patient insights in topical therapy in psoriasis · 2016-12-07 · pso-insightful study design...
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Patient Insights in Topical Therapy in Psoriasis
Dr. Kim Papp
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Speaker DisclosuresSpeaker, Consultant, Investigator
• Amgen ***• Anacor ***• AbbVie ***• Active Biotech *• Akesis *• Allergan **• Astellas ***• AstraZeneca **• Basilea **• Baxter **• Bayer **• Biogen-Idec *• Boehringer-Ingelheim ***• Bristol Myers Squibb **• Celgene ***• Cato *• CellScale Biomaterials *
• Medimmune **• Meiji Seika Pharma *• Merck (MSD) ***• Mylan ***• Merck-Serono ***• Novartis ***• Pfizer ***• Regeneron ***• Rigel *• Roche **• Sosei *• Takeda **• Sanofi-Aventis *• UCB ***• Vertex *• Xoma **
• Cepheid *• Centocor ***• Cipher **• Coherus **• Dow Pharma *• Eli Lilly ***• Endocyte *• Ferring Pharma *• Forward Pharma **• Galderma ***• Genentech **• Gilead **• GSK **• Janssen ***• Kyowa Hakko Kirin **• Kythera **• LEO Pharma ***
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Barriers• Medication efficacy• Messiness• Time-consuming/
complex regimens• Inconvenient • Side effects
AdherenceWhat do our
patients think?
Do I takewith food?.Do I takewith food?.
What if I miss
a dose?
What if I miss
a dose?
How do I takethe medication?.How do I takethe medication?.
What is adherenceWhat is adherence
What are the long-termeffects?
What are the long-termeffects?
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Breaking Barriers• Effective• Cosmesis• Convenient• Simple• Safe
AdherenceWhat do our
patients think?
Do I takewith food?.Do I takewith food?.
What if I miss
a dose?
What if I miss
a dose?
How do I takethe medication?.How do I takethe medication?.
What is adherenceWhat is adherence
What are the long-termeffects?
What are the long-termeffects?
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The Patient Gap
• Involvement of patients in product development
• Ex: Dovobet® Gel Applicator
• Patient Advocacy Groups
Using patient insight to get better patient outcomes
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Calcipotriol & Betamethasone Dipropionate Evolution
Dovobet® Ointment(Calcipotriol/betamethasone
dipropionate)2001
1995Dovonex®
(Calcipotriol)Cream, Ointment
Scalp Solution
2009 Dovobet® (Xamiol®) Gel
(Calcipotriol/ betamethasone dipropionate)
(Scalp Psoriasis)
Enstilar® Aerosol FoamCalcipotriol/betamethasone
dipropionate) Sept 2016
2015Dovobet® Gel
Applicator
Dovobet® Gel(Body Psoriasis)
2013
Stab
ility
CalcipotriolBDP
7pH
140
• Unique anhydrous formulation allows disparate substances to co-exist
• Maintains bioavailability
Calcipotriol/Betamethasone Dipropionate Formulation
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Enstilar® - Ingredients and Properties
Lind M, et al. Dermatol Ther (Heidelb). 2016;6(3):413-2; Enstilar Product Monograph 2016.
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Enstilar® - Ingredients and Properties
Vehicle base(paraffin + additives)
Lind M, et al. Dermatol Ther (Heidelb). 2016;6(3):413-2; Enstilar Product Monograph 2016.
Propellants (butane & dimethyl ether)
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Study Objective
Attributes effecting usability
Factors influencing patient preference
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PSO-Insightful Study DesignInternational, multi-centre, prospective, open-label, randomised, 2-arm, 2-week cross-over trial, N=200
Up to 14 days, if needed
Visit 3Day 15 Follow-up
ScreeningDay -28 to 1
4-week washout, if needed 7 days
Enstilar®
Aerosol Foam
Visit 1Day 1
Randomisation
Dovobet® Gel
7 days
Enstilar®
Aerosol Foam
Visit 2Day 8
Cross-over
Dovobet® Gel
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Main Assessments
*Only relevant for subjects that have used a topical anti-psoriatic treatment on treatment areas within last 3 months
Disease severity via PGA, BSA, mPASI, SGA (baseline measures)
Dermatology Life Quality Index (DLQI) (validated)
Subject’s Assessment of Behaviour and Attitudes (SABA)
( ) ( )Vehicle Preference Measure (VPM)
(Licensed from Wake Forest Health Sciences) (validated)
Subject’s Preference Assessment (SPA)
Comparison to Latest Topical Treatment (CLTT)*
Product Usability Questionnaire (TPUQ)
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PSO-Insightful: Patient Demographics
Age 52 years; 37% female (mean)Duration of psoriasis 20 years (mean)Disease severity • BSA (trunk/limbs): 5.7% (mean)
• Baseline PASI: 6.8 (mean)• PGA: mild 29%, moderate 57%, severe 14%
DLQI score 7.8 (mean)N • 212 subjects - Full analysis set
• 118 subject - CLTT analysis set
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Assessment of Psoriasis
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Subject’s Assessment of Behaviour and Attitudes (SABA)
0 50 100
Feels very self-conscious about psoriasis
worry about side effects
Busy lifestyle Limits Time for Treatment
Apply treatment quickly very important
Keen to try the newest treatment
I regularly seek out information on psoriasis
I prefer my doctor to recommend
slightly agreestrongly agree
Impact of Psoriasis (yes/no) Attitude to Psoriasis (5 pt scale)
0 10 20 30 40 50 60 70
impacts my well being
impacts my self-confidence
Physical impact
impacts my relationship/sex life
impacts my social life
impacts my work
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Audience Participation: Vehicle Sampling
On each table you will find:• Enstilar® Aerosol Foam Vehicle (Placebo)• Dovobet® Gel Vehicle (Placebo)
Consider the following characteristics for each product:• Application: ease and spreadability• Formulation: sensation and cosmetic properties
Sample each vehicle on your skin: Foam: Shake well - spray 3 cm from your skin Gel: Shake well - apply to your skin
• Rub each formulation into your skin
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QuestionIn your opinion, which of the following differentiates Enstilar®
from Dovobet® Gel?i. Quickly absorbedii. Soothing feeling on skiniii. Ease of applicationiv. Lack of mess when applyingv. Not greasy
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QuestionWhat do you think patients will feel differentiates Enstilar® from Dovobet® gel?i. Quickly absorbedii. Soothing feeling on skiniii. Ease of applicationiv. Lack of mess when applyingv. Not greasy
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Question
What other characteristics would you use to describe Enstilar®?i. Not greasyii. Cool feeling on applicationiii. Quick to applyiv. Good for use on large areas
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Product Assessments: Enstilar® Aerosol Foam - Dovobet® Gel
• Topical Product Usability Questionnaire (TPUQ)• Comparison to Last Topical Treatment (CLTT)• Vehicle Preference Measure (VPM)
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Topical Product Usability QuestionnaireEnstilar® Aerosol Foam – Top Scores
Application – Highest scores• ‘ease of spreading’• ‘quick to apply’• ‘total time spent acceptable’• ‘easily incorporated into daily routine’• ‘good for large areas’
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Topical Product Usability QuestionnaireEnstilar® Aerosol Foam – Top Scores
Formulation • ‘felt soothing’• ‘odourless’• ‘felt moisturising to my skin’
Satisfaction - Generally high scores• ‘would use product regularly’
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Topical Product Usability QuestionnaireDovobet ® Gel – Top Scores
Application – Highest scores• ‘ease of spreading’• ‘ease of application’• ‘good for use on larger areas’• ‘total time spent acceptable’• ‘easily incorporated into daily routine’
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Topical Product Usability QuestionnaireDovobet ® Gel – Top Scores
Formulation • ‘felt soothing’• ‘odourless’• ‘felt moisturising to my skin’
Satisfaction - Generally high scores• ‘would use product regularly’
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Aerosol Foam N=(209)
Gel N=(198)
‘immediate feeling of relief’(Foam = 1 vs Gel= 0.7; P < 0.01)
‘not greasy’(Foam = 0.0 vs Gel= 0.3; P < 0.05)
‘felt soothing to my skin’ (Foam = 1.2 vs Gel = 1.0; P < 0.01)
‘odourless’(Foam = 1.3 vs Gel= 1.6; P < 0.001)
Topical Product Usability Questionnaire (TPUQ)
Rating scale: -2 to +2.
Formulation - What do patients like most about the Foam & Gel
Aerosol Foam N=(209)
Gel N=(198)
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Age Groups Patients18 to 39 yrspreferred foam
Patients 40 to 59 yrs and ≥60 yrs preferred gel
Distribution of Psoriasis
Patients with a localiseddistribution favoured foam
Patients with a widespread distribution
favoured gel
Topical Product Usability Questionnaire (TPUQ)
Difference in Scores Between Treatments
Enstilar Aerosol® Foam N=(209)
Dovobet® Gel N=(198)
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Vehicle Preference Measure (VPM) Questionnaire (7 questions, 7 point scale)
What do patients like most about the vehicles?Foam Gel
• ‘time it takes to apply’• ‘how it feels on the skin’
• ‘time it takes to apply’• ‘ease of application’• ‘how it smells’
Younger subjects tended to give higher scores for foam
Older subjects tended to givehigher scoresfor gel
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Overall Summary
Both treatments showed high scores for usability and satisfaction
Aerosol Foam and gel are generally preferred over previous topical treatments:• 72% would recommend Foam to other patients• 66% would recommend Gel to other patients
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Overall Summary
Preference between gel and foam is shared between subjects
• younger patients favoured foam• older patients favoured gel
Foam highlights: ‘immediate feeling of relief’ & ‘felt soothing to my skin’Gel Highlights: ease and precision of application