AbbVie Announces ABT-494 Met Primary Endpoint in Two Phase II Studies In Severe Rheumatoid Arthritis Patients

AbbVie Announces ABT-494 Met Primary Endpoint in Two Phase II Studies In Severe Rheumatoid Arthritis Patients

AbbVie  recently announced positive data from two Phase II studies that evaluated the company’s selective JAK1 inhibitor, called ABT-494, in patients with rheumatoid arthritis (RA) with an inadequate response to either methotrexate or TNF inhibitors .

The results showed that in both BALANCE-I and BALANCE-II double-blind, placebo-controlled, dose-ranging Phase 2b studies, ABT-494 achieved ACR20 (a multidimensional outcome measure to evaluate treatments in rheumatoid arthritis) following 12 weeks across all dose levels, except for the lowest dose in the BALANCE-II study.

Both clinical trials assessed patients with a diagnosis of moderate to severe RA who had insufficient responses to prior methotrexate (MTX-IR) or anti-TNF (TNF-IR). “We believe ABT-494 has the potential to become a best-in-class therapy, particularly in the most challenging patient population of TNF-inadequate responders,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “We are encouraged by the results of our Phase 2 studies and we will advance ABT-494 to Phase 3 studies with a once-daily formulation.”

Across both clinical trials the experience of serious adverse events occurred in <3% of the patients and the overall rate of discontinuation was of <5%. Two patients (one on ABT-494 and one on placebo) experienced serious infections. Less than 5% of patients that received treatment with ABT-494 experienced headache, the most usual adverse event.

“These were well-designed studies across a broad dose range that allow us to understand the full potential of inhibiting this pathway,” said Mark Genovese, M.D., professor of medicine, Stanford University Medical Center, Division of Immunology and Rheumatology. “The consistency of response and the overall safety profile of ABT-494 in these two patient populations offer the potential for significant benefit and support advancing this compound into Phase 3 studies. In particular, the TNF-IR population is increasing and represents those failing current standard of care. Anything we can do to better help these patients would represent an important advancement to the field.”

A total of 276 patients took part in the BALANCE-I study. Of these, about 20% had an inadequate response to treatment with a non-TNF biologic and about 30% had an inadequate response to two or more anti-TNF drug agents. Concerning the BALANCE-II study, a total of 300 patients who had an inadequate response to prior treatment with methotrexate participated.

“The levels of ACR response across the ABT-494 studies are impressive and warrant further investigation, particularly in treatment-refractory patients with the highest unmet need,” said Joel Kremer, M.D., director of research, The Center for Rheumatology in Albany, New York and a clinical investigator on BALANCE-I.

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