People who take Orencia, or abatacept, to treat rheumatoid arthritis have the option of self-injecting the drug instead of going to the doctor for an infusion.
The FDA in 2011 approved Orencia SC, a subcutaneous formulation, joining the intravenous Orencia IV as a treatment option for moderate to severe rheumatoid arthritis, or RA. This is the first biologic treatment for RA to be available in both formulations. Either can be used alone or with other drugs commonly used to treat RA, such as methotrexate. Neither should be used in conjunction with other biologic treatments, including anti-TNF drugs.
“This new formation allows patients to have more significant autonomy in their own care. Instead of being dependent on infusions every four weeks, they can now self-inject the medication at home,” says Mark Genovese, MD, professor of medicine and co-chief of the division of immunology and rheumatology at Stanford University Medical Center, in Palo Alto, Calif.
“The ability to self-inject saves time and effort for the patient, and may have a cost-effect benefit to the health care industry,” because insurers or patients on the SC formulation will no longer have to pay for the infusion administration of the IV formulation, says Dr. Genovese, who was lead author of the phase III study leading to FDA approval of Orencia SC. “Certainly the efficacy and safety of the two formulations are comparable,” he adds.
Abatacept works by blocking the activity of T-cells, a type of immune cell that is thought to be responsible for the pain and swelling in joints of people with RA.
If patients have an inadequate response to methotrexate, a first-line treatment, they are usually treated with one of the five anti-TNF biologic drugs available. If they don’t respond well to that treatment, then they go on to another biologic therapy.
The third-line is where the new formulation of abatacept would fit in, notes Arthur Kavanaugh, MD, professor of medicine at University of California San Diego. Dr. Kavanaugh was not involved in the phase III study.
There are several other third-line biologics in addition to abatacept, including anakinra, sold as Kineret SC, rituximab, or Rituxan and tocilizumab, or Actemra. “I educate patients about these drugs and they have the choice,” Dr. Kavanaugh says.
FDA approval of Orencia SC was based on the Phase III trial of 1,457 patients, which showed that Orencia SC plus methotrexate was as effective as Orencia IV plus methotrexate. According to American College of Rheumatology response criteria, it was effective in alleviating the signs and symptoms of RA, inducing a major clinical response, inhibiting the progression of joint damage and improving physical function in adults with RA. Outcomes for pain, physical function, and global assessment of disease activity were similar between the two formulations at the six-month mark. As with Orencia IV, injection-site reactions to the new formulation were mild and moderate, and none of these reactions required discontinuation of the drug.
The most common side effects reported by more than 5 percent of patients treated with either formulation included headache, inflammation of the nose and pharynx, upper respiratory tract infection, diarrhea and nausea. Serious adverse events were reported in 4.2 percent of the SC group and 4.9 percent of the IV group; serious infections were reported in 0.7 percent and 1.4 percent, respectively.