Coronavirus, the doctor from Naples who first tested the anti-arthritis drug: "I remain cautious, but the data is welcoming"

The Italian Medicines Agency has authorized a study to evaluate the effectiveness of tocilizumab. Oncologist Paolo Ascierto: "Not all patients’ response experimentation will clarify who to focus on"

ROME. It's not the vaccine, of course. But for those affected by coronavirus it is a hope of cure. With a decision taken in record time, the Italian Medicines Agency (AIFA) announced Tuesday evening that it had authorized the Tocivid-19 study which will evaluate the efficacy and safety of tocilizumab - an immunosuppressant used for rheumatoid arthritis - in the treatment of pneumonia caused by the new coronavirus. The study is promoted by the National Institute for the Study and Treatment of Cancer in Naples with the University of Modena and Reggio Emilia and the IRCCS of Reggio Emilia, and with the Aifa Technical Scientific Commission. 

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It is the confirmation of the intuition and work carried out in Naples by Paolo Ascierto, president of the Melanoma Foundation and director of the Oncology Unit Melanoma, Oncological Immunotherapy and Innovative Therapies of the Pascale Cancer Institute of Naples, which in recent days, together to colleagues at Cotugno hospital, the regional reference centre for the coronavirus emergency, he had first used tocilizumab in the treatment of patients with Covid-19.

"Aifa has done an exceptional job - comments Ascierto - responding with great rapidity to what we hope will become a clinical study capable of counteracting lung complications from Covid-19 and therefore relieve intensive care".

Professor, this drug seems to work but has an unpronounceable name...We familiarly call it" toci ".

The experimentation starts, but in reality after the announcement of the results obtained in Naples the "toci" has already been used in these days with good results elsewhere, from Modena to Cosenza, from Milan to Latina. What is the situation right now?

«What we do know is that Roche has distributed around a thousand free treatments throughout Italy. Obviously so far there have been no absolute criteria. General criteria have been issued by Simit - the Italian Society of Infectious Diseases, Lombard section - but without uniform treatment. That's why experimentation is necessary and Aifa has burnt all the stages. Right now there are dozens of reports coming from both intensive and sub-intensive therapies as well as from wards, and the signs are encouraging. For us, the password is always cautious optimism, but it would seem that it works better in sub-intensive care and ward patients.

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What will experimentation tell us beyond this?

"The data are encouraging but not all patients respond. The trial will clarify which patients are unresponsive and who to target. The blood dosage of interleukin 6 - the protein that is the main vector of pulmonary inflammation produced by the coronavirus and which represents the target of tocilizumab - could give indications in this regard. The Chinese researchers with whom we interacted argue that patients with high interlukin 6 levels are the answer. It is something we are also checking, but keep in mind that in an emergency situation not everyone is able to do the interleukin 6. Interlocking 6 will not decide with the trial, but all the data will be collected. The values ​​of this protein do not always correlate with what happens in the lung. We'll see".

At this moment, therefore, how many patients are already treated in Italy with the drug?

 "A thousand treatments have been provided, therefore hundreds of people, because some patients may need a second or third treatment."

Are you moving forward in Naples too?

«Yes, 11 patients were treated at Cotugno hospital on Monday, all between the ages of fifty and sixty, including 7 in intensive care and 4 in the ward. Of the 7 in resuscitation 5 showed an important improvement while one is stationary and another, who had concomitant pathologies, unfortunately died. Of the 4 who were treated in the ward with severe respiratory insufficiency, 48 hours after the infusion all had signs of improvement".

Does this mean that if tocilizumab is used early in the disease the response is significant?

"These are the signs that come from the experiences gathered in all the centres; the experimentation will also clarify this". 

But could treating patients at an early stage prevent them from ending up in ICU?

Exactly! However, I am always very cautious also in giving this message: since we have anyway had ICU patients who have improved, I would not want the ICU patients to no longer be treated.

This drug has already been used in China. With what results?

"Chinese colleagues told us that they had tested it on the 21 patients who were the subject of the publication they sent us, and 20 out of 21 had had important results in 24-48 hours. Everyone then resolved the respiratory distress syndrome. They certainly did treatments that we do not have, but they also support what we say too: that is, if you can treat early it is better. They too, however, treated intubated patients and also saw important results in these patients ".

How did the idea of ​​using this drug in Covid patients come about?

«I am an oncologist and I deal with immunotherapy. Toci is used in the treatment of the side effects of some types of immunotherapy: haematologists know it well, because they use it in the treatment of the side effects of car-t cells. What is the most important side effect? The cytochemical storm! And what does this have to do with respiratory distress from Covid-19? Because what arises in the lung following the infection is a cytochemical storm! Hence the idea of ​​using it! It is a bit like Columbus's egg.

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So are you optimistic?

«I am very cautious, it is always important to be so. The data is encouraging, experimentation will tell us. When we treated the first two incubated patients and one of the two went really well, we said: ok, the data go in the direction indicated by the Chinese colleagues, but we were undecided whether to communicate it or not. At a certain point we said: let's communicate it, it's an emergency, it's a war, we knew that the company would make the drug available for free off label (use in clinical practice outside the authorized indications, Ed) and then we have communicated".

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You are a great professional who works in a southern region. It has been said that if the emergency arrives in the South, the system would not hold up. Do you think so too?

«Of course, if it arrived with the same entity that we are seeing in the North we would be in difficulty. At this moment there is an emergency but not a critical one: resuscitation beds are increasing, the regional system is trying to buffer and respond. It must be said that in Campania the social distancing that has started could bear fruit, our governor is doing an excellent job. The important lesson we need to learn from Wuhan is that they implemented social distancing and eventually came out of it. This is certainly the best solution!