Disease Analysis: Psoriasis
Author: Pammy Spicer
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 early in 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 deucravactinib, as well as for topical aryl hydrocarbon receptor modulator tapinarof and PDE4 inhibitor ARQ-151, are expected during 2022.
- The likelihood of approval of a Phase I psoriasis asset is just over 10%. Psoriasis drugs, on average, take just over seven years from Phase I to approval, 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 Patient segmentation – 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
14 Treatment guidelines
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
33 PIPELINE DRUGS
44 KEY REGULATORY EVENTS
44 UCB’s Bimekizumab Gets Fast-Track Funding For Severe Psoriasis In England
44 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
44 UCB’s Bimzelx Close To Challenging Major Psoriasis Players
44 Dermavant Sees PSOARING Prospects For Tapinarof
45 UCB Announces New User Fee Goal Date For Bimekizumab
45 sNDA Submission For Otezla
45 Coherus Gets Goal Date On US Adalimumab Biosimilar
45 Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
46 Innovent’s Adalimumab Gets New Indications In China
46 Celltrion Wins Race For High-Concentration Adalimumab
46 Henlius Gets Green Light For Adalimumab In China
47 Merck Matches Sandoz With Canadian Etanercept Indications
47 Cadila Pharma Adds To Indian Biosimilars With Adalimumab
48 PROBABILITY OF SUCCESS
49 LICENSING AND ASSET ACQUISITION DEALS
49 Intas Picks Up Global Rights To Meiji And Dong-A’s Stelara Biosimilar
49 Lipidor Licenses Two Psoriasis Candidates To Menarini Subsidiary
49 Sanofi Partnership On Oral IL-17 Could Be Turning Point For C4XD
50 Busy 2021 Ahead For Almirall On Business And Clinical Fronts
50 Novartis Signs 1Yao To Up Psoriasis Digital Push
50 Allergy Therapeutics Takes First Steps Into Broader Vaccine Field
52 CLINICAL TRIAL LANDSCAPE
53 Sponsors by status
54 Sponsors by phase
55 Recent events
60 DRUG ASSESSMENT MODEL
60 Biologics
64 Oral small molecules
64 Topicals
66 MARKET DYNAMICS
67 FUTURE TRENDS
67 Market access drives prescribing trends in a crowded market
67 Biosimilar prospects safeguard the relevance of older classes
67 Oral treatments will become increasingly attractive
68 CONSENSUS FORECASTS
74 RECENT EVENTS AND ANALYST OPINION
74 BMS-986165 for Psoriasis (April 23, 2021)
76 Imsidolimab for Psoriasis (March 8, 2021)
78 Bimekizumab for Psoriasis (February 4, 2021)
80 BMS-986165 for Psoriasis (February 2, 2021)
81 ARQ-151 for Psoriasis (February 1, 2021)
83 ARQ-151 for Psoriasis (November 23, 2020)
85 BMS-986165 for Psoriasis (November 3, 2020)
86 ALX-0761 for Psoriasis (September 10, 2020)
88 Tapinarof for Psoriasis (August 26, 2020)
91 KEY UPCOMING EVENTS
92 KEY OPINION LEADER INSIGHTS
92 Quotes regarding newer treatments
92 Quotes regarding the IL-23 inhibitor advantage
92 Quote regarding an IL-17 inhibitor advantage
92 Quotes regarding endpoints and comparators in psoriasis
94 UNMET NEEDS
94 Expanding market access
94 Complete disease clearance
94 Improved long-term benefits
94 More convenient dosing
94 Co-morbidities and psoriasis patient subsets
95 BIBLIOGRAPHY
96 APPENDIX
LIST OF FIGURES
18 Figure 1: Trends in prevalent cases of psoriasis, 2018–27
33 Figure 2: Overview of pipeline drugs for psoriasis in the US
33 Figure 3: Pipeline drugs for psoriasis, by company
34 Figure 4: Pipeline drugs for psoriasis, by drug type
34 Figure 5: Pipeline drugs for psoriasis, by classification
48 Figure 6: Probability of success in the psoriasis pipeline
52 Figure 7: Clinical trials in psoriasis
52 Figure 8: Top 10 drugs for clinical trials in psoriasis
53 Figure 9: Top 10 companies for clinical trials in psoriasis
53 Figure 10: Trial locations in psoriasis
54 Figure 11: Psoriasis trials status
55 Figure 12: Psoriasis trials sponsors, by phase
60 Figure 13: Datamonitor Healthcare’s drug assessment summary for psoriasis
66 Figure 14: Market dynamics in psoriasis
67 Figure 15: Future trends in psoriasis
76 Figure 16: BMS-986165 for Psoriasis (April 23, 2021): Phase III – POETYK-PSO-1, Phase III – POETYK-PSO-2
78 Figure 17: Imsidolimab for Psoriasis (March 8, 2021): Phase II – Palmoplantar Pustulosis (POPLAR)
80 Figure 18: Bimekizumab for Psoriasis (February 4, 2021): Phase III – BE VIVID
81 Figure 19: BMS-986165 for Psoriasis (February 2, 2021): Phase III – POETYK-PSO-2
83 Figure 20: ARQ-151 for Psoriasis (February 1, 2021): Phase III – Study 301 (DERMIS-1), Phase III – Study 302 (DERMIS-2)
85 Figure 21: ARQ-151 for Psoriasis (November 23, 2020): Phase IIb – Study 204
86 Figure 22: BMS-986165 for Psoriasis (November 3, 2020): Phase III – POETYK-PSO-1
88 Figure 23: ALX-0761 for Psoriasis (September 10, 2020): Phase IIb – Plaque Psoriasis
90 Figure 24: Tapinarof for Psoriasis (August 26, 2020): Phase III – PSOARING 1, Phase III – PSOARING 2
91 Figure 25: 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
35 Table 6: Pipeline drugs for psoriasis in the US
69 Table 7: Historical global sales, by drug ($m), 2016–20
72 Table 8: Forecasted global sales, by drug ($m), 2021–25
74 Table 9: BMS-986165 for Psoriasis (April 23, 2021)
77 Table 10: Imsidolimab for Psoriasis (March 8, 2021)
79 Table 11: Bimekizumab for Psoriasis (February 4, 2021)
80 Table 12: BMS-986165 for Psoriasis (February 2, 2021)
82 Table 13: ARQ-151 for Psoriasis (February 1, 2021)
84 Table 14: ARQ-151 for Psoriasis (November 23, 2020)
85 Table 15: BMS-986165 for Psoriasis (November 3, 2020)
87 Table 16: ALX-0761 for Psoriasis (September 10, 2020)
89 Table 17: Tapinarof for Psoriasis (August 26, 2020)
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