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

  • Sjogren's Syndrome - Unmet Need - 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
        • Products for Primary Sjögren's Syndrome
    • 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 Primary Sjögren's Syndrome
      • Importance of Efficacy Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Primary Sjögren's Syndrome: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Primary Sjögren's Syndrome: 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 Primary Sjögren's Syndrome: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Primary Sjögren's Syndrome: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Primary Sjögren's Syndrome: United States
      • Overall Performance of Key Therapies for Primary Sjögren's Syndrome: Europe
      • Mean Overall Performance of Key Therapies for Primary Sjögren's Syndrome: United States and Europe
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Primary Sjögren's Syndrome Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Primary Sjögren's Syndrome
      • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Primary Sjögren's Syndrome on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Rheumatologists’ Satisfaction with the Performance of Key Therapies for Primary Sjögren's Syndrome on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Primary Sjögren's Syndrome: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Primary Sjögren's Syndrome: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Primary Sjögren's Syndrome: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Primary Sjögren's Syndrome: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Primary Sjögren's Syndrome: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Primary Sjögren's Syndrome: Europe
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Primary Sjögren's Syndrome: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Primary Sjögren's Syndrome: Europe
      • Key Findings: Unmet Need in Primary Sjögren's Syndrome and Related Indications
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Primary Sjögren's Syndrome and Related Indications: United States
      • Surveyed Rheumatologists' Ascribed Level of Unmet Need in Primary Sjögren's Syndrome and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Primary Sjögren'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
        • Attributes and Attribute Levels
        • Attributes of Key Current and Late-Phase Emerging Therapies for Primary Sjögren’s Syndrome
      • Attribute Importance and Part-Worth Utilities
        • Primary Sjögren's Syndrome Target Product Profile: Attribute Importance
        • Placebo-Adjusted Mean Reduction in ESSDAI at 24 Weeks
        • Placebo-Adjusted Mean Reduction in ESSPRI at 24 Weeks
        • Percentage of Patients with 30 mm Reduction in Fatigue on a 100 mm VAS at 24 Weeks (placebo-adjusted)
        • Percentage of Patients with 30 mm Reduction in Dryness on a 100 mm VAS at 24 Weeks (placebo-adjusted)
        • Delivery Burden (route of administration and dosing frequency)
        • Percentage of Patients with Infectious Adverse Events (placebo-adjusted)
        • Price per Treated Day
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Primary Sjögren's Syndrome Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Primary Sjögren's Syndrome Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Primary Sjögren's Syndrome Market Simulations: Target Product Profiles Included in Scenario 1
        • Primary Sjögren's Syndrome Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Primary Sjögren's Syndrome Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Primary Sjögren's Syndrome Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • 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 Ph.D. from the University of Massachusetts Medical School and a Bachelor’s degree from Worcester Polytechnic Institute.


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