Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis
Rheumatol Ther 2023;11(1):97–112 doi 10.1007/s40744-023-00621-6
Rates of malignancy were similar between upadacitinib, adalimumab, and MTX. They were also consistent across RA, PsA, AS and nr-axSpA. A dose-dependent increased rate of NMSC was observed with upadacitinib in RA. For RA and PsA, being older (≥65 years) and male was associated with
an increased risk of malignancy excluding NMSC.
Data were pooled from 11 Phase 3 upadacitinib trials, six for RA, two for PsA, two for AS, and one for nr-axSpA. TEAEs were reported as exposure-adjusted event rates (events/100 patient-years), and HRs were used to identify risk factors.
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