Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial
| Autor: | Vyacheslav Zhdan, Sunghyun Kim, Rene Westhovens, Jee Hye Suh, Piotr Wiland, Janusz Jaworski, Seul Gi Lee, Marek Zawadzki, Pavel Shesternya, Roman Yatsyshyn, Delina Ivanova, Sergii Shevchuk, Paweł Hrycaj, Elias Chalouhi El-Khouri, Mykola Stanislavchuk, Éva Balázs, Alfredo Berrocal Kasay, Larisa Eliseeva, Dae Hyun Yoo, Sang Joon Lee, Noo Ri Han, Jakub Trefler |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
rheumatoid arthritis
Adult Male medicine.medical_specialty Randomization Injections Subcutaneous immunogenicity 030226 pharmacology & pharmacy Arthritis Rheumatoid 03 medical and health sciences 0302 clinical medicine Rheumatology Pharmacokinetics Double-Blind Method Internal medicine Clinical endpoint Medicine Humans Pharmacology (medical) Adverse effect Biosimilar Pharmaceuticals Syringe AcademicSubjects/MED00360 030203 arthritis & rheumatology non-inferiority business.industry switching Antibodies Monoclonal Clinical Science Middle Aged medicine.disease Infliximab Standard error Treatment Outcome Rheumatoid arthritis Antirheumatic Agents Injections Intravenous subcutaneous biosimilar business infliximab pharmacokinetics CT-P13 medicine.drug |
| Zdroj: | Rheumatology (Oxford, England) |
| ISSN: | 1462-0332 1462-0324 |
| Popis: | Objective To assess non-inferiority of s.c. to i.v. CT-P13 in RA. Methods Patients with active RA and inadequate response to MTX participated in this phase I/III double-blind study at 76 sites. Patients received CT-P13 i.v. 3 mg/kg [week (W) 0 and W2] before randomization (1:1) at W6 to CT-P13 s.c. via pre-filled syringe (PFS) 120 mg biweekly until W28, or CT-P13 i.v. 3 mg/kg every 8 weeks until W22. Randomization was stratified by country, W2 serum CRP and W6 body weight. From W30, all patients received CT-P13 s.c. In a usability sub-study, patients received CT-P13 s.c. via auto-injector (W46–54) then PFS (W56–64). The primary endpoint was change (decrease) from baseline in disease activity score in 28 joints (DAS28)-CRP at W22 (non-inferiority margin: −0.6). Results Of 357 patients enrolled, 343 were randomized to CT-P13 s.c. (n = 167) or CT-P13 i.v. (n = 176) at W6. The least-squares mean change (decrease) from baseline (standard error) in DAS28-CRP at W22 was 2.21 (0.22) for CT-P13 s.c. (n = 162) and 1.94 (0.21) for CT-P13 i.v. [n = 168; difference 0.27 (95% CI: 0.02, 0.52)], establishing non-inferiority. Efficacy findings were similar between arms at W54. Safety was similar between arms throughout: 92 (54.8%; CT-P13 s.c.) and 117 (66.9%; CT-P13 i.v.) patients experienced treatment-emergent adverse events (from W6). There were no treatment-related deaths or new safety findings. Usability was similar for CT-P13 s.c. via auto-injector or PFS. Conclusion CT-P13 s.c. was non-inferior to CT-P13 i.v. in active RA. The convenience of s.c. administration could benefit patients. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03147248. |
| Databáze: | OpenAIRE |
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