Browsing by Subject "effectiveness"
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(2018)This is a systematic review aiming to investigate the efficacy, effectiveness, and safety of biosimilars in the treatment of inflammatory bowel diseases. Biosimilar drugs used to treat inflammatory bowel diseases include biosimilar infliximab and biosimilar adalimumab. Biosimilar infliximab has been authorized by the European Medicines Agency (EMA) in 2013 and by the US Food and Drug Administration (FDA) in 2016. Biosimilar adalimumab has been authorized by EMA and FDA in 2017 and, at the time the literary search for this systematic review was conducted no studies were found regarding the treatment of adalimumab biosimilar for inflammatory bowel diseases. To acquire marketing authorization for biosimilars, it must be proven that the biosimilar is biologically similar to the original medicinal product. Bioequivalence is demonstrated through physicochemical trials and clinical trials. However, clinical trials do not have to be performed with all of the indications for which the original medical product is registered. After proving bioequivalence with one or more indication it is possible to extrapolate the biosimilar to be used in all of the original medical products indications. This has raised the question of whether biosimilars are really comparable to the originator in indications for which no clinical trials have been conducted. This systematic review was implemented using the Cochrane Handbook for Systematic Reviews and Interventions. Systematic literature searches were made in Cochrane, Medline (Ovid®), PubMed and Scopus databases on 12.05.2017. 14 observational studies, one systematic review and a randomized clinical trial that met the inclusion criteria were included in the systematic review. The quality of the publications was evaluated using the STROBE-, NOS- and CONSORT-checklists and information regarding the efficacy, effectiveness and safety of biosimilars was extracted. CD-patients receiving tumor necrosis factor alpha inhibitors for the first time, the clinical response was achieved in 50.0 % to 97.2 % of patients depending on patient population and the duration of treatment. Similarly, for UC-patients, the clinical response was achieved in 62.2 % to 100.0 %. The clinical remission was achieved among 28.9 % to 84.4 % of CD-patients and among 28.9 % to 84.4 % of UC-patients, depending on patient population and treatment follow-up. After the switch from original infliximab to biosimilar, the proportion of patients in clinical remission during follow-up ranged from 62.3 % to 100.0 % in CD-patients and from 45.5 % to 100.0 % in UC-patients. Clinical remission was sustained throughout the whole follow-up in 70 % to 100 % of CD-patients and 66.7 % to 92.0 % of UC-patients. The incidence of adverse events leading to the discontinuation of drug treatment was between 0.0 % and 25.0 %, and the incidence of all adverse events ranged from 0.0 % to 93.6 % in CD- and UC-patients. Biosimilar infliximab seems to be comparable to the original product regarding the efficacy, effectiveness and safety. This result is supported by the systematic literature review published earlier. Conducting a meta-analysis of the information contained in this systematic literature review could have led to a more final decision considering efficacy, effectiveness and safety of biosimilar-infliximab in the treatment of inflammatory bowel diseases.
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(2012)Inflammatory bowel diseases are among the fastest growing chronic disease of young people in Europe and they are increasing in Western countries for unknown reasons. Illness often occurs at a young age and the symptoms persist generally throughout life, Crohn's disease and ulcerative colitis are the most common diseases in this category. Inflammatory bowel diseases often cause persistent symptoms and require treatment usually for life, affect the quality of life and the ability to go to work. Conventional treatment usually consists of anti-inflammatory and immunosuppressive drug therapy or surgical intervention. In difficult cases, the biologic drug treatment is used. New biological drug products (TNF-blockers) have improved, in particular in Crohn's disease, a response to treatment. The aim of this study is to provide information about the effectiveness and the costs of the biological treatment in inflammatory bowel diseases. The main results presented are the changes of the quality of life during the observation period measured with the generic and disease-specific HRQoL instruments. The results are also reported on the matter of costs for quality-adjusted life-years gained during the follow-up period. The study consists of FinnIBDQ (inflammatory Bowel Disease Questionnaire) survey (n=2831) and the follow-up survey of the patients who used biologic drug products (n=189). Patients were selected into the follow-up if they reported using the biologic drugs to treat the illness. FinnIBDQ-survey was conducted in 2006/2008 and follow-up questionnaire in 2011. As a generic HRQoL instrument was the 15D-instrument used which is a standardized measure of the health related quality of life. 15D-instrument produces a single index number between 0-1. IBDQ is a disease-specific HRQoL instrument, which consists of 32 questions. The total number of points varies between 32 and 224 from the worst to the best. Patients' medical history, symptoms, medication and health care use were studied in their own partition on the questionnaire. Biological drug therapy group belonged at the baseline (n=148) improved the quality of life (p=0.004) during the follow-up. A disease-specific HRQoL instrument (IBDQ) shows the quality of life has changed in parallel (p=0.003)with the 15D-instrument. Dimensions, where progress was achieved (p<0.05) were the elimination, the usual activities, discomfort and symptoms, as well as vitality and sexual activity. In the research group (n=51), the average cost per patient per QALYs gained during the follow-up period proved to be very high, at over 5 million euro's. During this time, the patient gained an average of 0,01 quality adjusted additional years of life. The evidence of the long-term impact of the biologic drug treatment on the patient's quality of life is still scarce. In most of the research concerned with the benefits of biological treatment, the effectiveness data is derived from the pharmaceutical manufacturers' short-term clinical efficacy studies, or taken from any other quality of life studies.
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