Celebrating Women in Science: New Study Seeks to Explain Real-World Impact of Allergy Immunotherapy

In recognition of International Day of Women and Girls in Science on February 11th, I had the chance to discuss a recent, observational, retrospective study of a medical claims database on the real-world impact of allergy immunotherapy (AIT), published in Allergy and Asthma Proceedings, with my colleague and study author, Karen Rance, DNP, CPNP, Director of Medical Affairs North America at ALK. I’m proud to celebrate Karen on her study as well as women everywhere who are passionate about scientific discovery.

AIT is a treatment approach that uses the immune system to target the underlying cause of environmental allergies to reduce a person’s reaction to environmental triggers. According to the American Academy of Allergy, Asthma and Immunology, AIT may also reduce the chances of developing new allergies.[1] For more than a century, AIT has been available to patients suffering from allergic rhinitis. However, few studies have examined its use and impact in real-world practice, where important insights on patient outcomes, comorbidities, healthcare utilization and costs can be collected. 

This study looked at just that and found patients who persisted with AIT treatment had reduced allergy-related comorbidities and reduced healthcare utilization. I sat down with Karen to discuss these findings and what they mean for patients. 

Jorge: Thank you for joining me, Karen, and let me first say happy International Day of Women and Girls in Science! This publication coincides nicely with this day recognizing women’s achievements. Can you describe what you and your colleagues looked at in this study?

Karen: Thank you, Jorge. It’s an honor to be part of the research team that worked on this study and to celebrate the contributions that women bring to science and medicine. My colleagues and I wanted to better understand the patient and treatment landscape of allergic rhinitis, including what percentage of patients use AIT and the full potential impact AIT can have on a patient’s health. 

Allergic rhinitis is one of the leading causes of chronic disease in the U.S., affecting between 30 and 60 million Americans.[2] It’s caused by exposure to substances in the environment that would otherwise be harmless, such as grass pollens, animal dander or dust mites, and symptoms include a runny nose, congestion, itching around the nose, mouth, eyes or throat and sneezing.[3] Complications can include sinusitis (an infection of the sinuses) and ear infections.[3] Moreover, allergic rhinitis is associated with high direct and indirect medical costs related to treating and managing the disease.[4]  

Jorge: How did you and your colleagues go about assessing use of AIT in this population?

Karen: Our primary tool was IBM MarketScan, a large claims database. We identified more than 2.3 million allergic rhinitis patients between 2014 and 2017 who had one or more medical or pharmacy claims for AIT—either subcutaneous immunotherapy (SCIT) or sublingual immunotherapy tablets (SLIT-tablets)—and who were enrolled in a medical or pharmacy plan for at least 12 months. Of note, SLIT-tablet patients comprised less than 0.1% of the claims database. 

We then looked at what percentage of patients who were treated with AIT reached the maintenance phase of treatment (once the effective dose is reached), and patients were assessed for demographic characteristics, comorbid conditions and health care utilization.

Studies that look at treatments in a real-world context – their use in everyday clinical practice, outside of trials – provide useful insights across a broad population of patients. They complement clinical trials and can inform decisions about access and costs or illustrate gaps in care. Unfortunately, real-world evidence studies have been lacking to date in patients who undergo AIT for allergic rhinitis.

Jorge: What did the study show, and why are these results important?

Karen: The claims database findings that help us better understand AIT therapy include:[5]  

• Despite AIT being available to patients for more than a century, less than 5% of the study population had ever been treated with AIT. Of the patients who underwent AIT, one in five patients discontinued treatment after the first visit, and only 43.9% of patients remained on it long enough to reach the maintenance phase of treatment after 12 months. 
• Before initiating AIT, patients had higher rates of comorbidities (e.g., asthma, atopic dermatitis and conjunctivitis) and were more likely to fill prescriptions for allergy medicines.
• From the 12-month baseline period to follow-up, patients who persisted with AIT had notable reductions in all allergic rhinitis-related comorbidities that were assessed – eczema, chronic cough and sinusitis, among others. 
• AIT use had an associated reduction in healthcare utilization, including lower rates of hospitalizations and emergency room visits. 

The findings from the database review suggest that, given patients who initiated AIT had higher rates of comorbidities—and likely were more severely impacted by allergies—AIT may be underutilized by patients who may benefit, such as those with less severe symptoms. These findings are especially important to understand in an increasingly value-based healthcare system. 

Jorge: For patients who may be considering AIT, or who are currently receiving AIT, what do they need to know?  

Karen: Allergy immunotherapy is the only treatment option that uses a person’s own immune system to treat the underlying cause of environmental allergies, reducing symptoms and therefore reducing the need for allergy medications for patients with allergic rhinitis. When there is an improvement in disease control, that may impact a patient’s health and reduce healthcare expenditures.

The trends seen from this database review also show the importance of persistent adherence to treatment, which can help a patient achieve maintenance phase, and that adherence to AIT treatment may also help to curtail more severe allergic disease and minimize comorbidities.  

Lastly, as this database review has shown, AIT continues to be underutilized, especially when it comes to SLIT-tablet utilization, which comprised less than 0.1% of the claims database.

Jorge: Thank you for the informative discussion, Karen, and congratulations again on this study. It’s important for patients to understand their options when it comes to treatment for their allergic rhinitis. 

One reason patients have historically discontinued AIT is the inconvenience of frequent doctor visits associated with subcutaneous immunotherapy, administered as shots.[6] However, an alternative form of AIT, sublingual (under the tongue) immunotherapy tablets, or SLIT-tablets, is available. SLIT-tablets are FDA-approved and may be a more convenient alternative as they are taken once daily and, after the first dose is taken at the doctor’s office, the tablet is taken at home.[7,8] 

To learn more about allergies and allergy treatment options, including allergy immunotherapy, visit AllergyHomeFree.com and download the Klarify app. 

- Jorge Alderete, President ALK, Inc.

[1] American Academy of Allergy Asthma & Immunology. Immunotherapy can provide lasting relief. Available at: https://www.aaaai.org/conditions-and-treatments/library/allergy-library/immunotherapy-can-provide-lasting-relief. Accessed January 25, 2020. 

[2] Tran NP, Vickery J, Blaiss MS. Management of rhinitis: allergic and non-allergic. Allergy Asthma Immunol Res. 2011;3(3):148-156.

[3] Mayo Clinic. Allergies. Overview. Available at: https://www.mayoclinic.org/diseases- conditions/allergies/symptoms-causes/syc-20351497. Accessed July 21, 2020.

[4] Pawankar R. Allergic diseases and asthma: a global public health concern and a call to action. World Allergy Organ J. 2014;7(1):12.

[5] Stone B, Rance K, Waddell, BS, Aagren M, Hammerby E, Tkacz JP. Real-world mapping of allergy immunotherapy in the United States: The argument for improving adherence. Allergy Asthma Proc 42:55-64, 2021; doi: 10.2500/aap.2021.42.200114.

[6] Senna G, Caminati M, Lockey R. Allergen immunotherapy adherence in the real world: how bad is it and how can it be improved? Curr Treat Options Allergy. 2015; 2:39-53.

[7] Mayo Clinic. Allergy medications: Know your options. Available at: https://www.mayoclinic.org/diseases-conditions/allergies/in-depth/allergy-medications/art-20047403. Accessed January 25, 2020.

[8] Gunawardana NC and Durham SR. New approaches to allergen immunotherapy. Ann Allergy Asthma Immunol. 2018;121(3):293-305.