Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis
Conditions
Keywords
Rhinitis, Allergen immunotherapy
Brief summary
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.
Interventions
None listed
Sponsors
ALK-Abelló A/S
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops | Up to 5 years | 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). |
| Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment | At 5 years | 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. |
| Duration of Treatment With SCIT or SLIT | Up to 5 years | 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. |
| Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT | Up to 5 years | The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated. |
| Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone | Up to 5 years | 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. |
Participant flow
Recruitment details
This study involved a retrospective record review of patients in a private allergy and asthma practice who were recommended to receive allergen immunotherapy (AIT) to treat their allergic rhinitis (AR) by their physician between January 2005 and June 2011.
Participants by arm
| Arm | Count |
|---|---|
| Participants With AR Participants with AR whose records were retrospectively reviewed | 8,790 |
| Total | 8,790 |
Baseline characteristics
| Characteristic | Participants With AR |
|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 16.1 |
| Gender Female | 4439 Participants |
| Gender Male | 4351 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With AR | Duration of Treatment With SCIT or SLIT | SCIT | 2.4 years | Standard Deviation 1.8 |
| Participants With AR | Duration of Treatment With SCIT or SLIT | SLIT | 1.9 years | Standard Deviation 1.4 |
Primary
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
Population: The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With AR | Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops | Elected SCIT | 28.2 percentage of participants |
| Participants With AR | Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops | Elected SLIT | 8.0 percentage of participants |
Primary
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
Population: The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With AR | Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment | Completed 5 years of SCIT (n=2481) | 10.8 percentage of participants |
| Participants With AR | Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment | Completed 5 years of SLIT (n=701) | 2.6 percentage of participants |
Primary
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
Population: The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR, who initiated and subsequently discontinued AIT, and had their charts reviewed for the reason for discontinuation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With AR | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Adverse event | 7 percentage of participants |
| Participants With AR | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Financial | 4 percentage of participants |
| Participants With AR | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Lack of efficacy | 1 percentage of participants |
| Participants With AR | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Other reason | 21 percentage of participants |
| Participants With AR | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | No reason documented | 67 percentage of participants |
| Participants With AR Who Discontinued SLIT | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Other reason | 20 percentage of participants |
| Participants With AR Who Discontinued SLIT | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | No reason documented | 69 percentage of participants |
| Participants With AR Who Discontinued SLIT | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Adverse event | 4 percentage of participants |
| Participants With AR Who Discontinued SLIT | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Lack of efficacy | 3 percentage of participants |
| Participants With AR Who Discontinued SLIT | Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course | Financial | 4 percentage of participants |
Secondary
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.
Time frame: Up to 5 years
Population: The analysis population consisted of those participants with AR and asthma or AR alone who were advised by their physician to receive AIT to treat their AR and who initiated AIT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With AR | Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone | SCIT | 2.4 years | Standard Deviation 1.77 |
| Participants With AR | Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone | SLIT | 2.1 years | Standard Deviation 1.5 |
| Participants With AR Who Discontinued SLIT | Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone | SCIT | 2.4 years | Standard Deviation 1.82 |
| Participants With AR Who Discontinued SLIT | Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone | SLIT | 1.8 years | Standard Deviation 1.37 |
Secondary
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.
Time frame: Up to 5 years
Population: The analysis population consisted of those participants with AR and asthma who were advised by their physician to receive AIT to treat their AR and who initiated SCIT or SLIT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With AR | Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT | Initiated SCIT | 25.2 percentage of participants |
| Participants With AR | Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT | Initiated SLIT | 8.7 percentage of participants |