Browsing by Subject "efficacy"
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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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(2019)Objective. Transdiagnostic models of psychopathology assume that the commonalities across disorders may outweigh their differences. While these models acknowledge that disorder-specific symptoms and features undoubtedly exist, the same underlying factors are perceived to cause and maintain various disorders. In recent years, this approach has received growing attention and several new forms of therapy have been developed based on it. These may be well-suited for the treatment of mixed-diagnosis groups or individuals with comorbid disorders, and as such, they hold the promise of being very cost-effective. One of the most established transdiagnostic treatments is the Unified Protocol (UP), designed to help patients suffering from depression and the full range of anxiety disorders. The purpose of the present study is to review the evidence regarding the efficacy and effectiveness of the UP for the transdiagnostic treatment of adult anxiety and depression. Methods. For this review, systematic literature searches were performed using the PsychInfo and PubMed online databases in October 2018. The search term used was “Unified Protocol”. The search yielded 114 results in PsychInfo and 138 in PubMed. Ten of these matched the following study selection criteria and were included in the current review: a) the study measured either the efficacy or effectiveness of the cognitive-behavioral UP therapy developed by Barlow (2011), b) treatment was delivered face-to-face in either individual or group setting, c) treatment followed the UP therapist guide without major modifications, d) participants suffered from an anxiety disorder or depression, e) participants were over 18 years of age, d) the study was published in 2015 or later, and f) the study was published in English in a peer-reviewed journal. Results and conclusions. The UP appeared both efficacious and efficient in reducing the severity of adult anxiety and depression as well as the number of comorbid diagnoses; however, there were some conflicting findings regarding recovery rates and effect sizes. The results achieved were comparable to those achieved using diagnosis-specific cognitive-behavioral therapy. The UP treatment had a positive impact on the patients’ functioning and quality of life and the amount of positive and negative affect they experienced. Treatment retention was generally high, particularly when treatment was delivered individually, and the UP received high ratings from those who participated in the studies. All in all, the current empiric evidence regarding the UP appears fairly promising. However, these results must be interpreted with caution, as the research concerning the UP is still in its infancy and a large part of it has been conducted by researchers affiliated with the treatment.
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(2020)Erenumab (Aimovig®) is a first-in-class calcitonin gene-related peptide (CGRP) inhibitor approved for the preventive treatment of migraine by the FDA in May 2018 and by European Commission (EC) in July 2018. It is a human monoclonal antibody (mAb) binding to the CGRP receptor, antagonizing the effect of CGRP. The marketing authorization of Aimovig® was based on two phase II and two phase III clinical trials. In all trials, erenumab with doses 70 mg/mL and 140 mg/mL was found to have a significantly superior effect compared to placebo, with a similar safety profile between all groups. These conclusions are mainly in line with studies conducted post marketing authorization. However, questions about the optimal dose, and the frequency and types of adverse events in larger patient populations remain to be studied. A European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) are required by the European Commission for each human medicine with a marketing authorization within the European Union. The SmPC is produced by the applicant and it should contain all relevant information of the medicinal product as distilled during the assessment process. The SmPC can thus be viewed as a kind of summarized version of the EPAR. The aim of this study was to investigate the post-marketing efficacy and safety information of erenumab from three perspectives: 1) the EPAR was compared with recent systematic reviews and meta-analyses assessing the efficacy and safety of erenumab, 2) all existing literature on the efficacy and safety of erenumab on different subgroups of migraine patients was assessed and summarized, and 3) the efficacy and safety information of the EPAR was compared to those of the SmPC, to resolve whether important information is missing. This review found several points regarding the efficacy and safety of erenumab. First, the status of erenumab was further established as a safe and effective treatment for the prevention of migraine. Second, meta-analyses (n=3) with more extensive cohorts compared to those of the EPAR and SmPC, present a further case for the superiority of the 140 mg dose compared to the 70 mg dose. The difference in dose effect is addressed in the EPAR but its assessment may be based on limited information. Third, different subgroups seem to respond differently to erenumab treatment. This aspect should be further investigated by head-to-head studies. Lastly, the safety information of the SmPC seems insufficient due to lack of mention of upper respiratory infections. This adverse event was among the most common in all of the four clinical trials and has since been observed in a real-world study. Based on these findings, neither the EPAR nor the SmPC of erenumab seem to be fully up to date and information related to the dose and upper respiratory infections as a risk should be reconsidered.
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(2013)Sulfonylureas is large, widely, especially in cereal production, used herbicide group since 1980’. Continual unilateral use of sulfonylureas has resulted in development of sulfonylurea resistant weeds. Common chickweed [Stellaria media (L.) Vill.] is common weed in Finland, which is known to have developed sulfonylurea resistance. The aim of this work was to investigate herbicides to control sulfonylurea resistant chickweed as well as to optimize the timing of the weed control. Further attention paid to the effect of weed control to the barley grain yield and its quality. This study was organized as a field experiment in Somero during summer 2012 a randomized complete block design. Sulfonylurea resistant chickweed population was found from this specific field. Experiment included 14 herbicide treatments. One of the herbicides studied was sulfonylurea. Herbicides applied at early and late timing. After treatments, the number of chickweed was counted, its biomass was weighed and N content analysed. Furthermore, the coverage of chickweed and the herbicide efficacy was evaluated visually. Barley was harvested and the grain yield and its quality was analysed. Sulfonylurea Express 50 SX did not control chickweed as effectively as expected. Starane 180 was effective only when 0,6L/ha dosage was used. Ariane S, K-Trio and Primus were effective, with efficacies over 90%. Efficacies of these herbicides were not dependent of timing. Oxyril did not control chickweed as well as was assumed. Efficacy of Oxytril was better when applied at early timing. It seems that the best options to for weed management in case of sulfonylurea resistant chickweed are Starane 180, K-Trio and Ariane S.
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