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Non-Allergic Rhinitis (Vasomotor)

Patients Educational Materials Non-Allergic Rhinitis

Non-Allergic Rhinitis (Vasomotor)

Non-allergic rhinitis is a chronic condition that can occur at any age but is more common in adults. The most common symptoms are nasal congestion, post-nasal drainage, and headache, although runny nose, sneezing and itching of the nose may occur in some non-allergic individuals. Many non-allergic patients have recurrent sinusitis and middle ear infections or middle ear fluid collection.

Initial evaluation requires that surgical conditions (growths in the nose, crooked nasal septum, etc.) and general medical conditions (thyroid disease, pregnancy, etc.) are not responsible for the chronic symptoms. We recommend that ever patient have a family practitioner, internist, or pediatrician to follow them for their general medical care. If the history and physical examination are not positive for surgical or general medical problems, the patient most likely has the most common nasal problem of non-allergic or allergic nasal disease.

Non-allergic rhinitis is a very difficult topic to fully understand. The actual defect resulting in the symptoms commonly found is not known. We do know that the difficulty arises in the inability to correctly change the size of blood vessels and the quantity of mucus produced by mucus glands in the nose. Under normal circumstances the nose warms or cools the air entering the nose to 98 degrees F., increases the humidity to at least 80%, and filters unwanted substances resulting in relatively clean air at 98 degrees F. and 80% humidity entering the lungs regardless of current environmental conditions. These changes occur almost instantly with each breath. The non-allergic individual has lost the ability to make the necessary changes either from an ineffective blood vessel and mucus gland controlling mechanism, temperature and humidity sensing mechanism, or both. The end result is inappropriate blood vessel size and/or excess mucus production which can result in nasal congestion, post-nasal drainage, and headaches.

Many individuals with non-allergic nasal disease will have a significant amount of irritation, inflammation, and hyperreactivity in the nose contributing to the persistent, chronic nature of the disease.

Nasal allergy on the other hand usually presents with runny nose, sneezing, and itching but some patients can also have nasal congestion, post-nasal drainage, and headaches. With nasal allergy we usually see definite problems at certain seasons of the year or a correlation with exposures to dust, animal dander, mold or mildew exposures and in some patients’ extreme reactions to certain foods. Allergy symptoms also involving the eyes usually are redness, itching and watering of the eyes.

It is possible for an individual to have problems with both non-allergic rhinitis and allergic rhinitis, and this makes the problems at times more difficult to clearly diagnose and treat.

Several tests can be used to differentiate non-allergic rhinitis from allergic rhinitis. Skin testing, as one might expect, displays positivity in patients with allergic rhinitis, whereas a negative skin test will be obtained in patients with non-allergic rhinitis. In addition, the blood IgE levels and eosinophils (the allergy cell) are elevated in patients with allergic rhinitis but not in non-allergic rhinitis.

Non-allergic rhinitis often is triggered by drafts, temperature changes (especially cold air), by scented cosmetics (both men’s and women’s cosmetics), by cigarette and tobacco smoke, as well as fireplace smoke, scented or perfumed soaps. Many types of aerosol sprays, even scented deodorants can cause problems. Paint fumes, insecticides, bug sprays,
varnishes, and even the odor from new clothing, carpeting or furniture can cause problems. Kerosene, lighter fluids, oil and gas fumes can cause problems. House dust may act as an irritant, and should be avoided.

Do not overuse over-the-counter decongestant sprays or nose drops because these can cause “rebound” nasal congestion. All nasal decongestant sprays should be discontinued following 3 days of continuous use. Medications will be prescribed to help with this problem. A good part of the treatment is avoiding known problems and exposures, and working by trial and error to find medications that work best in your case. Medications that may be tried include: Astelin© nasal spray, decongestants, decongestant-antihistamine combinations, intranasal steroid sprays, and possibly an atropine-derivative nasal spray (Atrovent©).

Conditions Treated

Recent News

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FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE)

  • 12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older

  • EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing

OSAKA, Japan and CAMBRIDGE, Massachusetts, February 12, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).1 It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February.

EOHILIA is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE.1 Developed specifically for EoE, EOHILIA’s novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed.1,2

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With EOHILIA, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” said Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine. “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that EOHILIA offers as an oral medication.”

The FDA approval of EOHILIA 2 mg twice daily is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies (Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42, respectively) with EoE.1 In both studies, patients received at least one dose of either EOHILIA 2 mg twice daily or placebo orally twice daily. Efficacy endpoints included histologic remission (peak eosinophil count of ≤6 per high-powered field across all available esophageal levels) and the absolute change from baseline in patient-reported Dysphagia Symptom Questionnaire (DSQ) combined score after 12 weeks of treatment. The DSQ measures how often a patient with EoE has trouble swallowing and the behavioral adaptations they subsequently use, as reported directly by patients.3

Significantly more patients receiving EOHILIA achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%).1 In Study 2, 38% of EOHILIA patients achieved histologic remission vs. 2.4% of those in the placebo group. Absolute change from baseline in DSQ combined score in the EOHILIA vs. placebo groups in Study 1 was -10.2 (1.5) vs. -6.5 (1.8) and in Study 2, -14.5 (1.8) vs. -5.9 (2.1). During the last two weeks of each study, more patients receiving EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” as compared to placebo, as measured by the DSQ. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. The most common adverse reactions (≥2% of patients receiving EOHILIA and at a rate greater than placebo) in Study 1 included: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%) and erosive esophagitis (2%). The safety profile of EOHILIA in Study 2 was generally similar to Study 1.1

“For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” said Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda. “With EOHILIA, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.”

EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus.4 Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens.5,6 The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain.7 Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus).8,9 In fact, EoE is the leading cause of emergency room visits for food impaction.10

Takeda is assessing the financial impacts of the approval, including a reversal of impairment loss for intangible assets, on the fiscal year ending on March 31, 2024 (FY2023), but does not anticipate the impact to be material.

Indication and Limitations of Use

EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).

EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.

Important Safety Information

Contraindications

EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products.

Warnings and Precautions

Hypercorticism and Adrenal Axis Suppression

Systemic effects such as hypercorticism and adrenal axis suppression may occur. Monitor patients for signs and symptoms and consider reducing the dosage of EOHILIA. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child-Pugh Class B).

Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended.

Immunosuppression and Increased Risk of Infection

Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen. Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation of EOHILIA if the patient develops an infection.

  • Tuberculosis reactivation may occur. Closely monitor patients with latent tuberculosis or tuberculin reactivity while receiving EOHILIA.

  • Varicella Zoster and Measles can be serious or fatal in non-immune patients taking corticosteroids. Avoid exposure. If a patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

  • Hepatitis B Virus Reactivation can occur. Prior to starting EOHILIA for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

  • Amebiasis: It is recommended that latent or active amebiasis be ruled out before starting EOHILIA in patients who have spent time in the tropics or have unexplained diarrhea.

  • Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides (threadworm) infection, cerebral malaria, and active ocular herpes simplex.

  • Localized Infections: In clinical trials, some patients developed Candida albicans infections in the mouth, throat, and esophagus. Instruct patients: do not eat or drink for 30 minutes after taking EOHILIA; after 30 minutes rinse mouth with water and spit without swallowing. If oropharyngeal or esophageal candidiasis develops, treat with appropriate antifungal therapy and consider discontinuing EOHILIA.

Erosive Esophagitis

Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline esophagogastroduodenoscopy (EGD), and most were receiving concomitant therapy with a proton pump inhibitor (PPI). Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation as appropriate.

Effect on Growth

Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Monitor patients who are transferred from corticosteroids with high systemic effects to corticosteroids with lower systemic availability, such as EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema) previously controlled by the systemic drug.

Other Corticosteroid Effects

Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts, or with family history of diabetes, glaucoma, or with other conditions where corticosteroids may have unwanted effects.

Kaposi’s Sarcoma

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. The maximum recommended duration of treatment with EOHILIA is 12 weeks.

Adverse Reactions

Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis.

Drug Interactions

Budesonide is a substrate for CYP3A4. Avoid concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice), which can increase systemic budesonide concentrations.

Use in specific Populations

  • Pregnancy: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism and managed accordingly.

  • Lactation: Lactation studies have not been conducted with EOHILIA. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EOHILIA and any potential adverse effects on the breastfed infant from EOHILIA, or from the underlying maternal condition.

  • Hepatic Impairment: Not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), monitor for signs and/or symptoms of hypercorticism.

The post FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE) appeared first on Oklahoma Allergy and Asthma Clinic.

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