Biologic Therapy for CRSwNP: Exploring the Advanced Practice Provider’s Role in Patient Care

Chair and Presenter, Christine Franzese, MD, FARS, Jillian Bensko, PA-C, and Anju T. Peters, MD, MS, discuss chronic rhinosinusitis with nasal polyps in this CME/MOC/CC/AAPA/IPCE activity titled “Biologic Therapy for CRSwNP: Exploring the Advanced Practice Provider’s Role in Patient Care.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/CC/AAPA/IPCE information, and to apply for credit, please visit us at https://bit.ly/4gAe2nl. CME/MOC/CC/AAPA/IPCE credit will be available until May 25, 2026.

1. Biologic Therapy for CRSwNP

Exploring the Advanced Practice Provider’s Role
in Patient Care

Christine Franzese, MD, FARS Jillian Bensko, PA-C
Professor of Otolaryngology Division of Allergy and Clinical
Director of Allergy Immunology

University of Missouri Brigham and Women's Hospital
Columbia, Missouri Boston, Massachusetts

ai

Anju T. Peters, MD, MS

Professor of Medicine

Division of Allergy and Immunology
Northwestern University Feinberg
School of Medicine

Chicago, Illinois

Go online to access full CME/MOC/CC/AAPA/IPCE information, including faculty disclosures.

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2. Our Goals for Today

Improve your ability to recognize the signs, symptoms, and
impact of CRSwNP on patients

Equip you with strategies for determining which patients with
CRSwNP are most likely to benefit from targeted biologic therapy

+ Provide guidance on the use of targeted biologic therapy in
treatment plans for appropriately selected patients with CRSwNP

+ Enhance your ability to monitor response to biologic therapy
and inform management decisions of the care team

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3. Which Patients With CRSwNP Are
Candidates for Targeted Treatment?

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4. at Is Chronic Rhinosinusitis ?12
Inflammatory condition with multiple phenotypes

212-Week Duration of

22 Symptoms

4 : A + Nasal endoscopy
« Drainage (anterior, posterior, .
or both) — Drainage, mucosal edema,

or polyps
+ Sinus CT scan

— Inflammation of the
paranasal sinuses

+ Nasal congestion or obstruction
+ Facial pain/pressure/fullness
+ Decreased sense of smell

1. Rosenfeld RM eta toanngo! Head Neck Surg. 2015 2 sup 2) 51-539, 2. Oran RR el It Forum Alergy Fiol 2016 6 suppl 1) 822-8209 PeerView

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5. + ~14% of adults in the United States would meet symptom criteria
for CRS

+ Typical age at diagnosis: 40-60 years for CRSWNP
+ CRSwNP is more common in men (62%) than in women (38%)

- Although studies suggest women tend to have more
severe disease

PeerVi
1 Bach Get al JAsthme Ale 2021:4:127-14. 2. Chop his /eleryestanetverkergfeath-ezictreniorhnsisit-wahesa polyps. PeerView

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6. + Potential risk factors: asthma, aging, obesity

+ Common comorbidities: asthma, allergic rhinitis,
NSAID-exacerbated respiratory disease

+ Common symptom triggers: viruses, allergens, aspirin or NSAIDs

1. Bacher etal JAshme Men 2021:14:127-194, 2. Chop, hp lergyastanetvorkorgheat-ewctrenorhinesinuiiwilnnasl- papers PeerView

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7. CRSwNP: How to Establish Diagnosis!

In addition to subjective assessment, there must be objective
evidence of sinonasal inflammation and nasal polyps
on sinus CT scan and/or nasal endoscopy

CT: CRSwNP NP with mucinous debris NP and pus
1. Stevens Wet. J Alergy Gin mano Pac. 2016 585-572. PeerView

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8. Impact on QOL Is Higher in Patients With Greater Disease

Severity, Comorbidities, or Refractory Disease’?

in Pen
I Population norm MM CRS/NP (n = 355)" m CRS/NP with asthma (n = 135)" ME CRS/NP with N-ERD (n=
om ie

er 5.0
raat
60 En 22 29
a qe

Mean Score (SF-36)
Mean Score (SF-36)

o 0
Physical Component Summary Mental Component Summary Physical Component Summary Mental Component Summary

Patients with CRSWNP have significantly lower HRQOL compared w

population norms, and higher incidence of depression and anxiety

Number of patents observed. Clinically important ference (MID 22 points for Physical Component Summary score and 23 pois for Mental Component Summary score)
<P<05.+P<.01 P < 0001

A
1 khan At al Riot. 201955743351. 2 Kim etal. Oolayngel ead Meck Sug. 2019;145:19-918 PeerView

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9. Sleep Quality Disturbance and CRSWNP'

100.0%

93.1%
A total of 29 consecutive 90.0% ,
patients were enrolled and 80.0% 19.3%
their baseline sleep quality on
assessment were as follows 00%
60.0%
ESS of 7.9 (+ 4.5)
50.0%
ISI of 13.1 (£6.2) ds
PSQI of 9.2 (+ 3.7) 30.0% 24.1%
SNOT-22 sleep domain 20.0%
of 12.1 (+ 4.2) 10.0%
0.0% +
Patients With Patients With Insomnia Patients With Altered
Excessive Daytime (ISI >7) Sleep Quality (PSQI25)
Sleepiness (ESS >10)
1. Fe Set al. Am Alergy Asma Immunol 2024:1325975. PeerView

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10. Antibiotics

+ May be useful in treating infectious
exacerbations of CRSwNP but evidence
of clinically significant efficacy is lacking

>

Leukotriene modifiers (eg, montelukast)
may be helpful

Systemic steroids
+ Short-term use only due to
adverse effects

1 Rosenteld RM et al, folaryngo! Head Neck Surg. 2015;152'S1-539. 2 Rudmk et al. JAMA, 2015:314:926-938,
3 Stevens WW et J Alergy Cin Immunol Pract. 2016;4'565-572, 4. Leopold DA eta.) Alergy Gin Immunol 2019:143:126-134 65,

Ji 2
5 Kem RC ea Int Forum Alogy Pina 20188471461 View

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11. Sinus Surgery!

When Medical Treatment Is Unsuccessful

Goals of Surgery

+ Tailor to each patient Post-surgery
+ Decrease inflammatory load maintenance
+ Remove polyps therapy with

+ Make larger openings in sinus topical steroid

cavity to help deliver topical delivery
medication into sinus cavity

1. ain RB eta. fet Drug Resist. 20138114. PeerView

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12. rgery May Not Be a Cure for Nasal Polyps*®

+ Polyp recurrence can range from 10%-40%, and is more common in people
with comorbidities

— In older studies, polyp recurrence rates were:
> 6 months after surgery: 35%
> 12 months after surgery: 38%
> 18 months after surgery: 40%

+ Newer endoscopic approaches (eg, DRAF III, “reboot”) have reduced
2-year polyp recurrence rates to <10%

+ Type 2 inflammation is associated with more severe sinus disease and
symptoms and recurrence after surgery

1. Decende AS et al Laryngoscope. 2017:127550.555 2. Asha A etal Laryngoscope, 2018:128 1286-1282. PeerView
3.Bachert Cet al. J Alergy Oi Immunol. 2021,147.29-6,

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13. pe 2 Inflammatio!

+ CRSwNP is usually
characterized by
type 2 inflammation

+ Asthma has been
reported in 20%-60%
of patients with
CRSwNP

1. Huke KE etal Cin Exp Alergy. 2015.45320-346.2. Patel GB, Peters AT. J Alergy Cin Immuna Pret, 20208:1522:1531 7
3. Hakanssen Ke al PLOS One. 2015, 1000127228. PeerView

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14. atterns of Inflammatory Endotypes in CRS*

AILCRS CRSsNP CRSwNP

Ti single
T2 single

T3 single
TI mixed
TI mixed
T2 mixed
T1/28 mixed
Untypeable

21

AILCRS CRSSNP CRSwNP

go ie >paA Pe >

Mona Πra par

1. Stevens WH. J Alergy Clin Immunol Pret. 20197.2812-2820 25, PeerView

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15. 1. Hate KE et Cin Exp Aer 201545320948, 2. Patel GB el lJ Aergy Cn Immunol Pract. 2020818215. PeerView

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16. pe 2 Biologic Therapies Approved for CRSwNP

Target Drug Other Indications
Atopic dermatitis
Eosinophilic or oral corticosteroid-dependent asthma
IL-4/1L-13 Dupilumab: Eosinophilic esophagitis
= Age 12 y and older! Prurigo nodularis

Eosinophilic COPD
Chronic spontaneous urticaria

dl . Allergic asthma
IgE names > Chronic spontaneous urticaria
Age 18 y and older: Food allergy
e 3 Eosinophilic asthma
IL-5 Desert Eosinophilic granulomatosis with polyangiitis

Age 18 y and older? Hypereosinophilic syndrome

1. Dupsent (cuptumab) Preserbing Information. tps iu access data fda gowarugsatfsa_docs/abel 7022/76 1055s04401 pa
2 Klo (maizumab) resignation ps ww acess fe og So 202/100 62300 PeerView
‘Nucala (mepoizumab) Preserbing Information, ps ivr acces sal (da goverugeata_doce/abel2022/761 1228008, 125526501961 pe.

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17. Management Algorithm for Patients With CRSWNP!

Establish Diagnosis and Initial Management

Document subjective
symptoms severity

Cardinal symptoms: congestion,
decrease in smell, drainage, facial
pressure, QOL measures

Evidence of objective Start with intranasal steroid
findings sprays + consider short
(Anterior rhinoscopy, burst of oral steroids if
nasal endoscopy, or CT) not contraindicated

With persistence of

Reassess symptom response symptoms and evidence of
and objective evidence ldiesasa!
of disease with ; =
at least 4 wk of therapy (Consider allergy testing, ASA
challenge, CBC with diff, total IgE)

PD a

Escalation of Treatment (if refractory)

1. Han JK et al. nt Forum Afergy Rhinol 2021:11:1407-1416,

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18. Management Algorithm for Patients With CRSWNP! (Cont'd)

{Escalation of Treatment (if refractory) |

Majority of patients

z Post-operative management:
Sinus surgery Bi a

If symptoms persist or recur despi
post-operative topical steroid therapy (steroid irrigation, EDS-FLU, INS),
consider comprehensive (multispecialty) approach for management
(Shared decision-making approach)

1. Han JK ela Int Forum Atergy Rhino, 2021:11:1407-1416, PeerView

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19. Management Algorithm for Patients With CRSwNP' (Cont’d)

Escalation of Treatment (ifrefractory) |

Majority of patients

Post-operative management:
Saline imigaion, steroid irigation, INS
EDS-FLU, steroid sinus implant

If symptoms persist or recur despite appropriate sinus surgery and
y (steroid irrigation, EDS-FLU, INS),

post-operative topical steroid ther:
consider comprehensive (multispecialty) approach for management
(Shared decision-making approach)

gi for ASA desenetizaton constar
patents Zins || Revision are surta || ar

nn || a eee nun, || set

(eg, asthma) td (if no contraindication) pl steroids

Persistent disease

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1. Han Jk etal. nt Forum Alergy Rhino. 2024:11:1407-1416,
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20. Management Algorithm for Patients With CRSWNP! (Cont’d)

| _ Escalation of Treatment (if refractory)

Majority of patients

Post-operative management:
Saline imigation, steroid irrigation, INS,
EDS-FLU, steroid sinus implant

If symptoms persist or recur despite appropriate sinus surgery and
post-operative topical steroid therapy (steroid irrigation, EDS-FLU, INS),
consider comprehensive (multispecialty) approach for management
(Shared decision-making approach)

patients incleated || Reviston || Aou || sterom || ‚hörtdurse
‘comorbidities a with AERD ps || Not oral
(eg. asthma) ‘gery Jl dfno contraindication) la sterolds

4 T H

<=

1. Han JK eta. nt Forum Alergy Rhinol. 2024:11:1407-1416,

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Contraindication to surgery

Poorly controlled asthma
despite standard therapy/
OCS-dependent asthma

Declined surgery
(Shared decision-making process)

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21. Case Study/Practicum

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22. Rose: A 26-Year-Old Wo

+ 24 years old -> “Really bad cold” and persistent nasal congestion

+ 25 years old -> Diagnosis of asthma, continued congestion, lost sense of
smell and taste, ICU admission for asthma exacerbation

- Frequent episodes of dyspnea, wheezing, and cough;
initially treated with ICS/LABA and SABA 3-4 diwk, zileuton,
steroid sprays, cetirizine

+ 25 years old > Saw ENT surgeon, was “full of polyps,” had first polyp
surgery (great improvement!), but polyps returned in 6 months

- Now — Albuterol 3-4 d/wk, no sense of smell, antibiotics for sinusitis
2-3 times a year, polyps are back (3/4 bilaterally)

+ 26 years old — Prior to repeat surgery > 2 tablets of ibuprofen (400 mg);
2 h later, “really bad breathing problems,” wheezing, flushing, runny nose >
to ER for albuterol and IV steroids

— Oral challenge > Positive; same reaction

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O.
==

and blood recurrence

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23. Rose: A 26-Year-Old Wo

+ 26 years old — Second polyp surgery (great improvement!)

— Surgical path: polypoid edematous respiratory mucosa, marked
eosinophilic infiltrate (eos >100/hpf)

- BAL with 34% eosinophils

— ASA desens and intranasal budesonide post-op ‘ana py nam. vant pope enced
2010 Oranscham.N ws
+ 26 years old > ER visit for asthma exacerbation (3 months post-op)
~ ACT score 8, 3 OCS tapers, FEV, of 1.84 L (60% of predicted)
— Polypoid changes <3 months, SNOT-22 61, hyposmia
= CT scan, homogeneous pansinusitis with NP

- Peripheral eos 1.6 k/mcL

- Current meds: zileuton, beclomethasone, prednisone,

fexofenadine, aspirin 325 mg BID, and albuterol A
ds ds PeerView

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24. Identifying Patients Who May Be Candidates for Biologic

Therapy for CRSwNP: Updated EPOS/EUFOREA Criteria’

Presence of bilateral polyps in patient who had ESS*

J THREE criteria are required

t-Off Points

Tissue eos 210/hpf
or
Evidence of type 2 inflammation Blood eos 2150
or
Total IgE 2100
Need for systemic corticosteroids or 2 TE
contraindication to systemic steroids Laing rn ES monte) bce erates
Significantly impaired quality of ife SNOT-22 240

Anosmic on smell test

Significant loss of smell acte depending ón tae

In case of asthma: regular need

Diagnosis of comorbid asthma ion: de

"con cramsances east ter su vi
Fes VO tu rs STAR PeerView

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25. Practical Considerations in the Use
of Biologic Treatment for CRSwNP

What Does an Advanced Practice Provider Need

to Know and Do?

26. Importance of Multidirectional Communication and
Collaboration in Patient Care

+ Among specialties
(eg, ENT, pulmonology,
allergy/immunology,
and the patient's primary
care provider)

Allergy/immunology

Primary care

« Among professions, with a
focus on the specific role of
advanced practice providers in
CRSwNP management

+ Between clinician and patient

Advanced practice
providers

Pulmonology

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27. Engaging

Steps
Invite patient to participate
Present options
Provide information on benefits and risk
Assist patient in evaluating options
Facilitate deliberation and decision-making

Assist with implementation

«EEE

1. Butervrt JE tal Br J Gen Pret 201464709718. 2 ps pracicemmoraon rs unessrred decis main. PeerView

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28. gaging Patients in red Decisi

Topics to Discuss

Medications
Surgery
Comorbidities

Shared decision-making has a significant
impact on the patient's
psychological well-being, adherence, and
confidence in the provider

Symptoms
QOL
Adherence
Cost

1. Buterorh Æ etal. Er Gen Prac. 2044 4705-2710. 2 Mps precisos opresouces/sared-ecsn aking. PeerView

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29. Dupilumab: Efficacy and Safety in Patients
With CRSwNP Over 52 Weeks!

Dupilumab Treatment (300 mg) vs Placebo Significantly Improved NPS and NC Score in
the ITT Population Over the 52-Week Treatment Period?

Dupilumab vs Placebo Reduced NPS
With Nominal Significance at Week 4,
Continued to Week 52

Dupilumab 300 mg Q2W-Q4W

LS Mean Change

From Baseline + SE
ES
LS Mean Change
From Baseline + SE

Dupilumab vs Placebo Reduced NC
Score With Nominal Significance
at Week 4, Continued to Week 52

02
04

06 Placebo
08 Dupilumab 300 mg Q2W

Dupilumab 300 mg Q2W-Q4W

15
2.0
Dupilumab 300 mg Q2W
25
0 4 8 6 2 40 52
Time, wk

2 P< 0001 for duplumab vs plac
1. Bacher Cet al. Lancet. 2019.394.1838-1650.

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ebo, P < 0001 for duplumab 300 mg GA and 300 mg Q2W-CAW vs placebo at al me pots.

0 4 8 12 16 20 24 28 32 36 40 44 48 52
Time, wk

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30. Dupilumab: Impact on Steroid Use, Surgery,
d Asthma Symptoms’

Time to First Systemic Corticosteroid Use or Nasal Polyp Surgery
During the Treatment Period: Pooled Analysis

80

HR = 0.243 (95% CI, 0.169-0.351)

® P< 0001
¿o
€
E
& 0
2
$ Dupilumab Q2W
¿>
3
0
BL 4 6 12 16 20 24 28 32 36 40 44 48 82
Treatment Period, wk
1. Bacher etal. Lancet 2018,308:1636-4650, PeerView

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31. ng Response to Biologic Therapy in CRSwNP*

+ Reduced nasal polyp size

+ Improved quality of life
+ Improved sense of smell No response
+ Reduced impact of comorbidities

Evaluation of five criteria Good to excellent response
4-5 criteria

+ Reduced need for systemic oral corticosteroids Poor to moderate response

I

Evaluate treatment response after 6 months

if no response to

COW FS em

J Discontinue treatment

Evaluate treatment response after 1 year any of the criteria

1. Fokkers Wet al Rhinology. 2023.1:194:202.

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32. Therapeutic Effects of Dupilumab in CRSwNP
Sustained Over 3 Years!

1444 m =
ét |

‘Severe CRSWNP
n=1

36 mo

Sustained nn Effect After 3 Years of Continued Dupilumab Treatment}

y —_ SSIT-12 70 —SNOT-22 100 EUFOREA23—Res] one
/ \ I Poor moderate
E Goodencelent

ar eT (SS we OSS a em De 12 18 24 0 %
Time, mo Time, mo Time, mo Time, mo
1. Huber Peta. logy 2026703108911 PeerView

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33. Sleep Quality Disturbance and CRSwNP:

After Treatment With Dupilumab?

mBaseline After 1 Month After 3 Months

100.0%
A total of 29 consecutive pul
patients were enrolled, soe
and their baseline sleep 800% 23%
quality assessment were 69.0%
as follows RR ==]
600%
ESS of 7.9 (+ 4.5) 51.7% eae
50.0% 7
ISI of 13.1 (+ 6.2)
( 400% 37.9%
E 9.2 (+
PSQI of 9.2 (+ 3.7) 30.0% six
SNOT-22 sleep 20.0% 172%
domain of 12.1 (+ 4.2)
10.0% 6.9%
om Ei m | E
Patients With Excessive — Patients With Insomnia (ISI >7) Patients With Altered Sleep
Daytime Sleepiness (ESS >10) Quality (PSQI25)
1. Fon Seta An Alergy Aime Immun 20241928975, PeerView

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34. Omalizumab: Long-Term Efficacy and Safety!

24 Weeks

POLYP 1 Placebo (n = 66)

POLYP 2 Placebo (n = 65)

Mean Change From Baseline in NPS.

Continued omalizumab (n = 123) Switched to omalizumab (n = 126)
—=—On omalizumab = On omalizumab

Om:

umab (n = 72)

Open-Label Extension
Omalizumab continued for 52 weeks (n = 124)
Follow-up for
24 weeks

o to omalizumab for 28 weeks (n =

Mean Change From Baseline in NCS
Continued omalizumab (n = 123) Switched to omalizumab (n = 126)

== On omalizumab + On omalizumab
== Off omalizumab =~ Off omalizumab
000, — —

„Off omalizumab == Off omalizumab
T

as
040
ss
080
ass

Mean Change
From Baseline

140

8 “on
POLYP 1and OLE follow-up
POLwP2? | peros E period
(Omazumab Omalzumab
initiation in hose discontinuation
switching treatment inall patients

1. Gevaeıt Peta. J Alergy Cin Immunol. 2022:149:957:265..

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‘Mean Change
From Baseline

025
050
075
400
125 H
0 4 8 12 16 20.24 28 32 36 40 44 48 dh 56 60 64 68 72 76
Time, wk
OLE treatment
period

OLE follow-up

period
Omalzumab
discontinuation
in al patients

POLYP 1 and
POLYP 2

Omalzumab
initiation in those
‘switching treatment

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35. + SYNAPSE follow-up: Clinical improvements were partially evident 12 weeks after

discontinuation, despite blood eosinophil counts returning to bas

Change From Baseline in NPS in Overall Follow-Up Population

os H

Mean (95% Cl) Change From Baseline in NP
Score in All Patients in the Follow-Up Period

Wek 3 8 12 16 20 2 2 40 4 52 so 76
Treatment Period Follow-Up Period

1. Derosiers Metal. nt Forum Alergy Rhino. 2024:14:18-31.

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eline

Placebo (n = 65)

52 weeks of mepolizumab
100 mg SC (n= 69)

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36. Omalizumab Mepolizumab

+ Significant + Significantly reduced
improvements in need for surgery
Clinical and patient- Improvement in

reported outcomes symptom severity,
More effective than regardless of presence
placebo even in of AERD or comorbid
patients with high asthma

eosinophil levels or

with a history of

surgery for CRSWNP

1, Papacharamposs GX tal nt Forum Ay Ral 20241456108 aan
2 Barroso Beta Y Imeslg Algo! Cin Immunol. 202533419490. PeerView

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37. Return to Patient Case

Rose: Treatment Decision

+ 6 months post-op — Polyp regrowth (3/4 bilaterally), anosmia

+ Initiated treatment with dupilumab 300 mg/2 mL biweekly

3-months >

+ Peripheral eos
0.60 k/meL

+ SNOT-22 of 20, FEV,
80%

+ JA polyp score bilaterally

6-months >

+ Endoscopy; mild polypoid
edema at frontal recess
and skull base

+ Regained sense of smell
+ NoOCS

Currently >

+ No revision surgeries;
4 years on dupilumab!

Sense of smell and
taste intact

Endoscopy: evidence of
prior sinus surgery, middle
turbinate, middle meatus,
superior meatus normal
without polyps

Polyp score is 0 bilaterally!

ACT Score 24

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38. EVEREST Trial: Compari ilumab and Omalizumab in

Patients With Comorb SwNP and Asthma‘

Phase 4 trial: EValuating trEatment RESponses of Dupilumab Versus
Omalizumab in Type 2 Patients (EVEREST)

+ First head-to-head trial comparing biologics for efficacy and safety in patients with
CRSwNP and asthma

+ Primary endpoints: reduction in polyp size, improvement in sense of smell
+ Study recruitment completed
+ Anticipated primary completion date: January 2025

1. Mos Jcnicalialsgovistad NCTO4998604, 2. De Prado Gomez Let al Am J Rhinol Allızy. 2022.36788:708. PeerView

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39. pies for CRSwNP12

Agen Results and/or Estimated Completion Date

Both studies met the coprimary endpoints and improved
total endoscopic NPS at 52 weeks as well as mean
nasal obstruction score from weeks 49-52

Depemokimab (IL-5)
(ANCHOR-1 and -2)

Both coprimary endpoints were met and showed a

Tezepelumab (TSLP) statistically significant and clinically meaningful reduction
(WAYPOINT) in NPS size and reduced nasal congestion compared
to placebo
1. Gevet ell Lorca 2025 405911626 2. pm eM Eng ed 2025924178: PeerView

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40. CRSwNP is associated with substantial discomfort and negative impact on QOL

The condition can be refractory to traditional medical and surgical treatment

CRSwNP is usually characterized by type 2 inflammation; asthma is a common comorbidity

3
3
EY
<

Considerations for determining whether a patient is a candidate for biologic treatment

include CRSWNP severity and degree of control with other treatment approaches, as well
as presence of comorbidities

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