Orencia (abatacept) is a therapy developed by Bristol-Meyers Squibb and approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, juvenile arthritis, and psoriatic arthritis.
The medicine also is being investigated for the treatment of scleroderma.
How Orencia works
Scleroderma is an autoimmune disease, meaning it is caused by an overactive immune system that mistakenly attacks the body’s own tissues. The excessive inflammation caused by this overactivity damages the skin and other organs.
Orencia is a modified antibody (protein) that binds to a specific target. It blocks part of the immune system by interfering with the activity of certain immune cells called T-cells. T-cells normally are responsible for producing signals that alert other immune cells of foreign invaders, triggering inflammation.
Orencia in clinical trials for scleroderma
The safety and effectiveness of Orencia in patients with scleroderma first were evaluated in a Phase 1/2 clinical trial (NCT00442611). Researchers injected Orencia or a placebo into the bloodstream of 10 patients with diffuse systemic scleroderma. The injections were given on days 1, 15, and 30 before switching to monthly injections for a total of seven injections. The results of the trial that were published in the scientific journal Arthritis Research & Therapy in 2015 showed that most patients treated with Orencia experienced an improvement in the modified Rodnan skin score (MRSS), a measure of skin thickness, following the treatment.
A Phase 2 trial (NCT02161406), called ASSET was designed to evaluate the safety and effectiveness of Orencia in patients with diffuse systemic scleroderma compared to placebo. During the trial, patients received either 125 mg of Orencia, or placebo, injected under the skin for 12 months, where neither the clinician nor the patients know who is receiving the drug and who is receiving placebo. This is followed by a six-month period where all patients receive open-label Orencia.
The primary goals of the study include the incidence of adverse events and serious adverse events, and the effectiveness of the treatment in improving skin fibrosis, which is measured by changes in MRSS from the study start to month 12. Researchers also are collecting skin and blood samples to better understand the pathophysiology of the disease and to assess the effect of Orencia on different skin and blood biomarkers. The trial is still active, but no longer recruiting participants. It is expected to be completed in September 2018.
The most common side effects of Orencia include headaches, high blood pressure, flu-like symptoms, heartburn, dizziness, urinary tract infections, cough, rashes, back pain, and pain in the fingers and toes.
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