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Similar Efficacy, Safety, Immunogenicity Seen After Patients With RA Switched From INF to SB2
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Even after patients switched from infliximab, investigators of this study found SB2, a biosimilar to infliximab, maintained similar efficacy, safety and immunogenicity after 78 weeks in patients with rheumatoid arthritis.
Five hundred and eighty-four patients with moderate to severe RA and who previously received methotrexate were randomized to receive SB2 (Samsung Bioepis) or reference infliximab (INF; Remicade, Janssen Biotech) at weeks 0, 2, and 6, and every 8 weeks after that until week 46. After 54 weeks, patients who were originally administered INF were re-randomized to either continue with INF (INF/INF) or switch to SB2 (INF/SB2). Those initially given SB2 continued with SB2 (SB2/SB2) until week 70. Investigators evaluated efficacy, safety and immunogenicity through week 78.
Results showed all three treatment groups sustained efficacy and had similar scores. Investigators noted from week 54 to week 78, the ACR20 responses for INF/INF, INF/SB2 and SB2/SB2 ranged from 66.3% to 69.4%, 63.5% to 72.3% and 65.6% to 68.3%, respectively. Treatment-emergent adverse events occurred in 35.6% of patients given INF/INF, in 36.2% of patients given INF/SB2, and in 40.3% given SB2/SB2. Infusion-related reactions with INF/INF, INF/SB2 and SB2/SB2 were seen in 2%, 3.2% and 3.5%, respectively.
According to researchers, newly developed antidrug antibodies (ADAs) among patients who were negative for ADAs were seen in 14.9% of the INF/INF group, in 14.6% of the INF/SB2 group and in 14.1% of the SB2/SB2 group. – by Monica Jaramillo
Disclosures: Smolen reports he receives grant/research support from AbbVie, Janssen, MSD, Pfizer, Rocher and UCB; and is a consultant for AbbVie, Amgen, AstraZeneca, Astro-Pharma, Celgene, GSK, Janssen, Eli Lilly, MedImmune, MSD, Novartis-Sandoz, Novo Nordisk, Pfizer, Roche, Samsung Bioepis, Sanofi and UCB. Please see the full study for a list of all other authors’ relevant financial disclosures.
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