Disease Analysis: Psoriasis
Publisher: Datamonitor Healthcare
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Definition
Psoriasis is a chronic inflammatory skin disorder affecting around 2–3% of the world’s population. It is identified as thick scaling red plaques, resulting from an unusually high rate of skin cell growth. It usually involves the skin and nails, and leads to lesions which cause itching, stinging, and pain. While the main cause of psoriasis remains uncertain, several studies have reported that it is due to autoimmunity, genetic predisposition, and environmental factors. Additionally, psoriasis may be provoked by several triggers, including trauma, obesity, infection, systemic drugs, and stress.
Latest key takeaways
- Datamonitor Healthcare estimates that in 2021, there were 53.4 million prevalent cases of psoriasis worldwide, and forecasts that number to increase to 55.4 million prevalent cases by 2027.
- First-line treatment of milder forms of psoriasis will continue to be with cheaper, topical medications. Use of more expensive, systemic therapies will continue to be relegated to more severe psoriasis.
- While the psoriasis market will see downward pressure from the arrival of biosimilars of the key marketed anti-TNF brands Enbrel and Humira, overall growth will be driven partly by the recent launches of a number of more targeted and efficacious interleukin inhibitors which have expanded the market, as well as by increasing prevalence of the disease.
- Results from head-to-head studies solidly place IL-17 and IL-23 inhibitors ahead of older TNF-alpha inhibitors in terms of efficacy, while differentiating between these newer pathways may come down to speed of disease clearance and safety signals. AbbVie’s IL-23 inhibitor Skyrizi, with strong disease clearance, stands out among competitors with remarkably fast uptake on the market.
- Bimzelx (bimekizumab) received European approval in August 2021, while US approval is expected after UCB addresses minor concerns in a complete response letter it received from the FDA in May 2022. Positive readouts from Bimzelx’s three Phase III psoriasis trials, including head-to-head comparisons against Stelara and Humira, will ensure approval of UCB’s IL-17A/F inhibitor. Unlike Novartis’s Cosentyx and Eli Lilly’s Taltz, which target IL-17A, Bimzelx neutralizes both IL-17A and IL-17F.
- Results from the Phase III POETYK-PSO trials of Bristol Myers Squibb’s TYK2 inhibitor deucravacitinib demonstrate superiority over Otezla, giving deucravacitinib an advantage in the oral treatment market in moderate-to-severe psoriasis. US approval decisions for deucravacitinib and PDE4 inhibitor ARQ-151 are expected during H2 2022.
- The likelihood of approval of a Phase I psoriasis asset is just over 10%. Psoriasis drugs, on average, take 7.7 years from Phase I to approval, which is about two years faster than drugs in the overall autoimmune/immunology space.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Disease definition
8 Symptoms
8 Patient segmentation
9 Subtypes
10 TREATMENT
10 Topical agents remain the gold standard for mild psoriasis
10 Systemic therapies are the mainstay of treatment for moderate-to-severe disease
10 Classes of topical agents to treat psoriasis
13 Key oral systemic classes to treat psoriasis
14 Major biologic classes to treat psoriasis
15 Treatment guidelines
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
34 PIPELINE DRUGS
44 KEY REGULATORY EVENTS
44 Lupin Picks Up Canadian Approval For Enbrel Biosimilar
44 Alvotech Sets Sights On Stelara Submission By Close Of 2022
44 BMS Aims To Unseat Otezla In Psoriasis With US FDA-Approved Sotyktu
45 Alvotech Bullish As Facility Deficiencies Hold Up Humira Biosimilar Again
45 Boehringer’s Spesolimab Wins First Approval In Rare Skin Condition
46 Fresenius Kabi Breaks Into Brazilian Biosimilars Market
46 Arcutis Launches Zoryve For Psoriasis As A New Topical In A Growing Category
46 Sandoz Lines Up Higher-Strength Adalimumab In Europe
47 Stada And Alvotech Launch Higher-Strength Adalimumab In Europe
47 Dermavant Prepares For First Launch, Looking To Build A Blockbuster Psoriasis Brand
47 UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx
48 Shanghai Junshi Announces Chinese Adalimumab Approval
48 Alvotech Reveals Action Date For Interchangeable Adalimumab BLA
48 Amgen: Humira Interchangeability ‘A Nice To Have, Not A Need To Have’
49 Alvotech Eyes Canada Humira Launch As Celltrion Also Bags High-Strength Approval
49 Coherus Promises ‘Compelling Value Proposition’ After US Adalimumab Approval
50 BI Spesolimab Positioned For FDA Action By August 2022
50 Bristol Submits First-In-Class Psoriasis, Hematology Agents
50 Mochida And Ayumi Launch Unique Humira Biosimilar Formulation In Japan
51 Seventeen And Counting – Bumper Crop Of New EU Filings
51 Scotland’s HTA Body Says Fast-Track Yes To UCB’s Bimzelx
51 Boehringer Targets High Unmet Need With Spesolimab Filing
51 EU Fast-Track Rejected For Boehringer’s Spesolimab
52 UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug
52 Boehringer Ingelheim Wins Interchangeable Biosimilar To Humira, Setting Benchmark For Switching Studies
53 PROBABILITY OF SUCCESS
54 LICENSING AND ASSET ACQUISITION DEALS
54 Formycon Strengthens Biosimilars Portfolio With Athos Assets
54 Henlius Partners With Getz To Commercialize Adalimumab Biosimilar
54 Hikma Adds Remsima SC To Celltrion MENA Collaboration
55 Xbrane And Biogen Ally On Certolizumab Pegol Biosimilar
55 Assertio Acquires Otrexup From Antares Pharma
55 KoBioLabs, SPH Sine Ink $107.25m Microbiome Therapeutics Deal
56 CLINICAL TRIAL LANDSCAPE
57 Sponsors by status
58 Sponsors by phase
59 Recent events
63 DRUG ASSESSMENT MODEL
63 Biologics
68 Oral small molecules
68 Topicals
71 MARKET DYNAMICS
72 FUTURE TRENDS
72 Market access drives prescribing trends in a crowded market
72 Biosimilar prospects safeguard the relevance of older classes
72 Oral treatments will become increasingly attractive
73 CONSENSUS FORECASTS
80 RECENT EVENTS AND ANALYST OPINION
80 ARQ-154 for Psoriasis (September 26, 2022)
81 Piclidenoson for Psoriasis (June 29, 2022)
83 Bimzelx for Psoriasis (May 13, 2022)
84 Deucravacitinib for Psoriasis (May 12, 2022)
85 EDP1815 for Psoriasis (September 27, 2021)
88 KEY UPCOMING EVENTS
89 KEY OPINION LEADER INSIGHTS
92 UNMET NEEDS
92 More effective oral treatments
92 Safe topical treatments that enable compliance
92 Additional data on co-morbidities and options for patient subsets
94 BIBLIOGRAPHY
95 APPENDIX
LIST OF FIGURES
18 Figure 1: Trends in prevalent cases of psoriasis, 2018–27
34 Figure 2: Overview of pipeline drugs for psoriasis in the US
34 Figure 3: Pipeline drugs for psoriasis, by company
35 Figure 4: Pipeline drugs for psoriasis, by drug type
35 Figure 5: Pipeline drugs for psoriasis, by classification
53 Figure 6: Probability of success in the psoriasis pipeline
56 Figure 7: Clinical trials in psoriasis
56 Figure 8: Top 10 drugs for clinical trials in psoriasis
57 Figure 9: Top 10 companies for clinical trials in psoriasis
57 Figure 10: Trial locations in psoriasis
58 Figure 11: Psoriasis trials status
59 Figure 12: Psoriasis trials sponsors, by phase
63 Figure 13: Datamonitor Healthcare’s drug assessment summary for psoriasis
71 Figure 14: Market dynamics in psoriasis
72 Figure 15: Future trends in psoriasis
81 Figure 16: ARQ-154 for Psoriasis (September 26, 2022): Phase III – ARRECTOR
83 Figure 17: Piclidenoson for Psoriasis (June 29, 2022): Phase III – Comfort (EU)
87 Figure 18: EDP1815 for Psoriasis (September 27, 2021): Phase II – 201
88 Figure 19: Key upcoming events in psoriasis
LIST OF TABLES
12 Table 1: Topical corticosteroids for psoriasis – ultra-high and high potency
13 Table 2: Topical corticosteroids for psoriasis – moderate and low potency
15 Table 3: Psoriasis treatment guidelines
17 Table 4: Prevalent cases of psoriasis, 2018–27
20 Table 5: Marketed drugs for psoriasis
36 Table 6: Pipeline drugs for psoriasis in the US
74 Table 7: Historical global sales, by drug ($m), 2017–21
77 Table 8: Forecasted global sales, by drug ($m), 2022–26
80 Table 9: ARQ-154 for Psoriasis (September 26, 2022)
82 Table 10: Piclidenoson for Psoriasis (June 29, 2022)
84 Table 11: Bimzelx for Psoriasis (May 13, 2022)
85 Table 12: Deucravacitinib for Psoriasis (May 12, 2022)
86 Table 13: EDP1815 for Psoriasis (September 27, 2021)
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