ABT-494 met primary endpoints in Phase 3 trial
AbbVie (ABBV) announced top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial.
This ongoing study evaluated upadacitinib — ABT-494, an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate.
Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib met the study’s primary endpoints of ACR20 and low disease activity versus continuing prior stable methotrexate therapy. Both doses also achieved all ranked and all key secondary endpoints. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.”
The positive results from the SELECT-MONOTHERAPY study are encouraging, as they are the first evidence to support the potential of upadacitinib as a therapy without the need for background methotrexate,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.
“These findings add to the growing body of data showing the potential for upadacitinib as a meaningful treatment option for patients suffering from rheumatoid arthritis. We look forward to sharing additional data from the upadacitinib Phase 3 rheumatoid arthritis program with the scientific community in 2018.”
The study showed that at week 14, 68/42/23 percent of patients switched to 15 mg once-daily upadacitinib and 71/52/33 percent of patients switched to 30 mg once-daily upadacitinib achieved an ACR20/50/70 response, compared to 41/15/3 percent of patients continuing on methotrexate.
These results were statistically significant compared to patients who continued on their baseline methotrexate dose.
ABBV closed at $97.92.
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