A double-blind, randomized comparison study between Zytux� vs MabThera® in treatment of CLL with FCR regimen: Non-inferiority clinical trial

Background: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux� in comparison to MabThera® in treatment of CLL. Materials and Methods: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux�, and group B was treated with MabThera®. A non-inferiority margin of 20 for the primary outcome was defined to examine the similarity between Zytux� and MabThera®. Results: Baseline demographic characteristics showed no statistically significant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux� demonstrated a similar profile of adverse reactions in comparison to MabThera®. Moreover, the overall response rate was 88 and 89 for Zytux� and MabThera®, respectively (CI -0.17, 0.18). Conclusion: Results showed non-inferiority of Zytux� in terms of efficacy and adverse events as a biosimilar version of MabThera®. © 2018, Tehran University of Medical Sciences (TUMS). All rights reserved

A double-blind, randomized comparison study between Zytux� vs MabThera® in treatment of CLL with FCR regimen: Non-inferiority clinical trial

Background: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux� in comparison to MabThera® in treatment of CLL. Materials and Methods: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux�, and group B was treated with MabThera®. A non-inferiority margin of 20 for the primary outcome was defined to examine the similarity between Zytux� and MabThera®. Results: Baseline demographic characteristics showed no statistically significant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux� demonstrated a similar profile of adverse reactions in comparison to MabThera®. Moreover, the overall response rate was 88 and 89 for Zytux� and MabThera®, respectively (CI -0.17, 0.18). Conclusion: Results showed non-inferiority of Zytux� in terms of efficacy and adverse events as a biosimilar version of MabThera®. © 2018, Tehran University of Medical Sciences (TUMS). All rights reserved

Prospective Epidemiological Research Studies in Iran (the PERSIAN Cohort Study): Rationale, Objectives, and Design

Noncommunicable diseases (NCDs) account for 76% of deaths in Iran, and this number is on the rise, in parallel with global rates. Many risk factors associated with NCDs are preventable; however, it is first necessary to conduct observational studies to identify relevant risk factors and the most appropriate approach to controlling them. Iran is a multiethnic country; therefore, in 2014 the Ministry of Health and Medical Education launched a nationwide cohort study - Prospective Epidemiological Research Studies in Iran (PERSIAN) - in order to identify the most prevalent NCDs among Iran's ethnic groups and to investigate effective methods of prevention. The PERSIAN study consists of 4 population-based cohorts; the adult component (the PERSIAN Cohort Study), described in this article, is a prospective cohort study including 180,000 persons aged 35-70 years from 18 distinct areas of Iran. Upon joining the cohort, participants respond to interviewer-administered questionnaires. Blood, urine, hair, and nail samples are collected and stored. To ensure consistency, centrally purchased equipment is sent to all sites, and the same team trains all personnel. Routine visits and quality assurance/control measures are taken to ensure protocol adherence. Participants are followed for 15 years postenrollment. The PERSIAN study is currently in the enrollment phase; cohort profiles will soon emerge. © The Author(s) 2018. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved