PMID- 36253032
OWN - NLM
STAT- MEDLINE
DCOM- 20230103
LR  - 20230415
IS  - 1756-185X (Electronic)
IS  - 1756-1841 (Print)
IS  - 1756-1841 (Linking)
VI  - 26
IP  - 1
DP  - 2023 Jan
TI  - Lower injection-site reactions and long-term safety, immunogenicity, and efficacy 
      of etanercept biosimilar YLB113: Results from a post-hoc analysis of a 
      double-blind, randomized, phase III comparative study and its open-label 
      extension in patients with rheumatoid arthritis.
PG  - 108-115
LID - 10.1111/1756-185X.14462 [doi]
AB  - AIM: YLB113 biosimilar was evaluated in an open-label extension single-arm study 
      to assess long-term safety, efficacy, and immunogenicity in patients with 
      rheumatoid arthritis (RA). We also report post-hoc results on the incidence of 
      injection-site reactions (ISRs) and injection-site erythema (ISE) from a phase 
      III study. METHOD: Participants from the phase III, double-blind, randomized, 96 
      week equivalence study who completed the final visit received 50 mg YLB113 
      subcutaneously every 2 weeks. Key safety end points were assessed through adverse 
      events (AEs), ISRs, ISE, and anti-drug antibody (ADA) incidence. The efficacy end 
      point was change from baseline in Disease Activity Score 28-joint count (DAS28) 
      over time. RESULTS: Of 201 participants, 184 (91.5%) completed the study. 
      Treatment-emergent AEs were experienced by 93.5% and severe AEs by 10.0% of 
      participants. The discontinuation rate due to AEs was 2.0%. Overall, 20.0% of 
      participants reported an incidence of ISRs throughout the open-label extension 
      study. Two participants developed ADAs, and none developed neutralizing ADAs at 
      any time after study drug administration. The overall DAS28 (mean +/- SD) change 
      was 2.22 +/- 0.95 at the study transition, 2.10 +/- 0.91 at week 72, and 2.06 +/- 0.89 
      at the end of the study. In the post-hoc analysis, YLB113 showed a statistically 
      significant lower incidence of ISRs (10 [3.8%], P < 0.0001) and ISE (5 [1.9%], 
      P < 0.0001) compared with the reference product Enbrel(R). CONCLUSION: YLB113 
      demonstrated long-term safety and sustained efficacy for up to 96 weeks. Patients 
      on YLB113 experienced significantly lower ISRs and ISE in a post-hoc analysis of 
      the phase III study when compared with reference product.
CI  - (c) 2022 Viatris Pharma. International Journal of Rheumatic Diseases published by 
      Asia Pacific League of Associations for Rheumatology and John Wiley & Sons 
      Australia, Ltd.
FAU - Yamanaka, Hisashi
AU  - Yamanaka H
AD  - Sanno Medical Center, Tokyo, Japan.
AD  - Women's Medical University School of Medicine, Tokyo, Japan.
AD  - International University of Health and Welfare, Tokyo, Japan.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AUID- ORCID: 0000-0002-0807-7139
AD  - University of Occupational and Environmental Health, Kitakyushu, Japan.
FAU - Hibino, Toshihiko
AU  - Hibino T
AD  - YL Biologics Ltd., Tokyo, Japan.
FAU - Unmesh, Gopalakrishnan
AU  - Unmesh G
AD  - Viatris, Bengaluru, India.
FAU - Shah, Chirag
AU  - Shah C
AD  - Lupin LTD, Pune, India.
FAU - Bakhle, Dhananjay
AU  - Bakhle D
AD  - Lupin LTD, Pune, India.
FAU - Stefanidis, Dimitris
AU  - Stefanidis D
AUID- ORCID: 0000-0001-9018-981X
AD  - Viatris GmbH, Bad Homburg vor der Hohe, Germany.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20221017
PL  - England
TA  - Int J Rheum Dis
JT  - International journal of rheumatic diseases
JID - 101474930
RN  - OP401G7OJC (Etanercept)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Antibodies)
SB  - IM
MH  - Humans
MH  - Etanercept/adverse effects
MH  - *Antirheumatic Agents/adverse effects
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Treatment Outcome
MH  - *Arthritis, Rheumatoid/diagnosis/drug therapy/chemically induced
MH  - Antibodies
MH  - Injection Site Reaction/diagnosis/epidemiology/etiology
MH  - Double-Blind Method
PMC - PMC10092464
OTO - NOTNLM
OT  - YLB113
OT  - biosimilar
OT  - etanercept
OT  - injection-site reaction
OT  - long-term safety
OT  - rheumatoid arthritis
COIS- Hisashi Yamanaka has received speaker or consultant fees from Astellas, 
      Bristol-Meyers-Squibb, CorEvitas LLC, Eisai, Pfizer, Tanabe-Mitsubishi, Teijin 
      Pharma, and YLBio. Yoshiya Tanaka is an Editorial Board member of the journal and 
      co-author of this article and was excluded from the peer-review process and all 
      editorial decisions related to the acceptance and publication of this article. 
      Peer-review was handled independently by members of the Editorial Board to 
      minimize bias. Yoshiya Tanaka has received speaking fees and/or honoraria from 
      Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, 
      Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, and Teijin, 
      and has received research grants from Asahi Kasei, Mitsubishi-Tanabe, Chugai, 
      Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, and Ono. Toshihiko 
      Hibino is an employee of YL Biologics Limited. Chirag Shah is full-time employee 
      of Lupin Pharmaceuticals Ltd. Dhananjay Bakhle is a full-time employee and 
      shareholder of Lupin Pharmaceuticals Ltd. Dimitris Stefanidis and Unmesh G are 
      full-time employees of Viatris, Inc.
EDAT- 2022/10/18 06:00
MHDA- 2023/01/04 06:00
PMCR- 2023/04/12
CRDT- 2022/10/17 21:03
PHST- 2022/09/22 00:00 [revised]
PHST- 2022/07/08 00:00 [received]
PHST- 2022/09/26 00:00 [accepted]
PHST- 2022/10/18 06:00 [pubmed]
PHST- 2023/01/04 06:00 [medline]
PHST- 2022/10/17 21:03 [entrez]
PHST- 2023/04/12 00:00 [pmc-release]
AID - APL14462 [pii]
AID - 10.1111/1756-185X.14462 [doi]
PST - ppublish
SO  - Int J Rheum Dis. 2023 Jan;26(1):108-115. doi: 10.1111/1756-185X.14462. Epub 2022 
      Oct 17.