• Something wrong with this record ?

Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis

P. Emery, CH. Suh, ME. Weinblatt, JS. Smolen, EC. Keystone, M. Genovese, J. Vencovsky, J. Kay, E. Hong, Y. Baek, J. Ghil

. 2020 ; 49 (5) : 361-370. [pub] 20200529

Language English Country Great Britain

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc21012231

Objective: SB4, SB2, and SB5 are biosimilars of etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. This pooled analysis evaluated the immunogenicity of these treatments across three phase III randomized controlled trials of patients with rheumatoid arthritis (RA). Methods: Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study). The effect of ADAbs on American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs) were evaluated. Results: The study included 1709 patients. The cumulative incidences of ADAbs were 30.3% in the all-treatments-combined group, 29.1% in the biosimilars combined group, and 31.5% in the reference products combined group. ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups. ADAb-positive patients also had a higher likelihood of developing ISRs/IRRs in the all-treatments-combined group [0.56 (0.31, 1.01), p = 0.0550], predominantly due to the results observed with SB2 + INF combined rather than with SB4 + ETN or SB5 + ADA combined. Conclusion: In this pooled analysis, ADAbs were associated with reduced efficacy in patients with RA treated with biosimilars (SB4, SB2, and SB5) or their reference products (ETN, INF, and ADA). ADAbs were associated with an increased incidence of ISRs/IRRs in those treated with SB2 + INF. Clinical trial registration numbers: NCT01936181 (SB2 study), NCT01895309 (SB4 study), and NCT02167139 (SB5 study).

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21012231
003      
CZ-PrNML
005      
20210507104317.0
007      
ta
008      
210420s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1080/03009742.2020.1732458 $2 doi
035    __
$a (PubMed)32468892
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Emery, P $u Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital , Leeds, UK $u NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust , Leeds, UK
245    10
$a Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis / $c P. Emery, CH. Suh, ME. Weinblatt, JS. Smolen, EC. Keystone, M. Genovese, J. Vencovsky, J. Kay, E. Hong, Y. Baek, J. Ghil
520    9_
$a Objective: SB4, SB2, and SB5 are biosimilars of etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. This pooled analysis evaluated the immunogenicity of these treatments across three phase III randomized controlled trials of patients with rheumatoid arthritis (RA). Methods: Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study). The effect of ADAbs on American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs) were evaluated. Results: The study included 1709 patients. The cumulative incidences of ADAbs were 30.3% in the all-treatments-combined group, 29.1% in the biosimilars combined group, and 31.5% in the reference products combined group. ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups. ADAb-positive patients also had a higher likelihood of developing ISRs/IRRs in the all-treatments-combined group [0.56 (0.31, 1.01), p = 0.0550], predominantly due to the results observed with SB2 + INF combined rather than with SB4 + ETN or SB5 + ADA combined. Conclusion: In this pooled analysis, ADAbs were associated with reduced efficacy in patients with RA treated with biosimilars (SB4, SB2, and SB5) or their reference products (ETN, INF, and ADA). ADAbs were associated with an increased incidence of ISRs/IRRs in those treated with SB2 + INF. Clinical trial registration numbers: NCT01936181 (SB2 study), NCT01895309 (SB4 study), and NCT02167139 (SB5 study).
650    _2
$a adalimumab $x škodlivé účinky $x terapeutické užití $7 D000068879
650    _2
$a dospělí $7 D000328
650    _2
$a protilátky $7 D000906
650    _2
$a antirevmatika $x škodlivé účinky $x terapeutické užití $7 D018501
650    _2
$a revmatoidní artritida $x farmakoterapie $7 D001172
650    _2
$a biosimilární léčivé přípravky $x škodlivé účinky $x terapeutické užití $7 D059451
650    _2
$a etanercept $x škodlivé účinky $x terapeutické užití $7 D000068800
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a infliximab $x škodlivé účinky $x terapeutické užití $7 D000069285
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a výsledek terapie $7 D016896
650    _2
$a inhibitory TNF $x škodlivé účinky $x terapeutické užití $7 D000079424
655    _2
$a časopisecké články $7 D016428
700    1_
$a Suh, C-H $u Department of Rheumatology, Ajou University School of Medicine , Suwon, Republic of Korea
700    1_
$a Weinblatt, M E $u Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital , Boston, MA, USA
700    1_
$a Smolen, J S $u Division of Rheumatology, Department of Medicine, Medical University of Vienna , Vienna, Austria
700    1_
$a Keystone, E C $u Division of Rheumatology, Mount Sinai Hospital, University of Toronto , Toronto, ON, Canada
700    1_
$a Genovese, M $u Division of Immunology and Rheumatology, Stanford University Medical Center, Stanford University School of Medicine , Palo Alto, CA, USA
700    1_
$a Vencovsky, J $u Department of Rheumatology, Institute of Rheumatology , Prague, Czech Republic
700    1_
$a Kay, J $u Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School , Worcester, MA, USA
700    1_
$a Hong, E $u Samsung Bioepis Co. Ltd , Incheon, Republic of Korea
700    1_
$a Baek, Y $u Samsung Bioepis Co. Ltd , Incheon, Republic of Korea
700    1_
$a Ghil, J $u Samsung Bioepis Co. Ltd , Incheon, Republic of Korea
773    0_
$w MED00010604 $t Scandinavian journal of rheumatology $x 1502-7732 $g Roč. 49, č. 5 (2020), s. 361-370
856    41
$u https://pubmed.ncbi.nlm.nih.gov/32468892 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210420 $b ABA008
991    __
$a 20210507104316 $b ABA008
999    __
$a ok $b bmc $g 1650575 $s 1132610
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 49 $c 5 $d 361-370 $e 20200529 $i 1502-7732 $m Scandinavian journal of rheumatology $n Scand J Rheumatol $x MED00010604
LZP    __
$a Pubmed-20210420
Back

Find record

Citation metrics

Archiving options