The Itch We Could Never Scratch: Incorporating New and Emerging Therapies to Alleviate the Burden of Prurigo Nodularis With a Team-Based Approach
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About This Presentation
Chair and Presenter, Gil Yosipovitch, MD, Adam Friedman, MD, FAAD, Heather Gates, PA-C, DFAAPA, and patient Shayanne Boulet discuss prurigo nodularis in this CME/MOC/NCPD/CPE/AAPA/IPCE activity titled “The Itch We Could Never Scratch: Incorporating New and Emerging Therapies to Alleviate the Burde...
Slide Content
The Itch We Could Never Scratch
Incorporating New and Emerging Therapies to
Alleviate the Burden of Prurigo Nodularis
With a Team-Based Approach
Gil Yosipovitch, MD Adam Friedman, MD, FAAD
Professor of Dermatology x Professor and Chair of Dermatology
Stiefel Chair of Medical Dermatology Residency Program Director
Director Miami Itch Ctr Director of Translational Research
Dr Philip Frost Department of Dermatology Director of Supportive Oncodermatology
University of Miami Miller Department of Dermatology
School of Medicine A George Washington School of Medicine and Health Sciences
Miami, Florida Member of the Editorial Board of Precision Nanomedicine
The GW Medical Faculty Associates
Washington, DC
Heather Gates, PA-C, DFAAPA im Shayanne Boulet
President Patient
Florida Society of Dermatology PAs
The Dermatology Institute & Skin
Cancer Center
The Villages, Florida 4
Go online to access full CME/MOC/NCPD/CPE/AAPA/IPCE information, including faculty disclosures.
Incorporating New and Emerging Therapies to
Alleviate the Burden of Prurigo Nodularis
With a Team-Based Approach
Gil Yosipovitch, MD Adam Friedman, MD, FAAD
Professor of Dermatology x Professor and Chair of Dermatology
Stiefel Chair of Medical Dermatology Residency Program Director
Director Miami Itch Ctr Director of Translational Research
Dr Philip Frost Department of Dermatology Director of Supportive Oncodermatology
University of Miami Miller Department of Dermatology
School of Medicine A George Washington School of Medicine and Health Sciences
Miami, Florida Member of the Editorial Board of Precision Nanomedicine
The GW Medical Faculty Associates
Washington, DC
Heather Gates, PA-C, DFAAPA im Shayanne Boulet
President Patient
Florida Society of Dermatology PAs
The Dermatology Institute & Skin
Cancer Center
The Villages, Florida 4
Go online to access full CME/MOC/NCPD/CPE/AAPA/IPCE information, including faculty disclosures.
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Our Goals for Today
Help you recognize the impact of prurigo nodularis on patients’ lives
Improve your understanding of the pathophysiology of PN and how
it correlates to treatment selection and the development of novel
therapeutic strategies
Provide you with skills to incorporate new and emerging
therapeutic options into individualized treatment plans of patients
with PN
Enable you to collaborate with clinical colleagues across the
healthcare team to bridge gaps in disease management and
optimize outcomes in patients with PN
Our Goals for Today
Help you recognize the impact of prurigo nodularis on patients’ lives
Improve your understanding of the pathophysiology of PN and how
it correlates to treatment selection and the development of novel
therapeutic strategies
Provide you with skills to incorporate new and emerging
therapeutic options into individualized treatment plans of patients
with PN
Enable you to collaborate with clinical colleagues across the
healthcare team to bridge gaps in disease management and
optimize outcomes in patients with PN
Meeting the Needs and Closing the Gaps
Recognizing the Clinical
Presentation and Individual
Burdens of Prurigo Nodularis
Heather Gates, PA-C, DFAAPA ES”
President
Florida Society of Dermatology PAs J
The Dermatology Institute & Skin Cancer Center
The Villages, Florida I é
|
Copyright © 2000-2024, Peerview
Recognizing the Clinical
Presentation and Individual
Burdens of Prurigo Nodularis
Heather Gates, PA-C, DFAAPA ES”
President
Florida Society of Dermatology PAs J
The Dermatology Institute & Skin Cancer Center
The Villages, Florida I é
|
Copyright © 2000-2024, Peerview
Prurigo Nodularis Definition and Prevalence
+ PNis a distinct clinical disease defined by the presence of
chronic pruritus and multiple localized or generalized,
elevated, firm, and nodular lesions! Period Prevalence Estimates for
+ Estimated prevalence in the US: 87,634 (72 per 100,000)? PN (Per 100,000)
+ PN prevalence is increasing, possibly due to greater use of 2016 2017
PN coding and/or growing awareness of PN3
: Overall 18 32 45 58
+ Occurs more commonly in middle-aged adults
(median age = 66 years; usually first diagnosed between Children 2 4 6 7
the ages of 51 and 65) but can manifest at any age
Adults 22 39 54 70
+ Black individuals are 3.4 times more likely to experience
PN compared to White individuals
4. EimarahS et al. J Am Acad Dermatol 2021:34747.760.2. Huang AM tal. Invest Dormatol 2020;140:480-483 04. en
3. Wonguibusin $ ei al. J Invest Dermatol. 2021,141:2530-2533.01 PeerView.com
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+ PNis a distinct clinical disease defined by the presence of
chronic pruritus and multiple localized or generalized,
elevated, firm, and nodular lesions! Period Prevalence Estimates for
+ Estimated prevalence in the US: 87,634 (72 per 100,000)? PN (Per 100,000)
+ PN prevalence is increasing, possibly due to greater use of 2016 2017
PN coding and/or growing awareness of PN3
: Overall 18 32 45 58
+ Occurs more commonly in middle-aged adults
(median age = 66 years; usually first diagnosed between Children 2 4 6 7
the ages of 51 and 65) but can manifest at any age
Adults 22 39 54 70
+ Black individuals are 3.4 times more likely to experience
PN compared to White individuals
4. EimarahS et al. J Am Acad Dermatol 2021:34747.760.2. Huang AM tal. Invest Dormatol 2020;140:480-483 04. en
3. Wonguibusin $ ei al. J Invest Dermatol. 2021,141:2530-2533.01 PeerView.com
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Clinical Pictures of Patients With PN‘?
1. psldermnetnz org 2. Yang LL et al. Open Chem. 2020:18:463-47. PeerView.com
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1. psldermnetnz org 2. Yang LL et al. Open Chem. 2020:18:463-47. PeerView.com
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Common Additional Features!
Nodules are usually symmetrically distributed
on areas of the skin accessible to scratching
“Butterfly sign”
— Face, palms, soles, scalp, and genitals are
rarely affected
Additional lesions (eg, lichenified plaques,
excoriations, ulcerations, and/or scars) may be
induced by scratching/picking/rubbing
Pruritus may be accompanied by additional
burning, stinging, pain, and other sensations
1.Elmarih $ ot al. J Am Acad Dermatol. 2021:84:747-760. PeerView.com
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Nodules are usually symmetrically distributed
on areas of the skin accessible to scratching
“Butterfly sign”
— Face, palms, soles, scalp, and genitals are
rarely affected
Additional lesions (eg, lichenified plaques,
excoriations, ulcerations, and/or scars) may be
induced by scratching/picking/rubbing
Pruritus may be accompanied by additional
burning, stinging, pain, and other sensations
1.Elmarih $ ot al. J Am Acad Dermatol. 2021:84:747-760. PeerView.com
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Negative Impact of PN and Associated Itch’
Constant scratching in response to
intense, relentless pruritus often
leads to excoriations
Depression and Anxiety
Patients with PN have higher rates
of depression, anxiety, and other
psychiatric conditions vs those with
other inflammatory skin conditions
or with healthy controls
1. Wälams KA
1 Export Rev Cin Pharmacol 2021:14:67-77
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Intractable
itch/scratch of PN
and interconnected
QOL disruption
Sleep Disturbance
Because of Itch
The intractable itch results in sleep
deprivation, thereby contributing to
other diseases, including
psychiatric conditions
Psychosocial Disturbance
Patients report avoiding social
interactions due to
lesion-related
embarrassment or shame
A
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Constant scratching in response to
intense, relentless pruritus often
leads to excoriations
Depression and Anxiety
Patients with PN have higher rates
of depression, anxiety, and other
psychiatric conditions vs those with
other inflammatory skin conditions
or with healthy controls
1. Wälams KA
1 Export Rev Cin Pharmacol 2021:14:67-77
PeerView.com/NZV827
Intractable
itch/scratch of PN
and interconnected
QOL disruption
Sleep Disturbance
Because of Itch
The intractable itch results in sleep
deprivation, thereby contributing to
other diseases, including
psychiatric conditions
Psychosocial Disturbance
Patients report avoiding social
interactions due to
lesion-related
embarrassment or shame
A
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Impact of Itch on Sleep Disturbance’
Sleep Disturbance Effect Studied in Patients With PN vs AD
Extent Pruritus Disturbs Sleep (PN) Extent Pruritus Disturbs Sleep (AD)
N=39 N=81
Minimal, 8% 3
Mid, 3% Ds
Moderate,
10%
1. Gwilim EC et al. Acta Dorm Venereol. 2021:1010:20v00424. PeerView.com
Minimal, 4%
Mild, 5% de
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Sleep Disturbance Effect Studied in Patients With PN vs AD
Extent Pruritus Disturbs Sleep (PN) Extent Pruritus Disturbs Sleep (AD)
N=39 N=81
Minimal, 8% 3
Mid, 3% Ds
Moderate,
10%
1. Gwilim EC et al. Acta Dorm Venereol. 2021:1010:20v00424. PeerView.com
Minimal, 4%
Mild, 5% de
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Burden of Disease and Common Comorbidities!
Impaired QOL, sleep deprivation, missed work/school,
emotional impact (depression, anxiety, anger, shame,
helplessness), and social isolation
Dermatologic conditions such as AD and
other diseases (eg, chronic kidney disease, diabetes,
heart failure, chronic HBV/HCV, HIV, and non-Hodgkin
lymphoma) may be associated with PN
Although some of these conditions can be causative, the precise
relationship remains to be fully delineated
1. Eimarah $ ot a. J Am Acad Dormatol, 2021:84:747-760. PeerView.com
Copyright © 2000-2024, PeerView
Impaired QOL, sleep deprivation, missed work/school,
emotional impact (depression, anxiety, anger, shame,
helplessness), and social isolation
Dermatologic conditions such as AD and
other diseases (eg, chronic kidney disease, diabetes,
heart failure, chronic HBV/HCV, HIV, and non-Hodgkin
lymphoma) may be associated with PN
Although some of these conditions can be causative, the precise
relationship remains to be fully delineated
1. Eimarah $ ot a. J Am Acad Dormatol, 2021:84:747-760. PeerView.com
Copyright © 2000-2024, PeerView
Patient Interview
Physical and Emotional
Impact of PN
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Physical and Emotional
Impact of PN
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PN Differential Diagnosis!
Hypertrophic lichen planus
+ AD with lichen simplex
chronicus
+ Autoimmune blistering
diseases (eg, bullous
pemphigoid, dermatitis
herpetiformis)
+ Perforating disorders (may be
a subtype of PN in patients
receiving dialysis)
Neurotic excoriations
+ Skin-picking syndromes,
body-focused repetitive
behaviors
+ Lichen amyloidosis
+ Multiple keratoacanthomas
+ Arthropod bites
Scabies
1. Elmarah $ et al. J Am Acad Dermatol. 2021:84:747-760. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Hypertrophic lichen planus
+ AD with lichen simplex
chronicus
+ Autoimmune blistering
diseases (eg, bullous
pemphigoid, dermatitis
herpetiformis)
+ Perforating disorders (may be
a subtype of PN in patients
receiving dialysis)
Neurotic excoriations
+ Skin-picking syndromes,
body-focused repetitive
behaviors
+ Lichen amyloidosis
+ Multiple keratoacanthomas
+ Arthropod bites
Scabies
1. Elmarah $ et al. J Am Acad Dermatol. 2021:84:747-760. PeerView.com
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Distinguishing Between PN and Other Diagnoses’
Characteristic histopathologic features of PN
+ Thick, compact orthohyperkeratosis
+ Pseudoepitheliomatous hyperplasia, focal parakeratosis
+ Hypergranulosis in the epidermis
In the dermis
+ Papillary dermal fibrosis with vertically arranged collagen fibers
+ Increased numbers of capillaries, increased fibroblasts
+ Mixed superficial, perivascular, or interstitial inflammatory infiltrate
1. Eimarih $ ot al. J Am Acad Dormatol. 2021:84:747-760. PeerView.com
Copyright © 2000-2024, PeerView
Characteristic histopathologic features of PN
+ Thick, compact orthohyperkeratosis
+ Pseudoepitheliomatous hyperplasia, focal parakeratosis
+ Hypergranulosis in the epidermis
In the dermis
+ Papillary dermal fibrosis with vertically arranged collagen fibers
+ Increased numbers of capillaries, increased fibroblasts
+ Mixed superficial, perivascular, or interstitial inflammatory infiltrate
1. Eimarih $ ot al. J Am Acad Dormatol. 2021:84:747-760. PeerView.com
Copyright © 2000-2024, PeerView
Distinguishing Between PN and Other Diagnoses’
+ Skin biopsy may be performed (shave biopsy) to rule out
other diseases
+ Direct immunofluorescence may be indicated to rule out
autoimmune disorders
+ Skin scrapings if scabies or underlying fungal infections
are suspected
1.Elmaran ot al. JAm Acad Dermatol, 2021:84:747:760 PeerView.com
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+ Skin biopsy may be performed (shave biopsy) to rule out
other diseases
+ Direct immunofluorescence may be indicated to rule out
autoimmune disorders
+ Skin scrapings if scabies or underlying fungal infections
are suspected
1.Elmaran ot al. JAm Acad Dermatol, 2021:84:747:760 PeerView.com
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PN Diagnostic Workup‘
Initial Visit
(can initiate treatment)
Clinical examination, including a
complete review of systems
‘Assess for PN severity
- Extent of PN (number and
firmness of lesions)
Pruritus intensity (mild,
moderate, severe, or very
+ All patients (if clinically indicated)
- Complete blood cell count
with differenti
= Liver function tests
- Renal function tests
+ Ifrisk factors exist or as
indicated by review of symptoms
~ Thyroid function tests
— Diabetes assessment
= HIV and HBV/HCV serologies
severe; or use the numeric
rating scale?)
Disease burden (QOL, sieep
disturbance, anxiety/depression,
and associated comorbidities)
‘Assess the need for behavioral
and emotional support related to
anxiety or depression
Additional Tests to Consider
+ If malignancy is suspected and
patient has had pruritus for <1
year, refer for age-appropriate
malignancy screening
+ Biopsy, if suspicion of an
alternative or other contributing
condition
The numer rang scale isa useful, quick, and validated tool o reliably assess and monitor the severty of prurtus; however, patients may need some guidance on
howto use le
1. Elmariah Set
JAm Acad Dormatol.2021:84:747-760.
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Initial Visit
(can initiate treatment)
Clinical examination, including a
complete review of systems
‘Assess for PN severity
- Extent of PN (number and
firmness of lesions)
Pruritus intensity (mild,
moderate, severe, or very
+ All patients (if clinically indicated)
- Complete blood cell count
with differenti
= Liver function tests
- Renal function tests
+ Ifrisk factors exist or as
indicated by review of symptoms
~ Thyroid function tests
— Diabetes assessment
= HIV and HBV/HCV serologies
severe; or use the numeric
rating scale?)
Disease burden (QOL, sieep
disturbance, anxiety/depression,
and associated comorbidities)
‘Assess the need for behavioral
and emotional support related to
anxiety or depression
Additional Tests to Consider
+ If malignancy is suspected and
patient has had pruritus for <1
year, refer for age-appropriate
malignancy screening
+ Biopsy, if suspicion of an
alternative or other contributing
condition
The numer rang scale isa useful, quick, and validated tool o reliably assess and monitor the severty of prurtus; however, patients may need some guidance on
howto use le
1. Elmariah Set
JAm Acad Dormatol.2021:84:747-760.
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PN Lesional Skin: Epidermal Thickening With Hyperkeratosis,
Acanthosis, and Significant Inflammatory Infiltrate’
Histological Observations of Lesional Skin Biopsy From PN?
Original magnification x40 Original magnification x100
, hypergranuosis, and epidermal hyperplasia (arrow) the epidermis mosty consisted of keratinocytes.
*Lesiona kn biopsy showed ontohypertratoss, A
1. Yang LL et al. Open Chom. 2020,18:463-471, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Acanthosis, and Significant Inflammatory Infiltrate’
Histological Observations of Lesional Skin Biopsy From PN?
Original magnification x40 Original magnification x100
, hypergranuosis, and epidermal hyperplasia (arrow) the epidermis mosty consisted of keratinocytes.
*Lesiona kn biopsy showed ontohypertratoss, A
1. Yang LL et al. Open Chom. 2020,18:463-471, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Rating Scales for Itch and PN-Related QOL"?
Used in patient assessment and to assess treatment response
+ Average Itch Numeric Rating Scale (AI-NRS)
+ Worst Itch Numeric Rating Scale (WI-NRS)
+ Worst Itch Visual Analog Scale (WI-VAS)
+ Prurigo Activity and Severity Score
« Dermatology Life Quality Index (DLQI)
« ItchyQoL
1.Kimel Metal. JAMA Dormotol.2020,156:1354-1358, 2. Ständer S etal J Eur Acad Dermatol Venereol. 2022:36:573-581 PeerView.com
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Used in patient assessment and to assess treatment response
+ Average Itch Numeric Rating Scale (AI-NRS)
+ Worst Itch Numeric Rating Scale (WI-NRS)
+ Worst Itch Visual Analog Scale (WI-VAS)
+ Prurigo Activity and Severity Score
« Dermatology Life Quality Index (DLQI)
« ItchyQoL
1.Kimel Metal. JAMA Dormotol.2020,156:1354-1358, 2. Ständer S etal J Eur Acad Dermatol Venereol. 2022:36:573-581 PeerView.com
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The Role of the Wider Healthcare Team in PN
+ Clinical assessment and diagnosis
+ Treatment planning
+ Procedural interventions if
necessary
+ Follow-up and monitoring
+ Patient education and managing
AES
+ Patient education
+ Treatment administration
+ Patient support/counseling
Clinical assessment and diagnosis
Procedural interventions if
necessary
Prescribe medications; adjust dose
ent Follow-up and monitor
+ Medication management p: y
+ Educating patients and
managing AEs
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+ Clinical assessment and diagnosis
+ Treatment planning
+ Procedural interventions if
necessary
+ Follow-up and monitoring
+ Patient education and managing
AES
+ Patient education
+ Treatment administration
+ Patient support/counseling
Clinical assessment and diagnosis
Procedural interventions if
necessary
Prescribe medications; adjust dose
ent Follow-up and monitor
+ Medication management p: y
+ Educating patients and
managing AEs
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Faculty Discussion
Exploring PN Pathophysiology and
Its Impact on Identifying Likely
Treatment Targets
Gil Yosipovitch, MD
Professor of Dermatology
Stiefel Chair of Medical Dermatology
Director Miami Itch Ctr
Dr Philip Frost Department of Dermatology
University of Miami Miller School of Medicine
Miami, Florida
aa
Copyright © 2000-2024, PeerView
Its Impact on Identifying Likely
Treatment Targets
Gil Yosipovitch, MD
Professor of Dermatology
Stiefel Chair of Medical Dermatology
Director Miami Itch Ctr
Dr Philip Frost Department of Dermatology
University of Miami Miller School of Medicine
Miami, Florida
aa
Copyright © 2000-2024, PeerView
Pathogenesis of PN: Complex Interplay Between Neural and
Immune Modulators Leading to a Vicious Itch-Scratch Cycle!
Involves an
altered neural and
immune response
with cross-talk
between the two
systems
The increased
growth factors
lead to endothelial
cell growth and
nodule formation
1. Willams KA et al. Expert Rev Cin Pharmacol, 2021:14:67-77, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Immune Modulators Leading to a Vicious Itch-Scratch Cycle!
Involves an
altered neural and
immune response
with cross-talk
between the two
systems
The increased
growth factors
lead to endothelial
cell growth and
nodule formation
1. Willams KA et al. Expert Rev Cin Pharmacol, 2021:14:67-77, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Neural and Immunologic Mediators of PN Itch’
1. gras G tal. Arch Dorma! Ros. 2022:314405415 PeerView.com
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1. gras G tal. Arch Dorma! Ros. 2022:314405415 PeerView.com
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Cells and Cytokine Pathways in
Neural-Immune Dysregulation!
1. Ingrasci G et al. Exp Dormatol.2021.30:1208-1217. PeerView.com
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Neural-Immune Dysregulation!
1. Ingrasci G et al. Exp Dormatol.2021.30:1208-1217. PeerView.com
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Periostin Accumulation in PN Lesional Dermis Is
Significantly Increased and Correlated to Itch’
Immunostaining for periostin in healthy skin
Healthy individual PN
2 2
Sa Pi = Fee
E 52
514 5
a a
Er 3
E E
fo i
0 6 8 10
6 6 Ich Intensity (NRS)
This study provides insi hanism of P
1. Hashimoto Teta. Acta Derm Venereol, 2021;10%:adv00375.
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Significantly Increased and Correlated to Itch’
Immunostaining for periostin in healthy skin
Healthy individual PN
2 2
Sa Pi = Fee
E 52
514 5
a a
Er 3
E E
fo i
0 6 8 10
6 6 Ich Intensity (NRS)
This study provides insi hanism of P
1. Hashimoto Teta. Acta Derm Venereol, 2021;10%:adv00375.
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Pathways of Neural Sensitivity’
Iara Loo
+ Roma nneraton iced | caused by prolonged ch (og, PF ACC)
by inflammation/scratching |
+ PAR-2 activation
er
Upregulation of itch-elated
receptors and molecules.
(eg, Substance P, BONF)
Dyst
inhibitory circuits In.
neurons, NPY neurons)
1. Yosipovteh 6 etal. Allergy Cin immune. 2018;142:1375-1300. PeerView.com
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Iara Loo
+ Roma nneraton iced | caused by prolonged ch (og, PF ACC)
by inflammation/scratching |
+ PAR-2 activation
er
Upregulation of itch-elated
receptors and molecules.
(eg, Substance P, BONF)
Dyst
inhibitory circuits In.
neurons, NPY neurons)
1. Yosipovteh 6 etal. Allergy Cin immune. 2018;142:1375-1300. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
PN Neuronal Signaling May Be Interconnected With Pain,
PN Is Associated With Increased Neuronal Sensitization Disorders!
Patients with PN hav ed odds of experiencing
fibromyalgia, chronic and IBS than patients
Peripheral nerve injury may be perceived as itch and/or pain!
_Chronic
Fibromyalgia _ interstitial IBS
OR (95% CI) cysti OR (95% CI)
OR (95% CI)
3.38 24.40 2.10
Peptides and neurons in (19.42-30.64)> (1.52-2.90P
the pain pathway can 16410
inhibit th signals
+ This study included hosplalzation record between 2016-2019 and included 24.210.007 completed cases. The prevalence of PN was 0.006%: prevalence of
fromyalga was 1439%, prevalence of chronc nerstilcystis was 0.040% and prevalence ol mlable bowel syndrome was 1 040%.
* Models were constructed using suvey weighted multivariable logistic regression: exposure = the presence of prungo nodulars (es v no) outcomes ~ the presence
‘of feromyalga or chronic intrstal sts rire bowel syndrome (yes vs 0) ni
1. Schmalz M. Front Med. 20196:167. 2. Choragudi $, Yosipovich G. Br J Dermatol. 2023:189:240-242. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
PN Is Associated With Increased Neuronal Sensitization Disorders!
Patients with PN hav ed odds of experiencing
fibromyalgia, chronic and IBS than patients
Peripheral nerve injury may be perceived as itch and/or pain!
_Chronic
Fibromyalgia _ interstitial IBS
OR (95% CI) cysti OR (95% CI)
OR (95% CI)
3.38 24.40 2.10
Peptides and neurons in (19.42-30.64)> (1.52-2.90P
the pain pathway can 16410
inhibit th signals
+ This study included hosplalzation record between 2016-2019 and included 24.210.007 completed cases. The prevalence of PN was 0.006%: prevalence of
fromyalga was 1439%, prevalence of chronc nerstilcystis was 0.040% and prevalence ol mlable bowel syndrome was 1 040%.
* Models were constructed using suvey weighted multivariable logistic regression: exposure = the presence of prungo nodulars (es v no) outcomes ~ the presence
‘of feromyalga or chronic intrstal sts rire bowel syndrome (yes vs 0) ni
1. Schmalz M. Front Med. 20196:167. 2. Choragudi $, Yosipovich G. Br J Dermatol. 2023:189:240-242. PeerView.com
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Epidermis
Decreased nerve fibers
Dermis
Increased nerve fibers
1.Labb A et a. Inmunotorgts The. 2022:11:1121. PeerView.com
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Decreased nerve fibers
Dermis
Increased nerve fibers
1.Labb A et a. Inmunotorgts The. 2022:11:1121. PeerView.com
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3D Animation
Pathophysiology
of PN
Copyright © 2000-2024, PeerView
Pathophysiology
of PN
Copyright © 2000-2024, PeerView
Incorporating New and Emerging
Therapies to Provide Relief From
PN Using a Team-Based Approach
Adam Friedman, MD, FAAD
Professor and Chair of Dermatology
Residency Program Director
Director of Translational Research
Director of Supportive Oncodermatology
Department of Dermatology
George Washington School of Medicine and Health Sciences
Member of the Editorial Board of Precision Nanomedicine
The GW Medical Faculty Associates
Washington, DC
<4
Copyright © 2000-2024, PeerView
Therapies to Provide Relief From
PN Using a Team-Based Approach
Adam Friedman, MD, FAAD
Professor and Chair of Dermatology
Residency Program Director
Director of Translational Research
Director of Supportive Oncodermatology
Department of Dermatology
George Washington School of Medicine and Health Sciences
Member of the Editorial Board of Precision Nanomedicine
The GW Medical Faculty Associates
Washington, DC
<4
Copyright © 2000-2024, PeerView
Prurigo Nodularis: Treatment Goals!
hr
+ Reduce pruritus e.
+ Interrupt the itch-scratch cycle
+ Completely heal PN lesions
1. Elmariah $ et al. J Am Acad Dormatol. 2021:84:747-760. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
hr
+ Reduce pruritus e.
+ Interrupt the itch-scratch cycle
+ Completely heal PN lesions
1. Elmariah $ et al. J Am Acad Dormatol. 2021:84:747-760. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Prurigo Nodularis Treatment Ladder!
+ Topical + NKi receptor + Thalidomide — + Cannabinoids* + Intralesional + IL-31 + Azabiomine + Mophenoate
ketamine antagonists® + KOR/MOR Corticosteroids inhiiters® + Cyclosporine
amitiptyine/ + High-dose antagonists (<tO lesionsy + Dupilumab* + Methotrexate
lidocaine gebapentinoids cryotherapy + Narrowband
+ Topical + Antidepressants + Topical UVBIPUVA
capsaicin (SNRI > SSRI Calcipotriot phototherapy!
DTA, + Topical RC
. calcineurin
en inhibitors
a; _
+ investigational therapies, * Therapies that have been helpful in chronic pruftus but current lack ata in PN
“FDR approved. Therapy may funcion va mie mechansms, mmunooge or han. m
1. Adapted from Elmariah S et a. Am Acad Dermatol 2021:84:747-760. PeerView.com
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+ Topical + NKi receptor + Thalidomide — + Cannabinoids* + Intralesional + IL-31 + Azabiomine + Mophenoate
ketamine antagonists® + KOR/MOR Corticosteroids inhiiters® + Cyclosporine
amitiptyine/ + High-dose antagonists (<tO lesionsy + Dupilumab* + Methotrexate
lidocaine gebapentinoids cryotherapy + Narrowband
+ Topical + Antidepressants + Topical UVBIPUVA
capsaicin (SNRI > SSRI Calcipotriot phototherapy!
DTA, + Topical RC
. calcineurin
en inhibitors
a; _
+ investigational therapies, * Therapies that have been helpful in chronic pruftus but current lack ata in PN
“FDR approved. Therapy may funcion va mie mechansms, mmunooge or han. m
1. Adapted from Elmariah S et a. Am Acad Dermatol 2021:84:747-760. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Prurigo Nodularis Treatment Ladder!
The 2022 US FDA approval of a PN
indication for dupilumab means a
new rung on the treatment ladder
eerView.com
The 2022 US FDA approval of a PN
indication for dupilumab means a
new rung on the treatment ladder
eerView.com
Dupilumab: First FDA-Approved Treatment for PN12
FDA approval for adults based on results of phase 3 LIBERTY-PN PRIME
and PRIMEZ2 trials (N = 311)
24 weeks vs placebo
+ Added to background topical corticosteroids or calcineurin inhibitors
+ 600 mg SC loading dose followed by 300 mg every 2 weeks for ©
+ Primary outcome: Proportion of patients with 24-point improvement from baseline
on the WI-NRS
+ Key secondary outcomes
— Proportion of patients with skin clear or nearly clear of nodules
(0 or 1 on IGA PN-S scale) at week 24
— Proportion of patients who achieved a response on both scales at week 24
In phase 3 study for children 26 months to <18 years
1. hips la govideugsinews-eventshuman-drugs/da-approves-rst-teatment-pruigo-nodulans, 2. www cnicatals gov. PeerView.com
Copyr
FDA approval for adults based on results of phase 3 LIBERTY-PN PRIME
and PRIMEZ2 trials (N = 311)
24 weeks vs placebo
+ Added to background topical corticosteroids or calcineurin inhibitors
+ 600 mg SC loading dose followed by 300 mg every 2 weeks for ©
+ Primary outcome: Proportion of patients with 24-point improvement from baseline
on the WI-NRS
+ Key secondary outcomes
— Proportion of patients with skin clear or nearly clear of nodules
(0 or 1 on IGA PN-S scale) at week 24
— Proportion of patients who achieved a response on both scales at week 24
In phase 3 study for children 26 months to <18 years
1. hips la govideugsinews-eventshuman-drugs/da-approves-rst-teatment-pruigo-nodulans, 2. www cnicatals gov. PeerView.com
Copyr
Pooled Results From LIBERTY-PN PRIME and PRIME2:
2-4 weeks
screening
24 weeks
treatment
1. Yosipovich G eta. Br Dermatol. 2023:188{supl 29432.
PeerView.com/NZV827
Phase 3 RCTs!
Both trials planned to demonstrate safety and efficacy of
dupilumab in adults with PN inadequately controlled with topical
medication or for whom topical medication was not advised
Itch severity assessed by WI-NRS
— Range: 0 (no itch) to 10 (worst itch imaginable)
Skin lesions assessed by IGA PN-S
— 0 (no nodules)
1 (1-5 nodules)
— 2 (6-19 nodules)
— 3 (20-99 nodules)
— 4 (2100)
Enrollment criteria: WI-NRS 27 and IGA PN-S 3 or 4
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2-4 weeks
screening
24 weeks
treatment
1. Yosipovich G eta. Br Dermatol. 2023:188{supl 29432.
PeerView.com/NZV827
Phase 3 RCTs!
Both trials planned to demonstrate safety and efficacy of
dupilumab in adults with PN inadequately controlled with topical
medication or for whom topical medication was not advised
Itch severity assessed by WI-NRS
— Range: 0 (no itch) to 10 (worst itch imaginable)
Skin lesions assessed by IGA PN-S
— 0 (no nodules)
1 (1-5 nodules)
— 2 (6-19 nodules)
— 3 (20-99 nodules)
— 4 (2100)
Enrollment criteria: WI-NRS 27 and IGA PN-S 3 or 4
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Pooled Results From LIBERTY-PN PRIME and PRIME2:
Efficacy Endpoints’
Proportion of Week 12
Patients ...
Dupilumab Dupilumab
= with WI-NRS
score reduction
24 points
62 (40.5%)
30 (19.0%) 90 (58.8%)
. who achieved
an IGAPN-S
score of 0 or 1
44 (28.8%) 19 (12.0%) <.0001 71 (46.4%)
.. who achieved
WLNRS score
reduction 24
points and an
IGA PN-S score
of O or 1 at
weeks 12 and 24
28 (18.3%) 11(7%) 0021 54 (35.3%)
30 (19.0%)
27 (17.1%)
14 (8.9%)
<.0001
< 0001
Treatment-related adverse events: dupilumab, 59.9%; placebo, 51.0%
1. Vosipovich G etal. Br. Dermatol. 2023;188(suppl2)432
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Efficacy Endpoints’
Proportion of Week 12
Patients ...
Dupilumab Dupilumab
= with WI-NRS
score reduction
24 points
62 (40.5%)
30 (19.0%) 90 (58.8%)
. who achieved
an IGAPN-S
score of 0 or 1
44 (28.8%) 19 (12.0%) <.0001 71 (46.4%)
.. who achieved
WLNRS score
reduction 24
points and an
IGA PN-S score
of O or 1 at
weeks 12 and 24
28 (18.3%) 11(7%) 0021 54 (35.3%)
30 (19.0%)
27 (17.1%)
14 (8.9%)
<.0001
< 0001
Treatment-related adverse events: dupilumab, 59.9%; placebo, 51.0%
1. Vosipovich G etal. Br. Dermatol. 2023;188(suppl2)432
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Dupilumab Safety: PRIME and PRIME2'
| PRIME (N = 151)
Placebo
(n=75)
PRIME2 (N = 160)
Dupilumab
(n= 77)
Placebo
(n=82)
Dupilumab
(n=75)
Serious TEAE 3 (4%)?
TEAE leading to 0
discontinuation
Nasopharyngitis 4 (5.3%)
Herpes viral 0
infections
Conjunctivitis 2 (2.7%)
* Considered unrelated tothe study drug
‘SYosipowtch © oral. Nat Mod: 202323: 1180-1189.
PeerView.com/NZV827
5 (6.7%)
2 (2.7%)
3 (4.0%)
0
2 (2.7%)
2 (2.6%)?
o
2 (2.6%)
4 (5.2%)
3 (3.9%)
1(1.2%)?
1(1.2%)
0
0
0
PeerView.com
Copyright © 2000-2024, PeerView
| PRIME (N = 151)
Placebo
(n=75)
PRIME2 (N = 160)
Dupilumab
(n= 77)
Placebo
(n=82)
Dupilumab
(n=75)
Serious TEAE 3 (4%)?
TEAE leading to 0
discontinuation
Nasopharyngitis 4 (5.3%)
Herpes viral 0
infections
Conjunctivitis 2 (2.7%)
* Considered unrelated tothe study drug
‘SYosipowtch © oral. Nat Mod: 202323: 1180-1189.
PeerView.com/NZV827
5 (6.7%)
2 (2.7%)
3 (4.0%)
0
2 (2.7%)
2 (2.6%)?
o
2 (2.6%)
4 (5.2%)
3 (3.9%)
1(1.2%)?
1(1.2%)
0
0
0
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Copyright © 2000-2024, PeerView
Further LIBERTY-PN PRIME and PRIME2 Findings’
sy
In dupilumab-treated patients, improvement of skin lesions may lag
behind improvement in itch
+ Or dupilumab may exert independent treatment effects on itch and
skin remodeling
À
N
Post hoc results support dupilumab efficacy despite prior
immunosuppressant or phototherapy use, which may indicate PN with
greater severity or that is refractory to treatment
1.Kwatra SG et al. BJ Dermatol. 2023;188(suppl 2)1304432.2. Kwatra SG et al. Br J Dermatol. 2023; 188(suppi 2}i29. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
sy
In dupilumab-treated patients, improvement of skin lesions may lag
behind improvement in itch
+ Or dupilumab may exert independent treatment effects on itch and
skin remodeling
À
N
Post hoc results support dupilumab efficacy despite prior
immunosuppressant or phototherapy use, which may indicate PN with
greater severity or that is refractory to treatment
1.Kwatra SG et al. BJ Dermatol. 2023;188(suppl 2)1304432.2. Kwatra SG et al. Br J Dermatol. 2023; 188(suppi 2}i29. PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Clinically Meaningful Improvements: Other Post-Hoc Results From
PRIME and PRIME2—WI-NRS and Skin Pain-NRS*
EX
Significantly greater 22
proportion of $3
dupilumab-treated es
patients with PN vs
placebo demonstrated
clinically meaningful
improvements in PRO 100
measures of symptoms =
and QOL Es
u
u
1. Kwatra SG et al. Eur Acad Dormatol Vonereol. 2024 May 24, Epub ahead af rn.
PeerView.com/NZV827
WI-NRS Improvement, 24
OR at week 24 (95% Cl)
7.6 (4.03-14.24)
Dupilumab En
Placebo
y 2 y 2 à
Time, wk.
Skin Pain-NRS Improvement 24
OR at week 24 (95% Cl):
49 (2.77883)
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PRIME and PRIME2—WI-NRS and Skin Pain-NRS*
EX
Significantly greater 22
proportion of $3
dupilumab-treated es
patients with PN vs
placebo demonstrated
clinically meaningful
improvements in PRO 100
measures of symptoms =
and QOL Es
u
u
1. Kwatra SG et al. Eur Acad Dormatol Vonereol. 2024 May 24, Epub ahead af rn.
PeerView.com/NZV827
WI-NRS Improvement, 24
OR at week 24 (95% Cl)
7.6 (4.03-14.24)
Dupilumab En
Placebo
y 2 y 2 à
Time, wk.
Skin Pain-NRS Improvement 24
OR at week 24 (95% Cl):
49 (2.77883)
PeerView.com
Copyright © 2000-2024, PeerView
Clinically Meaningful Improvements: Other Post-Hoc Results From
PRIME and PRIME2—Sleep-NRS and DLQI*
Sleep-NRS Improvement 22
OR at week 24 (95% Cl):
2.9(1.71-4.90)
»
Significantly greater a
proportion of » es
E 34
dupilumab-treated a
patients with PN vs Les 7 ; = 3 > à
placebo demonstrated Time, wh
clinically meaningful DLOS improvement 23
improvements in PRO > ee 2.
measures of symptoms re a
and QOL Bs 0
ge ® ji
aS » Placebo 2
0
o
Baseline Wear ans Wonk 12 Wer 24
Time, wk
1. Kwatra SG et al. J Eur Acad Dermatol Venereol 2024 May 24. Epub ahead o print PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
PRIME and PRIME2—Sleep-NRS and DLQI*
Sleep-NRS Improvement 22
OR at week 24 (95% Cl):
2.9(1.71-4.90)
»
Significantly greater a
proportion of » es
E 34
dupilumab-treated a
patients with PN vs Les 7 ; = 3 > à
placebo demonstrated Time, wh
clinically meaningful DLOS improvement 23
improvements in PRO > ee 2.
measures of symptoms re a
and QOL Bs 0
ge ® ji
aS » Placebo 2
0
o
Baseline Wear ans Wonk 12 Wer 24
Time, wk
1. Kwatra SG et al. J Eur Acad Dermatol Venereol 2024 May 24. Epub ahead o print PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Nemolizumab: Mechanism of Action‘?
Human monoclonal antibody
Inhibits binding of IL-31 to its
=: receptor and subsequent
| AS signaling
Macrophage II-31/IL-31RA axis is an
a F Le important factor in pruritus and
"za: =: 4 acts as a bridge between the
CE 1 — AR immunologic and neural
Eosinophil components of itch
Keratinocyte
hu £ hy CET Granted FDA Breakthrough
ia: ES Therapy status in December
2019 for the treatment of PN
esta (© ote sal ord
(intestine, lung) peripheral sensory
neuron (subset)
1. Dati A et al. Alery. 2021:76:2982-2987. 2. Stander Seta. N Eng J Med, 2020:382706-716, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Human monoclonal antibody
Inhibits binding of IL-31 to its
=: receptor and subsequent
| AS signaling
Macrophage II-31/IL-31RA axis is an
a F Le important factor in pruritus and
"za: =: 4 acts as a bridge between the
CE 1 — AR immunologic and neural
Eosinophil components of itch
Keratinocyte
hu £ hy CET Granted FDA Breakthrough
ia: ES Therapy status in December
2019 for the treatment of PN
esta (© ote sal ord
(intestine, lung) peripheral sensory
neuron (subset)
1. Dati A et al. Alery. 2021:76:2982-2987. 2. Stander Seta. N Eng J Med, 2020:382706-716, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Nemolizumab: Phase 3 OLYMPIA Design!
+ N = 274 (183 nemolizumab; 91 placebo)
+ Primary endpoints at week 16
— Itch response (improvement from baseline of 4 points or more on the PP-NRS)
— IGA response (score of 0 or 1 plus a reduction of at least 2 points from baseline)
+ Key secondary endpoints
— Reduction from baseline of 4 points or more on the PP-NRS score at week 4
— Weekly average PP-NRS score of less than 2 at weeks 4 and 16
— Reduction from baseline of 4 or more points on the SD-NRS at weeks 4
and 16
1. Kwatra SG et al. N Engl J Med. 2028:389:1579-1589, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
+ N = 274 (183 nemolizumab; 91 placebo)
+ Primary endpoints at week 16
— Itch response (improvement from baseline of 4 points or more on the PP-NRS)
— IGA response (score of 0 or 1 plus a reduction of at least 2 points from baseline)
+ Key secondary endpoints
— Reduction from baseline of 4 points or more on the PP-NRS score at week 4
— Weekly average PP-NRS score of less than 2 at weeks 4 and 16
— Reduction from baseline of 4 or more points on the SD-NRS at weeks 4
and 16
1. Kwatra SG et al. N Engl J Med. 2028:389:1579-1589, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Nemolizumab: Efficacy Findings From Phase 3 OLYMPIA!
iR Peak Pruritus Numeric Rating Scale Investigator’s Global Assessment Scale
1
& 90 2
= 5 9
8 80 Fd
Fi 5 80
8 70 Nemolizumab 2
3 57
e [3
6 a 9
F 550 Nemolizumab
8 8
= =
2 2
È &
Baseline Wk4 Ws WKI2 WK16 Baseline Wk4 WEB WKk12 WK16
Visit Visit
1.Kwatra SG et al. N Engl J Mod. 2023,389:1579-1589, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, Peerview
iR Peak Pruritus Numeric Rating Scale Investigator’s Global Assessment Scale
1
& 90 2
= 5 9
8 80 Fd
Fi 5 80
8 70 Nemolizumab 2
3 57
e [3
6 a 9
F 550 Nemolizumab
8 8
= =
2 2
È &
Baseline Wk4 Ws WKI2 WK16 Baseline Wk4 WEB WKk12 WK16
Visit Visit
1.Kwatra SG et al. N Engl J Mod. 2023,389:1579-1589, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, Peerview
Nemolizumab: Safety Findings From Phase 3 OLYMPIA‘
| Patients, n (%)
Most common
adverse events
in the 21 adverse event 112 (61.2) 48 (52.7)
(n = 183) (n= 91)
| Nemolizumab Placebo
nemolizumab .
group were 21 serious adverse
atopic dermatitis event
and headache
4 (22) 5 (5.5)
Adverse event
leading to treatment 4 (2.2) 2 (2.2)
discontinuation
1. Kwatra SG et al. N Eng! J Mod. 2023;389:1579-1589, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
| Patients, n (%)
Most common
adverse events
in the 21 adverse event 112 (61.2) 48 (52.7)
(n = 183) (n= 91)
| Nemolizumab Placebo
nemolizumab .
group were 21 serious adverse
atopic dermatitis event
and headache
4 (22) 5 (5.5)
Adverse event
leading to treatment 4 (2.2) 2 (2.2)
discontinuation
1. Kwatra SG et al. N Eng! J Mod. 2023;389:1579-1589, PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Nalbuphine: Phase 2/3 Results Show
Improvement in Itch at Week 141
NAL ER 162 mg
Primary endpoint Placebo
The proportion of patients in the NAL
ER group who had 24-point
improvement from baseline in WI-NRS
score was significantly greater than
in the placebo
Responders, % (SE)
onsaunen
1. Weisshaar etal. J Eur Acad Dermatol Venereol 2022:96:453-461 PeerView.com
PeerView.com/NZV827 Copyright © 2000-2024, PeerView
Improvement in Itch at Week 141
NAL ER 162 mg
Primary endpoint Placebo
The proportion of patients in the NAL
ER group who had 24-point
improvement from baseline in WI-NRS
score was significantly greater than
in the placebo
Responders, % (SE)
onsaunen
1. Weisshaar etal. J Eur Acad Dermatol Venereol 2022:96:453-461 PeerView.com
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Agent
Abrocitinib
Povorcitinib
Ruxolitinib
cream
Vixarelimab
Barzolvolimab
(CDX-0159)
1. ps ini gov
PeerView.com/NZV827
Other Emerging Therapies for PN in
Late-Stage Clinical Development!
MOA
JAKA inhibitor
JAK inhibitor
JAK 1/2 inhibitor
OSMR inhibitor
KIT (CD117)
Adults With PN à
and Chronic Pruritus of Unknown Origin (NCT05038982)
A Study to Evaluate the Efficacy and Safety of INCB054707 in 2
Participants With PN (NCTO5061693)
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in
Participants With Prurigo Nodularis (PN) (TRUE-PN1) a
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in
Participants With Prurigo Nodularis (PN) (TRUE-PN2)
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab 2
in Reducing Pruritus in PN (NCT03816891)
A Study of Barzolvolimab in Patients with Prurigo Nodularis 2
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Abrocitinib
Povorcitinib
Ruxolitinib
cream
Vixarelimab
Barzolvolimab
(CDX-0159)
1. ps ini gov
PeerView.com/NZV827
Other Emerging Therapies for PN in
Late-Stage Clinical Development!
MOA
JAKA inhibitor
JAK inhibitor
JAK 1/2 inhibitor
OSMR inhibitor
KIT (CD117)
Adults With PN à
and Chronic Pruritus of Unknown Origin (NCT05038982)
A Study to Evaluate the Efficacy and Safety of INCB054707 in 2
Participants With PN (NCTO5061693)
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in
Participants With Prurigo Nodularis (PN) (TRUE-PN1) a
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in
Participants With Prurigo Nodularis (PN) (TRUE-PN2)
Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab 2
in Reducing Pruritus in PN (NCT03816891)
A Study of Barzolvolimab in Patients with Prurigo Nodularis 2
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Patient Interview
Experiences With
PN Treatment
Copyright © 2000-2024, PeerView
Experiences With
PN Treatment
Copyright © 2000-2024, PeerView
Faculty Discussion
Summary
The goals of PN treatment include reducing pruritus, interrupting the
itch-scratch cycle, healing PN lesions, and improving patient QOL
An interprofessional approach is critical for optimal patient management
Treatment for PN has begun to evolve with the approval of targeted
biologic therapy (dupilumab) in 2022;
other agents (eg, nemolizumab, JAK inhibitors) are in development
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Copyright
The goals of PN treatment include reducing pruritus, interrupting the
itch-scratch cycle, healing PN lesions, and improving patient QOL
An interprofessional approach is critical for optimal patient management
Treatment for PN has begun to evolve with the approval of targeted
biologic therapy (dupilumab) in 2022;
other agents (eg, nemolizumab, JAK inhibitors) are in development
PeerView.com
Copyright
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