PMID- 35822806
OWN - NLM
STAT- MEDLINE
DCOM- 20230417
LR  - 20230417
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 33
IP  - 3
DP  - 2023 Apr 13
TI  - Safety and effectiveness of certolizumab pegol in Japanese patients with 
      rheumatoid arthritis: Results from a 24-week post-marketing surveillance study.
PG  - 460-471
LID - 10.1093/mr/roac073 [doi]
AB  - OBJECTIVES: To report 24-week safety and effectiveness of certolizumab pegol 
      (CZP) in Japanese patients with rheumatoid arthritis from a post-marketing 
      surveillance study. METHODS: Enrolled patients were newly receiving CZP. All 
      adverse events (AEs) and adverse drug reactions (ADRs) were recorded for patients 
      who received >/=1 CZP dose. Effectiveness outcomes included: 28-joint Disease 
      Activity Score with erythrocyte sedimentation rate (DAS28-ESR) and European 
      Alliance of Associations for Rheumatology (EULAR) response. Missing data were 
      imputed using the last observation carried forward. RESULTS: 3727 patients were 
      enrolled; safety and effectiveness were evaluated in 3586 and 1794 patients, 
      respectively. 24.9% of patients reported AEs (893/3586), 14.7% reported ADRs 
      (528/3586), 8.3% (298/3586) reported serious AEs and 5.3% (190/3586) reported 
      serious ADRs. Selected serious ADRs of interest: infections (110; 3.1%), 
      tuberculosis (6; 0.2%), interstitial pneumonia (15; 0.4%), malignancy (8; 0.2%), 
      and hepatic function disorder (7; 0.2%). No allergic reactions, autoimmune 
      disease, cardiac failure, demyelinating diseases, or pancytopenia were reported. 
      Mean DAS28-ESR reduced from 4.8 (baseline) to 3.4 (final evaluation). At final 
      evaluation, 34.7% of patients achieved EULAR good response. CONCLUSIONS: These 
      real-world safety and effectiveness results were consistent with previously 
      reported data, with no new safety signals identified. Long-term, real-world CZP 
      safety and effectiveness data are needed.
CI  - (c) Japan College of Rheumatology 2022. Published by Oxford University Press.
FAU - Kameda, Hideto
AU  - Kameda H
AD  - Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, 
      Toho University (Ohashi Medical Center), Tokyo, Japan.
FAU - Nishida, Keiichiro
AU  - Nishida K
AD  - Department of Orthopaedic Surgery, Okayama University Graduate School of 
      Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
FAU - Nanki, Toshihiro
AU  - Nanki T
AD  - Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, 
      Toho University (Omori Medical Center), Tokyo, Japan.
FAU - Watanabe, Akira
AU  - Watanabe A
AD  - Research Division for Development of Anti-Infective Agents, Faculty of Medical 
      Science and Welfare, Tohoku Bunka Gakuen University, Sendai, Japan.
FAU - Oshima, Yukiya
AU  - Oshima Y
AD  - PMS Group, Drug Safety, UCB Pharma, Tokyo, Japan.
FAU - Momohara, Shigeki
AU  - Momohara S
AD  - Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, 
      Japan.
LA  - eng
GR  - UCB Pharma/
PT  - Journal Article
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - UMD07X179E (Certolizumab Pegol)
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Humans
MH  - Certolizumab Pegol/adverse effects
MH  - *Antirheumatic Agents/adverse effects
MH  - East Asian People
MH  - Treatment Outcome
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - Product Surveillance, Postmarketing
OTO - NOTNLM
OT  - Certolizumab pegol
OT  - effectiveness
OT  - post-marketing surveillance
OT  - rheumatoid arthritis
OT  - safety
EDAT- 2022/07/14 06:00
MHDA- 2023/04/17 06:41
CRDT- 2022/07/13 08:13
PHST- 2022/02/25 00:00 [received]
PHST- 2022/06/20 00:00 [accepted]
PHST- 2023/04/17 06:41 [medline]
PHST- 2022/07/14 06:00 [pubmed]
PHST- 2022/07/13 08:13 [entrez]
AID - 6643032 [pii]
AID - 10.1093/mr/roac073 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2023 Apr 13;33(3):460-471. doi: 10.1093/mr/roac073.