Ozoralizumab: Extension study data

Data from a 48-week, open-label extension study in 231 evaluable patients who completed 1 of 2 double-blind, 16-week Phase II trials showed that ozoralizumab given every 4 weeks led an ACR20 response rate of 84.4% at week 48 compared to 47.4% at baseline of the extension study. At week 48, ACR50 and ACR70 response rates were 63.5% and 32.5%, respectively, compared to 23.7% and 9.8% at baseline of the extension study. Additionally, 38% of patients achieved DAS28 remission at week 48 and 97% of patients had a EULAR response of good or moderate.

Furthermore, 61% of patients achieved >=1 of the following indicators of low or no disease activity during the extension study - DAS28 score of <=3.2 points, DAS28 score of <2.6 points, no joint disease activity (no swollen or tender joints) and clinical remission (<=1 tender and swollen joint in joint count and C-reactive protein (CRP) levels of <=1 mg/dL). Ablynx also said that only 2.6% of patients tested positive for neutralizing anti-drug antibodies at some point during the extension study. The company also said the neutralizing anti-drug antibodies did not affect the efficacy or safety of ozoralizumab. Ozoralizumab was well tolerated with infections, hypertension and rash reported as the most common adverse events. All patients initially received 10 mg ozoralizumab every 4 weeks and were escalated to 30 or 80 mg ozoralizumab every 4 weeks depending on their disease activity index. ...