Stakeholder Opinions: Osteoarthritis - Preconceptions Damage Awareness and Treatments

Published by: Datamonitor

Published: Mar. 29, 2006 - 160 Pages

Table of Contents

About the CNS, Arthritis and Pain pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Datamonitor insight into the osteoarthritis market

High unmet need and a large patient population are key drivers towards research and innovation in osteoarthritis (OA), but ageist perceptions and low awareness have a substantial negative impact on the market.

The need for a paradigm shift in the way osteoarthritis is treated has been suggested in the wake of drug controversy and the failure of disease modifying approaches. Treatment currently centers on NSAID use, but following recent controversies, there is demand for an alternative. However, many alternatives are battling against their own preconceptions. This currently adds to the drive for a disease-modifying treatment, but would be more successfully directed towards a holistic approach.

Clinical trials for disease-modifying products for OA are increasingly regulated and require careful design. However, the best design for disease modification assessment has not yet been decided upon by experts. Advances in imaging offer promise for clinical trial end-points, but interpretation of results must be unified and new biomarkers are being identified but are often difficult to utilize.

CHAPTER 2 INTRODUCTION AND EPIDEMIOLOGY

Classifications

Primary (idiopathic) osteoarthritis

Secondary osteoarthritis

Epidemiology of osteoarthritis

Country calculations

US population

European population

Japanese population

Radiographic hugely outweighs symptomatic joint involvement

Changes in the osteoarthritis population as the "baby boomer" generation reaches retirement age

Knee osteoarthritis usually assessed in trials and epidemiology studies but hip OA may offer an easier assessment target

Additional international osteoarthritis epidemiology studies

Beijing OA study, China

Joint-replacement study, 2004, and the Australian National Health Survey, 1995

Prevalence of Rheumatic diseases in Greece: A cross-sectional, population-based epidemiological study: The ESORDIG Study, Andrianakos et al., 2003, 2005

Risk factors and patient-group segmentation are key in OA definition

Age

Gender

Mechanical stress

Obesity

Treatment

CHAPTER 3 UNMET NEEDS

Disease Modification is the key unmet need in OA

Restraints outweigh the current drivers for DMOAD development

Clinical-trial design is challenging for both DMOADs and symptom-modifying treatments as "gold-standard methods" are rapidly changing

Patient-group segmentation in clinical trials offers a way to gain approval, but risks restricted use

Quality of life and patient education should be addressed for all treatments

Osteoarthritis awareness and perception in society reduces treatment uptake

Collaboration and dedicated government-funded research organization to aid this are the key to successful future OA treatment

The role of pharmaceutical companies

Direct to consumer advertising must be responsible in order to change public perception

Emerging imaging and biomarker research will impact both diagnosis and trial endpoints

Whole-organ MRI scoring system (WORMS): not perfect but a step forward

Biomarker research offers promise

CHAPTER 4 CURRENT TREATMENT CONTROVERSIES

The Vioxx withdrawal is old news, but it still affects physician perception of osteoarthritis treatments

What is a Cox-2 inhibitor and should it still command a higher price?

Opioid use in osteoarthritis offers a good alternative to NSAIDs, but "opioid-phobia" prevents high uptake

Topical opioids appear to break down perceptual barriers

The impact of "professional patients" is increasing in industry and government

Non-pharmacological treatments are the first and the last resort in osteoarthritis

Physiotherapy

Joint replacement

Nutraceuticals, supplements and alternative therapy invade the market

The Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

The Glucosamine Unum In Die Efficacy Trial (GUIDE)

So does glucosamine work?

What can medical foods offer OA patients?

Is the competitive and profitable hyaluronic-acid market based on the placebo effect?

CHAPTER 5 PIPELINE DRUGS

Pain- and inflammatory-relief pipeline treatments are particularly diverse in mechanism

HCT 3012

Sativex

Licofelone

Botox

Disease modifiers in OA are yet to progress past Phase II

Matrix Metalloproteinase (MMP) inhibition

IL-1 inhibition

Enhancing cartilage repair

Autologous chondrocytes transplantation

CHAPTER 6 OPINION LEADER TRANSCRIPTS

Contributing experts

Professor Howard Bird

Dr. Felix Eckstein

Dr. Robin Poole

Jane Tadman, Arthritis Research Campaign (ARC)

Professor Paul Dieppe

Cheryl Koehn, Arthritis Consumer Expert

CHAPTER 7 APPENDIX

Bibliography

Websites

The knee injury and osteoarthritis outcome score (KOOS)

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's research and analysis methodologies

Datamonitor Healthcare's therapy area capabilities

Disclaimer

List of Tables

Table 1: Estimated adult OA populations in the seven major markets, by age group, 2006 (000s)

Table 2: OA sufferers who present with the disease in specific parts of the body (%): US, Japan and 5 EU markets, 2003

Table 3: US OA patient population by age group and gender, 2006 (000s)

Table 4: Breakdown of arthritis population from NHIS survey and estimated OA percentages, 2003

Table 5: Adult OA population in five major EU countries, by age and gender, 2006 (000s)

Table 6: Combined sample of northern England studies, radiographic knee OA by age and gender

Table 7: Estimated symptomatic knee OA prevalence: UK adults

Table 8: Spanish EPISER study showing breakdown of hand and knee OA by age group, 2001

Table 9: Adult OA population in Japan, by age and gender, 2006 (000s)

Table 10: Results of Framingham Heart Study/knee OA cohort, 1983-85

Table 11: Results of Framingham Heart Study/knee OA cohort Follow-Up, 1992-93

Table 12: Estimated US adult population and projected prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitations, among adults aged 18 years and older, US, 2005-2030

Table 13: Hip and knee OA patients in seven major markets (millions), 2006

Table 14: WHO statistics for obesity and average systolic blood pressure in the seven major markets

Table 15: Duragesic (fentanyl) trial results in OA, 2005

Table 16: GAIT study response rates by treatment group and pain level, 2005

Table 17: Pain and anti-inflammatory products in clinical trials for OA, 2006

Table 18: Disease-modifying treatments for OA, 2006

List of Figures

Figure 1: Adult (15+) OA population in the seven major markets, 2006

Figure 2: Adult OA population, five major EU countries, by age group, 2006

Figure 3: Relationship between radiographic and symptomatic OA

Figure 4: Drivers of and impediments to DMOAD development and their comparative importance and difficulty

Figure 5: Opportunities and threats to companies wishing to enter the Cox-2 market

Figure 6: Guidelines for selecting the appropriate NSAID in various clinical situations, 2006

Figure 7: Effects of various NSAIDs on the concentration of Cox-1 and Cox-2 in vitro

Figure 8: US and UK knee and hip replacements, 2000-2002

Figure 9: Knee and hip replacement procedures per 100,000 population, by country, 2000

Figure 10: The knee injury and osteoarthritis outcome score

Figure 11: The knee injury and osteoarthritis outcome score (cont.)

Abstract

• Assessment of patient size across the seven major markets (US, Japan, France, Germany, Italy, Spain, UK), including split by age and gender
• Transcripts based on qualitative interviews with key opinion leaders including physicians, patient advocates and research scientists
• Investigation of the current unmet needs from a range of professionals involved in osteoarthritis treatment and research
• Current treatment controversies and novel therapies in the developmental pipeline

• Identify the challenges in disease modifying clinical trial design including end-point selection
• Understand the key issues for alternative treatments propelled into the treatment algorithm by the Cox-2 controversies
• Gain insight into opinion leaders' thoughts on the challenges facing the osteoarthritis market

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