Janssen’s psoriatic arthritis approved in US and Europe

Johnson & Johnson’s Janssen has announced the US and European approval of its psoriatic arthritis drug, Stelara (ustekinumab).

Stelara is the first in a new class of biologics now available for patients living with active psoriatic arthritis, a chronic autoimmune disease characterised by joint swelling and tenderness, periarticular tissue inflammation (enthesitis, inflammation of the site where ligaments or tendons insert into the bones, and dactylitis, inflammation of an entire digit, e.g., finger or toe, often called “sausage digit”), as well as psoriasis.

The US Food and Drug Administration (FDA) has approved Stelara alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis.

The European Commission has approved Stelara alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

“It is critical for dermatologists and rheumatologists to be able to offer new and novel treatment options to our adult patients living with psoriatic arthritis, a disease where additional biologic options are very much needed. Therapy that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), two naturally occurring proteins believed to play a role in the development of this debilitating immune-mediated inflammatory disease, could improve patient care.”

Alice B. Gottlieb, triple board certified in dermatology, rheumatology and internal medicine, M.D., Ph.D, Chief and Dermatologist-in-Chief, Department of Dermatology, Tufts Medical Center.

The disease affects approximately 4.2 million people across Europe and over 2 million people in the US – there is currently no cure.


Related news:

J&J says Stelara approved for psoriatic arthritis (Businessweek)

Reference links:

Janssen press release (FDA approval)

Janssen press release (EC approval)

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