PMID- 29029185
OWN - NLM
STAT- MEDLINE
DCOM- 20171207
LR  - 20180504
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 56
IP  - 12
DP  - 2017 Dec 1
TI  - Patient-reported outcomes in newly diagnosed early rheumatoid arthritis patients 
      treated to target with a tocilizumab- or methotrexate-based strategy.
PG  - 2179-2189
LID - 10.1093/rheumatology/kex319 [doi]
AB  - OBJECTIVE: To evaluate the effect of initiation of tocilizumab, with or without 
      MTX, compared with MTX alone on patient-reported outcomes (PROs), in DMARD-naive 
      patients with early RA. METHODS: In U-Act-Early, patients initiated 
      treat-to-target step-up MTX, tocilizumab or tocilizumab plus MTX therapy. PROs 
      assessed included the Functional Assessment of Chronic Illness Therapy-Fatigue, 
      36-item Short Form (SF-36), five dimensional EuroQol (EQ-5D) and the Revised 
      Illness Perception Questionnaire. Differences between strategy groups over time 
      and proportions of patients exceeding minimum clinically important differences 
      (MCID) were evaluated. RESULTS: During the 2-year study period, significant 
      improvements were found in the tocilizumab strategies in the SF-36 physical 
      component score (tocilizumab, P = 0.012; tocilizumab plus MTX, P = 0.044) and 
      EQ-5D score (tocilizumab plus MTX, P = 0.020) when compared with the MTX 
      strategy. No significant differences were noted in other PROs (P ⩾ 0.052, except 
      for the domain 'identity' in the Illness Perception Questionnaire; tocilizumab vs 
      MTX, P = 0.048). The proportions of patients achieving MCID in SF-36 physical 
      component score were significantly higher at 12 and 52 weeks (P ⩽ 0.049) in the 
      tocilizumab arms when compared with the MTX arm. At week 24, the proportion 
      achieving MCID in EQ-5D was significantly higher in the tocilizumab plus MTX arm 
      vs the MTX arm (P = 0.045). CONCLUSION: Initiation of treat-to-target tocilizumab 
      therapy resulted in significantly improved PROs, especially within the first 24 
      weeks, when compared with initiation of MTX therapy. Also on the patients' level, 
      initiating tocilizumab may be considered as a valuable strategy in DMARD-naive 
      patients with early RA. TRIAL REGISTRATION: ClinicalTrials.gov, 
      http://clinicaltrials.gov, NCT01034137.
CI  - (c) The Author 2017. Published by Oxford University Press on behalf of the British 
      Society for Rheumatology. All rights reserved. For Permissions, please email: 
      journals.permissions@oup.com
FAU - Teitsma, Xavier M
AU  - Teitsma XM
AD  - Department of Rheumatology & Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, the Netherlands.
FAU - Jacobs, Johannes W G
AU  - Jacobs JWG
AD  - Department of Rheumatology & Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, the Netherlands.
FAU - Welsing, Paco M J
AU  - Welsing PMJ
AD  - Department of Rheumatology & Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, the Netherlands.
FAU - Petho-Schramm, Attila
AU  - Petho-Schramm A
AD  - F Hoffmann-La Roche, Basel, Switzerland.
FAU - Borm, Michelle E A
AU  - Borm MEA
AD  - Roche Nederland BV, Woerden.
FAU - Hendriks, Lidy
AU  - Hendriks L
AD  - Department of Rheumatology, Medical Center Leeuwarden, Leeuwarden.
FAU - Denissen, Natasja H A M
AU  - Denissen NHAM
AD  - Department of Rheumatology, Amphia Hospital Breda, Breda, the Netherlands.
FAU - van Laar, Jacob M
AU  - van Laar JM
AD  - Department of Rheumatology & Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, the Netherlands.
FAU - Lafeber, Floris P J G
AU  - Lafeber FPJG
AD  - Department of Rheumatology & Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, the Netherlands.
FAU - Bijlsma, Johannes W J
AU  - Bijlsma JWJ
AD  - Department of Rheumatology & Clinical Immunology, University Medical Center 
      Utrecht, Utrecht, the Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT01034137
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - I031V2H011 (tocilizumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Antirheumatic Agents/*administration & dosage
MH  - Arthritis, Rheumatoid/diagnosis/*drug therapy
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Early Diagnosis
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/*administration & dosage
MH  - Middle Aged
MH  - *Minimal Clinically Important Difference
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
OTO - NOTNLM
OT  - early rheumatoid arthritis
OT  - methotrexate
OT  - patient-reported outcomes
OT  - randomized controlled trial
OT  - tocilizumab
EDAT- 2017/10/14 06:00
MHDA- 2017/12/08 06:00
CRDT- 2017/10/14 06:00
PHST- 2017/07/05 00:00 [received]
PHST- 2017/10/14 06:00 [pubmed]
PHST- 2017/12/08 06:00 [medline]
PHST- 2017/10/14 06:00 [entrez]
AID - 4210354 [pii]
AID - 10.1093/rheumatology/kex319 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2017 Dec 1;56(12):2179-2189. doi: 
      10.1093/rheumatology/kex319.