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

Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study

S. Cohen, MC. Genovese, E. Choy, F. Perez-Ruiz, A. Matsumoto, K. Pavelka, JL. Pablos, W. Rizzo, P. Hrycaj, N. Zhang, W. Shergy, P. Kaur,

. 2017 ; 76 (10) : 1679-1687. [pub] 20170605

Language English Country Great Britain

Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc18016564

OBJECTIVES: ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS: In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. RESULTS: A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. CONCLUSIONS: Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. TRIAL REGISTRATION NUMBER: NCT01970475; Results.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc18016564
003      
CZ-PrNML
005      
20180515103657.0
007      
ta
008      
180515s2017 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1136/annrheumdis-2016-210459 $2 doi
035    __
$a (PubMed)28584187
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Cohen, Stanley $u Metroplex Clinical Research Center, Dallas, Texas, USA.
245    10
$a Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study / $c S. Cohen, MC. Genovese, E. Choy, F. Perez-Ruiz, A. Matsumoto, K. Pavelka, JL. Pablos, W. Rizzo, P. Hrycaj, N. Zhang, W. Shergy, P. Kaur,
520    9_
$a OBJECTIVES: ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS: In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. RESULTS: A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. CONCLUSIONS: Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. TRIAL REGISTRATION NUMBER: NCT01970475; Results.
650    _2
$a adalimumab $x škodlivé účinky $x terapeutické užití $7 D000068879
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
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 krev $x farmakoterapie $7 D001172
650    _2
$a biosimilární léčivé přípravky $x škodlivé účinky $x farmakokinetika $x terapeutické užití $7 D059451
650    _2
$a C-reaktivní protein $x metabolismus $7 D002097
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
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 mladý dospělý $7 D055815
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Genovese, Mark C $u Stanford University School of Medicine, Palo Alto, California, USA.
700    1_
$a Choy, Ernest $u CREATE Centre, Section of Rheumatology, Institute of Infection and Immunity, Cardiff University, Cardiff, UK.
700    1_
$a Perez-Ruiz, Fernando $u Rheumatology Division, Cruces University Hospital, OSI EE-Cruces and Biocruces Health Research Institute, Vizcaya, Spain.
700    1_
$a Matsumoto, Alan $u Arthritis and Rheumatism Associates, Wheaton, Maryland, USA.
700    1_
$a Pavelka, Karel $u Na Slupi 4 Praha 2, Praha, Czech Republic.
700    1_
$a Pablos, Jose L $u Instituto de Investigación Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain.
700    1_
$a Rizzo, Warren $u Advanced Arthritis Care & Research, Scottsdale, Arizona, USA.
700    1_
$a Hrycaj, Pawel $u Department of Rheumatology and Clinical Immunology, Poznań University of Medical Sciences, Poznań, Poland.
700    1_
$a Zhang, Nan $u Amgen Inc., Thousand Oaks, California, USA.
700    1_
$a Shergy, William $u RANA Clinical Research Center, Huntsville, Alabama, USA.
700    1_
$a Kaur, Primal $u Amgen Inc., Thousand Oaks, California, USA.
773    0_
$w MED00000444 $t Annals of the rheumatic diseases $x 1468-2060 $g Roč. 76, č. 10 (2017), s. 1679-1687
856    41
$u https://pubmed.ncbi.nlm.nih.gov/28584187 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20180515 $b ABA008
991    __
$a 20180515103831 $b ABA008
999    __
$a ok $b bmc $g 1300188 $s 1013404
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2017 $b 76 $c 10 $d 1679-1687 $e 20170605 $i 1468-2060 $m Annals of the rheumatic diseases $n Ann Rheum Dis $x MED00000444
LZP    __
$a Pubmed-20180515

Find record

Citation metrics

Archiving options