Biologics in CRSwNP: Putting a Paradigm Shift Into Practice
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About This Presentation
Co-Chairs, Joseph K. Han, MD, and Seth J. Isaacs, MD, discuss chronic rhinosinusitis with nasal polyps in this CME/MOC/CC/AAPA/IPCE activity titled “Biologics in CRSwNP: Putting a Paradigm Shift Into Practice.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/CC/AAPA/I...
Slide Content
Biologics in CRSwNP
Putting a Paradigm Shift Into Practice
Joseph K. Han, MD Seth J. Isaacs, MD
Professor, Eastern Virginia Medical School Medical Director Otolaryngology
Vice Chair, Department of Otolaryngology - TriHealth
Head and Neck Surgery Chief of Otolaryngology
Chief, Division of Rhinology and Endoscopic Good Samaritan Hospital
Sinus-Skull Base Surgery Cincinnati, Ohio
Chief, Division of Allergy
ARS, Past President
AAAAI, RROAC, Past Chair
Norfolk, Virginia
Go online to access full CME/MOC/CC/AAPA/IPCE information, including faculty disclosures.
Copyright © 2000-2024, PeerView
Putting a Paradigm Shift Into Practice
Joseph K. Han, MD Seth J. Isaacs, MD
Professor, Eastern Virginia Medical School Medical Director Otolaryngology
Vice Chair, Department of Otolaryngology - TriHealth
Head and Neck Surgery Chief of Otolaryngology
Chief, Division of Rhinology and Endoscopic Good Samaritan Hospital
Sinus-Skull Base Surgery Cincinnati, Ohio
Chief, Division of Allergy
ARS, Past President
AAAAI, RROAC, Past Chair
Norfolk, Virginia
Go online to access full CME/MOC/CC/AAPA/IPCE information, including faculty disclosures.
Copyright © 2000-2024, PeerView
Our Goals for Today
Recognize the clinical characteristics of CRSwNP and the overlap
with other type 2 inflammatory disorders
Determine which patients with CRSwNP may be candidates
for biologic therapy
Collaborate with care team members to use biologics in the
TT management of CRSWNP
Monitor patients during treatment with biologics, to assess
—
response and inform future management
PeerView.com/AMJ827
Recognize the clinical characteristics of CRSwNP and the overlap
with other type 2 inflammatory disorders
Determine which patients with CRSwNP may be candidates
for biologic therapy
Collaborate with care team members to use biologics in the
TT management of CRSWNP
Monitor patients during treatment with biologics, to assess
—
response and inform future management
PeerView.com/AMJ827
Defining and Classifying CRSwNP in the
Context of Type 2 Inflammatory Disorders
Joseph K. Han, MD
Professor, Eastern Virginia Medical School
Vice Chair, Department of Otolaryngology Head and Neck Surgery
Chief, Division of Rhinology and Endoscopic Sinus-Skull Base Surgery
Chief, Division of Allergy
ARS, Past President
AAAAI, RROAC, Past Chair
Norfolk, Virginia
Copyright © 2000-2024, PeerView
Context of Type 2 Inflammatory Disorders
Joseph K. Han, MD
Professor, Eastern Virginia Medical School
Vice Chair, Department of Otolaryngology Head and Neck Surgery
Chief, Division of Rhinology and Endoscopic Sinus-Skull Base Surgery
Chief, Division of Allergy
ARS, Past President
AAAAI, RROAC, Past Chair
Norfolk, Virginia
Copyright © 2000-2024, PeerView
What Is Chronic Rhinosinusitis ?12
Inflammatory condition with multiple phenotypes
212-Week Duration of Inflammation
22 Symptoms 21 Objective Criteria
A 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 etal. Otolanygol Head Neck Surg. 2015.152(supp! 2) 51-539. 2. Orlandi RR et al. In Forum Alergy Rhinol. 20166 supp 1525209. PeerView.com
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Inflammatory condition with multiple phenotypes
212-Week Duration of Inflammation
22 Symptoms 21 Objective Criteria
A 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 etal. Otolanygol Head Neck Surg. 2015.152(supp! 2) 51-539. 2. Orlandi RR et al. In Forum Alergy Rhinol. 20166 supp 1525209. PeerView.com
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CRSwNP Diminishes Quality of Life!
Patients with CRSwNP report significant impairment of QOL
in both physical and emotional domains
Emotional/Sleep
Nasal Symptoms Ear Symptoms Symptoms
+ Blockage/congestion + Ear congestion and pain |» Anxiety and depression
+ Rhinorrhea, postnasal |» Pressure + Difficulty with sleep >
drip daytime fatigue
+ Loss of senses of smell
and taste
+ Cough, aggravation
of asthma
1. Schneider S et al. Gin Med. 20209:925, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Patients with CRSwNP report significant impairment of QOL
in both physical and emotional domains
Emotional/Sleep
Nasal Symptoms Ear Symptoms Symptoms
+ Blockage/congestion + Ear congestion and pain |» Anxiety and depression
+ Rhinorrhea, postnasal |» Pressure + Difficulty with sleep >
drip daytime fatigue
+ Loss of senses of smell
and taste
+ Cough, aggravation
of asthma
1. Schneider S et al. Gin Med. 20209:925, PeerView.com
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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 al. J Allergy Cin Immunol Pract 2016:4:565-572 PeerView.com
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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 al. J Allergy Cin Immunol Pract 2016:4:565-572 PeerView.com
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CRS: Classification!
+ High tissue eosinop! Th2-predominant inflammation
mu 80% CRS without nasal polyps
ilic infiltration
+ Th1-predominant inflammation, less eosinophi
Past reactions to any NSAIDs should be
(Gm evaluated for possible diagnosis of AERD
1. Han Jk. Layngoscope. 2013:1231suppl 2:15:27. 2. Benjamin MR tal. J Allergy Cin Immunol Prat. 20197:1010-1016. e
3. Gain RB et al Infect Drug Resist 20158:1-14 PeerView.com
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+ High tissue eosinop! Th2-predominant inflammation
mu 80% CRS without nasal polyps
ilic infiltration
+ Th1-predominant inflammation, less eosinophi
Past reactions to any NSAIDs should be
(Gm evaluated for possible diagnosis of AERD
1. Han Jk. Layngoscope. 2013:1231suppl 2:15:27. 2. Benjamin MR tal. J Allergy Cin Immunol Prat. 20197:1010-1016. e
3. Gain RB et al Infect Drug Resist 20158:1-14 PeerView.com
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Prevalence of Type 2 Inflammatory Comorbidities:
Focus on Asthma!
Up to 65% of patients with CRSwNP have comorbid asthma in
some studies
+ Prevalence of asthma in the general US population is 8.5%
+ CRSwhP tends to be associated with adult-onset asthma, rathe:
childhood-onset asthma
1.Bachert Cet al. J Asthma Allorgy. 2021:14:127-134.2. Wang M et al. Clin Tans! Alergy. 2020:10:2. er
3.Laglaw TM et al J Alergy Cin Immunol Pract. 2021.9:1139-1141, eerView.com
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Focus on Asthma!
Up to 65% of patients with CRSwNP have comorbid asthma in
some studies
+ Prevalence of asthma in the general US population is 8.5%
+ CRSwhP tends to be associated with adult-onset asthma, rathe:
childhood-onset asthma
1.Bachert Cet al. J Asthma Allorgy. 2021:14:127-134.2. Wang M et al. Clin Tans! Alergy. 2020:10:2. er
3.Laglaw TM et al J Alergy Cin Immunol Pract. 2021.9:1139-1141, eerView.com
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Which Therapy for Which Patient?
Identifying Patients Who May Benefit
From Biologic Treatment for CRSwNP
and Its Common Comorbidities
Joseph K. Han, MD
Professor, Eastern Virginia Medical School
Vice Chair, Department of Otolaryngology Head and Neck Surgery
Chief, Division of Rhinology and Endoscopic Sinus-Skull Base Surgery
Chief, Division of Allergy
ARS, Past President
AAAAI, RROAC, Past Chair
Norfolk, Virginia
Copyright © 2000-2024, PeerView
Identifying Patients Who May Benefit
From Biologic Treatment for CRSwNP
and Its Common Comorbidities
Joseph K. Han, MD
Professor, Eastern Virginia Medical School
Vice Chair, Department of Otolaryngology Head and Neck Surgery
Chief, Division of Rhinology and Endoscopic Sinus-Skull Base Surgery
Chief, Division of Allergy
ARS, Past President
AAAAI, RROAC, Past Chair
Norfolk, Virginia
Copyright © 2000-2024, PeerView
Type 2 Inflammation: CRSwNP Pathophysiology’
CRSWNP is usually
characterized by
type 2 inflammation
Asthma has been
reported in 26%-48%
of patients with
CRSwNP
1. Hulse KE et al. Gin Exp Allorgy. 2015,45:328:346. 2. Patel GB, Peters AT. JACI in Practice, 2020;8:1522-1531, PeerView.com
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CRSWNP is usually
characterized by
type 2 inflammation
Asthma has been
reported in 26%-48%
of patients with
CRSwNP
1. Hulse KE et al. Gin Exp Allorgy. 2015,45:328:346. 2. Patel GB, Peters AT. JACI in Practice, 2020;8:1522-1531, PeerView.com
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Targeting Key Proximal Drivers in Type 2 Inflammation
gens sac ease
: Le
Corticosteroids ettectve
Dendie cet THO cel
* Severe asthma, atopic dermatiis, chronic hinosinusitsnasal polyps, eosnophiic esophagts, and prurgo nodular. :
1. Gandhi NA et al. Nat Rev Drug Discov. 2016:15:36-50. PeerView.com
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gens sac ease
: Le
Corticosteroids ettectve
Dendie cet THO cel
* Severe asthma, atopic dermatiis, chronic hinosinusitsnasal polyps, eosnophiic esophagts, and prurgo nodular. :
1. Gandhi NA et al. Nat Rev Drug Discov. 2016:15:36-50. PeerView.com
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Traditional Treatment Approaches to CRSwNP15
es
+ 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. Rosenfield RM et al. Otolaryngol Head Neck Surg. 2015:152:51-530. 2. Rudmik Let al JAMA, 2015:314:026-030.
23. Stevens WW et al. J Allrgy Cin Immunol Pract. 2016 4:585-572. 4. Leopold DA et al. J Allrgy Clin Immunol, 2019,143:128-134.e6
5. Kem RC etal. Int Forum Allergy Rhinol. 2018:8:471-481. PeerView.com
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es
+ 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. Rosenfield RM et al. Otolaryngol Head Neck Surg. 2015:152:51-530. 2. Rudmik Let al JAMA, 2015:314:026-030.
23. Stevens WW et al. J Allrgy Cin Immunol Pract. 2016 4:585-572. 4. Leopold DA et al. J Allrgy Clin Immunol, 2019,143:128-134.e6
5. Kem RC etal. Int Forum Allergy Rhinol. 2018:8:471-481. PeerView.com
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Oral Corticosteroids: Adverse Effects!
Neuopsyenlare
Osteoporosis Adverse Glaucoma/cataracts
Effects
Metabolic/fractures
Grow suppression
1. Del Pozo V eta. Front Immunol 2028:14:1310211. 2, Price DB et a. J Asthma Alergy. 2018:11:193-204. 3. David GE et al. Clin Ther 2022.44:1187-1202. PeerView.com
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Neuopsyenlare
Osteoporosis Adverse Glaucoma/cataracts
Effects
Metabolic/fractures
Grow suppression
1. Del Pozo V eta. Front Immunol 2028:14:1310211. 2, Price DB et a. J Asthma Alergy. 2018:11:193-204. 3. David GE et al. Clin Ther 2022.44:1187-1202. PeerView.com
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Sinus Surgery!
hen Medical Treatment Is Unsuccessful
Goals of Surgery
Tailor to each patient
Decrease inflammatory load
Remove eosinophils
Remove polyps
Make larger openings in sinus
cavity to help deliver topical
medication into sinus cavity
Postsurgery
maintenance
therapy
with topical
steroid delivery
1. Gain RB et a. Infect Drug Resist 2013:6:1-16 PeerView.com
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hen Medical Treatment Is Unsuccessful
Goals of Surgery
Tailor to each patient
Decrease inflammatory load
Remove eosinophils
Remove polyps
Make larger openings in sinus
cavity to help deliver topical
medication into sinus cavity
Postsurgery
maintenance
therapy
with topical
steroid delivery
1. Gain RB et a. Infect Drug Resist 2013:6:1-16 PeerView.com
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Surgery 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. DeConde AS et al Laryngoscope. 2017:127-550-555. 2. Asha A e al. Lonmgoscope. 2019; 120:1286-1202, —
3. Bachert Cet a. J Alergy in Immunol. 2021:147:208. PeerView.com
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+ 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. DeConde AS et al Laryngoscope. 2017:127-550-555. 2. Asha A e al. Lonmgoscope. 2019; 120:1286-1202, —
3. Bachert Cet a. J Alergy in Immunol. 2021:147:208. PeerView.com
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Type 2 Biologic Therapies Approved for CRSwNP
Indi
Target Drug oO ns
Atopic dermatitis; eosinophilic or oral
corticosteroid-dependent asthma;
= il jl
IL-4/IL-13 Dupilumab eosinophilic esophagitis;
prurigo nodularis
IgE Omalzumab? Allergic asthma; chronic
spontaneous urticaria; food allergy
Eosinophilic asthma; eosinophilic
IL-5 Mepolizumab? granulomatosis with polyangiitis;
hypereosinophilic syndrome
1. Dupixen (duplumab) Presebing Information. tps ww accessdata fda govldrogsatida_docs/abe/2022/76 10558044 pt.
2 Xoa omalaumao) Peserting formation. hips Ivor accesadata da govldnugatäa_docaJabe1202 10307085230 a
3 Nucala(mepoizumab) Prescriing Information, psu accessdata fé govlorugstida_docs/abel2022/761122s008,12552680190 pdt PeerView.com
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Indi
Target Drug oO ns
Atopic dermatitis; eosinophilic or oral
corticosteroid-dependent asthma;
= il jl
IL-4/IL-13 Dupilumab eosinophilic esophagitis;
prurigo nodularis
IgE Omalzumab? Allergic asthma; chronic
spontaneous urticaria; food allergy
Eosinophilic asthma; eosinophilic
IL-5 Mepolizumab? granulomatosis with polyangiitis;
hypereosinophilic syndrome
1. Dupixen (duplumab) Presebing Information. tps ww accessdata fda govldrogsatida_docs/abe/2022/76 10558044 pt.
2 Xoa omalaumao) Peserting formation. hips Ivor accesadata da govldnugatäa_docaJabe1202 10307085230 a
3 Nucala(mepoizumab) Prescriing Information, psu accessdata fé govlorugstida_docs/abel2022/761122s008,12552680190 pdt PeerView.com
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Dupilumab: Efficacy and Safety in Patients
With CRSwNP Over 52 Weeks!
Dupilumab Treatment (300 mg Q2W and 200 mg Q2W-Q4W) vs Placebo Significantly Improved NPS
and NC Score in the ITT Population Over the 52-Week Treatment Period
* P< 0001 fr duplumab vs placebo. P< 0001 for dupilumad 300 mg ZW and 300 mg Q2W-C4W ve placebo a al ime points, .
1 Bacher Cet a Lancet 2019,304:1638-1650, PeerView.com
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With CRSwNP Over 52 Weeks!
Dupilumab Treatment (300 mg Q2W and 200 mg Q2W-Q4W) vs Placebo Significantly Improved NPS
and NC Score in the ITT Population Over the 52-Week Treatment Period
* P< 0001 fr duplumab vs placebo. P< 0001 for dupilumad 300 mg ZW and 300 mg Q2W-C4W ve placebo a al ime points, .
1 Bacher Cet a Lancet 2019,304:1638-1650, PeerView.com
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Dupilumab: Impact on Steroid Use, Surgery,
and Asthma Symptoms’
Time to First Systemic Corticosteroid
Use or Nasal Polyp Surgery During
the Treatment Period: Pooled
Analysis
80
HR = 0.243 (95% Cl, 0.169-0.351)
P<.0001
60
40
20
Dupilumab Q2W
‘Cumulative Event Rate, %
o
BL 4 8 12 16 20 24 28 32 36 40 44 48 52
Treatment Period, wk
1. Bacher Cet al. Lancet 2019:304:1638-1050,
PeerView.com/AMJ827
Prespecified
Pooled
Asthma
Analyses
FEV, L
ACOS,
scale 0-6
Impact on Asthma Control
LS Mean Change From
Baseline at Week 24 (SE)
Pooled PBO | Pooled UP | LS Mean
With azw With | Difference
Comorbid | Comorbid | YSPBO
Asthma Asthma
(n=170) (n=258)
-0.07 (0.04) 0.14 (0.03) 021 <.0001
-0.02(0.07) — -0.84(0.06) -0.82 <.0001
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and Asthma Symptoms’
Time to First Systemic Corticosteroid
Use or Nasal Polyp Surgery During
the Treatment Period: Pooled
Analysis
80
HR = 0.243 (95% Cl, 0.169-0.351)
P<.0001
60
40
20
Dupilumab Q2W
‘Cumulative Event Rate, %
o
BL 4 8 12 16 20 24 28 32 36 40 44 48 52
Treatment Period, wk
1. Bacher Cet al. Lancet 2019:304:1638-1050,
PeerView.com/AMJ827
Prespecified
Pooled
Asthma
Analyses
FEV, L
ACOS,
scale 0-6
Impact on Asthma Control
LS Mean Change From
Baseline at Week 24 (SE)
Pooled PBO | Pooled UP | LS Mean
With azw With | Difference
Comorbid | Comorbid | YSPBO
Asthma Asthma
(n=170) (n=258)
-0.07 (0.04) 0.14 (0.03) 021 <.0001
-0.02(0.07) — -0.84(0.06) -0.82 <.0001
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Omalizumab: Long-Term Efficacy and Safety!
24 WEEKS OPEN-LABEL EXTENSION
Mean Change From Baseline in NPS Mean Change From Baseline in NCS
Cont ota» 129) Sut cam 12) Cond mm (123 Saeed atra 126)
Fe main ne Oro
POLYP 1 and OLE vostre OLEYotowp
POP? pomos poros
Olzumabivtaton Omsizumab
Innos sucio discontmuaten in
me pts
1. Gevaert Peta. J Alergy Gin Immunol. 2022:149:957-965 3, PeerView.com
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24 WEEKS OPEN-LABEL EXTENSION
Mean Change From Baseline in NPS Mean Change From Baseline in NCS
Cont ota» 129) Sut cam 12) Cond mm (123 Saeed atra 126)
Fe main ne Oro
POLYP 1 and OLE vostre OLEYotowp
POP? pomos poros
Olzumabivtaton Omsizumab
Innos sucio discontmuaten in
me pts
1. Gevaert Peta. J Alergy Gin Immunol. 2022:149:957-965 3, PeerView.com
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Mepolizumab: SYNAPSE Results!
Total Endoscopic NPS (Week 52) Nasal Obstruction VAS Score (Weeks 49-52)
Median difference (95% Cl)": -0.73 (-1.11 to -0.34); P< .001 Median difference (95% Cl)”: -3.14 (-4.09 to -2.18); P < 001
D Mepolizumab 100 mg SC M Placebo
0, 50 a
41 hd
40
: = *
E Ss ¢
go = Ë 2
= =
$ |z E a
ss 5
$ 20
“5 4 a
E o E a ye
4 10 8 ES u
he ° Il
o =,
>0 0 1 $ 3 4 25 >1 sist >1-3 >3-5 >5
Point Worsening Point Improvement Point Worsening Point Improvement
+ Median diferenc in change rom baseine for mepolzumab vs placebo estimated using quantile regression wi covariates of treatment group. geographic region,
baseline score, and lg, baseline BEC. P values based on Wicoron rank-sum test. a
1 Hopkins © et al ERS 2020. Abstract 4616. PeerView.com
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Total Endoscopic NPS (Week 52) Nasal Obstruction VAS Score (Weeks 49-52)
Median difference (95% Cl)": -0.73 (-1.11 to -0.34); P< .001 Median difference (95% Cl)”: -3.14 (-4.09 to -2.18); P < 001
D Mepolizumab 100 mg SC M Placebo
0, 50 a
41 hd
40
: = *
E Ss ¢
go = Ë 2
= =
$ |z E a
ss 5
$ 20
“5 4 a
E o E a ye
4 10 8 ES u
he ° Il
o =,
>0 0 1 $ 3 4 25 >1 sist >1-3 >3-5 >5
Point Worsening Point Improvement Point Worsening Point Improvement
+ Median diferenc in change rom baseine for mepolzumab vs placebo estimated using quantile regression wi covariates of treatment group. geographic region,
baseline score, and lg, baseline BEC. P values based on Wicoron rank-sum test. a
1 Hopkins © et al ERS 2020. Abstract 4616. PeerView.com
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Mepolizumab: Sustained Clinical Benefits
After Discontinuation
SYNAPSE follow-up: Clinical improvements were partially evident 12 weeks after
discontinuation, despite blood eosinophil counts returning to baseline’
10
Placebo (n = 65)
52 weeks of mepolizumab
100 mg SC (n= 69)
ange From Baseline in NP
Patients in the Follow-Up Period
Wee S812 16 2 2 3 0 48 52
60 se 7
Treatment Period Follow-Up Period
Change from baseline in NPS in overall follow-up population
1. Derosiers Metal. Int Forum Allergy Rhinol. 2024:14:18:31 PeerView.com
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After Discontinuation
SYNAPSE follow-up: Clinical improvements were partially evident 12 weeks after
discontinuation, despite blood eosinophil counts returning to baseline’
10
Placebo (n = 65)
52 weeks of mepolizumab
100 mg SC (n= 69)
ange From Baseline in NP
Patients in the Follow-Up Period
Wee S812 16 2 2 3 0 48 52
60 se 7
Treatment Period Follow-Up Period
Change from baseline in NPS in overall follow-up population
1. Derosiers Metal. Int Forum Allergy Rhinol. 2024:14:18:31 PeerView.com
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Comparing Biologics for CRSwNP Treatment:
Systematic Reviews
+ Lack of head-to-head trials and heterogeneity among published studies make comparisons difficult
+ Asystematic review of 37 eligible studies used indirect comparisons to answer the question which agent to select and why!
- Conclusion: All agents showed significant improvements in polyp size, sinus opacification, severity of symptoms, need for
surgery, and systemic corticosteroid use, but authors concluded that “dupilumab appeared to be the most beneficial agent,
in terms of primary and secondary outcomes”
+ Asystematic review of 36 eligible studies similarly examined impact on sense of smell?
= Conclusion: Dupilumab demonstrated improvement within 1 week, which was sustained for up to 52 weeks; omalizumab
improved sense of smell at 24 weeks but not to a clinically relevant degree; and mepolizumab improved sense of smell at
24 and 52 weeks, measured with a subjective scale
Mepolizumab
+ Significantly reduced need
for surgery
Improvement in symptom
Omalizumab Dupilumab
+ Significant improvements in + Significant improvements
clinical and patient-reported across all outcomes
‘outcomes Significant reduction in need
severity, regardless of
presence of AERD or
comorbid asthma
More effective than placebo for surgery and use of
even in patients with high systemic corticosteroids
eosinophil levels or with a Efficacy independent of
history of surgery for baseline eosinophil/igE
CRSwNP values or comorbidities
1. Papacharalampous GX et al. Int Forum Allergy Rhinol. 2026:14:96-108, el
2 Barroso Bet al J Investig Allrgal Cin Inmunel.2023:38:419-430, PeerView.com
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Systematic Reviews
+ Lack of head-to-head trials and heterogeneity among published studies make comparisons difficult
+ Asystematic review of 37 eligible studies used indirect comparisons to answer the question which agent to select and why!
- Conclusion: All agents showed significant improvements in polyp size, sinus opacification, severity of symptoms, need for
surgery, and systemic corticosteroid use, but authors concluded that “dupilumab appeared to be the most beneficial agent,
in terms of primary and secondary outcomes”
+ Asystematic review of 36 eligible studies similarly examined impact on sense of smell?
= Conclusion: Dupilumab demonstrated improvement within 1 week, which was sustained for up to 52 weeks; omalizumab
improved sense of smell at 24 weeks but not to a clinically relevant degree; and mepolizumab improved sense of smell at
24 and 52 weeks, measured with a subjective scale
Mepolizumab
+ Significantly reduced need
for surgery
Improvement in symptom
Omalizumab Dupilumab
+ Significant improvements in + Significant improvements
clinical and patient-reported across all outcomes
‘outcomes Significant reduction in need
severity, regardless of
presence of AERD or
comorbid asthma
More effective than placebo for surgery and use of
even in patients with high systemic corticosteroids
eosinophil levels or with a Efficacy independent of
history of surgery for baseline eosinophil/igE
CRSwNP values or comorbidities
1. Papacharalampous GX et al. Int Forum Allergy Rhinol. 2026:14:96-108, el
2 Barroso Bet al J Investig Allrgal Cin Inmunel.2023:38:419-430, PeerView.com
'eerView.com/AMJ827 Copyright © 2000-2024, PeerView
EVEREST Trial: Comparing Dupilumab and Omalizumab
in Patients With Comorbid CRSwNP 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. hpsesnicatvials gov/tucyNCTO4098604. fi
2. De Prado Gomez Let al Am J Rhinol Alergy. 2022:3688-795, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
in Patients With Comorbid CRSwNP 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. hpsesnicatvials gov/tucyNCTO4098604. fi
2. De Prado Gomez Let al Am J Rhinol Alergy. 2022:3688-795, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Additional Biologics in Phase 3 Trials for CRSwNP
Agent
Benralizumab
(ORCHID)!
Depemokimab
(ANCHOR-1)?
Depemokimab
(ANCHOR-2)?
Tezepelumab
(WAYPOINT)*
NCT Number
NCT04157335
NCT05274750
NCT05281523
NCT04851964
1. ps cinicalias govstudyiNCTOS157335. 2. ps ua cinicalrias govistudy NCTOS274750.
3 Mos us. cicalrals gov/tuoyNCTOS281523. 4. Ms ru: cinicalral gowstudyNCTOSES 1968
PeerView.com/AMJ827
Estimated Completion
10/2025
9/2024
8/2024
12/2024
PeerView.com
Copyright © 2000-2024, PeerView
Agent
Benralizumab
(ORCHID)!
Depemokimab
(ANCHOR-1)?
Depemokimab
(ANCHOR-2)?
Tezepelumab
(WAYPOINT)*
NCT Number
NCT04157335
NCT05274750
NCT05281523
NCT04851964
1. ps cinicalias govstudyiNCTOS157335. 2. ps ua cinicalrias govistudy NCTOS274750.
3 Mos us. cicalrals gov/tuoyNCTOS281523. 4. Ms ru: cinicalral gowstudyNCTOSES 1968
PeerView.com/AMJ827
Estimated Completion
10/2025
9/2024
8/2024
12/2024
PeerView.com
Copyright © 2000-2024, PeerView
Integrating Biologic Management Strategies
for CRSwNP in Real-World Clinical Care
Practical Guidance on Initiation and Ongoing Treatment
Seth J. Isaacs, MD
Medical Director Otolaryngology
TriHealth
Chief of Otolaryngology
Good Samaritan Hospital
Cincinnati, Ohio
Copyright © 2000-2024, PeerView
for CRSwNP in Real-World Clinical Care
Practical Guidance on Initiation and Ongoing Treatment
Seth J. Isaacs, MD
Medical Director Otolaryngology
TriHealth
Chief of Otolaryngology
Good Samaritan Hospital
Cincinnati, Ohio
Copyright © 2000-2024, PeerView
Identifying Patients Who May Be Candidates for Biologic
Therapy for CRSwNP: Updated EPOS/EUFOREA Criteria!
In
ation for Biological Treatment in CRSWNP
Presence of bilateral polyps in patient who had ESS*
J THREE criteria are required
Criteria Cut-Off Points
Tissue eos 210/hpf
or
Evidence of type 2 inflammation blood eos 2150
or
total IgE 2100
22 courses per year
or
long term (>3 months) low-dose steroids
Significantly impaired quality of life SNOT-22 240
Anosmic on smell test
(score depending on test)
Need for systemic corticosteroids or
contraindication to systemic steroids
Significant loss of smell
In case of asthma: regular need
PEC for inhaled corticosteroids
* Exceptional cicumstances excuded (eg, not or surgery) A
Y Fottene IO el a Rinlogy, 202361 194202 PeerView.com
Peerview.com/AMJ827 Copyright © 2000-2024, Peerview
Therapy for CRSwNP: Updated EPOS/EUFOREA Criteria!
In
ation for Biological Treatment in CRSWNP
Presence of bilateral polyps in patient who had ESS*
J THREE criteria are required
Criteria Cut-Off Points
Tissue eos 210/hpf
or
Evidence of type 2 inflammation blood eos 2150
or
total IgE 2100
22 courses per year
or
long term (>3 months) low-dose steroids
Significantly impaired quality of life SNOT-22 240
Anosmic on smell test
(score depending on test)
Need for systemic corticosteroids or
contraindication to systemic steroids
Significant loss of smell
In case of asthma: regular need
PEC for inhaled corticosteroids
* Exceptional cicumstances excuded (eg, not or surgery) A
Y Fottene IO el a Rinlogy, 202361 194202 PeerView.com
Peerview.com/AMJ827 Copyright © 2000-2024, Peerview
Determining When to Initiate Treatment With a Biologic’
Confirm diagnosis of uncontrolled, severe CRSWNP
Check for comorbidity (asthma, N-ERD) and
lt CRSwNP and Asthma
Check that type 2 inflammation is highly likely
Collaboration with an
Inform patient on treatment options, perspectives, asthma specialist is
and risks essential for the
indication and selection
Make decision on surgery or biologic drug with an
Loli of biologics
informed patient
Select biologic drug (note limitations applicable for
specific drugs)
1. Bacher et al. Alergy Cin Immunol. 2021:147:20-36. -eerView.com
1827 Copyright © 2000-2024, PeerView
Confirm diagnosis of uncontrolled, severe CRSWNP
Check for comorbidity (asthma, N-ERD) and
lt CRSwNP and Asthma
Check that type 2 inflammation is highly likely
Collaboration with an
Inform patient on treatment options, perspectives, asthma specialist is
and risks essential for the
indication and selection
Make decision on surgery or biologic drug with an
Loli of biologics
informed patient
Select biologic drug (note limitations applicable for
specific drugs)
1. Bacher et al. Alergy Cin Immunol. 2021:147:20-36. -eerView.com
1827 Copyright © 2000-2024, PeerView
Engaging Patients in Shared Decision-Making’
Steps Topics to Discuss
Invite patient to participate
Present options Medications
Ay ee is | : > = Surgery
Provide information on benefits and risk Comorbidities
m Symptoms
ssist patient in evaluating options
QOL
Facilitate deliberation and decision-making Adherence
ssist with implementation
Shared decision-making has a significant impact on the patient's psychological
well-being, adherence, and confidence in the provider
1. Butterworth JE et al. Br J Gen Pract 2014:04:2709-e718, 2, tps /practiceimnovations orgresouroesishared-deciion-making, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Steps Topics to Discuss
Invite patient to participate
Present options Medications
Ay ee is | : > = Surgery
Provide information on benefits and risk Comorbidities
m Symptoms
ssist patient in evaluating options
QOL
Facilitate deliberation and decision-making Adherence
ssist with implementation
Shared decision-making has a significant impact on the patient's psychological
well-being, adherence, and confidence in the provider
1. Butterworth JE et al. Br J Gen Pract 2014:04:2709-e718, 2, tps /practiceimnovations orgresouroesishared-deciion-making, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Monitoring Patients’ Response to Biologic Treatment:
6 Months!
Improvement of at least
‘one symptom/score
+ Sense of smell: from anosmia
to hyposmia/normosmia, smell
score increase 20.5
+ NCS: decrease by 20.5 or
objective testing
+ NPS: decrease by 21 by
nasal endoscopy
+ SNOT-22: reduction of 28.9
(minimal clinically important
difference)
+ VAS total symptoms:
reduction of 22 cm
Stop;
change to surgery or
another biologic drug
Salvage surgery under
biologic protection
Improvement not
acceptable to the patient
Additional short course
of systemic GCS
Continue with
biologic treatment
Improvement acceptable
to the patient
1. Bacher et al J Alergy Cin Immunol. 2021:147:20-36 PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
6 Months!
Improvement of at least
‘one symptom/score
+ Sense of smell: from anosmia
to hyposmia/normosmia, smell
score increase 20.5
+ NCS: decrease by 20.5 or
objective testing
+ NPS: decrease by 21 by
nasal endoscopy
+ SNOT-22: reduction of 28.9
(minimal clinically important
difference)
+ VAS total symptoms:
reduction of 22 cm
Stop;
change to surgery or
another biologic drug
Salvage surgery under
biologic protection
Improvement not
acceptable to the patient
Additional short course
of systemic GCS
Continue with
biologic treatment
Improvement acceptable
to the patient
1. Bacher et al J Alergy Cin Immunol. 2021:147:20-36 PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Monitoring Patients’ Response to Biologic Treatment:
12 Months!
Adequate response
(all of these definitions are fulfilled)
+ NPS <4 (total of both sides)
+ NCS <2
+ VAS total symptoms <5.
+ SNOT-22 score <30
Further, there should be
no current need for surgery
or systemic GCS
1. Bacher et al J Allergy Cin Immunol. 2021:147:20-36.
PeerView.com/AMJ827
Consider another
biologic drug
Surgery
Continue with
biologic treatment
PeerView.com
Copyright © 2000-2024, PeerView
12 Months!
Adequate response
(all of these definitions are fulfilled)
+ NPS <4 (total of both sides)
+ NCS <2
+ VAS total symptoms <5.
+ SNOT-22 score <30
Further, there should be
no current need for surgery
or systemic GCS
1. Bacher et al J Allergy Cin Immunol. 2021:147:20-36.
PeerView.com/AMJ827
Consider another
biologic drug
Surgery
Continue with
biologic treatment
PeerView.com
Copyright © 2000-2024, PeerView
Defining Response to Biologic Therapy in CRSwNP!
Defi
ing Response to Bi
logical Treatment in CRSWNP
Evaluation of five criteria Good - excellent response
+ Reduced nasal polyp size Tee
+ Reduced need for systemic oral corticosteroids Foor inoderata response
+ Improved quality of life
+ Improved sense of smell No response
\ + Reduced impact of comorbidities festa!
Discontinue treatment
if no response to
any of the criteria
Evaluate treatment response after 6 months
oa BS B
I
Evaluate treatment response after 1 year
1.Fokkens Ws etal. Rhinology. 2023:61:104-202. PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Defi
ing Response to Bi
logical Treatment in CRSWNP
Evaluation of five criteria Good - excellent response
+ Reduced nasal polyp size Tee
+ Reduced need for systemic oral corticosteroids Foor inoderata response
+ Improved quality of life
+ Improved sense of smell No response
\ + Reduced impact of comorbidities festa!
Discontinue treatment
if no response to
any of the criteria
Evaluate treatment response after 6 months
oa BS B
I
Evaluate treatment response after 1 year
1.Fokkens Ws etal. Rhinology. 2023:61:104-202. PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Current and Future Role of Imaging in CRSwNP!
CT Imaging
After 16 weeks of
Before treatment dupilumab treatment
+ Plays a role in determining need for
surgery, guiding surgery, and evaluating
response to medical treatment
+ CT remains the gold standard for
objective involvement; MRI complements
diagnosis, particularly in cases of soft
tissue involvement or complications
+ Radiomics using Al algorithms shows
promise as a tool for quantitative
image analysis, with possible insights
into CRSWNP endotypes and
personalized therapy
1. Poto Ret at. Curr Opin Aleray Cin Immunol 2024 Jan 11 [Epub ahead of print PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
CT Imaging
After 16 weeks of
Before treatment dupilumab treatment
+ Plays a role in determining need for
surgery, guiding surgery, and evaluating
response to medical treatment
+ CT remains the gold standard for
objective involvement; MRI complements
diagnosis, particularly in cases of soft
tissue involvement or complications
+ Radiomics using Al algorithms shows
promise as a tool for quantitative
image analysis, with possible insights
into CRSWNP endotypes and
personalized therapy
1. Poto Ret at. Curr Opin Aleray Cin Immunol 2024 Jan 11 [Epub ahead of print PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Ethnic/Geographic Differences May Affect
Response to Biologics in CRSwNP'2
+ Th cytokine levels, eosinophilic/neutrophilic patterns, and SE-specific
IgE expressions show extreme diversity among patients with CRS
from Europe, Asia, and Oceania
+ Patients with CRS from Asian regions may be less susceptible to
Th2-mediated disease than patients from European regions, possibly
due to a combination of genetic and environmental factors
— NP tissue was eosinophilic in 27% of Asian patients versus 65%
of White patients with CRS
4. Wang X et a. J Alergy Cin Immunol. 2016:138:1344-1353. 2. Mahdaviia Metal. J Alergy Cin Immuno. 2015:135:576-579 PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Response to Biologics in CRSwNP'2
+ Th cytokine levels, eosinophilic/neutrophilic patterns, and SE-specific
IgE expressions show extreme diversity among patients with CRS
from Europe, Asia, and Oceania
+ Patients with CRS from Asian regions may be less susceptible to
Th2-mediated disease than patients from European regions, possibly
due to a combination of genetic and environmental factors
— NP tissue was eosinophilic in 27% of Asian patients versus 65%
of White patients with CRS
4. Wang X et a. J Alergy Cin Immunol. 2016:138:1344-1353. 2. Mahdaviia Metal. J Alergy Cin Immuno. 2015:135:576-579 PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
What We Still Need to Know About Biologic Use
in CRSwNP, According to EPOS/EUFOREA!
Unmet Needs Plan to Address
Identify biomarkers related to CRSWNP
disease activity
Well-designed RCT and/or real-life
data studies
Biomarkers to identify responders to biologics
Duration of therapy
Definition of remission Real-world data and registries
Criteria for switching Real-world data and registries
Feasibility of prolonging dosing intervals Real-world data and registries
Positioning of biologics in the treatment pathway Well-designed RCT and/or real-life
(eg, surgery vs biologics, surgery + biologics) data studies
1. Fokkens Ws et al. Rhinology. 2023:61:194-202, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
in CRSwNP, According to EPOS/EUFOREA!
Unmet Needs Plan to Address
Identify biomarkers related to CRSWNP
disease activity
Well-designed RCT and/or real-life
data studies
Biomarkers to identify responders to biologics
Duration of therapy
Definition of remission Real-world data and registries
Criteria for switching Real-world data and registries
Feasibility of prolonging dosing intervals Real-world data and registries
Positioning of biologics in the treatment pathway Well-designed RCT and/or real-life
(eg, surgery vs biologics, surgery + biologics) data studies
1. Fokkens Ws et al. Rhinology. 2023:61:194-202, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, Peerview
Phase 4 Trials Assessing Biologic/Surgical Combinations:
Mepolizumab
52-week, 3-arm trial! comparing
effects of Primary outcome: Change in SNOT-22 score
+ Mepolizumab alone Secondary outcomes: Change in polyp severity
+ In-office polypectomy alone on VAS, change in NPS, symptom
+ Mepolizumab + in-office improvement, and need for rescue systemic
polypectomy corticosteroid use
52-week, 2-arm trial? comparing
effects of
+ Mepolizumab alone Primary outcome: Change in SNOT-22 score
Mepolizumab + functional Secondary outcomes: Change in NPS, ACQ,
endoscopic sinus surgery 2 weeks and FEVI
post first mepolizumab injection
1. htpsetinicatials govistudyiNCTOS923047. 2. ps www clnicaiials govistudyINCTOSS98B14, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Mepolizumab
52-week, 3-arm trial! comparing
effects of Primary outcome: Change in SNOT-22 score
+ Mepolizumab alone Secondary outcomes: Change in polyp severity
+ In-office polypectomy alone on VAS, change in NPS, symptom
+ Mepolizumab + in-office improvement, and need for rescue systemic
polypectomy corticosteroid use
52-week, 2-arm trial? comparing
effects of
+ Mepolizumab alone Primary outcome: Change in SNOT-22 score
Mepolizumab + functional Secondary outcomes: Change in NPS, ACQ,
endoscopic sinus surgery 2 weeks and FEVI
post first mepolizumab injection
1. htpsetinicatials govistudyiNCTOS923047. 2. ps www clnicaiials govistudyINCTOSS98B14, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Phase 4 Trials Assessing Biologic/Surgical Combinations:
Dupilumab
52-week, 2-arm trial!
Ec + Primary outcome: Nonrecurrence of sinus cavity
+ Dupilumab vs edema, assessed endoscopically
placebo (both + + Secondary outcomes: Polyp recurrence; oral steroid
mometasone furoate use for polyp recurrence; reoperation; differences in
nasal spray) operative bleeding
1. tips. cnialals govstudyNCTO4S96 189, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Dupilumab
52-week, 2-arm trial!
Ec + Primary outcome: Nonrecurrence of sinus cavity
+ Dupilumab vs edema, assessed endoscopically
placebo (both + + Secondary outcomes: Polyp recurrence; oral steroid
mometasone furoate use for polyp recurrence; reoperation; differences in
nasal spray) operative bleeding
1. tips. cnialals govstudyNCTO4S96 189, PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Importance of Multidirectional Communication and
Collaboration in Patient Care
+ Among specialties (eg, ENT, pulmonology, allergy/immunology,
and the patient’s primary care provider)
+ Among professions, with a focus on the specific role of the PA
in CRSWNP management
« Between clinician and patient
PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Collaboration in Patient Care
+ Among specialties (eg, ENT, pulmonology, allergy/immunology,
and the patient’s primary care provider)
+ Among professions, with a focus on the specific role of the PA
in CRSWNP management
« Between clinician and patient
PeerView.com
PeerView.com/AMJ827 Copyright © 2000-2024, PeerView
Multidisciplinary Collaboration and
Coordination of CRSwNP Treatment!
Proposal of the Multidisciplinary EUFOREA Expert Board Meeting
+ Integrated care
pathways for CRSWNP
require collaboration
— Education of patients
and PCPs can
facilitate timely and
accurate diagnosis
— Patients with a
high-risk phenotype
(eg, asthma, N-ERD)
should be referred to
specialists early in
disease to optimize
multidisciplinary
management
1. Fokkens WJ eta. Alergy. 2019.742312-2319,
PeerView.com/AMJ827
Every patient with CRS should have
at least one evaluation for asthma
and allergy
Validated questionnaire
Spirometry
Skin prick or measurement of IgE
Measurement of eosinophils,
Evaluate upper and lower airways at
every visit
Adjust treatment with attention to full
unified airways
Regularly measure type 2
biomarkers
Monitor the use of systemic
corticosteroids
PeerView.com
Copyright © 2000-2024, PeerView
Coordination of CRSwNP Treatment!
Proposal of the Multidisciplinary EUFOREA Expert Board Meeting
+ Integrated care
pathways for CRSWNP
require collaboration
— Education of patients
and PCPs can
facilitate timely and
accurate diagnosis
— Patients with a
high-risk phenotype
(eg, asthma, N-ERD)
should be referred to
specialists early in
disease to optimize
multidisciplinary
management
1. Fokkens WJ eta. Alergy. 2019.742312-2319,
PeerView.com/AMJ827
Every patient with CRS should have
at least one evaluation for asthma
and allergy
Validated questionnaire
Spirometry
Skin prick or measurement of IgE
Measurement of eosinophils,
Evaluate upper and lower airways at
every visit
Adjust treatment with attention to full
unified airways
Regularly measure type 2
biomarkers
Monitor the use of systemic
corticosteroids
PeerView.com
Copyright © 2000-2024, PeerView
Conclusions
CRSWNP is associated with substantial discomfort and negative impact on QOL
Type 2-directed biologic therapies approved for CRSwNP—as well as asthma and other
inflammatory conditions—include dupilumab, omalizumab, and mepolizumab, with others
in development
+ These therapies can reduce nasal polyp size, improve QOL, and reduce the burden of disease
for patients
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
erView.com
M5827 Copyright © 2000-2024, PeerView
CRSWNP is associated with substantial discomfort and negative impact on QOL
Type 2-directed biologic therapies approved for CRSwNP—as well as asthma and other
inflammatory conditions—include dupilumab, omalizumab, and mepolizumab, with others
in development
+ These therapies can reduce nasal polyp size, improve QOL, and reduce the burden of disease
for patients
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
erView.com
M5827 Copyright © 2000-2024, PeerView
Audience Q&A O ,
Copyright © 2000-2024, PeerView
Copyright © 2000-2024, PeerView
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