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AbbVie's rheumatoid arthritis drug succeeds in late stage trial

AbbVie Inc. said its experimental rheumatoid arthritis drug upadacitinib met the main goal of significantly reducing symptoms of the disease in a late stage study.

The phase 3 trial, called Select-Early, enrolled adult patients with moderate to severe rheumatoid arthritis who had not been treated with chemotherapy agent methotrexate. Patients were randomized evenly to receive 15 milligrams of upadacitinib, 30 mg of upadacitinib or methotrexate once a day. A sub-study in Japan added a fourth group of patients who received 7.5 mg of upadacitinib.

After 12 weeks of treatment, 52% of patients who received 15 mg of upadacitinib achieved ACR50, compared to 56% in the 30 mg group. Only 28% of patients treated with methotrexate achieved ACR50.

ACR50 is a clinical trial measure and reaching it means patients experience at least 50% improvement in arthritis symptoms such as tender and swollen joints.

Upadacitinib was also superior to methotrexate in the trial's secondary measures of ACR20 of ACR70, which require 20% and 70% symptom improvements, respectively.

After 24 weeks of treatment, 48% of patients in the 15 mg group did not show any disease activity and were in clinical remission, compared to 50% in the 30 mg group. Of those treated with methotrexate, only 18% were in clinical remission.

Upadacitinib's safety profile was consistent with previous results in AbbVie's Select clinical trial program, which comprises six studies. The drug has yet to be approved for commercial use.

"Select-Early is the fifth pivotal trial that will support regulatory submissions for upadacitinib in rheumatoid arthritis later this year," said AbbVie's chief scientific officer, Michael Severino.

Rheumatoid arthritis affects an estimated 23.7 million people worldwide, but many patients do not respond to or cannot tolerate methotrexate, which is also used to treat certain types of cancer, the Illinois-based biotechnology company said in a release.