BMS 945429 (BMS) shows promising efficacy in RA
A Phase IIb dose-ranging study of subcutaneous BMS 945429 (clazakizumab), from Bristol-Myers Squibb, in adults with moderate-to-severe Rheumatoid Arthritis (RA) and an inadequate response to methotrexate (MTX) shows promising efficacy and safety results. Clazakizumab is a humanized anti-IL-6 monoclonal antibody that is directed against the IL-6 cytokine. In the study clazakizumab doses ranging from 25-200 mg monotherapy and in combination with MTX were studied vs. MTX alone. Adalimumab in combination with MTX was included as an active reference arm. All clazakizumab treatment arms, both as monotherapy as well as in combination with MTX, met the primary endpoint of ACR20 response at 12 weeks, compared to MTX alone, and demonstrated efficacy in controlling the signs and symptoms of RA.
Clazakizumab also demonstrated promising rates of low disease activity and remission based on DAS28, CDAI and SDAI criteria in the study which included MTX and anti-TNF comparator arms. Overall the safety profile was consistent with the known pharmacology of IL-6 blockade and adverse event (AE) rates were similar across all clazakizumab arms. The most frequent AEs were dose-related injection site reactions and these were mostly mild with few leading to discontinuation. Data were presented at the American College of Rheumatology annual meeting.
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