PMID- 33317345
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20211125
IS  - 1744-7682 (Electronic)
IS  - 1471-2598 (Linking)
VI  - 21
IP  - 1
DP  - 2021 Jan
TI  - Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and 
      adalimumab reference product in patients with moderate-to-severe chronic plaque 
      psoriasis: results from the randomized Phase III VOLTAIRE-PSO study.
PG  - 87-96
LID - 10.1080/14712598.2021.1851362 [doi]
AB  - Background: BI 695501 is an approved biosimilar to Humira(R) reference product 
      (RP). Research design and methods: In this randomized Phase III trial 
      (VOLTAIRE-PSO), patients with moderate-to-severe chronic plaque psoriasis 
      received BI 695501 or adalimumab RP (24-week treatment). Primary efficacy 
      endpoint: the proportion of patients with >/=75% reduction in Psoriasis Area and 
      Severity Index (PASI 75) response at week 16 (+/-18% equivalence limits for 
      two-sided 95% confidence interval between treatment groups). Safety, 
      pharmacokinetics, and immunogenicity were also assessed. Results: Baseline 
      characteristics were balanced between treated groups (BI 695501, n = 159; 
      adalimumab RP, n = 158). PASI 75 response rates (full analysis set, n = 158; n 
      = 157) were 68.2% (BI 695501) and 70.4% (adalimumab RP) at week 16 (95% CI: 
      -14.4%, 8.7%), and 75.3% and 72.4%, at week 24, respectively. At week 24, 41.5% 
      (BI 695501) and 44.9% (adalimumab RP) of treated patients had treatment-emergent 
      adverse events (AEs), 3.1% and 4.4% had serious AEs, and 0.0% and 1.9% had AEs of 
      special interest. Of treated patients, 75.3% (BI 695501) and 77.9% (adalimumab 
      RP) were anti-drug antibody-positive. Conclusion: These data demonstrate 
      equivalent efficacy and highly similar safety and immunogenicity between BI 
      695501 and adalimumab RP in patients with chronic plaque psoriasis. Study 
      identifier: NCT02850965.
FAU - Menter, Alan
AU  - Menter A
AUID- ORCID: 0000-0002-9314-0007
AD  - Institute for Rehabilitation, Baylor Scott & White , Dallas, TX, USA.
FAU - Arenberger, Petr
AU  - Arenberger P
AD  - Department of Dermatology and Venereology, University Hospital Kralovske 
      Vinohrady , Prague, Czech Republic.
FAU - Balser, Sigrid
AU  - Balser S
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riss, Germany.
FAU - Beissert, Stefan
AU  - Beissert S
AD  - Department of Dermatology, Universitatsklinikum Carl Gustav Carus, TU Dresden , 
      Dresden, Germany.
FAU - Cauthen, Ashley
AU  - Cauthen A
AD  - Renstar Medical Research , Ocala, FL, USA.
FAU - Czeloth, Niklas
AU  - Czeloth N
AD  - Boehringer Ingelheim International GmbH , Ingelheim am Rhein, Germany.
FAU - Soung, Jennifer
AU  - Soung J
AD  - Southern California Dermatology Inc ., Santa Ana, CA, USA.
FAU - Jazayeri, Sasha
AU  - Jazayeri S
AD  - Alliance Dermatology and Mohs Center PC , Phoenix, AZ, USA.
FAU - Weisenseel, Peter
AU  - Weisenseel P
AD  - TFS GmbH , Hamburg, Germany.
FAU - Jayadeva, Girish
AU  - Jayadeva G
AD  - Boehringer Ingelheim International GmbH , Ingelheim am Rhein, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02850965
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201229
PL  - England
TA  - Expert Opin Biol Ther
JT  - Expert opinion on biological therapy
JID - 101125414
RN  - 0 (BI 695501)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/adverse effects
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - *Psoriasis/drug therapy
MH  - Severity of Illness Index
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adalimumab
OT  - BI 695501
OT  - biosimilar
OT  - equivalence
OT  - psoriasis
EDAT- 2020/12/16 06:00
MHDA- 2021/11/26 06:00
CRDT- 2020/12/15 05:38
PHST- 2020/12/16 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2020/12/15 05:38 [entrez]
AID - 10.1080/14712598.2021.1851362 [doi]
PST - ppublish
SO  - Expert Opin Biol Ther. 2021 Jan;21(1):87-96. doi: 10.1080/14712598.2021.1851362. 
      Epub 2020 Dec 29.