Latest news with #omalizumab
Medscape
6 days ago
- Health
- Medscape
Allergy Med Dilemma: Is Drug Working? Still Needed?
A new allergy medication is prompting clinicians to adjust their approach to oral food challenges — medically supervised tests in which clinicians give increasing doses of an allergen like peanut or milk to see how a patient reacts. The FDA in 2024 approved omalizumab (Xolair) to help reduce allergic reactions in adults and children aged 1 year or older with immunoglobulin E-mediated food allergy. Patients receiving the injections are supposed to avoid foods to which they are allergic. In the event of an accidental exposure, the medication can afford protection against a serious reaction. The approval opened a new frontier in allergy therapy but also raised questions without clear answers, like: How can patients be sure the medication is working? And how will they know if they 'outgrow' an allergy, as some people do? After the approval, clinicians wrote to the American Academy of Allergy, Asthma & Immunology seeking advice. Earlier this year, a committee for the academy published a report with 'consensus-based guidance' on using omalizumab for food allergy and acknowledged that clinical guidance will likely evolve as groups monitor and report real-world outcomes. In the meantime, the committee suggested that various approaches to treatment, including the use of oral food challenges to assess treatment response, could be used. 'Clinicians should consider assessing treatment success against individualized goals that the patient and prescribing clinician have set for therapy,' they wrote. Any food challenges 'to assess treatment response should be offered no earlier than 16-20 weeks after initiating omalizumab therapy,' the duration of treatment in a randomized trial that supported the drug's approval for food allergy, they wrote. 'In nonresponding patients, the clinician should strongly consider discontinuation of omalizumab given lack of benefit.' Although its use for food allergy is relatively new, omalizumab is not a new medication. The drug first was approved for asthma in 2003. The drug also is approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. 'Bite Safe' Testing? Scott Sicherer, MD, director of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai in New York City, fielded the inquiry when a clinician wrote to the American Academy of Allergy, Asthma, & Immunology's 'Ask the Expert' column last year wondering: 'With recent approval of Xolair for management of food allergies, how do we approach food challenges?' In some cases, additional food challenges make sense before starting omalizumab to confirm or rule out possible allergies, so patients are not avoiding certain foods unnecessarily while on therapy, responded Sicherer, who coauthored a 2024 paper in The New England Journal of Medicine about omalizumab for the treatment of multiple food allergies. After starting therapy, a scaled back food challenge to determine whether treatment has rendered an allergen 'bite safe' might be reasonable, added Sicherer, meaning a patient could accidentally have a bite of the food in question without a severe reaction. 'Given that the commitment to treatment includes time and expense and there are no good biomarkers yet, and a small percentage of people do not respond, I think many patients would like an [oral food challenge] to some agreed upon amount of the food, perhaps something they would view as 'bite safe,'' Sicherer wrote in his response. 'If the treatment is not protecting them to small amounts, why continue?' The exact parameters of such a test could depend on the patient's goals, Sicherer told Medscape Medical News . Some patients might simply look for reassurance that they could eat half a peanut without a problem. If that is the case, 'maybe that is what we would aim for,' Sicherer said. 'It's not like there is a rule written down about this.' Introducing Egg Sicherer's reply also discussed ways to handle a scenario where a patient on omalizumab had egg, cashew, and peanut allergies — with the egg allergy expected to resolve. One approach could involve discontinuing omalizumab for at least 4-5 months before performing an oral food challenge with egg, he wrote. Alternatively, clinicians might conduct a food challenge with egg while the patient remains on omalizumab. If they tolerate the full amount of egg on therapy, they could be encouraged to eat that food regularly, Sicherer said. Then if the patient eventually stops omalizumab and has symptoms after eating egg, then perhaps the allergy never resolved, he added. Shared Decisions Understanding a family's goals and preferences is crucial, said Jennifer Dantzer, MD, assistant professor of pediatrics in the Division of Allergy, Immunology, and Rheumatology at Johns Hopkins University School of Medicine in Baltimore. Decisions about food challenges for patients on omalizumab is 'something that we are talking through with every family,' said Dantzer, who has studied the medication and coauthored the article in The New England Journal of Medicine with Sicherer. The definition of treatment success can vary. In some cases, a child might be able to consume a full serving of an allergen. Or a patient might react to a relatively small amount but have a reaction that is far less severe than before. Either instance could be deemed a success. Results from food challenges can provide reassurance that certain activities like dining out are now lower risk, Dantzer said. For now, clinicians have no firm guidelines about when to reassess therapy or consider adjusting the dose. 'I think the allergy community would like there to be a bit more guidance,' Dantzer said. 'Hopefully with time that will become available.'
Medscape
24-06-2025
- Health
- Medscape
Head-to-Head Trial Finds Winner for CRSwNP With Asthma
Dupilumab significantly outperformed omalizumab in reducing the size of nasal polyps and improving sense of smell in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma, according to the head-to-head EVEREST phase 4 biologics trial . The study is the first to demonstrate the superiority of dupilumab over omalizumab across both upper and lower airway disease outcomes — resulting in a significant reduction in nasal polyp score and a greater improvement in pre-bronchodilator forced expiratory volume 1. The two therapies had generally similar safety profiles, according to the researchers. "The data provide important insights that can help guide patients and physicians through the treatment decision-making process,' said Eugenio De Corso, MD, ENT specialist at the A. Gemelli University Hospital Foundation, Rome, Italy, who presented the findings at the 2025 annual congress of the European Academy of Allergy and Clinical Immunology. 'Dupilumab also demonstrated nominally greater improvements in asthma-related endpoints, including lung function and asthma control, compared to omalizumab.' De Corso said that the results do not change the approved indications for dupilumab and do not support starting treatment with the drug earlier in the course of care. But 'they do provide important insight into how two long-standing biologics in the treatment landscape compare to each other in patients with CRSwNP and coexisting asthma, which could support treatment decision-making for physicians,' he said. Tackling a Dual Burden CRSwNP is often marked by persistent nasal congestion, facial pain, and anosmia, and when asthma coexists, as it frequently does in this patient population, disease burden increases and managing symptoms becomes even more complex. Existing treatments have limited long-term benefit. Type 2 inflammation, driven largely by the interleukin-4 and interleukin-13 pathways, plays a central role in the pathophysiology of both CRSwNP and asthma. Dupilumab targets signalling of both molecules, whereas omalizumab primarily targets immunoglobulin E (IgE), a different antibody involved in allergic responses, and this mechanistic difference underpinned the rationale for the EVEREST trial. The EVEREST randomized, double-blind, active-controlled phase 4 trial enrolled 360 adults with severe, uncontrolled CRSwNP and coexisting asthma. Participants received either 300 mg of dupilumab subcutaneously every 2 weeks (n = 181) or omalizumab (n = 179) dosed based on body weight and baseline serum IgE levels every 2 or 4 weeks. All patients continued to receive mometasone furoate nasal spray as background therapy. Participants had a mean age 51.5 years, were 55% men, 42.5% had respiratory symptoms worsened by their use of nonsteroidal anti-inflammatory drugs, and roughly half had used systemic corticosteroids in the 2 years prior to the start of the study. Primary endpoints were nasal polyp score (range, 0-8) and University of Pennsylvania Smell Identification Test (range, 0-40). Greater improvement with dupilumab compared with omalizumab was evident by week 4 and continued through week 24, De Corso and his colleagues reported. At 24 weeks, dupilumab demonstrated statistically and clinically significant superiority over omalizumab in both primary endpoints with a 1.6-point greater reduction in nasal polyp score ( P < .001); and an eight-point greater improvement in smell identification ( P < .001). Secondary endpoints also favored dupilumab with a 0.58-point greater reduction in nasal congestion score; a 0.81-point greater improvement in loss of smell ( P < .001); a 1.74-point greater reduction in overall severity of symptoms; and a 12.7-point greater improvement in patient-reported quality of life ( P < .0001), the researchers reported. Use of dupilumab was also associated with small but statistically significant improvements in expiratory volumes and control of asthma, the study found. Safety profiles were similar between groups, with adverse events occurring in 64% of dupilumab recipients and 67% of omalizumab recipients, the researchers reported. Serious adverse events were reported in 2% of patients in the dupilumab arm and 4% in the omalizumab arm, and a slightly higher proportion of patients discontinued dupilumab due to adverse events (3% vs 1%), although no new safety concerns emerged in the analysis. 'These new results further reinforce those from the pivotal, regulatory phase 3 trials — SINUS-24 and SINUS-52 , where effects on nasal congestion and loss of smell were also observed as early as 4 weeks and showed continued improvement for the duration of the trial,' De Corso told Medscape Medical News . 'For patients living with both CRSwNP and asthma, the availability of a treatment that addresses both conditions effectively and quickly is a substantial advancement.' Michael S. Blaiss, MD, a clinical professor at the Medical College of Georgia at Augusta University, said, 'dupilumab showed statistically superior results on both primary endpoints — nasal polyp score, indicating polyp reduction, and UPSIT, measuring sense of smell improvement. These are key indicators of symptom relief and quality of life for my patients.' 'This type of head-to-head trial is exactly what clinicians have long called for to better guide treatment decisions in managing this complex condition,' he added. Javier Dominguez-Ortega MD, of the Department of Allergy at the Hospital Universitario La Paz, in Madrid, Spain, said EVEREST was 'indeed a highly innovative trial, particularly as it is the first head-to-head study examining two medications indicated for CRSwNP within a clinical trial setting. The preliminary data suggest that dupilumab demonstrates greater efficacy, especially in the area of olfaction, which has been objectively measured through olfactometry.' However, Dominguez-Ortega said that without clinical characteristics of the patients, including their inflammatory profiles prior to inclusion, or their concomitant treatments, drawing definitive conclusions was not possible. Better Sleep for Dermatitis Patients? In another study presented as an electronic poster at the meeting, researchers looked at the effects of dupilumab on sleep in adults with moderate-to-severe atopic dermatitis. The phase 4, double-blind trial, called DUPISTAD, randomly assigned adults to receive 300 mg of dupilumab or placebo every 2 weeks for 12 weeks, followed by a 12-week open-label extension. Actigraphy, using a wrist-wearable device, measured sleep disturbance objectively and non-invasively, while subjective measurement comprised patients' perceptions of sleep defined as the ratio of total sleep time to total time in bed. The mean difference from baseline to week 12 provided an estimate of weekly average sleep efficiency. In addition, actigraphy was studied in a subset of patients with poor sleep efficiency (≤ 70%) at baseline. A total of 127 patients received dupilumab and 60 received placebo. Patients reported significant sleep efficiency improvements with dupilumab based on sleep diaries but actigraphy did not generate consistent results. 'While patients reported significant sleep efficiency improvements following dupilumab treatment, actigraphy assessment was inconclusive,' the researchers reported. 'In this study, most patients had acceptable sleep efficiency at baseline, highlighting the limitations of wrist actigraphy to objectively assess sleep in patients with AD. The characteristics of AD may mean that these wrist-wearable devices are not appropriate to evaluate sleep.' Sensors mounted on walls and other nonwearable devices might better detect body movement at night and provide more accurate information about itching and sleep disturbance, they added. De Corso reported receiving funding from AstraZeneca, Firma, GlaxoSmithKline, Novartis, Regeneron, and serving on an advisory board and receiving fees from Sanofi. Blaiss has received speaking fees from Sanofi, Regeneron, and AstraZeneca, and consulting fees from Novartis and GlaxoSmithKline. Dominguez-Ortega has received consultation fees and compensation for participation in company sponsored speaker's events from AstraZeneca, CHIESI, Sanofi, Novartis, ALK, Leti Pharma, Cipla, Allergy Therapeutics GlaxoSmithKline, and Gebro. The EVEREST trial was funded by Sanofi, in collaboration with Regeneron Pharmaceuticals.
Medscape
08-05-2025
- Health
- Medscape
UK Study Maps Solar Urticaria Features and Treatments
TOPLINE: In a multicentre cross-sectional study, the majority of patients with solar urticaria were of European ethnicity, with Fitzpatrick skin phototypes I-III; urticaria provocation was achieved using monochromator phototesting in 94.2% of participants, and omalizumab showed the highest complete response rate at 37.5%. METHODOLOGY: Researchers conducted a cross-sectional study at six tertiary photobiology units in the United Kingdom between October 2019 and June 2023 and analysed clinical and photobiological features of 178 phototest-positive patients with solar urticaria. Included participants had a diagnosis of solar urticaria done by a consultant photodermatologist and successful urticaria provocation via phototesting. TAKEAWAY: Overall, 67% of participants were women, with a median age of 35 years at disease onset, and the majority self-reported European ethnicity (89.2%), with Fitzpatrick skin phototypes I (16.6%), II (57.3%), and III (14.6%) being most prevalent (88.5%). Urticaria provocation was achieved using monochromator phototesting in 94.2% of participants and using solar simulated radiation in 5.8% of participants. Ultraviolet A (UVA) alone triggered symptoms in 31.3% of patients, UVA combined with visible light affected 29.4% of patients, and UVA with ultraviolet B affected 15.6% of patients. A treatment response analysis revealed that sunscreen and H1-antihistamines were most commonly used (98.2% and 97.6%, respectively), with partial response rates of 61.8% and 69.6%, respectively. Omalizumab demonstrated superior efficacy, with a partial response rate of 53.1% and complete disease control in 37.5% of patients compared with lower complete disease control for other treatments including montelukast (8.5%) and H1-antihistamines (13.5%). IN PRACTICE: "This study describes the clinical presentation of SU [solar urticaria] in 178 individuals and recapitulates several of its characteristics as reported by other investigators. Importantly, it highlights that SU affects individuals of all ethnicities and skin phototypes, although whether ethnicity-specific disease susceptibility exists cannot be ascertained from these data," the authors wrote. SOURCE: This study was led by Navandeep K. Thumber, St John's Institute of Dermatology, London, England. It was published online on April 28, 2025, in the British Journal of Dermatology. LIMITATIONS: This study was limited by the eligibility criteria excluding phototest-negative individuals and the subjective nature of treatment response reporting. DISCLOSURES: This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors reported having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
