Daratumumab n= 10 Trial Norway - encouraging preliminary results Oct 2024

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Intermediate encouraging results from Daratumumab Pilot study in Norway n= 10

Recently in October, Norwegian researchers presented preliminary results
- The initial response rate is promising and it’s well tolerated.
- A larger RCT trial is going to be planned (in 2025?j

It’s a 15 minute presentation - check between minute 13 and 15 for most essential slides
‘https://youtu.be/nCik6NamXdo’

So Daratumumab = a Mab = monoclonal antibodies
- in my laymen terms: it targets - reduces antibody production / immunoglobins

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I attached the most interesting slide showing 3 patients : 2 responders + 1 non-responder

2 responders:

- seem to be moderate ME CFS - according to steps (2000/day)
- IgG / immunoglobines go down to 4 g/L (from 8 to 4)
- at the same time daily steps increase from around 2000 to around 10,000 in 1 year
- physical function and fatigue score improve a lot (SPF PF + DSQ score).

1 non-responder:
- IgG went down from 10 to 8 IgG g/L
- 2000 Steps per day and fatigue scores went down 18 weeks after treatment and recovered 30 weeks after treatment
- so patient dipped for 4 months - and recovered to the same baseline (more or less)

*note if I remember correctly, also responders in the cyclophosphamide (CycloME) study lowered their IgG levels (?)

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Although it’s only 3 patients from a small promising pilot there are still some interesting questions:
1) How come the Daratumumab didn’t really lower IGG much in 1 non-responder patient ?
2) what is the correlation with patients (a) improvements ME CFS, and (b) getting lower initial IGG because of Dara treatment
(and cyclophosphamide) ?
-could this indicate there is some auto-immunity ME CFS subgroup?
- or could lowering antibodies / IgGs lead to other mechanisms improving ME CFS and PEM ?

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