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SB2 biosimilar to Remicade shows comparable response, safety profile in patients with RA
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Patients with rheumatoid arthritis showed a comparable response with SB2 compared to originator biologic Remicade, and a similar safety, immunogenicity and pharmacokinetic profile was observed, according to a recently published study.
In a phase 3, random, double-blind multicenter parallel group study, 291 patients with rheumatoid arthritis (RA) were randomized to SB2 (infliximab, Merck/Samsung Bioepis) and 293 patients were randomized to Remicade (infliximab, Janssen Biotech) at 3 mg/kg IV each. Infusions were administered over 2-hour periods at weeks 0, 2, 6,14, 22,30, 38 and 46 with follow-up at week 54 between August 2013 and November 2014. Dose were allowed after week 30 at 1.5 mg/kg up to 7.5 mg/kg. The median follow-up was 296 days. One person in the SB2 group withdrew before the first infusion.
Corticosteroids and NSAIDs were allowed concomitantly if doses were stable for 4 weeks prior to randomization. Treatment with other disease-modifying anti-rheumatic drugs (DMARDs) was not permitted.
The American College of Rheumatology (ACR) criteria for a 20% response to treatment (ACR20) was observed in 64.1% of patients who received SB2 compared to 66% of patients who received originator infliximab in the per protocol set. In the full analysis set, an ACR20 response was seen in 55.5% of patients who received SB2 compared to 59% of patients who received originator infliximab, and similar time response curves were seen with both agents.
Patients who developed anti-drug antibodies presented a lower response rate, but the number of patients who developed anti-drug antibodies and the response rates similar with both SB2 and originator infliximab. The proportion of patients who reached low disease activity was 11.1% in patients who received SB2 compared to 9.8% in patients who received the originator agent based on Disease Activity Score in 28 joints (DAS28). Remission was achieved by 14.6% of patients who received SB2 compared to 15.9% of patients who received the originator infliximab based on DAS28.
Treatment-emergent adverse events (n = 499) occurred in 167 patients treated with SB2 and in 170 patients (n = 529 events) treated with originator infliximab. Latent tuberculosis (TB), increased alanine aminotransferase levels and headache were the most common adverse events. The proportion of serious adverse events was comparable between SB2 and originator infliximab treatment groups (9% vs. 8.9%). Nine patients developed a serious infection or TB. Fifteen patients in the SB2 group had an infusion-related reaction compared to 13 patients in the originator infliximab group. Two cases of malignancies arose in the SB2 treatment group and one case of fatal heart failure in the originator infliximab group. – by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.
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