AbbVie records another win with its JAK1 inhibitor upadacitinib (ABT-494) but a death and pulmonary embolism were also recorded in the data.
The phase 3 SELECT-MONOTHERAPY study examined upadacitinib in patients with moderate to severe rheumatoid arthritis (RA) that did not see positive results from a standard drug for the disease, methotrexate. Results revealed following 14 weeks of treatment, the drug met the study’s primary endpoints of ACR20 and low disease activity (LDA) compared to continuing prior methotrexate therapy.
The study indicated at week 14, 68/42/23 percent of patients converted to 15mg once-daily upadacitinib and 71/52/33 percent of patients converted to 30mg once-daily upadacitinib hit an ACR20/50/70 response versus 41/15/3 percent of patients on methotrexate. Low disease activity was achieved by 45% and 53% of patients in the 15mg and 30mg groups compared to 19% of patients continuing methotrexate. As for clinical remission, it was reached by 28% and 41% of patients in the 15mg and 30mg groups versus just 8% for patients continuing methotrexate.
Serious adverse events were also recorded. One patient, which AbbVie stated had “pre-existing cardiovascular risk factors,” died of a hemorrhagic stroke as a result of a ruptured aneurysm, while on the lower dose of upadacitinib. Also, a pulmonary embolism (PE) was recorded during the study, the patient was taking the lower dose of the drug as well. Again, AbbVie stated that the patient had a “pre-existing risk factors for PE.”
The biotech stated: “Across the SELECT rheumatoid arthritis program, including both the placebo-controlled and extension periods, the rate of deep vein thrombosis and PE remains consistent with the background rate for the RA patient population.”
This year, the drug hit the targets in eczema and has already defeated placebo in reducing symptoms of the disease. The drug could become a $3.5 billion star if it claims approval in other inflammatory conditions, which include rheumatoid arthritis and inflammatory bowel disease (IBS). Upadacitinib is also in tests for psoriatic arthritis, Crohn’s disease, ulcerative colitis as well as atopic dermatitis.
“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., EVP research and development and chief scientific officer.
“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” added Severino.