PMID- 34251303
OWN - NLM
STAT- MEDLINE
DCOM- 20220519
LR  - 20220519
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 40
IP  - 5
DP  - 2022 May
TI  - Comparison of the efficacy and safety of LBAL, a candidate adalimumab biosimilar, 
      and adalimumab reference product in patients with active rheumatoid arthritis 
      inadequately responding to methotrexate: a 52-week phase III randomised study.
PG  - 1025-1033
LID - 10.55563/clinexprheumatol/cyudn8 [doi]
AB  - OBJECTIVES: To evaluate the similarities between LBAL (adalimumab biosimilar 
      candidate) and the adalimumab reference product (ADL) in terms of efficacy and 
      safety, including immunogenicity, in patients with active rheumatoid arthritis 
      despite methotrexate treatment. METHODS: This phase III, multicentre, randomised, 
      double-blind, parallel-group, 56-week study was conducted in Japan and Korea. 
      During the first 24 weeks, patients subcutaneously received 40 mg of LBAL or ADL 
      every two weeks (LBAL and ADL groups). During the subsequent 28 weeks, the LBAL 
      group patients and half of the ADL group patients received LBAL (L-L and A-L 
      arms). The remaining ADL group patients continued to receive ADL (A-A arm). The 
      primary efficacy endpoint was the change from baseline in disease activity score 
      28-erythrocyte sedimentation rate (DAS28-ESR) at Week 24. American College of 
      Rheumatology (ACR) response rates, adverse events (AEs), and anti-drug antibody 
      (ADA) were also assessed. RESULTS: In total, 383 patients were randomised. The 
      least squares (LS) mean changes from baseline in DAS28-ESR at Week 24 were -2.45 
      and -2.53 in the LBAL (n=191) and ADL (n=190) groups, respectively. The 95% 
      confidence interval (CI; -0.139, 0.304) of the difference (0.08) was within the 
      pre-specified equivalence margin (-0.6, 0.6). Up to Week 52, the decreases in 
      DAS28-ESR were maintained in all three arms. No notable differences in 
      ACR20/50/70 were observed. The AE and ADA incidences were comparable between the 
      arms. CONCLUSIONS: LBAL was equivalent in efficacy and comparable in safety, 
      including immunogenicity, to ADL. Switching from ADL to LBAL did not impact on 
      efficacy and safety.
FAU - Matsuno, Hiroaki
AU  - Matsuno H
AD  - Matsuno Clinic for Rheumatic Disease, Toyama, and Immuno-Rheumatology Center, St. 
      Luke's International Hospital, Tokyo, Japan.
FAU - Kang, Young Mo
AU  - Kang YM
AD  - Division of Rheumatology, Department of Internal Medicine, Kyungpook National 
      University Hospital, Daegu, South Korea.
FAU - Okada, Masato
AU  - Okada M
AD  - Immuno-Rheumatology Center, St. Luke's International Hospital, Tokyo, Japan.
FAU - Lee, Sang-Il
AU  - Lee SI
AD  - Division of Rheumatology, Gyeongsang National University Hospital, Jinju, South 
      Korea.
FAU - Park, Sung-Hwan
AU  - Park SH
AD  - Division of Rheumatology, The Catholic University of Korea, Seoul St. Mary's 
      Hospital, Seoul, South Korea.
FAU - Sheen, Dong Hyuk
AU  - Sheen DH
AD  - Division of Rheumatology, Eulji University School of Medicine, Daejeon, South 
      Korea.
FAU - Sato, Masaki
AU  - Sato M
AD  - Mochida Pharmaceutical Co. Ltd., Tokyo, Japan.
FAU - Hagino, Atsushi
AU  - Hagino A
AD  - Mochida Pharmaceutical Co. Ltd., Tokyo, Japan.
FAU - Lee, Jiyoon
AU  - Lee J
AD  - LG Chem Ltd., Seoul, South Korea.
FAU - Shin, Seonghye
AU  - Shin S
AD  - LG Chem Ltd., Seoul, South Korea.
FAU - Song, Yeong Wook
AU  - Song YW
AD  - Division of Rheumatology, Department of Internal Medicine, Seoul National 
      University Hospital, Seoul, South Korea. ysong@snu.ac.kr.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210707
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - FYS6T7F842 (Adalimumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adalimumab/adverse effects
MH  - *Antirheumatic Agents/adverse effects
MH  - *Arthritis, Rheumatoid/diagnosis/drug therapy
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - Methotrexate/adverse effects
MH  - Treatment Outcome
EDAT- 2021/07/13 06:00
MHDA- 2022/05/20 06:00
CRDT- 2021/07/12 12:22
PHST- 2020/12/23 00:00 [received]
PHST- 2021/05/24 00:00 [accepted]
PHST- 2021/07/13 06:00 [pubmed]
PHST- 2022/05/20 06:00 [medline]
PHST- 2021/07/12 12:22 [entrez]
AID - 16868 [pii]
AID - 10.55563/clinexprheumatol/cyudn8 [doi]
PST - ppublish
SO  - Clin Exp Rheumatol. 2022 May;40(5):1025-1033. doi: 
      10.55563/clinexprheumatol/cyudn8. Epub 2021 Jul 7.