Abatacept improves subclinical arthritis in patients at high risk for RA
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Abatacept is superior to placebo in improving subclinical inflammation in patients who are at high risk for rheumatoid arthritis, and in slowing arthritis progression, at 6 months, according to data presented at ACR Convergence 2021.
“We know that antibodies against citrullinated proteins (ACPA) emerge years before the clinical onset of RA, and imaging data have also shown structural and inflammation signs preceding the onset of RA,” Juergen Rech, MD, of the University Clinic Erlangen, in Germany, told attendees at the virtual meeting. He then referenced a graph showing the typical progression to RA.
“Starting with just the detection of ACPA and being asymptomatic, then moving to where the patient complains about arthralgia but without also being positive through imaging with subclinical inflammation, and then we have clinical arthritis, where we normally start the treatment,” Rech said. “Our hypothesis was starting therapy in RA at-risk patients being in a symptomatic phase might increase the chance of reversing subclinical inflammation in patients at high-risk for the development of RA, or even prolong time until the clinical onset.”
To test this hypothesis, Rech and colleagues conducted the randomized, placebo-controlled, double-blinded ARIAA study. Between November 2014 and December 2019, the researchers enrolled and randomized 100 patients who were at-risk for RA, being ACPA-positive and demonstrating signs of inflammation on MRI, from 14 sites in Germany, Spain and the Czech Republic. Participants received either 125 mg of subcutaneous abatacept (Orencia, Bristol Myers Squibb) weekly or placebo and 12 months of follow-up with no treatment.
The primary endpoint was improvement in at least one of the MRI inflammation parameters — defined as any change from baseline greater than 0 in synovitis, tenosynovitis and osteitis — based on Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS). The researchers conducted their analysis in an intension-to-treat population, with missing values rated as treatment failures. The final analysis included 49 patients in the abatacept group and 49 who received placebo.
According to the researchers, 61% of patients who received abatacept showed improvement in at least one of the MRI parameters, compared with 31% in the placebo group (P = .0043). In addition, arthritis developed in 34.7% of patients in the placebo group, compared with 8.2% of those treated with abatacept (P = .0025). Regarding safety, there were 12 serious adverse events reported between 2014 and 2021. However, only one — a case of pneumonia — was determined to have a causal relationship to the study treatment, according to the researchers.
“Abatacept is superior to placebo in improving subclinical inflammation in RA
at-risk patients at 6 months,” Rech said. “Abatacept is superior to placebo in inhibiting the progression to arthritis at 6 months and, as I said before, use of abatacept in RA at-risk patients is safe and no new safety issue emerged.”
“Follow-up results at 18 months revealed that the effect of a time-limited intervention of abatacept has a sustained effect on inhibition of progression to arthritis,” he added. “It’s not in my slide, but I did get the results yesterday. We know that it was also significant at 18 months, which means 6 months of treatment with abatacept will delay or even prohibit the development of RA at 18 months.”
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Rech J. Abstract 0455. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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