Inflammation is a core driver of many burdensome diseases. More than one billion people worldwide suffer from classic inflammatory diseases – including psoriasis, atopic dermatitis, arthritides, asthma, allergies, and inflammatory bowel disease. While each of these diseases presents differently, all are characterized by systemic inflammation, and all have a significant, negative impact on people’s lives.
Chronic inflammation impacts billions of people worldwide
Classic, chronic inflammatory diseases include:
- Atopic dermatitis
- Psoriasis
- Psoriatic arthritis
- Rheumatoid arthritis
- Asthma
- Allergy
- Axial spondylarthritis
- Inflammatory bowel disease
Suffer from classic, chronic inflammatory diseases1,2
1/3 of world’s population impacted by a broader set of inflammatory diseases3
1 Datamonitor Healthcare. 2 Pahwa R, Goyal A, Bansal P, Jialal I. Chronic Inflammation. 2021 Aug 11, PMID: 29630225. 3 Global Disease Burden 2017.
Two of these highly prevalent, chronic inflammatory diseases are psoriasis and atopic dermatitis. Worldwide, psoriasis affects over 50 million people and atopic dermatitis over 200 million people. For both diseases, the vast majority of sufferers have mild or moderate disease. In the United States, roughly 93% of psoriasis sufferers and 85% of atopic dermatitis sufferers have either mild or moderate disease, with similar distributions throughout the world. People who suffer from psoriasis and atopic dermatitis report a significant impact on their quality of life and experience a significant psycho-social burden which has been estimated to be greater than the impact of diabetes, cardiovascular disease, and even some cancers.
Psoriasis
55M Worldwide prevalence
8.6M US prevalence
6.7M US diagnosed
|
71% 4.8M |
22% 1.5M |
7% 0.4M |
Atopic Dermatitis
201M Worldwide prevalence
21.3M US prevalence
10M US diagnosed
|
54% 5.4M |
31% 3.1M |
15% 1.5M |
- Mild
- Moderate
- Severe
Source: Datamonitor Healthcare Vanderpuyre-Orgle et al. J Am Acad Dermatol. 2015: 72:961–7
Psoriasis is driven by Th17-inflammation, which typically results in the formation of thickened red plaques with scaling. Psoriatic lesions can appear anywhere on the body, but are most often seen on the knees, elbows, scalp, and lumbar area. There is a strong association between psoriasis and psoriatic arthritis, depression, and metabolic syndrome.
Atopic dermatitis typically presents as a red, intensely itchy rash that may cause lifelong symptoms. Due to the chronic nature and frequency of flares, atopic dermatitis is associated with a substantial physical and psychosocial burden on patients and their families. Atopic dermatitis can also occur alongside other atopic diseases including food allergy, asthma, and allergic rhinitis, as these conditions are all associated with an imbalance towards a Th2 inflammatory response.
It is recognized that sufferers with mild or moderate psoriasis or atopic dermatitis are underserved by current treatments. These sufferers are often treated with topical medications, which are inconvenient and burdensome in application, leading to poor adherence and reduced efficacy. Beyond topicals, sufferers have limited treatment options, especially those with mild or moderate disease. These sufferers may not have access to high-cost, injectable antibody therapies or may be uncomfortable with tolerability issues, toxicity concerns and/or monitoring requirements of systemic immunosuppressants. Even within the moderate to severe segments, where the majority of novel systemic therapies are approved, most sufferers do not use these therapies due to a number of factors, including safety, convenience, and high cost. There is a large need across the spectrum of disease severity, and especially for mild and moderate sufferers, for an effective, safe, well-tolerated, and affordable oral medicine that resolves the systemic inflammation that is at the core of psoriasis and atopic dermatitis.
Despite the high prevalence of psoriasis and atopic dermatitis, several myths continue to exist regarding the nature of these diseases, the unmet clinical need, and access to innovative therapies. Scroll down as we address several of these myths:
Myth 1:
Mild psoriasis and atopic dermatitis are not serious conditions
The disease severity labels of “mild,” “moderate,” and “severe” serve to characterize how much of a patient’s body is covered in skin lesions, but do not necessarily reflect the severity of individual lesions or the burden that psoriasis and atopic dermatitis have on the lives of sufferers. Despite their label, “mild” psoriasis and atopic dermatitis are serious conditions for sufferers, with lesions that can be extremely painful with skin cracking and bleeding, itchy, often highly visible, and may be located on very inconvenient areas of the body (scalp, hands, feet, etc.). In one survey, ~65% of sufferers with mild psoriasis reported a moderate to high impact of their disease on daily life. “Mild” disease can also have a significant psycho-social impact. Sufferers with mild psoriasis or mild atopic dermatitis have a higher risk of depression than people who do not suffer from these diseases.
Mild psoriasis and atopic dermatitis are serious conditions
Burdensome lesions
- Painful, cracked skin
- Itchy and irritating
- Often highly visible
Quality of life impacts
- 65% of “mild” PsO sufferers report moderate – extremely high impact on daily life1
- Mild AD sufferers report greater impact to quality of life vs. people without AD2
Psycho-social impacts
- 34% of “mild” PsO sufferers have depression; 27% suffer sleep disturbance3
- 50% higher risk of depression for mild-moderate AD sufferers vs. people without AD4
1 Martin G., et al., J Clin Aesthet Dermatol. 2019:12(4):13-26. 2 Chiesa Fuxench, Z., et al., J Investigative Dermatol. 2019:139:583-590. 3 Luca M, Musumeci ML, D’Agata E, Micali G. Int J Psychiatry Clin Pract. 2020 Mar;24(1):102-104. 4 Toron, F., Neary, M.P., Smith, T.W. et al. Dermatol Ther (Heidelb) 11, 907–928 (2021).
Myth 2:
Psoriasis and atopic dermatitis are diseases only of the skin
Psoriasis and atopic dermatitis sufferers often experience a number of comorbidities, including psoriatic arthritis for sufferers with psoriasis and asthma and allergies for sufferers with atopic dermatitis. Psoriasis and atopic dermatitis sufferers are also at increased risk for adverse cardiovascular events.
PsO and AD are associated with multiple comorbidities
Psoriasis sufferers
42% suffer from psoriatic arthritis1
58% increased risk of major cardiac event2
3X increased risk of inflammatory bowel disease1
Atopic dermatitis sufferers
Up to 20% have asthma3
30% suffer from allergies4
20% increased risk of cardiovascular death5
1 Oliveira Mde F, Rocha Bde O, Duarte GV. An Bras Dermatol. 2015 Jan-Feb;90(1):9-20. 2 Addressing NCD Psoriasis and its Comorbidities – Shared Opportunities for Action.” International Federation of Psoriasis Associations and NCD Alliance. 2017. 3 Silverberg et al. J Allergy Clin Immunol; 2013;132(5):1132-1138. 4 Silverberg JI. Ann Allergy Asthma Immunol; 2019;123(2):144-151. 5 Silverwood R J, Forbes H J, Abuabara K, Ascott A, Schmidt M, Schmidt S A J et al. BMJ 2018; 361 :k1786.
Though psoriasis and atopic dermatitis are diseases that manifest in skin plaques and lesions, these diseases are driven by chronic, systemic inflammation. PET scans of sufferers with psoriasis and atopic dermatitis have shown increased inflammation throughout the body, including around the heart. This underscores the importance of therapies that address the core driver of these diseases- systemic inflammation. Topical therapies, which have been mainstay treatments for sufferers with psoriasis and atopic dermatitis, treat the skin symptoms of these diseases but do not address the underlying systemic inflammation.
PsO and AD are diseases of systemic inflammation
Systemic
Inflammation
PET scans of people suffering from PsO1 and AD2 confirm systemic inflammation, including in:
1 Mehta, Nehal N., et al. Archives of dermatology 147.9 (2011): 1031-1039. 2 Ungar, Benjamin, et al, The Journal of Allergy and Clinical Immunology: In Practice 8.10 (2020): 3500-3506.
Myth 3:
Little unmet need remains in psoriasis and atopic dermatitis
Innovative therapies for psoriasis and atopic dermatitis, including injectable antibody therapies and oral immunosuppressants, are targeted towards sufferers with moderate and severe disease. It is estimated that in the US, where people have very high access to innovative therapies relative to other regions of the world, less than 8% of sufferers with psoriasis and less than 2% of sufferers with atopic dermatitis have received these treatments.
Few sufferers with PsO or AD receive innovative therapies that address their systemic disease
Psoriasis
Atopic dermatitis
As many as 50% of PsO and AD sufferers in the US are not on any Rx treatment2,7,8
1 IQVIA and Symphony Health Data 2 Datamonitor Healthcare, accessed June 2021. 3 Armstrong A, et al., Dermatol Ther (Heidelb). 2017 Mar; 7(1). 4 IQVIA Prescription data from Analyst Report, Oct 2020. 5 DRG Epidemiology Database 2017 6 Lebwohl MG, et al., J Am Acad Dermatol. 2014 May;70(5):871-81.e1-30. 7 Silverberg JI, et al., Allergy Asthma Immunol. 2018 Dec;121(6):729-734.e4. 8 Armstrong, April W., et al. JAMA dermatology 149.10 (2013): 1180-1185. 9 Regeneron 2020 4th quarter earnings call.
Safety, tolerability, convenience, and high cost are significant barriers to treatment, with many people, especially those with mild and moderate disease, opting for topical treatments or no treatment at all. Approximately 50% of psoriasis and atopic dermatitis sufferers in the U.S are not treated with any prescription therapy. The majority of treated sufferers use topicals, which are time intensive and inconvenient to administer, have low compliance rates, and address only the outward, dermatologic manifestations of disease, leaving the systemic inflammation that characterizes these conditions untreated. Oral immunosuppressants address systemic inflammation, but often do so at the cost of safety concerns, monitoring requirements, and / or tolerability issues including diarrhea and nausea. Limitations of injectable antibody therapy include administration by injection, the potential for immunosuppression, and high cost.
Therapies for PsO and AD have limitations related to safety, tolerability, convenience, and price
>50% of PsO and >90% of AD sufferers are dissatisfied with current treatment options1,2
Topicals
PsO/AD
- Steroids, calcineurin inhibitors, others
- Not convenient
- Low compliance
- No systemic impact
Old-school Systemics
PsO
- Safety concerns
- Monitoring requirement
- Immunosuppressant
Oral Immunosuppressant
PsO
- Apremilast:
- Safety and tolerability issues
- High price
Injectable
Biologics
PsO/AD
- Not convenient & needle fear
- Immunosuppressant
- High price
1 Florek, Aleksandra G., et al., Archives of dermatological research 310.4 (2018): 271-319. 2 National Eczema Association report, 2020.
Clinicians weigh a number of factors and product attributes when selecting therapies for psoriasis and atopic dermatitis sufferers. For both psoriasis and atopic dermatitis, surveyed physicians indicated safety and tolerability as the most important therapy attribute, ahead of efficacy.
Dermatologists rank safety and tolerability as most important when selecting a treatment for PsO and AD
Psoriasis1
- Safety and Tolerability
- Efficacy
- Affordability
- Other non-efficacy or safety related attributes
Atopic dermatitis2
- Safety and Tolerability
- Efficacy
- Affordability
- Other non-efficacy or safety related attributes
1 Alcusky, M., et al. Dermatol Ther (Heidelb) 7, 463–483 (2017). 2 Okubo, Yukari, et al. Journal of Dermatological Treatment 31.8 (2020): 821-830.
Simply put, there remains a significant need for oral medicines that are effective, safe, well-tolerated and affordable for the millions of people suffering from psoriasis and atopic dermatitis around the globe, especially for people with mild and moderate disease.
Myth 4:
High drug cost is the price paid for innovative medicine
High priced therapies for PsO and AD reach a fraction of sufferers
Traditional Pharma High-Price Model
Antibody therapies and innovative oral therapies for PsO and AD are priced high and used by a small portion of moderate – severe sufferers
New Affordable Volume-Based Model
An effective, safe, well tolerated, oral, and affordable therapy could expand the addressable patient population
Traditional Pharma High-Price Model
Antibody therapies and innovative oral therapies for PsO and AD are priced high and used by a small portion of moderate – severe sufferers
New Affordable Volume-Based Model
An effective, safe, well tolerated, oral, and affordable therapy could expand the addressable patient population
High drug prices are often cited as the price for sustaining innovation. For example, within the psoriasis and atopic dermatitis category, innovative products command prices between $40,000 and $80,000 per person per year in the US and are used by only a small proportion of moderate and severe sufferers. Outside of the US, even fewer sufferers have access to these medicines due, in part, to high costs. Relative to these products, a safe, well tolerated, oral therapy that is affordable could expand the addressable patient population- allowing hundreds of millions of sufferers around the world access to such a therapy.
The time has come for the pharma industry to explore affordable, volume-based business models that maximize the access of sufferers to medicines on a global basis.
Time is ripe to explore affordable, volume-based business models that maximize impact
Affordable, oral, effective, safe therapies expand patient access
Targeting underserved populations unlocks new market potential
Affordable pricing accelerates penetration and displaces expensive therapies
Digital/remote technology accelerates delivery and care
Remote technology expands access to physicians and care to underserved patients
On-demand telemedicine grows volume and access to patient populations
Direct to patient and pharmacy distribution models scale access
Digitized solutions and prescription delivery streamlines experience
Maximize impact of sales force and HCP productivity
