Orencia Receives FDA Approval for Psoriatic Arthritis

Abatacept (Orencia) receives approval for third autoimmune condition.

Bristol-Myers Squibb recently announced the approval of abatacept (Orencia) for the treatment of patients with active psoriatic arthritis (PsA), which is an inflammatory condition that affects the skin and the musculoskeletal system. The FDA has approved abatacept as an intravenous (IV) formulation or subcutaneous injection.

Bristol-Myers cautions that patients should not use abatacept in conjunction with a TNF antagonist and it should not be used with other biologic rheumatoid arthritis treatments, according to a press release.

This latest approval is the third autoimmune disorder indication abatacept has received.

“This approval underscores the efficacy of Orencia in adult patients with active Psoriatic Arthritis, who have been in need of new treatments,” said Brian J. Gavin, Vice President, Orencia development lead at Bristol-Myers Squibb. “Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce Orencia, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”

PsA is characterized by joint pain, stiffness, and diminished range of motion that may affect day-to-day activities. PsA is driven by inflammation and T cell activation that attacks healthy joints and skin.

Abatacept works by inhibiting T cell activation and the associated events that lead to inflammation.

“Psoriatic arthritis takes a toll on patients and families over time,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “We welcome the introduction of an additional treatment option for adults with active psoriatic arthritis, because we believe advancements, along with further research, education and support services, are critical to helping improve the lives of those impacted.”

The newest approval was based on results from 2 clinical trials that found treatment with abatacept reduced disease activity among patients with high disease activity, high tender and swollen joints, and disease duration of longer than 7 years, according to the release.

The efficacy of the drug was explored in that PsA-I and PsA-II clinical trials.

Included in the PsA-I trial were 170 patients receiving the IV formulation of a drug on days 1, 15, 29, and then every 28 days, according to the study. Patients were randomized to receive abatacept or placebo and were able to continue therapy with methotrexate, low-dose corticosteroids, and non-steroidal anti-inflammatory drugs (NSAIDs).

Included in the PsA-II trial were 424 patients randomized to receive weekly subcutaneous injections for 24 weeks. Patients were allowed to continue therapy with methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids, or NSAIDs.

The investigators found that a higher number of patients treated with either formulation of abatacept achieved ACR20 at week 24 compared with placebo, regardless of prior or current treatments, according to the study.

The authors also noted that both formulations of abatacept resulted in improvements in enthesitis and dactylitis at week 24.

Additionally, 45% of patients treated with abatacept IV had at least a 0.30 decrease from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 24 compared with 19% of patients in the placebo group, according to the release.

The proportion of patients treated with abatacept subcutaneous with at least a 0.35 decrease from baseline in HAQ-DI was 31% compared with 24% in the placebo group.

The investigators noted that the safety profile of abatacept was consistent with its known profile in rheumatoid arthritis. Common adverse events reported in PsA-II were nasopharyngitis, upper respiratory tract infection, and bronchitis, according to the release.

“It can be difficult to treat active psoriatic arthritis patients because the disease course is unpredictable, and patients are often treated with a variety of medications such as classic DMARDs and TNFs over time. Furthermore, once they have been treated, it may be more difficult to obtain an adequate efficacy response,” said Philip Mease, MD, clinical professor at the University of Washington School of Medicine and director of the Rheumatology Clinical Research Division of Swedish Medical Center. “The data that formed the basis of this approval demonstrate that ORENCIA offers an additional treatment option for patients with active psoriatic arthritis who have already tried a TNF inhibitor, as well as those who have not.”