Systemic lupus erythematosus (SLE) is a
complex autoimmune disease affecting multiple organ systems, manifesting at
various levels of severity, and involving periods of remission and relapse. The
autoimmune reactions that characterize SLE can result in severe organ damage,
and, in some instances, ultimately lead to death. In 2011, IV belimumab (Human
Genome Sciences/GlaxoSmithKline’s Benlysta) became the first drug approved for
SLE in more than 50 years, highlighting the difficulty in successfully bringing
to market agents to treat this multifactorial disease. Several biological
therapies are in late-stage development for SLE, but based on the most recently
reported trial data, significant opportunity remains for drugs that reliably
reduce disease activity and corticosteroid use.
Attributes included in conjoint analysis-based assessment of target product profiles for moderate to severe SLE (excluding severe active renal and severe active CNS):
- Effect on disease activity at 52 weeks (placebo-adjusted composite responder rate).
- Reduction in use of corticosteroids at 52 weeks (percentage of patients who reach ≤ 7.5 mg/day).
- Rate of flares (percentage of patients).
- Improvement in health-related quality of life score (SF-36 PCS) score at 52 weeks.
- Risk of serious infections (percentage of patients).
- Drug formulation.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for moderate to severe SLE (excluding severe active renal and severe active CNS):
- Effect on disease activity (placebo-adjusted percentage of patients achieving a response on a composite responder index).
- Effect on flares (placebo-adjusted percentage of patients experiencing a severe flare).
- Time to response.
- Reduction in use of corticosteroids.
Physicians surveyed: 60 U.S. and 30 European rheumatologists
Payers surveyed: 21 U.S. MCO PDs
Comprehensive List of Therapies Included in Our Research and Modeling:
- IV belimumab (Human Genome Sciences/GlaxoSmithKline’s Benlysta)
- Rituximab (Biogen Idec/Roche/Genentech/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera)
- Mycophenolate mofetil (Roche/Galenica’s CellCept, generics)
- Subcutaneous belimumab (Human Genome Sciences/GlaxoSmithKline)
- Epratuzumab (Immunomedics/UCB)
- Blisibimod (Anthera Pharmaceuticals)
- Forigerimod (ImmuPharma’s Lupuzor, P140, CEP-33457)
- Tabalumab (Eli Lilly’s LY-2127399)
- Atacicept (Merck Serono)
- Rontalizumab (Genentech/Chugai)