Enbrel showed strong safety profile for extended periods of use. In the studies, rates of serious adverse events and serious infections remained low. The numbers of observed malignancies, excluding non-melanoma skin cancers, were similar in type and number to what would be expected in the general population.
Additionally, data showed that 77 early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid arthritis (LRA) patients who completed Enbrel treatment for up to eight years experienced substantial improvements in their ACR scores. Additionally, 73 LRA patients who completed Enbrel treatment for up to nine years experienced similar improvements. ACR scores are a composite measure of improvement in rheumatoid arthritis symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician assessment, and an objective marker of inflammation.
The ability to perform daily activities was also improved upon treatment with Enbrel may help them achieve this goal. Through eight years of treatment with Enbrel, data showed that 73 to 85% of patients with ERA and 53 to 72% of patients with LRA achieved a clinically significant improvement in the Health Assessment Questionnaire score, a patient questionnaire that measures disability.
These studies were designed to assess the safety and long-term efficacy of Enbrel in adult LRA patients who have failed to respond to at least one disease-modifying antirheumatic drug, and adult patients with ERA.