Real-life drug persistence in patients with rheumatic diseases treated with CT-P13: a prospective observational cohort study (PERSIST)
| Autor: | Robin Christensen, Peter C. Taylor, Ruffy Guilatco, Heather Fowler, Boulos Haraoui, Pamela Selema, K. F. Liau, Shahrzad Moosavi, Markus Mueller |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
safety
medicine.medical_specialty Rheumatology real life Internal medicine Medicine Dosing observational Prospective cohort study Adverse effect Respiratory tract infections business.industry PERSIST persistence medicine.disease Infliximab rheumatic diseases Bronchitis Observational study Original Article biosimilar business AcademicSubjects/MED00010 infliximab CT-P13 Cohort study medicine.drug |
| Zdroj: | Rheumatology Advances in Practice Taylor, P C, Christensen, R, Moosavi, S, Selema, P, Guilatco, R, Fowler, H, Mueller, M, Liau, K F & Haraoui, B 2021, ' Real-life drug persistence in patients with rheumatic diseases treated with CT-P13 : a prospective observational cohort study (PERSIST) ', Rheumatology advances in practice, vol. 5, no. 2, rkab026 . https://doi.org/10.1093/rap/rkab026 |
| ISSN: | 2514-1775 |
| DOI: | 10.1093/rap/rkab026 |
| Popis: | ObjectiveThe aim was to report results from PERSIST, a real-life, observational, prospective cohort study of CT-P13, an infliximab (IFX) biosimilar, for treatment of patients with RA, AS or PsA who were biologic naïve or switched from an IFX reference product (IFX-RP; Remicade).MethodsAdult patients were recruited during usual care at 38 sites in Europe and Canada and enrolled by their physicians after meeting eligibility criteria according to the country-approved label for CT-P13. Primary outcomes were to determine drug utilization and treatment persistence and to assess safety. Patients were followed for up to 2 years. Data were analysed and reported descriptively.ResultsOf 351 patients enrolled, 334 were included in the analysis (RA, 40.4%; AS, 34.7%; PsA, 24.9%). The safety analysis set comprised all 328 patients treated with CT-P13. The majority (58.2%) of patients received CT-P13 monotherapy, most (72.6%) by dosing every 6 or 8 weeks. The mean treatment persistence was 449.2 days; 62.3% of patients completed 2 years of treatment. In all, 214 treatment-emergent adverse events (TEAEs) were reported in 38.4% of patients. Most TEAEs were of mild or moderate intensity; 13 were severe. The most commonly reported TEAEs were drug ineffective (9.5%) and infusion-related reactions (5.2%). The most frequently reported infection-related TEAEs were upper respiratory tract infections (3.0%), nasopharyngitis (2.1%) and bronchitis (1.5%). No patients experienced tuberculosis.ConclusionDrug utilization and treatment persistence with CT-P13 were consistent with historical reports of IFX-RP in this patient population. Safety findings did not identify new concerns for CT-P13 in the treatment of patients with RA, AS or PsA.Trial registrationClinicalTrials.gov: NCT02605642. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|