A5020978466- Biosimilars and Bioanalytical Methods
- Rheumatoid Arthritis Research and Therapies
- Pharmaceutical studies and practices
- Bone Metabolism and Diseases
- Bone health and osteoporosis research
- Bone health and treatments
- Cardiovascular Function and Risk Factors
- Monoclonal and Polyclonal Antibodies Research
- Systemic Lupus Erythematosus Research
- Nutrition and Health in Aging
- Vitamin D Research Studies
- Inflammatory Myopathies and Dermatomyositis
- Acute Ischemic Stroke Management
- Statistical Methods in Clinical Trials
- Thyroid Disorders and Treatments
- Muscle metabolism and nutrition
- Thyroid and Parathyroid Surgery
- Adipose Tissue and Metabolism
- Parathyroid Disorders and Treatments
- Cardiovascular Health and Disease Prevention
- Regulation of Appetite and Obesity
- Hypertrophic osteoarthropathy and related conditions
- Cerebrovascular and Carotid Artery Diseases
- Cardiovascular Effects of Exercise
- NF-κB Signaling Pathways
University of Banja Luka
2013-2020
Military Medical Academy
2009-2017
University clinical center of Republika Srpska
2012
Academy of Medical Sciences of Bosnia and Herzegovina
2008
<h3>Objectives</h3> To compare the efficacy and safety of innovator infliximab (INX) CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. <h3>Methods</h3> Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients disease despite MTX (12.5–25 mg/week) were randomised receive 3 mg/kg CT-P13 (n=302) or (n=304) folic acid. The primary endpoint was American College Rheumatology 20% (ACR20)...
Objectives To assess the efficacy and safety of switching from infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing in patients with rheumatoid arthritis (RA) for an additional six infusions. Methods This open-label extension study recruited RA who had completed 54-week, randomised, parallel-group comparing RP (PLANETRA; NCT01217086 ). (3 mg/kg) was administered intravenously every 8 weeks 62 102. All received concomitant methotrexate....
<h3>Objectives</h3> To compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to infliximab reference product (INF) in patients with moderate severe rheumatoid arthritis (RA) despite methotrexate therapy. <h3>Methods</h3> This is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients RA therapy were randomised 1:1 ratio receive either or INF 3 mg/kg. The primary end point was American College Rheumatology 20% (ACR20) response...
Efficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar reference infliximab (INF), were previously reported through 54 weeks. This transition period compared in patients with rheumatoid arthritis (RA) who switched INF to SB2 those maintained treatment or SB2.Patients moderate severe RA despite methotrexate randomised (1:1) receive at weeks 0, 2 6 every 8 thereafter until week 46. At 54, receiving rerandomised switch (INF/SB2 (n=94)) continue on (INF/INF...
SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between INF up 30 weeks were previously reported. This report investigates such clinical similarity 54 weeks, including structural joint damage. In this phase III, double-blind, parallel-group, multicentre study, patients with moderate severe RA despite MTX randomized (1:1) receive 3 mg/kg of either or at 0, 2, 6 every 8 thereafter. Dose escalation by 1.5 maximum dose 7.5 was allowed after week...
Introduction. Brain detrimental effects are under-recognised complication of chronic heart failure (CHF). One the major causes may be cerebral hypoperfusion. This study was designed to investigate relationship between blood flow (CBF) and severity CHF as well evaluate its determinants among different parameters cardiac dysfunction.Methods. Seventy-one males with NYHA class II III 20 control subjects age ≥ 55 years were recruited. CBF evaluated by colour duplex sonography extracranial...
Secondary hyperparathyroidism (SHPT) may contribute to the systemic illness that accompanies chronic heart failure (CHF). Healthy elderly with vitamin D deficiency who did not develop (functional hypoparathyroidism, FHPT) had lower mortality than those did. This study was designed examine determinants of PTH response in insufficient CHF patients. Sixty five males NYHA class II and III 20 control subjects age ≥ 55 years were recruited. Echocardiography, physical performance, NT-pro-BNP, PTH,...
Purpose: We aimed at evaluating androgen status (serum testosterone [TT] and estimated free [eFT]) its determinants in non-diabetic elderly men with heart failure (HF). Additionally, we investigated associations body composition long-term survival.Methods: Seventy three HF 20 healthy aged over 55 years were studied. Echocardiography, 6-min walk test, grip strength, measurement by DEXA method performed. TT, sex hormone binding globulin, NT-proBNP, adipokines (adiponectin leptin) measured....
<h3>Background</h3> CT-P13 was developed as a biosimilar product to infliximab (Remicade®), chimeric monoclonal antibody approved in the European Union 1999 for treatment of rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. <h3>Objectives</h3> To compare clinical efficacy overall safety with those patients active RA. <h3>Methods</h3> Six hundred six RA despite previous disease-modifying anti-rheumatic drugs including...
<h3>Background</h3> SB2 is developed as a biosimilar of the infliximab reference product (INF). The 30-week and 54-week results Phase III study have been reported<sup>1,2</sup>. <h3>Objectives</h3> To evaluate safety, immunogenicity, efficacy in patients with RA who transitioned from INF to vs maintained continued receive after Week 54 up 78. <h3>Methods</h3> This randomised, double-blind phase transition study. Patients moderate severe were randomised 1:1 ratio either or at Weeks 0, 2, 6,...
<h3>Background</h3> SB2 is developed as a biosimilar of the infliximab reference product (INF). <h3>Objectives</h3> This phase III equivalence study to compare efficacy, safety, immunogenicity and pharmacokinetics (PK) INF in patients with moderate severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. <h3>Methods</h3> Patients RA MTX therapy were randomised 1:1 ratio receive either or (3 mg/kg). Dosing occurred at week 0, 2, 6 then every 8 weeks until 46. The primary endpoint...
Introduction. Osteoporosis usually affects post-menopausal women. Treatment is individualized and requires an approach that will provide long-term compliance to prevent fractures. Studies conducted so far suggest inadequate persistence in weekly bisphosphonate treatment (under 43% after a year of treatment). Ibandronate, as powerful bisphosphonate, has made it possible for the first time treat osteoporosis with single tablet per month. Objective. Study efficacy, safety tolerance ibandronate...
Rheumatoid arthritis is a polygenic disease of unknown etiology, occurs worldwide in both developed and underdeveloped countries involves all races. The aim this study to determine the correlation between hematological parameters (DBC ESR) biomarkers inflammation (CRP) patients with RA predisposing gene variants HLA-DRB1*04orHLA-DRB1*03. This analyzed results biochemical 33 diagnosed RA, carriers ofgene HLA-DRB1*04 or HLA-DRB1*03, subjects control group non-carriers for HLA-DRB1*03. All...
<h3>Background</h3> Long-term treatment of anti-TNF agents in patients with immune mediated disease can increase the risk active tuberculosis infection (ATBI) by reactivation latent (LTBI) or de novo infection. CT-P13 is a biosimilar innovator infliximab (INX), approved EMA 2013 based on studies PLANETAS and PLANETRA. <h3>Objectives</h3> To identify positive conversion QuantiFERON®-TB Gold in-tube (QTF) test over 2 years ankylosing spondylitis (AS) rheumatoid arthritis (RA) receiving INX...
The aim of this work was to study the effect two modalities antiosteoporotic therapy in postmenopausal women at level biochemical markers bone turnover such as specific alkaline phosphatase (BALP) and deoxypiridinoline (Dpd) well mineral density (BMD). included 87 patients with osteoporosis (OP). Group A consisted 48 treated alendronate (AL), whereas group B 39 hormone replacement (HRT). BMD measured by Lunar DPX 2000 device, on lumbar spine femur, (BM) were commercial ELISA assays. There a...