Abstract Objectives SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. Methods In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. Results A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. Conclusion SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. Trial registration ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37)

Introduction: Many epidemiological studies have shown that there are numerous risk factors for acute coronary disease. The aim is to determine the effect of risk factors on the echocardiographic changes and quality of life in patients treated with different methods 1 year after myocardial infarction. Methods: The research was a prospective–retrospective, clinical, epidemiological study and was conducted at the Clinic of Cardiology, University Clinical Center Sarajevo. Patients were divided into four groups based on the therapy treatment they got. The patients were divided into four groups based on the therapy treatment they received. The first group consisted of 40 patients who had had myocardial infarction and were treated with medications. The patients in the groups II and III were treated with percutaneous coronary intervention (PCI) [who immediately after incident underwent primary PCI or delayed PCI], and each group consisted of 40 patients. The group IV consisted of 40 patients, who underwent surgical revascularization (coronary artery bypass surgery). After the treatments have finished, an echocardiogram was performed on every patient. The Short Form (SF)-36 health survey was used for testing the life quality. Echocardiogram and the quality of life (QoL) testing were repeated a year after the treatment. Results: The study included 160 patients with a history of myocardial infarction, of which 130 (81.3%) were men, and 30 (18.8%) were women. The average age in the total sample was 54.9 ± 8.8 years. The review of risk factors’ presence showed that in the total sample, most present was hypertension with 134 (83.8%), smoking with 120 (75.0%), and hypercholesterolemia with 110 or 68.8% of patients. Hypertension showed a statistically significant negative effect on the SF-scales only in the group III according to the mental health (P = 0.020), social functioning (P = 0.013), and pain (P = 0.011). A statistically significant effect of smoking was observed in the group III according to left ventricular internal dimension in end-diastole (P = 0.000) and left ventricular internal dimension in end-systole (P = 0.001) in the sense that smokers have the higher values of these parameters, and negative to ejection fraction (EF) (P = 0.001) in the sense that smokers have lower EF. In the group IV, positive correlation was observed to EF (P = 0.038), and negative toward the mitral regurgitation (P = 0.032). Conclusion: High blood pressure negatively affected the QoL. Smoking is negatively associated with all observed echocardiographic parameters in all the groups except with the size of the left atrium.

Introduction: Cardiovascular diseases are the leading cause of death in most countries. The aim was to examine the quality of life and to determine the differences in the quality of life in patients one year after myocardial infarction and the relationship between quality of life and echocardiographic parameters in these patients. Material and Methods: The research was a prospective, clinical, epidemiological study and was conducted at the Clinic of Cardiology, University Clinical Center Sarajevo (UCCS). The research was conducted on a sample of 160 patients who had acute myocardial infarction, which are based on the therapeutic procedures divided into four groups. The average age in the total sample was 54.9±8.8 years (range 37-76 years). The research was conducted one year after myocardial infarction (I group of subjects) or 12 months after PCI therapeutic procedures (II and III group of respondents) or coronary artery bypass surgery (IV group of respondents). Results: Comparison of the mean scores of scales in SF-36 questionnaire showed that the highest total score had patients in the group II 67.3±15.2, and the lowest in the group I 57.8±21.4. The increase in ejection fraction leads to a statistically significant increase in quality of life scores at all subscales, in all groups, so that EF has the greatest impact on the quality of life in all respondents. Statistically significant differences in the effects of mitral regurgitation in particular groups have been recorded only in the case of the mental health scale. Conclusions: Ejection fraction has the greatest impact on the quality of life in all patients, regardless of the type of medical treatment.

Objectives To compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. Methods This is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients with moderate to severe RA despite methotrexate therapy were randomised in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. Inclusion of the 95% CI of the ACR20 response difference within a ±15% margin was required for equivalence. Results 584 subjects were randomised into SB2 (N=291; 290 analysed) or INF (N=293). The ACR20 response at week 30 in the per-protocol set was 64.1% in SB2 versus 66.0% in INF. The adjusted rate difference was −1.88% (95% CI −10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF. The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF. Efficacy, safety and PK by ADA subgroup were comparable between SB2 and INF. Conclusions SB2 was equivalent to INF in terms of ACR20 response at week 30. SB2 was well tolerated with a comparable safety profile, immunogenicity and PK to INF. Trial registration number NCT01936181.

ABSTRACT Introduction: Non-alcoholic (NAFLD) encompasses a spectrum of disease states, from steatosis (fatty liver) to non-alcoholic steatohepatitis (also called NASH steatosis with inflammatory changes) followed by progression to fibrosis and cirrhosis and hepatocellular carcinoma Excess liver fat is believed to be a manifestation of the metabolic syndrome and not surprisingly NASH is associated with obesity, insulin resistance, dyslipidemia and type 2 diabetes in humans. Aim of the study: is to establish anthropometric and biochemical specificities in patients with non-alcoholic steatohepatitis diagnosed with non-invasive diagnostic methods Material and methods: Study enrolled 170 participants, 130 with NASH steatosis. The non-alcoholic group (control), consisted of 40 normal weight patients without metabolic syndrome. Alcohol intake was estimated with established protocol. Routine biochemistry analysis were performed by standard laboratory procedures; serum levels of serum levels of fasting cholesterol and triglycerides, fasting glucose and insulin, insulin resistance estimated by HOMA index (Homeostasis model assessment), biochemistry tests and a liver ultrasound examination. Results: In study participants group, patients were more obese comparing with controls p < 0, 01, waist line extent also was of greater statistical significance in the non-alcoholic group fatty liver (p < 0, 01). Comparing biochemical parameter values, significant statistical deference has been noted in glaucosis and insulin levels, total cholesterol and gama-glutamil transferase levels, between groups (p<0, 01). Fasting glucose and insulin levels, HOMA-IR were significantly greater in study cohort group patients, as was significantly positive correlation between BMI and waist line extent. Conclusion: Patients with non-alcoholic fatty liver are excessively obese, have greater waist line extent, consequently insulin resistance and impaired glucose metabolism, insulin resistance, dyslipidemia, risk factors known to be associated with the development of cardiovascular disease.