study design
This study was designed as a nationwide, multicenter, retrospective and non-interventional study in which data collection was conducted between March 2020 and June 2020 with contributions from 15 different rheumatology centers in Turkey. Patients with a diagnosis of RA who were receiving TCZ as a first-line biologic treatment with follow-up data of at least 6 months were included in the study. Secondary data were obtained from the TURKBIO registry, which is an online registry of patients with rheumatic diseases receiving biologic DMARDs.
Covariates
The primary objective was to assess the efficacy of TCZ as a first-line biologic treatment at 6, 12, and 24 months by mean change in clinical disease activity index (CDAI) and disease activity score of disease in 28 joints with ESR scores (DAS28-ESR) from baseline. The secondary objectives were to analyze the efficacy of TCZ by route of drug administration (TCZ-SC or TCZ-IV), to assess the retention rate and safety profile of TCZ over time, and assess quality of life using the Health Assessment Questionnaire Disability Index (HAQ-DI). Data were obtained from the TURKBIO registry for demographics, smoking status (current, previous or never), concurrent diseases, duration of RA, prior and concurrent csDMARD treatments, presence and number of swollen joints and pain, European Alliance of Rheumatology Associations (EULAR) response rate (good or moderate), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, CDAI score1 2DAS28-ESR score13HAQ-DI score14, start and stop date of TCZ treatment and adverse events. CDAI disease activity was defined as remission (≤ 2.8), low disease activity (> 2.8 and ≤ 10), moderate disease activity (> 10 and ≤ 22) and high disease activity (>22). Similarly, DAS28-ESR disease activity was defined as remission (< 2,6), une faible activité de la maladie (≥ 2,6 et ≤ 3,2), une activité modérée de la maladie (> 3.2 and ≤ 5.1) and high disease activity (> 5.1).
statistical analyzes
This was a secondary study using data from an existing registry and therefore no study sample size was calculated. All data collected during the study were summarized using descriptive statistics; the numerical variables were expressed as mean (standard deviation) or median (minimum and maximum or quartiles); categorical variables were expressed as numbers and percentages. Normality was assessed with visual (histogram and probability plots) and analytical (Kolmogorov-Smirnov/Shapiro-Wilk tests) methods. Kaplan-Meier estimates were calculated for the retention rate of TCZ. To compare 6-, 12-, and 24-month values of a continuous variable with the reference data, the paired-samples t-test for pairs of matched hypotheses or, if normality was questionable, the Wilcoxon signed rank test has been used. Binary, multinomial, and ordinal logistic regression analysis was performed to assess the effects of demographic and baseline disease characteristics on retention of TCZ treatment. Medication retention was selected as the dependent variable, and age, gender, concurrent diseases, smoking status, concurrent csDMARD therapy, baseline disease activity scores, and baseline disease status were selected. articulation were selected as independent variables. For statistical analysis, PASW 18.0 for Windows was used. A p a value < 0.05 was considered significant.
Ethical approval and consent to participate
The TURKBIO registry setup was approved by the Ministry of Health in July 2013 and this study was approved by the Ethics Committee for Non-Interventional Clinical Research of Kocaeli University on May 14, 2020, with an application number. Approval: KİA 2020/100. Participants provided written informed consent for the TURKBIO registry, and additional consent was waived due to the retrospective nature of this study. The study was performed in accordance with the Declaration of Helsinki and relevant guidelines/regulations.
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