DecisionBase

March 2013

Systemic Lupus Erythematosus

Introduction:

Which Clinical Attributes Will Most Effectively Position Emerging Biologics Against IV Belimumab in the Moderate to Severe Patient Segment?

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.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including the percent of patients able to reduce their oral corticosteroid dose to ≤ 7.5 mg/day prednisone at 52 weeks, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European rheumatologists weight efficacy measures and other drug attributes in their prescribing decisions for moderate to severe SLE?

  *   Therapies with an improved effect on renal organ domain scores, a greater efficacy in reducing disease activity, an improved ability to spare corticosteroid use, and a lower risk of serious infections are key areas of unmet need for moderate to severe SLE according to the insights of surveyed U.S. and European rheumatologists. Which therapies in development for moderate to severe SLE are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   A therapy’s effect on disease activity and the risk of serious infections with which it is associated are key drivers of physicians’ prescribing decisions and/or are a focus of drug development for new moderate to severe SLE therapies. What trade-offs across these and other clinical attributes are U.S. rheumatologists willing to make when considering the use of emerging therapies for the treatment of moderate to severe SLE? Based on the trade-offs in price and performance across key drug attributes that U.S. rheumatologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for moderate to severe SLE?

  *   Based on its clinical profile, rituximab (Biogen Idec/Roche/Genentech/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge rituximab as the future gold standard in 2016 or 2021?

Scope:

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.

- Price/day.

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:

Current Therapies

- 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)

Emerging Therapies

- 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)


Search Reports

Mentioned in this report:

  • - Active Biotech
  • - Anthera Pharmaceuticals
  • - Biogen Idec
  • - Cephalon
  • - Chugai
  • - Dava Pharmaceuticals
  • - Eli Lilly
  • - Galapagos
  • - Galenica
  • - Genentech
  • - GlaxoSmithKline
  • - Human Genome Sciences
  • - Immunomedics
  • - ImmuPharma
  • - Merck Serono
  • - Novartis
  • - Prometheus
  • - Roche
  • - Sanofi
  • - SymBio Pharmaceuticals
  • - Teva Pharmaceuticals
  • - UCB
  • - Zenyaku Kogyo
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