Tolerability and efficacy of s.c. IgG self-treatment in ME/CFS patients with IgG/IgG subclass deficiency: a proof-of-concept study, by Carmen Scheibenbogen, Franziska Sotzny, Jelka Hartwig, Sandra Bauer, Helma Freitag, Kirsten Wittke, Wolfram Doehner, Nadja Scherbakov, Madlen Loebel, Patricia Grabowski in J Clin Med. 2021 May 29;10(11):2420 [doi: 10.3390/jcm10112420]
Chronic fatigue syndrome (ME/CFS) is a complex disease frequently triggered by infections. IgG substitution may have therapeutic effect both by ameliorating susceptibility to infections and due to immunomodulatory effects.
We conducted a proof of concept open trial with s.c. IgG in 17 ME/CFS patients suffering from recurrent infections and mild IgG or IgG subclass deficiency to assess tolerability and efficacy. Patients received s.c. IgG therapy of 0.8 g/kg/month for 12 months with an initial 2 months dose escalation phase of 0.2 g and 0.4 g/kg/month.
Primary outcome was improvement of fatigue assessed by Chalder Fatigue Scale (CFQ; decrease ≥ 6 points) and of physical functioning assessed by SF-36 (increase ≥ 25 points) at month 12. Of 12 patients receiving treatment per protocol 5 had a clinical response at month 12. Two additional patients had an improvement according to this definition at months 6 and 9. In four patients treatment was ceased due to adverse events and in one patient due to disease worsening. We identified LDH and soluble IL-2 receptor as potential biomarker for response.
Our data indicate that self-administered s.c. IgG treatment is feasible and led to clinical improvement in a subset of ME/CFS patients.
Taken together, our study has several limitations, including a small patient number and a lack of a control arm. The strength of this study is to show the feasibility of a dose escalation s.c. IgG home treatment in ME/CFS patients. Furthermore, it provides first evidence for efficacy of an intermediate dose s.c. IgG treatment and potential biomarkers for response. This warrants an RCT study.