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

ALK-Abelló A/S8,790 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

8,790

Conditions

Perennial Allergic Rhinitis Seasonal Allergic Rhinitis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 5 years

Secondary Outcomes

Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT

Data from ClinicalTrials.gov

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