麻豆传媒

LIVERPOOL -- Switching from etanercept (Enbrel) to its biosimilar Benepali was successfully implemented in a single-center study of patients with rheumatoid arthritis, investigators reported here.

Among 151 patients who were switched from the originator etanercept to the biosimilar, 4 months after the switch the mean Disease Activity Score in 28 joints (DAS28) was 2.66, compared with 2.97 before the switch (P=0.0019), according to Kavina Shah, MBBS, of Northwick Park Hospital in Middlesex, and colleagues.

This improvement in DAS28 was "the most significant finding" of this study, "with many patients achieving clinical remission," which was defined as DAS28 below 2.6, the researchers reported in a poster session at the annual conference of the British Society for Rheumatology.

"This could be explained by lower levels of immunogenicity with Benepali, or may be an artifact introduced by lower rates of anxiety at follow-up," they noted.

The switch program took place during 2017, and resulted in a cost saving of approximately £500,000 ($680,000) annually at current prices. Patients were sent a letter before the program began from the clinic's pharmacist, explaining the switch, and also received a telephone call to answer any questions they might have. Participants then attended an education session and were seen in a dedicated clinic staffed by a rheumatology consultant and specialist pharmacist.

Before the switch, patients on etanercept had a median DAS28 of 292, which fell to 2.41 post-switch (P=0.0004), while the mean score on the Health Assessment Questionnaire declined from 1.16 to 1.03 (P=0.0938).

The mean score on the European Quality of Life-5 Dimensions scale remained stable, at 0.82 before the switch and 0.83 4 months after switching.

Participants also completed an 11-part questionnaire that asked about tolerability and adverse events associated with the biosimilar. As to the ease of using the injector pen, there was an 11% increase after the switch to Benepali, from 7.8 to 8.6 on a scale, with 1 representing "very difficult" and 10 being "very easy."

"The Benepali pen was preferred to Enbrel, and patients commented on the easier technique and less manual dexterity required," the investigators noted.

Oral Steroid

When asked how patients felt their rheumatoid arthritis was responding, 75% said it was no different, 11% said it had improved, and 17% felt it was worse. And when asked "how pleased" they felt about the switch, 43% of patients said they were pleased and 23% were not pleased, while the remainder were indifferent or not sure.

A total of eight patients ultimately switched back to the originator etanercept. In five patients, this was because of adverse events including rash and diarrhea, and in three, it was because of difficulty with the autoinjector pen. In addition, there were two disease flares after the switch.

"The reassuring results of this switching program should positively encourage clinicians and patients to switch to the biosimilar in order to optimize the cost saving to the National Health Service," Shah and colleagues concluded.

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