This article is sponsored by ALK, Inc.
The house dust mite (HDM),and specificallyHDM speciesDermatophagoides farina and Dermatophagoides pteronyssinus, are common causes of allergic rhinitis (AR).1 In 2013, approximately 84% of households in the United States reported detectable levels of dust mite allergens.2 Commonly used therapeutic approaches for the management of HDM-induced AR include HDM avoidance, pharmacotherapy, and allergen immunotherapy1; however, each of these therapeutic strategies has its advantages and limitations. Strict HDM avoidance is difficult to accomplish due to the ubiquitous presence of dust mites in human habitats3 and pharmacotherapies are not always effective in all patients.4
Unlike allergen avoidance and pharmacotherapy whose beneficial effects are lost when treatment is discontinued, immunotherapy can alter the course of allergic disease through desensitization and sustain treatment benefits long term.5 Subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) are the most common forms of allergen immunotherapy.6 SCIT delivers allergen extracts via a subcutaneous injection in increasingly higher doses until the maintenance dose is reached5; it requires regular office visits for injections and carries a potential risk of systemic allergic reaction.7 SLIT on the other side, requires less patient time, can be administered at home6, and has shown tolerability in clinical trials.8
The advantages and effectiveness of SLIT-tablet therapy for HDM-induced AR
Since 2014, the US Food and Drug Administration (FDA) has approved four SLIT-tablet formulations. Three of the formulations treat common pollen-induced AR (ORALAIR®, GRASTEK® and RAGWITEK®), and the fourth treats HDM-induced AR (ODACTRA® House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract Tablet for Sublingual Use 12SQ-HDM).* ODACTRA received FDA approval on March 1, 2017, and is the first sublingual formulation approved for the treatment of HDM-induced AR in people aged 18 to 65 years. It is a rapidly dissolving tablet intended for use once daily under the tongue and offers the convenience of at-home administration after the initial dose is given under the supervision of the healthcare provider.9 *ORALAIR® is a registered trademark of Stallergenes S.A.; GRASTEK®, RAGWITEK®, and ODACTRA® are registered trademarks of ALK-Abelló A/S.
“There are many patients who don’t have the time to come to the doctor’s office approximately once a week to get allergy injections and these are often patients with significant allergic symptoms,” says Jose Bardelas, MD, allergist/immunologist at the Allergy & Asthma Center of North Carolina in High Point. “For those patients, 18 and older, who have AR that is not well-controlled and who have been determined to be HDM-positive by either the skin test or blood test, ODACTRA is a suitable alternative because it can be given at home after the first dose is given in the doctor’s office.”
ODACTRA is an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in adults 18 through 65 years of age.
ODACTRA was studied in approximately 2500 subjects in the US, Canada, and Europe before receiving FDA approval. In the Environmental Exposure Chamber Study, daily treatment with a standardized quality (SQ) house dust mite SLIT- tablet resulted in statistically significant reductions in the nasal symptoms of AR, as early as week 8, and demonstrated continued improvement toward week 24.10 In addition, through the European Field Efficacy Study, ODACTRA showed a statistically significant reduction in combined nasal symptom and medication usage scores, starting as early as week 14 and continuing throughout the year, when compared with placebo.11 ODACTRA tablets, available as 12 SQ-HDM tablets, are shaped as a circle and white to off-white in color. The SQ stands for standardized quality of the allergen extract (content, potency, and complexity) and SQ-HDM designates the dose unit for ODACTRA.9 According to the ODACTRAPrescribing Information (PI), the first dose should be administered in a healthcare setting under the supervision of a physician who is experienced in managing allergic diseases.9