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Browsing by Subject "infliksimabi"

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  • Biosimilaarien teho, vaikuttavuus ja turvallisuus tulehduksellisten suolistosairauksien hoidossa 
    Mäkinen, Arttu (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.
  • Järjestelmällinen kirjallisuuskatsaus ja meta-analyysi TNF-salpaajien tehosta ja turvallisuudesta nivelreuman hoidossa 
    Aaltonen, Kalle (2010)
    Rheumatoid arthritis is an inflammatory autoimmune disease with prevalence of 0,8 per cent of Finnish people. Rheumatoid arthritis may lead to immobility and premature death. Treatment of Rheumatoid Arthritis includes disease modifying anti-rheumatic drugs and surgery. TNF-blockers are efficacious new drugs, which halt the progression of joint destruction caused by inflammation. The first TNF-blocker to receive permission of the national agency for medicines was Infliximab in 1999. Since then Infliximab has been followed by Etanercept, Adalimumab, Golimumab and Certolizumab. TNF-blockers have been found to be more efficacious than placebo in both clinical trials and register studies. In addition they are considered to be safe enough for clinical use despite the increased risk for tuberculosis and certain cancers. The number of patients annually treated with TNF-blockers in Finland increased threefold between 2004 and 2008. In 2008 the medication costs per patient were 11 669€ for Etanercept and 13 074€ for adalimumab. Systematic literature review is a study, which searches, identifies and combines individual studies. Usually Systematic reviews include a meta-analysis, which uses statistical methods to combine the results of the studies. Meta-analysis aims for increasing power and generalisibility of the studies and reducing the potential bias in individual studies. In order not to introduce bias by itself the systematic review must be done following the methods approved by the scientific community. In addition the process must be documented in detail. Following a predefined search strategy the systematic literature search found 5308 references. After a process involving the evaluation of the patients, intervention, control, outcomes, study design and the risk of bias 27 studies were selected to be included in the systematic review and meta-analysis. Of the included studies, nine had adalimumab, six had etanercept, five had infliximab, four had golimumab and three certolizumab as intervention. TNF-blocker was used either alone or in combination with methotrexate whereas control was either placebo or methotrexate. Altogether, there were 11 533 patients in the intervention group and 9027 in the control group. The results of the meta-analysis indicate reveal that the patients treated with TNF-blockers are twice as likely to reach a 20 % increase on ACR criteria compared to control patients. The likelihood to reach improvements of 50 and 70 % was 3 and 3.5 times higher, respectively. There were no statistically significant differences in efficacy between individual TNFblockers. Increasing the dosage of a TNF-blocker did not increase efficacy. However, combination of TNF-blocker and methotrexate was superior to monotreatment of TNF-blocker without increasing the likelihood of discontinuation of treatment. There were no statistically significant differences between the efficacy of TNF-blocker monotherapy and methotrexate. Adalimumab, infliximab and certolizumab lead more often to treatment discontinuation compared to etanercept and golimumab, which do not differ from control. This systematic review probably found all studies that investigated the efficacy of TNF-blockers in a randomized controlled trial. Study selection and evaluation were based on widely accepted methods. This study has two weaknesses. Firstly, literature search and study selection and evaluation were done only by a single researcher. Secondly, unpublished studies and study results were not actively obtained outside electronic databases.
  • Tuumorinekroositekijän salpaajien kustannusvaikuttavuus selkärankareuman hoidossa 
    Nenonen, Satu (2017)
    Ankylosing spondylitis is an inflammatory rheumatoid disease, that is typically diagnosed in young adults. The symptoms include inflammatory back pain, rigidity in the lumbar and thoracic spines, and peripheral inflammations. The incidence of ankylosing spondylitis among northern European population ranges from 0.2 to 0.5%. The mortality rate of people with ankylosing spondylitis is about 50% higher than in the average population. First-line treatment for ankylosing spondylitis includes physiotherapy and NSAIDs. TNF inhibitors are used for patients whose symptoms cannot be controlled with first-line treatment. In Finland, there are five TNF inhibitors indicated for ankylosing spondylitis on the market: infliximab, etanercept, adalimumab, golimumab, and sertolizumab pegol. In 2015, the average medication cost for a patient entitled to reimbursement for TNF inhibitors in Finland was over 12 000 €. The cost-effectiveness of TNF inhibitors in the treatment of ankylosing spondylitis compared to conventional care has been extensively studied, but there is less data on the differences between TNF inhibitors. In this thesis, previously published literature on the cost-effectiveness of TNF inhibitors in the treatment of ankylosing spondylitis was reviewed, and a patient-specific simulation model based on data from the National Register for Biologic Treatment in Finland was conducted. The aim of the simulation was to compare the cost-effectiveness of TNF inhibitors (infliximab, etanercept, adalimumab and golimumab) in the treatment of ankylosing spondylitis as the patient's first biological treatment compared to other TNF inhibitors. The simulation was conducted on a lifetime time horizon and incorporated direct health care and medication costs in 2015 euros. As conclusions of the model, all other TNF inhibitors were found dominant over etanercept. The greatest effectiveness was achieved with golimumab, while the costs were lowest with infliximab. The incremental cost-effectiveness ratio of golimumab compared to infliximab was 63 840 €/QALY. In sensitivity analyzes, the model was found to be very sensitive to TNF inhitors' prices. In addition, sensitivity was also observed for the discount rate and time horizon used.

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