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.

Bizalom az üzleti kapcsolatokban. A diadikus adatelemzés egy alkalmazása = Trust in business relations - an application of dyadic data analysis

A tanulmány arra a feltevésre épül, hogy minél erősebb a bizalomra méltóság szintje egy adott üzleti kapcsolatban, annál inkább igaz, hogy nagy kockázatú tevékenységek mennek végbe benne. Ilyen esetekben a bizalomra méltóság a kapcsolatban zajló események, cselekvések irányítási eszközévé válik, és az üzleti kapcsolatban megjelenik a cselekvési hajlandóságként értelmezett bizalom. A tanulmány felhívja a figyelmet a bizalom és a bizalomra méltóság fogalmai közötti különbségre, szisztematikus különválasztásuk fontosságára. Bemutatja az úgynevezett diadikus adatelemzés gazdálkodástudományi alkalmazását. Empirikus eredményei is igazolják, hogy ezzel a módszerrel az üzleti kapcsolatok társas jellemzőinek (köztük a bizalomnak) és a közöttük lévő kapcsolatoknak mélyebb elemzésére nyílik lehetőség. ____ The paper rests on the behavioral interpretation of trust, making a clear distinction between trustworthiness (honesty) and trust interpreted as willingness to engage in risky situations with specific partners. The hypothesis tested is that in a business relation marked by high levels of trustworthiness as perceived by the opposite parties, willingness to be involved in risky situations is higher than it is in relations where actors do not believe their partners to be highly trustworthy. Testing this hypothesis clearly calls for dyadic operationalization, measurement, and analysis. The authors present the first economic application of a newly developed statistical technique called dyadic data analysis, which has already been applied in social psychology. It clearly overcomes the problem of single-ended research in business relations analysis and allows a deeper understanding of any dyadic phenomenon, including trust/trustworthiness as a governance mechanism.