pharmatimesApril 02, 2020
Tag: COVID-19 , siltuximab , SARS-CoV-2
A third of patients with COVID-19 taking EUSA Pharma's interleukin (IL)-6 targeted monoclonal antibody siltuximab have experienced a clinical improvement, according to early findings from an observational case-control trial in Italy.
The SISCO study, which is sponsored by the Papa Giovanni XXIII Hospital with support from Ergomed plc in the form of clinical research services, has enrolled 25 patients with confirmed SARS-CoV-2 infection (COVID-19) and respiratory complications.
According to interim interim data, presented from the first 21 patients treated with siltuximab and followed for up to seven days, one-third (33%) of patients experienced a clinical improvement with a reduced need for oxygen support and 43% of patients saw their condition stabilise, indicated by no clinically relevant changes.
"Combined, this means that over three-quarters of patients treated with siltuximab (76%) had either stable or improved disease at this interim analysis." the firm noted.
A worsening of the disease was seen in 14% patients whilst one patient died and one experienced a cerebrovascular event.
Also of note, C-Reactive Protein (CRP) levels, a marker of systemic inflammation, declined from baseline through to Day 5 following treatment with siltuximab in all patients with sufficient recorded values. This level of reduction was maintained in those patients seven days after receiving treatment with siltuximab.
Siltuximab is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as well as in a number of other jurisdictions worldwide for the treatment of certain patients with multicentric Castleman disease (MCD), and is currently is under investigation for patients who have developed serious respiratory complications.
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