Orencia® (abatacept) Receives FDA Approval for Psoriatic Arthritis

On July 6, 2017, the U.S. Food and Drug Administration (FDA) approved Orencia (abatacept) for the treatment of adults with active psoriatic arthritis (PsA). This is the third autoimmune disease Orencia has been approved to treat, having previously received approval for rheumatoid arthritis (RA) and juvenile idiopathic arthritis.

Orencia is classified as a biologic – a drug that has been designed to act upon a specific immunological target. Orencia inhibits the activation of T-cells, a type of lymphocyte (white blood cell) that is actively involved in the inflammatory process.1,2

Clinical trial evidence of the benefit of Orencia in psoriatic arthritis

The effectiveness and safety of Orencia was studied in two large clinical trials in which patients with active PsA (more than three swollen joints and more than three tender joints) were randomly assigned either Orencia or a placebo (an inert substance). In each of the trials, some of the patients had previously received a TNF inhibitor (another biologic treatment). Positive response in the trials was measured using the American College of Rheumatology (ACR) guidelines and the Health Assessment Questionnaire-Disability Index (HAQ-DI).

In the first trial, patients were randomly selected to receive placebo or various intravenous (IV) doses of Orencia. Of those who received a 10mg/kg dose of IV Orencia, 47.5% had an ACR20 response compared to 19.0% of those receiving placebo having a positive response. The ACR20 response means a 20% improvement in joint pain, swelling and disability. In addition, a higher percentage of patients receiving Orencia (45.0%) achieved at least a 30% decrease in their HAQ-DI score compared to those receiving placebo (19.0%).

The second trial compared subcutaneous (under the skin) injections of Orencia to placebo injections. Of those who received Orencia, 39.4% achieved an ACR20 response compared to 22.3% of those receiving placebo.1,2

Dosing of Orencia

As the clinical trials demonstrated, Orencia can be used as either an IV injection or a subcutaneous injection to treat people with PsA. The dose of Orencia when given as by IV is based on the weight of the patient: 500 mg Orencia for patients weighing less than 60 kg (less than about 132 lbs), 750 mg Orencia for patients weighing between 60 kg and 100 kg (approximately 132 lbs to 220 lbs), and 1000 mg Orencia for patients weighing more than 100 kg (more than 220 lbs). The IV dose is administered every two weeks for the first month of treatment, and then once a month.

For subcutaneous injections, Orencia is given in a single-dose prefilled autoinjector that contains 125 mg/mL. Patients or their caregivers can be taught to give the subcutaneous injections at home, with injections given once a week.2

Safety of Orencia

The safety profile of Orencia in PsA was consistent with previous studies of Orencia in RA. The most serious side effects were serious infections (3%), such as pneumonia or sepsis, and malignancies (1.3%), including lung cancer and lymphoma. The most common side effects experienced by people with RA taking Orencia were headache, upper respiratory tract infections, nasopharyngitis (common cold), and nausea. In the trials of people with PsA, the most common side effects experienced by people taking Orencia were nasopharyngitis, upper respiratory tract infections, and bronchitis.1,2

Because biologics can interfere with the immune response and increase the risk of infections, Orencia should not be taken at the same time as TNF antagonists. Before beginning treatment with Orencia, people should receive a test for a latent tuberculosis (TB) infection. Live vaccines should not be given while receiving treatment with Orencia or for three months after treatment concludes. Treatment with Orencia should be stopped if a serious infection develops. Some people experience hypersensitivity or anaphylaxis reactions (severe allergic reactions) to Orencia.2

View References
  1. FirstWord Pharma, press release. Accessed online on 7/18/17 at https://www.firstwordpharma.com/node/1485815#axzz4m9CLjXRw.
  2. Orencia prescribing information. Accessed online on 7/18/17 at http://packageinserts.bms.com/pi/pi_orencia.pdf.