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Subcutaneous and Sublingual Immunotherapy To Treat Allergic Rhinitis/Rhinoconjunctivitis and Asthma

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Title: Subcutaneous and Sublingual Immunotherapy To Treat Allergic Rhinitis/Rhinoconjunctivitis and Asthma


1
Subcutaneous and Sublingual Immunotherapy To
Treat Allergic Rhinitis/Rhinoconjunctivitis and
Asthma
  • Prepared for
  • Agency for Healthcare Research and Quality (AHRQ)
  • www.ahrq.gov

2
Outline of Material
  • Agency for Healthcare Research and Quality
    Comparative Effectiveness Review (CER) Process
  • Background
  • Clinical Questions Addressed in the CER
  • Summary of CER Results
  • Conclusions
  • Gaps in Knowledge
  • Resources for Shared Decisionmaking

3
Agency for Healthcare Research and Quality (AHRQ)
Comparative Effectiveness Review (CER) Development
  • Topics are nominated through a public process,
    which includes submissions from health care
    professionals, professional organizations, the
    private sector, policymakers, the public, and
    others.
  • A systematic review of all relevant clinical
    studies is conducted by independent researchers,
    funded by AHRQ, to synthesize the evidence in a
    report summarizing what is known and not known
    about the select clinical issue.
  • The research questions and the results of the
    report are subject to expert input, peer review,
    and public comment.
  • The results of these reviews are summarized into
    a Clinician Research Summary and a Consumer
    Research Summary for use in decisionmaking and in
    discussions with patients.
  • The Research Summaries and the full report are
    available at www.effectivehealthcare.ahrq.gov/alle
    rgy-asthma-immunotherapy.cfm.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

4
Rating the Strength of Evidence From the
Comparative Effectiveness Review
  • The strength of evidence ratings are classified
    into four broad ratings

High High confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect.
Moderate Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate.
Low Low confidence that the evidence reflects the true effect. Further research is likely to change the confidence in the estimate of effect and is likely to change the estimate.
Insufficient Evidence either is unavailable or does not permit a conclusion.
  • AHRQ Methods Guide for Effectiveness and
    Comparative Effectiveness Reviews. Available at
    http//www.effectivehealthcare.ahrq.gov/methodsgui
    de.cfm.Lin SY, Erekosima N, Suarez-Cuervo C, et
    al. AHRQ Comparative Effectiveness Review No.
    111. Available at http//www.effectivehealthcare.a
    hrq.gov/allergy-asthma-immunotherapy.cfm.
  • Owens DK, Lohr KN, Atkins D, et al. J Clin
    Epidemiol. 2010 May63(5)513-23. PMID 19595577.

5
BackgroundAllergic Rhinitis/Rhinoconjunctivitis
and Asthma
  • Allergic rhinitis is a common clinical problem
    affecting about 20 percent of the general
    population in North America.
  • Allergens such as tree, grass, and weed pollens
    characteristically cause seasonal
    rhinoconjunctivitis and/or asthma.
  • Allergens such as cat dander, cockroach, or dust
    mite may induce symptoms year-round and are
    associated with perennial rhinitis and/or asthma.
  • The prevalence of asthma in the general U.S.
    population is approximately 9 percent, and
    approximately 62 percent of individuals with
    asthma have evidence of atopy (i.e., the genetic
    predisposition to produce elevated immunoglobulin
    E IgE in response to environmental allergens).
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.
  • Min YG. Allergy Asthma Immunol Res. 2010
    Apr2(2)65-76. PMID 20358020.

6
Background Management of Allergy Symptoms
  • The medical management of patients with allergic
    rhinitis and allergic asthma includes
  • Allergen avoidance
  • Pharmacotherapy
  • Immunotherapy
  • Daily use of pharmacotherapies for allergic
    asthma and rhinitis symptoms raises issues
    related to adherence, safety, and cost.
  • Long-term use of inhaled steroids, long-acting
    bronchodilators, and leukotriene antagonists for
    asthma control can have adverse effects.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm

7
BackgroundSubcutaneous Immunotherapy for
Allergies
  • Allergen-specific immunotherapy is typically used
    for
  • Patients whose allergic rhinoconjunctivitis and
    asthma symptoms cannot be controlled by
    medication and environmental control
  • Patients who cannot tolerate their medications
  • Patients who do not comply with chronic
    medication regimens
  • The U.S. Food and Drug Administration has
    approved the use of allergen extracts for
    subcutaneous immunotherapy in treating seasonal
    and perennial allergic rhinitis and allergic
    asthma.
  • In the United States, a patient with allergies
    undergoing immunotherapy receives subcutaneous
    injectionsin increasing doses until a
    maintenance dose is foundof an
    allergen-containing extract comprised of the
    relevant allergens to which he or she is
    sensitive in an attempt to suppress or eliminate
    allergy-related symptoms.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

8
BackgroundSublingual Immunotherapy for Allergies
  • There is considerable interest in using similar
    allergen extracts as sublingual immunotherapy
    (SLIT) as an alternative to subcutaneous
    immunotherapy.
  • SLIT involves placing drops or tablets with the
    allergen extract under the tongue for local
    absorption to desensitize the allergic individual
    over a period of months to years and to diminish
    allergic symptoms.
  • In the United States, there currently are no
    sublingual forms of immunotherapy approved by the
    U.S. Food and Drug Administration.
  • However, some U.S. physicians are using
    subcutaneous aqueous extracts off-label for
    sublingual desensitization in the treatment of
    allergic respiratory conditions.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

9
Systematic Review Objective and Key Questions
  • Objective
  • To evaluate the efficacy, effectiveness, and
    safety of subcutaneous (SCIT) and sublingual
    (SLIT) immunotherapies that are presently
    available for use by clinicians and patients in
    the United States
  • Key Questions
  • For patients with allergic rhinoconjunctivitis
    and/or asthma
  • Efficacy and effectiveness of SCIT, SLIT, and
    SCIT versus SLIT
  • Safety of SCIT, SLIT, and SCIT versus SLIT
  • Safety and effectiveness of SCIT, SLIT, and SCIT
    versus SLIT in the pediatric subpopulation
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm

10
Outcomes of Interest
  • Primary Outcomes
  • Clinical endpoints
  • Symptom control
  • Medication use
  • Quality of life
  • Disease evolution/remission
  • New allergen sensitivities
  • Overall health care utilization
  • Missed days of school/work
  • Secondary Outcomes
  • Functional tests (pulmonary function test?forced
    expiratory volume)
  • Provocational test
  • Adherence
  • Convenience and compliance
  • Biomarkers
  • Adverse Effects
  • Local reactions
  • Skin, mouth, and throat (including irritation,
    itching, swelling, or pain in the oral cavity)
  • General symptoms (such as headache, fatigue,
    arthritis)
  • Systemic reactions
  • Ocular
  • Rhinitis/nasal
  • Cutaneous
  • Rash
  • Gastrointestinal
  • Respiratory/asthma
  • Cardiovascular
  • Anaphylaxis
  • Death
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

11
Overview of Studies Included in theSystematic
Review
  • 142 studies were included in the review with
    these populations adults only (52), children
    only (24), and adults and children (22).
  • Studies on SLIT mainly included patients with
    allergic rhinitis and/or mild asthma.
  • All included studies were randomized controlled
    trials.
  • Efficacy and safety of SCIT n 74
  • Efficacy and safety of SLIT n 60
  • Comparisons of SCIT versus SLIT n 8
  • The types of scales/scoring systems used in the
    studies were not uniform.
  • Followup varied and ranged from one pollen season
    to 6 years.
  • Standard therapy varied across trials.
  • Due to heterogeneity in reported outcomes,
    results often only reflect the percentage of
    trials in which a significant effect was seen for
    the immunotherapy arm versus controls and not the
    magnitude of effect.

SLIT refers to allergen extracts that are
administered sublingually in the form of drops.
Studies on sublingual tablets are not included
here.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

12
Included Studies by Type of Allergen for SCIT,
SLIT, and SCIT Versus SLIT
Allergen SCIT SLIT SCIT vs. SLIT
Dust mite 21 14 6
Grass 11 15 ?
Weeds 9 7 ?
Cat 5 2 ?
Dog 1 ? ?
Mold 6 2 ?
Tree 6 13 2
Multiple allergens 15 7 ?
SCIT subcutaneous immunotherapy SLIT
sublingual immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

13
Included Studies for Subcutaneous Immunotherapy
Versus Placebo or Standard Therapy
  • 74 articles were included with a total of 4,350
    patients.
  • The primary diagnoses were
  • Asthma in 19 studies
  • Asthma with rhinitis in 18 studies
  • Rhinoconjunctivitis in 14 studies
  • Asthma with rhinoconjunctivitis in 14 studies
  • Types of allergens evaluated
  • Seasonal allergens such as trees, grasses, weeds,
    and seasonal molds in 59 percent of studies
  • Perennial allergens in 38 percent of studies
  • Seasonal and perennial allergens in 3 percent of
    studies
  • The heterogeneity of the data on clinical
    outcomes precluded pooling of the data for
    further analysis. Consequently, the results often
    only reflect the percentage of trials in which a
    significant effect was seen for the immunotherapy
    arm versus controls and not the magnitude of
    effect.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

14
Subcutaneous Immunotherapy Versus Placebo or
Standard Therapy Asthma Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma symptom score 17?84 greater improvement vs. controls 16 RCTs, n 1,178 High
Use of asthma medications Decreased in 42 of studies vs. controls 12 RCTs, n 1,062 High
Combined asthma symptom and medication score Significant improvement in 83 of studies vs. placebo 6 RCTs, n 196 Low
RCT randomized controlled trial
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

15
SCIT Versus Placebo or Standard Therapy
Rhinitis/Rhinoconjunctivitis Outcomes (1 of 2)
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Rhinitis/rhinoconjunctivitis symptoms Significant improvement in 73 of studies vs. controls 25 RCTs, n 1,734 High
Use of rhinitis/rhinoconjunctivitis medications Significantly decreased in 70 of studies vs. controls 10 RCTs, n 564 Moderate
Combined rhinitis/rhinoconjunctivitis symptom and medication score Significant improvement in 83 of studies vs. controls 6 RCTs,n 400 Low
RCT randomized controlled trial SCIT
subcutaneous immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

16
SCIT Versus Placebo or Standard Therapy
Rhinitis/Rhinoconjunctivitis Outcomes (2 of 2)
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Conjunctivitis symptoms Significant improvement in 43 of studies vs. placebo 14 RCTs, n 1,104 High
Combined symptoms (nasal, ocular, and bronchial) Significant improvement in 67 of studies vs. placebo 6 RCTs, n 591 High
Disease-specific quality of life in patients with rhinitis/ rhinoconjunctivitis Significant improvement by RQLQ in 67 of studies vs. placebo 6 RCTs, n 889 High
RCT randomized controlled trial RQLQ
Rhinoconjunctivitis Quality of Life
Questionnaire SCIT subcutaneous immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

17
SCIT Versus Placebo or Standard Therapy Asthma
Plus Rhinitis/Rhinoconjunctivitis Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma plus rhinitis/rhinoconjunctivitis symptoms 21?68 greater improvement vs. controls 5 RCTs, n 175 Moderate
Use of asthma plus rhinoconjunctivitis medications 1483 greater reduction in asthma-based studies vs. controls Significantly decreased in 91 of rhinitis-based studies vs. controls 5 RCTs, n 203 11 RCTs,n 768 High
RCT randomized controlled trial SCIT
subcutaneous immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

18
Included Studies for Sublingual Immunotherapy
Versus Placebo or Standard Therapy
  • 60 articles on sublingual immunotherapy (SLIT)
    that included 4,870 patients were eligible for
    inclusion.
  • Allergens evaluated included
  • Seasonal allergens (66)
  • Perennial allergens (31)
  • Both seasonal and perennial allergens (3)
  • Comparators included
  • Placebo (71)
  • Another sublingual intervention without a placebo
    group (15)
  • Conventional treatment without placebo
    (pharmacotherapy or rescue medications 14)
  • Duration of treatment ranged from 3 months to 5
    years.
  • There was great heterogeneity in
  • Dosages of maintenance or cumulative treatments
  • The units to report dosing
  • Standard therapy used across trials
  • Reported results often only reflect the
    percentage of trials in which a significant
    effect was seen for the immunotherapy arm versus
    controls and not the magnitude of effect.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

19
Sublingual Immunotherapy Versus Placebo or
Standard Therapy Asthma Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma symptom score Significant improvement across all studies vs. controls 13 RCTs, n 625 High
RCT randomized controlled trial
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

20
SLIT Versus Placebo or Standard Therapy
Rhinitis/Rhinoconjunctivitis Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Rhinitis/ rhinoconjunctivitis symptoms Significant improvement in 56 of studies vs. controls 36 RCTs, n 2,658 Moderate
Conjunctivitis symptoms Significant improvement in 46 of studies vs. placebo 13 RCTs, n 1,074 Moderate
Disease-specific quality of life in patients with rhinitis/ rhinoconjunctivitis Significant improvement by RQLQ in 75 of studies vs. controls 8 RCTs, n 819 Moderate
RCT randomized controlled trial RQLQ
Rhinoconjunctivitis Quality of Life Questionnaire
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

21
SLIT Versus Placebo or Standard Therapy Asthma
Plus Rhinitis/Rhinoconjunctivitis Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma plus rhinitis/ rhinoconjunctivitis symptoms Significantly improved in 80 of studies vs. controls 5 RCTs, n 308 Moderate
Use of asthma plus rhinoconjunctivitis medications Significant improvement in 47 of studies vs. controls 38 RCTs, n 2,724 Moderate
Asthma plus rhinitis/ rhinoconjunctivitis symptom and medication score Significant improvement in 68 of studies vs. controls 19 RCTs, n 1,462 Moderate
RCT randomized controlled trial
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

22
Subcutaneous Versus Sublingual Immunotherapy All
Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Improves asthma symptom score SCIT may improve asthma symptoms more effectively than SLIT 4 RCTs, n 171 Low
Improves rhinitis/rhinoconjunctivitis symptoms SCIT is superior to SLIT for improving allergic nasal and/or eye symptoms 6 RCTs, n 412 Moderate
Decreases use of asthma plus rhinoconjunctivitis medications There are no consistent differences between SCIT and SLIT 5 RCTs, n 219 Low
Improves asthma plus rhinitis/rhinoconjunctivitis symptom and medication score SCIT is favored in 1 of 2 studies 2 RCTs, n 65 Low
RCT randomized controlled trial SCIT
subcutaneous immunotherapy SLIT sublingual
immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

23
Included Studies for SCIT Versus Placebo or
Standard Therapy in the Pediatric Population
  • Thirteen studies on subcutaneous immunotherapy
    included 920 pediatric patients.
  • The pediatric population ranged in age from 3 to
    18 years.
  • Primary diagnoses included
  • Asthma in 7 studies
  • Asthma with rhinitis in 3 studies
  • Asthma with rhinoconjunctivitis in 2 studies
  • Rhinoconjunctivitis in 1 study
  • All studies allowed either conventional
    pharmacotherapy or rescue allergy medications
    during the study.
  • Standard therapy varied across studies.
  • Due to heterogeneity in reported clinical
    outcomes, results often only reflect the
    percentage of trials in which a significant
    effect was seen for the immunotherapy arm versus
    controls and not the magnitude of effect.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

24
Pediatric PatientsSCIT Versus Placebo or
Standard Therapy Asthma Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma symptom score Significant improvement in 50 of studies vs. controls 6 RCTs, n 550 Moderate
Use of asthma medications Significant reduction in 50 of studies 4 RCTs, n 470 Low
RCT randomized controlled trial SCIT
subcutaneous immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

25
Pediatric PatientsSCIT Versus Placebo or
Standard Therapy Rhinitis/Rhinoconjunctivitis
Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Rhinitis/rhinoconjunctivitis symptoms Significant improvement in 67 of studies vs. placebo 3 RCTs, n 285 Moderate
Conjunctivitis symptoms Significant improvement in 67 of studies vs. placebo 3 RCTs, n 285 Low
Disease-specific quality of life in patients with rhinitis/rhinoconjunctivitis Significant improvement in both studies vs. controls 2 RCTs, n 350 Low
RCT randomized controlled trial SCIT
subcutaneous immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

26
Pediatric PatientsSCIT Versus Placebo or
Standard Therapy Asthma Plus Rhinitis/Rhinoconjun
ctivitis Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Use of asthma plus rhinoconjunctivitis medications Decreased in both studies vs. controls 2 RCTs,n 80 Low
Improves combined asthma or asthma plus rhinitis/rhinoconjunctivitis symptom and medication score Significant improvement in both studies vs. placebo 2 RCTs, n 85 Low
RCT randomized controlled trial SCIT
subcutaneous immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

27
Included Studies for SLIT Versus Placebo or
Standard Therapy in the Pediatric Population
  • 18 studies including 1,583 pediatric patients (
    18 years of age)
  • Primary diagnoses
  • Asthma (n 3 studies)
  • Rhinitis (n 2 studies)
  • Rhinoconjunctivitis (n 4 studies)
  • Asthma and rhinitis (n 4 studies)
  • Asthma with rhinoconjunctivitis (n 5 studies)
  • Perennial and/or seasonal allergies were included
  • Comparator groups included
  • Placebo (n 15 studies)
  • Sublingual immunotherapy (SLIT) comparator group
    (n 3 studies)
  • Pharmacotherapy/symptomatic therapy (n 2
    studies)
  • Due to heterogeneity in reported clinical
    outcomes, results often only reflect the
    percentage of trials in which a significant
    effect was seen for the immunotherapy arm versus
    controls and not the magnitude of effect.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

28
Pediatric PatientsSLIT Versus Placebo or
Standard Therapy Asthma Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma symptom score Significant improvement in all studies vs. controls 9 RCTs, n 471 High
RCT randomized controlled trial SLIT
sublingual immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

29
Pediatric PatientsSLIT Versus Placebo or
Standard Therapy Rhinitis/Rhinoconjunctivitis
Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Rhinitis/rhinoconjunctivitis symptoms Significant improvement in 42 of studies vs. controls 12 RCTs, n 1,065 Moderate
Conjunctivitis symptoms Significant improvement in 40 of studies vs. placebo 5 RCTs, n 513 Moderate
RCT randomized controlled trial SLIT
sublingual immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

30
Pediatric PatientsSLIT Versus Placebo or
StandardTherapy Asthma Plus Rhinitis/Rhinoconjun
ctivitis Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Asthma plus rhinitis/ rhinoconjunctivitis symptoms Significant improvement with high- and low-dose SLIT vs. placebo 1 RCT, n 98 Moderate
Use of asthma plus rhinoconjunctivitis medications Significantly reduced in 42 of studies vs. controls 13 RCTs, n 1,078 Moderate
Asthma plus rhinitis/ rhinoconjunctivitis symptom and medication score Significant improvement in 50 of studies vs. controls 2 RCTs, n 329 Low
RCT randomized controlled trial SLIT
sublingual immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

31
Pediatric PatientsSCIT Versus SLITAll Outcomes
Primary Outcome Results No. of RCTs, No. of Patients (n) Strength of Evidence
Improves asthma symptom score SCIT is favored in 67 of studies vs. SLIT 3 RCTs, n 135 Low
Improves asthma plus rhinitis/ rhinoconjunctivitis symptoms SCIT may be favored over SLIT for reducing nasal and/or eye symptoms 3 RCTs, n 135 Low
Decreases use of asthma plus rhinoconjunctivitis medications SLIT may decrease medication use more than SCIT, but results are inconsistent 3 RCTs, n 135 Low
RCT randomized controlled trial SCIT
subcutaneous immunotherapy SLIT sublingual
immunotherapy
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

32
Adverse EffectsSubcutaneous Immunotherapy in
Adults
  • Local reactions (such as redness, swelling,
    pruritus, or induration at the injection site)
    were usually mild and occurred in 5 to 58 percent
    of patients and 0.6 to 54 percent of injections
    and were more common than systemic reactions.
  • The most common systemic reactions were
    respiratory reactions, occurring in up to 46
    percent of patients and in up to 3 percent of
    injections.
  • General symptoms (such as headache, fatigue, and
    arthritis) occurred in up to 44 percent of
    patients and were usually mild or unspecified.
  • Gastrointestinal reactions were reported in only
    one study.
  • Thirteen anaphylactic reactions were reported in
    four trials.
  • No deaths were reported in the included studies.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

33
Adverse EffectsSublingual Immunotherapy in
Adults
  • Local reactions (such as irritation, itching,
    swelling, or pain in the oral cavity) were common
    and usually mild and occurred in 0.2 to 97
    percent of patients receiving sublingual
    immunotherapy (SLIT).
  • Systemic reactions occurred more frequently in
    the SLIT arm versus controls and included ocular,
    rhinitis/nasal, respiratory/asthma, cutaneous,
    gastrointestinal, and cardiovascular adverse
    effects.
  • No life-threatening reactions, anaphylaxis, or
    deaths were reported in the included trials.
  • SLIT studies mainly include patients with
    allergic rhinitis and/or mild asthma. Safety
    outcomes should not be extrapolated to more
    severely affected patients.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

34
Adverse Effects Subcutaneous Versus Sublingual
Immunotherapy in Adults
  • The recording and reporting of the adverse events
    was neither uniform nor comparable across
    studies.
  • Local reactions were common and were all of mild
    or moderate severity.
  • There was one report of anaphylaxis with
    subcutaneous immunotherapy.
  • There were no reported deaths in the included
    studies.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

35
Adverse Effects Subcutaneous Immunotherapy in
Pediatric Patients
  • Local reactions were the most common adverse
    reactions in the pediatric population receiving
    subcutaneous immunotherapy.
  • There were no reports of anaphylaxis or deaths.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

36
Adverse Effects Sublingual Immunotherapy in
Pediatric Patients
  • Local reactions (such as irritation, itching,
    swelling, or pain in the oral cavity) were common
    but mild.
  • No life-threatening reactions, anaphylaxis, or
    deaths were reported in these trials.
  • The strength of evidence for all other adverse
    effects is insufficient.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

37
Adverse Effects Subcutaneous Versus Sublingual
Immunotherapy in Pediatric Patients
  • Local reactions were reported in both patient
    groups.
  • No systemic reactions were reported in patients
    receiving sublingual immunotherapy.
  • In the pediatric population taking subcutaneous
    immunotherapy, one anaphylaxis event and three
    respiratory systemic reactions were reported.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

38
Overview of Conclusions (1 of 2)
  • There is sufficient evidence to support the
    overall effectiveness and safety of both
    subcutaneous immunotherapy (SCIT) and sublingual
    immunotherapy (SLIT) for treating allergic
    rhinoconjunctivitis and asthma.
  • However, there is not enough evidence to
    determine if either SCIT or SLIT is superior.
  • SCIT and SLIT are usually safe, although local
    reactions are commonly reported regardless of the
    mode of delivery.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

39
Overview of Conclusions (2 of 2)
  • Serious, life-threatening reactions are rare,
    although they can occur.
  • Studies of sublingual immunotherapy (SLIT) mainly
    include patients with allergic rhinitis and/or
    mild asthma.
  • Safety outcomes should not be extrapolated to
    more severely affected patients.
  • Most of the studies in the review used a single
    allergen for immunotherapy, and it may be
    difficult to extrapolate these results to the use
    of multiple-allergen regimens, which are commonly
    used in clinical practice in the United States.
  • Due to the wide variety of reported regimens, the
    target SLIT maintenance dose and duration of
    therapy are unclear.
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

40
Gaps in Knowledge
  • Additional studies are needed on
  • The efficacy and safety of multiple-allergen
    subcutaneous (SCIT) and sublingual (SLIT)
    immunotherapy
  • The effectiveness of single-allergen versus
    multiple-allergen SCIT and SLIT for
    desensitization
  • The efficacy and safety of SCIT and SLIT in
    specific subpopulations (pregnant women,
    monosensitized vs. polysensitized patients,
    patients with severe asthma, and urban vs. rural
    patients)
  • Whether or not SCIT and SLIT can prevent or
    modify the atopic march in pediatric patients at
    high risk for allergic rhinitis and asthma, as
    well as the optimal age to initiate therapy
  • Determining the target maintenance dose, dosing
    strategies, and the necessary durations of
    treatment for SCIT and SLIT
  • Direct comparisons of SCIT to SLIT in pediatric
    and adult patients
  • Optimizing allergen standardization for
    subcutaneous and sublingual regimens
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

41
Shared Decisionmaking What To Discuss With Your
Patients
  • The benefits and adverse effects of subcutaneous
    (SCIT) or sublingual (SLIT) immunotherapy for
    them or their child
  • Any comorbid conditions that they or their child
    may have that would affect their ability to take
    SCIT or SLIT
  • Other prescription or over-the-counter
    medications they are taking during SCIT or SLIT
    treatment
  • What adverse effects to look for and when to call
    their doctor
  • How often they should be taking SCIT or SLIT
  • How long they can expect to take SCIT or SLIT
  • The costs of SCIT and SLIT
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.

42
Resource for Patients
  • Allergy Shots and Allergy Drops for Adults and
    Children, A Review of the Research is a free
    resource that can help patients talk with their
    health care professionals about treatment
    options. It provides information about
  • Allergies in general
  • How allergies are treated
  • Allergy shots and allergy drops
  • The benefits of allergy shots and allergy drops
    for adults and children
  • Possible side effects of allergy shots and
    allergy drops for adults and children
  • Questions to discuss with their doctor
  • Lin SY, Erekosima N, Suarez-Cuervo C, et al. AHRQ
    Comparative Effectiveness Review No. 111.
    Available at http//www.effectivehealthcare.ahrq.g
    ov/allergy-asthma-immunotherapy.cfm.
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