Opportunistic Autoimmunity Secondary to cancer Immunotherapy (OASI)
In the context of cancer immunotherapy, notably checkpoint inhibitors, T-cell activation is induced by releasing the PD-1/PDL-1 ligands or CTLA-4/CD28 co-inhibitory signals, leading to a cytotoxic attack of tumor cells. However, this T-cell activation may also promote the emergence of autoimmune manifestations and other “immunological” effects such as tumor progression or paradoxical worsening of opportunistic infections, similarly observed during an immune reconstitution syndrome.
OASI for "Opportunistic Autoimmunity Secondary to cancer Immunotherapy" focus on emergence of new autoimmune manifestation following a check-point inhibitor treatment initiation, that can impact a large variety of organs. Dermatological, gastrointestinal, endocrine, hepatic, articular are some exemples of OASI that have been reported in literature.
The PRAISE e-cohort
This is a real life observational longitudinal study concerning specific drugs, based on patients reported experience, recruited in cancer centers in France.
The main objective is to determine the incidence, severity and outcome of Opportunistic Autoimmunity Secondary to cancer Immunotherapy (OASI).
900 patients in sites in France will be included.
This is a e-cohort with two main data sources:
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Patient reported outcome provided regularly by the patient on a e-platform combined with data reported by physician at the inclusion of the patient;
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Healthcare claims database with a linkage.
Additional data sources will be used on a case per case basis
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Upon a specific patient consent: biological data (antibodies, ADN, ARN) from blood samples collected during the patient inclusion and stored in a biobank,
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in case of autoimmune effect: additional medical information provided by the specialist in charge of the patient for the event.
The PRAISE study is sponsored by Les Hôpitaux Universitaires de Strasbourg (France).
Recent posts
PRAISE in numbers:
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RIPH2 | Biobank
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42 months of enrolment phase | 2 years of follow-up
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900 patients expected
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77 investigator sites
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1st patient enrolled: 29.11.2019
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ClinicalTrials.gov
Why the PRAISE e-cohort?
Checkpoint inhibitors targeting CTLA-4 and PD-1/L1 marked a turning point in cancer immunotherapy treatment...
Secondary autoimmune responses to checkpoint inhibitors are sometimes severe...
Precise epidemiology is
poorly known due to inadequate reporting of clinical trials and the partitioning of the health system
PRAISE study objectives
Principal objective:
To determine, using a prospective electronic cohort of 900 patients treated in French oncology unit, the incidence, severity and outcome of autoimmune manifestations in patients treated with BMS checkpoint inhibitors.
Secondary objectives:
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To compare baseline characteristics of patients who develop or not severe autoimmune manifestations
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To compare overall survival and event-free survival of patients who develop or not severe autoimmune manifestations
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To analyze the incidence of flares or worsening of pre-existing autoimmune diseases
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To analyze baseline predictive factors of autoimmune manifestations
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To evaluate incidence, severity and outcome of severe autoimmune manifestations in patients treated with checkpoint inhibitors who are not included in the e-cohort, thanks to Healthcare claims database.