PMID- 37237267
OWN - NLM
STAT- MEDLINE
DCOM- 20230529
LR  - 20230529
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 23
IP  - 1
DP  - 2023 May 26
TI  - Fatigue, depression, and product tolerability during long-term treatment with 
      intravenous immunoglobulin (Gamunex(R) 10%) in patients with chronic inflammatory 
      demyelinating polyneuropathy.
PG  - 207
LID - 10.1186/s12883-023-03223-5 [doi]
LID - 207
AB  - INTRODUCTION/AIMS: Chronic inflammatory demyelinating polyradiculoneuropathy 
      (CIDP) is characterized by progressive weakness and sensory loss, often affecting 
      patient's ability to walk and perform activities of daily living independently. 
      Furthermore, patients often report fatigue and depression which can affect their 
      quality of life. These symptoms were assessed in CIDP patients receiving 
      long-term intravenous immunoglobulin (IVIG) treatment. METHODS: GAMEDIS was a 
      multi-center, prospective, non-interventional study in adult CIDP patients 
      treated with IVIG (10%) and followed for two years. Inflammatory Neuropathy Cause 
      and Treatment (INCAT) disability score, Hughes Disability Scale (HDS), Fatigue 
      Severity Scale (FSS), Beck Depression Inventory II (BDI), Short Form-36 health 
      survey (SF-36) and Work Productivity and Activity Impairment Score Attributable 
      to General Health (WPAI-GH) were assessed at baseline and quarterly. Dosing and 
      treatment intervals, changes in outcome parameters, and adverse events (AEs) were 
      analyzed. RESULTS: 148 evaluable patients were followed for a mean of 83.3 weeks. 
      The mean maintenance IVIG dose was 0.9 g/kg/cycle (mean cycle interval 38 days). 
      Disability and fatigue remained stable throughout the study. Mean INCAT score: 
      2.4 +/- 1.8 at baseline and 2.5 +/- 1.9 at study end. HDS: 74.3% healthy/minor 
      symptoms at baseline and 71.6% at study end. Mean FSS: 4.2 +/- 1.6 at baseline and 
      4.1 +/- 1.7 at study end. All patients reported minimal/no depression at baseline 
      and throughout. SF-36 and WPAI-GH scores remained stable. Fifteen patients (9.5%) 
      experienced potentially treatment-related AEs. There were no AEs in 99.3% of 
      infusions. DISCUSSION: Long-term treatment of CIDP patients with IVIG 10% in 
      real-world conditions maintained clinical stability on fatigue and depression 
      over 96 weeks. This treatment was well-tolerated and safe.
CI  - (c) 2023. The Author(s).
FAU - Klehmet, Juliane
AU  - Klehmet J
AD  - Charite - Universitatsmedizin Berlin, Neurocure Clinical Research Center Berlin, 
      Chariteplatz 1, 10117, Berlin, Germany.
AD  - Judisches Krankenhaus Berlin, Heinz-Galinski-Strasse 1, 13347, Berlin-Mitte, 
      Germany.
FAU - Tackenberg, Bjorn
AU  - Tackenberg B
AD  - Klinik Und Poliklinik Fur Neurologie, Baldingerstrasse 1, 35043, Marburg, 
      Germany.
FAU - Haas, Judith
AU  - Haas J
AD  - Judisches Krankenhaus Berlin, Heinz-Galinski-Strasse 1, 13347, Berlin-Mitte, 
      Germany.
FAU - Kieseier, Bernd C
AU  - Kieseier BC
AD  - Klinik Fur Neurologie, Heinrich-Heine Universitat, Moorenstrasse 5, 40225, 
      Dusseldorf, Germany. bernd.kieseier@uni-duesseldorf.de.
LA  - eng
PT  - Journal Article
DEP - 20230526
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Immunoglobulins, Intravenous/adverse effects
MH  - *Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/diagnosis
MH  - Quality of Life
MH  - Activities of Daily Living
MH  - Prospective Studies
MH  - Fatigue/diagnosis
MH  - Treatment Outcome
PMC - PMC10214666
OTO - NOTNLM
OT  - CIDP
OT  - IVIG
OT  - Patient-reported outcome measures
OT  - Quality of life
OT  - Real-world evidence
COIS- JK has received personal compensation for activities associated with Grifols, CSL 
      Behring and Octapharma, and has received research support from Grifols and 
      Octapharma. BT has received personal compensation for lecturing, consulting 
      services and travel expenses from Bayer Healthcare, Biogen-idec, CSL Behring, 
      Grifols, Merck Serono, Novartis, Octapharma, Roche, Sanofi Genzyme, TEVA and UCB 
      Pharma. There have been different research cooperation's with Biogen-idec, 
      Novartis, TEVA, Bayer Healthcare, CSL-Behring, Grifols, Octapharma, Sanofi 
      Genzyme and UCB Pharma. JH declares no conflict of interest. BCK has received 
      honoraria for lecturing, travel expenses for attending meetings, and financial 
      support for research from Bayer Health Care, Biogen, Genzyme/Sanofi Aventis, 
      Grifols, Merck Serono, Mitsubishi Europe, Novartis, Roche, Talecris, and TEVA. He 
      is currently also employee of Biogen.
EDAT- 2023/05/27 09:42
MHDA- 2023/05/29 06:41
PMCR- 2023/05/26
CRDT- 2023/05/26 23:32
PHST- 2022/09/20 00:00 [received]
PHST- 2023/04/22 00:00 [accepted]
PHST- 2023/05/29 06:41 [medline]
PHST- 2023/05/27 09:42 [pubmed]
PHST- 2023/05/26 23:32 [entrez]
PHST- 2023/05/26 00:00 [pmc-release]
AID - 10.1186/s12883-023-03223-5 [pii]
AID - 3223 [pii]
AID - 10.1186/s12883-023-03223-5 [doi]
PST - epublish
SO  - BMC Neurol. 2023 May 26;23(1):207. doi: 10.1186/s12883-023-03223-5.