Systemic lupus erythematosus (SLE) is an autoimmune disease that can affect different organ systems of the body and manifest in a wide range of clinical symptoms, from general fatigue to serious renal and CNS manifestations. Most drugs used to treat SLE are older, generically available, and off-label. To date, GlaxoSmithKline’s Benlysta—viewed by many physicians as only modestly effective—is the only drug approved for moderate to severe SLE (excluding severe active renal and severe active CNS manifestations). Thus, unmet need remains high in the moderate to severe subpopulation, leaving significant commercial opportunity for novel SLE therapies offering a better efficacy profile than that of Benlysta.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals in moderate to severe SLE (excluding severe active renal and severe active CNS manifestations)?
  • What drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for moderate to severe SLE (excluding severe active renal and severe active CNS manifestations)?
  • What are the prevailing areas of unmet need and opportunity in the treatment of moderate to severe SLE (excluding severe active renal and severe active CNS manifestations)?
  • What trade-offs across different clinical attributes and price are acceptable to rheumatologists for a hypothetical new drug for moderate to severe SLE (excluding severe active renal and severe active CNS manifestations)?

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 61 U.S. and 30 European rheumatologists fielded in December 2019

Key companies: GlaxoSmithKline, Bristol-Myers Squibb, Roche, AstraZeneca, Janssen, Eli Lilly

Key drugs: Benlysta, Rituxan / MabThera, CellCept, hydroxychloroquine, methotrexate, azathioprine

Table of contents

  • Systemic Lupus Erythematosus - Unmet Need - Detailed, Expanded Analysis: Moderate To Severe Systemic Lupus Erythematosus
    • Executive Summary
      • Unmet Need - Moderate to Severe SLE - Executive Summary - March 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Moderate to Severe SLE and Rationale for Drug Selection
      • Treatment Drivers and Goals
        • Key Findings: Attribute Importance
        • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Rheumatologists' Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS)
        • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Key Findings: Stated vs. Derived Importance
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Overall Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Mean Overall Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States and Europe
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS)
        • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS): Europe
        • Key Findings: Unmet Need in SLE and Related Indications
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) and Related Indications: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Market and Emerging Therapy Insights
          • Opportunity: A Novel Agent Offering Superior Efficacy in Reducing Disease Activity in Moderate to Severe SLE
          • Opportunity: A Novel Agent Offering Superior Efficacy in Reducing Cutaneous Disease Activity in Moderate to Severe SLE
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
          • Assigned Prohibitions for the Conjoint Module
        • Attribute Importance and Part-Worth Utilities
          • Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Target Product Profile: Attribute Importance
          • Reduction in Disease Activity at 52 Weeks (Composite Responder Rate; Placebo-Adjusted)
          • Reduction in Percentage of Patients Enduring a Severe Flare Over 52 Weeks; Placebo-Adjusted
          • Reduction in Cutaneous Disease Severity (CLASI) Over 52 Weeks; Placebo-Adjusted
          • Percentage of Patients Who Reduce Steroid Dose to ≤7.5 mg/Day at 52 Weeks; Placebo-Adjusted
          • Rate of Serious Adverse Events (% of Patients; Placebo-Adjusted)
          • Drug Formulation and Frequency
          • Price per Day
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Moderate to Severe SLE (Excluding Severe Active Renal and Severe Active CNS) Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Experts Interviewed
        • Bibliography

    Author(s): Ajay Puri, MBA

    Ajay Puri is an Associate Analyst in the Immune and Inflammatory team at Decision Resources Group and works on indications like Ulcerative Colitis, Crohn’s disease, and Systemic Lupus Erythematosus.

    He holds a Bachelor’s degree in Pharmacy and has earned his MBA (Pharmaceutical) in marketing from NIPER, Mohali. Prior to joining DRG, Ajay worked as a Knowledge Management Associate (Oncology Vertical) at ZS Associates and worked on strategic projects such as competitive assessment, company and product profiling, conference coverage for clients, client specific newsletters and other business development initiatives.
     


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