Biosimilar Shown Effective for Rheumatoid Arthritis

(National Institutes of Health)

4 February 2015. A biologic therapy for rheumatoid arthritis was shown to work as well as an approved name-brand biologic treatment in a late-stage clinical trial, according to findings released by biotechnology company Amgen. The study found Amgen’s biologic code-named ABP501 performed as well as adalimumab, marketed as Humira by AbbVie, in relieving symptoms of patients with moderate to severe rheumatoid arthritis.

Rheumatoid arthritis is an autoimmune disease, where the immune system is tricked into attacking healthy cells, that leads to inflammation of joints (wrists, fingers, feet, and ankles) and surrounding tissue. In the U.S., rheumatoid arthritis is estimated to affect 1.3 million people, making it the most prevalent autoimmune disease. While the rate of occurrence is declining, the disorder occurs in twice as many women as men.

Adalimumab is an engineered antibody designed to relieve pain and inflammation caused by rheumatoid arthritis by limiting the effects of tumor necrosis factors, proteins in the body known to cause inflammation. The drug, given as an injection under the skin, can also treat other autoimmune disorders including Crohn’s disease, ulcerative colitis, psoriatic arthritis, and chronic plaque psoriasis. ABP501 is also an engineered antibody designed to block the actions of tumor necrosis factors, with a dosage similar to adalimumab.

The clinical trial enrolled 526 patients with moderate to severe rheumatoid arthritis at 111 sites in North America and Europe. Patients were randomly assigned to receive either an injection of adalimumab or ABP501 every 2 weeks for 22 weeks. Researchers looked primarily at improvement in a standard index of symptom occurrence devised by American College of Rheumatology, using a gain of 20 percent or more after 24 weeks as the main measure of effectiveness. The study also tallied patients’ scores on other effectiveness scales over the study period, as well as safety indicators and ability of the drugs to generate an immune response.

Amgen, in Thousand Oaks, California, says patients given ABP501 scored within a specified margin on the American College of Rheumatology symptom index after 24 weeks as patients given adalimumab, indicating clinical equivalence. In addition, patients receiving ABP501 had similar adverse effects as patients receiving adalimumab, as well as similar immune responses.

In October 2014, Amgen released results of a similar test of ABP501 with patients having moderate-to-severe plaque psoriasis. That trial showed ABP501 relieved plaque psoriasis symptoms — red, itchy, scaly skin — among patients as well as adalimumab, with similar safety and immune response results.

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Hat tip: FirstWord Pharma

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