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Antibodies to biological infliximab cross-reacted with infliximab biosimilars
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LONDON — Findings presented at the EULAR Annual Congress showed antibodies to infliximab in patients who received the biological treatment cross-reacted with infliximab biosimilars.
According to a press release, the findings indicate antibody-positive patients on biological infliximab should not be switched to treatment using the biosimilar.
“Our results have shown that all the antibodies that developed in patients being treated with Remicade [infliximab, Janssen Biotech] cross-reacted with the biosimilar,” Daniel Nagore, PhD, of Progenika Biopharma, said in a press release. “The presence of these anti-infliximab antibodies is likely to enhance clearance of the drug from the body, potentially leading to a loss of response, as well as increasing the risk of side effects. Therefore, in patients where biological infliximab is ineffective due to the presence of circulating antibodies, switching to its biosimilar will lead to the same problems.”
Nagore and his colleagues retrospectively selected 250 patients with active rheumatoid arthritis (RA) and spondyloarthritis under infliximab treatment and never exposed to infliximab biosimilars, and assayed 37 infliximab-naïve rheumatic patients, 19 infliximab-naïve rheumatic patients with anti-adalimumab antibodies and 21 healthy individuals as controls. Researchers measured antibodies to infliximab trough levels in parallel with Progenika’s Promonitor-anti-IFX, which uses infliximab to crosslink patients’ anti-drug antibodies; the same assay but using the infliximab biosimilar Remsima (Mundipharma); and the same assay but using Hospira’s infliximab biosimilar Inflectra.
According to the release, 50.4% of infliximab-treated patient samples tested positive for anti-infliximab antibodies using Promonitor-anti-IFX, while all samples that tested positive for anti-infliximab antibodies also showed antibody reactivity against the biosimilars.
References:
Ruiz-Argüello B, et al. Paper# OP0015. Presented at: EULAR Annual Congress; June 8-11, 2016; London.
Disclosure: Nagore is an employee of Progenika Grifols.