06 Aug 2013, BioSpectrum Bureau , BioSpectrum
Singapore: US-based Isis Pharmaceuticals highlighted that rheumatoid arthritis (RA) patients treated with ISIS-CRPRx achieved rapid, dose-dependent mean reductions of up to 67 percent in C-reactive protein (CRP) in a phase II study, however, these improvements were not statistically significant when compared to those observed in patients in the placebo group.
The placebo group demonstrated a higher than expected response in both symptom score and CRP reduction. A phase II study of ISIS-CRPRx in patients with atrial fibrillation is currently ongoing with data anticipated in the first half of 2014.
Dr Richard Geary, senior vice president, development, Isis, said that, "CRP is strongly associated with the presence and severity of many diseases, including numerous inflammatory and cardiovascular diseases. In this study, by treating patients with chronically elevated CRP with ISIS-CRPRx, we hoped to accomplish three things: to confirm in patients the substantial CRP-lowering activity we observed in our earlier clinical studies, to gain additional experience with the drug before testing it in more severe indications, and to evaluate whether lowering CRP correlates with an improvement in RA symptoms. The study accomplished its goals."
"We are pleased with the consistency of CRP lowering across all of our clinical studies, but we are disappointed that we did not see a greater impact on RA symptoms in these patients. While we do not plan to further develop ISIS-CRPRx for RA, we do plan to continue to evaluate ISIS-CRPRx to treat other diseases," he added.
The phase II study was a randomized, placebo-controlled, multiple-dose study in patients with RA who had chronically elevated CRP. In this study, 51 patients received 100 mg, 200 mg or 400 mg dose of ISIS-CRPRx or placebo for 12 weeks. Patients also experienced improvements in the signs and symptoms of RA, as measured by ACR20 and ACR50 scores.