• Something wrong with this record ?

Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two-Week Phase III Randomized Study Results

ME. Weinblatt, A. Baranauskaite, E. Dokoupilova, A. Zielinska, J. Jaworski, A. Racewicz, M. Pileckyte, K. Jedrychowicz-Rosiak, I. Baek, J. Ghil,

. 2018 ; 70 (6) : 832-840. [pub] 20180424

Language English Country United States

Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19035399

OBJECTIVE: The 24-week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate-to-severe rheumatoid arthritis (RA) have been reported previously. We undertook this transition study to evaluate patients who switched from ADA to SB5 or who continued to receive SB5 or ADA up to 52 weeks. METHODS: In this phase III study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every other week). At 24 weeks, patients receiving ADA were rerandomized 1:1 to continue with ADA (ADA/ADA group) or to switch to SB5 (ADA/SB5 group) up to week 52; patients receiving SB5 continued with SB5 for 52 weeks (SB5 group). Efficacy, safety, and immunogenicity were evaluated up to 52 weeks. RESULTS: The full analysis set population consisted of 542 patients (269 in the SB5 group, 273 in the ADA overall group [patients who were randomized to receive ADA at week 0], 125 in the ADA/SB5 group, and 129 in the ADA/ADA group). The percentages of patients meeting the American College of Rheumatology 20%, 50%, or 70% improvement criteria (achieving an ACR20, ACR50, or ACR70 response) at week 24 were maintained after the transition from ADA to SB5, and these response rates were comparable across treatment groups throughout the study. ACR20 response rates ranged from 73.4% to 78.8% at week 52. Radiographic progression was minimal and comparable across treatment groups. The safety profile and the incidence of antidrug antibodies were comparable across treatment groups after transition. CONCLUSION: SB5 was well tolerated over 1 year in patients with RA, with efficacy, safety, and immunogenicity comparable to those of ADA. Switching from ADA to SB5 had no treatment-emergent issues such as increased adverse events, increased immunogenicity, or loss of efficacy.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc19035399
003      
CZ-PrNML
005      
20191010104646.0
007      
ta
008      
191007s2018 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1002/art.40444 $2 doi
035    __
$a (PubMed)29439289
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Weinblatt, Michael E $u Brigham and Women's Hospital, Boston, Massachusetts.
245    10
$a Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two-Week Phase III Randomized Study Results / $c ME. Weinblatt, A. Baranauskaite, E. Dokoupilova, A. Zielinska, J. Jaworski, A. Racewicz, M. Pileckyte, K. Jedrychowicz-Rosiak, I. Baek, J. Ghil,
520    9_
$a OBJECTIVE: The 24-week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate-to-severe rheumatoid arthritis (RA) have been reported previously. We undertook this transition study to evaluate patients who switched from ADA to SB5 or who continued to receive SB5 or ADA up to 52 weeks. METHODS: In this phase III study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every other week). At 24 weeks, patients receiving ADA were rerandomized 1:1 to continue with ADA (ADA/ADA group) or to switch to SB5 (ADA/SB5 group) up to week 52; patients receiving SB5 continued with SB5 for 52 weeks (SB5 group). Efficacy, safety, and immunogenicity were evaluated up to 52 weeks. RESULTS: The full analysis set population consisted of 542 patients (269 in the SB5 group, 273 in the ADA overall group [patients who were randomized to receive ADA at week 0], 125 in the ADA/SB5 group, and 129 in the ADA/ADA group). The percentages of patients meeting the American College of Rheumatology 20%, 50%, or 70% improvement criteria (achieving an ACR20, ACR50, or ACR70 response) at week 24 were maintained after the transition from ADA to SB5, and these response rates were comparable across treatment groups throughout the study. ACR20 response rates ranged from 73.4% to 78.8% at week 52. Radiographic progression was minimal and comparable across treatment groups. The safety profile and the incidence of antidrug antibodies were comparable across treatment groups after transition. CONCLUSION: SB5 was well tolerated over 1 year in patients with RA, with efficacy, safety, and immunogenicity comparable to those of ADA. Switching from ADA to SB5 had no treatment-emergent issues such as increased adverse events, increased immunogenicity, or loss of efficacy.
650    _2
$a adalimumab $x aplikace a dávkování $7 D000068879
650    _2
$a dospělí $7 D000328
650    _2
$a antirevmatika $x aplikace a dávkování $7 D018501
650    _2
$a revmatoidní artritida $x farmakoterapie $7 D001172
650    _2
$a biosimilární léčivé přípravky $x aplikace a dávkování $7 D059451
650    _2
$a dvojitá slepá metoda $7 D004311
650    12
$a náhrada léků $7 D057915
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 časové faktory $7 D013997
650    _2
$a výsledek terapie $7 D016896
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Baranauskaite, Asta $u Lithuanian University of Health Sciences, Kaunas, Lithuania.
700    1_
$a Dokoupilova, Eva $u Medical Plus, Uherske Hradiste, Czech Republic, and University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic.
700    1_
$a Zielinska, Agnieszka $u Medica Pro Familia, Warsaw, Poland.
700    1_
$a Jaworski, Janusz $u Reumatika-Centrum Reumatologii, Warsaw, Poland.
700    1_
$a Racewicz, Artur $u Zdrowie Osteo-Medic, Białystok, Poland.
700    1_
$a Pileckyte, Margarita $u Lithuanian University of Health Sciences, Kaunas, Lithuania.
700    1_
$a Jedrychowicz-Rosiak, Krystyna $u Mazowieckie Centrum Badań Klinicznych, Grodzisk Mazowiecki, Poland.
700    1_
$a Baek, Inyoung $u Samsung Bioepis, Incheon, Republic of Korea.
700    1_
$a Ghil, Jeehoon $u Samsung Bioepis, Incheon, Republic of Korea.
773    0_
$w MED00188151 $t Arthritis & rheumatology (Hoboken, N.J.) $x 2326-5205 $g Roč. 70, č. 6 (2018), s. 832-840
856    41
$u https://pubmed.ncbi.nlm.nih.gov/29439289 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20191007 $b ABA008
991    __
$a 20191010105104 $b ABA008
999    __
$a ok $b bmc $g 1452059 $s 1073949
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2018 $b 70 $c 6 $d 832-840 $e 20180424 $i 2326-5205 $m Arthritis & rheumatology $n Arthritis Rheumatol $x MED00188151
LZP    __
$a Pubmed-20191007

Find record

Citation metrics

Archiving options