Allergy Symptom Response Allergy Symptom Response Following Conversion from Following Conversion from Injection Immunotherapy to Injection Immunotherapy to Sublingual ImmunotherapySublingual Immunotherapy

CDR Timothy Clenney, MD, MPHCDR Timothy Clenney, MD, MPH

Naval Medical Center PortsmouthNaval Medical Center Portsmouth

Department of Otolaryngology/Head and Department of Otolaryngology/Head and Neck SurgeryNeck Surgery

DisclaimerDisclaimer

The views expressed in this article The views expressed in this article are those of the author(s) and do are those of the author(s) and do not reflect the official policy or not reflect the official policy or position of the Department of the position of the Department of the Navy, Department of Defense, or Navy, Department of Defense, or the United States Government.the United States Government.

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BackgroundBackground Allergy immunotherapy has traditionally Allergy immunotherapy has traditionally

been administered via subcutaneous been administered via subcutaneous injection injection

Interest in non-injection routes, such as Interest in non-injection routes, such as the sublingual route have arisen out of the sublingual route have arisen out of concerns for safety and convenience.concerns for safety and convenience.

Non-injection routes may be of particular Non-injection routes may be of particular interest for active duty personnel due to interest for active duty personnel due to logistical and safety considerations of logistical and safety considerations of immunotherapy administration outside immunotherapy administration outside the MTF. the MTF.

Passalacqua, G., C. Lombardi, and G.W. Canonica, Curr Opin Allergy Clin Immunol 2004; 4(1)

BackgroundBackground

Waibal KH. Allergic rhinitis in the Middel East. Military Medicine 2005 (170)

Background Background

In Europe, sublingual immunotherapy (SLIT) In Europe, sublingual immunotherapy (SLIT) has been regarded as a preferred has been regarded as a preferred alternative to subcutaneous immunotherapy alternative to subcutaneous immunotherapy since its introduction in 1986since its introduction in 1986..

In the United States, sublingual route is not In the United States, sublingual route is not FDA approved and is an “off-label” use.FDA approved and is an “off-label” use.

Although the efficacy and safety of SLIT are Although the efficacy and safety of SLIT are well established, no studies have examined well established, no studies have examined symptom control in patients converted from symptom control in patients converted from injection immunotherapy to SLIT injection immunotherapy to SLIT

Leatherman BD, et al. Otolaryngol Head Neck Surg 2007;136

AIMSAIMS

Determine the allergy symptom Determine the allergy symptom response in patients converted from response in patients converted from injection immunotherapy to SLITinjection immunotherapy to SLIT

Assess allergy-related quality of life in Assess allergy-related quality of life in a cohort of patients converted from a cohort of patients converted from injection immunotherapy to SLITinjection immunotherapy to SLIT

Examine the effectiveness and utility Examine the effectiveness and utility of SLIT in a small group of active-duty of SLIT in a small group of active-duty military personnel military personnel

MethodsMethods Questionnaires were offered to a sample ENT Questionnaires were offered to a sample ENT

allergy patients receiving SLIT that had allergy patients receiving SLIT that had previously been managed with injection previously been managed with injection immunotherapyimmunotherapy– Four categories of allergy symptoms:Four categories of allergy symptoms:

Eye Symptoms Eye Symptoms Nasal SymptomsNasal Symptoms Sleep SymptomsSleep Symptoms Constitutional symptomsConstitutional symptoms

– Quality of life was assessed using a Quality of life was assessed using a validated rhinoconjunctivitis QOL instrumentvalidated rhinoconjunctivitis QOL instrument

Juniper EF, Thompson AK, Ferrie PJ, et al. Clinical and experimental allergy 2000; 30 (1)

All patients continued current allergy All patients continued current allergy medical treatments (antihistamines,etc)medical treatments (antihistamines,etc)

Multi-antigen SLIT was started on all Multi-antigen SLIT was started on all patients using a standardized protocolpatients using a standardized protocol⁴⁴

Antigen treatment concentration was Antigen treatment concentration was based upon the results of allergy in-vitro based upon the results of allergy in-vitro testingtesting

This study was approved by the Naval This study was approved by the Naval Medical Center Portsmouth institutional Medical Center Portsmouth institutional review boardreview board

MethodsMethods

200 patients currently receiving SLIT200 patients currently receiving SLIT 58 of the 200 had previously received 58 of the 200 had previously received

injection immunotherapyinjection immunotherapy– 28 patients lost to follow-up or not 28 patients lost to follow-up or not

available during the study periodavailable during the study period– 30 patients receiving SLIT were 30 patients receiving SLIT were

invited to participate in this surveyinvited to participate in this survey– 100% agreed to participate100% agreed to participate

ResultsResults

Subject Subject CharacteristicsCharacteristics

% Male% Male 51.7%51.7%

Average age (years)Average age (years) 48.648.6 SD 15.1 SD 15.1

% Active Duty Military% Active Duty Military 27.5%27.5%

Type of AllergyType of Allergy SeasonalSeasonal10 (34%)10 (34%)

PerennialPerennial20 (66%)20 (66%)

Immunotherapy History

Duration(months)

Range(months)

Std Dev

Average time on injection immunotherapy

37.6 1 - 182 45.4

Average time on SLIT

14.8 2 - 24 6.5

Average time between injection immunotherapy and SLIT

1.2 1 - 10 2.06

Concurrent Medical Concurrent Medical Therapy with SLITTherapy with SLIT

ResultsResults

Nasal SymptomsNasal Symptoms– 30 (100%) reported nasal symptoms.30 (100%) reported nasal symptoms.

22(73%) – Improved nasal symptoms22(73%) – Improved nasal symptoms 8 (28%) – No change in nasal 8 (28%) – No change in nasal

symptomssymptoms 0 (0%) – Worsening of nasal 0 (0%) – Worsening of nasal

symptoms symptoms

P = 0.016P = 0.016

ResultsResults

Eye SymptomsEye Symptoms– 27 (90%) reported eye symptoms27 (90%) reported eye symptoms

19 (70%) – Improved eye symptoms19 (70%) – Improved eye symptoms 7 (26.9%) – No change in eye 7 (26.9%) – No change in eye

symptomssymptoms 1 (3%) – Worsening of eye 1 (3%) – Worsening of eye

symptomssymptoms

P < 0.001P < 0.001

ResultsResults

Sleep SymptomsSleep Symptoms– 26 (86%) reported sleep symptoms26 (86%) reported sleep symptoms

12 (46%) – Improved sleep symptoms12 (46%) – Improved sleep symptoms 13 (50%) – No change in sleep 13 (50%) – No change in sleep

symptomssymptoms 1 (3%) – Worsening in sleep 1 (3%) – Worsening in sleep

symptomssymptoms

P=0.006P=0.006

Constitutional SymptomsConstitutional Symptoms– 26 (86%) reported constitutional 26 (86%) reported constitutional

symptomssymptoms 15 (58%) – Improved constitutional 15 (58%) – Improved constitutional

symptomssymptoms 9 (35%) – No change in constitutional 9 (35%) – No change in constitutional

symptomssymptoms 2 (7%) – Worsening of constitutional 2 (7%) – Worsening of constitutional

symptomssymptoms

P = 0.008P = 0.008

ResultsResults

Symptom Control Symptom Control Following Conversion to Following Conversion to

SLITSLIT

0

5

10

15

20

25

Nasal Eye Sleep Other

Symptom

Fre

qu

en

cy

Better

Unchanged

Worse

Constitutional

P = 0.016

P<0.001

P=0.006

P=0.008

Mean Mean Rhinoconjunctivitis Rhinoconjunctivitis QOL score (0 – 84)QOL score (0 – 84)

Std DevStd Dev

Subjects converted Subjects converted from SCIT to SLIT (N from SCIT to SLIT (N = 30)= 30)

19.219.2 12.412.4

Rhinoconjunctivitis Rhinoconjunctivitis QOLQOL

SLIT in Active-Duty Military SLIT in Active-Duty Military

15 active-duty patients receiving 15 active-duty patients receiving SLITSLIT– 8 previously on injection IT8 previously on injection IT– 7 No previous immunotherapy7 No previous immunotherapy

No reported adverse reactionsNo reported adverse reactions None discontinued therapyNone discontinued therapy 3 deployed while receiving SLIT3 deployed while receiving SLIT

Rhinoconjunctivitis QOLRhinoconjunctivitis QOL(military group)(military group)

Mean Mean Rhinoconjunctivitis Rhinoconjunctivitis QOL score (0 – 84)QOL score (0 – 84)

Std DevStd Dev

Subjects converted Subjects converted from SCIT to SLIT (N from SCIT to SLIT (N = 30)= 30)

14.114.1 7.47.4

Concurrent Medical Concurrent Medical Therapy Therapy

(military group)(military group)

DiscussionDiscussion

The primary objective of this study was to The primary objective of this study was to determine the self-reported clinical response determine the self-reported clinical response to sublingual immunotherapy (SLIT) among to sublingual immunotherapy (SLIT) among patients previously managed with patients previously managed with subcutaneous injected immunotherapy subcutaneous injected immunotherapy (SCIT).(SCIT).

The results of this study, though limited by The results of this study, though limited by small sample size, suggest that most small sample size, suggest that most patients can be converted from injection patients can be converted from injection immunotherapy to sublingual immunotherapy to sublingual immunotherapy with good symptom control. immunotherapy with good symptom control.

DiscussionDiscussion

Specific symptom control reported by patients Specific symptom control reported by patients were consistent with rhinoconjuctivitis quality were consistent with rhinoconjuctivitis quality of life scores which suggested overall good of life scores which suggested overall good quality of life based on a validated instrument.quality of life based on a validated instrument.

These results are tempered by the fact that These results are tempered by the fact that most patients continued to use allergy most patients continued to use allergy pharmocotherapy to manage symptoms. pharmocotherapy to manage symptoms.

Because military personnel are often unable to Because military personnel are often unable to use injection immunotherapy due to logistical use injection immunotherapy due to logistical limitations, we evaluated the use SLIT in this limitations, we evaluated the use SLIT in this group. group.

DiscussionDiscussion

In this smaller, separate analysis, In this smaller, separate analysis, military personnel using SLIT reported military personnel using SLIT reported very good rhinoconjunctivitis quality of very good rhinoconjunctivitis quality of life scores, whether or not they life scores, whether or not they previously received immunotherapy.previously received immunotherapy.

Concurrent pharmacotherapy was Concurrent pharmacotherapy was used less often by military personnelused less often by military personnel

The potential benefit here may be The potential benefit here may be limiting medication side-effectslimiting medication side-effects

ConclusionsConclusions

Allergy patients receiving injection Allergy patients receiving injection immunotherapy can be converted to SLIT with immunotherapy can be converted to SLIT with either improvement or no reduction in either improvement or no reduction in rhinoconjunctivitis symptom control.rhinoconjunctivitis symptom control.

Patients converted from injection Patients converted from injection immunotherapy to SLIT report good overall immunotherapy to SLIT report good overall quality of life quality of life

Because it can be safely self-administered and Because it can be safely self-administered and efficacious, SLIT may be an ideal approach to efficacious, SLIT may be an ideal approach to allergy management when immunotherapy is allergy management when immunotherapy is indicated for military personnel. indicated for military personnel.

ReferencesReferences

1)1) Passalacqua, G., C. Lombardi, and G.W. Canonica, Passalacqua, G., C. Lombardi, and G.W. Canonica, Sublingual immunotherapy: an update. Curr Opin Sublingual immunotherapy: an update. Curr Opin Allergy Clin Immunol 2004; 4(1)Allergy Clin Immunol 2004; 4(1)

2)2) Leatherman BD, Owen S, Parker M, et al. Sublingual Leatherman BD, Owen S, Parker M, et al. Sublingual immunotherapy: Past, present, paradigm for the immunotherapy: Past, present, paradigm for the future? A review of the literature. Otolaryngol Head future? A review of the literature. Otolaryngol Head Neck Surg 2007;136Neck Surg 2007;136

3)3) Juniper EF, Thompson AK, Ferrie PJ, et al. Development Juniper EF, Thompson AK, Ferrie PJ, et al. Development and validation of the Mini Rhinoconjunctivitis Quality and validation of the Mini Rhinoconjunctivitis Quality of Life Questionnaire. Clinical and experimental of Life Questionnaire. Clinical and experimental allergy 2000; 30 (1)allergy 2000; 30 (1)

4)4) La Crosse Method, sublingual immunotherapy practice La Crosse Method, sublingual immunotherapy practice protocol, 2008. Allergychoices, inc La Crosse Wi.protocol, 2008. Allergychoices, inc La Crosse Wi.