Increasingly Crowded Market for
Second-Line Therapies Improving Treatment Options for Moderate-to-Severe
Rheumatoid Arthritis Patients
Rheumatoid Arthritis (RA) is a
chronic, progressive and currently incurable autoimmune disease that primarily
affects joints. It is characterized by synovial inflammation and gradual bone
erosion over many years, and disease progression results in stiffness and pain,
especially in the hands and feet, which hinders patient mobility. Without
treatment, the disease leads to joint destruction and disability. Prior to
1998, treatment options were limited to small-molecule disease-modifying therapies,
such as Methotrexate (MTX), sulfasalazine and anti-malarials. However, while
MTX is efficacious in controlling RA symptoms in a large percentage of
patients, approximately 33% are unresponsive to these first-line drugs. The
approval of revolutionary biological therapies, including Enbrel, Remicade and
Humira, for the treatment of RA patients that are refractory to MTX has
triggered unparalleled growth in the market.
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Globally, there are at least 12
biological therapies, including monoclonal antibodies (mAb), biosimilars and
therapeutic proteins, competing as second-line therapies for this
sub-population. Over the past 16 years, the therapeutic market for RA has
become extremely competitive as a result of the high number of new drug
approvals. Competition for Tumor Necrosis Factor Alpha (TNF-a) inhibitors is
particularly fierce, and now dominates the treatment market for RA patients who
are refractory to first-line Disease Modifying Anti-Rheumatic Drugs (DMARD). In
2013, three TNF-a targeting mAbs, Humira (adalimumab), Remicade (infliximab)
and Enbrel (etanercept), were ranked among the top-10 best-selling drugs in the
world, with global revenues of $11.1 billion, $9.9 billion and $8.9 billion
respectively, reflecting their groundbreaking clinical and commercial success.
Despite this, 30% of RA patients fail to achieve clinical responses when
treated with TNF-a inhibitors (Rubbert-Roth and Finckh, 2009). However,
patients who are unresponsive to TNF-a inhibitors can also be medicated with
the cytokine modulators Rituxan and Xeljanz. Thus, the extensive range of
available therapies is addressing the need for efficacious therapies for a
broad spectrum of RA patients.
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