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

A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy

JY. Choe, N. Prodanovic, J. Niebrzydowski, I. Staykov, E. Dokoupilova, A. Baranauskaite, R. Yatsyshyn, M. Mekic, W. Porawska, H. Ciferska, K. Jedrychowicz-Rosiak, A. Zielinska, J. Choi, YH. Rho, JS. Smolen,

. 2017 ; 76 (1) : 58-64. [pub] 20150828

Language English Country England, Great Britain

Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc17024232

OBJECTIVES: To compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. METHODS: This is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients with moderate to severe RA despite methotrexate therapy were randomised in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. Inclusion of the 95% CI of the ACR20 response difference within a ±15% margin was required for equivalence. RESULTS: 584 subjects were randomised into SB2 (N=291; 290 analysed) or INF (N=293). The ACR20 response at week 30 in the per-protocol set was 64.1% in SB2 versus 66.0% in INF. The adjusted rate difference was -1.88% (95% CI -10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF. The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF. Efficacy, safety and PK by ADA subgroup were comparable between SB2 and INF. CONCLUSIONS: SB2 was equivalent to INF in terms of ACR20 response at week 30. SB2 was well tolerated with a comparable safety profile, immunogenicity and PK to INF. TRIAL REGISTRATION NUMBER: NCT01936181.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17024232
003      
CZ-PrNML
005      
20170720123702.0
007      
ta
008      
170720s2017 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/annrheumdis-2015-207764 $2 doi
035    __
$a (PubMed)26318384
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Choe, Jung-Yoon $u Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.
245    12
$a A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy / $c JY. Choe, N. Prodanovic, J. Niebrzydowski, I. Staykov, E. Dokoupilova, A. Baranauskaite, R. Yatsyshyn, M. Mekic, W. Porawska, H. Ciferska, K. Jedrychowicz-Rosiak, A. Zielinska, J. Choi, YH. Rho, JS. Smolen,
520    9_
$a OBJECTIVES: To compare the efficacy, safety, immunogenicity and pharmacokinetics (PK) of SB2 to the infliximab reference product (INF) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy. METHODS: This is a phase III, randomised, double-blind, multinational, multicentre parallel group study. Patients with moderate to severe RA despite methotrexate therapy were randomised in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. Inclusion of the 95% CI of the ACR20 response difference within a ±15% margin was required for equivalence. RESULTS: 584 subjects were randomised into SB2 (N=291; 290 analysed) or INF (N=293). The ACR20 response at week 30 in the per-protocol set was 64.1% in SB2 versus 66.0% in INF. The adjusted rate difference was -1.88% (95% CI -10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF. The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF. Efficacy, safety and PK by ADA subgroup were comparable between SB2 and INF. CONCLUSIONS: SB2 was equivalent to INF in terms of ACR20 response at week 30. SB2 was well tolerated with a comparable safety profile, immunogenicity and PK to INF. TRIAL REGISTRATION NUMBER: NCT01936181.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a protilátky $x krev $7 D000906
650    _2
$a antirevmatika $x škodlivé účinky $x farmakokinetika $x terapeutické užití $7 D018501
650    _2
$a revmatoidní artritida $x farmakoterapie $7 D001172
650    _2
$a biosimilární léčivé přípravky $x škodlivé účinky $x farmakokinetika $x terapeutické užití $7 D059451
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a infliximab $x škodlivé účinky $x imunologie $x farmakokinetika $x terapeutické užití $7 D000069285
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a methotrexát $x terapeutické užití $7 D008727
650    _2
$a lidé středního věku $7 D008875
650    _2
$a stupeň závažnosti nemoci $7 D012720
650    _2
$a terapeutická ekvivalence $7 D013810
650    _2
$a výsledek terapie $7 D016896
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Prodanovic, Nenad $u Clinical Center Banja Luka, Banja Luka, Bosnia and Herzegovina.
700    1_
$a Niebrzydowski, Jaroslaw $u Medica Pro Familia, Gdynia, Poland.
700    1_
$a Staykov, Ivan $u MHAT "Dr. Ivan Seliminski", AD, Sliven, Bulgaria.
700    1_
$a Dokoupilova, Eva $u MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic.
700    1_
$a Baranauskaite, Asta $u Lithuanian University of Health Sciences, Kaunas, Lithuania.
700    1_
$a Yatsyshyn, Roman $u Internal Medicine #1 Department, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.
700    1_
$a Mekic, Mevludin $u University Clinic Centre Sarajevo, Sarajevo, Bosnia and Herzegovina.
700    1_
$a Porawska, Wieskawa $u Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland.
700    1_
$a Ciferska, Hana $u Institute of Rheumatology and First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
700    1_
$a Jedrychowicz-Rosiak, Krystyna $u MCBK S.C., Grodzisk Mazowiecki, Poland.
700    1_
$a Zielinska, Agnieszka $u Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland.
700    1_
$a Choi, Jasmine $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.
700    1_
$a Rho, Young Hee $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.
700    1_
$a Smolen, Josef S $u Medical University of Vienna, Vienna, Austria.
773    0_
$w MED00000444 $t Annals of the rheumatic diseases $x 1468-2060 $g Roč. 76, č. 1 (2017), s. 58-64
856    41
$u https://pubmed.ncbi.nlm.nih.gov/26318384 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20170720 $b ABA008
991    __
$a 20170720124155 $b ABA008
999    __
$a ok $b bmc $g 1239913 $s 985145
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 76 $c 1 $d 58-64 $e 20150828 $i 1468-2060 $m Annals of the rheumatic diseases $n Ann Rheum Dis $x MED00000444
LZP    __
$a Pubmed-20170720
Back

Find record

Citation metrics

Archiving options