IMAGiNE Study Publications

Rasch-Built Overall Disability Scale for IgM-Associated Polyneuropathy With and Without Anti-MAG Antibodies: IgM-RODS 

2025

IgM polyneuropathy is a rare condition in which the immune system attacks the nerves. The disease can cause symptoms such as numbness, tingling, weakness, and difficulties with movement. These symptoms often have a significant impact on daily activities and quality of life. At this moment, there is no effective treatment available for this disease. 

Until now, there has been no tool to measure these symptoms properly. It is important to have this tool because it is needed for future studies regarding a possible treatment. 

Therefore, researchers from the IMAGiNe study have developed a special Questionnaire: the IgM-RODS. This Questionnaire contains questions about how the disease affects the patient’s daily activities and functionality. The Questionnaire was tested in 244 patients from the IMAGiNe cohort with IgM polyneuropathy from several countries. 

The study shows that the IgM-RODS is reliable and useful. The questionnaire can clearly show how much difficulty someone has with daily activities. This helps doctors to better monitor how the disease progresses and whether a (future) treatment is effective. 

The IgM-RODS is the first measurement tool specifically designed for patients with IgM polyneuropathy. In the future, researchers from the IMAGiNe study want to further study how well the questionnaire can measure changes in daily activities over time. 

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The Role of Complement Activation in IgM M-Protein–Associated Neuropathies

2025

Aim of the study

Anti-MAG antibodies are thought to contribute to nerve damage by triggering another part of the immune system called complement, which can cause inflammation and injury.

In this study, researchers analyzed blood samples from 101 patients to better understand how these antibodies and complement activation are related to each other and to disease severity. They used lab tests to measure how strongly the antibodies reacted to MAG and whether this reaction led to activation of the complement system.

What did the researchers find?

• People had very different levels of anti-MAG antibodies, from none at all to very high.
• In general, higher levels of anti-MAG antibodies led to more complement activation in the lab.
• However, some patients without anti-MAG antibodies also showed signs of complement activation, suggesting that other harmful antibodies may be involved.
• Importantly, the amount of nerve damage or symptoms a patient had did not clearly match with antibody levels or complement activation.

What does this mean for patients?

While the study confirms that anti-MAG antibodies can trigger immune responses, it also shows that these responses do not always explain how severe someone’s symptoms are. More research is needed to understand which patients might benefit from which treatments.

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IgM anti-MAG^± peripheral neuropathy (IMAGiNe) study protocol: An international, observational, prospective registry of patients with IgM M-protein peripheral neuropathies

2023

AThis article outlines how previous clinical trials in this area have often failed to provide meaningful results, largely due to small sample sizes, short follow-up times, inconsistent use of outcome measures, and a lack of standardization in data collection. As a result, there is still no strong evidence base for how best to monitor or treat these patients.

To address these challenges, the article describes in detail the setup of the IMAGiNe study. Standardized clinical assessments at each timepoint are:

• Documentation of symptoms, disease course, treatments, and response to therapy
• Laboratory and electrophysiological data, including antibody titers
• Development of a new disease-specific patient-reported outcome measure (IgM-PNP-RODS)
• Optional biobanking of blood and DNA samples

Ultimately, this article lays the foundation for future research into IgM PNP by establishing a structured, standardized, and international framework for studying the natural history of the disease, identifying subtypes, and developing validated outcome measures. At the time of publication, 236 patients from multiple countries had already been enrolled, with more centers in the process of joining.

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