ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 548

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

Rene Westhovens1, Piotr Wiland 2, Marek Zawadzki 3, Delina Ivanova 4, Alfredo Berrocal 5, Elias Chalouhi 6, Éva Balázs 7, Sergii Shevchuk 8, Larisa Eliseeva 9, Mykola Stanislavchuk 10, Roman Yatsyshyn 11, SangJoon Lee 12, SungHyun Kim 12, NooRi Han 13, YooBin Jung 13 and DaeHyun Yoo 14, 1University Hospitals, Leuven, Belgium, 2Medical Univeristy, Dpt of Rheumatology , Wroclaw, Wroclaw, Poland, 3Medical Univeristy, Dpt of Rheumatology, Wroclaw, Wroclaw, Poland, 4Diagnostic-Consultative Center Aleksandrovska EOOD, Sofia, Bulgaria, 5Cayetano Heredia University, Lima, Peru, 6Clinica Internacional Sede Lima, Lima, Peru, 7Dr. Bugyi István Hospital, Szentes, Hungary, 8Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov, Vinnytsia, Ukraine, 9Siberian State Medical University of Roszdrav, Tomsk, Russia, 10National Pirogov Memorial Medical University, Vinnytsya, Vinnytsia, Ukraine, 11Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine, 12Celltrion Inc., Incheon, Republic of Korea, 13Celltrion, Inc., Incheon, Republic of Korea, 14Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea

Meeting: 2019 ACR/ARP Annual Meeting

Keywords:

Session Information

Date: Sunday, November 10, 2019

Title: RA – Treatments Poster I: Novel Treatments

Session Type: Poster Session (Sunday)

Session Time: 9:00AM-11:00AM

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.

References:

[1] R. Westhovens, et al.,  Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1158

Disclosure: R. Westhovens, Celltrion, 5, 8, 9, Celltrion, Inc., 2, 5, Galapagos, 5, 8, Galapagos NV, 5, 9, Galapagos/Gilead, 2, 5, Gilead Sciences, Inc., 5, 8, 9; P. Wiland, Celltrion, Inc., 2, Novartis, 8, Pfizer, 8, Abbvie, 8, Gedeon-Richter, 8, Lilly, 8, Roche, 8, Sandoz, 8; M. Zawadzki, Celltrion, Inc., 2; D. Ivanova, Celltrion, Inc., 2, PPD, 2, Quintiles, 2, Egis Pharmaceuticals, 2, Pfizer, 2; A. Berrocal, ABK Reuma SRL, 2, Celltrion, Inc., 2, Pfizer, 8; E. Chalouhi, Celltrion, Inc., 2; �. Balázs, Celltrion, Inc., 2, Amgen, 5; S. Shevchuk, Celltrion, Inc., 2; L. Eliseeva, Celltrion, Inc., 2; M. Stanislavchuk, Celltrion, Inc., 2, Gilead, 2, Abbvie, Inc., 2, Celgene, 2, Amgen, 2, GlaxoSmithKline, 2, Pfizer, 2, Eli Lilly, 2, Sanofi, 2, Novo Nordisk, 2, AstraZeneca, 2, Regeneron, 2; R. Yatsyshyn, Celltrion, Inc., 2; S. Lee, Celltrion, Inc., 3; S. Kim, Celltrion, Inc., 3; N. Han, Celltrion, Inc., 3; Y. Jung, Celltrion, Inc., 3; D. Yoo, Celltrion Healthcare, 8, Celltrion, Inc., 2, 5, 8.

To cite this abstract in AMA style:

Westhovens R, Wiland P, Zawadzki M, Ivanova D, Berrocal A, Chalouhi E, Balázs �, Shevchuk S, Eliseeva L, Stanislavchuk M, Yatsyshyn R, Lee S, Kim S, Han N, Jung Y, Yoo D. 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 [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). 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/. Accessed .

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