Systematic review and analysis of evidences on clinical efficacy and cost-effectiveness of biological drugs for the treatment of Ankylosing Spondylitis

Technology: Infliximab and comparator biological such as adalimumab, etanercept, golimumab. Conditions: Ankylosing spondylitis (AS) Issue: Infliximab is registered to be used in patients with AS. The aim of the Report is to evaluate the clinical efficacy and safety of infliximab and comparator biologicals for the treatment of adult AS. Methods: Systematic literature review and analysis as well as meta-analysis (direct and indirect comparison) of published randomised controlled clinical trials (RCT) were performed, all relevant health economics literature were identified ad analysed. Results: Clinical efficacy of biological therapies is based on good clinical evidences regarding to all clinical efficacy endpoints (ASAS20, ASAS40, ASAS 5/6, and BASDAI 50% response). Altogether, 22 trials are included in our meta-analysis, 12 infliximab, 3 adalimumab studies, 6 etanercept and 1 golimumab. Efficacy of biological treatments for the treatment of AS has been established by clinical scientific evidences, significant improvement at all outcomes considered was confirmed. According to the results of indirect comparison, there were no significant difference between biological treatments and placebo in terms of safety and tolerability endpoints. We found no significant difference between the clinical efficacy and safety of infliximab, adalimumab, etanercept and golimumab therapies. Cost-utility analysis of adalimumab and/or infliximab, etanercept and golimumab treatment for AS were performed in the UK, Canada, The Netherlands, Germany, Spain and France. There are no cost-utility studies from Eastern Central Europe. Implications for decision making: Efficacy of infliximab and comparator biologicals for the treatment of Ankylosing Spondylitis (AS) was proved by clinical evidence, significant improvement at all outcomes considered was confirmed. We found no significant differences in efficacy and safety of different biological treatments. Health economics results suggest that biological therapies are cost-effective alternatives for the treatment of AS in group of developed high income countries. There is a lack of health economics results in Central-Eastern European countries however these data are more and more required by governments and funders as part of the company economic dossiers.

Költség- és időcsökkentési eljárások alkalmazása a projekttervezésben és a nyomon követésben = Application of cost and time reduction procedures in project planning and the follow-up

A válság okozta megszorítások a projektek költségvetését sem hagyták változatlanul. Nagyon sokszor nemcsak a jövőbeni projekttervek költségvetését kell átgondolni, hanem a már futó projektek költségvetését is újra kell szabni. E tanulmány ilyen esetekben nyújthat módszertani támogatást. A szerző ebben a kutatásban négy költség- és időcsökkentő módszert hasonlít össze. Ismerteti, hogy ezeket az eljárásokat milyen módon lehet ötvözni, illetve mikor, melyiket célszerű alkalmazni. Az eljárások között van olyan módszer, amely a hagyományos projektmenedzsment (pl. építési, beruházási projektek menedzselésének) eszköztárát gazdagítja, de találkozhatunk olyan eljárásokkal is, amelyek az agilis projektszemléleten alapuló módszerek körét szélesítik. A bemutatott módszerek nemcsak a hálótervezési, hanem a mátrixos projekttervezési eljárások esetén is alkalmazhatók. ____ Due to the effects of the crisis, budgets of present as well as future projects are decreasing steadily. In this study four different methods are introduced for minimising budget and time demands. These introduced methods support not only the traditional but also the agile project management. Furthermore these methods can be used not only in case of network planning, but also for matrix-based project planning.