PMID- 29439591 OWN - NLM STAT- MEDLINE DCOM- 20191018 LR - 20191018 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 34 IP - 10 DP - 2018 Oct TI - Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis. PG - 1763-1769 LID - 10.1080/03007995.2018.1441144 [doi] AB - OBJECTIVE: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS). METHODS: This multi-center, non-interventional, observational study was conducted in Bulgaria, the Czech Republic, and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations. Effectiveness was assessed using the 4-item Disease Activity Score 28 with C-reactive protein (DAS28-CRP) for RA patients, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. Safety was assessed by withdrawals and adverse events (AEs). RESULTS: A total of 129 patients (RA: 67; AS: 62) were included in the effectiveness analysis. CT-P13 treatment significantly improved DAS28-CRP scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with RA and BASDAI scores at 12 and 24 weeks (p = .0001 vs baseline for both timepoints) in patients with AS. CRP levels were significantly reduced at 12 and 24 weeks (p = .0001 vs baseline for both timepoints). Among 713 infusions, 34 AEs were reported (4.8% of infusions), of which 11 were considered related to CT-P13 treatment. Two of seven serious AEs were considered possibly (hepatocellular injury) or definitely (dyspnoea due to allergic infusion reaction) treatment-related. Eight patients discontinued CT-P13 due to AEs and four patients were withdrawn due to therapeutic failure. CONCLUSIONS: CT-P13 was effective and safe in a real-life setting in patients with active RA or AS. FAU - Codreanu, Catalin AU - Codreanu C AD - a Center for Rheumatic Diseases , University of Medicine and Pharmacy , Bucharest , Romania. FAU - Sirova, Klara AU - Sirova K AD - b Revmatologie , Revmatologie MU Dr. Klara Sirova, sro , Ostrava , Czech Republic. FAU - Jarosova, Katerina AU - Jarosova K AD - c Institute of Rheumatology , Prague , Czech Republic. FAU - Batalov, Anastas AU - Batalov A AD - d Rheumatology , Medical University of Plovdiv, UMHAT "Kaspela" , Plovdiv , Bulgaria. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20180416 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antirheumatic Agents) RN - 0 (Biosimilar Pharmaceuticals) RN - 0 (CT-P13) SB - IM MH - Adult MH - Aged MH - *Antibodies, Monoclonal/administration & dosage/adverse effects MH - Antirheumatic Agents/administration & dosage/adverse effects MH - *Arthritis, Rheumatoid/diagnosis/drug therapy MH - Biosimilar Pharmaceuticals/administration & dosage/adverse effects MH - Bulgaria MH - Czech Republic MH - Drug Monitoring/methods MH - *Drug Substitution/adverse effects/methods MH - Drug-Related Side Effects and Adverse Reactions/diagnosis/etiology MH - Female MH - Humans MH - Male MH - Middle Aged MH - Patient Acuity MH - Romania MH - *Spondylitis, Ankylosing/diagnosis/drug therapy MH - Treatment Outcome OTO - NOTNLM OT - Ankylosing spondylitis OT - CT-P13 OT - Infliximab biosimilar OT - Rheumatoid arthritis EDAT- 2018/02/15 06:00 MHDA- 2019/10/19 06:00 CRDT- 2018/02/15 06:00 PHST- 2018/02/15 06:00 [pubmed] PHST- 2019/10/19 06:00 [medline] PHST- 2018/02/15 06:00 [entrez] AID - 10.1080/03007995.2018.1441144 [doi] PST - ppublish SO - Curr Med Res Opin. 2018 Oct;34(10):1763-1769. doi: 10.1080/03007995.2018.1441144. Epub 2018 Apr 16.