allergies & sublingual immunotherapy · when sublingual immunotherapy is administered into the...

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ALLERGIES & SUBLINGUAL IMMUNOTHERAPY Board Certified Otolaryngologists Head & Neck Surgeons Trent W. Quinlan, M.D., F.A.C.S. Patrick C. Farrell, M.D. David A. Denman, M.D., F.A.C.S. Debora W. Goebel, M.D. Ryan K. Sewell, M.D., J.D. Louis D. Sully, PA-C 720 North 129th Street Omaha, Nebraska 68154 (402) 397-0670 (402) 354-2754 after hours www.omahaent.com 720 North 129th Street Omaha, Nebraska 68154 (402) 397-0670 (402) 354-2754 after hours www.omahaent.com References 1. Ferguson, BJ, Golla S. Allergies for the Otolaryngologist. Otolaryngologic Clinics of North America 2011. 44(3): 753-764. 2. Durham SR, Walker SM, Varga EM et al. Long-term clinical efficacy of grass pollen immunotherapy. N England J Med 1999; 341: 468-475. 3. Purello-D’ambrosio F, Gangemi S, Merendino RA, et al. Prevention of new sensitizations in monosensitized subjects submitted to specific immunotherapy or not. A retrospective study. Clin Exp Allergy 2001; 31: 1295-1302. 4. Polosa R, Al-Delaimy WK, Russo C, et al. Greater risk of incident asthma cases in adults with allergic rhinitis and effect of allergen immunotherapy: a retrospective cohort study. Respir Res 2005; 6:153. 5. Bousquet J, Lockey R, Maling H. World Health Organization Position Paper: allergen immunotherapy: therapeutic vaccines for allergic diseases. Allergy 1998; 53:1-14. 6. Calamita Z, Saconato H, Pela AG, et al. Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method. Allergy 2006; 62(10):1162-1172. 7. Marogna M, Tomassetti D, Bernasconi A, et al. Preventive effects of sublingal immunotherapy in childhood: An open randomized controlled study. Ann Allergy Asthma Immunol 2008; 101(2): 206-211. 8. Allergic Rhinitis, Sinusitis and Rhinosinusitis. American Academy of Otolaryngology Head and Neck Surgery 2013. http://www.entnet.org/HealthInformation/rhinitis.cfm 9. Otolaryngology Spotlight. MD News 2012. Treatment of reactions If you experience mild reactions to sublingual immunotherapy, an antihistamine should be taken. If symptoms worsen, call 911. If you have any questions, please call ENT Specialists, PC at 402-397-0670. Is Sublingual Immunotherapy safe? Sublingual immunotherapy is a very safe allergy treatment for both adults and children. Numerous published scientific studies have confirmed sublingual immunotherapy is both safe and effective for the treatment of allergic rhinitis and asthma caused by allergies to dust mites, grass, ragweed, cat dander and tree pollens. Evidence is emerging that sublingual therapy may be effective for treating red, itchy eyes caused by pollen during hay fever season. Additionally, it has shown signs of being an effective therapy for children with mild atopic dermatitis (eczema) and is currently being studied for its potential in treating food allergies. Why is Sublingual Immunotherapy not yet FDA Approved? Multiple studies are currently being conducted for the purpose of trying to get sublingual therapy approved in the United States. The extracts that are used in preparing sublingual therapy are the same extracts that are used in skin testing and in traditional allergy shots. These extracts are approved and monitored by the United States Food and Drug Administration (FDA) and approved for allergy shots, but not specifically for use under the tongue. Therefore, allergy drops are considered an off-label use of the FDA-approved allergen extracts. Many medications are commonly used in an FDA off-label manner when a physician determines it is best for treatment of the patient. 1 Sublingual immunotherapy has been used for many years in Europe, South America, Asia and Australia and has been proven safe and effective in numerous studies, which will likely lead to one or more allergy extract manufacturers obtaining an FDA indication for allergy drops in the near future. The World Health Organization has endorsed sublingual immunotherapy as a viable alternative to injection immunotherapy 5 . Sublingual immunotherapy is also supported by the World Allergy Association and the European Academy of Allergy and Clinical Immunology.

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Page 1: ALLERGIES & SUBLINGUAL IMMUNOTHERAPY · When sublingual immunotherapy is administered into the gastrointestinal tract, the immune system tolerates the allergen, instead of causing

ALLERGIES & SUBLINGUAL

IMMUNOTHERAPY

Board Certified OtolaryngologistsHead & Neck Surgeons

Trent W. Quinlan, M.D., F.A.C.S.Patrick C. Farrell, M.D.

David A. Denman, M.D., F.A.C.S.Debora W. Goebel, M.D.

Ryan K. Sewell, M.D., J.D.Louis D. Sully, PA-C

720 North 129th StreetOmaha, Nebraska 68154

(402) 397-0670(402) 354-2754 after hours

www.omahaent.com

720 North 129th StreetOmaha, Nebraska 68154

(402) 397-0670(402) 354-2754 after hours

www.omahaent.com

References1. Ferguson, BJ, Golla S. Allergies for the Otolaryngologist. Otolaryngologic Clinics of North America 2011. 44(3): 753-764.2. Durham SR, Walker SM, Varga EM et al. Long-term clinical efficacy of grass pollen immunotherapy. N England J Med 1999; 341: 468-475.3. Purello-D’ambrosio F, Gangemi S, Merendino RA, et al. Prevention of new sensitizations in monosensitized subjects submitted to specific immunotherapy or not. A retrospective study. Clin Exp Allergy 2001; 31: 1295-1302.4. Polosa R, Al-Delaimy WK, Russo C, et al. Greater risk of incident asthma cases in adults with allergic rhinitis and effect of allergen immunotherapy: a retrospective cohort study. Respir Res 2005; 6:153.5. Bousquet J, Lockey R, Maling H. World Health Organization Position Paper: allergen immunotherapy: therapeutic vaccines for allergic diseases. Allergy 1998; 53:1-14.6. Calamita Z, Saconato H, Pela AG, et al. Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method. Allergy 2006; 62(10):1162-1172.7. Marogna M, Tomassetti D, Bernasconi A, et al. Preventive effects of sublingal immunotherapy in childhood: An open randomized controlled study. Ann Allergy Asthma Immunol 2008; 101(2): 206-211.8. Allergic Rhinitis, Sinusitis and Rhinosinusitis. American Academy of Otolaryngology Head and Neck Surgery 2013. http://www.entnet.org/HealthInformation/rhinitis.cfm9. Otolaryngology Spotlight. MD News 2012.

Treatment of reactionsIf you experience mild reactions to sublingual immunotherapy, an antihistamine should be taken. If symptoms worsen, call 911. If you have any questions, please call ENT Specialists, PC at 402-397-0670.

Is Sublingual Immunotherapy safe?Sublingual immunotherapy is a very safe allergy treatment for both adults and children. Numerous published scientific studies have confirmed sublingual immunotherapy is both safe and effective for the treatment of allergic rhinitis and asthma caused by allergies to dust mites, grass, ragweed, cat dander and tree pollens. Evidence is emerging that sublingual therapy may be effective for treating red, itchy eyes caused by pollen during hay fever season. Additionally, it has shown signs of being an effective therapy for children with mild atopic dermatitis (eczema) and is currently being studied for its potential in treating food allergies.

Why is Sublingual Immunotherapy not yet FDA Approved?Multiple studies are currently being conducted for the purpose of trying to get sublingual therapy approved in the United States. The extracts that are used in preparing sublingual therapy are the same extracts that are used in skin testing and in traditional allergy shots. These extracts are approved and monitored by the United States Food and Drug Administration (FDA) and approved for allergy shots, but not specifically for use under the tongue. Therefore, allergy drops are considered an off-label use of the FDA-approved allergen extracts. Many medications are commonly used in an FDA off-label manner when a physician determines it is best for treatment of the patient.1

Sublingual immunotherapy has been used for many years in Europe, South America, Asia and Australia and has been proven safe and effective in numerous studies, which will likely lead to one or more allergy extract manufacturers obtaining an FDA indication for allergy drops in the near future. The World Health Organization has endorsed sublingual immunotherapy as a viable alternative to injection immunotherapy 5. Sublingual immunotherapy is also supported by the World Allergy Association and the European Academy of Allergy and Clinical Immunology.

Page 2: ALLERGIES & SUBLINGUAL IMMUNOTHERAPY · When sublingual immunotherapy is administered into the gastrointestinal tract, the immune system tolerates the allergen, instead of causing

When sublingual immunotherapy is administered into the gastrointestinal tract, the immune system tolerates the allergen, instead of causing an over-reactivity of the immune system, such as with allergic disease. This results in less allergy symptoms when the body is exposed to the allergy source, such as airborne pollen or pet dander.

The first step in sublingual immunotherapy is to confirm a patient’s allergies through allergy testing. ENT Specialists, PC, offers a simple blood test called specific IGE testing. A custom-mixed vial of drops is prepared for the patient based on the results of testing. Then, the patient begins taking drops under the tongue, typically once per day. The dosage concentration is gradually increased during the initial months of treatment. Eventually, the patient reaches “maintenance phase,” which is when the same dose of drops are taken every day. Generally, it is recommended a person continue taking drops for 3-5 years to ensure the body builds lasting immunity against the allergens.

Why Sublingual Immunotherapy?People with documented allergic disease by allergy testing may be considered for sublingual immunotherapy. Young children have been shown to tolerate and benefit from sublingual immunotherapy, as have older adults.

Medications such as antihistamines and nasal sprays treat symptoms of allergic rhinitis and other allergy-related disorders whereas immunotherapy induces a

natural immunity or tolerance to the allergen. The gradual introduction of the “causative allergen” to the allergic patient reduces the allergic symptoms and lessens the need for

medications 1-4. Sometimes the need for medications can be eliminated altogether.

Sublingual immunotherapy is an alternative to subcutaneous therapy (allergy shots). The immunologic changes seen after sublingual immunotherapy administration are similar to those seen after subcutaneous immunotherapy 1. It is a more convenient and comfortable form of allergy therapy. It does not involve injections or weekly visits to the doctor’s office.

Benefits of Sublingual Immunotherapy• Sublingual immunotherapy has been shown in multiple

studies to be effective in treating allergic rhinitis in both adults and children. Other countries have been using this therapy to treat allergic rhinitis for many years.

• Sublingual immunotherapy has been shown to be helpful in asthma and in preventing the development of new sensitivities to allergens 1,6,7.

• Sublingual immunotherapy is very safe. If a reaction occurs, it is usually very mild.

• Sublingual immunotherapy does not involve the use of needles.

• Sublingual immunotherapy allows for administration to be performed at home, so frequent, time-consuming clinic visits are not required.

Drawbacks of Allergy Drops• Takes approximately 3-6 months to experience benefits

and requires you to continue medication during the build-up/escalation phase.

• Insurance companies generally do not cover sublingual immunotherapy.

Reactions to ImmunotherapyThe safety of sublingual immunotherapy is well documented, and serious reactions are very rare 1. Mild reactions, such as an itchy mouth, occur in the majority of people and tend to resolve over time. The following is a review of reactions:• There is a possibility of having an anaphylaxis

reaction, but reactions are usually mild with sublingual immunotherapy.

• At the present time, there have been no fatalities reported from sublingual immunotherapy treatment.

• Swelling of the tongue or lips may occur (if this occurs, take an antihistamine).

• Itching of the mouth may occur temporarily.• Gastrointestinal discomfort (usually mild).

Allergic rhinitis occurs when the body’s immune system over-responds to specific particles such as plant pollens, molds, dust mites, animal hair, foods, medicines and more. Symptoms of allergic rhinitis may include sneezing, runny nose, nasal congestion, nasal drainage and itchy eyes. There is a close relationship between allergic rhinitis and sinusitis. Sinusitis is often preceded by rhinitis 8.

Allergic rhinitis is a very common health problem that affects nearly ¼ of all Americans and results in a decreased quality of life. Medical management costs of allergic rhinitis are substantial with more than $1 billion spent on medical management of allergic rhinitis each year in the United States1. The discomfort involved in recurrent acute rhinosinusitis can lead to work absenteeism and substantially decreased productivity. Each sinus infection can last as long as 4 weeks 9.

What is Sublingual Immunotherapy?Sublingual immunotherapy (SLIT) is a form of immunotherapy that involves putting drops of allergen extracts under the tongue. The allergy drops can be customized to a person’s problematic allergens. This form of immunotherapy has been used for years in Europe and recently has had increased interest in the United States. Unlike traditional subcutaneous therapy (allergy shots), sublingual immunotherapy is completely shot-free.

How does Sublingual Immunotherapy work?The immune system of the gastrointestinal tract tends to “tolerate” foreign substances, meaning that it does not respond in an over-active way to swallowed material.