Positive data from the phase IIb BALANCE-I and BALANCE-II trials for experimental JAK1 inhibitor, ABT-494 in rheumatoid arthritis were announced.
The BALANCE-I study evaluated one of four twice-daily doses of ABT-494 against placebo in 276 adults with moderate-to-severe rheumatoid arthritis who had an inadequate response or intolerance to anti-TNF biologic therapy.
Roughly 30% of the patients had inadequately responded to at least two anti-TNF agents, while 20% had an insufficient response to treatment with a non-TNF biologic.
Meanwhile, in the placebo-controlled BALANCE-II trial, 300 adults with moderate-to-severe rheumatoid arthritis who had a poor response to Methotrexate were treated with one of five doses of ABT-494, with all administered twice daily, except for the highest 24-mg dose, which was given once a day.
In both studies, the primary endpoint was the proportion of patients achieving an ACR20 response at week 12, while secondary endpoints included safety and tolerability measures, in addition to the proportion of patients with ACR50 and ACR70 responses.
Results from BALANCE-I demonstrated that all four active treatment arms had met the primary endpoint of ACR20 response, with rates ranging from 56% to 73%, versus 35% for placebo.
In the BALANCE-II study, the primary endpoint was also achieved for all except the lowest dose, with ACR20 rates as high as 82% among ABT-494-treated patients, compared with 50% for placebo.
ACR50 and ACR70 responses of as great as 44% and 27%, respectively, were observed among patients in the ABT-494 arms in BALANCE-I, compared to 17% and 4% in the respective placebo groups.
In BALANCE-II, ACR50 and ACR70 rates were as high as 50% and 31%, respectively, versus 20% and 7% for placebo.
The overall rates of discontinuation and adverse events across both studies were less than 5% and less than 3%, respectively. ( Xagena )
Source: Abbvie, 2015