Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis.

OBJECTIVES: To compare the efficacy and safety of infliximab-biosimilar with other biological drugs for the treatment of active ankylosing spondylitis (AS). METHODS: Systematic literature review for randomized controlled trials (RCTs) with adalimumab, etanercept, golimumab, infliximab and infliximab-biosimilar in AS was performed and indirect meta-analysis (Bayesian mixed treatment comparison) was carried out. The proportion of patients reaching 20 % improvement by the assessment of Spondyloarthritis International Society response criteria (ASAS20) at weeks 12 and 24 was used as efficacy endpoints, and the occurrence of serious adverse events at week 24 was applied to compare the safety of the biologicals. RESULTS: Altogether, 13 RCTs, identified by the systematic literature search, were included in the analysis. Results on the ASAS20 efficacy endpoint were reported for week 12 in 12 RCTs involving 2,395 patients, and for week 24 in 5 RCTs comprising 1,337 patients. All the five biological agents proved to be significantly superior to placebo. Infliximab showed the highest odds ratio (OR) of 7.2 (95 % CI 3.68-13.19) compared to placebo, followed by infliximab-biosimilar with OR 6.25 (95 % CI 2.55-13.14), both assessed at week 24. No significant difference was found between infliximab-biosimilar and other biological treatments regarding their efficacy and safety. CONCLUSIONS: This is the first study which includes a biosimilar drug in the meta-analysis of biological treatments in AS. The results have proven the similar efficacy and safety profile of infliximab-biosimilar treatment compared to other biologicals.

Tanácsadói szerepek, kompetenciák (Consultant roles and competencies)

A szakirodalomban található tipikus tanácsadói szerepek, tulajdonságok rendszerezését követően került sor a Borsod-Abaúj-Zemplén megyei tanácsadók kompetenciáinak vizsgálatára a tanácsadók, valamint a vállalkozók értékrendje szerint. A nemzetközi összehasonlíthatóság érdekében a szerző, Frank Höselbarth (2000) reprezentatív felmérésében alkalmazott 21 tulajdonság, kompetencia alapján vizsgálta meg a megyei helyzetet 2001-ben és 2005–06-ban is. A szakirodalomban található tipikus tanácsadói tulajdonságok, kompetenciák (tudás, készség, tapasztalat) összefoglalását tartalmazza a németországi felmérésben alkalmazott 21 jellemző. A magyar és német tanácsadók tulajdonságaiban a szerző nem tapasztal lényeges eltérést. Az elméleti és empirikus kutatási eredményei alapján vázolja fel a tanácsadói kompetencia modellt. _______ After the taxonomy of the typical characteristics of consultants, the author made a surveys and analysis of the characteristics of consultants located in Borsod- Abaúj-Zemplén County according to the value systems of consultants and entrepreneurs. In order the maintain international comparability, she applied the 21 factors used in the representative study of Frank Höselbarth (2000) to analyse the situation of B-A-Z County both in 2001 and in 2005-06 as well. The 21 criteria applied in the German study is a summary of the typical characteristics of consultants, found in the literature. The author did not find significant difference in the characteristics of Hungarian and German consultants.