Study suggests BMS rheumatoid arthritis drug Orencia could prevent disease
14 Feb 2024
Phase 2Clinical ResultDrug ApprovalPhase 3
A new study in The Lancet suggests Bristol Myers Squibb's Orencia (abatacept), approved nearly 20 years ago to reduce symptoms of rheumatoid arthritis, could help high-risk patients avoid progression to the chronic inflammatory disease in the first place.
"This is the largest rheumatoid arthritis prevention trial to date and the first to show that a therapy licensed for use in treating established rheumatoid arthritis is also effective in preventing the onset of disease in people at risk," said study leader Andrew Cope of King's College London.
The biologic drug, a selective T-cell costimulation modulator first approved in 2005, can be taken as an at-home weekly injection or at the hospital as an infusion. It is currently used as monotherapy or together with conventional disease-modifying antirheumatic drugs in the second- or third-line settings for people who have established rheumatoid arthritis.
Hints of early benefit
There are currently no drugs available that prevent the potentially crippling disease, although some studies suggest that Orencia has efficacy in early rheumatoid arthritis patients, who've had symptoms for less than 18 months, particularly among those with high concentrations of autoantibodies to citrullinated protein antigens (ACPA).
The authors noted that although the presence of autoantibodies might precede disease onset by a decade or more, the combination of ACPA plus symptoms, and evidence of subclinical synovitis by imaging, makes it more likely to correctly identify those who are most at risk of progressing to rheumatoid arthritis within two years.
The Phase IIb APIPPRA study recruited 213 high-risk patients to understand whether a year-long treatment with Orencia could be used to prevent progression to full-blown disease. Researchers recruited men and women over the age of 18 with early symptoms such as inflammatory joint pain, but no joint swelling. They were randomly assigned either Orencia or placebo every week for a year, and then the study drug was stopped and participants monitored for another 12 months.
Sustained through two years
The primary endpoint was the time to development of clinical synovitis in three or more joints or rheumatoid arthritis. After 12 months, 6% of patients treated with Orencia went on to develop arthritis, compared to 29% in the placebo arm. The differences were still significant at the 24-month mark, with a total of 25% of Orencia patients progressing to rheumatoid arthritis versus 37% for placebo.
Orencia was also associated with improvements in pain scores, functional wellbeing, and quality-of-life measurements at the 12-month mark, as well as low scores of subclinical synovitis by ultrasonography, compared with placebo. However, these effects were not sustained at 24 months.
"Our next steps are to understand people at risk in more detail so that we can be absolutely sure that those at highest risk of developing rheumatoid arthritis receive the drug," Cope said.
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