Strategic Overview of Spondyloarthropathies: Tapping the Market Opportunity of Niche Immune Diseases

Published by: Decision Resources

Published: Apr. 30, 2009 - 106 Pages

Table of Contents

Executive Summary

What is the current state of the SpA market?

What opportunities remain in the SpA market?

What are the challenges for developers of SpA therapies?

What is the outlook for the SpA market?

What companies are the current and emerging leaders of the SpA market?

1. Introduction

2. Overview of the Spondyloarthropathies

Ankylosing Spondylitis

Disease Definition, Pathophysiology, and Etiology

Symptoms and Peripheral Involvement

Diagnosis and Disease Progression

Psoriatic Arthritis

Disease Description and Etiology

Symptoms

Diagnosis and Disease Progression

Reactive Arthritis

Disease Description and Etiology

Symptoms

Joint Symptoms

Eye Symptoms

Skin Symptoms

Diagnosis and Disease Progression

3. Epidemiology

Ankylosing Spondylitis

Overview

Methods

Psoriatic Arthritis

Overview

Disease Definition

Methods

Reactive Arthritis

Overview

Disease Definition

Methods

4. Current Treatment Approaches

Drug Classes Used to Treat Spondyloarthropathies

Nonsteroidal Anti-Infl ammatory Drugs

Conventional Disease-Modifying Antirheumatic Drugs

TNF-á Inhibitors

Corticosteroids

Bisphosphonates

Medical Practice

Ankylosing Spondylitis

Treatment Goals

NSAID Use in AS Treatment

DMARD Use in AS

TNF-á Inhibitor Use in AS

Corticosteroid Use in AS

Bisphosphonate Use in AS

Psoriatic Arthritis

Treatment Goals

DMARD Use in PsA

NSAID Use in PsA

TNF-á Inhibitor Use in PsA

Reactive Arthritis

Treatment Goals

NSAID Use in ReA

DMARD Use in ReA

TNF-á Use in ReA

5. Emerging Therapies for Spondyloarthropathies

Centocor/Schering-Plough/Janssen/Mitsubishi Tanabe’s Simponi

Findings and Outlook for AS

Findings and Outlook for PsA

Findings and Outlook for ReA

Novartis’s AIN-457

Findings and Outlook for AS

Findings and Outlook for PsA

Pozen/AstraZeneca’s PN-400

Findings and Outlook for AS

Array BioPharma’s ARRY-371797

Findings and Outlook in AS

Bristol-Myers Squibb’s Orencia

Findings and Outlook for PsA

Centocor/Medarex’s Stelara

Findings and Outlook for PsA

Celgene’s Apremilast

Findings and Outlook for PsA

6. 2008 Market and Future Market Considerations

Ankylosing Spondylitis

Psoriatic Arthritis

Reactive Arthritis

Appendix A. Bibliography

Tables and Figures

Table 2-1. Criteria Used in Evaluating Ankylosing Spondylitis

Table 2-2. Major Mediators in the Pathogenesis of Psoriatic Arthritis

Table 2-3. Summary of the 2006 CASPAR Criteria for the Classification of Psoriatic Arthritis

Table 4-1. Nonsteroidal Anti-Infl ammatory Agents Commonly Prescribed for Spondyloarthropathies

Table 4-2. Conventional Disease-Modifying Antirheumatic Drugs Commonly Prescribed for Spondyloarthropathies

Table 4-3. Marketed TNF-á Inhibitors

Table 4-4. Relative Strengths and Weaknesses of TNF-á Inhibitors in Ankylosing Spondylitis Treatment

Table 4-5. TNF-á Inhibitors for Psoriatic Arthritis: Summary of Clinical Trial Data

Table 5-1. Agents in Active Development for the Treatment of Spondyloarthropathies

Table 6-1. Sales of Agents to Treat Spondyloarthropathies in the United States and Europe, 2008

Figure ES-1. Snapshot of the Spondyloarthropathy Markets

Figure ES-2. Prevalent Cases of Spondyloarthropathies in the United States and Europe, 2007

Figure ES-3. Surveyed Rheumatologists’ Willingness to Prescribe the Emerging Agent Golimumab to Spondyloarthropathy Patient

Figure 2-1. Rheumatologist-Estimated Percentage of Ankylosing Spondylitis Patients with Specific Ankylosing Spondylitis Symptoms

Figure 2-2. Rheumatologist-Estimated Percentage of Psoriatic Arthritis Patients with Specific Psoriatic Arthritis Symptoms

Figure 2-3. Rheumatologist-Estimated Percentage of Reactive Arthritis Patients with Specific Reactive Arthritis Symptoms

Figure 3-1. Total Prevalent Cases of Spondyloarthropathies in the Six Major Markets, 2007 and 2017

Figure 3-2. Prevalent Cases of Ankylosing Spondylitis in the United States and Europe, 2007-2017

Figure 3-3. Prevalent Cases of Psoriatic Arthritis in the United States and Europe, 2007-2017

Figure 3-4. Prevalent Cases of Reactive Arthritis in the United States and Europe, 2007-2017

Figure 4-1. Timeline of TNF-Alpha Approvals for Spondyloarthropathies in the United States and Europe Figure 4-2. Survey Question: Please indicate your first-, second-, and third-line therapy choice for the treatment of ankylosing spondylitis Strategic Overview of Spondyloarthropathies

Figure 4-3. Survey Question: What percentage of your ankylosing spondylitis patients require new or additional therapies within these time frames?

Figure 4-4. Surveyed Rheumatologist Opinion: Why TNF-Alpha Inhibitors Are Not Prescribed as

First-Line Therapy for Ankylosing Spondylitis

Figure 4-5. Survey Question: Please indicate your first-, second-, and third-line therapy choice for the treatment of psoriatic arthritis

Figure 4-6. Survey Question: What percentage of your psoriatic arthritis patients move to/add on a second-line therapy within the following time frames?

Figure 4-7. Survey Question: What are the reasons why you do not prescribe TNF-alpha inhibitors as a first-line therapy for psoriatic arthritis?

Figure 4-8. Survey Question: Please indicate your first-, second-, and third-line therapy choice for the treatment of reactive arthritis

Figure 4-9. Survey Question: How many of your reactive arthritis patients will require new or additional therapy within the following time frames?

Figure 4-10. Survey Question: What percentage of your reactive arthritis patients receive the following biologic therapies?

Figure 5-1. Survey Question: Would you switch your ankylosing spondylitis patients currently taking other tumor necrosis factor alpha inhibitors to golimumab one the agent is available?

Figure 5-2. Survey Question: If golimumab is approved for psoriatic arthritis, will you prescribe it to your patients?

Figure 5-3. Survey Question: Would you prescribe golimumab to your reactive arthritis patients?

Figure 5-4. Survey Question: Will you prescribe Novartis’s AIN-457 to your ankylosing spondylitis patients?

Figure 5-5. Survey Question: If AIN-457 is approved for psoriatic arthritis, will you prescribe it to your patients?

Figure 5-6. Survey Question: Will you prescribe Pozen’s PN-400 to your ankylosing spondylitis patients?

Figure 5-7. Survey Question: What agents do you think are most likely to be replaced by Pozen’s PN-400?

Figure 5-8. Survey Question: If apremilast is approved for psoriatic arthritis, will you prescribe it to your patients?

Figure 6-1. Spondyloarthropathy Market by Drug Class and TNF-á Inhibitor Share, 2008

Abstract

• Although ankylosing spondylitis, psoriatic arthritis, and reactive arthritis a re grouped together as SpAs, treatment approaches have varied. What are the current first-, second-, and third-line therapies for these indications? What are their unique etiological components and unmet needs? What kind of efficacy and uptake have biologics seen in each indication?
• The SpAs are underdiagnosed and undertreated. What are the symptoms of these diseases? How are they diagnosed? How many people in the United States and Europe have an SpA? How will this population grow over the next ten years?
• Because of the high cost and increased use of TNF-alpha inhibitors, the SpA market overall has experienced strong growth over the past few years. How large is the SpA market? Will this market continue to grow? What new agents are in the pipeline for these diseases, and how will these agents perform in the market?
• In April 2009, the FDA approved Simponi (Centocor/Schering-Plough/Janssen/Mitsubishi Tanabe’s golimumab) for RA, AS, and PsA. What are this agent’s advantages? How do surveyed rheumatologists expect to use it in their medical practice?

• Primary research: Three disease-specific surveys of more than 100 U.S. rheumatologists.
• Overview of SpAs: Etiology, symptoms, and diagnosis.
• Current treatments and medical practice: NSAIDs, DMARDs, TNF-á inhibitors, corticosteroids, bisphosphonates; SpA treatment goals; first, second, and third lines of therapy; therapy switching trends.
• Epidemiology: Decision Resources epidemiology, disease-specific patient populations, tenyear growth forecasts, epidemiology methodology.
• Emerging agents: Centocor/Schering-Plough/Janssen/Mitsubishi Tanabe’s golimumab, approved by the FDA in April 2009; and the following developmental agents: Novartis’s AIN-457, Pozen/AstraZeneca’s PN-200 and PN-400, Bristol-Myers Squibb’s Orencia, Centocor/Medarex’s Stelara, Array Biopharma’s ARRY-371797, Celgene’s apremilast
• Market overview: 2008 AS, PsA, ReA, and undifferentiated SpA markets; outlook for current and emerging agents.
• Geographic scope: Six major markets—United States, France, Germany, Italy, Spain, United Kingdom.

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