• Something wrong with this record ?

A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy

P. Emery, J. Vencovský, A. Sylwestrzak, P. Leszczyński, W. Porawska, A. Baranauskaite, V. Tseluyko, VM. Zhdan, B. Stasiuk, R. Milasiene, AA. Barrera Rodriguez, SY. Cheong, J. Ghil,

. 2017 ; 76 (1) : 51-57. [pub] 20150706

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/bmc17024243

OBJECTIVES: To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. RESULTS: 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). CONCLUSIONS: SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. TRIAL REGISTRATION NUMBERS: NCT01895309, EudraCT 2012-005026-30.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17024243
003      
CZ-PrNML
005      
20170720123705.0
007      
ta
008      
170720s2017 enk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/annrheumdis-2015-207588 $2 doi
035    __
$a (PubMed)26150601
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a enk
100    1_
$a Emery, Paul $u Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK. NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
245    12
$a A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy / $c P. Emery, J. Vencovský, A. Sylwestrzak, P. Leszczyński, W. Porawska, A. Baranauskaite, V. Tseluyko, VM. Zhdan, B. Stasiuk, R. Milasiene, AA. Barrera Rodriguez, SY. Cheong, J. Ghil,
520    9_
$a OBJECTIVES: To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. METHODS: This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured. RESULTS: 596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%). CONCLUSIONS: SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN. TRIAL REGISTRATION NUMBERS: NCT01895309, EudraCT 2012-005026-30.
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 imunologie $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 etanercept $x škodlivé účinky $x imunologie $x farmakokinetika $x terapeutické užití $7 D000068800
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
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 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 Vencovský, Jiří $u Institute of Rheumatology, Prague, Czech Republic.
700    1_
$a Sylwestrzak, Anna $u NZOZ Medica Pro Familia Sp. z o.o., Warsaw, Poland.
700    1_
$a Leszczyński, Piotr $u Poznan University of Medical Sciences, Poznan, Poland.
700    1_
$a Porawska, Wieslawa $u Poznanski Osrodek Medyczny NOVAMED, Pultusk, Poland.
700    1_
$a Baranauskaite, Asta $u Lithuanian University of Health Sciences, Kaunas, Lithuania.
700    1_
$a Tseluyko, Vira $u Kharkiv Medical Academy of Postgraduate Education, Kharkiv, Ukraine.
700    1_
$a Zhdan, Vyacheslav M $u M.V.Sklifosovskyi Poltava Regional Clinical Hospital, Poltava, Ukraine.
700    1_
$a Stasiuk, Barbara $u Medicome Sp. z o.o., Oswiecim, Poland.
700    1_
$a Milasiene, Roma $u Klaipeda University Hospital, Klaipeda, Lithuania.
700    1_
$a Barrera Rodriguez, Aaron Alejandro $u Unidad de Atención Medica e Investigación en Salud (UNAMIS), Yucatán, México.
700    1_
$a Cheong, Soo Yeon $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.
700    1_
$a Ghil, Jeehoon $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea.
773    0_
$w MED00000444 $t Annals of the rheumatic diseases $x 1468-2060 $g Roč. 76, č. 1 (2017), s. 51-57
856    41
$u https://pubmed.ncbi.nlm.nih.gov/26150601 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20170720 $b ABA008
991    __
$a 20170720124158 $b ABA008
999    __
$a ok $b bmc $g 1239924 $s 985156
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 76 $c 1 $d 51-57 $e 20150706 $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