- Istituto Buddista Italiano Soka Gakkai
“developing approaches and metrics to measure the impact and improve clinical outcomes of fragile patients in the era of Covid-19 – Acronym – COMETA
IFO – IRE Capofila P.I. Prof. Gennaro Ciliberto
ASL – ROMA1
IFO – ISG
Sant’Andrea (La Sapienza)
Istituto Tumori di Bari “Giovanni Paolo II” IRCCS
AUSL Reggio Emilia IRCCS
The outbreak of the coronavirus-2 disease 2019 (Covid-19) is challenging health care systems worldwide. The need to allocate more health care resources to the Covid-19 emergency, the possible deferral of routine health care visits, and the recommendation to avoid medical visits if not strictly necessary are expected to impact on patients’ adherence to treatments and/or on follow up programs. In patients with severe chronic diseases – such as cancer, autoimmune diseases, and immunodeficiencies – this may translate into worsening health outcomes.
With this in mind, we propose a multicenter study with the following three aims:
1) Assess the direct and indirect impact of Covid-19 outbreak on patients with cancer, autoimmune diseases, and immunodeficiencies in terms of Covid-19 outcomes severity and adherence to treatment protocols. To this purpose we will conduct a multicenter study involving institutions located in different geographical areas in Italy and data concerning patient examination, evaluation and care will be gathered from the Covid-19 registry and health information systems made available thanks to the participation in the network of the Department of Epidemiology (DEP) of the Lazio Regional Health Service. The impact of Covid-19 on indicators of drug compliance or switch to other therapies will be studied.
2) Implement and maintain a non-Covid status, while ensuring continuation of health care activities, in non-Covid centres. Implement the already set up differential paths for Covid positive versus Covid negative patients in mixed-modality centers, to provide the most appropriate level of care and ensure safety. Implement the long-term ability to perform elective diagnosis and surgery in fragile patients.
3) Carry out serial collection and rigorous biobanking of blood samples with the purpose in the future to assess a) the serum levels of anti-SARS-Cov-2 antibodies (Abs) (IgG/IgM/IgA); b) the ongoing pattern of mutations of the virus in the infected population and c) the immune response alterations in Covid-19 patients bearing relevant co-morbidities using omics techniques.
BANDO AIFA 2012 (Rif. FARM1275JK)
TITLE: “MONITORING THE EFFECTIVENESS AND SAFETY OF BIOLOGICAL DRUGS FOR TREATING PSORIASIS. A CLINICAL AND BIOMEDICAL EVALUATION”
GROUP: UOC Dermatologia Clinica – Responsabile Dott. Antonio Cristaudo
Background: Approved therapies for psoriatic patients comprise conventional treatments and newer biological agents. These include TNF-alpha inhibitors and, a new antibody, recently introduced in the clinical practice for psoriasis, targeting the common p40 subunit of IL-23 and IL- 12 (ustekinumab). In contrast to conventional immunosuppressive drugs used for the management of psoriasis such as methotrexate and cyclosporine, biological agents have demonstrated to have rapid onset of action and pronounced disease reducing activity when administered as monotherapy or in combination with Methotrexate.
However, psoriasis has proven to be a difficult disease to treat and treatment failures, even with newer biologic therapies, are not uncommon. Identification of soluble or cellular biomarkers that predict response to therapy, or can potentially assist psoriasis case management, or can give information about long term safety and patient improvement also in terms of immune integrity represents a perceived need among clinicians managing patients.
Aims: The study is aimed a) to assess comparative effectiveness of the therapeutic biologic drugs anti-TNF-alfa (etanercept) and anti-p40 subunit of IL-12 and IL-23 (ustekinumab) on psoriasis patients with cutaneous and joint involvement; b) to identify markers and/or correlates of protection/progression exploitable for clinical management and immune monitoring of psoriatic patients