Detail
Article
Online article
FT
Medvik - BMC
  • Something wrong with this record ?

Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial

V. Bril, RDM. Hadden, TH. Brannagan, M. Bar, E. Chroni, K. Rejdak, A. Rivero, H. Andersen, N. Latov, T. Levine, M. Pasnoor, S. Sacconi, N. Souayah, C. Anderson-Smits, K. Duff, E. Greco, S. Hasan, Z. Li, L. Yel, H. Ay

. 2023 ; 28 (3) : 436-449. [pub] 20230706

Language English Country United States

Document type Randomized Controlled Trial, Case Reports, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc23016414

BACKGROUND AND AIMS: ADVANCE-CIDP 1 evaluated facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) efficacy and safety in preventing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse. METHODS: ADVANCE-CIDP 1 was a phase 3, double-blind, placebo-controlled trial conducted at 54 sites in 21 countries. Eligible adults had definite or probable CIDP and adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores of 0-7 (inclusive), and received stable intravenous immunoglobulin (IVIG) for ≥12 weeks before screening. After stopping IVIG, patients were randomized 1:1 to fSCIG 10% or placebo for 6 months or until relapse/discontinuation. fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population. Secondary outcomes included time to relapse and safety endpoints. RESULTS: Overall, 132 patients (mean age 54.4 years, 56.1% male) received fSCIG 10% (n = 62) or placebo (n = 70). CIDP relapse was reduced with fSCIG 10% versus placebo (n = 6 [9.7%; 95% confidence interval 4.5%, 19.6%] vs n = 22 [31.4%; 21.8%, 43.0%], respectively; absolute difference: -21.8% [-34.5%, -7.9%], p = .0045). Relapse probability was higher with placebo versus fSCIG 10% over time (p = .002). Adverse events (AEs) were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common. INTERPRETATION: fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc23016414
003      
CZ-PrNML
005      
20231026105902.0
007      
ta
008      
231013s2023 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1111/jns.12573 $2 doi
035    __
$a (PubMed)37314318
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Bril, Vera $u The Ellen & Martin Prosserman Centre for Neuromuscular Diseases, University Health Network, University of Toronto, Toronto, Ontario, Canada $1 https://orcid.org/0000000258054883
245    10
$a Hyaluronidase-facilitated subcutaneous immunoglobulin 10% as maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP 1 randomized controlled trial / $c V. Bril, RDM. Hadden, TH. Brannagan, M. Bar, E. Chroni, K. Rejdak, A. Rivero, H. Andersen, N. Latov, T. Levine, M. Pasnoor, S. Sacconi, N. Souayah, C. Anderson-Smits, K. Duff, E. Greco, S. Hasan, Z. Li, L. Yel, H. Ay
520    9_
$a BACKGROUND AND AIMS: ADVANCE-CIDP 1 evaluated facilitated subcutaneous immunoglobulin (fSCIG; human immunoglobulin G 10% with recombinant human hyaluronidase) efficacy and safety in preventing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse. METHODS: ADVANCE-CIDP 1 was a phase 3, double-blind, placebo-controlled trial conducted at 54 sites in 21 countries. Eligible adults had definite or probable CIDP and adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores of 0-7 (inclusive), and received stable intravenous immunoglobulin (IVIG) for ≥12 weeks before screening. After stopping IVIG, patients were randomized 1:1 to fSCIG 10% or placebo for 6 months or until relapse/discontinuation. fSCIG 10% was administered at the same dose (or matching placebo volume) and interval as pre-randomization IVIG. The primary outcome was patient proportion experiencing CIDP relapse (≥1-point increase in adjusted INCAT score from pre-subcutaneous treatment baseline) in the modified intention-to-treat population. Secondary outcomes included time to relapse and safety endpoints. RESULTS: Overall, 132 patients (mean age 54.4 years, 56.1% male) received fSCIG 10% (n = 62) or placebo (n = 70). CIDP relapse was reduced with fSCIG 10% versus placebo (n = 6 [9.7%; 95% confidence interval 4.5%, 19.6%] vs n = 22 [31.4%; 21.8%, 43.0%], respectively; absolute difference: -21.8% [-34.5%, -7.9%], p = .0045). Relapse probability was higher with placebo versus fSCIG 10% over time (p = .002). Adverse events (AEs) were more frequent with fSCIG 10% (79.0% of patients) than placebo (57.1%), but severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common. INTERPRETATION: fSCIG 10% more effectively prevented CIDP relapse than placebo, supporting its potential use as maintenance CIDP treatment.
650    _2
$a dospělí $7 D000328
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a ženské pohlaví $7 D005260
650    12
$a chronická zánětlivá demyelinizační polyneuropatie $x farmakoterapie $7 D020277
650    _2
$a intravenózní imunoglobuliny $x terapeutické užití $7 D016756
650    _2
$a hyaluronoglukosaminidasa $x terapeutické užití $7 D006821
650    _2
$a výsledek terapie $7 D016896
650    _2
$a lokální recidiva nádoru $x chemicky indukované $x farmakoterapie $7 D009364
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a kazuistiky $7 D002363
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Hadden, Robert D M $u King's College Hospital, London, UK $1 https://orcid.org/0000000297020256
700    1_
$a Brannagan, Thomas H $u Neurological Institute, Columbia University, New York City, New York, USA $1 https://orcid.org/0000000218128331
700    1_
$a Bar, Michal $u University Hospital and Faculty of Medicine, Ostrava, Czechia
700    1_
$a Chroni, Elisabeth $u University of Patras, Rion, Greece
700    1_
$a Rejdak, Konrad $u Department of Neurology, Medical University of Lublin, Lublin, Poland
700    1_
$a Rivero, Alberto $u Institute for Neurological Research (FLENI), Buenos Aires, Argentina
700    1_
$a Andersen, Henning $u Aarhus University, Aarhus, Denmark
700    1_
$a Latov, Norman $u Weill Cornell Medicine, New York City, New York, USA
700    1_
$a Levine, Todd $u CND Life Sciences, Phoenix, Arizona, USA
700    1_
$a Pasnoor, Mamatha $u The University of Kansas Medical Center, Kansas City, Kansas, USA
700    1_
$a Sacconi, Sabrina $u University Hospital of Nice, Nice, France
700    1_
$a Souayah, Nizar $u Rutgers New Jersey Medical School, Newark, New Jersey, USA $1 https://orcid.org/0000000338733448
700    1_
$a Anderson-Smits, Colin $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
700    1_
$a Duff, Kim $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
700    1_
$a Greco, Erin $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
700    1_
$a Hasan, Shabbir $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
700    1_
$a Li, Zhaoyang $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
700    1_
$a Yel, Leman $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
700    1_
$a Ay, Hakan $u Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA
773    0_
$w MED00007709 $t Journal of the peripheral nervous system : JPNS $x 1529-8027 $g Roč. 28, č. 3 (2023), s. 436-449
856    41
$u https://pubmed.ncbi.nlm.nih.gov/37314318 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20231013 $b ABA008
991    __
$a 20231026105856 $b ABA008
999    __
$a ok $b bmc $g 2000121 $s 1202776
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2023 $b 28 $c 3 $d 436-449 $e 20230706 $i 1529-8027 $m Journal of the peripheral nervous system $n J Peripher Nerv Syst $x MED00007709
LZP    __
$a Pubmed-20231013
Back

Find record

Citation metrics

Archiving options