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RDF description of Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: Comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study - http://orbis.uaslp.mx/vivo/individual/scopus4952
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Objectives To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions. Methods This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102. All patients received concomitant methotrexate. Endpoints included American College of Rheumatology 20%25 (ACR20) response, ACR50, ACR70, immunogenicity and safety. Data were analysed for patients who received CT-P13 for 102 weeks (maintenance group) and for those who received RP for 54 weeks and then switched to CT-P13 (switch group). Results Overall, 302 of 455 patients who completed the PLANETRA study enrolled into the extension. Of these, 158 had received CT-P13 (maintenance group) and 144 RP (switch group). Response rates at week 102 for maintenance versus switch groups, respectively, were 71.7%25 vs 71.8%25 for ACR20, 48.0%25 vs 51.4%25 for ACR50 and 24.3%25 vs 26.1%25 for ACR70. The proportion of patients with antidrug antibodies was comparable between groups (week 102: 40.3%25 vs 44.8%25, respectively). Treatment-emergent adverse events occurred in similar proportions of patients in the two groups during the extension study (53.5%25 and 53.8%25, respectively). Conclusions Comparable efficacy and tolerability were observed in patients who switched from RP to its biosimilar CT-P13 for an additional year and in those who had long-term CT-P13 treatment for 2 years. Trial registration number NCT01571219; Results. © 2017 Published by the BMJ Publishing Group Limited.
ctp 13, Celltrion, South Korea; inflectra; remicade, Janssen Biotech, United States; remsima
Celltrion, South Korea; Janssen Biotech, United States
infliximab, 170277-31-3; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; Antibodies; Antibodies, Monoclonal; Antirheumatic Agents; Biosimilar Pharmaceuticals; CT-P13; Infliximab; Methotrexate
Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: Comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
Anti-TNF; DMARDs (biologic); Rheumatoid Arthritis; Treatment infliximab; infliximab dyyb; methotrexate; antibody; antirheumatic agent; biosimilar agent; CT-P13; infliximab; methotrexate; monoclonal antibody; adult; aged; anemia; Article; bursitis; cohort analysis; controlled study; contusion; diarrhea; double blind procedure; drug efficacy; drug safety; drug substitution; drug tolerability; drug withdrawal; female; fever; headache; herpes virus infection; human; immunogenicity; infusion related reaction; latent tuberculosis; liver function test; lower respiratory tract infection; major clinical study; male; open study; psoriasis; randomized controlled trial; rash; rheumatoid arthritis; rhinitis; side effect; treatment response; upper respiratory tract infection; urinary tract infection; urticaria; uterus bleeding; vaginitis; adolescent; Arthritis, Rheumatoid; clinical trial; combination drug therapy; comparative study; drug substitution; immunology; middle aged; multicenter study; treatment outcome; young adult; Adolescent; Adult; Aged; Antibodies; Antibodies, Monoclonal; Antirheumatic Agents; Arthritis, Rheumatoid; Biosimilar Pharmaceuticals; Drug Substitution; Drug Therapy, Combination; Female; Humans; Infliximab; Male; Methotrexate; Middle Aged; Treatment Outcome; Young Adult
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