No disease-modifying therapies are approved to treat primary Sjögren’s syndrome (pSS), a progressive, autoimmune disease characterized by sicca symptoms, which are caused by chronic inflammation and lymphocytic infiltration of the exocrine glands, as well as potentially severe systemic disease manifestations. Fatigue and arthralgia (joint pain) are among the most common systemic manifestations of pSS, but liver or kidney inflammation, lung involvement, peripheral sensory neuropathy, and vasculitis can also occur. Although immune-targeting agents are used off-label as needed to manage the symptoms of pSS, more-effective options are greatly needed.

QUESTIONS ANSWERED

  • What are the key efficacy metrics that surveyed rheumatologists prioritize for pSS? How do respondents rate the performance of off-label therapies on these attributes as well as on safety/tolerability, delivery, and nonclinical factors?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
  • What are the most compelling unmet needs in the treatment of pSS that would drive positive differentiation in this arena? How well poised are pipeline agents (e.g., Novartis’s iscalimab [CFZ533]) to capitalize on them?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European rheumatologists for a hypothetical new pSS drug?

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. Two market scenarios are 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 60 U.S. and 30 European rheumatologists fielded in April 2019.

Key companies: Amgen, AstraZeneca, Bristol-Myers Squibb, Galapagos, Gilead, Novartis.

Key drugs: hydroxychloroquine, rituximab, methotrexate, leflunomide, iscalimab, Orencia.

Table of contents

  • Detailed, Expanded Analysis (US & EU) Primary Sjogren's Syndrome
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Key Findings: Stated vs. Derived Importance
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Primary Sjogren's Syndrome
      • Key Findings: Unmet Need in Primary Sjogren's Syndrome and Related Indications
    • Opportunity Analysis
      • Areas of Opportunity in the Primary Sjogren's Syndrome Market and Emerging Therapy Insights
        • Opportunity: An Approved Disease-Modifying Therapy with Broad Spectrum Efficacy
        • Opportunity: A Safe, Well-Tolerated Drug Offering a Meaningful Impact on Core Symptoms: Dryness, Fatigue, and Pain
        • Opportunity: A Drug That Reduces Systemic Manifestations Across Organ Systems
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
      • Attribute Importance and Part-Worth Utilities
        • Primary Sjogren's Syndrome Target Product Profile: Attribute-Level Part-Worth Utilities
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Scenario 1
        • Scenario 2
    • Appendix
      • Bibliography

Author(s): John Crowley

John leads DRG’s Infectious, Niche, & Rare Diseases team and manages the market research portfolio across niche and rare diseases, anti-infectives, and vaccines. Prior to his current role, he was a Director on the team overseeing syndicated and custom work on niche and rare disease markets, as well as atopic dermatitis content in DRG’s Dermatology portfolio. He also served as a DRG analyst in the neurology space, focused mainly on the multiple sclerosis market. John holds a from the University of Massachusetts Medical School and a Bachelor’s degree from Worcester Polytechnic Institute.


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