Is Oral Immunotherapy (OIT) ready for community practice?

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Food allergies are challenging. The risk and fear of allergic reactions make life hard for children and parents. Unfortunately, food allergies are becoming more common and taking longer to outgrow. Oral Immunotherapy (OIT) is a new option that may help to keep your child safe while reducing anxiety, allowing your child to eat out or attend school with less worry.

OIT involves retraining the immune system to tolerate the allergic food (i.e. peanut or milk).  This is done by feeding the food allergic person small amounts of the food.  The amount increases slowly over time. As the dose goes up, so does the level of protection.

Working as a Nurse Practioner at the food allergy institute of Mount Sinai in NYC, allowed me to gain valuable experience and insights regarding OIT. Historically, food allergy treatment included strict avoidance and carrying emergency medications. That was it, do your best and wait.  OIT is a novel option. Studies have shown OIT reduces allergic reactions from cross contamination and increase quality of life.

As the treatment is still new, there are uncertainties. It is currently unknown if OIT leads to long term tolerance and a ‘cure’ for food allergy. Or is the benefit only temporary.  Optimal dosing protocols are still being worked out. Also, it is not clear which patients would benefit from addition of adjuvants, like Xolair or probiotics.

OIT can be a great option for some patients. It should only be done in an office that has the training and staff to safely navigate them through the process.  The undertaking can be difficult and time consuming and there can be side effects.  Despite the unknowns and risks, OIT can have a huge impact on reducing food allergy reactions and increasing quality of life.  It can be a great option for families to be less afraid of cross contaminations and to gain the possibility of eventually outgrowing their allergy.

OIT has great potential and I am excited and hopeful to see further success.

Allergy Center Welcomes Beth Strong

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Elizabeth (Beth) Strong is a board certified Family Nurse Practitioner.  She completed her Bachelor of Science in Nursing at SUNY Buffalo and went on to earn her Masters of Science in Nursing at the University of Rochester. Beth learned world-class allergy care while working closely with and training under top researchers and experts.  For the past eleven years, she worked through the Jaffe Food Allergy Institute at Mount Sinai in NYC.  She treated patients with food allergies, eczema, seasonal allergies and asthma.  She managed several clinical trials studying immunotherapies for food allergy and was highly integral in opening the Food Allergy Treatment and Research Center to treat food allergic patients with an advanced oral desensitization protocol.  In her free time, Beth enjoys being outdoors and traveling.  Most of all, she loves spending time with her husband and two young children.

FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

EpiPen

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017

 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm

FDA approves dupilumab for moderate to severe eczema

eczema

“Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.”

After much anticipation, dupilumab becomes the first biologic approved for the treatment of atopic dermatitis (a form of eczema). Dupilumab is indicated for adults with moderate to severe eczema that are not well controlled with steroid creams or ointments. The current options for these patients are limited. Most often oral immunosuppressants, like prednisone or cyclosporine, are used. These medications may have several adverse effects. Dupilumab is a biologic that aims to more specifically target the underlying factors driving allergic inflammation. In this case it blocks the signals of two molecules, Il-4 and IL-13.

Approval was based on three studies. The results of these studies showed the medication to be effective for the majority of patients. Additionally, 36-38% of patients achieved clear to almost clear skin.

Dupilumab will come in a pre-filled syringe for self-administration, to be given by subcutaneous injection every other week. A loading dose in your physician’s office may be required.

The wholesale cost was reported $37,000 per year. However, the actual cost to patients is still unknown.

Future directions. Two studies are currently testing safety and effectiveness in children, 6 months to 11 years and 12 to 17 years of age. Other uses under investigation include asthma, nasal polyps and eosinophilic esophagitis.

If you do have atopic dermatitis that is not well controlled, speak to your allergy doctor to see if dupilumab is right for you.

To read more about dupilumab, click here. Also, to read about nemolizumab, a new and similar treatment option, click here.

 

Fish oil supplementation during pregnancy may lower asthma risk

fish oil

Preventing allergy is a priority for both physicians and parents. There have been many studies attempting to lessen the risk of both food and environmental allergies.

Here are a few examples of possible interventions to decrease the risk of allergy;

  • Frequent application of emollients (moisturizers) from birth.
  • Breast feeding, hypoallergenic formulas, early introduction of foods.
  • Probiotics.
  • Avoiding pets OR adding more pets.

A study, started in 1990 and recently completed and accepted for publication, looked at fish oil supplementation in pregnancy*. Over 500 pregnant mothers were given supplements containing fish oil, olive oil or no oil. The hypothesis was that maternal supplementation with long chain n-3 polyunsaturated fatty acids (PUFAs) may have immunological effects on the developing fetus and decrease allergies and asthma. The children were evaluated when they reached 18 years of age.

RESULTS:

The probability of having had asthma medication prescribed was significantly reduced in the fish oil group compared to the olive oil group (HR=0.54, 95% CI: 0.32-0.90, p=0.02). The probability of having had allergic rhinitis medication prescribed was also reduced in the fish oil group compared to the olive oil group (HR=0.70, 95% CI: 0.47-1.05, p=0.09), but the difference was not statistically significant. Self-reported information collected at age 18-19 years supported these findings.

CONCLUSION:

Maternal supplementation with fish oil may have prophylactic potential for long-term prevention of offspring asthma.

REFERENCE:

Hansen S, Strøm M, Maslova E, Dahl R, Hoffmann HJ, Rytter D, Bech BH, Henriksen TB, Granström C, Halldorsson TI, Chavarro JE, Linneberg A, Olsen SF, Fish oil supplementation during pregnancy and allergic respiratory disease in the adult offspring, Journal of Allergy and Clinical Immunology (2016), doi: 10.1016/j.jaci.2016.02.042.