Improving Outcomes for Pediatric Patients With Uncontrolled Moderate-to-Severe Asthma Using a Collaborative Approach: Recognition, Referral, and Management in the Era of Targeted Treatment Options

Chair, William Anderson, MD, discusses severe asthma in this CME/MOC/NCPD/CPE/AAPA activity titled “Improving Outcomes for Pediatric Patients With Uncontrolled Moderate-to-Severe Asthma Using a Collaborative Approach: Recognition, Referral, and Management in the Era of Targeted Treatment Options.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/NCPD/CPE/AAPA information, and to apply for credit, please visit us at https://bit.ly/3IJWFAR. CME/MOC/NCPD/CPE/AAPA credit will be available until June 13, 2025.

1. Improving Outcomes for Pediatric Patients
With Uncontrolled, Moderate-to-Severe
Asthma Using a Collaborative Approach
Recognition, Referral, and Management
in the Era of Targeted Treatment Options

William Anderson, MD wr J

Associate Professor
Department of Pediatrics, Allergy & Immunology Section
Children’s Hospital Colorado -

University of Colorado School of Medicine
‚Aurora, Colorado A

Go online to access full CME/MOC/NCPD/CPE/AAPA information, including faculty disclosures.

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2. Recognition and Referral
The Importance of Collaboration in Managing

Uncontrolled Moderate-to-Severe Asthma
in the Pediatric Population

Go online to access full CME/MOC/NCPD/CPE/AAPA information, including faculty disclosures.

3. Our Goals for Today

Enhance your ability to recognize and assess the severity of
uncontrolled, moderate-to-severe asthma in pediatric patients
according to evidence-based guidelines and expert recommendations
Improve your skills at referring pediatric patients with uncontrolled,
moderate-to-severe asthma as appropriate to specialty care
Augment your ability to identify pediatric patients with uncontrolled,
moderate-to-severe asthma who may be eligible for treatment with
targeted biologic therapy

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4. Highlighting the Problem: Referral of Patients With Asthma
to Specialty Care Occurs Suboptimally’*

+ Areview of asthma management in the US, based on National Asthma Education and
Prevention Program (NAEPP) guidelines observed:

— The majority of asthma patients were uncontrolled and only 22% had visited a specialist
— Approximately 50% of patients with asthma had never visited a specialist
+ Aretrospective review of a pediatric asthma population showed:
— Only 44% visited an asthma specialist within 12 months of an ED visit, contrary to
guideline recommendations
+ Conversely, after visiting a specialist, the average number of visits to immediate care
centers and EDs decreased significantly among children with asthma (P < .01), in addition
to:
— Average all-cause hospitalizations and hospitalizations due to asthma exacerbation
also decreased significantly (P < .01 for both)

1. Price Det a. J Asthma Alergy. 2017:10:200-223.2. Aragona E etal. Am J Respir Cit Care Med. 2014:189:A3838, —
3 Rosman Yell. Asthma Alergy. 2021:14:1367-1373. PeerView.com

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5. Definition of Uncontrolled Persistent Asthma!

+ Asthma requiring treatment with high-dose ICS and LABA or leukotriene modifier/theophylline in
the last year or systemic CS for >50% of the previous year to prevent the asthma from
becoming or remaining “uncontrolled” despite treatment

Uncontrolled asthma is defined as at least one of the following:

— Poor symptom control

— Frequent severe exacerbations requiring at least two bursts of systemic CS (23 days each) in
the previous year

— Serious exacerbations requiring at least one hospitalization, ICU stay, or mechanical
ventilation in the previous year

— Airflow limitation: FEV1 <80% predicted (in the presence of reduced FEV1/FVC defined as
less than the lower limit of normal) following a withhold of both short- and long-acting
bronchodilators

Controlled asthma that worsens when tapering high doses of ICS or systemic CS, or additional

biologic therapy

1. Chung KF eta. Eur Respir J. 2014:43:243:973, PeerView.com

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6. Differentiating Between Difficult-to-Treat Asthma
and Severe Asthma’?

Difficult-to-Treat Asthma
Poorly controlled due to comorbidities,

poor medication adherence, After systematic evaluation

environmental exposures of children referred as
severe asthma,

30% to 50% are eventually
Severe Asthma diagnosed as

Remains uncontrolled despite difficult-to-treat asthma

assessment and control of the
above factors

1. Chung KF et al. Eur Respir J. 2014:43:343-373, 2 Bracken M et al. Arch Dis Chi. 2009:94:780-74. PeerView.com

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7. Differentiating Between Difficult-to-Treat Asthma
and Severe Asthma!

Difficult.

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8. Differential Diagnosis of Severe Asthma in Children!

+ Dysfunctional breathing
- Vocal cord dysfunction
— Panic attacks

+ Swallow dysfunction and chronic
silent/micro aspiration

+ Anatomic abnormalities/external

compression
Congenital vascular malformations
(eg, vascular ring)
Tracheobronchomalacia
Mediastinal mass
Enlarged lymph node
Tracheoesophageal fistula

1. Abul MH, Phipatanakul W. Alrgology Intemational, 2019;68:180-187.

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Cystic fibrosis

Primary ciliary dyskinesia
Protracted bacterial bronchitis
Congenital or acquired immune deficiency
Bronchiectasis

Interstitial lung disease
Connective tissue diseases
Vasculitis

Congenital heart diseases
Foreign body aspiration
Bronchopulmonary dysplasia
Endobronchial mass/tumor
Hypersensitivity pneumonitis

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9. Comorbidities Affecting Asthma Control!

Gastroesophageal Vocal cord Obstructive sleep

reflux disease dysfunction apnea

Medication (ACE
Psychological | inhibitors, B blockers,
disorders Aspirin and other

NSAIDs)

1. Abul MH, Phipatanakul W. Allrgology Intemational. 2019:68:150-157. PeerView.com

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10. Psychosocial Assessment of Children and Caregivers!*

* Children with severe asthma have significant anxiety and
difficulty in coping with their disease, which can lead to poor
medication adherence and asthma control

* Caregiver’s psychosocial stress is associated with high
asthma morbidity regardless of medication adherence

— Depressive symptoms in the caregiver are important and
associated with beliefs and attitudes that may significantly
influence asthma management and adherence to asthma
medications, leading to poor asthma control

1. Abul MH, Phipatanakul W. Allergology Intemational, 2019:68:150-157. 2. Gilaspy SR el Pediatr Psychol. 2002:27:363-371, Ba
3. Lavoie KL eta. Chest 2010,137:1324-1331. 4 Bartet SJ eta. Pediatrics. 2004.113229-237 PeerView.com

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11. Identifying and Addressing Modifiable Causes
of Asthma Control’

Medication Adherence and Inhaler Technique

+ Very common across all

severities of asthma; a frequent MAMA: Associated with poor asthma

USA reason for “difficult asthma’ in technique control and frequent ED visits

adults and children Clinicians should observe

Must be a priority in the clinical patient's inhaler technique and

assessment of difficult asthma compare with a device-specific
checklist

When nonadherence is

identified, clinicians should have Errors should be corrected

an empathetic discussion with Technique should be rechecked

patients about barriers to frequently

adherence

1. Lindsay JT, Heaney LG. Paton Prefer Adherence. 20137329:336.2 Heaney LG, Home R. Thorax. 2012:67-268-270. 3. AlJahdal H ea. Alergy Asthma Cin né
Immune. 2013:9:3, 4. ps gnasthma orgwp-contentvploads/2019/04/GINA.2019-main- Pocket-Guide-wms.pa. Accessed October 11, 2019. PeerView.com

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12. Goals of Asthma Management:
Reduce Current Impairment and Future Risk‘?

Improve Reduce

+ Symptom control (daytime + Exacerbations
symptoms, night-time

awakening) + Rescue medication

+ Management of comorbidities si ‘Treatment lated AEs
+ Lung function + Visits to ED

Effective asthma management requires a partnership between the patient
and the healthcare provider to define and achieve treatment goals

1. tpslginasirma orghwp-contenVuploads20207/GINA-2023-Fulbcepor-23_07_08AWMS pat 7
2 np srw aN nin gov ealh-po'gudeinesicurenastyma-guidetnesfulrepot. PeerView.com

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13. From Primary Care to Specialist...

When is it time

to refer?

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14. Approach to Severe Asthma’?

v Diagnosis

a v Adherence
Review

v Choice of inhaler device

Y” Inhaler technique

Children with persistent symptoms and frequent exacerbations despite
appropriate inhaler technique and good adherence to standard GINA Step 4
asthma treatments should be referred to an asthma specialist with expertise

in management of severe asthma.

1. Hekng PP eta. Alergy Cin Immunol. 2018:135'896-002 2. rel E, Reddel HK. N Eng! J Med, 2017:377:065-976 PeerView.com

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15. Prior to Referral

y” CBC with differential (for blood EOS)

Obtain y Total IgE

Y Spirometry

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16. GINA: Treatment Approaches—Children 6-11 Years of Age’

‘Assess.

| Confirmation of
diagnosis

¥ ‘Symptom control and
modifiable is factors
(ncluing ung function)

7. Comorbidties

Y Inhaler technique and
‘adherence

¥ Child and parent
references and goals

Dally LTRA® or

low-dose ICS Low-dose

taken whenever SABA ICS + LTRA®
taken"

RELIEVER: As-needed short-acting B2-agonis (or ICS-formoterol reliever in MART in Steps 3 and 4)
*Antvintammator relievers (AIR). ° preseñbing leukotriene receptor antagonists, note concerns about potential neuropsychiatric adverse eflecs

“ Verptow-dose:budesonide-formoter! 1008 meg * Low-dose. budesoniceformoteol 2006 mcg (metered doses) —
1. ps giasihma orghwp-contenVuploads/2024/05/GINA-2024-Strategy-Report-24_05 22, WMS pa PeerView.com

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17. GINA: Treatment Approaches—12 Years and Older!

Personalized asthma management for adults and adolescents aged 212 years: assess, adjust, review for individual patient needs

Contention gran Tracassan = Corse
Simple consol and modal rk < nba tchnaue and adherence
tacos (pcia lung actor): Palenpriarncas and goals

CONTROLLER and PREFERRED
RELIEVER (rack 1)

ALTERNATIVE CONTROLLER
and RELIEVER (Tack 2
Bette conserng regimen wth
‘SABA ler check fe patas

aly to be here wth ay
ie
pe, on cs mm SAN te ty
ps aay

Antinfammatory relever (AIR) ® prescribing LTRA advise patieticaregiver about risk of neuropsychiatic adverse eects.
1. ps ginastrma orgiwp-contenVuploads/2024/5/GINA-2024-Stategy-Report-24_05 22. WMS pat pa

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Be
= El

RELIEVER Ascended de aci ont

mater name
eam dre, alte ashe THO

cris
en

PT ci De.
u an

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18. Patient Cases

When to Refer?

19. Patient Case: Connor, a 9-Year-Old Boy

Connor is a 9-year-old male with a history of asthma, food allergies, eczema, reflux,
uncontrolled rhinitis, and secondhand smoke exposure

He also has a history of a prior PICU admission for asthma

Asthma triggers: viral illnesses, activity, and environmental allergen exposures

He has been using albuterol daily for exercise-induced symptoms and awakening four
nights a week with wheeze and cough

Connor splits time between his mother’s and father’s homes with concern of inconsistent
adherence to controller therapies

There are two dogs in his mother’s house and three dogs in his father’s house
What should be done now?

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20. Patient Case: Connor, a 9-Year-Old Boy

Connor is referred to a specialist for evaluation of poorly controlled asthma

Started on SMART therapy with an ICS-formoterol with review of importance of
adherence

Skin testing showed sensitization to multiple aeroallergens including dog > addressed
environmental exposures, including dog mitigation strategies

Counseled family on secondhand smoke exposure and smoking cessation

Concern for eosinophilic esophagitis, referred to Gl for work up, negative for EoE but
started on omeprazole

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21. Patient Case: Rita, an 8-Year-Old Girl

In the last year, Rita has had two ED visits and four courses of steroids for shortness of
breath and chest tightness

She describes her symptoms as difficulty getting air into her lungs and chest and neck

tightness
Asthma triggers include animals, exercise, smoke, and weather changes
She reports that some symptoms improve with albuterol but others do not
She is already taking high dose ICS-LABA therapy

What should be done now?

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22. Patient Case: Rita, an 8-Year-Old Girl

Rita is referred to a specialist and given high dose ICS-LABA therapy, in addition to:
— Spirometry, which showed obstruction with reversibility
— Environmental testing was done and was negative to all aeroallergens

Additional discussion showed significant anxiety in Rita that was unrecognized and
untreated

Symptoms were suggestive of possible inducible laryngeal obstruction (ILO)/vocal cord
dysfunction (VCD) > she was evaluated by SLP and treated with breathing exercises

With treatment of underlying anxiety and ILO, her symptoms improved; she did not have
additional ED visits or oral steroids; her ICS-LABA dose was able to be reduced

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23. Improving Outcomes
in Pediatric Patients

Understanding How to Use Biologic
Therapy in Children with Uncontrolled
Moderate-to-Severe Asthma

Go online to access full CME/MOC/NCPD/CPE/AAPA information, including faculty disclosures.

24. Asthma Is a Heterogeneous Disease!

Patients respond

differently to
different treatments

1. Chung KF eta. Eur Respir. 2014:43:243:93, PeerView.com

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25. Inflammatory Subtypes of Asthma

Airway inflammation
Biomarkers: sputum, BAL, bronchial biopsies, FeNO, blood eosinophils, allergic sensitization

Phenotypes

Mixed Eos and
neutrophilic

Neutrophilic

Allergic

Type 2/12 High a) Non-Type 2/T2 Low

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Paucigranulocytic|

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26. Type 2 Inflammation and Asthma’

Pollutants, viral infections, allergens

IL-25, IL-33, TSLP

IgE-switched
B cell
4

Th2 cell

Eosinophil

1.Brussele GG eta N Engl J Med, 2022:386:187-171.

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IgE plasma cell

Mast cell

Zu ie N

ne

LS Smooth muscle
Ss hypertrophy
@ ==. obstruction_|
and hyper-reactivity

| bos,
Mo

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27. Multiple Patient Types Fall Under
the Type 2 Asthma Umbrella!

Type 2 asthma a
is defined by elevated levels D & &
of type 2 inflammatory cytokines

No single biomarker
captures the full range
of type 2 inflammation =>
in patients with T2-high asthma

f

Mild CS-naive/
CS-responsive
early onset

‘Moderate to severe
CS-treated

1. Canonica GW et a. Eur Med J 2018;3:24-33. allergic/eosinophilic PeerView.com

Late-onset
eosinophilic

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28. Biomarker Limitations

* Peripheral eosinophils do not always reflect BAL eosinophils

— Peripheral blood and BAL eosinophils were weakly
correlated without statistical significance

— 12 of 25 subjects had discordance
+ Phenotypes can vary over time
- 63% of pediatric patients demonstrated 22 phenotypes
over 12 months based on sputum

— 41% fulfilled criteria for noneosinophilic asthma on one
occasion and eosinophilic on other

1. Fleming Letal. Thorax. 20129775691. 2. Ribeiro Vet al J Allergy Clin Immunol. 2019.7:2494-2498, PeerView.com

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29. Type 2 Inflammation and the Shared Relationship
Between Asthma and Common Comorbidities

Atopic
dermatitis &
asthma

Asthma &
CRSWNP

Atopic

dermatitis CRSwNP

Type 2

Inflammation

Prurigo
nodularis

EoE & food Food
allergies allergies

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30. Targeted Biologic Approaches to Treat Asthma

Omalizumab

(SubQ)

Benralizumab Mepolizumab

(SubQ)

(Suba)

Reslizumab Tezepelumab

(IV)

(SubQ)

Dupilumab
(SubQ)
Target IL-4R/13
Age, y 26
Frequency Q2W
Atopic
Other dermatitis,
approved CRSwNP, EoE,
indications prurigo
nodularis

IgE
26

Q2W or Q4W

Chronic
spontaneous
urticaria,
nasal polyps

IL-5R
26

Q4W for
first 3 doses
then Q8W

N/A

IL-5

26

EGPA, HES,
CRSWNP

IL-5

218

Q4W

N/A

TSLP

212

Q4w

N/A

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31. Efficacy and Safety of Biologics
Moderate-to-Severe Asthma’

+ Multiple clinical studies + Very low incidence of side
= + quality of life effects in trials (<3%),
a including

— | exacerbations
= isite - Headache

= visits
Sl _ = Nasopharyngitis

A - | hospitalizations =

— Injection-site reactions

— Ocular effects
(dupilumab, in atopic
dermatitis patients)

- Rare anaphylactic
reactions

- | steroid requirements

1. Kavanagh JE etal. Broahe,2021:17:210164 PeerView.com

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32. Long-Term Efficacy and Safety of Dupilumab in
Children With Asthma: LIBERTY ASTHMA EXCURSION'

+ 365 of 408 children with moderate-to-severe asthma from VOYAGE enrolled in
EXCURSION, a 52-week open-label extension study

+ Long-term treatment was well tolerated with an acceptable safety profile

3.000 2.560
$ 250 2160, mu
3 er Placebo (VOYAGE placebo (VOYAGE)
é n= 108 to dupilumab (EXCURSION)
Unadjusted annualized 2 g 0
exacerbation rates in children E
e Ss = Dupilumab (VOYAGE Ydupilumab
with moderate-to-severe 28150 (VOYAGE) to dupilumab (EXCURSION)
type 2 asthma® £ 2
2 8 1000 2670,
ER n= 106
SG 6500
3 u
E
É
> 0
Number of Exacerbations VOYAGE EXCURSION
in the Year Before VOYAGE (52 weeks) (52 weeks)
Blood eos count 2160 colnet. or FeNO 220| =
dé PeerView.com

4. Bacharier LB et al, Lancet. 2024:12:45-54,

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33. Long-Term Efficacy and Safety of Dupilumab in
Children With Asthma: LIBERTY ASTHMA EXCURSION'

dr Placebo (VOYAGE) placebo (VOYAGE) to duplumab (EXCURSION)
—- Duplumab (VOYAGEYdupllumab (VOYAGE) to duplumab (EXCURSION)

VOYAGE EXCURSION

Atte ttt
H RER

Prebronchodilator ppFEV;
Mean Change From PSBL, %

s
PSBLZ 4681012 16 20 24 2 32 36 40 4 4 02 8 12 2 Py

Time, wk
Change from parent study baseline (PSBL) in prebronchodilator ppFEV,
over time in children with moderate to severe type 2 asthma?

* Blood eos count 2150 easel or FeNO 220 N
LS al Lancet DOLAR PeerView.com

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34. Long-Term Efficacy and Safety of Dupilumab in
Children With Asthma: LIBERTY ASTHMA EXCURSION'

se Placebo VOYAGE plcato (VOYAGE) a Supkumab (EXCURSION)

“© Diphumad (VOYAGE) pluma (VOYAGE) o duplumes (EXCURSION)
4 yorace EXCURSION

80888

Change From Parent Study Baseline
in Serum Tota IgE, %

88385588

Din a % ®

Pd
8

Time, wh Timo, wk

Median (IQR) % change from PSBL in (A) serum total IgE and (B) blood
eosinophil over time in the overall (safety) population

1. Bacharer LB et a. Lancet 2024:124554, PeerView.com

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35. Benralizumab in Children Aged 6-11 With Severe Asthma:
Phase 3 TATE Study’

FEV, Change From Baseline Be 'ACQ-A Change From Baseline

Benraizumad 30 mg

>

Benralizuma 10 mo.

Benralzumab
30mg

ACQ-IA Score Mean (2SE)
Change From Baseline

Mean (#SE) Change
in FEV, From Baseline, L

&

20

04

EME an e248 DE EE EX
Timepoint, wk (€or) Timepoint, wk

No.of Patents No of Patents

Include in Analia Included in Anais

Demon 15 15 18 16 11 “ 1g 122 Oma fs tS 1S UM US CS HS
Bo 0 0 7 $" 12 Bag BI 13 M NW Zn Ze

1: Wedner HJ eta. Podatr Alergy Immunol 2024:35(3)14082. PeerView.com

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36. Factors Impacting Biologic Therapy Selection

Patient
characteristics
(eg, BMI, age)

Asthma phenotype Asthma Long-term safety and
and endotype comorbidities efficacy profile

o Adherence
Patient preference administration Frequency of dosing SERA

inistration
(IV vs subQ) vs office visits)

Cost
| (insurance coverage,
prior authorization).

“experience

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37. Selection of Biologic Therapy’

Severe asthma despite high-dose IGs + LABA
and adequate management

AAA) AZ

—

T ——
u Be
ut

hemacioge eaves and cer
peta,

aan

“Teper Os grat menso for arenal many.

1. Brusselle 66 et al. N Engl J Med. 2022:386:157-171 PeerView.com

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38. Patient Cases

Identifying Eligible Pediatric
Patients for Biologic Therapy

39. Patient Case: Patrick, an 11-Year-Old Boy

Patrick was initially diagnosed with asthma at 4 years of age, and also has allergic rhinitis

Patrick has been referred for uncontrolled asthma; Patrick’s asthma is primarily triggered by viral
illnesses, but he also has exercise-induced symptoms

He has three dogs and a cat in his father’s house and a cat in his mother’s house
He has required 5-6 steroid courses a year and was recently diagnosed with iatrogenic adrenal

insufficiency secondary to his recurrent steroid courses

He is currently maintained on ICS-formoterol, tiotropium, nasal fluticasone, and oral cetirizine, and has
been found to have good adherence and technique with inhaled ICS-formoterol

Patrick was worked up for obstructive sleep apnea which was found to be negative

Significant weight gain associated with steroid use and met with dietitian to discuss healthy weight
management

What should be done now?

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40. Patient Case: Patrick, an 11-Year-Old Boy

Patrick began dupilumab and after 3 months showed marked improvement in asthma

control

He no longer requires oral steroids and has been able to step down on controllers and
stopped tiotropium

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41. Patient Case: Carlos, a 6-Year-Old Boy

In the past year, Carlos has had approximately one course of oral steroids a month for
viral-induced symptoms

Carlos has had four ED visits in the last year

He was previously found to be dog sensitized > his family rehomed his dog but

symptoms persisted

He was treated with high-dose ICS-LABA therapy and inhaled tiotropium

He has had significant weight gain with the steroid courses

He demonstrated good technique and pharmacy records shows appropriate adherence
What should be done now?

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42. Patient Case: Carlos, a 6-Year-Old Boy

After further testing, which showed high IgE and perennial aeroallergen sensitization,

Carlos was begun on omalizumab

Carlos showed improved asthma control 4 months later and no exacerbations or ED
visits occurred

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43. Summary

The referral of patients with asthma to specialty care occurs suboptimally,

particularly for children

+ Differentiating between difficult-to-treat and severe asthma is a key step in
recognizing when to refer to specialty care

Important advances in treatment include new understanding of
+ The heterogeneity of moderate-to-severe asthma
« The identification of T2 airway inflammation as a key treatable trait

Anumber of highly specific and effective biologics that inhibit T2 inflammation
are now available for children with uncontrolled moderate-to-severe asthma
that can can significantly reduce asthma exacerbations

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