Parameter, Silibinin, Placebo, p-value n (%) n = 15 n = 15 ACR20
13% (91/115) of the patients reached ACR20
, including 62.
Participants in a study by Karanikolas and colleagues (2008) demonstrated significant improvement in overall functioning, with 57% reporting ACR20
at 24 weeks of treatment and 73% reporting ACR20
at 48 weeks of treatment.
or ACR50 does not provide optimal improvement in outcomes.
The results from the OPTION trial showed that 59% of the patients with rheumatoid arthritis who had incomplete responses to methotrexate achieved an ACR20
response following treatment with tocilizumab 8 mg/kg compared with 26% of patients treated with placebo, and 27% of the patients on tocilizumab achieved remission compared with 0.
The study met the primary endpoint -- achieving the ACR20
treatment efficacy standard at 24 weeks, which indicates a 20% or greater improvement in the number of swollen and tender joints.
The aim was to work out how many patients would see a 20% improvement, according to criteria set by the American College of Rheumatology (known as the ACR20
The primary efficacy endpoint in this study was the proportion of PMI-001 subjects who achieved an ACR20
response at the end of the trial in comparison to the proportion of sulfasalazine-treated subjects.
The primary end point, ACR20
response at 30 weeks, was met by 50% of patients who received MTX + 3 mg/kg infliximab and in 20% of patients who received MTX alone.
The company previously announced statistical significance for the primary endpoint of ACR20
for patients receiving apremilast in the PALACE-1 study, the first of three pivotal phase III, randomized, placebo-controlled studies evaluating the Company's novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) in patients with psoriatic arthritis who had received oral disease-modifying antirheumatic drugs (DMARD) and/or biologic therapy and/or had failed on an anti-tumor necrosis factor (TNF) agent.
In OPAL Broaden, 50% of patients taking XELJANZ 5 mg BID achieved an ACR20
response, compared to 33% of patients taking placebo (p?
Results from both studies demonstrated that patients treated with Taltz achieved significant improvement in joint symptoms, as measured by ACR20
, compared with placebo.