Registry of Severe Adverse Reactions to Immunomodulatory Antibodies used in Oncology (REISAMIC)
Novel immunotherapies, and notably PD-1 and PD-L1 targeted antibodies, are currently revolutionizing the treatment of certain cancers. Their use in everyday practice is becoming reality as these innovative agents have obtained marketing authorizations in several indications. However, they also expose patients to complications previously unknown in oncology: immune-related adverse reactions (irAES). Reactions of this nature require specific management that differs from that of the toxicities observed with chemotherapy and targeted therapeutic agents.
In order to build upon its experience in this area, Gustave Roussy has set up a special programme, the GRIP (Gustave Roussy Immunotherapy Program) to manage immune-related toxicities, with 4 main orientations:
- A network of reference organ specialists (see list of ImmunoTox reference specialitsts)
- Institution-wide management Guidelines *
- A specific pharmacovigilance registry (REISAMIC)
- A dedicated multidisciplinary consultative meeting (MCM), the ImmunoTox MCM:
- The meeting takes place at Gustave Roussy the first Wednesday of each month, and is also accessible via Web conferencing to physicians from outside who wish to discuss a clinical case. The meeting brings together the reference specialists on toxicities and the REISAMIC pharmacovigilance team along with prescribing oncologists 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 specialized opinion from the ImmunoTox MCM can be submitted on-line at www.reisamic.fr.
What is REISAMIC?
REISAMIC is a nation-wide multicenter registry that was set up to collect and analyze data on suspected immune-related and/or severe adverse reactions that occur in patients treated with immunomodulatory monoclonal antibodies used in oncology. REISAMIC is accessible via a Web platform, smart phone and tablet computer.
What data is collected?
The data collected in the framework of the Registry concerns 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 combination, in the context of a marketing authorization, a temporary authorization for use or a clinical trial (on condition that the Sponsor has given formal approval).
What happens to the data?
The safety data collected are reviewed by the network of ImmunoTox reference specialists, which brings together recognized experts in the field of autoimmune and drug-related toxicities. The data are presented and discussed during MCMs that are held the first 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 immunotherapy.
How do I connect to REISAMIC?
To access the Web portal of the Registry, you need a user-name and password, which are provided by the UFPV(Pharmacovigilance Unit of the Clinical Research Division 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 on-line access you can enter information related to your patients and you can also view all data recorded by your fellow oncologists 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.
No time to enter data in REISAMIC?
You can also report adverse reactions to us via e-mail.
The causal relationship remains to be ascertained? The case is poorly documented? The reaction is atypical?
Report the case anyway.
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 such as App Store and Google Play containing notes on the course of action and management of various types of toxicity, contact details for reference specialists, and more. The app can be downloaded free of charge at the App Store and on Google Play.
** (Champiat, S., Lambotte, O., Barreau, E., Belkhir, R., Berdelou, A., Carbonnel, F., Cauquil, C., Chanson, P., Collins, M., Durrbach, A., et al. (2016). Management of immune checkpoint blockade dysimmune toxicities: A collaborative position paper. Ann. Oncol. 27.)