Wyeth K.K. and Takeda Pharmaceutical Company Limited have announced the official completion of new patient enrolment in the post marketing surveillance of Enbrel (etanercept). This study is a post-licensure requirement and the Pharmaceutical Affairs and Food Sanitation Council of the Japan reported the completion of new patient enrollment Ministry of Health, Labour and Welfare (MHLW) on April 27, 2007.
Since the launch of Enbrel in March 2005, patients have been required to be registered and participate in an all-patient study for the confirmation of the product's safety and efficacy in Japan. Now that new patient enrolment has been completed, Enbrel will be available to a larger number of physicians, thereby increasing the treatment options available to Rheumatoid Arthritis (RA) patients across Japan.
"The results of the post marketing surveillance with Enbrel in Japan are very encouraging for doctors. We have observed the safety of this product in the world's largest surveillance study of RA therapies. We have gained significant evidence of the product's efficacy, including how the therapeutic effect manifests itself." Says Dr Takao Koike, chairman of the post marketing surveillance committee and the president of the Japan College of Rheumatology, Professor, Department of Medicine II, Hokkaido University Graduate School of Medicine. Dr. Koike was a counsellor to this post marketing surveillance program and provided expert advice from an academic and scientific standpoint.
The official decision to end enrolment was based on a full report of 7,091 case reports, which constitutes the largest all-case surveillance programme ever conducted to investigate a single biologic product's safety and efficacy.
The overall response rate of Enbrel was as high as 84.1 per cent, as measured by The Disease Activity Score (DAS 28), one of the most established and used disease measurement methods advocated by the European League Against Rheumatism. The majority (56%) of the patients in this program administered Enbrel by self-injection, demonstrating a reduced reliance on healthcare professionals for administration. The rate of severe side effects was low, only 5.7 per cent, including pneumonia, fever, and other types of infections.
"We will continue to contribute to progress in the treatment of RA based on the evidence of Enbrel's safety and efficacy gathered in this surveillance," says Dr Michio Suzukawa, corporate officer, director of medical affairs division of Wyeth K.K.
"We look forward to working closely with Wyeth colleagues in providing Enbrel to a larger number of RA patients as a treatment option to significantly reduce the painful symptoms of their disease, and to improve their quality of life" says Yasuhiko Yamanaka, corporate officer, general manager of Pharmaceutical marketing division of Takeda.
Enbrel is co-promoted by Wyeth and Takeda in Japan and was approved in January 2005, and was launched in March 2005.