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Therapeutic Class Overview : Psoriasis – Plaque Psoriasis & Psoriatic Arthritis - Novel Oral Drugs And Biologics To Change Future Treatment Paradigm

  • ID: 2763286
  • Report
  • Region: Global
  • 55 Pages
  • MP Advisors
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Over the last decades, therapeutic options for Plaque Psoriasis (PsO) and Psoriatic Arthritis (PsA) have expanded considerably and improved patients' pain, function, and quality of life. Approved biologics fill in a critical unmet need of limited efficacy of DMARDs; however, as in most cases one drug does not fit the bill for all the patients.

The lack of targeted immune therapies other than TNF-a inhibitors in Psoriasis signals opportunities for drug developers to bring agents to market that offer treatment alternatives (Anti-IL-17, IL-13, JAK, PDE4 inhibitors, etc). Pfizer launched the first oral Rheumatoid Arthritis (RA) drug –Xeljanz (tofacitinib/ CP-690,550, JAK 1/3 inhibitor) in 2012 for pts with moderately to severely active RA who are inadequate responder or intolerant to Methotrexate (MTX) at a price almost at par with biologics. In the last couple of years, the face of healthcare has been changing due to challenges – quality and its affordability and accessibility to the providers and patients.

The authors believe there is an ample room for an efficacious affordable therapy to tap the mild to moderate RA pts population where biologics have not made a dent and expect few potential launches in 2014-15 (OTEZLA – apremilast, Xeljanz – tofacitinib) and onwards. In this report, the authors highlight the novel targets – oral, injectables, and topical drugs in the pipeline for the treatment of Psoriasis, compare their clinical trials data, and their commercial potential!
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Executive Summary

Unmet Need in Psoriasis

Limitations of Anti-TNFs
Scope for Entrants with Better Efficacy and Safety Profiles
Specific Unmet Need and Emerging Therapies
Plaque Psoriasis
Psoriatic Arthritis
Pipeline – Biologics Products
IL-12 and IL-23 inhibitors
Stelara
tildrakizumab (MK-3222/ SCH 900222)
Guselkumab (CNTO 1959)
Fezakinumab (ILV-094)
Interleukin-17 (IL-17) and Receptor (IL-17RA) 14-19
Secukinumab
Ixekizumab (LY2439821)
Brodalumab (AMG 827)
Other Targets 19-22
Cimzia
Itolizumab
Tregalizumab
Pipeline – Oral Treatment 24-35
Targeting JAK-STATs 24-28
Tofacitinib
LY3009104
INCB39110
ASP015K
GSK2586184

Approved/ Marketed Products 3
A. Psoriasis' Pipeline: Small Molecules – Oral/ Injectable
B. Psoriasis' Pipeline: Topical
Psoriasis' Pipeline: Biologics
Select Late- & Mid-Stage Pipeline: Plaque Psoriasis
Select Late- & Mid-Stage Pipeline: Psoriatic Arthritis
Ixekizumab: Phase III Clinical Trial Designs
Brodalumab: Phase III Clinical Trial Designs
Clinical Data Comparison: Plaque Psoriasis – Biologics
A. Tofacitinib: PASI Improvement from Baseline
B. Tofacitinib: Improvement in Quality-of-Life (QOL)Measures
Other Targets in Clinical Development for RA
Genes Associated with Psoriasis Susceptibility
Competitive Landscape: Plaque Psoriasis
Competitive Landscape: Psoriatic Arthritis

FIGURES

PFE's Xeljanz Launch vs. Other Recent RA Launches
The Structure and Function of the Cytokines IL-12 And IL-23
Clinical Data: ACCEPT – Head-To-Head Trial with Enbrel
MK-3222Neutralizes IL-23, Specifically
Immunology and Immunotherapeutic Targets of Psoriasis
IL-17-Induced Signaling Pathways
Ixekizumab: Clinical Response (PASI And sPGA) @ week 20
Itolizumab Value Proposition with Marketed Products
Regulation of JAK–STAT Signaling
INCB39110: Response Rate - Exploratory Efficacy Analyses
ASP015K – Changes from Baseline in PASI at Day 42
PDE Inhibitors Crosstalk
AEB071 – PASI 75 Reductions Compared with Baseline
DRM02– Novel Mechanism of Action
DLX105 – PhIa Results (PASI Changes @ Day 14)
Psoriasis Treatment Ladder (Schematic)
US Psoriasis Market Estimation
Proposed Schema of the Evolution of A Psoriatic Lesion
Distribution of Psoriasis Severity
Use of Therapies Depending on the Disease Severity
Targeted Therapy Classification Based on Pathogenesis
Comparison of GRAPPA and AAD Treatment Guidelines

Fig. # Title Pg. No.

PFE's Xeljanz Launch vs. Other Recent RA Launches
The Structure and Function of the Cytokines IL-12 And IL-23
Clinical Data: ACCEPT – Head-To-Head Trial with Enbrel
MK-3222Neutralizes IL-23, Specifiably
Immunology and Immunotherapeutic Targets of Psoriasis
IL-17-Induced Signaling Pathways
Ixekizumab: Clinical Response (PASI And sPGA) @ week 20 17-18
Itolizumab Value Proposition with Marketed Products
Regulation of JAK–STAT Signaling
INCB39110: Response Rate - Exploratory Efficacy Analyses
ASP015K – Changes from Baseline in PASI at Day 42
PDE Inhibitors Crosstalk
AEB071 – PASI 75 Reductions Compared with Baseline
DRM02– Novel Mechanism of Action
DLX105 – PhIa Results (PASI Changes @ Day 14)
Psoriasis Treatment Ladder (Schematic)
US Psoriasis Market Estimation
Proposed Schema of the Evolution of A Psoriatic Lesion
Distribution of Psoriasis Severity
Use of Therapies Depending on the Disease Severity
Targeted Therapy Classification Based on Pathogenesis
Comparison of GRAPPA and AAD Treatment Guidelines
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