Trial Report Plasma cell targeting with the anti-CD38 antibody daratumumab in ME/CFS -a clinical pilot study, 2025, Fluge et al

[EndME]

Does the very binary response tell us anything at all? There were no middle responders for example - all reached normal levels or remained at baseline

May also be a consequence of choice of outcome measures.

For example for the placebo-controlled trial the outcome measures seems to be:
Primary: DSQ-SF total score
Secondary: 2 modified DSQ-SF scores, SF-36 Physical Function, steps, Function level, AEs
and then a whole host of exploratory outcome measures (FUNCAP, heart rate and HRV, handgrip strength, NASA lean, workload, PVP,....).

 

[ryanc97]

What is the link between the measure used and this binary response in this case? It’s either line went up by a big amount or line stayed flat.

No line went up in the midele

 

[EndME]

What is the link between the measure used and this binary response in this case? It’s either line went up by a big amount or line stayed flat.

No line went up in the midele

Insofar that not all of the data of the study might look like that, but then I realised that expect for a few exceptions (like NIRS which might have failed for other reasons and as a consequence is also not part of the larger trial and HRV which is probably anyways not particularly interesting) they are reporting all data.

But I would suggest that at least one or 2 people are looking a bit variable, which should be expected.