The European Commission (EC) has approved RINVOQTM (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. RINVOQ is also indicated for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy.
“Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of life for those living with these conditions,” said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. “We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS. These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases.”
“Psoriatic arthritis and ankylosing spondylitis are multi-faceted diseases that can cause severe pain, restricted mobility, and lasting structural damage,” said Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK. “In clinical trials, RINVOQ demonstrated improvements across multiple manifestations of these diseases. The approvals of RINVOQ for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms.”
Psoriatic arthritis and Ankylosing spondylitis are debilitating diseases that can cause severe pain, restricted mobility and lasting structural damage. Despite treatment advances, many people with AS and PsA often do not achieve their treatment goals.
Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including skin and joints. In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.
Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine and characterized by debilitating symptoms of pain, limited mobility and structural damage.
Please see the full SmPC for complete prescribing information at www.EMA.europa.eu.