Axial Spondyloarthritis – Unmet Need – Detailed, Expanded Analysis: Nonradiographic Axial Spondyloarthritis (US & EU5)

TNF-α inhibitors (AbbVie’s Humira, Amgen’s Enbrel, Janssen’s Remicade and Simponi, UCB’s Cimzia) are approved for the treatment of nonradiographic axial spondyloarthritis (nr-AxSpA) in Europe and are increasingly used off-label in the United States, where Cimzia is the only FDA-approved TNF-α inhibitor for nr-AxSpA. In addition, IL-17 inhibitors—Novartis’s Cosentyx and Eli Lilly’s Taltz—were recently approved for this subpopulation in both regions. In this report, we examine areas of unmet need in the treatment of nr-AxSpA, including short-term efficacy, improvement in patient-reported outcomes, mechanism of action, safety and tolerability, delivery, and price. With quantitative insight into U.S. and European rheumatologists’ assessment of the unmet need in nr-AxSpA, we discuss the commercial opportunities for this difficult-to-diagnose indication and how emerging therapies may capitalize on these opportunities.

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QUESTIONS ANSWERED

  • What are the treatment drivers and goals for nr-AxSpA?
  • Which 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 nr-AxSpA?
  • What are the prevailing areas of unmet need and opportunity in nr-AxSpA?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European rheumatologists for a hypothetical new nr-AxSpA 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. One market scenario is profiled in detail by Clarivate 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 March 2021.

Key companies: AbbVie, Amgen, Janssen, UCB, Novartis, Eli Lilly

Key drugs: Humira, Enbrel, Remicade, Cimzia, Cosentyx, Taltz, NSAIDs

Table of contents

  • Axial Spondyloarthritis - Unmet Need - Detailed, Expanded Analysis: Nonradiographic Axial Spondyloarthritis (US & EU5)
    • Executive Summary
      • Unmet Need - Nonradiographic Axial Spondyloarthritis - Executive Summary - May 2021
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for Nonradiographic Axial Spondyloarthritis 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 Nonradiographic Axial Spondyloarthritis
        • Importance of Efficacy Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: 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 Nonradiographic Axial Spondyloarthritis: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Nonradiographic Axial Spondyloarthritis: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis: United States
        • Overall Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis: Europe
        • Mean Overall Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis: United States and Europe
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in Nonradiographic Axial Spondyloarthritis
        • Surveyed Rheumatologistsu2019 Satisfaction with the Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Rheumatologistsu2019 Satisfaction with the Performance of Key Therapies for Nonradiographic Axial Spondyloarthritis on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Efficacy Attributes in Nonradiographic Axial Spondyloarthritis: United States
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Efficacy Attributes in Nonradiographic Axial Spondyloarthritis: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Nonradiographic Axial Spondyloarthritis: United States
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Nonradiographic Axial Spondyloarthritis: Europe
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Nonradiographic Axial Spondyloarthritis: United States
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Nonradiographic Axial Spondyloarthritis: Europe
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Nonclinical Factors in Nonradiographic Axial Spondyloarthritis: United States
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need Across Key Nonclinical Factors in Nonradiographic Axial Spondyloarthritis: Europe
        • Key Findings: Unmet Need in Nonradiographic Axial Spondyloarthritis and Related Indications
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need in Nonradiographic Axial Spondyloarthritis and Related Indications: United States
        • Surveyed Rheumatologistsu2019 Ascribed Level of Unmet Need in Nonradiographic Axial Spondyloarthritis and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the Nonradiographic Axial Spondyloarthritis Market and Emerging Therapy Insights
          • Opportunity: Treatment With An Alternative Mechanism of Action
          • Opportunity: Treatments With Greater Ability to Induce Clinical Remission
          • Opportunity: An Agent With Demonstrated Efficacy in Associated Autoimmune Manifestations
      • Target Product Profiles
        • Assessing Drug Development Opportunities
        • Target Product Profile Methodology
          • Attributes and Attribute Levels
        • Attribute Importance and Part-Worth Utilities
          • Nonradiographic Axial Spondyloarthritis Target Product Profile: Attribute Importance
          • % of nr-AxSpa Patients Achieving ASAS 40 Response at 12-16 Weeks
          • % of nr-AxSpa Patients Achieving ASAS Partial Remission at 12-16 Weeks
          • Average Improvement in the ASQoL Questionnaire from Baseline at 12-16 Weeks
          • Mechanism of Action
          • % of Patients Reporting Serious Adverse Events (e.g., IBD, Uveitis) at 12 Weeks
          • Route and Frequency of Administration
          • Price per Day (Relative to Humira)
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • Nonradiographic Axial Spondyloarthritis Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • Nonradiographic Axial Spondyloarthritis Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • Nonradiographic Axial Spondyloarthritis Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Experts Interviewed
        • Bibliography