Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis

MC. Genovese, J. Sanchez-Burson, M. Oh, E. Balazs, J. Neal, A. Everding, T. Hala, R. Wojciechowski, G. Fanjiang, S. Cohen

. 2020 ; 22 (1) : 60. [pub] 20200326

Jazyk angličtina Země Velká Británie

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21012779

BACKGROUND: ABP 710 is being developed as a biosimilar to infliximab reference product (RP). Analytical similarity and pharmacokinetic equivalence between the two have been previously demonstrated. Here we report results from a comparative clinical study that evaluated the efficacy and safety of ABP 710 relative to the RP in patients with rheumatoid arthritis (RA). METHODS: In this multicenter, randomized, double-blind, 50-week equivalence study, patients with moderate to severe active RA despite methotrexate received 3-mg/kg infusions of ABP 710 or RP at predetermined intervals based on initial randomization and then with re-randomization at week 22. The primary endpoint was response difference (RD) of ACR20 at week 22, with clinical equivalence evaluated based on 90% CI of - 15%, 15%. Secondary endpoints included Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP), ACR20, ACR50, and ACR70 across time, as well as safety and immunogenicity assessments. RESULTS: A total of 558 patients were randomized for the initial treatment (ABP 710 n = 279; RP n = 279). The estimated RD of ACR20 at week 22 was 9.37% with 90% CI (2.67%, 15.96%). The lower bound was within the pre-specified criteria, thus confirming non-inferiority; the upper bound exceeded the pre-specified criteria by 0.96% such that superiority could not be ruled out statistically. In a post hoc analysis with adjustment for random imbalance in baseline factors, the CI of RD was narrowed (0.75%, 13.62%). Changes from baseline in DAS28-CRP as well as ACR20, ACR50, and ACR70 response rates across time and hybrid ACR evaluations were similar for the initial and initial/re-randomized treatment groups. Adverse events and incidence of anti-drug antibodies were similar between treatment groups. CONCLUSIONS: These efficacy and safety results support similarity with no clinically meaningful differences between ABP 710 and infliximab RP. Although we were unable to statistically confirm non-superiority, post hoc analysis was supportive of non-superiority. DAS28-CRP, ACR20, ACR50, ACR70, and hybrid ACR evaluations over the entire study were consistently comparable as were safety and immunogenicity. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT02937701. Registered August 30, 2016.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21012779
003      
CZ-PrNML
005      
20210507101609.0
007      
ta
008      
210420s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1186/s13075-020-2142-1 $2 doi
035    __
$a (PubMed)32216829
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Genovese, Mark C $u Division of Immunology and Rheumatology, Stanford University, 1000 Welch RD #203, Palo Alto, CA, USA. genovese@stanford.edu
245    10
$a Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis / $c MC. Genovese, J. Sanchez-Burson, M. Oh, E. Balazs, J. Neal, A. Everding, T. Hala, R. Wojciechowski, G. Fanjiang, S. Cohen
520    9_
$a BACKGROUND: ABP 710 is being developed as a biosimilar to infliximab reference product (RP). Analytical similarity and pharmacokinetic equivalence between the two have been previously demonstrated. Here we report results from a comparative clinical study that evaluated the efficacy and safety of ABP 710 relative to the RP in patients with rheumatoid arthritis (RA). METHODS: In this multicenter, randomized, double-blind, 50-week equivalence study, patients with moderate to severe active RA despite methotrexate received 3-mg/kg infusions of ABP 710 or RP at predetermined intervals based on initial randomization and then with re-randomization at week 22. The primary endpoint was response difference (RD) of ACR20 at week 22, with clinical equivalence evaluated based on 90% CI of - 15%, 15%. Secondary endpoints included Disease Activity Score 28-joint count C-reactive protein (DAS28-CRP), ACR20, ACR50, and ACR70 across time, as well as safety and immunogenicity assessments. RESULTS: A total of 558 patients were randomized for the initial treatment (ABP 710 n = 279; RP n = 279). The estimated RD of ACR20 at week 22 was 9.37% with 90% CI (2.67%, 15.96%). The lower bound was within the pre-specified criteria, thus confirming non-inferiority; the upper bound exceeded the pre-specified criteria by 0.96% such that superiority could not be ruled out statistically. In a post hoc analysis with adjustment for random imbalance in baseline factors, the CI of RD was narrowed (0.75%, 13.62%). Changes from baseline in DAS28-CRP as well as ACR20, ACR50, and ACR70 response rates across time and hybrid ACR evaluations were similar for the initial and initial/re-randomized treatment groups. Adverse events and incidence of anti-drug antibodies were similar between treatment groups. CONCLUSIONS: These efficacy and safety results support similarity with no clinically meaningful differences between ABP 710 and infliximab RP. Although we were unable to statistically confirm non-superiority, post hoc analysis was supportive of non-superiority. DAS28-CRP, ACR20, ACR50, ACR70, and hybrid ACR evaluations over the entire study were consistently comparable as were safety and immunogenicity. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT02937701. Registered August 30, 2016.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a antirevmatika $x farmakokinetika $x terapeutické užití $7 D018501
650    _2
$a revmatoidní artritida $x farmakoterapie $x patologie $7 D001172
650    _2
$a biosimilární léčivé přípravky $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 infliximab $x farmakokinetika $x terapeutické užití $7 D000069285
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a terapeutická ekvivalence $7 D013810
650    _2
$a výsledek terapie $7 D016896
650    _2
$a mladý dospělý $7 D055815
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
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Sanchez-Burson, Juan $u Hospital Infanta Luisa, Calle San Jacinto 87, Sevilla, Spain
700    1_
$a Oh, MyungShin $u Biosimilars, Amgen, One Amgen Center Dr., Thousand Oaks, CA, USA
700    1_
$a Balazs, Eva $u Csongrád Megyei dr. Bugyi István Kórház Mozgásszervi Rehabilitációs, Sima Ferenc u. 44-58, Csongrad, Hungary
700    1_
$a Neal, Jeffrey $u Bluegrass Community Research, 330 Waller Avenue, Lexington, KY, USA
700    1_
$a Everding, Andrea $u Hamburger Rheuma Forschungszentrum II, Hamburg, Germany
700    1_
$a Hala, Tomas $u CCR Czech a.s., Trida miru 2800, 53002, Pardubice, Czech Republic
700    1_
$a Wojciechowski, Rafal $u Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Bydgoszcz, Poland
700    1_
$a Fanjiang, Gary $u Biosimilars, Amgen, One Amgen Center Dr., Thousand Oaks, CA, USA
700    1_
$a Cohen, Stanley $u Metroplex Clinical Research, 8144 Walnut Hill Lane, Dallas, TX, USA
773    0_
$w MED00007534 $t Arthritis research & therapy $x 1478-6362 $g Roč. 22, č. 1 (2020), s. 60
856    41
$u https://pubmed.ncbi.nlm.nih.gov/32216829 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210420 $b ABA008
991    __
$a 20210507101609 $b ABA008
999    __
$a ok $b bmc $g 1651026 $s 1133158
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 22 $c 1 $d 60 $e 20200326 $i 1478-6362 $m Arthritis research & therapy $n Arthritis Res Ther $x MED00007534
LZP    __
$a Pubmed-20210420

Najít záznam

Citační ukazatele

Možnosti archivace