Bristol-Myers Says ORENCIA Trial Positive for Rheumatoid Arthritis Treatment
Rheumatoid arthritis (RA) is an autoimmune disease that leads to inflammation of the joints and surrounding tissue causing joint damage and chronic pain and stiffness. ORENCIA, a medication by Bristol-Myers Squibb, is FDA-approved to treat RA but is currently only offered in a monthly intravenous dose. The company announces that a Phase III clinical study on a new formulation of ORENCIA has shown promising results and hopes to expand options for RA patients, allowing for self-administered weekly injections instead.
New Formulation of Abatacept May Provide Patient Options for Rheumatoid Arthritis Treatment
Orencia (abatacept) belongs to a group of medications called DMARD’s, or disease-modifying anti-rheumatic drugs. It works by blocking the activity of T-cells, a type of immune cell that causes swelling and joint damage. Other recently approved DMARD’s include Actemra (Genentech), Simponi (Centocor Ortho Biotech), and Cimzia (UCB).
The ACQUIRE trial (Abatacept Comparison of Sub(Qu)cutaneous vs. Intravenous in Inadquate Responders to Methotrexate) is a multinational study involving 1,457 patients with moderate to severe rheumatoid arthritis who had failed to achieve a positive response using methotrexate. The subjects were given ORENCIA either by injections of the new formulation of the drug (1.0 mL solution containing a 125 mg subcutaneous dose of ORENCIA) or by monthly IV administration as is currently approved.
Disease activity was measured using the ACR20 criteria, an accepted measure of drug response. A patient achieving at least 20% improvement in RA disease state is considered successful.
After six months, the groups experienced similar results in achieving ACR20, significant because “they demonstrate that subcutaneous ORENCIA may provide an additional administration option for patients and physicians,” said lead author Dr. Mark C. Genovese, professor of medicine and co-chief of the Division of Immunology and Rheumatology at Stanford University Medical Center.
Intravenously, the drug is given at a doctor’s office every 2 weeks for the first three doses and then every 4 weeks after that. Side effects can include headache, dizziness, runny nose, sore throat, nausea, heartburn, and back, arm or leg pain. Side effects and adverse events were slightly less in the injection group versus the IV group.
While ORENCIA is showing positive results in rheumatoid arthritis, the drug has not had success with preventing flares in patients with systemic lupus erythematosus (SLE). Because T-cell activation also plays a role in the immunopathology of lupus, researchers at the Oklahoma Medical Research Foundation studied the drug in 180 patients with active disease (mostly white women, mean age 39 years with mean disease duration of seven years). The scientists found that 79.7% of patients receiving abatacept had new flares versus 82.5% of those on placebo.
The ACQUIRE results will be presented this week at the American College of Rheumatology (ACR) Annual Scientific Meeting in Atlanta, GA. The lupus study was published in the October issue of Arthritis and Rheumatism.