AbbVie said Wednesday that a Phase III study of the experimental drug upadacitinib in patients with moderate-to-severe rheumatoid arthritis met its primary endpoints of ACR20 and low disease activity. The company noted that the oral JAK1-selective inhibitor also met key secondary goals of the SELECT-NEXT trial, including ACR50, ACR70 and clinical remission.
"Selective inhibition of the JAK1 pathway may offer a novel treatment for rheumatoid arthritis patients who do not adequately respond to conventional therapies," commented chief scientific officer Michael Severino, adding "we are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission."
In the study, patients with moderate-to-severe rheumatoid arthritis who were on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs were randomised to 12 weeks of treatment with upadacitinib at one of two doses or placebo. The trial's primary endpoints included the percentage of subjects achieving an ACR20 response and low disease activity after 12 weeks of treatment, while important secondary endpoints included the proportion of patients achieving ACR50 and ACR70 responses, as well as clinical remission at week 12.
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Top-line results from the study showed that the low and high doses of upadacitinib were associated with ACR20 rates of 64 percent and 66 percent, respectively, compared to 36 percent for placebo, while the proportions of patients achieving ACR50 in the two dose groups were 38 percent and 43 percent, respectively, versus 15 percent in the placebo group. AbbVie noted that ACR70 responses were recorded in 21 percent of patients in the low-dose group and 27 percent of those receiving the high dose, compared to 6 percent in the placebo arm.
Additionally, the drugmaker said that low disease activity was achieved by 48 percent of patients in both the low- and high-dose upadacitinib groups, versus 17 percent of placebo-treated subjects. Meanwhile, clinical remission was observed in 31 percent and 28 percent of patients in the low- and high-dose upadacitinib groups, respectively, versus 10 percent of those in the placebo group. AbbVie indicated that full study results will be submitted for publication in a research journal and presentation at a future medical meeting.
The company noted that the entire SELECT Phase III programme consists of six studies evaluating the efficacy, safety and tolerability of upadacitinib in more than 4000 patients with moderate-to-severe rheumatoid arthritis. AbbVie said the therapy is also in late-stage development for psoriatic arthritis, as well as under investigation for the treatment of Crohn's disease, ulcerative colitis and atopic dermatitis.
In April, the FDA issued a complete response letter regarding Eli Lilly and partner Incyte's marketing application for the oral JAK inhibitor Olumiant (baricitinib) as a potential treatment for patients with moderate-to-severe rheumatoid arthritis. Commenting on the latest study results, Jefferies analyst Jeffrey Holford said it is possible that upadacitinib might edge out baricitinib on efficacy as more data are released.
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