We asked Dr Lianne Kearsley Fleet, UK JIA Biologics Register Co-Investigator, to explain her recent research: Outcomes following anti-TNF originator to biosimilar switching in children and young people with Juvenile Idiopathic Arthritis, which was published in The Lancet Rheumatology, July 2024.

What is already known?

Biologic therapies are one of the main treatment options for children and young people with juvenile idiopathic arthritis (JIA). Over time, the patents for the original drugs have started to expire in Europe, and consequently other pharmaceutical companies have been able to make the drug; known as biosimilars. Biosimilar therapies must demonstrate in clinical trials that they work the same as the originator therapy. However, these trials are often done in conditions in adults (such as rheumatoid arthritis) rather than in children and young people with JIA. Due to the competitive pricing of biosimilar therapies, many children and young people with JIA are being switched from an originator therapy onto the biosimilar product which is termed a non-medical switch (i.e. not for ineffectiveness or an adverse event).

What was discovered?

This analysis included 164 children and young people with JIA from the UK JIA Biologics Register who are swapped from an originator (the original) onto the biosimilar (of the same product) and compared them with a matched cohort of patients who did not switch, and instead remained on the original. Those who swapped treatments (onto the biosimilar) were no more likely to need to stop treatment compared with those who remained on the original. In addition, patients did equally well regardless of whether they switched or not when looking at their disease activity after six months. Most patients were still receiving their biosimilar after one year, with switching back to originator uncommon, 9% overall by one year.

Why is this important / what is the benefit to patients?

This is one of the largest analyses of children and young people with JIA showing that those who switch from an originator to a biosimilar product appear to do just as well with regards to how long they remain on treatment for (a sign they are doing well on treatment) and also how well their arthritis is, compared with those who remained on the originator. This information is reassuring to clinicians and patients regarding the impact of non-medical biological switching. The data suggest good tolerance of non-medical switching in this patient population.

Should you wish to read this scientific paper in full, the text can be found online here: https://doi.org/10.1016/s2665-9913(24)00087-0

Related