Axial Spondyloarthritis – Unmet Need – Detailed, Expanded Analysis: Nonradiographic Axial Spondyloarthritis (US/EU)
TNF-α inhibitors (AbbVie’s Humira, Amgen’s Enbrel, Janssen’s Simponi, and UCB’s Cimzia) are approved to treat 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. Additionally, two IL-17 inhibitors—Novartis’s Cosentyx and Eli Lilly’s Taltz—and a JAK inhibitor—AbbVie’s Rinvoq—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 quality of life, mechanism of action, safety and tolerability, delivery, and price. With quantitative insight into U.S. and European rheumatologists’ assessment of the unmet need in the treatment of nr-AxSpA, we discuss the commercial opportunities for this difficult-to-diagnose indication and how emerging therapies may capitalize on these opportunities.
QUESTIONS ANSWERED
- What are the treatment drivers and goals for nr-AxSpA?
- Which drug attributes are key influences, 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
Provides quantitative insight into U.S. and European physician perceptions of key treatment drivers and goals and the current level of unmet need for a specific disease. Commercial opportunities are analyzed, and the extent to which emerging therapies may capitalize on these opportunities is evaluated.
Markets covered: United States, United Kingdom, France, Germany
Primary research: Survey of 62 U.S. and 31 European rheumatologists fielded in April 2023
Key companies: AbbVie, Amgen, UCB, Novartis, Eli Lilly
Key drugs: Humira, Enbrel, Cimzia, Cosentyx, Taltz, Rinvoq, NSAIDs
Table of contents
- Axial Spondyloarthritis - Unmet Need - Detailed, Expanded Analysis: Nonradiographic Axial Spondyloarthritis (US/EU)
- Executive summary
- Unmet Need - Nonradiographic axial spondyloarthritis - Executive Summary - July 2023
- 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 rheumatologists' ascribed level of unmet need across key efficacy attributes in nonradiographic axial spondyloarthritis: United States
- Surveyed rheumatologists' 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 rheumatologists' ascribed level of unmet need across key safety and tolerability attributes in nonradiographic axial spondyloarthritis: Europe
- Surveyed rheumatologists' ascribed level of unmet need across key convenience of administration attributes in nonradiographic axial spondyloarthritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key convenience of administration attributes in nonradiographic axial spondyloarthritis: Europe
- Surveyed rheumatologists' ascribed level of unmet need across key nonclinical factors in nonradiographic axial spondyloarthritis: United States
- Surveyed rheumatologists' 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 rheumatologists' ascribed level of unmet need in nonradiographic axial spondyloarthritis and related indications: United States
- Surveyed rheumatologists' 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: treatments with greater ability to induce clinical remission
- Opportunity: a novel agent that improves patients' quality of life
- Opportunity: treatment with an alternative mechanism of action
- Areas of opportunity in the nonradiographic axial spondyloarthritis market and emerging therapy insights
- 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
- Percentage of nr-AxSpA patients achieving ASAS 40 response at 12-16 weeks
- Percentage of nr-AxSpA patients achieving ASAS 40 response at 52 weeks
- Average improvement in the ASQOL Questionnaire from baseline at 12-16 weeks
- Mechanism of action
- Percentage of patients reporting serious adverse events (e.g., IBD, uveitis) at 12-16 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 of target product profiles included in the market scenario
- Nonradiographic axial spondyloarthritis market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Bibliography
- Executive summary
Rohit Rout, M.Pharm., Research Associate, Immune and Inflammation. Mr. Rout joined as an intern on the China-In-Depth team at Clarivate, where he performed secondary market research for China’s biopharmaceutical market. Before joining Clarivate, he was an associate scientist in the biopharmaceutics (IVIVC) department at Lupin Pvt. Ltd. He holds an M.Pharm. degree in pharmaceutics from the Birla Institute of Technology and Science in Pilani, India.