Bristol-Myers Squibb’s ORENCIA (abatacept) receives TGA Approval for treatment of active Psoriatic Arthritis in adults

ORENCIA® demonstrated symptom improvement in adult psoriatic arthritis patients with active musculoskeletal symptoms

Melbourne, Tuesday 23 January 2018: Bristol Myers-Squibb has today announced that the Australian Therapeutic Goods Administration (TGA) has approved an additional indication for ORENCIA (abatacept) for the treatment of active Psoriatic Arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. ORENCIA can be used with or without non-biologic DMARDs.

Professor Graeme Jones, Head of the Musculoskeletal Unit at the Menzies Institute for Medical Research Hobart said this new development will provide an additional treatment option for Australians living with this chronic2, inflammatory disease.

“There have been exciting developments in the therapy of PsA in recent years. Previously we had only one mode of action, but now we have several which gives much more flexibility of choice for patients and rheumatologists,” said Professor Graeme Jones.

“ORENCIA is one of these new options, which is both effective and generally well tolerated and many patients and rheumatologists have considerable experience based on its earlier approval for rheumatoid arthritis. This suggests it will have clinical utility for patients and will be welcomed into the extended list of treatment options,” said Professor Jones.

ORENCIA inhibits T-cell activation via its co-stimulation blockade mechanism to reduce inflammation and treat symptoms of psoriatic arthiritis.2

Brent Pfeiffenberger, General Manager for Bristol-Myers Squibb Australia and New Zealand, welcomed the decision, “This approval highlights the efficacy of ORENCIA in adult patients with active psoriatic arthritis, who have been in need of additional treatment options.”

“Immunology is an area of focus for Bristol-Myers Squibb, and this approval is another demonstration of our commitment to advancing the science and addressing clinical needs for patients,” said Brent Pfeiffenberger.

The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PsA-I and PsA-II) in 594 adult patients with disease duration of more than seven years. Patients had active Psoriatic Arthritis ( 3 swollen joints and 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.1,2,7

In PsA-I, 170 patients received IV ORENCIA or placebo at Days 1, 15, 29, and then every 28 days thereafter in a double-blind manner for 24 weeks, followed by open-label IV ORENCIA every 28 days.1

In PsA-II, 424 patients were randomized 1:1 to receive weekly doses of SC ORENCIA or placebo without a loading dose for 24 weeks, followed by open-label SC ORENCIA weekly. 1

A higher proportion of patients treated with ORENCIA 10 mg/kg IV or 125 mg SC achieved an ACR20 response at Week 24 compared to placebo, 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05), respectively.1 Responses were seen regardless of prior anti-TNFi treatment and regardless of concomitant non-biologic DMARD treatment.1 Improvements in enthesitis and dactylitis were seen with ORENCIA treatment at Week 24 in both IV and SC. 1 The overall safety profile of ORENCIA was comparable with placebo in both PsA-I9 and PsA-II2 and was consistent with the safety profile of ORENCIA in rheumatoid arthritis.1

This approval marks the third autoimmune disease indication for ORENCIA in Australia, including rheumatoid arthritis and juvenile idiopathic arthritis. 1

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.PsA can cause joint pain, stiffness and reduced range of motion as the immune system attacks healthy joints and skin,5 potentially affecting the ability to do everyday activities, such as getting dressed and tying shoes.4,6 Most commonly affecting the distal joints (those closest to the nail) of the fingers or toes, as well as the wrists, knees, ankles and lower back. The disease usually appears between the ages of 30 to 50, but can begin as early as childhood.4 Men and women are equally at risk.4 Early recognition, diagnosis and treatment of Psoriatic Arthritis are critical to helping relieve pain and inflammation.4

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