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EULAR2019. 램시마SC 1/3상 데이터
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A NOVEL FORMULATION OF CT-P13 FOR SUBCUTANEOUS ADMINISTRATION: 30 WEEK RESULTS FROM A PART 2 OF PHASE I/III RANDOMIZED CONTROLLED TRIAL IN PATIENTS WITH RHEUMATOID ARTHRITIS
Background: CT-P13 subcutaneous (SC) formulation showed comparable efficacy and safety with CT-P13 intravenous (IV) formulation in rheumatoid arthritis (RA) 1 and Crohn’s disease 2 preliminary studies (Part 1).
Objectives: The purpose of this study was to demonstrate non-inferiority (NI) of efficacy and compare safety profiles of CT-P13 SC to CT-P13 IV in RA patients over 30 weeks of Part 2.
Methods: In this randomized, controlled, double blinded, phase I/III study, RA patients received CT-P13 IV 3 mg/kg at Weeks 0 and 2 and were randomized at Week 6 to receive CT-P13 SC 120 mg every 2 weeks or CT-P13 IV 3 mg/kg every 8 weeks. From Week 30, all patients received CT-P13 SC 120 mg every 2 weeks. The primary efficacy endpoint, change of DAS28 (C-reactive protein [CRP]) from baseline to Week 22, was analyzed by using an analysis of covariance (ANCOVA). Non-inferiority is to be concluded if the lower bound of the 95% CI for the treatment difference in the change of DAS28 (CRP) from baseline to Week 22 is greater than the pre-specified NI margin of -0.6.
Results: A total of 362 patients were enrolled, of whom 348 were randomly assigned at Week 6 into 2 treatment arms in a 1:1 ratio (169 and 179 patients in SC 120 mg and IV 3 mg/kg arms, respectively). The mean change of DAS28 (CRP) from baseline to Week 22 was similar between the arms. The lower limit of two-sided 95% CI (0.03) was greater than the pre-specified NI margin (-0.6) which indicated NI of SC 120 mg compared to IV 3 mg/kg ( Table 1 ). Additional efficacy including ACR responses were similar between two treatment arms up to Week 22 with slightly higher response rate trend observed in SC 120 mg arm at Week 30 ( Figure 1 ). The safety profiles which occurred after study drug administration at Week 6 in SC 120 mg arm were generally comparable to IV 3 mg/kg arm. All of injection site reactions were grade 1 or 2 in intensity. Majority of administration-related reactions (ARRs) were grade 1 or 2 in intensity except 1 patient in IV 3 mg/kg arm who experienced grade 3 ARR and was withdrawn from the study due to this event ( Table 2 ).
Conclusion: The study demonstrated NI of efficacy for CT-P13 SC to the CT-P13 IV. Also, CT-P13 SC showed similar efficacy and safety profiles to CT-P13 IV up to Week 30. CT-P13 SC could provide a favorable benefit to patients with an alternative convenient way of administration.
REFERENCES:
[1] Westhovens R, et al. Annals of the Rheumatic Diseases 2018;77(-):315 (suppl2)
[2] Schreiber, S, et al. Gastroenterology2018;154(6):S-1371
결론 : ACR20, 50,70 반응율에서 SC가 높게 나온게 고무적이네요. (22주까지는 유사. 30주는 높습니다) 안전성에서도 IV보다 상대적으로 좋습니다. 램시마SC RA는 120mg 출시하겟네요
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