Introduction:
Rheumatoid arthritis is a
chronic disease affecting more than 5 million people in the major markets
(United States, France, Germany, Italy, Spain, United Kingdom, and Japan). Many
highly effective disease-modifying antirheumatic drugs (DMARDs), including
several biological DMARDs, are already available to treat RA, and the market
will become increasingly competitive following the launch of new agents from
existing and novel drug classes. As a result, physicians are unwilling to
accept agents with inferior efficacy and are becoming increasingly reluctant to
accept new agents without longer-term safety data. However, owing to various
safety and delivery shortcomings of current agents and because many patients
remain unresponsive to treatment even after exhausting all treatment options,
opportunity remains for emerging therapies that offer clinical profiles at
least on par with those of marketed agents.
Questions Answered in This Report:
*
Improving signs and symptoms of RA, inducing remission,
inhibiting/slowing the progression of structural damage, and improving physical
function are key goals in the treatment of RA.
What key primary and
secondary end points are most compelling to rheumatologists in revealing
therapies’ effect on signs and symptoms, joint damage, physical function, and
other key measures? Do U.S. and European rheumatologist feel differently about
specific drug attributes and their importance in prescribing decisions for RA?
*
Tumor necrosis factor (TNF)-α inhibitors are the 2008
major-market sales-leading drug class for RA.
Do thought leaders expect
recently launched TNF-α inhibitors to offer meaningful improvements in safety
and tolerability or delivery over established agents in this class? How will
sales-leading etanercept (Amgen/Pfizer/Takeda’s Enbrel) and other current TNF-α
inhibitors fare against emerging therapies with novel mechanisms of action?
Which drugs will suffer the most from entry of these new agents?
*
Despite the potential launch of several emerging therapies in
the RA market over the next ten years, etanercept (the major-market sales
leader) will remain the gold-standard therapy in our drug comparator model.
On
what efficacy attribute does etanercept differentiate itself from its
competitors? What attributes of this therapy will emerging therapies improve
upon? How will these emerging therapies position themselves in the RA treatment
algorithm?Scope:
Key drug development opportunity tested in our target
product profiles for RA: A disease-modifying drug with a novel mechanism of
action for patients who are refractory to TNF-α inhibitors.
Physicians surveyed for this study: 60 U.S. and 30
European rheumatologists.
Comprehensive List of Therapies Included in Our Research and Modeling
Current Therapies
- Etanercept (Amgen/Pfizer/Takeda’s Enbrel)
- Adalimumab (Abbott/Eisai’s Humira)
- Abatacept (Bristol-Myers Squibb’s Orencia)
- Rituximab (Roche/Biogen Idec/Chugai/Zenyaku Kogyo’s Rituxan,
Roche’s MabThera)
- Tocilizumab (Chugai/Roche’s Actemra/RoActemra)
Emerging Therapies
- Golimumab (Centocor Ortho Biotech/Merck & Co./Mitsubishi
Tanabe/Janssen’s Simponi)
- Certolizumab pegol (UCB/Otsuka’s Cimzia)
- CP-690550 (Pfizer)
- Fostamatinib disodium (AstraZeneca)
- Ofatumumab (Genmab/GlaxoSmithKline’s Arzerra)