Abstract
Introduction
Lupus erythematosus (LE), a family of chronic autoimmune diseases, ranges from
skin disease to life-threatening systemic disease. Multiple therapy options
are necessary, even for patients with similar symptoms-and there is great need
for agents that can control the complications of systemic disease. LE therapy
development is increasing, and many companies are investigating LE as an
expansion indication.
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The small lupus erythematosus (LE) patient population poses challenges to
companies that are developing agents for this indication: enrollment for
clinical trials can be diffi cult, and the sales potential of these agents is
limited. What are companies doing to surmount these challenges?
Although effective, few existing agents for cutaneous LE are considered safe
enough for long-term use. An effective agent that is safe for prolonged
treatment will have a signifi cant competitive advantage. Which agent now
in development has the best chance to satisfy this need? Is any agent
currently in development likely to displace current fi rst-line therapies?
Because of the heterogeneous nature of systemic LE, the market can support
many agents. But owing to the number of effective generics available, emerging
agents must prove their greater effi cacy and safety to ensure adoption.
What are the advantages and disadvantages of the emerging therapies' modes
of action? How soon are new therapies likely to reach the market? What are
their prospects for success in competition with generics and established
therapies?
Scope
Etiology, pathophysiology, and prevalence: relationship of cutaneous lupus
erythematosus (CLE) to systemic lupus erythematosus (SLE); prevalence of
systemic lupus erythematosus in the three major-market regions by gender.
- Current therapies: overview of leading therapies for CLE and for SLE.
- Indications covered: CLE (discoid LE), acute CLE, subacute CLE, and SLE.
- Emerging therapies: overview of agents for development for CLE and SLE;
late-stage agents are discussed in detail.
- Market outlook: challenges that emerging agents will face and their
prospects for success.
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