Real-world use of an etanercept biosimilar including selective versus automatic substitution in inflammatory arthritis patients: a UK-based electronic health records study

摘要

Lay Summary What does this mean for patients? People with arthritis are often treated with medicines known as biologics. These medicines reduce symptoms and improve quality of life. However, biologics are very expensive to make because they are complex proteins. When the biologic drug patent expires, other companies are able to make highly similar, but not identical, medicines to treat arthritis. These are known as biosimilars. Biosimilar drugs are much less expensive and therefore, in time, more individuals can access these as treatment. We investigated the biosimilar version of a biologic called etanercept. We found that the biosimilar drug worked well in treating people with arthritis when people were able to choose whether to switch to a biosimilar. However, when automatically switching from biologic to biosimilar, there was a slight worsening of symptoms, suggesting that it is better to involve patients in decisions on biosimilar use. Objective Biosimilars are approved as an alternative treatment to their originators. We compared the clinical outcomes of etanercept (ETN) biosimilar compared with ETN originator in real-world practice, from two local health boards in Wales with different policies on switching: automatic vs selective. Methods Data from the Secure Anonymised Information Linkage (SAIL) databank in Wales were used to create a retrospective cohort study using linked primary and secondary care data. Patients aged >= 18 years with diagnosis codes for RA, PsA or AS were included. Outcomes included treatment failure and DAS-28 score (for RA). The local health board with a policy of automatic switching (i.e. clinician/nurse involvement not mandated) is labelled as automatic switch area, and the other, which required clinician/nurse supervision, as selective switch. Results Of 8925 individuals with inflammatory arthritis, 13.3 (365) received ETN biosimilar and 31.5 (863) ETN originator. The treatment discontinuation rate was similar for ETN biosimilar and originator by Kaplan-Meier analysis. More biosimilar failure patients were treated in the automatic switch area (15 vs 4.8). In the automatic switch area, 28.8 (75 of 260) of patients switched automatically from ETN originator to biosimilar compared with 10.5 (11 of 105) in the selective switch area. ETN biosimilar reduced DAS-28 by 1.6 +/- 1.8 in the selective switch area vs 0.4 +/- 0.6 in the automatic switch area. Conclusion The ETN biosimilar was well tolerated. Fewer people were switched using selective policy, but this was associated with lower failure rates. Automatic switch policy led to more patients being switched and did not lead to significant worsening of disease.