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.
Objective The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. Methods In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. Results Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (− 2.7 and − 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. Conclusion CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. ClinicalTrials.gov identifier NCT02149121. Electronic supplementary material The online version of this article (10.1007/s40259-018-00331-4) contains supplementary material, which is available to authorized users.
The aim: To estimate the prevalence of anemia in patients with ankylosing spondylitis, major pathogenetic variants and their relationship with the activity of the inflammatory process and the severity of the disease. Materials and methods: 118 patients with ankylosing spondylitis participated in the study, which performed hematologic, biochemical, immunological studies with general haemopoiesis and ferrokinetics parameters, plasma levels of CRP and IL-6. Results: It was found that in Ukrainian population of patients with ankylosing spondylitis, 28.8% of patients has anemic syndrome. The anemia spectrum is represented by ACD (44.1%), ACD with iron deficiency (29.4%) and IDA (23.5%). It is shown that the severity of anemic syndrome increases with the increase of the stage of activity of the inflammatory process. The presence and severity of anemia are closely related to the severe course of the disease, evaluated by the BASDAI and ASDAS index, and laboratory markers of inflammation CRP and IL-6 of serum. Conclusions: The obtained data is promising for the search of effective means of correction of anemic syndrome in patients with ankylosing spondylitis.
1,, 1 2 ABSTRACT Introduction: According to present knowledge, hyperhomocysteinemia is one of the risk factors of cardio-vascular pathology. Patients with chronic kidney disease are known to develop hyperhomocysteinemia more often than those in general population. Іmportant cause of hyperhomocysteinemia is the deficiency of vitamins В6, В9 and В12 that are involved in homocysteine metabolism. Vitamins deficiency, we believe, can be one of the causes of hyperhomocysteinemia in the patients with chronic renal failure. The aim: To analyze the plasma homocysteine level in patients with chronic kidney disease and its assosiation with the levels of vitamins B6, B9, B12 in Ukraine. Materials and methods: The study involved 148 persons with different stagesis of chronic kidney disease who underwent immunoenzyme determination of total plasma homocysteine, B9, cobalamin and vitamin В6 status. Results: It was found that in ukrainian patient population with chronic kidney disease 58.7% of patients have hyperhomocysteinemia. Homocysteine level was shown to increase with the increase of chronic kidney disease stage. Supply of vitamins В6, В9 та В12 in the patients with chronic kidney disease was lower than in apparently healthy persons, but there was significant decrease of folic acid level proportionally to the increase of chronic kidney disease stage. There was close relationship between homocysteine level and folic acid status in the patients with chronic kidney disease, but it appeared to be independent on cobalamin and pyridoxin status. Conclusions: The obtained data are promising for finding effective means of correction of hyperhomocysteinemia in patients with chronic kidney disease by normalizing the vitamin status of such patients.
Background CT-P13 is a biosimilar of innovator infliximab (INX), approved by the European Medicines Agency in 2013. Clinical data up to 1 year from PLANETRA have been reported at EULAR 20131 Objectives To compare the radiographic progression between CT-P13 and INX treatment and to assess its association with anti-drug antibody (ADA) and clinical disease activity in active rheumatoid arthritis (RA) patients, who participated in the PLANETRA study. Methods Radiographs obtained at baseline and week 54 were evaluated with the “paired review” method and the evaluation was performed by two independent readers without knowing the time point of the radiographs. The individual component scores of the joint damage progression (JDP) were calculated according to the van der Heijde modification of the Sharp scoring system. The analysis was performed to demonstrate comparability in JDP between two treatment groups using Student's t-test and elucidate an association of JDP with ADA and clinical parameters such as ACR20, IgM rheumatoid factor (RF), and anti-CCP. Results Among the 606 patients, 336 patients had radiographs both at baseline and week 54. The mean change from baseline JDP was similar between CT-P13 and INX treatment groups with respect to total Sharp score (TSS), joint space narrowing (JSN) score and erosion score at week 54 (CT-P13, 1.0/0.4/0.7; INX, 0.6/0.7/0.0, respectively). At week 54, a higher progression of TSS could be observed in the ADA positive patients (CT-P13, 1.1; INX, 1.2) compared with the ADA negative patients (CT-P13, 0.9; INX, 0.0), but the scores were comparable between two groups. The ACR20 responders tended to show a similar progression of TSS between two treatment groups (CT-P13, 0.6; INX, 0.5) at week 54. The mean change of TSS in ACR20 non-responders from baseline to week 54 were also comparable between the two treatment groups (CT-P13, 2.0; INX, 0.9). ACR20 responders showed less progression of TSS compared with non-responders in both treatment groups but these results were statistically not significant with respect to response status and treatment groups. At week 54, the progression of TSS was similar between treatment groups for each of the negative and positive baseline IgM RF subgroups (CT-P13, -0.5/1.4; INX, -0.2/0.7, respectively). The patients who belong to the negative and positive baseline anti-CCP subgroups showed also a comparable radiographic progression between treatment groups (CT-P13, 0.5/1.0; INX, 0.2/0.7, respectively). In both CT-P13 and INX, there was less progression of TSS in the patients who had negative baseline IgM RF or anti-CCP but the changes were statistically not significant. Conclusions Patients treated with CT-P13 showed a comparable radiographic progression as compared to those treated with INX at week 54. The ADA and clinical parameters such as ACR20, IgM RF, and anti-CCP showed tendency of association with radiographic progression. References Yoo DH, et al. Ann Rheum Dis 2013;72(S3):73 Disclosure of Interest : D. Yoo Grant/research support...
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.