PMID- 36401881
OWN - NLM
STAT- MEDLINE
DCOM- 20231115
LR  - 20231115
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 33
IP  - 6
DP  - 2023 Nov 1
TI  - Safety and effectiveness of tofacitinib in Korean adult patients with rheumatoid 
      arthritis: A post-marketing surveillance study.
PG  - 1087-1096
LID - 10.1093/mr/roac136 [doi]
AB  - OBJECTIVES: The aim of this article is to assess the safety and effectiveness of 
      tofacitinib in patients with rheumatoid arthritis in routine clinical settings in 
      Korea. METHODS: This is a prospective, multi-centre post-marketing surveillance 
      study. Data were prospectively collected within 6 months after the start of 
      tofacitinib therapy. Safety was evaluated based on the presence of adverse events 
      (AEs) observed in patients who received at least one dose of tofacitinib. 
      Effectiveness was assessed according to the proportion of patients who achieved 
      low disease activity and remission, American College of Rheumatology 20 criteria 
      (ACR20), European League Against Rheumatism (EULAR) response, and change of 
      Disease Activity Score in 28 Joints (DAS28). RESULTS: The incidence rates 
      [patients with events per 100 patient-years (PY)] of AEs and serious AEs were 
      56.92 and 10.69, respectively. Regarding AEs of special interest, the incidence 
      rates were 4.33 per 100 PY for serious infections and infestations, 5.78 per 100 
      PY for herpes zoster, no event of tuberculosis, 0.29 per 100 PY for malignancy, 
      0.29 per 100 PY for venous thromboembolism (one event of deep vein thrombosis and 
      no event of pulmonary embolism), 0.87 per 100 PY for major adverse cardiovascular 
      event, and 0.58 per 100 PY for mortality. Moreover,  approximately 40.48% and 21.60% of 
      patients achieved low disease activity and remission of DAS28-erythrocyte 
      sedimentation rate. The EULAR response was classified as good responders with 
      39.12% in the DAS28-erythrocyte sedimentation rate. CONCLUSIONS: The benefit/risk 
      profile of tofacitinib in adult patients with rheumatoid arthritis in routine 
      clinical settings in Korea was similar to long-term clinical trial data.
CI  - (c) Japan College of Rheumatology 2022. Published by Oxford University Press. All 
      rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
FAU - Ju, Ji Hyeon
AU  - Ju JH
AD  - Division of Rheumatology, Department of Internal Medicine, College of Medicine, 
      The Catholic University of Korea, Seoul, Korea.
FAU - Sung, Yoon-Kyoung
AU  - Sung YK
AD  - Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 
      Seoul, Korea.
FAU - Jo, Joo-Young
AU  - Jo JY
AD  - Pfizer Pharmaceuticals Korea Ltd, Seoul, Korea.
FAU - Jeon, Ja-Young
AU  - Jeon JY
AD  - Pfizer Pharmaceuticals Korea Ltd, Seoul, Korea.
FAU - Yoo, Hyun-Jeong
AU  - Yoo HJ
AD  - Pfizer Pharmaceuticals Korea Ltd, Seoul, Korea.
FAU - Lee, Eun Bong
AU  - Lee EB
AUID- ORCID: 0000-0003-0703-1208
AD  - Division of Rheumatology, Department of Internal Medicine, College of Medicine, 
      Seoul National University, Seoul, Korea.
AD  - Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School 
      of Convergence Science and Technology, Seoul National University, Seoul, Korea.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Pyrroles)
RN  - 87LA6FU830 (tofacitinib)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Antirheumatic Agents/therapeutic use
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Pyrroles/adverse effects
MH  - Republic of Korea
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Tofacitinib
OT  - effectiveness
OT  - post-marketing surveillance
OT  - rheumatoid arthritis
OT  - safety
EDAT- 2022/11/20 06:00
MHDA- 2023/11/08 06:42
CRDT- 2022/11/19 17:42
PHST- 2021/12/24 00:00 [received]
PHST- 2022/11/04 00:00 [accepted]
PHST- 2023/11/08 06:42 [medline]
PHST- 2022/11/20 06:00 [pubmed]
PHST- 2022/11/19 17:42 [entrez]
AID - 6833487 [pii]
AID - 10.1093/mr/roac136 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2023 Nov 1;33(6):1087-1096. doi: 10.1093/mr/roac136.