Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial
DC Field | Value | Language |
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dc.contributor.author | Westhovens, Rene | - |
dc.contributor.author | Wiland, Piotr | - |
dc.contributor.author | Zawadzki, Marek | - |
dc.contributor.author | Ivanova, Delina | - |
dc.contributor.author | Berrocal, Alfredo | - |
dc.contributor.author | Chalouhi, Elias | - |
dc.contributor.author | Balazs, Eva | - |
dc.contributor.author | Shevchuk, Sergii | - |
dc.contributor.author | Eliseeva, Larisa | - |
dc.contributor.author | Stanislavchuk, Mykola | - |
dc.contributor.author | Yatsyshyn, Roman | - |
dc.contributor.author | Lee, SangJoon | - |
dc.contributor.author | Kim, SungHyun | - |
dc.contributor.author | Han, Noori | - |
dc.contributor.author | Jung, YooBin | - |
dc.contributor.author | Yoo, DaeHyun | - |
dc.date.accessioned | 2021-08-02T10:32:17Z | - |
dc.date.available | 2021-08-02T10:32:17Z | - |
dc.date.created | 2021-06-02 | - |
dc.date.issued | 2019-11-10 | - |
dc.identifier.issn | 2326-5191 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/12129 | - |
dc.description.abstract | Background/Purpose: Efficacy and safety of a new subcutaneous (SC) formulation (CT-P13 SC) were evaluated up to Week 30. The phase I/III randomized controlled trial in patients with active rheumatoid arthritis (RA) study demonstrated non-inferiority of efficacy (mean change [decrease] from baseline in DAS28 [CRP] at Week 22) for CT-P13 SC 120 mg versus CT-P13 IV 3 mg/kg and showed similar safety profile between 2 arms [1]. This is to investigate the efficacy and safety of CT-P13 SC when used over 1-year and after switching from CT-P13 IV in patients with active RA. Methods: In this randomized, controlled, double-blinded, phase I/III study, patients who received full doses of CT-P13 IV 3 mg/kg at Weeks 0 and 2 were randomly assigned to receive either CT-P13 SC 120 mg via pre-filled syringe biweekly or CT-P13 IV 3 mg/kg every 8 weeks from Week 6 to Week 28. From Week 30, all patients received CT-P13 SC 120 mg via pre-filled syringe biweekly up to Week 54. Efficacy and safety were evaluated for 54 Weeks. Results: A total of 362 patients were enrolled, of whom 348 patients were randomly assigned at Week 6 into 2 arms in a 1:1 ratio (169 and 179 patients in SC 120 mg and IV 3 mg/kg arms, respectively). The mean DAS28 (CRP) and ACR response rates were similar between 2 arms up to Week 22 with a slightly greater response in SC 120 mg arm at Week 30. After switching from CT-P13 IV 3 mg/kg to CT-P13 SC 120 mg at Week 30 in IV 3 mg/kg arm, the mean DAS28 (CRP) was similar between 2 arms (Figure 1) whereas ACR response rates were slightly higher in SC 120 mg arm compared to IV 3 mg/kg arm at Week 54 (Figure 2). The safety profiles which occurred on or after Weeks 6 and 30 in SC 120 mg arm were generally comparable to IV 3 mg/kg arm. The majority of the localized injection site reactions were grade 1 or 2 in intensity (Table 1). Conclusion: The effectiveness and tolerability were confirmed over the 1-year treatment of CT-P13 SC 120 mg. The results after switching from CT-P13 IV 3 mg/kg to CT-P13 SC 120 mg at Week 30 were comparable to that of maintaining CT-P13 SC 120 mg up to Week 54. These results show that the novel SC formulation of CT-P13 via pre-filled syringe could provide a favorable benefit to patients with an alternative convenient way of administration. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.title | Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial | - |
dc.type | Conference | - |
dc.contributor.affiliatedAuthor | Yoo, DaeHyun | - |
dc.identifier.wosid | 000507466900549 | - |
dc.identifier.bibliographicCitation | 2019 ACR/ARP Annual Meeting | - |
dc.relation.isPartOf | 2019 ACR/ARP Annual Meeting | - |
dc.relation.isPartOf | ARTHRITIS & RHEUMATOLOGY | - |
dc.citation.title | 2019 ACR/ARP Annual Meeting | - |
dc.citation.conferencePlace | US | - |
dc.citation.conferenceDate | 2019-11-10 | - |
dc.type.rims | CONF | - |
dc.description.journalClass | 1 | - |
dc.identifier.url | https://acrabstracts.org/abstract/efficacy-and-safety-of-a-novel-subcutaneous-formulation-of-ct-p13-over-the-1-year-treatment-period-and-after-switching-from-intravenous-ct-p13-in-patients-with-active-rheumatoid-arthritis-results-fro/ | - |
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