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Upadacitinib vs placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: Results of a phase 3, double-blind, randomized controlled trial

Arthritis & Rheumatology Jul 16, 2019

Fleischmann R, et al. - A total of 1,629 patients with inadequate response to methotrexate were categorized to take once-daily upadacitinib 15mg, placebo, or adalimumab 40mg, on stable background methotrexate by the researchers in order to assess the efficiency, including inhibition of radiographic progression, and safety of upadacitinib, a JAK1-selective inhibitor, vs placebo and adalimumab in subjects with rheumatoid arthritis and an incomplete response to methotrexate. More people on upadacitinib vs placebo or adalimumab attained low disease activity or remission, At week 26. Radiographic progress was less and noted in fewer subjects who received upadacitinib vs placebo. Adverse events (AEs) including serious infections were relative for upadacitinib and adalimumab up to week 26. The proportions of subjects with serious AEs and AEs that resulted in discontinuation were maximum for adalimumab whereas the proportion with herpes zoster and CPK elevations was maximum for upadacitinib. Three malignancies, five MACE, and four deaths were announced, however, none were on upadacitinib Also, six venous thromboembolic events were announced. Hence, in order to improve signs, symptoms and physical function in RA patients on background methotrexate upadacitinib was higher to placebo and adalimumab, and it markedly hindered radiographic progression vs placebo, while the overall safety profile was commonly similar to adalimumab, besides for greater rates of herpes zoster and CPK elevations on upadacitinib.
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