79 Prevention of rheumatoid arthritis The Abatacept study to Determine the effectiveness in preventing the development of rheumatoid arthritis in patients with Undifferentiated inflammatory arthritis and to evaluate Safety and Tolerability (ADJUST) trial assessed the efficacy of abatacept in preventing RA in patients with UA/very early RA. Patients were considered eligible if they met a maximum of three criteria for RA diagnosis, as classified by ACR 1987 criteria, with concomitant symptomatic clinical synovitis. Moreover, all participants had circulating ACPA and symptoms for less than 18 months. Corticosteroids were allowed with a dose ≤ 10 mg prednisolone or equivalent, but no previous treatment with biological drugs or DMARD was allowed. Fifty-six patients were included in the study and stratified for the presence of erosions. Patients received intravenous abatacept (10 mg/kg) or placebo for six months (days 1, 15, 29, 57, 85, 113, 141, and 169), and were followed-up for 18 additional months [58]. The primary endpoint was RA diagnosis as defined by the 1987 ACR criteria. Additionally, radiographic progression (hands, wrists and feet), bone erosions, osteitis and synovitis (MRI of hand and wrist with the most prominent clinical synovitis), antibody levels, and DAS28 based on CRP levels were assessed. The percentage of patients in the abatacept group who developed RA at 1 year (46.2%) was numerically lower compared to placebo (66.7%) but the difference was not statistically significant. Moreover, abatacept treatment slowed radiographic progression and was associated with improved osteitis, erosion, and synovitis scores at 6 months and 1 year, while patients in the placebo group had worsening of their scores. ACPA positivity was reduced at 6 months (90.9%) and 1 year (86.7%) in the abatacept group, but remained unaltered in the placebo group. Abatacept also caused a decrease in the percentage of RF-positive patients at 6 months (59.1%) and 1 year (73.3%) in comparison with baseline (85.7%), which was not observed in the control group. Moreover, 71.4% of patients treated with abatacept had DAS28-defined remission at 6 months vs. 35.0% of placebo treated patients. This was also seen at 1 year (47.4% in abatacept group vs. 28.5% in the placebo group). Of the abatacept patients, 62.5% had zero swollen and tender joint after 6 months, which decreased to 30.0% at 1 year follow-up, whereas the proportion of patients in the placebo group with zero swollen and tender joints remained constant at 6 and 12 months (14.3%) [57]. The Abatacept Reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia (ARIAA) study investigated the efficacy of abatacept in improving subclinical inflammation in ACPA-positive arthralgia patients as measured by the presence of tenosynovitis, synovitis, or osteitis on MRI of the dominant hand. Patients were randomized to receive either abatacept subcutaneously (125 mg weekly) or placebo (NaCl 0.9%) for 6 months, and were followed for an additional 12 months [59]. Ninety-eight patients received either treatment or placebo, and the 4
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