210. SWITCHING TO BIOSIMILARS: AN EARLY CLINICAL REVIEW

Abstract

Background: Currently there is no clear guidance on how or when to switch patients from biologic medications to biosimilar medications but instead it is recommended on a case by case basis. It is important to pursue the most safe, efficacious and cost-effective treatments for our patients. At Musgrove Park Hospital in the South West of England the decision was made to switch all patients from the biologic Etanercept to the Etanercept biosimilar, Benepali. The patients were informed by letter and then Healthcare at Home were involved to provide support for the new pen injection device. As far as we are aware, we are the first hospital worldwide to globally switch all patients on Etanercept biologic to Benepali, Etanercept biosimilar. It therefore was important for us to have a preliminary look at our outcomes. Methods: A list of all patients on biologic or biosimilar medicines was created by our specialist nurses. All patients prescribed Etanercept biologic or biosimilar were identified. We performed data collection by looking through our records for all patients on Etanercept. Data were collected on their diagnosis, pre switch outcome measures and then post switch outcome measures (DAS28, number of tender and swollen joints, BASDAI scores, HAQ). Switch-over dates were obtained from the patients and Healthcare at Home. Patients completed a biologic follow-up questionnaire at review assessing both the new pen device and their experiences. Results: As of mid-August 2016 we had 83 patients taking Benepali. Just over a third of these had Rheumatoid Arthritis, 19% had Psoriatic arthritis with the remainder a mix of Ankylosing Spondylitis, Seronegative Spondyloarthropathies and Adult Juvenile Idiopathic Arthritis. 13 patients were started directly on Benepali, 4 of these have had a good response and 2 have not found it beneficial. The remainder are still in early stages and yet to be assessed. 70 patients were switched from Etanercept to Benepali starting at the beginning of April 2016. 44 of these patients have now been reviewed with 84% patients having continued efficacy with Benepali. 3 patients have paused treatment due to infection or planned surgery. 5 patients have failed on Benepali. Conclusion: From our early clinical review we are reassured that our patients continue to have a good response from the biosimilar Benepali. We have not reported any adverse safety events in this time period. Patients have reported that the new pen device is easier to use and they report less injection side reactions. It is vital that we continue surveillance of these patients to ensure longer term safety and clinical effectiveness data is collected and this includes the use of registers such as the BSRBR.