European Commission grants marketing authorisation for Celgene’s OTEZLA to treat psoriasis and psoriatic arthritis

• For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
• Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

"The approval of OTEZLA is an important new option for the treatment of patients who are not experiencing adequate relief for their conditions. OTEZLA has shown significant and clinically meaningful improvements in psoriasis and psoriatic arthritis, including difficult to treat areas such as nail, scalp, and itch, which can all be the cause of great burden for patients," said Dr. Diamant Thaci, Professor of Dermatology and the Head of the Comprehensive Center of Inflammation and Medicine at the University of Lübeck, in Germany.

"OTEZLA has also been generally well tolerated and does not require routine laboratory monitoring, which can be beneficial for both physicians and patients."

OTEZLA is the first in a new class of medicines for the treatment of both psoriasis and psoriatic arthritis, two diseases involving dysregulated immune system activity. Psoriasis is a systemic inflammatory condition characterised by raised scaly lesions on the skin. It affects approximately 14 million people across Europe4 and about 125 million people worldwide.

Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing approximately 80 percent of cases. Additionally, up to 30 percent of people with psoriasis may develop psoriatic arthritis. Psoriatic arthritis, which is also an immune-mediated disease, is estimated to affect nearly 38 million people worldwide. It is a chronic condition characterised by pain, stiffness, swelling and tenderness of the joints, and a decrease in physical functioning.

Enthesitis (inflammation at sites where tendons or ligaments insert into bone) and dactylitis (inflammation of fingers and toes, commonly known as "sausage fingers and toes") are specific disease manifestations related to psoriatic arthritis, which can contribute to significant disability.

"The approval of OTEZLA in Europe marks an important juncture in Celgene’s mission to follow the path of science and innovation where the greatest unmet need resides, and where we can make a considerable difference in the lives of people living with debilitating, inflammatory diseases," stated Tuomo Pätsi, President, Celgene Europe, the Middle East and Africa (EMEA).

"Patients with psoriasis and psoriatic arthritis may require lifelong treatment due to the chronic nature of their conditions, and we believe it is our responsibility to offer them a new option which could significantly reduce their symptoms and allow them to live a better life."

The marketing authorisation is based on efficacy and safety data from two Phase III programs, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis (ESTEEM) and psoriatic arthritis (PALACE) treated with OTEZLA through 52 weeks, across multiple endpoints.

In the ESTEEM studies, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75 percent improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint.

Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch,1 known to have a marked impact on patients’ quality of life and perception of disease severity.

In the PALACE program, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20 percent improvement in the American College of Rheumatology disease activity criteria) response at week 16, the primary endpoint. Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, dactylitis, enthesitis and overall physical function and quality of life.

Consistently, across these Phase III clinical studies, the most commonly reported adverse reactions were diarrhoea, nausea, upper respiratory tract infection, tension headache and headache. Gastrointestinal (GI) adverse reactions were mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as being severe. These adverse reactions generally occurred within the first two weeks of treatment and usually resolved within four weeks. Overall, most adverse reactions were considered to be mild or moderate in severity.

The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November 2014.12 OTEZLA® will be launched in the European Union in the coming months in accordance with local requirements.

OTEZLA® was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and on September 23, 2014 for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Marketing authorisation applications are ongoing in other countries, including Australia and Switzerland.