Success was measured by a decrease of at least 20% in the number of tender and swollen joints and an improvement of at least 20% on three of five domains in an American College of Rheumatology Scale after 12 weeks of therapy.
By that metric the treatment success rate was 36.2% with placebo, 65.0% with adalimumab, 70.6% with 15 mg of upadacitinib daily and 78.5% with 30 mg daily. Only the 30 mg dose was superior to adalimumab.
When it came to improvements of at least 70%, the rates at 12 weeks were 2.4%, 13.8%, 15.6% and 25.3%, respectively.
The adverse-event rates, assessed through week 24, were similar in the four groups, but hepatic disorders were seen in 9.1% who got lower-dose upadacitinib, 12.3% who received the higher dose, and 15.6% on adalimumab.
"The incidence of serious infections was 1.2% with the 15-mg dose of upadacitinib, 2.6% with the 30-mg dose of upadacitinib, 0.9% with placebo, and 0.7% with adalimumab," Dr. Iain McInnes of the University of Glasgow and colleagues report in the New England Journal of Medicine.
AbbVie paid for the phase-3 trial, designed it, and helped collect, analyze and interpret the data. The company reported topline results for the trial on February 5, 2020. The drug is sold under the brand name Rinvoq as a treatment for rheumatoid arthritis.
The study looked at 1,704 volunteers who were not well controlled by or had too many side effects from non-biologic disease-modifying arthritis drugs. It was done at 281 sites in 45 countries.
The high-dose treatment would cost more than $10,000 a month and the low-dose regimen would be half that, according to prices on goodrx.com. The adalimumab therapy used in the study costs $6,000 a month, based on data from the website.
SOURCE: https://bit.ly/3cwOQQ1 The New England Journal of Medicine, online March 31, 2021
By Reuters Staff
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