 DecisionBase PDFs --
2008
 Overview:
The late-stage development pipeline for rheumatoid arthritis
(RA) is dominated by biological agents and encompasses therapies with varied,
and mostly familiar, mechanisms of action, including novel tumor necrosis
factor-alpha inhibitors, B-cell-targeted therapies, and
interleukin (IL)-6-based therapies. The introduction of biological
agents—especially the TNF-alpha inhibitors—to the RA market in the late 1990s represented
a significant advance in the therapeutic options available to treat this
disease and has significantly raised the bar for emerging therapies.
Nonetheless, therapies with greater disease-modifying ability are still needed.
Questions Answered in This Report:
 A drug’s performance on at least eight efficacy end points,
including reduction in the signs and symptoms of RA at one year and
inhibition/slowing the progression of structural damage at one and two years,
is important for the treatment of RA. What are the key primary and secondary
clinical trial end points with which new therapies are evaluated? How do
rheumatologists weight efficacy measures and other drug attributes in their
prescribing decisions for RA?
Surveyed rheumatologists report a high level of satisfaction
with etanercept (Amgen/Wyeth/Takeda’s Enbrel) and adalimumab (Abbott/Eisai’s
Humira) for the treatment of RA. On what clinical attributes are etanercept and
adalimumab most differentiated from their competitors? What are the weaknesses of
these therapies upon which emerging therapies can capitalize? Which emerging
therapies, if any, pose the great threat to etanercept and adalimumab?
Etanercept is the 2006 major-market sales leader for RA and,
based on its clinical profile, is also the 2006 clinical gold standard in our
drug comparator model. How will emerging agents fare against etanercept? Will
emerging therapies offer improvements in the efficacy end points and drug
attributes that are most influential in physician prescribing decisions? Which
emerging therapies, if any, are best positioned to challenge the
market-leading, gold standard status of etanercept?
Scope:
Key drug development opportunity tested in our target
product profiles for rheumatoid arthritis: A therapy that is combined with
methotrexate that can induce remission (Disease Activity Score in 28 joints [DAS28]
<2.6) at two years in a larger percentage of RA patients than etanercept
plus methotrexate.
Physicians surveyed for this study: 60 U.S. rheumatologists.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Etanercept (Amgen/Wyeth/Takeda’s Enbrel)
- Methotrexate (Dava Pharmaceuticals’ Rheumatrex, generics)
- Adalimumab (Abbott/Eisai’s Humira)
- Abatacept (Bristol-Myers Squibb’s Orencia)
- Rituximab (Biogen Idec/Genentech/Chugai/Zenyaku Kogyo’s
Rituxan, Roche’s MabThera)
Emerging therapies:
- Certolizumab pegol (UCB’s Cimzia)
- Golimumab (Centocor/Schering-Plough/Mitsubishi
Tanabe/Janssen)
- Tocilizumab (Roche/Chugai’s Actemra)
- Ocrelizumab (Biogen Idec/Genentech/Roche)
About DecisionBase
Rheumatoid Arthritis: Competitive, Crowded Market Sets the
Bar High for Novel Agents is a DecisionBase 2008 study from Decision Resources.
DecisionBase 2008 combines market forecasts with clinical and commercial end
points to assess market share projections in 35 indications. These outputs are
driven by quantitative and qualitative primary research. DecisionBase 2008
provides detailed market share, patient share, and price-per-day projections
for emerging drugs in development. The market share projections are based on
prescriber surveys that compare physicians’ expectations of a potential target
product profile with an emerging product profile of the leading drugs in
development.
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