2019 Saw Mounting Evidence to Support Nonmedical Switching, Review Article Says

The year 2019 brought new evidence supporting nonmedical switching from infliximab (Remicade) and etanercept (Enbrel) to biosimilars (CT-P13 and SB4, respectively) for inflammatory arthritis, plus research suggesting using positive messages with patients improves willingness to switch to biosimilars.

In a year-in-review article published in Nature Reviews Rheumatology, author Jonathan Kay of UMass Memorial Medical Center and the University of Massachusetts Medical School outlines studies published in last year on nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.¹

Infliximab biosimilar CT-P13

In 2019, results were published from the 26-week open-label extension of the NOR-SWITCH trial,² which had previously established similar efficacy and safety upon nonmedical switching from infliximab to biosimilar CT-P13 in 2017. In the extension of the trial, patients from the infliximab group were switched to CT-P13, and patients who had switched to CT-P13 remained on the biosimilar. Similar proportions of patients in the 2 groups experienced disease activity worsening. Rates of adverse events, infusion reactions, and antidrug antibodies were also similar, providing additional evidence supporting nonmedical switching from infliximab to its biosimilar CT-P13.

Real-world evidence for etanercept biosimilar SB4

In 2016, Denmark mandated etanercept be replaced with its lower-cost biosimilar SB4 in most patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. An observational cohort study published in 2019 revealed the real-world effects of this mandatory switch.³ There were no differences in disease activity comparing the 3 months before and after the switch, a smaller proportion of switched patients withdrew from treatment compared to those who remained on etanercept, and 1-year adjusted retention rates were similar. Reasons for switching back to etanercept were mainly subjective, and according to Kay, some switches back to the originator were likely due to the nocebo effect.

Communicating with patients about biosimilars

Also published in 2019 was a randomized controlled trial in New Zealand in which patients being treated with originator biologics received 1 of 4 video explanations on biosimilars, 2 with positive messaging and 2 negative. Those participants who saw a positively framed message were more than twice as willing to switch to a biosimilar and thought the biosimilar would be more effective compared to those who saw negative messages.⁴

Kay also notes the previously published BIO-SPAN study, in which staff were instructed to inform patients of cost savings and lower rate of injection site reactions associated with SB4; they were also trained to discuss the nocebo effect with patients. In that study, 99% of patients who were asked to switch to SB4 were willing to switch.⁵

According to the author, because the messages patients receive from healthcare providers shape their expectations, emphasizing the potential benefits of biosimilars may increase willingness to switch, reduce failure due to the nocebo effect, and improve medication persistence.

References:

1. Kay J. Overcoming barriers to biosimilars in inflammatory arthritis. Nat Rev Rheumatol. 2020;16(2):65—66. doi:10.1038/s41584-019-0359-7
2. Goll GL, Jørgensen KK, Sexton J, et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019;285(6):653—669. doi:10.1111/joim.12880
3. Glintborg B, Loft AG, Omerovic E, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019;78(2):192—200. doi:10.1136/annrheumdis-2018-213474
4. Gasteiger C, Jones ASK, Kleinstäuber M, et al. The effects of message framing on patients' perceptions and willingness to change to a biosimilar in a hypothetical drug switch [published online ahead of print, 2019 Jun 24]. Arthritis Care Res. 2019;10.1002/acr.24012. doi:10.1002/acr.24012
5. Tweehuysen L, Huiskes VJB, van den Bemt BJF, et al. Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study. Arthritis Rheumatol. 2018;70(9):1408—1418. doi:10.1002/art.4051