Trial Outcomes & Findings for Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022) (NCT NCT01549340)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

8790 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2017-03-03

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Participants With AR Participants with AR whose records were retrospectively reviewed
Overall Study STARTED	8790
Overall Study Started AIT	3182
Overall Study COMPLETED	385
Overall Study NOT COMPLETED	8405

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With AR n=8790 Participants Participants with AR whose records were retrospectively reviewed
Age, Continuous	26.8 years STANDARD_DEVIATION 16.1 • n=5 Participants
Gender Female	4439 Participants n=5 Participants
Gender Male	4351 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Participants With AR n=8790 Participants Participants with AR whose records were retrospectively reviewed	Participants With AR Who Discontinued SLIT Participants with AR whose records were retrospectively reviewed and discontinued SLIT
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	—
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	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With AR n=3182 Participants Participants with AR whose records were retrospectively reviewed	Participants With AR Who Discontinued SLIT Participants with AR whose records were retrospectively reviewed and discontinued SLIT
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	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With AR n=3182 Participants Participants with AR whose records were retrospectively reviewed	Participants With AR Who Discontinued SLIT Participants with AR whose records were retrospectively reviewed and discontinued SLIT
Duration of Treatment With SCIT or SLIT SCIT	2.4 years Standard Deviation 1.8	—
Duration of Treatment With SCIT or SLIT SLIT	1.9 years Standard Deviation 1.4	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With AR n=785 Participants Participants with AR whose records were retrospectively reviewed	Participants With AR Who Discontinued SLIT n=231 Participants Participants with AR whose records were retrospectively reviewed and discontinued SLIT
Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course Adverse event	7 percentage of participants	4 percentage of participants
Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course Other reason	21 percentage of participants	20 percentage of participants
Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course Lack of efficacy	1 percentage of participants	3 percentage of participants
Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course Financial	4 percentage of participants	4 percentage of participants
Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course No reason documented	67 percentage of participants	69 percentage of participants

SECONDARY outcome

Timeframe: 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.

The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.

Outcome measures

Outcome measures
Measure	Participants With AR n=3175 Participants Participants with AR whose records were retrospectively reviewed	Participants With AR Who Discontinued SLIT Participants with AR whose records were retrospectively reviewed and discontinued SLIT
Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT Initiated SCIT	25.2 percentage of participants	—
Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT Initiated SLIT	8.7 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With AR n=1076 Participants Participants with AR whose records were retrospectively reviewed	Participants With AR Who Discontinued SLIT n=2106 Participants Participants with AR whose records were retrospectively reviewed and discontinued SLIT
Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone SCIT	2.4 years Standard Deviation 1.77	2.4 years Standard Deviation 1.82
Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone SLIT	2.1 years Standard Deviation 1.50	1.8 years Standard Deviation 1.37

Adverse Events

Participants With AR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor shall be notified and have a right to timely and prior review of public disclosures of the results, including without limitation, disclosures at research seminars, lectures and professional meetings and submission of papers for publication.
Publication restrictions are in place

Restriction type: OTHER