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AbbVie s Rinvoq bags two new EU approvals
26th January 2021
The European Commission (EC) has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).
The oral JAK inhibitor has been indicated for the treatment of active PsA in adult patients who have inadequately responded to or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Rinvoq has also been indicated for the treatment of active AS in adult patients who have responded inadequately to conventional therapy.
These new approvals for Rinvoq were supported by data from three clinical trials – SELECT-PsA 1, SELECT-PsA 2 and SELECT-AXIS 1.
European Commission Approves AbbVie s RINVOQ™ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis
- RINVOQ (15 mg, once daily) is the first oral, once-daily, selective and reversible JAK inhibitor approved for three adult rheumatic indications in the European Union: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis[1,2]
- Approval is supported by data from three pivotal clinical studies in psoriatic arthritis and ankylosing spondylitis where RINVOQ met all primary and met key secondary endpoints with a safety profile consistent with that seen in rheumatoid arthritis[2-6]
- Approvals underscore AbbVie s longstanding commitment to deliver innovative medicines for people living with rheumatic diseases
MAXIMISE: Secukinumab significantly improves signs, symptoms of axial disease in PsA Disclosures: Baraliakos reports grant or research support from AbbVie, and Novartis; consulting fees from AbbVie, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Gilead, MSD, Novartis, Pfizer, and UCB; and speakers fees from AbbVie, Bristol Myers Squibb, Celgene, Chugai, MSD, Novartis, Pfizer, and UCB. Please see the study for all other authors’ relevant financial disclosures. ADD TOPIC TO EMAIL ALERTS Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . Subscribe ADDED TO EMAIL ALERTS
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Secukinumab (Cosentyx) was effective for axial manifestations of psoriatic arthritis in a 52-week multicenter phase III study, investigators reported.
The primary endpoint of a 20% response on the criteria of the Assessment of Spondyloarthritis International Society (ASAS20) at week 12 was met by 63% and 66% of patients randomized to subcutaneous secukinumab, 300 mg or 150 mg every 4 weeks, compared with 31% of those given placebo, according to Xenofon Baraliakos, MD, PhD, of Rheumazentrum Ruhrgebiet, Ruhr-University of Bochum in Germany, and colleagues.
Compared with placebo, the odds ratios of achieving ASAS20 responses were 3.8 (95% CI 2.4-6.1) and 4.4 (95% CI 2.7-7,
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