Rhodes, Greece, 5 October 2006 -- There was good news for psoriasis patients today as the latest study confirming the established safety profile of ENBREL (etanercept) for up to 2.5 years , was presented at the 15th European Academy of Dermatology and Venereology (EADV) Congress. ENBREL is a biologic, meaning a biotechnologically produced medicine, which acts on one of the root causes of psoriasis by targeting one of the key mediators of the inflammatory process. It is the number one biologic prescribed worldwide and is now approved in 25 mg and 50 mg prefilled syringes offering flexibility to tailor treatment according to patient needs.
According to Bruce Strober MD PhD, codirector of the Psoriasis and Psoriatic Arthritis Center at New York University, "These results are important because they confirm the safety profile of ENBREL, which is key information in the context of wider discussion about the long-term use of biologics."
The 48-week open label (OL) extension study (n=921) enrolled patients from two blinded, randomized, placebo-controlled "parent" studies (PS). The OL study confirmed that the overall safety profile of ENBREL did not change with extended dosing for up to 2.5 years.1,2 No cases of demyelinating diseases, tuberculosis, opportunistic infections or lymphoma were reported in the study.1,2 These findings reinforce the conclusions of an earlier 96-week study of ENBREL 50 mg twice weekly in which the rate of adverse events was similar to that of placebo, and no new safety signals were identified.
In one of the parent studies, at 24 weeks patients were discontinued from treatment and treatment was re-initiated when at least half of the improvement achieved through week 24 was lost. With re-treatment, PASI 75 rates were similar to those attained during the initial treatment course, resulting in repeated success after re-treatment. , There was no treatment interruption in the other parent study.