15,000 Patient-Years: Safety Data for Upadacitinib Treatment Across Multiple Rheumatic Conditions

EULAR 2024 (Vienna)—In a poster presentation at EULAR 2024, Gerd R. Burmester MD, professor of medicine, Department of Rheumatology and Clinical Immunology, the Charité University Hospital, Free University and Humboldt University of Berlin, described the long-term, integrated safety profile of upadacitinib for multiple rheumatology indications. The investigators used data from the SELECT clinical trials with active comparators.¹

The review characterized the safety of upadacitinib across the following indications: rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), resulting in more than 15,000 patient-years of exposure.

Background

Upadacitinib is an orally administered Janus kinase (JAK) inhibitor. This agent is approved by the U.S. Food & Drug administration (FDA) as a 15 mg extended-release tablet for the treatment of:

• Adults with active, moderate to severe RA who have had an inadequate response to or cannot tolerate methotrexate;
• Adults with active PsA who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors;
• Adults and children 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drugs, including biologics, or when the use of those therapies is inadvisable;
• Adults with moderate to severe active ulcerative colitis or Crohn’s disease who have had an inadequate response to or cannot tolerate one or more TNF inhibitors;
• Adults with active AS who have had an inadequate response to or cannot tolerate one or more TNF inhibitors;
• Adults with active nr-axSpA with objective signs of inflammation who have not had an adequate response to or cannot tolerate TNF inhibitor therapy; and
• Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active PsA who have had an inadequate response to or cannot tolerate one or more TNF inhibitors.²

Methods

Safety data were analyzed from 11 upadacitinib clinical trials, assembled with a cutoff date of Aug. 15, 2023. Of these trials, six were on RA, two were on PsA, two were on AS and one was on nr-axSpA.¹

Any treatment-emergent adverse event that occurred at the beginning of the study, after the first drug dose, 30 days or fewer after the last drug dose of upadacitinib and methotrexate use (doses not stated)—or 70 days or fewer for adalimumab, which was given as a 40 mg dose every other week—were coded using the most current version of the Medical Dictionary for Regulatory Activities (MedDRA), which uses standardized medical terminology to facilitate the sharing of regulatory information and is used internationally to monitor adverse events. Treatment-emergent adverse events were summarized and presented as exposure-adjusted event rates (events/100 patient-years with 95% confidence intervals).