Forschungsinstitut für Logistik

Abstract Background Intravenous (IV) iron is frequently used in patients with iron deficiency (ID) when conventional oral ferrous products are ineffective or cannot be used (e.g. due to poor tolerability). Oral ferric maltol is a new iron ferric product registered in Europe and US. The aim of this study was to quantify the use of IV iron before and after the introduction of the new oral ferric maltol in real world settings and extrapolate the overall costs involved. Methods Data were collected from a single centre German clinical practice, MVZ für Immunologie, in inflammatory bowel disease (IBD) patients treated with iron therapy for ID with or without anaemia between 2013 and 2019 through the systematic CEDUR IBD registry and local medical records. The first cohort was formed of patients treated between 2013 and 2015, receiving only IV iron as ferric carboxymaltose (FCM). The second cohort was formed of patients treated between 2017 and 2019, receiving either oral ferric maltol only or ferric maltol in combination with FCM. Costs involved in each cohort were extrapolated using a societal perspective. Results Following the introduction of oral ferric maltol, the actual total number of FCM infusions observed was 138, showing a decrease of 70% compared to the first cohort in which oral ferric maltol was not available. This decreased number of infusions between the two cohorts was associated with total costs-savings of €56,933. In the first cohort, the administration costs were €44,536, the drug acquisition costs were €59,536 and the productivity loss were €30,944. In the second cohort, the administration costs were €13,597 the drug acquisition costs were €55,028 and the productivity loss were €9,447. A secondary scenario strictly applying the doses taken from respective SmPCs was tested and resulted in greater costs-savings. Noteworthy, the mean (SD) haemoglobin (Hb) level at baseline in the first cohort was lower with 11.5g/dl (1.19) vs. 12.2g/dl (1.18) in the second cohort. Three to six months after the treatment had been stopped, the mean (SD) Hb level was 13g/dl in both the first and second cohort with a SD of 1.31 and 1.37 respectively, showing that Hb levels were maintained in both cohorts. Conclusion The introduction of the new oral ferric maltol resulted in a decrease of 70% in terms of number of FCM infusions which was associated with costs-savings of €56,933 in terms of administration, drug acquisition and productivity loss costs. Considering that Hb levels were maintained in both cohorts, these results indicate that ID patients with or without anaemia previously treated with IV iron can also be managed effectively with oral ferric maltol resulting in overall societal cost-savings.

Background and Aims:To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis [TSO] versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn’s disease [CD].Methods:Adults with active CD [n = 252] randomly received six fortnightly doses of 250, 2500, or 7500 TSO/15 ml suspension/day [TSO 250, TSO 2500, TSO 7500], or 15 ml placebo solution/day, in a double-blind fashion, with 4 weeks’ follow-up. Primary endpoint was the rate of clinical remission [Crohn’s Disease Activity Index [CDAI] < 150] at end of treatment, ie at Week 12 or withdrawal. Secondary endpoints included the course of clinical remission, rate of clinical response, change in CDAI, change in markers of inflammation, mucosal healing, and Physician’s Global Assessment.Results:Clinical remission at Week 12 occurred in 38.5%, 35.2%, and 47.2% of TSO 250, TSO 2500, and TSO 7500 patients, respectively, and in 42.9% of placebo recipients. TSO induced a dose-dependent immunological response. There was no response regarding laboratory markers of inflammation. Other secondary efficacy variables also showed no advantage of TSO over placebo for treatment of active CD. Administration of TSO did not result in any serious adverse drug reaction. Review of non-serious suspected adverse drug reactions following TSO did not reveal any safety concerns.Conclusions:Administration of 250–7500 TSO fortnightly over 12 weeks was safe and showed a dose-dependent immunological response, but no TSO dose showed a clinically relevant effect over placebo for induction of clinical remission or response in mildly-to-moderately active, ileocolonic CD.

Zwei Kernpolyedervirus‐Isolate der Kohleule aus Deutschland (MbKPV‐D) und Moldawien (MbKPV‐Ki) wurden im Biotest gepruft und der Genotyp mit Hilfe der Restriktionsenzym‐Fragmentanalyse (REN) untersucht. Beide Isolate ergaben eine gleiche biologische Aktivitat. Die REN‐Profile zeigten weitestgehende Ubereinstimmung in der DNA‐Struktur. Geringe Unterschiede wurden in den Profilen der Eco RI‐ und Hind III‐ Schnitte gefunden. Die erhaltenen REN‐Profile stimmen im wesentlichen mit den fur ein niederlandisches MbKPV‐Isolate beschriebenen Bandenmustern uberein.