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Disease Analysis: Psoriasis

  • Report

  • 98 Pages
  • June 2021
  • Region: Global
  • Citeline
  • ID: 5086944
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

  • The publisher estimates that in 2018, there were 52.2 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 launch of a number of more targeted and efficacious interleukin inhibitors, expanding 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.
  • Positive readouts from bimekizumab’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, bimekizumab neutralizes both IL-17A and IL-17F. Approval decisions for bimekizumab in the US and Europe are expected in 2021.
  • 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. However, Amgen is looking to extend Otezla’s label into mild disease, which would help this product to maintain share in the psoriasis market.
  • The overall likelihood of approval of a Phase I psoriasis asset is 10.9%, and the average probability a drug advances from Phase III is 75%. Psoriasis drugs, on average, take 7.7 years from Phase I to approval.

Table of Contents

OVERVIEW
  • Latest key takeaways

DISEASE BACKGROUND
  • Disease definition
  • Symptoms
  • Patient segmentation
  • Patient segmentation – subtypes

TREATMENT
  • Topical agents remain the gold standard for mild psoriasis
  • Systemic therapies are the mainstay of treatment for moderate-to-severe disease
  • Classes of topical agents to treat psoriasis
  • Key oral systemic classes to treat psoriasis
  • Major biologic classes to treat psoriasis
  • Treatment guidelines

EPIDEMIOLOGY
  • Prevalence methodology

MARKETED DRUGSPIPELINE DRUGS
KEY REGULATORY EVENTS
  • UCB Announces New User Fee Goal Date For Bimekizumab
  • sNDA Submission For Otezla
  • Coherus Gets Goal Date On US Adalimumab Biosimilar
  • Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
  • Innovent’s Adalimumab Gets New Indications In China
  • Celltrion Wins Race For High-Concentration Adalimumab
  • Henlius Gets Green Light For Adalimumab In China
  • Merck Matches Sandoz With Canadian Etanercept Indications
  • Cadila Pharma Adds To Indian Biosimilars With Adalimumab
  • Lupin And Mylan Launch Etanercept in Germany
  • FDA Approves Mylan’s Humira Biosimilar
  • Japan Approves First Humira Biosimilar
  • Sun Pharmaceutical Receives Japan Approval of Ilumya for Psoriasis

PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • Sanofi Partnership On Oral IL-17 Could Be Turning Point For C4XD
  • Busy 2021 Ahead For Almirall On Business And Clinical Fronts
  • Novartis Signs 1Yao To Up Psoriasis Digital Push
  • Allergy Therapeutics Takes First Steps Into Broader Vaccine Field
  • Itching To Succeed: UNION Buys LEO Pharma’s PDE4 Inhibitor Series
  • Sun And Hikma Strike Ilumya Deal
  • Medac Will Market Fresenius Kabi’s Adalimumab In Germany

CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL
  • Biologics
  • Oral small molecules
  • Topicals

MARKET DYNAMICS
FUTURE TRENDS
  • Market access drives prescribing trends in a crowded market
  • Biosimilar prospects safeguard the relevance of older classes
  • Oral treatments will become increasingly attractive

CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST OPINION
  • BMS-986165 for Psoriasis (April 23, 2021)
  • Imsidolimab for Psoriasis (March 8, 2021)
  • Bimekizumab for Psoriasis (February 4, 2021)
  • BMS-986165 for Psoriasis (February 2, 2021)
  • ARQ-151 for Psoriasis (February 1, 2021)
  • ARQ-151 for Psoriasis (November 23, 2020)
  • BMS-986165 for Psoriasis (November 3, 2020)
  • ALX-0761 for Psoriasis (September 10, 2020)
  • Tapinarof for Psoriasis (August 26, 2020)
  • Bimekizumab for Psoriasis (July 24, 2020)
  • Mirikizumab for Psoriasis (July 17, 2020)

KEY UPCOMING EVENTS
KEY OPINION LEADER INSIGHTS
  • Quotes regarding newer treatments
  • Quotes regarding the IL-23 inhibitor advantage
  • Quote regarding an IL-17 inhibitor advantage
  • Quotes regarding endpoints and comparators in psoriasis

UNMET NEEDS
  • Expanding market access
  • Complete disease clearance
  • Improved long-term benefits
  • More convenient dosing
  • Co-morbidities and psoriasis patient subsets

BIBLIOGRAPHYAPPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of psoriasis, 2018–27
Figure 2: Overview of pipeline drugs for psoriasis in the US
Figure 3: Pipeline drugs for psoriasis, by company
Figure 4: Pipeline drugs for psoriasis, by drug type
Figure 5: Pipeline drugs for psoriasis, by classification
Figure 6: Probability of success in the psoriasis pipeline
Figure 7: Clinical trials in psoriasis
Figure 8: Top 10 drugs for clinical trials in psoriasis
Figure 9: Top 10 companies for clinical trials in psoriasis
Figure 10: Trial locations in psoriasis
Figure 11: Psoriasis trials status
Figure 12: Psoriasis trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for psoriasis
Figure 14: Market dynamics in psoriasis
Figure 15: Future trends in psoriasis
Figure 16: BMS-986165 for Psoriasis (April 23, 2021): Phase III - POETYK-PSO-1, Phase III - POETYK-PSO-2
Figure 17: Imsidolimab for Psoriasis (March 8, 2021): Phase II - Palmoplantar Pustulosis (POPLAR)
Figure 18: Bimekizumab for Psoriasis (February 4, 2021): Phase III - BE VIVID
Figure 19: BMS-986165 for Psoriasis (February 2, 2021): Phase III - POETYK-PSO-2
Figure 20: ARQ-151 for Psoriasis (February 1, 2021): Phase III - Study 301 (DERMIS-1), Phase III - Study 302 (DERMIS-2)
Figure 21: ARQ-151 for Psoriasis (November 23, 2020): Phase IIb - Study 204
Figure 22: BMS-986165 for Psoriasis (November 3, 2020): Phase III - POETYK-PSO-1
Figure 23: ALX-0761 for Psoriasis (September 10, 2020): Phase IIb - Plaque Psoriasis
Figure 24: Tapinarof for Psoriasis (August 26, 2020): Phase III - PSOARING 1, Phase III - PSOARING 2
Figure 25: Bimekizumab for Psoriasis (July 24, 2020): Phase III - BE RADIANT
Figure 26: Mirikizumab for Psoriasis (July 17, 2020): Phase III - OASIS-2 (vs. Secukinumab)
Figure 27: Key upcoming events in psoriasis
LIST OF TABLES
Table 1: Topical corticosteroids for psoriasis – ultra-high and high potency
Table 2: Topical corticosteroids for psoriasis – moderate and low potency
Table 3: Psoriasis treatment guidelines
Table 4: Prevalent cases of psoriasis, 2018–27
Table 5: Marketed drugs for psoriasis
Table 6: Pipeline drugs for psoriasis in the US
Table 7: Historical global sales, by drug ($m), 2016–20
Table 8: Forecasted global sales, by drug ($m), 2021–25
Table 9: BMS-986165 for Psoriasis (April 23, 2021)
Table 10: Imsidolimab for Psoriasis (March 8, 2021)
Table 11: Bimekizumab for Psoriasis (February 4, 2021)
Table 12: BMS-986165 for Psoriasis (February 2, 2021)
Table 13: ARQ-151 for Psoriasis (February 1, 2021)
Table 14: ARQ-151 for Psoriasis (November 23, 2020)
Table 15: BMS-986165 for Psoriasis (November 3, 2020)
Table 16: ALX-0761 for Psoriasis (September 10, 2020)
Table 17: Tapinarof for Psoriasis (August 26, 2020)
Table 18: Bimekizumab for Psoriasis (July 24, 2020)
Table 19: Mirikizumab for Psoriasis (July 17, 2020)