UK Researchers Report a Successful Switch to Biosimilar Etanercept

Yesterday, at the British Society for Rheumatology’s Annual Conference held in Liverpool, United Kingdom, researchers presented a study that investigated the clinical outcomes of a multi-disciplinary switch to biosimilar etanercept from the reference product in patients with rheumatoid arthritis (RA).

Developed by drug manufacturer Samsung Bioepis, the biosimilar etanercept (sold as Benepali in the European Union) is licensed to treat RA, psoriatic arthritis, and psoriasis. The drug has been approved in the European Union since January 1, 2016.

Researchers noted that there are limited study data available on switching patients with RA from the originator product to biosimilar etanercept with regard to clinical efficacy, tolerability, and safety. The study investigated these criteria in addition to evaluating patient perspectives on switching to a biosimilar.

The study enlisted 151 patients with RA, and enrollees were offered an education session as well as a dedicated biosimilar switching clinic staffed by a rheumatology consultant, a registrar, and specialty pharmacist both before the switch and 4 months after the switch.

During the 2 assessments, a disease activity score in 28 joints (DAS-28) was evaluated in addition to each patient completing a health assessment questionnaire (HAQ), European Quality of Life-5 Dimensions questionnaire (EQ-5D), and an 11-part biosimilars questionnaire that asked about tolerability and adverse events related to the biosimilar.

The patients were switched from the reference etanercept to the biosimilar between January 2017 and June 2017. Researchers found that the switch would result in a cost savings of approximately $675,902 (£500,000) per year based on the drugs’ prices during the time the study was conducted.

The researchers also found that, in a relatively short period of time, a large number of patients with RA were able to safely switch to the biosimilar etanercept in a controlled setting with the 114 patients achieving a mean DAS-28 score of 2.66 with the etanercept biosimilar versus a mean score of 2.97 with the originator etanercept (P =.0019).

In total, 8 patients were switched back to the reference product. This was due to 5 patients experiencing adverse events (rash and diarrhea were reported), and 3 patients having difficulty using the auto-injector pen. Two patients experienced disease flares.

When asked how they felt about their RA disesase control after the switch, 75% of patients said they felt no different. Furthermore, when 113 patients were asked how pleased they were with the switch, 50 (43%) reported they were pleased, 8 (7%) reported they were indifferent, 9 (8%) reported they weren’t sure, 27 (23%) reported they were not pleased. (The remaining patients did not answer the question.)

In addition, the method of delivery of the biosimilar was preferred by most patients, who commented on the easier technique and reduced manual dexterity required to administer the drug.

The researchers concluded by stating that the positive results of this switching study should encourage physicians and patients to switch to a biosimilar in order to optimize cost savings.

Reference

Shah K, Flora K, Penn H. Clinical outcomes of a multi-disciplinary switching program to biosimilar etanercept for patients with rheumatoid arthritis. Abstract presented at The British Society for Rheumatology’s Annual Conference; May 1-3, 2018; Liverpool, United Kingdom. Abstract 232. abstractsonline.com/pp8/#!/4506/presentation/1539.