My study is about the early, or the up-front, use of romiplostim, a thrombopoietin receptor agonist, in acute ITP patients. So for many years guidelines for ITP have recommended the use of steroids or steroids and intravenous immunoglobulins as first-line treatment. Second-line treatments have changed considerably over the last 10-15 years of the introduction of thrombopoietin receptor agonists, however, increasingly although this drug is used as second line and usually for chronic ITP, which is defined as either six or twelve months after the diagnosis, there has been increasing use of TPO-RA, thrombopoietin receptor agonists, in recent years and there’s a drive in the community to bring forward the use of thrombopoietin receptor agonists perhaps to acute ITP or frontline treatment of ITP.

In the literature, most of the early use of TPO, so the use of TPO up front or in acute phase, has been patients who have either failed first-line treatment with steroids or patients who are intolerant to steroids, such as patients with diabetes or patients with cardiovascular disease and so forth.

So this is a study where we looked at our real-world evidence from the ITP Registry to look for patients who received thrombopoietin, specifically romiplostim, as up-front treatment for ITP. We’ve chosen a specific period in time, we’ve chosen the COVID period because during this period we were allowed by our regulatory authorities to use the drug up front but this drug is usually licensed for second-line treatment, not for up-front treatment. So we identified about 34 patients, 17 who had up-front romiplostim single agent and another 17 patients who initiated steroids but then went on to receive romiplostim within 28 days of diagnosis. So we compared both the response to treatment as well as the loss of response to treatment in both groups of patients.

What we have found is that the response to treatment is equally good in both groups of patients, those who had steroids first followed by romiplostim within 28 days versus those who had single agent romiplostim.  So the majority of patients responded within 12 days of starting treatment and response is defined as reaching either a platelet count of 30 or a platelet count of 50, these were our endpoints.

When we looked at the loss of response, we saw essentially the difference was not statistically significant. So both had overall equal median time to failure of treatment. However, there was a trend for those patients who had steroids and romiplostim at the same time, early on within 28 days of diagnosis, seemed to have a better response duration or a lesser rate of failure. The other observation was that the two groups that we identified, those with single agent romiplostim and those with steroids and romiplostim did reflect a difference in disease severity. Those who had both steroids and romiplostim had a much lower starting platelet count, around 3, a median of 3, whereas those who had romiplostim single agent had a median platelet count of over 10.

So, in conclusion, we can say that overall steroids plus romiplostim is probably better than romiplostim single agent. However, we will be able to stratify patients into a group where initial romiplostim would be sufficient, especially if those patients had other comorbidities such as diabetes, intolerance to steroids and so forth. So this is one of the few studies looking at the use of romiplostim up front at time of diagnosis of ITP.