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news.Bristol-Myers Squibb Company has announced positive results from a Phase IIIb study in adult patients with early moderate-to-severe erosive rheumatoid arthritis who had never received previous methotrexate treatment.
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This study showed that Orencia (abatacept) in combination with methotrexate (MTX) had significantly more patients achieve a disease activity score 28 using C-reactive protein [DAS28 (CRP)]-defined remission, compared with MTX plus placebo (PBO) (41.4% versus 23.3%, respectively; p-value less than 0.001). The safety profile of Orencia in combination with MTX was similar to that of MTX plus PBO.
In this randomized, double-blind, Phase IIIb study, patients had moderate-to-severe rheumatoid arthritis (RA) with a mean duration of RA of seven months and existing erosive disease. Additionally, all subjects were positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibodies, suggestive of a poor prognosis for their RA.
In this study, 509 MTX-naive individuals with early erosive RA who were positive for RF (96%), anti-CCP antibodies (92%) or both (89%), and had evidence of joint erosion in hands, wrists or feet, were randomized to receive either combination therapy of Orencia (abatacept) plus MTX (n=256) or MTX plus PBO (MTX alone, n=253). Orencia was administered at a dose approximating 10mg/kg based on weight range, and MTX was initiated at 7.5mg/week and titrated to 20mg/week by week eight. The mean dose of MTX was 18.1 and 19mg/week for Orencia plus MTX and MTX alone, respectively, at year one.
The primary endpoints of this study were DAS28 (CRP)-defined remission [DAS28 (CRP) less than 2.6] and joint damage progression measured using the Genant-modified total sharp score, which uses x-ray to measure change at year one. Secondary endpoints included the number of patients who achieved an American College of Rheumatology (ACR) 50% response criteria score and the number of patients who achieved a major clinical response, defined as achieving an ACR 70% response criteria score for six consecutive months. Safety was assessed throughout.
Brian Daniels, rheumatologist and senior vice president of global development and medical affairs at Bristol-Myers Squibb, said: “Bristol-Myers Squibb is committed to advancing treatment options for individuals with RA. These results provide important insight into Orencia and its utility in the treatment of patients with early erosive RA.”