PMID- 30903535
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2193-8253 (Print)
IS  - 2193-6536 (Electronic)
IS  - 2193-6536 (Linking)
VI  - 8
IP  - 1
DP  - 2019 Jun
TI  - Efficacy and Safety of Octagam(R) in Patients With Chronic Inflammatory 
      Demyelinating Polyneuropathy.
PG  - 69-78
LID - 10.1007/s40120-019-0132-5 [doi]
AB  - INTRODUCTION: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is 
      a debilitating autoimmune neuropathy that is treated with intravenous 
      immunoglobulin (IVIG). The aim of this retrospective study was to investigate the 
      efficacy and safety of the sucrose-free IVIG Octagam(R) (Octapharma AG, Lachen, 
      Switzerland) in patients with CIDP. METHODS: Data from 47 patients who received 
      at least one dose of Octagam were collected from the records of 11 centres in 
      France. Efficacy was assessed using Overall Neuropathy Limitation Scale (ONLS). 
      Safety was evaluated using adverse event rates. RESULTS: Data from 24 patients 
      who were IVIG naive (n = 11) or had stopped IVIG >/= 12 weeks before   initiation 
      of Octagam therapy (washout group; n  = 13) were included in the efficacy 
      analysis. At 4 months post-initiation of Octagam treatment, 41.7% of patients had 
      improved their functional status (decrease of >/= 1 ONLS score) with a significant 
      change   in the ONLS score from baseline (- 0.42; p = 0.04; signed test). 
      Functional status was reduced in only two patients: one patient in the IVIG-naive 
      group and one patient in the IVIG-washout group. All 47 patients were included in 
      the safety analysis, which showed that Octagam was well tolerated, with a 
      frequency of 0.04 adverse events per Octagam course. The most common adverse drug 
      reaction was headache. CONCLUSIONS: These real-life results are consistent with 
      the efficacy and safety of IVIG reported in randomised controlled studies. A 
      long-term prospective study of Octagam in patients with CIDP is warranted. 
      FUNDING: Octapharma, France SAS.
FAU - Belmokhtar, Chafke
AU  - Belmokhtar C
AD  - Octapharma SAS, 62 bis Avenue Andre Morizet, Boulogne-Billancourt, 92100, Paris, 
      France. chafke.belmokhtar@octapharma.com.
FAU - Lozeron, Pierre
AU  - Lozeron P
AD  - Lariboisiere University Hospital, 2 Rue Ambroise Pare, 75010, Paris, France.
FAU - Adams, David
AU  - Adams D
AD  - INSERM UMR115 and Kremlin Bicetre University Hospital, Assistance 
      Publique-Hopitaux de Paris (APHP), 78 Rue du General Leclerc, 94270, Le 
      Kremlin-Bicetre, France.
FAU - Franques, Jerome
AU  - Franques J
AD  - La Timone University Hospital,, Assistance Publique-Hopitaux de Marseilles 
      (APHM), 264 rue Saint Pierre, 13005, Marseille, France.
FAU - Lacour, Arnaud
AU  - Lacour A
AD  - Lille University Hospital, Avenue Oscar Lambret, 59000, Lille, France.
FAU - Godet, Etienne
AU  - Godet E
AD  - Bon-Secours Hospital, 1 Place Philippe de Vigneulles, 57000, Metz, France.
FAU - Bataille, Mathieu
AU  - Bataille M
AD  - Caen University Hospital, Avenue de La Cote de Nacre, 14003, Caen, France.
FAU - Dubourg, Odile
AU  - Dubourg O
AD  - Pitie-Salpetriere University Hospital, 47-83 Boulevard de l'Hopital, 75013, 
      Paris, France.
FAU - Angibaud, Gilles
AU  - Angibaud G
AD  - Pont de Chaume Clinic, 330 Avenue Marcel Unal, 82000, Montauban, France.
FAU - Delmont, Emilien
AU  - Delmont E
AD  - Nice University Hospital, 4 Avenue Reine Victoria, 06003, Nice Cedex 1, France.
FAU - Bouhour, Francoise
AU  - Bouhour F
AD  - Pierre Wertheimer Hospital, 59 Boulevard Pinel, 69677, Lyon-Bron, France.
FAU - Corcia, Philippe
AU  - Corcia P
AD  - Tours University Hospital, 2 Boulevard Tonnelle, 37000, Tours, France.
FAU - Pouget, Jean
AU  - Pouget J
AD  - La Timone University Hospital,, Assistance Publique-Hopitaux de Marseilles 
      (APHM), 264 rue Saint Pierre, 13005, Marseille, France.
LA  - eng
PT  - Journal Article
DEP - 20190322
PL  - New Zealand
TA  - Neurol Ther
JT  - Neurology and therapy
JID - 101637818
PMC - PMC6534624
OTO - NOTNLM
OT  - Chronic inflammatory demyelinating polyneuropathy
OT  - Immunoglobulins
OT  - Immunotherapy
OT  - Octagam(R)
OT  - Peripheral nervous system disease
EDAT- 2019/03/25 06:00
MHDA- 2019/03/25 06:01
PMCR- 2019/03/22
CRDT- 2019/03/24 06:00
PHST- 2019/01/10 00:00 [received]
PHST- 2019/03/25 06:00 [pubmed]
PHST- 2019/03/25 06:01 [medline]
PHST- 2019/03/24 06:00 [entrez]
PHST- 2019/03/22 00:00 [pmc-release]
AID - 10.1007/s40120-019-0132-5 [pii]
AID - 132 [pii]
AID - 10.1007/s40120-019-0132-5 [doi]
PST - ppublish
SO  - Neurol Ther. 2019 Jun;8(1):69-78. doi: 10.1007/s40120-019-0132-5. Epub 2019 Mar 
      22.