Pharmacovigilance Unit (UFPV)

Registry of Severe Adverse Reactions to Immunomodulatory Monoclonal Antibodies used in Oncology (REISAMIC)

 

Novel immunotherapies, and notably PD-1 and PD-L1 pathway inhibitors, are currently revolutionising the treatment of certain cancers. Their use in everyday practice is becoming reality as these innovative agents obtain marketing authorisations in several indications. However, they also expose patients to complications previously unknown in oncology: immune-related adverse events. Reactions of this nature require specific management that differs from that of the toxicities observed with chemotherapy and targeted therapeutic agents.

 

Within the framework of the Gustave Roussy Immunotherapy Programme (GRIP), the Institute has created a unique structure to manage immune-related toxicities, with four main orientations:

 

Meetings take place at Gustave Roussy on the first and the third Wednesday of each month and are also accessible via Web conferencing for physicians from outside the Institute who wish to discuss a case. The meetings bring together referent specialists on toxicity and the REISAMIC pharmacovigilance team, along with prescribing physicians, who find themselves confronted with toxicity patterns that are unusual or recurrent or that occur in patients with a specific diathesis. A form to request a specialised opinion from the ImmunoTox MCM can be submitted online by sending an e-mail to the address: rcp.itox@gustaveroussy.fr

 

REISAMIC is a national, multicentre registry set up to collect and analyse data on suspected immune-related and/or severe adverse reactions that occur in patients treated with the immunomodulatory monoclonal antibodies (mAb) used in oncology. REISAMIC is accessible via a Web platform, smart phone or tablet computer.

 

The data collected in the framework of the Registry concern all suspected immune-related adverse reactions at CTCAE grade 2 or higher and all non-immune-related adverse reactions at CTCAE grade 3 or higher that occur in patients treated with any immunomodulatory mAb, regardless of the indication and of whether it is used alone or in association, in the context of a marketing authorisation, an early access authorisation programme and compassionate access programme or a clinical trial (on condition that the study sponsor has given formal approval).

 

The safety data collected are reviewed by the network of ImmunoTox referent specialists, which brings together recognised experts in the field of autoimmune and drug-related toxicities. The data are presented and discussed during multidisciplinary consultative meetings (MCMs) that are held on the first and the third Wednesday of each month. The role of the expert network and of the ImmunoTox MCM is to prepare and to update the specific institution-wide guidelines* for the management of toxicities related to immune therapy. 

 

To access the Web portal of the Registry, you need a user-name and password, which are provided by the UFPV of Gustave Roussy.

Once you have received your log-in details, all you have to do is enter “reisamic.fr” in the address bar of your browser and you can access the Web portal of the Registry.

 

Using this online access you can enter information related to your patients and you can also view all data recorded by your fellow physicians concerning adverse reactions that have occurred in patients treated within your healthcare facility.

 

A User Manual is available on the Home page of the Web platform and will guide you through the various steps in data entry.

 

You can also report adverse reactions to us via e-mail.

 

The causal relationship remains uncertain? The case is poorly documented? The reaction is out of the ordinary?

Report the case anyway.

 

Contact us!

 

For further information on the Registry, to obtain your log-in details or to report a case, feel free to contact the UFPV at Gustave Roussy by e-mail.

 

 

 

* The guidelines form a part of the “Practical Manual of Oncology” at Gustave Roussy, a mobile app containing notes on the course of action and management of various types of toxicities, contact details for referent specialists, and more. The app can be downloaded free of charge at the App Store and on Google Play.