Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)

Evaluation of Patient Initiation and Persistence With Advised Allergen Immunotherapy

The purpose of this study is to determine the proportion of participants that initiate allergen immunotherapy (AIT) upon the recommendation of their physician and the proportion of participants that persist with their AIT throughout the recommended course.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis

• Study Type: Observational
• Enrollment (Actual): 8790

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were managed by physicians in a large allergy practice, recommended for AIT between 2005 and 2011 and identified by their electronic health records.

Description

Inclusion Criteria:

• Diagnosis of AR with or without allergic conjunctivitis (AC)
• Documented provider-to-patient or parent discussion of AIT as a treatment option

Exclusion Criteria:

• Participants receiving AIT as an AR treatment without documented provider-to-patient or parent discussion of AIT as a treatment option
• Participants receiving immunotherapy for insect sensitivities only
• AIT started before 2005

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with Allergic Rhinitis (AR); Patients in a private allergy practice who were diagnosed with AR, with or without asthma, and advised to consider AIT between January 2005 and June 2011 and whose medical records were retrospectively reviewed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops	The percentage of participants who were advised by their physician to start AIT and elected to initiate AIT was calculated. AIT initiation was broken down by type of AIT initiated (SCIT or SLIT).	Up to 5 years
Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment	The percentage of participants who initiated SCIT or SLIT and completed 5 years of treatment was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled. If extract refills continued past the recommended time for therapy (e.g. 5 years from the start of therapy), the participant was deemed successful in completing the recommended course. If the extract refills stopped prior to the end of the recommended time for therapy, but the last refill occurred within 6 months of the recommended time for therapy, this participant was deemed successful in completing the recommended course.	At 5 years
Duration of Treatment With SCIT or SLIT	The mean duration in years of SCIT or SLIT treatment for all participants with AR who initiated SCIT or SLIT was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled.	Up to 5 years
Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course	The reason for discontinuation of SCIT or SLIT treatment more than 6 months before completion of the recommended course of therapy was recorded. The percentage of participants whose records were reveiwed and who discontinued SCIT or SLIT due to different reasons was calculated.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT	The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.	Up to 5 years
Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone	The mean duration in years of SCIT or SLIT treatment for all participants with AR and asthma and for all participants with AR only was calculated. Duration of SCIT or SLIT treatment was based on dates when allergy extract prescriptions were refilled.	Up to 5 years

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S

Publications and helpful links

General Publications

• Anolik R, Schwartz AM, Sajjan S, Allen-Ramey F. Patient initiation and persistence with allergen immunotherapy. Ann Allergy Asthma Immunol. 2014 Jul;113(1):101-7. doi: 10.1016/j.anai.2014.04.008. Epub 2014 May 9.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Allergen immunotherapy; Rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 7243-022