistical inferences for subsequent secondary endpoints.
  • In both trials, adverse event occurrence was comparable between the two groups.

The findings showed that depemokimab decreased the annualized rate of exacerbations in patients with severe asthma characterized by an eosinophilic phenotype.

“The study’s outcomes signal a promising advancement in asthma care, especially for those suffering from the eosinophilic form of the disease. With ongoing research and potential regulatory approvals on the horizon, Depemokimab could soon become a vital tool in the fight against severe asthma,” the researchers concluded.

Reference:

Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luíz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Sep 9. doi: 10.1056/NEJMoa2406673. Epub ahead of print. PMID: 39248309.

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