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.
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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. 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).
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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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