Rheumatoid arthritis (RA) patients refractory to one or more tumor necrosis factor-alpha (TNF-α) inhibitors are generally prescribed a non-TNF targeted therapy (e.g., Bristol-Myers Squibb’s Orencia, Roche’s Actemra / RoActemra, Roche’s Rituxan / MabThera). The recent launch of AbbVie’s Rinvoq in the United States and Europe, along with Pfizer’s Xeljanz in Europe and Eli Lilly / Incyte’s Olumiant in both the United States and Europe, gives physicians more treatment options with a convenient route of administration (i.e., oral). The launch of an additional interleukin(IL)-6 inhibitor, Regeneron / Sanofi’s Kevzara, has further expanded the treatment armamentarium. Although the RA therapy market offers multiple efficacious and relatively safe agents, patients refractory to TNF-α inhibitors have limited options, even with the recent entry of newer agents; therefore, substantial unmet need remains in the treatment of tumor necrosis factor inhibitor (TNFi)-refractory RA.

Questions Answered:

  • What are the treatment drivers and goals in TNFi-refractory RA?
  • What drug attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • What are the prevailing areas of unmet need and opportunity in TNFi-refractory RA?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European rheumatologists for a hypothetical new drug targeting TNFi-refractory RA?

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, France, Germany, United Kingdom

Primary research: Survey of 60 U.S. rheumatologists and 30 European rheumatologists, fielded in January 2020

Key companies: Roche,  Bristol-Myers Squibb,  AbbVie,  Pfizer,  Eli Lilly,  Incyte,  Sanofi, Regeneron

Key drugs: Rituxan / MabThera, Orencia, Actemra / RoActemra, Xeljanz, Olumiant, Rinvoq

Table of contents

  • Rheumatoid Arthritis - Unmet Need - Detailed, Expanded Analysis: TNF-alpha Refractory Rheumatoid Arthritis (US & EU )
    • Executive Summary
      • Unmet Need - TNFi-Refractory RA - Executive Summary - April 2020
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Rationale for Drug Selection
          • Products for TNFi-Refractory RA 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 TNFi-Refractory RA Patients
        • Importance of Efficacy Attributes to Prescribing Decisions in TNFi-Refractory RA: United States
        • Importance of Efficacy Attributes to Prescribing Decisions in TNFi-Refractory RA: Europe
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in TNFi-Refractory RA: United States
        • Importance of Safety and Tolerability Attributes to Prescribing Decisions in TNFi-Refractory RA: Europe
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in TNFi-Refractory RA: United States
        • Importance of Convenience of Administration Attributes to Prescribing Decisions in TNFi-Refractory RA: Europe
        • Importance of Nonclinical Factors to Prescribing Decisions in TNFi-Refractory RA: United States
        • Importance of Nonclinical Factors to Prescribing Decisions in TNFi-Refractory RA: Europe
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in TNFi-Refractory RA: United States
        • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in TNFi-Refractory RA: Europe
      • Product Performance Against Treatment Drivers and Goals
        • Key Findings
        • Overall Performance of Key Therapies for TNFi-Refractory RA: United States
        • Overall Performance of Key Therapies for TNFi-Refractory RA: Europe
        • Mean Overall Performance of Key Therapies for TNFi-Refractory RA: United States and Europe
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Efficacy Attributes: United States
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Efficacy Attributes: Europe
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Safety and Tolerability Attributes: United States
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Safety and Tolerability Attributes: Europe
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Convenience of Administration Attributes: United States
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Convenience of Administration Attributes: Europe
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Nonclinical Attributes: United States
        • Relative Performance of Key Therapies for TNFi-Refractory RA Across Select Nonclinical Attributes: Europe
      • Assessment of Unmet Need
        • Key Findings: Unmet Need in TNFi-Refractory RA
        • Surveyed Rheumatologists' Satisfaction with the Performance of Key Therapies for TNFi-Refractory RA on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
        • Surveyed Rheumatologists' Satisfaction with the Performance of Key Therapies for TNFi-Refractory RA on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in TNFi-Refractory RA: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in TNFi-Refractory RA: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in TNFi-Refractory RA: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in TNFi-Refractory RA: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in TNFi-Refractory RA: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in TNFi-Refractory RA: Europe
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in TNFi-Refractory RA: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in TNFi-Refractory RA: Europe
        • Key Findings: Unmet Need in TNFi-Refractory RA and Related Indications
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need in TNFi-Refractory RA and Related Indications: United States
        • Surveyed Rheumatologists' Ascribed Level of Unmet Need in TNFi-Refractory RA and Related Indications: Europe
      • Opportunity Analysis
        • Areas of Opportunity in the TNFi-refractory RA Market and Emerging Therapy Insights
          • Opportunity: A New Therapy That Offers Improved Efficacy
          • Opportunity: A New Therapy with an Improved Safety Profile
          • Opportunity: Therapies with a Novel Mechanism of Action
      • 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 TNFi-Refractory RA
        • Attribute Importance and Part-Worth Utilities
          • TNFi-Refractory RA Target Product Profile: Attribute Importance
          • ACR 20 Response in TNFi-Refractory Patients at Six Months (% of Patients)
          • Remission (DAS28 < 2.6) in TNFi-Refractory Patients at Six Months (% of Patients)
          • Change from Baseline in SF-36 Physical Component Score at Six Months
          • Rate of Serious Infections (% of Patients)
          • Length of Postmarketing Safety Surveillance (Time on Market)
          • Delivery Burden (Route and Frequency of Administration)
          • Price per Day (Relative to SC Orencia)
        • Conjoint Analysis-Based Simulation of a Market Scenario
          • TNFi-Refractory RA Market Simulation: Share of Preference of Target Product Profiles Included in the Market Scenario
          • TNFi-Refractory RA Market Simulation: Likelihood to Prescribe Target Product Profiles Included in the Market Scenario
          • TNFi-Refractory RA Market Simulation: Target Product Profiles Included in the Market Scenario
      • Appendix
        • Key Abbreviations
        • Bibliography

    Author(s): Prerna Sharma

    Prerna Sharma is a senior analyst on the Immune and Inflammatory Disorders team at Decision Resources Group. She performs in-depth research to understand the rheumatology therapy area, specializing in rheumatoid arthritis, and creates disease landscape and forecast syndicated reports. Prior to joining DRG, she was a senior analyst at Evalueserve, where she fulfilled the research and market requirements of global pharmaceutical companies in creating syndicated and nonsyndicated reports detailing disease landscapes. Ms. Sharma has expertise in creating market assessments, competitive intelligence reports, and in-depth company profiles for the pharmaceutical and consumer healthcare sectors. She graduated from Amity University in India with a bachelor’s degree in biotechnology.


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