AbbVie’s rheumatoid arthritis drug succeeds in phase 3 study

The investigational oral agent upadacitinib was evaluated in a phase 3 clinical trial, dubbed SELECT-NEXT, in patients with moderate to severe RA who did not respond adequately to treatment with conventional synthetic DMARDs (csDMARDs).

Upadacitinib selectively inhibits JAK1, which plays a key role in the pathophysiology of rheumatoid arthritis.

The phase 3 trial evaluated the safety and efficacy of upadacitinib in two doses of 15mg and 30mg given daily once. AbbVie could demonstrate the safety trial of the drug was on par with what was observed in earlier trials of the drug.

Both the doses saw the primary and ranked secondary endpoints achieved during the trial with high statistical significance when compared to placebo treatment.

As per AbbVie, about half of the patients on upadacitinib treatment at both doses had recorded low disease activity (LDA) while about 30% of them showed clinical remission.

The primary endpoints of the 12-week SELECT-NEXT were ACR20 and LDA. On the other hand, the secondary endpoints included ACR50, ACR70 and clinical remission.

AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: “Selective inhibition of the JAK1 pathway may offer a novel treatment for rheumatoid arthritis patients who do not adequately respond to conventional therapies.

"We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission. We look forward to seeing the full results from our Phase 3 program.”

ACR20/50/70 is the percentage of improvement in RA symptoms as defined by the American College of Rheumatology.