Major Advance in the Treatment of Axial Spondyloarthritis Coming medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
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Below are specific updates on pipeline assets since our previous earnings announcement on October 27, 2020: Abrocitinib (PF-04965842) In November 2020, Pfizer announced positive top-line results from the fifth Phase 3 trial of abrocitinib, JADE REGIMEN, a 52-week study which investigated abrocitinib in patients 12 and older with moderate to severe atopic dermatitis (AD) following response to initial open label induction treatment with abrocitinib 200 mg. Patients were randomized into one of three arms: 200 mg, 100 mg or placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing a loss of response requiring rescue treatment compared to those randomized to placebo. Both doses also met the key secondary endpoint of a larger percentage of patients maintaining an Investigator’s Global Assessment (IGA) response of clear or almost clear relative to placebo.
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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