APIPPRA Trial: Abatacept in at-risk rheumatoid arthritis patients Save

Abatacept has been studied in seropositive clinically suspect arthralgia patients (at risk for rheumatoid arthritis) and shows the potential to delay or prevent the disease. 

Individuals with serum antibodies to citrullinated protein antigens (ACPA), rheumatoid factor, and arthralgia are estimated to have a 30% risk of developing rheumatoid arthritis (RA).  The current study looks at arthritis prevention in the pre-clinical phase of rheumatoid arthritis.

APIPPRA was a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial that enrolled adults who were seropositive for ACPA and rheumatoid factor with inflammatory joint pain (but no synovitis) and were randomized to receive either 125 mg abatacept subcutaneous injections weekly or placebo for 12 months, and then followed up for 12 months off of abatacept (ABA). The primary endpoint was the development of RA at 24 months.

A total of 213 participants were treated. At month 24, seven (6%) of 110 participants in the abatacept group and 30 (29%) of 103 participants in the placebo group met the primary endpoint. At 24 months, 27 (25%) of 110 participants in the abatacept group had progressed to rheumatoid arthritis, compared with 38 (37%) of 103 in the placebo group.

Arthritis-free survival favoured abatacept (log-rank test p=0·044), with a mean survival time between groups was 53 days at 12 months and 99 days at 24 months in favour of abatacept.

Serious adverse events occurred in the 7 abatacept and 11 placebo treated patients, with one death in each group (unrelated to treatment).

Professor Andrew Cope, from King’s College London, said: “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. These initial results could be good news for people at risk of arthritis as we show that the drug not only prevents disease onset during the treatment phase but can also ease symptoms such as pain and fatigue. This is also promising news for the NHS as the disease affects people as they age and will become more expensive to treat with a growing aging population.”

The APIPPRA trial is an Investigator-Sponsored Research (ISR) study, funded by Bristol Myers Squibb.