Upadacitinib: safety profile in rheumatoid arthritis
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Upadacitinib: safety profile in rheumatoid arthritis An integrated analysis of the SELECT clinical trial programme revealed that the overall safety profile of upadacitinib is comparable with other Janus kinase (JAK) inhibitors, according to study results reported in the Annals of Rheumatic Diseases, "with no new or unexpected safety risks identified". The five phase III trials* included patients with moderately to severely active rheumatoid arthritis (RA). Those randomised to extended-release updacitinib 15mg (n=2630) or 30mg (n=1204) once daily were compared with those who received placebo, methotrexate or adalimumab. The most common treatment-emergent adverse events (TEAEs) in upadacitinib recipients were upper respiratory tract infection, nasopharyngitis, and urinary tract infection, with increased blood creatine phosphokinase (CPK) levels in recipients of the higher dose. The exposure-adjusted event rates for serious TEAEs with upadacitinib 15mg were comparable to those with adalimumab, but higher than those with methotrexate; rates were higher with upadacitinib 30mg. The treatment-emergent deaths for upadacitinib recipients included 10 cardiovascular deaths and 12 noncardiovascular deaths. The rates of herpes zoster infections and elevated CPK levels were higher in upadacitinib recipients compared with adalimumab or methotrexate recipients. In addition, the gastrointestinal perforation rate was higher in upadacitinib 30mg recipients. However, there were similar between-group rates of death, malignancy, major adverse cardiovascular events and venous thromboembolic rates. "These results support an acceptable safety profile of upadacitinib 15mg once daily for the treatment of moderately to severely active RA", conclude the authors. * SELECT-EARLY; SELECT-NEXT; SELECT-COMPARE; SELECT-MONOTHERAPY; and SELECT-BEYOND. Cohen SB, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Annals of the Rheumatic Diseases : 803515032 28 Oct 2020. Available from: URL: http://dx.doi.org/10.1136/annrheumdis-2020-218510
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