Carmen Scheibenbogen1,2, Franziska Sotzny1, Jelka Hartwig1, Sandra Bauer1, Helma Freitag1, Kirsten Wittke1, Wolfram Doehner2,3, Nadja Scherbakov2,3, Madlen Loebel4, Patricia Grabowski1. 1. Institute of Medical Immunology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. 2. Berlin Institute of Health Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. 3. Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. 4. Research Center, Carl-Thiem-Klinikum Cottbus gGmbH, Thiemstraße 111, 03048 Cottbus, Germany.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: Our data indicate that self-administered s.c. IgG treatment is feasible and led to clinical improvement in a subset of ME/CFS patients.
BACKGROUND: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. METHODS: 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. RESULTS: 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. CONCLUSION: Our data indicate that self-administered s.c. IgG treatment is feasible and led to clinical improvement in a subset of ME/CFS patients.
Authors: Elena E Perez; Jordan S Orange; Francisco Bonilla; Javier Chinen; Ivan K Chinn; Morna Dorsey; Yehia El-Gamal; Terry O Harville; Elham Hossny; Bruce Mazer; Robert Nelson; Elizabeth Secord; Stanley C Jordan; E Richard Stiehm; Ashley A Vo; Mark Ballow Journal: J Allergy Clin Immunol Date: 2016-12-29 Impact factor: 10.793
Authors: Mary A Fletcher; Xiao R Zeng; Kevin Maher; Silvina Levis; Barry Hurwitz; Michael Antoni; Gordon Broderick; Nancy G Klimas Journal: PLoS One Date: 2010-05-25 Impact factor: 3.240
Authors: Øystein Fluge; Ove Bruland; Kristin Risa; Anette Storstein; Einar K Kristoffersen; Dipak Sapkota; Halvor Næss; Olav Dahl; Harald Nyland; Olav Mella Journal: PLoS One Date: 2011-10-19 Impact factor: 3.240
Authors: Øystein Fluge; Kristin Risa; Sigrid Lunde; Kine Alme; Ingrid Gurvin Rekeland; Dipak Sapkota; Einar Kleboe Kristoffersen; Kari Sørland; Ove Bruland; Olav Dahl; Olav Mella Journal: PLoS One Date: 2015-07-01 Impact factor: 3.240
Authors: Ashley R Valdez; Elizabeth E Hancock; Seyi Adebayo; David J Kiernicki; Daniel Proskauer; John R Attewell; Lucinda Bateman; Alfred DeMaria; Charles W Lapp; Peter C Rowe; Charmian Proskauer Journal: Front Pediatr Date: 2019-01-08 Impact factor: 3.418
Authors: Carlo Cervia; Yves Zurbuchen; Patrick Taeschler; Tala Ballouz; Dominik Menges; Sara Hasler; Sarah Adamo; Miro E Raeber; Esther Bächli; Alain Rudiger; Melina Stüssi-Helbling; Lars C Huber; Jakob Nilsson; Ulrike Held; Milo A Puhan; Onur Boyman Journal: Nat Commun Date: 2022-01-25 Impact factor: 14.919
Authors: Ingrid G Rekeland; Kari Sørland; Ove Bruland; Kristin Risa; Kine Alme; Olav Dahl; Karl J Tronstad; Olav Mella; Øystein Fluge Journal: PLoS One Date: 2022-09-19 Impact factor: 3.752