PMID- 30210123
OWN - NLM
STAT- MEDLINE
DCOM- 20190422
LR  - 20200225
IS  - 1349-7235 (Electronic)
IS  - 0918-2918 (Print)
IS  - 0918-2918 (Linking)
VI  - 58
IP  - 4
DP  - 2019 Feb 15
TI  - An Analysis of the Biological Disease-modifying Antirheumatic Drug-free Condition 
      of Adalimumab-treated Rheumatoid Arthritis Patients.
PG  - 511-519
LID - 10.2169/internalmedicine.1332-18 [doi]
AB  - Objectives The present study was performed with the aim of analyzing the 
      biological disease-modifying antirheumatic drug (bDMARD)-free (Bio-free) 
      condition of adalimumab (ADA)-treated rheumatoid arthritis (RA) patients in a 
      real-world setting. Methods ADA was used in the treatment of 130 (male, n=21; 
      female, n=109 females) RA patients. Among them, 26 patients (20.0%) discontinued 
      ADA due to a good response. We analyzed 20 patients who were followed up for more 
      than 6 months after the discontinuation of ADA. The Disease Activity Score 28 
      based on C-reactive protein (DAS28-CRP) and modified health assessment 
      questionnaires (mHAQs) were evaluated. Results The mean age of the patients was 
      53.4+/-11.1 years. The mean disease duration was 4.5+/-4.3 years. Sixteen patients 
      were bDMARD-naive, while 4 switched from bDMARDs to ADA. At 6 months after the 
      discontinuation ADA, 19 patients had achieved a clinical remission, and 1 had 
      achieved a low disease activity. The Bio-free period was 26.4+/-15.5 months. The 
      dose of prednisolone was significantly reduced from baseline (3.45+/-3.17 mg/day) 
      at 6 months after the discontinuation of ADA (2.63+/-2.78 mg/day). The dose of 
      methotrexate was unchanged. The number of conventional synthetic DMARDs 
      (csDMARDs) was significantly increased (0.8+/-0.6 to 1.4+/-1.06). The mHAQ values 
      were significantly ameliorated by ADA and remained good in patients with a 
      Bio-free condition. A multivariate analysis showed that the dose of methotrexate 
      (MTX) was an important factor for achieving a Bio-free condition. Conclusion A 
      sustainable Bio-free condition in a real clinical setting can be achieved and may 
      be a suitable way of reducing medical costs. The dose of MTX and the additional 
      administration of csDMARDs is therefore thought to be important for ensuring a 
      good outcome in these patients.
FAU - Ito, Satoshi
AU  - Ito S
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Kobayashi, Daisuke
AU  - Kobayashi D
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
AD  - Division of Clinical Nephrology and Rheumatology, Niigata University Graduate 
      School of Medical and Dental Sciences, Japan.
FAU - Hasegawa, Eriko
AU  - Hasegawa E
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
AD  - Division of Clinical Nephrology and Rheumatology, Niigata University Graduate 
      School of Medical and Dental Sciences, Japan.
FAU - Takai, Chinatsu
AU  - Takai C
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
AD  - Division of Clinical Nephrology and Rheumatology, Niigata University Graduate 
      School of Medical and Dental Sciences, Japan.
FAU - Nemoto, Tetsuya
AU  - Nemoto T
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Lee, Hyunho
AU  - Lee H
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Abe, Asami
AU  - Abe A
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Otani, Hiroshi
AU  - Otani H
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Ishikawa, Hajime
AU  - Ishikawa H
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Murasawa, Akira
AU  - Murasawa A
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
FAU - Narita, Ichiei
AU  - Narita I
AD  - Division of Clinical Nephrology and Rheumatology, Niigata University Graduate 
      School of Medical and Dental Sciences, Japan.
FAU - Nakazono, Kiyoshi
AU  - Nakazono K
AD  - Department of Rheumatology, Niigata Rheumatic Center, Japan.
LA  - eng
PT  - Journal Article
DEP - 20180912
PL  - Japan
TA  - Intern Med
JT  - Internal medicine (Tokyo, Japan)
JID - 9204241
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - FYS6T7F842 (Adalimumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adalimumab/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*therapeutic use
MH  - Antirheumatic Agents/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/*therapeutic use
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC6421140
OTO - NOTNLM
OT  - adalimumab
OT  - biologics free condition
OT  - conventional synthetic disease-modifying antirheumatic drugs
OT  - methotrexate
OT  - rheumatoid arthritis
COIS- Author's disclosure of potential Conflicts of Interest (COI). Satoshi Ito: 
      Honoraria, Abbvie Japan, Eisai, Mitsubishi Tanabe Pharma, Chugai Pharmaceutical 
      and Bristol-Myers Squibb.
EDAT- 2018/09/14 06:00
MHDA- 2019/04/23 06:00
PMCR- 2019/02/15
CRDT- 2018/09/14 06:00
PHST- 2018/09/14 06:00 [pubmed]
PHST- 2019/04/23 06:00 [medline]
PHST- 2018/09/14 06:00 [entrez]
PHST- 2019/02/15 00:00 [pmc-release]
AID - 10.2169/internalmedicine.1332-18 [doi]
PST - ppublish
SO  - Intern Med. 2019 Feb 15;58(4):511-519. doi: 10.2169/internalmedicine.1332-18. 
      Epub 2018 Sep 12.