Systemic Lupus Erythematosus – Unmet Need – Detailed, Expanded Analysis: Lupus Nephritis (US/EU)
Renal inflammation associated with SLE, also known as LN, is among the most serious manifestations of the disease. Until recently, no therapy was specifically approved for LN. Most treatments are old, genericized, and off-label, owing to the difficulty of developing novel treatments for this complex disease. In December 2020, the FDA granted a label extension for GlaxoSmithKline’s Benlysta, making it the first drug to gain approval for the treatment of active LN. In January 2021, Aurinia’s Lupkynis was granted FDA approval for the same patient population. Despite these approvals, unmet need remains high in this indication, leaving significant commercial opportunity for novel LN therapies.
Questions answered
- What are the treatment drivers and goals for active LN?
- What clinical and nonclinical drug attributes are key influences, which have limited impact, and which are hidden opportunities in the treatment of active LN?
- How do rheumatologists and nephrologists rate current therapies in terms of their performance on key treatment drivers and goals for active LN?
- What are the prevailing areas of unmet need and opportunity in the treatment of active LN?
- What trade-offs across key drug attributes and price are acceptable to physicians for a hypothetical new drug for LN?
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 31 U.S. rheumatologists, 30 U.S. nephrologists, and 30 European rheumatologists fielded in February 2023.
Key companies: GlaxoSmithKline, Aurinia Pharmaceuticals, Biogen / Roche / Genentech.
Key drugs: Lupkynis, Benlysta (IV/SC), Rituxan / MabThera, mycophenolate mofetil, cyclophosphamide (IV), hydroxychloroquine, tacrolimus.
Table of contents
- Systemic Lupus Erythematosus - Unmet Need - Detailed, Expanded Analysis: Lupus Nephritis (US/EU)
- Executive summary
- Unmet Need - Lupus Nephritis - Executive Summary - April 2023
- Introduction
- ISN / RPS 2003 classification of lupus nephritis
- Methodology
- Rationale for treatment drivers and goals selection
- Rationale for drug selection
- Products for lupus nephritis 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 nephrologists' prescribing decisions in lupus nephritis
- Relative importance of efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to surveyed rheumatologists' prescribing decisions in lupus nephritis
- Importance of efficacy attributes to prescribing decisions in lupus nephritis: U.S. nephrologists
- Importance of efficacy attributes to prescribing decisions in lupus nephritis: U.S. rheumatologists
- Importance of efficacy attributes to prescribing decisions in lupus nephritis: European rheumatologists
- Importance of safety and tolerability attributes to prescribing decisions in lupus nephritis: U.S. nephrologists
- Importance of safety and tolerability attributes to prescribing decisions in lupus nephritis: U.S. rheumatologists
- Importance of safety and tolerability attributes to prescribing decisions in lupus nephritis: European rheumatologists
- Importance of convenience of administration attributes to prescribing decisions in lupus nephritis: U.S. nephrologists
- Importance of convenience of administration attributes to prescribing decisions in lupus nephritis: U.S. rheumatologists
- Importance of convenience of administration attributes to prescribing decisions in lupus nephritis: European rheumatologists
- Importance of nonclinical factors to prescribing decisions in lupus nephritis: U.S. nephrologists
- Importance of nonclinical factors to prescribing decisions in lupus nephritis: U.S. rheumatologists
- Importance of nonclinical factors to prescribing decisions in lupus nephritis: European rheumatologists
- 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 lupus nephritis: U.S. nephrologists
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in lupus nephritis: U.S. rheumatologists
- Stated vs. derived importance of key efficacy, safety and tolerability, convenience of administration, and nonclinical attributes to prescribing decisions in lupus nephritis: European rheumatologists
- Product performance against treatment drivers and goals
- Key findings
- Overall performance of key therapies for lupus nephritis: U.S. nephrologists
- Overall performance of key therapies for lupus nephritis: U.S. rheumatologists
- Overall performance of key therapies for lupus nephritis: European rheumatologists
- Mean overall performance of key therapies for lupus nephritis: U.S. nephrologists
- Mean overall performance of key therapies for lupus nephritis: U.S. and European rheumatologists
- Relative performance of key therapies for lupus nephritis across select efficacy attributes: U.S. nephrologists
- Relative performance of key therapies for lupus nephritis across select efficacy attributes: U.S. rheumatologists
- Relative performance of key therapies for lupus nephritis across select efficacy attributes: European rheumatologists
- Relative performance of key therapies for lupus nephritis across select safety and tolerability attributes: U.S. nephrologists
- Relative performance of key therapies for lupus nephritis across select safety and tolerability attributes: U.S. rheumatologists
- Relative performance of key therapies for lupus nephritis across select safety and tolerability attributes: European rheumatologists
- Relative performance of key therapies for lupus nephritis across select convenience of administration attributes: U.S. nephrologists
- Relative performance of key therapies for lupus nephritis across select convenience of administration attributes: U.S. rheumatologists
- Relative performance of key therapies for lupus nephritis across select convenience of administration attributes: European rheumatologists
- Relative performance of key therapies for lupus nephritis across select nonclinical attributes: U.S. nephrologists
- Relative performance of key therapies for lupus nephritis across select nonclinical attributes: U.S. rheumatologists
- Relative performance of key therapies for lupus nephritis across select nonclinical attributes: European rheumatologists
- Assessment of unmet need
- Key findings: unmet need in lupus nephritis
- Surveyed nephrologistsu2019 satisfaction with the performance of key therapies for lupus nephritis on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed rheumatologistsu2019 satisfaction with the performance of key therapies for lupus nephritis on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: United States
- Surveyed rheumatologistsu2019 satisfaction with the performance of key therapies for lupus nephritis on efficacy, safety and tolerability, convenience of administration, and nonclinical factors: Europe
- Surveyed nephrologists' ascribed level of unmet need across key efficacy attributes in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key efficacy attributes in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key efficacy attributes in lupus nephritis: Europe
- Surveyed nephrologists' ascribed level of unmet need across key safety and tolerability attributes in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key safety and tolerability attributes in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key safety and tolerability attributes in lupus nephritis: Europe
- Surveyed nephrologists' ascribed level of unmet need across key convenience of administration attributes in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key convenience of administration attributes in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key convenience of administration attributes in lupus nephritis: Europe
- Surveyed nephrologists' ascribed level of unmet need across key nonclinical factors in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key nonclinical factors in lupus nephritis: United States
- Surveyed rheumatologists' ascribed level of unmet need across key nonclinical factors in lupus nephritis: Europe
- Key findings: unmet need in lupus nephritis and related indications
- Surveyed nephrologists' ascribed level of unmet need in lupus nephritis and related indications: United States
- Surveyed rheumatologists' ascribed level of unmet need in lupus nephritis and related indications: United States
- Surveyed rheumatologists' ascribed level of unmet need in lupus nephritis and related indications: Europe
- Opportunity analysis
- Areas of opportunity in the lupus nephritis market and emerging therapy insights
- Opportunity: a novel therapy offering improved efficacy in inducing and maintaining renal remission
- Opportunity: a novel therapy demonstrating greater reduction in the use of corticosteroids
- Areas of opportunity in the lupus nephritis 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
- Lupus nephritis target product profile: attribute importance
- Percentage of patients who achieve complete renal response at 24 weeks; placebo-adjusted
- Percentage of patients in complete renal response at 52 weeks; placebo-adjusted
- Percentage of patients who reduce steroid dose to u2264 7.5 mg/day at 52 weeks; placebo-adjusted
- Reduction in SLE disease activity at 52 weeks (SLEDAI; placebo-adjusted)
- Rate of serious adverse events at 52 weeks (percentage of patients; placebo-adjusted)
- Drug formulation and frequency
- Price per day
- Conjoint analysis-based simulation of a market scenario
- Lupus nephritis market simulation: share of preference of target product profiles included in the market scenario
- Lupus nephritis market simulation: likelihood to prescribe of target product profiles included in the market scenario
- Lupus nephritis market simulation: target product profiles included in the market scenario
- Appendix
- Key abbreviations
- Experts interviewed
- Bibliography
- Executive summary
Girdhari Roy, Ph.D., Associate Healthcare Research & Data Analyst, Immune and Inflammation. Prior to joining Clarivate, Dr. Roy was a product selection and ideation scientist at Dr. Reddy’s Laboratory. He also worked as a drug metabolism and pharmacokinetics scientist at ADTL Hyderabad. He holds bachelor’s and master’s degrees in pharmacy and a doctorate in pharmaceutical sciences from BITS Pilani, Hyderabad Campus, India.