Researchers reported on 1-year follow-up among patients at 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.
As more healthcare systems elect to switch patients from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), more data on the safety and efficacy of the biosimilar begin to emerge from real-world practice. While many of these data are from the European experience with CT-P13, additional data are beginning to be reported in other territories where the biosimilar has gained authorization and has entered the treatment landscape for inflammatory diseases.
One such example is a study published this month researchers from 2 centers in Brazil, where CT-P13 was authorized in 2016 by local authorities. In the study, published in Anais Brasileiros de Dermatologia, researchers reported on 1-year follow-up among patients at the 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.
The study included 36 patients who had been treated with the reference drug previously and 4 new starts who began treatment with CT-P13. Among the treatment-naïve patients, 2 had psoriatic arthritis. Among the patients who had been treated with the reference drug, 17 had psoriatic arthritis. Patients who had received the reference in the past had a mean 5 years (range, 1-16) of treatment with infliximab before the switch.
During the 1 year of follow-up, 2 patients reported mild worsening of skin lesions, but there was no significant increase in Psoriasis Area and Severity Index (PASI) score observed.
Two patients had infusion-related reactions (IRRs); one occurred in a treatment-naïve patient during the second infusion of infliximab, and the other occurred in a patient who has previous treatment with the reference, but had stopped treatment 4 months prior dur to a medication shortage. This second patient experienced the IRR during the first infusion of the biosimilar.
One patient developed tuberculosis (TB), after which treatment with infliximab was discontinued and treatment for TB was initiated.
The remaining 35 patients had no IRRs or adverse events and had controlled skin and joint symptoms. Their PASI scores ranged from 0 to 2.7.
“Studies with larger cohorts and longer follow-up are still needed,” write the authors, “but our preliminary results show that biosimilars may provide an opportunity to reduce health system costs because of their similarity to reference drugs in terms of safety and efficacy.”
Kurizky PS, Galvão LO, Martinis GA. Efficacy and safety of biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis: 1-year follow-up. An Bras Dermatol. 2019;94(4):483-484. doi: 10.1590/abd1806-4841.20198358.