H2H study - good results, but poorly worded26 May 2020 13:09
I am amazed at how STX is underplaying the results from the H2H study. See below
The issue is that the 12 week end point included the ITT group in addition to PP. ITT are those who dropped out during the 12 week period so clearly would have lower iron levels than those who completed the full 12 weeks. These people should never have been included - of the PP population the iron levels were consistent at 12 weeks with those who were given the IV injection.
Additionally after 12 weeks another 40 weeks was administered, so 52 weeks in total, and these results were very good too.
So in 1 year how many IV injection hospital visits would be required? This is the Feraccru USP
During 2019 the results of the AEGIS-H2H clinical study became available although the Group announced in March 2020 that it had initiated a review of the analysis of the data which is currently ongoing. This study compared Feraccru® to Ferinject®, the market-leading intravenously-delivered iron replacement therapy. The AEGIS-H2H study was a multi-national Phase IIIb randomised, active-controlled trial in inflammatory bowel disease (IBD) patients with iron deficiency anaemia (IDA) and whose haemoglobin (Hb) measurements were as low as 8.0g/dL. The objective of the study was to assess whether the effect of Feraccru® on Hb response (defined by the protocol as normalisation of Hb or a >2g/dL rise in Hb from baseline) was comparable to the effect seen with IV treatment at 12 weeks. This was followed by a 40-week extension phase, during which eligible subjects continued treatment with Feraccru® or received IV therapy in line with clinical need. The key findings of the study were:
· The study did not meet its overall primary end point of non-inferiority at twelve weeks because this was clearly not achieved in the "intention to treat" (ITT) population, although there was a high response rate;
· IDA re-occurred at least once in approximately 39% (49) of the subjects in the IV arm of the study following the initial treatment with IV therapy, requiring a total of 69 additional IV iron infusions to be administered; and
· Feraccru®/Accrufer® was effective and generally well tolerated over 52 weeks of treatment with a side effect profile consistent to that seen in previous placebo-controlled studies.
The positive long term data provides further evidence to support results of earlier clinical studies that Feraccru® is effective and well tolerated over 52 weeks, even in patients who have been unable to tolerate oral iron salts previously. It also shows that Feraccru® is a real oral alternative to IV iron for patients with IDA and it can prevent the need for repeated IV infusions. The outcome of this study is therefore very helpful for health economics evaluations and will also be beneficial in pricing and reimbursement negotiations in countries around the world as it will help to justify attractive pricing. The results of the ongoing review of the data analysis will
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