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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 

A very high number of infants and toddlers who have been peanut-sensitized and live with 

 are already co-sensitized to tree nuts, according to recent findings, suggesting a high likelihood for 

 in a considerable number of such individuals.

These data suggest the potential value in determining specific IgE (sIgE) to tree nuts among children who are peanut-sensitized if tree nuts have not yet been consumed. The data result from new research led by Lara Meixner, MSc, from the department of pediatric respiratory medicine at the Universitätsmedizin Berlin in Germany.

The investigators highlighted recent increases in popularity of tree nuts such as cashews and hazelnuts among the rising number of vegan and plant-based diets.

 Such dietary habit shifts may result in a wider spread of tree nut allergens and peanut allergy has been previously suggested to lead to increases in likelihood of being allergic to tree nuts versus the general population.

“Therefore, the aim of this study was to investigate how often peanut-sensitized infants and toddlers are sensitized to cashew, hazelnut and walnut as well as their seed storage proteins, which might be associated with a high risk for clinical reactivity,” Meixner and colleagues wrote.

The investigative team looked at data on both infants and toddlers who had been referred to the department of pediatric respiratory medicine, immunology, and critical care medicine at Charité—Universitätsmedizin Berlin. Among these children, some had been given oral food challenges (OFCs) due to their routine diagnostic procedures between 2007 - 2020.

The team collected clinical information as well as blood samples from all of the participants, requiring participants to be 2 years of age or younger. Additionally, they were required to have had specific IgE (sIgE) levels to peanut at or above 0.1 kU/l.

The investigators’ conducted their detection of sIgE to hazelnut, peanut, walnut, cashew, and their respective 2S albumins (Cor a 14, Ara h 2, Jug r 1, Ana o 3) in addition to the 7S vicilin-like globulin Ara h 1, through the use of the NOVEOSTM immunoanalyzer from Garden Grove, California. They defined sensitization as the presence of an sIgE level of 0.1 kU/l at least.

For the purposes of evaluating subjects’ likelihood of positive food challenges for hazelnut and cashew, probability curves were applied, correlating the resulting outcomes with Cor a 14-sIgE and Ana o 3-sIgE levels, respectively. However, given that no probability curve exists for walnut, the team concluded that it was impossible to determine one’s individual risk of one’s positive OFC for such an allergen.

The researchers assessed sera from 101 patients who had been sensitized to peanuts (defined as peanut-sIgE ≥0.1 kU/l). During the time of the investigators’ blood collection period, they noted that their subjects’ median ages was 16 months, though a range between 5 - 24 months was reported. They added that 98% also had eczema.

The researchers concluded that sIgE levels of ≥0.1 kU/l were present among 96.0% of the participants for at least 1 tree nut. The team reported that 94.1% of the evaluated children were sensitized to hazelnuts, followed by walnuts at 87.1%, and cashews at 84.2%.

The investigators noted that sensitization to 1 2S albumin at least was observed among 58.4% of subjects. They added that 41.6% showed sensitization to both Cor a 14 and Jug r 1 and 39.6% showed sensitization to Ana o 3.

Among a subset of 101 peanut-sensitized children in the analysis, the research team found that 5.0% showed a 90% probability of hazelnut reaction and 13.9% to cashews. In total, 15.8% of those who were peanut-sensitized were predicted by the team to have at least a 90% probability of having allergies to cashews and/or hazelnuts.

Overall, the investigators concluded that peanut-sensitized infants and toddlers are frequently co-sensitized to tree nuts and their 2S albumins. It was also noted 98% of the analysis’s subjects suffered from eczema, a known risk factor for sensitization and the development of food allergy.

“A few limitations of our study have to be mentioned. As this was a retrospective analysis of stored serum samples, we had no data on the clinical relevance of the tree nut sensitization,” they wrote. “In particular, we lacked information on whether an oral food challenge had been conducted or what its outcome was. Moreover, the period of study inclusion was relatively long (2007–2020).”

Meixner L, Heller S, Bluhme F, Trendelenburg V, Beyer K, Kalb B. Infants and toddlers with sensitization to peanut are often co-sensitized to tree nuts. Clin Transl Allergy. 2024;e70008. https://doi.org/10.1002/clt2.70008.

Reese I, Schäfer C, Ballmer-Weber B, et al. Vegan diets from an allergy point of view - position paper of the DGAKI working group on food allergy. Allergol Select. 2023; 7(1): 57-83. https://doi.org/10.5414/alx02400e.

McWilliam V, Peters R, Tang MLK, et al. Patterns of tree nut sensitization and allergy in the first 6 years of life in a population-based cohort. J Allergy Clin Immunol. 2019; 143(2): 644-650.e5.

Articles

Infants and toddlers with peanut sensitization and eczema often show co-sensitization to tree nuts, indicating a high risk of allergic reactions. Research suggests assessing specific IgE (sIgE) to tree nuts in peanut-sensitized children who haven't consumed them. The study, involving 101 children, found high sensitization rates to hazelnuts, walnuts, and cashews. A significant percentage showed a high probability of allergic reactions to these nuts. The study highlights the need for careful monitoring of peanut-sensitized children, though it acknowledges limitations like lack of clinical relevance data.

This analysis evaluated the frequency of peanut-sensitized infants and toddlers being sensitized to other types of nuts.

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Peanut-Sensitized Infants with Eczema Already Co-Sensitized to Tree Nuts

Professor Stephen Nicholls is a world-renowned cardiologist, and leads the Victorian Heart Hospital (VHH) at Monash University.

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.

 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 

Zerlasiran Achieves Durable Lp(a) Reductions at 60 Weeks, with Stephen J. Nicholls, MD, PhD

Data from the ALPACAR-360 trial, presented at the 

American Heart Association (AHA) Scientific Sessions 2024

, confirm that zerlasiran (formerly SLN360) achieves sustained reductions in lipoprotein(a) [Lp(a)] through 60 weeks. Zerlasiran, a gene-silencing therapy, offers a potential treatment for elevated Lp(a), a genetic risk factor affecting 20% of the global population and a significant driver of 

Launched in 2023, the Phase 2 trial randomized 178 patients with baseline Lp(a) levels >125 nmol/L and high cardiovascular risk to 3 dosing regimens of zerlasiran or placebo therapy. Upon analysis, at 36 weeks, zerlasiran showed a least-squares mean time-averaged Lp(a) reduction of –81.3% to –85.6%.

“I think there’s two elements to the efficacy. There’s the degree of Lp(a) lowering that we can but then there’s the durability,” Stephen J. Nicholls, MD, PhD, Victorian Heart Institute, Monash University, told HCPLive. “If we follow patients out 3-, 6-, and 12-months after an injection, what we’re seeing with these agents is that your Lp(a) doesn’t come back to beeline. Our ability to show more and more durability, more Lp(a) lowering 6-, 12-months after injections, has implications for potentially less frequent dosing.”

These dose reductions were observed in the zerlasiran 450 mg every 24 weeks (–85.6%; 95% CI, –90.9% to −80.3%), 300 mg every 16 weeks (–82.8%; 95% CI, –88.2% to –77.4%), and 300 mg every 24 weeks (–81.3%; 95% CI, –86.7 to 76.0) cohorts, respectively. These reductions remained consistent through 60 weeks, and zerlasiran was well-tolerated. A total of 20 serious adverse events in 17 patients, but none were deemed to be related to the study drug—injection site reactions were the most common treatment-related adverse event.

Nicholls indicated data from the ALPACAR-360 trial demonstrate the competitive profile of zerlasiran as a potential long-term, infrequent-dose therapy. Zerlasiran will progress into Phase 3 trials as a potentially promising new treatment for patients with high Lp(a).

“I think that finding suggests that if you do big enough trials, you do see adverse events.,” Nicholls told HCPLive. “...All seemed to be pretty mild in severity, and they resolve pretty quickly. These are important, not only in terms of the conversation we have with our patients about starting therapy, but then about kind of keeping patients on treatment long term.”

Disclosures: Nicholls reports relevant disclosures including Amgen, Eli Lilly, Novartis, Sanofi-Regeneron, Silence Therapeutics, and others.

Nissen SE, Wang Q, Nicholls SJ, et al. Zerlasiran—A Small-Interfering RNA Targeting Lipoprotein(a): A Phase 2 Randomized Clinical Trial. JAMA. Published online November 18, 2024. doi:10.1001/jama.2024.21957

Packer M. Tirzepatide for Patients with Heart Failure with Preserved Ejection Fraction and Obesity: the SUMMIT Trial. Paper presented at: American Heart Association Scientific Sessions 2024; November 15 - 18; Chicago, Il. Accessed November 16, 2024.

Videos

Zerlasiran, a gene-silencing therapy, has shown promising results in the ALPACAR-360 trial, achieving sustained reductions in lipoprotein(a) [Lp(a)] levels over 60 weeks. This Phase 2 trial involved 178 patients with high cardiovascular risk and elevated Lp(a) levels, demonstrating significant Lp(a) reductions across various dosing regimens. Zerlasiran was well-tolerated, with no serious adverse events linked to the drug. The trial's findings suggest zerlasiran's potential as a long-term, infrequent-dose therapy for managing elevated Lp(a), a genetic risk factor for cardiovascular disease, warranting progression to Phase 3 trials.

Stephen J. Nicholls, MD, PhD discusses the robust efficacy and tolerability of zerlasiran for Lp(a) lowering, paving the way for Phase 3 development.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

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Atherosclerotic Cardiovascular Disease

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Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Noaiseh discussed data from the DAHLIAS study linking, for the first time, clinical responses, with autoantibody levels.

Gaith Noaiseh, MD: Nipocalimab Improves Disease Measures, Reduces Autoantibodies in Sjogren’s

Nipocalimab led to significant improvements compared with placebo inkey efficacy endpoints in people with Sjogren disease (SjD), supporting the mechanism of anti-neonatal Fc receptor (FcRn) monoclonal antibodies and reduction of IgG autoantibodies.

Data from the phase 2 DAHLIAS study, the first to evaluated an FcRn blocker in SjD, were presented at the 

can College of Rheumatology (ACR) Convergence 2024

“SjD is the underdog of autoimmune rheumatological disorders. Really, it's the disease that that attracted the least attention, I would argue, over the last 30-40, years, until recently, and often… many clinicians misdiagnose SjD and misclassify it, meaning that those patients are often [diagnosed with] lupus or rheumatoid arthritis, especially when they have certain blood testing when they show up to the doctor. So, we know that, and there's a lot of literature for that,” investigator Gaith Noaiseh, MD, associate professor, Allergy, Clinical Immunology, and Rheumatology, University of Kansas Medical Center, told 

Participants with moderate-to-severe SjD receiving 15 mg/kg nipocalimab (n = 54) met the primary endpoint of change from baseline in total Clinical European League Against Rheumatism SjD Activity Index score at week 24 compared with placebo (least squares mean difference, 2.65 [90% CI, –4.03 to –1.28]; 

= .002) with similar favorable improvements in in Physician Global Assessment of Disease Severity and ESSDAI score, treatment response according to SjD Tool for Assessing Response, Composite of Relevant Endpoints for SjD, disease activity level response, and patient-reported outcomes. This group had a serious adverse event rate of 7.4% compared with 5.4% in the placebo group, no severe infections/infections were considered related to nipocalimab, and there were no deaths.

“Every time we lecture about SjD, we always highlight those points to clinicians who may not be aware of these dynamics, to try to bring more attention on their mind about the disease and how to diagnose it, and the challenges that we come across when we try to diagnose a given patient in a given scenario,” Noaiseh said.

Gottenberg JA, Sivils K, Campbell K, et al. Efficacy and Safety of Nipocalimab, an Anti-FcRn Monoclonal Antibody, in Primary Sjogren’s Disease: Results from a Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study (DAHLIAS). Presented at: ACR Convergence 2024; November 14-19; Washington, DC. Abstract 2527.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

UCB has announced that US Food and Drug Administration (FDA) approved bimekizumab-bkzx (Bimzelx) for 

moderate-to-severe hidradenitis suppurativa (HS)

This treatment is a humanized IgG1 monoclonal antibody. It is distinct as it is the first and only medication specifically formulated with the aim of targeting and inhibiting both interleukin (IL)-17A and IL-17F cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex and impacting inflammation.

“The approval of (bimekizumab) in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” Alexa B. Kimball, MD, MPH, investigator and professor of dermatology at Harvard Medical School, said in a statement. “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

HS itself is a chronic inflammatory skin disease which often results in recurring symptoms including abscesses, nodules, and pus-draining tunnels in bodily areas such as the armpits, groin, and buttocks. The substantial flare-ups and pain experienced by those with HS often lead to major impacts on patients’ overall life quality.

The approval of bimekizumab to treat this condition was based upon findings resulting from two phase 3 clinical trials known as 

 These studies looked into the drug’s efficacy and safety among adults with moderate-to-severe disease.

The studies were double-blind, placebo-controlled analyses with enrollment of over 1,000 individuals. The set of studies used HiSCR50 as their main endpoint, defined as a minimum reduction of 50% of the total abscesses and inflammatory nodules as well as no increase in draining tunnels. They used HiSCR75 and pain reduction as key secondary measures.

Both trials indicated that a greater percentage of those given bimekizumab successfully recieved at least a 50% disease sign and symptom reduction by the 160 week mark (as measured by HiSCR50) versus those in the placebo arms of the studies. Significant improvements were also observed by the research teams in HiSCR75, with such results sustained through to the 48-week mark.

Additionally, bimekizumab’s safety profile aligned with that of the earlier studies into the drug across various indications. There were no new safety concerns.

This approval by FDA officials adds to bimekizumab’s growing list of indications, including recent approvals for active non-radiographic axial spondyloarthritis with objective signs of inflammation, psoriatic arthritis, and ankylosing spondylitis.

UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa. UCB. November 20. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-receives-us-fda-approval-for-bimzelxr-bimekizumab-bkzx-as-the-first-il-17a-and-il-17f-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa.

UCB announces late-breaking two-year data for BIMZELX[®] (bimekizumab) in moderate to severe hidradenitis suppurativa at EADV 2024. September 27, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-late-breaking-two-year-data-for-BIMZELXRVbimekizumab-in-moderate-to-severe-hidradenitis-suppurativa-at-EADV-2024. Date accessed: November 20, 2024.

The FDA has approved bimekizumab-bkzx (Bimzelx) for treating moderate-to-severe hidradenitis suppurativa (HS) in adults. This humanized IgG1 monoclonal antibody uniquely targets IL-17A and IL-17F cytokines, addressing inflammation. Phase 3 trials, BE HEARD I and II, demonstrated significant efficacy and safety, with patients achieving substantial symptom reduction. The trials used HiSCR50 as the primary endpoint, with HiSCR75 and pain reduction as secondary measures. Bimekizumab's safety profile was consistent with previous studies, and this approval expands its indications to include other inflammatory conditions.

UCB has announced the FDA’s approval of bimekizumab, also known as Bimzelx, for patients with moderate-to-severe HS.

Hidradenitis Suppurativa

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FDA Approves Bimekizumab for Adults with Hidradenitis Suppurativa

The American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI), and the American Academy of Otolaryngic Allergy (AAOA) have released a set of guidelines to insurance companies concerning necessary requirements for 

Known to be the most widely implemented and effective form of allergen immunotherapy, subcutaneous immunotherapy (SCIT) is commonly referred to as allergy shots and maintains a unique ability to alter a patient’s immune system. By doing this, it diminishes one’s sensitivity to allergens and helps to prevent the emergence of newer allergies and conditions like asthma.

“Burdensome and unreasonable requests for documentation regarding these services threaten the ability of allergists/immunologists and otolaryngologists to administer these therapies,” J. Allen Meadows, MD, ACAAI’s executive director of advocacy and government affairs and the lead author, said in a statement. “They also hinder the ability of patients with allergic conditions to obtain relief.”

These new recommendations were formed through a work group that was begun by the ACAAI. They were published in Annals of Allergy, Asthma and Immunology, with the principal aim being to assist payers in the development of a process for claims reviews submitted under the CPT Codes 95115, 95165, and 95117.

Each and every one of the procedures covered by these 3 codes are deemed medically necessary for individuals who have asthma, allergic rhinitis, or atopic dermatitis. However, the paper notes that insurers have increasingly asked for extensive, unnecessary documentation.

“At the end of the day, not only are physicians hamstrung by excessive demands from insurance companies, but patients may not get the care they need,” Meadows said in a statement. “Patients who suffer from allergic diseases such as allergic rhinitis, asthma and atopic dermatitis rely on consistent delivery of allergen immunotherapy to keep their symptoms under control. When they can’t get it, their quality of life is compromised.”

This, it noted, has created major delays in payment—or denial of payment entirely—for valid claims, jeopardizing access to necessary allergen immunotherapy. The latest guidance lays out, for allergy immunotherapy, what the authors view to be either reasonable or unreasonable requests for related documentation.

In reference to CPT 95165, referring to the services for the supervision of preparation and provision of antigens necessary for allergen immunotherapy, the following payer requests for documentation were described as reasonable:

A response to allergy immunotherapy description and the necessity for continued allergen immunotherapy during the course of routine visits.

Patients’ identities alongside a short description of clinical indications for allergen immunotherapy.

The identity of one’s clinician who determined the plan for immunotherapy treatment.

A small description of a patient’s treatment plan as well as the date on which it was determined.

In claims submitted under 95115 or 95117, the authors and sponsoring societies for these recommendations noted that the following payer requests for documentation are deemed as reasonable:

The administered dose with specifications on dilution, volume, and injection numbers.

Signature or initials of the individual who administers one’s injection.

The name, the date of patient’s injection, and their birth date.

When determining what forms of documentation were unnecessary, the AAAAI, the ACAAI, and the AAOA decided that the following documentation was included in such a list and was often unduly burdensome for those providing the information:

A patient’s fully planned schedule for dosing.

Credentials of the individual providing the injection administration

Signature of one’s ordering healthcare professional

Specification of subcutaneous administration

Joint recommendations outline reasonable and unreasonable requests for documentation. ACAAI. November 6, 2024. https://acaai.org/news/new-guidelines-for-insurers-help-patients-receive-necessary-allergen-immunotherapy-treatment/. Date accessed: November 19, 2024.

The AAAAI, ACAAI, and AAOA have issued guidelines to insurers on allergen immunotherapy documentation, emphasizing the need to streamline requirements. Subcutaneous immunotherapy (SCIT) is highlighted for its efficacy in modifying immune responses and reducing allergen sensitivity. Excessive documentation demands from insurers are seen as barriers to care, potentially delaying or denying payments for necessary treatments. The guidelines specify reasonable documentation requests for CPT codes 95115, 95165, and 95117, while identifying unnecessary documentation that burdens healthcare providers and impedes patient access to essential therapies.

In these guidelines compiled by the ACAAI, the AAAAI, and the AAOA, recommendations are provided to insurance companies for documentation needed for allergen immunotherapy.

Food Allergy

New Medical Guidance Provides Insurance Recommendations for Allergen Immunotherapy

The panel of experts focus on strategies for distinguishing primary biliary cholangitis (PBC) from other liver diseases with similar clinical presentations, emphasizing key diagnostic markers and assessment techniques.

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Disease Progression and Extrahepatic Manifestations of PBC

Over half of patients treated with LEVI-04 had at least a 50% reduction in pain and over 25% had at least a 75% reduction.

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LEVI-04 Improved Outcomes in Knee Osteoarthritis Compared With Placebo

These data were announced by Protagonist Therapeutics, resulting from the 2 pivotal ICONIC-LEAD and ICONIC-TOTAL studies on the oral peptide icotrokinra.

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Positive Phase 3 Results Announced for JNJ-2113 Treatment of Psoriasis

Chelsie Derman is an assistant editor for 

who covers psychiatry, sleep medicine, and geriatrics. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

At NASPGHAN, HCPLive spoke to Hamant about her team’s study that showed their algorithm was linked to increased VTE Prophylaxis among Pediatric IBD.

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Laura Hamant, MD: Standardized Algorithm Increases VTE Prophylaxis Among Children

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.

Barritt reviews real-world data about the use and benefits of GLP-1 RAs in patients with MASLD.

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A. Sidney Barritt, MD: Real-World Data Suggest Benefit of GLP-1 RAs for MASLD

Bifidobacterium longum 35624TM reduces IBS symptom severity in children and adolescents, according to a study presented at NASPGHAN 2024.

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B. longum 3562 Improves IBS Severity in Children but Does Not Persist after Intake

The phase 3 PHOENYCS GO trial met its primary endpoint in achieving BICLA response at week 48 compared with placebo.

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DZP Improves Disease Activity and Reduces Corticosteroid Use in SLE

Kowdley reviews open-label extension data for biochemical response, ALP normalization, and pruritus improvement from the phase 3 ELATIVE study.

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Kris Kowdley, MD: Elafibranor Remains Safe, Efficacious for PBC Through 3 Years

At NASPGHAN 2024, HCPLive spoke with Duncan about how treating infants who appear to have reflux may actually result in greater repeat hospital visits.

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Latest News

Peanut-Sensitized Infants with Eczema Already Co-Sensitized to Tree Nuts

Zerlasiran Achieves Durable Lp(a) Reductions at 60 Weeks, with Stephen J. Nicholls, MD, PhD

Gaith Noaiseh, MD: Nipocalimab Improves Disease Measures, Reduces Autoantibodies in Sjogren’s

FDA Approves Bimekizumab for Adults with Hidradenitis Suppurativa

New Medical Guidance Provides Insurance Recommendations for Allergen Immunotherapy