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Allergy Month in Review: March 2025

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March Allergy Updates: FDA approved the first biosimilar for omalizumab, epicutaneous and oral immunotherapy trials showed promise, and experts discussed allergy trends.

March brought a mix of challenges and advancements in healthcare. Anaphylaxis treatment remains underwhelming, with many not receiving the guideline-recommended adrenaline. Climate change further exacerbated allergy season, lengthening pollen exposure and triggering new conditions such as alpha-gal syndrome.

This review captures US Food and Drug Administration (FDA) news, phase 2 and 3 data on promising treatments for peanut allergies, and a recap of late breakers presented at the 2025 American Academy of Allergy, Asthma, & Immunology annual meeting on when to refer to endoscopic sinus surgery for chronic rhinosinusitis, oral immunotherapy with autoclaved peanuts, and more.

FDA's Latest Decision on Allergy

FDA Approves First Interchangeable Biosimilar for Omalizumab

The FDA has approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to omalizumab (Xolair) and the first respiratory biosimilar. Approved for conditions like asthma, CRSwNP, IgE-mediated food allergy, and CSU, it offers 2 dosage forms: a 75 mg/0.5 mL or 150 mg/mL injection. A phase 3 study confirmed its bioequivalence, ensuring similar efficacy and safety.

Insights from Phase 2 and 3 Trials

Epicutaneous Immunotherapy Shows Favorable Long-Term Safety for Peanut Allergy

The phase 3 REALISE study found that epicutaneous immunotherapy with VP250 had a strong long-term safety profile for peanut allergy. Severe adverse events declined from 9.7% in year 1 to 0.3% in year 3, with high patient adherence (96.5%). Local skin reactions decreased over time, and anaphylaxis remained rare.

Oral Immunotherapy Shows Promise for High Threshold Peanut Allergy, with Scott Sicherer, MD

A phase 2 study found that 100% of children on peanut oral immunotherapy (OIT) tolerated 9043 mg of peanuts, compared to just 10% in the avoidance group. The study targeted children with high-threshold peanut allergies, representing nearly half of the peanut-allergic population. Scott Sicherer, MD, from Mt. Sinai School of Medicine, emphasized that using home-measured peanut butter under allergist supervision could help children safely consume peanuts as regular food, providing a practical alternative to strict avoidance.

AAAAI Recap

When to Test for Insect Sting Allergies, with David Golden, MD

David Golden, MD, from Johns Hopkins University, emphasized the limitations of insect sting allergy testing, warning that a positive test does not confirm an allergy. Many people with positive tests experience no reaction to stings, making unnecessary testing misleading and anxiety-inducing. Golden stressed that testing should be reserved for those with anaphylactic reactions or severe quality-of-life burdens.

When an Allergist Should Refer Endoscopic Sinus Surgery for Chronic Rhinosinusitis, with Kent Lam, MD

Kent Lam, MD, from Eastern Virginia Medical School at Old Dominion University, discussed when allergists should refer patients with chronic rhinosinusitis for endoscopic sinus surgery. Surgery is considered if symptoms persist despite topical steroids or nasal irrigation. Lam emphasized setting patient expectations about risks and benefits, noting that modern techniques are minimally invasive.

While surgery improves sinus drainage and ventilation, risks include bleeding, scarring, and symptom persistence. Post-surgical follow-ups are crucial to monitor healing and prevent complications, ensuring optimal patient outcomes.

Patients Tolerate Oral Immunotherapy Better with Autoclaved vs Blanched Peanuts, with Casey Cohen, PhD

A study found that peanut-allergic patients tolerated oral immunotherapy better with autoclaved peanuts than with blanched peanuts. Casey Cohen, PhD, from McGill University, explained that autoclaving reduces peanut-specific immunoglobulin binding, leading to higher tolerated doses and fewer severe reactions. Unlike with blanched peanuts, none of the participants required epinephrine with autoclaved peanuts.

Omalizumab Outperforms Oral Immunotherapy for Food Allergies in Johns Hopkins Study

A Johns Hopkins study found omalizumab was more effective than oral immunotherapy for food allergies, with fewer adverse events and higher completion rates. Among 117 participants allergic to peanuts and other allergens, 88% completed treatment with omalizumab versus 51% with oral immunotherapy. No serious adverse reactions occurred in the omalizumab group.

What Additional Research Reveals

Many Patients with Anaphylaxis Do Not Receive First-Line Adrenaline Treatment

A study found that only 7% of adults and 8% of children with severe anaphylaxis in Dresden received adrenaline, the guideline-recommended first-line treatment. However, the research linked adrenaline use to improved outcomes.

How Climate Change is Making Allergies Worse—And What Clinicians Can Do

Climate change worsens allergies by extending pollen seasons, increasing air pollution, and altering allergen exposure. Allergy experts emphasized strategies for clinicians, including air filtration, refined allergy diagnostics, and expanded allergen testing.


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