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Updated: Mar 20, 2026
Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
Published on: June 14, 2018
The role of neutralizing antibodies to interferon-β as a biomarker of persistent MRI activity in multiple sclerosis:
Damiano Paolicelli1, A Manni2, A Iaffaldano2
1Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari Aldo Moro, Policlinico, Piazza Giulio Cesare 11, 70124, Bari, Italy. damiano.paolicelli@uniba.it.
Purpose:
During interferon-β (IFN-β) therapy, up to 45 % of patients may develop neutralizing antibodies (NAbs), associated with a decreased efficacy of the drug. We investigated in a real-life setting the impact of NAbs on magnetic resonance imaging (MRI) outcomes in a population of 567 IFN-β-treated relapsing-remitting (RR) multiple sclerosis (MS) patients up to 7 years. We also evaluated NAbs' role as a biomarker of the persistence of MRI disease activity.
Methods:
Patients' sera were tested for NAbs' presence by cytopathic effect (CPE) assay every 6-12 months. MRI scans were performed every 12 months. Generalized hierarchical linear models accounting for within-patient correlation were used to analyze T1 gadolinium-enhancing and new T2 lesions. Moreover, further tests were carried out to assess the overall outcome difference from year 1 to year 7 according to NAb status and the possible interaction between NAb status and time of follow-up.
Results:
Seventy-five patients (13.2 %) became NAb positive (NAb+) during the follow-up. Considering T1 gadolinium-enhancing (GD+) lesions, we observed a significantly higher incidence in NAb+ patients (52 %, p = 0.0091). Also for new T2 lesions, we found a higher incidence in NAb+ patients (50 %, p = 0.0075). The negative impact of NAbs on the MRI outcomes considered did not change during the follow-up.
Conclusions:
Our 7-year results show the negative effect of NAbs on MRI measures of disease activity and confirm their role as a surrogate marker of IFN-β treatment efficacy.
Insights
Neutralizing antibodies (NAbs) to interferon-beta (IFN-β) therapy in multiple sclerosis patients are linked to increased MRI-detected disease activity. These NAbs serve as a biomarker for reduced treatment efficacy over seven years.
Area of Science:
- Neuroimmunology
- Pharmacology
- Radiology
Background:
- Interferon-beta (IFN-β) is a common treatment for relapsing-remitting multiple sclerosis (RRMS).
- Up to 45% of patients develop neutralizing antibodies (NAbs) against IFN-β, potentially reducing treatment effectiveness.
- Monitoring NAb development is crucial for managing MS treatment efficacy.
Purpose of the Study:
- To investigate the real-world impact of NAbs on MRI outcomes in RRMS patients treated with IFN-β over seven years.
- To assess NAbs as a biomarker for persistent MRI disease activity during IFN-β therapy.
Main Methods:
- A cohort of 567 RRMS patients treated with IFN-β was followed for up to seven years.
- Patient sera were tested for NAbs using a cytopathic effect (CPE) assay every 6-12 months.
- MRI scans were analyzed for T1 gadolinium-enhancing (GD+) lesions and new T2 lesions, with statistical models accounting for within-patient correlation.
Main Results:
- 13.2% of patients developed NAbs (NAb+) during the follow-up period.
- NAb+ patients showed a significantly higher incidence of T1 GD+ lesions (52%) and new T2 lesions (50%).
- The negative impact of NAbs on MRI outcomes remained consistent throughout the seven-year follow-up.
Conclusions:
- Neutralizing antibodies to IFN-β negatively affect MRI measures of disease activity in RRMS patients.
- NAbs serve as a reliable surrogate marker for decreased IFN-β treatment efficacy.
- These findings underscore the importance of monitoring NAbs in MS patients undergoing IFN-β therapy.
