With the prospect of personalised medicine in the treatment of MG patients, patient involvement is of great importance.
There are internationally recognised guidelines and international consensus on how to treat Myasthenia Gravis (MG). Today, the patients are treated more or less in the same way. But there is a wide difference in the treatment response, they respond differently to the drugs they get. Therefore, we need a much more personalised approach.
Says Paola Cavalcante from her office in Milano, where she is the coordinator of the EU-financed project MG-PerMed. The project is trying to find ways of personalising the treatment of MG patients, so the different available drugs are selected according to the ways each patient can react.
“Based on data we can take into account patient-specific factors and identify factors that can affect the individual response to the different treatments,” says Paola Cavalcante. Among the patient-specific factors are genetic factors: “Some genetic variants act as risk factors, predisposing the patient to a poorer or better response, and therefore some patients are more respondent than others to the treatment. We want the treatment to be more efficient”
So, the project’s neurologists and scientists aim to identify which genetic factors can predict how the patient will respond to the different drugs for MG, thus guiding therapeutic decisions and avoiding ineffective therapies or side effects. Other patient-specific factors – or bio-markers – are small RNAs and proteins circulating in the blood. Such biomarkers can warn the doctors about the status of the illness and how to treat it individually in each patient.
The goal of the three-year project is to combine all the data – clinical data and biomarker data from at least 150 patients from respectively Italy, Israel, and France. Combined they can be used to develop an AI model, a biomarker-based tool that can help clinicians choose the best treatment for MG patients.
With the help of a DPO (Data Protection Officer) the project uses data such as sex, age, nature of the autoantibodies causing the disease, drug use, treatment, and disease severity scores. The latter include scores reported by clinicians and scores reported by patients who themselves scored their quality of life and the treatment outcome they experienced. The data comes directly from the hospitals and patients themselves. Data is stored anonymously at Zenodo, an open-access research data repository, partly funded by the EU Commission, and uses the existing infrastructure and services at CERN, the intergovernmental organisation based in Switzerland.
“We try to address each possible ethical issue of the future use of the AI tool. For example, the tools must be only assisting – not substituting – the neurologist who always makes the final decision,” according to Cavalcante.
Another ethical issue is the risk of discrimination, including economic equality. It is important to secure equal opportunities and ensure all patients will have access to the tools in the end.
There’s also the issue of responsibility.
“We are trying to include all possible treatments, so the AI tool can provide all the best suggestions. If we are inclusive, the doctor can have an overview of all possibilities. In the end, the doctor will be responsible for the chosen treatment,” says Calvacante.
Involvement of the Patient
The patients are an important part of the project. For example, the use of telemedicine and the involvement of patients in the different steps of the research can set the basis for a more patient-centered care, that takes into account all the patients’ needs. It is important to understand to what extent patients can participate into the clinical decisions, as they can have different point of view than the neurologist; in this case, medical quality and patients’ safety should be safeguarded. Also concerning the use of genetic data for research, patients need to understand and decide what they want to know. Do they, for example, want to know their risk of getting cancer, or what if the clinicians discover a genetic variance that can be risky for the patient, who then informs them?
“We are following patients closely in the project, but we want to increase the interactions between the patients and the clinicians even more,” said Calvacante thus the project will understand how the European-developed Myrealworld App could be improved to increase patient-clinician interactions in the context of patient-centered care approaches.
Myasthenia Gravis (MG) is a rare, chronic autoimmune disorder. It is like a communication breakdown between nerves and muscles, caused by the body’s immune system. This leads to muscle weakness that comes and goes. While it can be challenging, it’s often manageable with the right treatment and lifestyle adjustments.
Personalised Medicine and the MG-PerMed Project This series of articles focuses on the ethical aspects of personalised medicine. We use Myasthenia Gravis (MG) as a case, as we follow the EU-financed project (MG-PerMed) dealing with personalised medicine for MG patients. However, the same ethical aspects of personal medicine exist in the personal treatment of all other diseases. MG makes muscles weak because the body’s immune system attacks them. People with MG often need medicines that weaken their immune system to control the disease. But it varies a lot from person to person, what medicines they need. This project, Prevention in Personalised Medicine, aims to tailor treatments to each person’s unique needs instead of a one-size-fits-all approach.
