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NEDA Fudge and Alemtuzumab

Posted on December 1, 2025 by
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No evidence of disease control is typically no relapse no MRI lesions and no progression. Whilst as mentioned I think progtrssion is a composite surrogate of different biologies the question is how good are drugs at inducing NEDA.

Here we hear about alemtuzumab and they tell us that the proportion of patients achieving NEDA-3 was 51.7% (15/29) in the first year, 56.2% (12/26) in the second year, 47.4% (9/19) in the third year, and 47.1% (8/17) in the fourth year.

So about 50% worsen each year, this is about the same as was found in the clinical trials but this is rubbish….and a misleading fudge, They essentially start again each year and half worse each yer but is it the same or a different half, is it half of the people without disease that get disease so the rate of NEDA would be 25% (50% x 50% = 25%). So this is not telling people the proper story. In the beginning there were 29 people and by the time it ends there are 17 what happened to the twelve? Disease activity and they didn’t want to be keep in the study so the real NEDA is likely to much less. The neuros attached to these trial studies need to get a back bone and grow some and agree to standardised outcomes such that pharma cannot fudge the news. It stops us comparing one agent to the others.

Herrero-Poch L, Fortes-González MS, Pato-Pato A, Gaveiras-Araújo P, Lorenzo-García M, García-Estévez DA, Lorenzo-González JR. Alemtuzumab in relapsing-remitting multiple sclerosis in clinical practice: Annual NEDA-3 follow-up for up to 4 years. Farm Hosp. 2025 Nov 26:S1130-6343(25)00147-3.

Objective: The effectiveness of alemtuzumab in patients with relapsing-remitting multiple sclerosis (RRMS) have been demonstrated in clinical trials. The primary endpoint was to describe the annual effectiveness of alemtuzumab over a 4-year period, according to the different parameters of the NEDA-3 concept (no evidence of disease activity) in clinical practice.

Methods: A retrospective, observational multicentric open study of patients with RRMS treated with alemtuzumab between 2015 and 2024. Effectiveness was assessed according to different parameters of the NEDA-3 concept (absence of relapses, stability in disability status according to the EDSS scale, and absence of new lesions and/or contrast enhancement in brain magnetic resonance imaging) with annual follow-up for up to four years. The proportion of patients achieving NEDA-3 was 51.7% (15/29) in the first year, 56.2% (12/26) in the second year, 47.4% (9/19) in the third year, and 47.1% (8/17) in the fourth year.

Results: A cohort of 32 patients (71.9% women, mean age 40.3 ± 11 years) were included. The proportion of patients achieving NEDA-3 was 51.7% (15/29) in the first year, 56.2% (12/26) in the second year, 47.4% (9/19) in the third year, and 47.1% (8/17) in the fourth year. At the end of the study, 82% of patients remained relapse-free, 59% had stable disability according to the EDSS scale, and over 47% were free of radiological activity.

Conclusions: Alemtuzumab has proven to be effective, over 4 years, in clinical practice in patients with RRMS according to the different parameters of the NEDA-3 concept.

Source: multiple-sclerosis-research.org

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