Stakeholder Opinions: Skin and soft tissue infections

Introduction

Treatment of skin and skin structure infections often requires systemic antibacterial therapy. Two trends are concerning physicians: the spread of methicillin-resistant Staphylococcus aureus (MRSA), particularly community-acquired strains (CA-MRSA) have become the most important pathogen in the US; and a slow but measurably declining susceptibility to vancomycin by these bacteria.

Scope

*Epidemiological trends and economic impact of key pathogens

*Overview of diagnosis and referral patterns

*Analysis of present and future unmet needs with outline of key drugs in development for SSTIs

*Outline of drivers of treatment choice in both the hospital and the community setting

Highlights

Guideline adoption for skin and soft tissue infections (SSTIs) among specialists is fairly strong, but less so among primary care physicians (PCPs). PCPs treat mild-to-moderate forms of disease, representing an estimated 70% of SSTI patients, while specialists treat severe SSTI sufferers (30%).

Resistance is the single most important factor affecting the SSTI drug market, in both the community and hospital settings. Vancomycin has traditionally been viewed as the most effective treatment option for SSTIs caused by MRSA, although bacterial resistance to the drug is emerging and it is becoming less effective for the treatment of SSTIs.

A highly valuable new SSTI drug should possess a number of important characteristics, including strong bactericidal activity against MRSA, VISA, and H-VISA strains, a good toxicity and side effect profile, cost-effectiveness, good tissue penetration for systemic use, superior efficacy versus vancomycin, and broad spectrum coverage.

Reasons to Purchase

*Identify key opportunities that will impact the use and uptake of new and existing products

*Understand the critical issues that drive prescription choice in skin and soft tissue infections

*Learn about the difference between key antibacterial drug attributes relevant to hospital and community-based physicians

Report Highlights
Highlights

Guideline adoption for skin and soft tissue infections (SSTIs) among specialists is fairly strong, but less so among primary care physicians (PCPs). PCPs treat mild-to-moderate forms of disease, representing an estimated 70% of SSTI patients, while specialists treat severe SSTI sufferers (30%).

Resistance is the single most important factor affecting the SSTI drug market, in both the community and hospital settings. Vancomycin has traditionally been viewed as the most effective treatment option for SSTIs caused by MRSA, although bacterial resistance to the drug is emerging and it is becoming less effective for the treatment of SSTIs.

A highly valuable new SSTI drug should possess a number of important characteristics, including strong bactericidal activity against MRSA, VISA, and H-VISA strains, a good toxicity and side effect profile, cost-effectiveness, good tissue penetration for systemic use, superior efficacy versus vancomycin, and broad spectrum coverage.
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DATAMONITOR HEALTHCARE 2
About the Infectious Diseases and Respiratory pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the analysis 4
Datamonitor insight into the skin and soft tissue infections market 4
Contributing experts 5
Related reports 6
Upcoming related reports 6
CHAPTER 2 EPIDEMIOLOGY AND DISEASE BACKGROUND 8
Etiology and symptoms 9
Types of skin and soft tissue infections 9
Cellulitis 9
Erysipelas 10
Erythrasma 10
Folliculitis and skin abscesses 10
Impetigo 11
Furunculosis 11
Lymphadenitis 12
Lymphangitis 12
Necrotizing skin infections 12
Staphylococcal scalded skin syndrome 13
Complicated and uncomplicated skin and soft tissue infections 13
Recurrent skin and soft tissue infections 14
Pathogens 15
Staphylococcus and Streptococcus bacterial species are the main SSTI pathogens in both the community and hospital settings 15
Staphylococcus aureus 17
Methicillin-resistant Staphylococcus aureus (MRSA) 18
Risk groups 19
General risk factors for SSTIs 19
Epidemiological trends 20
SSTIs are a major driver for ambulatory care utilization 20
US 21
Increasing incidence of SSTIs in the US may be driven by CA-MRSA 21
Incidence of MRSA is lower in Japan compared to the US and Europe 22
Europe 23
Economic burden of skin and soft tissue infections 24
CHAPTER 3 PRESENTATION, DIAGNOSIS AND REFERRAL OPTIONS 26
Overview 27
Presentation 27
Diagnosis 27
Diagnosis of skin and soft tissue infections is commonly based purely on clinical impression 27
Guidelines for the diagnosis and management of skin and soft tissues infections are sparse across the seven major markets 29
Laboratory tests used in the diagnosis of skin and soft tissue infections 30
Tissue swab with bacterial culture 30
Blood cultures 31
Needle aspiration 31
X-rays and ultrasound 32
Computed tomography (CT) and magnetic resonance imaging (MRI) scans 32
Gram stain 32
Referral 33
Primary care physicians treat most skin and soft tissue infections, although a referral may be made in more severe cases 33
Reasons for hospital admission for SSTIs 34
Mild-to-moderate nosocomial skin and soft tissue infections are treated by the attending physician 35
Unmet needs and future developments in the diagnosis of skin and soft tissue infections 36
Cepheid has developed a rapid molecular diagnostic test for SSTIs caused by MRSA and methicillin-susceptible S. aureus 36
CHAPTER 4 CURRENT TREATMENT OPTIONS AND TRENDS 38
Market overview 39
Treatment guidelines 40
Guideline adherence for SSTIs is strong among specialists, but poor among primary care physicians 40
Treatment options 42
Current skin and soft tissue infection therapies 42
Levofloxacin 42
Ciprofloxacin 43
Moxifloxacin 43
Imipenem and cilastatin 44
Clindamycin 44
Daptomycin 45
Linezolid 45
Tigecycline 46
Cefazolin 46
Cefalexin 46
Vancomycin 46
Piperacillin/tazobactam 47
Quinupristin/dalfopristin 47
Resistance issues for skin and soft tissue infections 47
Resistance issues are growing for bacterial skin and soft tissue infections caused by staphylococci and streptococci 47
Studies and key opinion leaders acknowledge that vancomycin is becoming less effective at treating SSTIs caused by MRSA 51
Emerging pathogens 54
Community-acquired methicillin-resistant Staphylococcus aureus is the most dangerous emerging pathogen for skin and soft tissue infections 54
Treatment choice 55
Efficacy against pathogens is highly influential in treatment choice for skin and soft tissue infections, although safety and cost also play a role 55
CHAPTER 5 UNMET NEEDS AND NEW DEVELOPMENTS 61
Unmet needs and future developments 62
Gaining regulatory approval represents a significant challenge for pharmaceutical companies developing drugs for the treatment of skin and soft tissue infections 62
The different characteristics of therapies can all contribute to the uptake of new antibacterial drugs for SSTIs 63
Treatment satisfaction 64
Variation in resistance patterns may be highly influential in the levels of skin and soft tissue infection treatment satisfaction expressed by physicians 64
Unmet needs in the treatment of skin and soft tissue infections 68
Despite the availability of efficacious therapies and a busy pipeline, increasing resistance highlights the need for novel skin and soft tissue infection drugs 68
Key pipeline drugs in development for skin and soft tissue infections 71
Telavancin 73
Ceftobiprole 74
Oritavancin 75
Ceftaroline 76
Iclaprim 76
Torezolid 77
Dalbavancin 77
Radezolid (RX-1741) 78
Delafloxacin (RX-331) 78
Razupenem (PZ-601) 79
BIBLIOGRAPHY 80
Journal papers 80
Websites 85
APPENDIX A 91
Contributing experts 91
APPENDIX B 92
About Datamonitor 92
About Datamonitor Healthcare 92
About the Infectious Diseases and Respiratory pharmaceutical analysis team 93
Disclaimer 94
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List of Tables
Table 1: Occurrence of pathogens causing skin and soft tissue infections in North America, Europe, Latin America, and Asia-Pacific region, 1999-2004 16
Table 2: Occurrence of pathogens responsible for causing skin and soft tissue infections in the US and Canada, 1997-2000 16
Table 3: Etiologic risk factors for skin and soft tissue infections and their associated bacterial causes 20
Table 4: Drug susceptibilities of methicillin-susceptible Staphylococcus aureus isolated from SSTI outpatients across the US, France, Germany, Italy, and Spain, 2001 49
Table 5: Drug susceptibilities of methicillin-resistant Staphylococcus aureus isolated from SSTI outpatients across the US, France, Germany, Italy, and Spain, 2001 49
Table 6: Drug susceptibilities of methicillin-susceptible Staphylococcus aureus isolated from SSTI inpatients and intensive care unit patients across the US, France, Germany, Italy, and Spain, 2001 50
Table 7: Drug susceptibilities of methicillin-resistant Staphylococcus aureus isolated from SSTI inpatients and intensive care unit patients across the US, France, Germany, Italy, and Spain, 2001 50
Table 8: Drug susceptibilities of Streptococcus pyogenes isolated from SSTI inpatients and intensive care unit patients across the US, France, Germany, Italy, and Spain, 2001 51
Table 9: Vancomycin susceptibility results for Staphylococcus aureus isolates across the five major EU markets, 2001-06 53
Table 10: Importance of different characteristics of drugs in treatment choice in both the community and hospital settings 55
List of Figures
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