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AbbVie's rheumatoid arthritis drug bests even its own blockbuster Humira at Phase 3

Published on 11/04/18 at 10:58am

AbbVie posted a strong showing this week from its JAK1 inhibitor upadacitinib, indicating that the drug outperformed even its own best-selling blockbuster Humira (adalimumab) at Phase 3 in the treatment of moderate to severe rheumatoid arthritis in patients who have had an inadequate response to methotrexate, hitting both its primary and secondary endpoints.

The results of the trial showed that after 12 weeks of receiving once-daily 15mg doses of upadacitinib, 71% of patients achieved an ACR20 response, representing a 20% improvement in symptoms – the study’s primary endpoint – compared to 36% of those taking placebo, and 63% taking 40mg Humira. 45% of upadacitinib patients achieved an ACR50 response, while just 29% of those taking Humira and 15% of those taking placebo achieved the same. For those who achieved a response of ACR70, these rates dropped to 25%, 13% and 5% respectively.

Additionally, clinical remission was achieved by 29% of patients taking upadacitinib, compared to 18% taking Humira and just 6% taking placebo. There were no cases of venous thromboembolism in any of the 1,629 participants – a problem which has arisen in two earlier trials of the drug and even claimed patient lives.

“These results show a significant impact on both signs and symptoms and radiographic progression compared to placebo, as well as improvements in important measures such as ACR response and low disease activity compared to adalimumab," said Dr Michael Severino, AbbVie’s Executive Vice President, Research and Development and Chief Scientific Officer. “We are excited by these strong results which add to the body of evidence that support the potential of upadacitinib to be an important treatment option for patients with rheumatoid arthritis.”

Matt Fellows

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