Switching Between Biosimilar Infliximab Products Not Associated With AEs or Change in PASI

This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases.

During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.

In the study, 24 patients with psoriasis (12 of whom also had psoriatic arthritis) were switched from one infliximab biosimilar, CT-P13 (Inflectra, Remsima), to another, SB2 (Renflexis, Flixabi). The patients, who had a previous exposure to CT-P13 of 23.2 (± 7.51) months, were then followed for 6 months after switching. Psoriasis Area and Severity Index (PASI) scores were measured at the time of the switch and at months 2, 4, and 6.

The investigators found that PASI scores at each measurement were substantially unchanged; mean scores at the time of the switch and at months 2, 4, and 6 were 0.67 (±1.38), 0.76 (±1.08), 0.71 (±0.93), and 0.42 (±0.62), respectively.

In terms of adverse events (AEs), in total, 2 infusion-related reactions were observed, and 2 upper respiratory bacterial infections were observed.

Despite the fact that the sample size and length of follow-up were limited, the switch between the biosimilars, say the researchers, was not associated with a statistically significant change in PASI score or with increased AEs.

These findings mark a contribution to the literature on such switches. Switching among multiple products is increasingly common in countries where single-winner tenders for biosimilars are undertaken and in which patients may be asked to transition among products regularly based on the winner of the tender.

However, fewer data are available concerning switches among multiple biosimilars of the same reference than between 1 biosimilar and its reference, and these data may provide reassurance to prescribers who have concerns about the safety and efficacy of switching among multiple biosimilars.

Reference

Gisondi P, Virga C, Girolomoni G. Cross-switch from CT-P13 to sb2 infliximab biosimilars in patients with chronic plaque psoriasis. Presented at: 6th Congress of Skin Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France. Abstract P049.