PMID- 32851365
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220416
IS  - 2618-6500 (Electronic)
IS  - 2148-5046 (Print)
IS  - 2148-5046 (Linking)
VI  - 35
IP  - 2
DP  - 2020 Jun
TI  - Efficacy and Safety of Opinercept Tumor Necrosis Factor Inhibitor Therapy for 
      Drug-Refractory Rheumatoid Arthritis: A Randomized Clinical Trial.
PG  - 170-179
LID - 10.46497/ArchRheumatol.2020.7464 [doi]
AB  - OBJECTIVES: This study aims to evaluate the efficacy and safety profile of 
      opinercept for rheumatoid arthritis (RA) patients undergoing disease- modifying 
      anti-rheumatic drugs (DMARDs) therapy. PATIENTS AND METHODS: A total of 98 
      patients with active RA (17 males, 81 females; mean age 58.6+/-12.2 years; range, 
      24.3 to 85.3 years) were randomized into opinercept plus DMARDs (OD group) or 
      placebo plus DMARDs (PD group), in a 24-week treatment period. Primary outcome 
      was American College of Rheumatology score (ACR20) at week 24. Other exploratory 
      endpoints included ACR50, ACR70 and disease activity score-28 (DAS28) at week 12 
      and 24, tender/swollen joint counts, pain, Health Assessment 
      Questionnaire-Disability Index, erythrocyte sedimentation rate, and C-reactive 
      protein level. Incidence of adverse events (AEs), vital signs and physical 
      findings, and laboratory test results were also evaluated. RESULTS: Patients in 
      OD group showed significantly higher achievement percentage of ACR20 at week 24 
      than the PD group (76.6% vs. 30.3%, p<0.001). The evaluation of DAS28 was 
      significantly improved in OD patients compared to PD patients at weeks 12 and 24. 
      Most of the occurred AEs were mild or moderate and considered unrelated to study 
      treatments. CONCLUSION: Opinercept concurrent with DMARDs was superior to DMARDs 
      alone in slowing RA progression and ameliorating symptoms, with well- tolerated 
      and acceptable safety profile.
CI  - Copyright (c) 2020, Turkish League Against Rheumatism.
FAU - Liang, Toong-Hua
AU  - Liang TH
AUID- ORCID: 0000-0003-3416-5770
AD  - Department of Internal Medicine, Taipei City Hospital Renai Branch, Taipei, 
      Taiwan.
FAU - Lee, Chyou-Shen
AU  - Lee CS
AUID- ORCID: 0000-0001-9433-9387
AD  - Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
FAU - Lee, Shinn-Shing
AU  - Lee SS
AUID- ORCID: 0000-0002-2812-7623
AD  - Department of Internal Medicine, Cheng Hsin General Hospital, Taipei, Taiwan.
FAU - Wu, Chien-Sheng
AU  - Wu CS
AUID- ORCID: 0000-0003-2815-1743
AD  - Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan.
FAU - Chen, Kun-Hung
AU  - Chen KH
AUID- ORCID: 0000-0002-9993-844X
AD  - Division of Rheumatology and Immunology, Cathay General Hospital, Taipei, Taiwan.
FAU - Hsu, Ping-Ning
AU  - Hsu PN
AUID- ORCID: 0000-0003-4479-3391
AD  - National Taiwan University, Graduate Institute of Immunology, College of 
      Medicine, Taipei, Taiwan.
FAU - Lin, Hsiao-Yi
AU  - Lin HY
AUID- ORCID: 0000-0003-4739-795X
AD  - Department of Medicine, Cheng Hsin General Hospital, Taipei, Taiwan.
LA  - eng
PT  - Journal Article
DEP - 20200108
PL  - Turkey
TA  - Arch Rheumatol
JT  - Archives of rheumatology
JID - 101639000
PMC - PMC7406163
OTO - NOTNLM
OT  - Clinical trial
OT  - disease-modifying anti-rheumatic drugs
OT  - opinercept
OT  - rheumatoid arthritis
COIS- Conflict of Interest: The authors declared no conflicts of interest with respect 
      to the authorship and/or publication of this article.
EDAT- 2020/08/28 06:00
MHDA- 2020/08/28 06:01
PMCR- 2020/01/08
CRDT- 2020/08/28 06:00
PHST- 2019/03/06 00:00 [received]
PHST- 2019/06/24 00:00 [accepted]
PHST- 2020/08/28 06:00 [entrez]
PHST- 2020/08/28 06:00 [pubmed]
PHST- 2020/08/28 06:01 [medline]
PHST- 2020/01/08 00:00 [pmc-release]
AID - 10.46497/ArchRheumatol.2020.7464 [doi]
PST - epublish
SO  - Arch Rheumatol. 2020 Jan 8;35(2):170-179. doi: 10.46497/ArchRheumatol.2020.7464. 
      eCollection 2020 Jun.