PMID- 26344671
OWN - NLM
STAT- MEDLINE
DCOM- 20151216
LR  - 20220318
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 33
IP  - 5
DP  - 2015 Sep-Oct
TI  - Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of 
      tocilizumab and on factors associated with fatigue. The French multicentre 
      prospective PEPS Study.
PG  - 664-70
AB  - OBJECTIVES: Fatigue is an important aspect of rheumatoid arthritis (RA). The 
      objective was to assess fatigue levels and its determinants over the first 4 
      months of tocilizumab (TCZ) treatment in RA patients. METHODS: We performed a 
      multicentre prospective study of RA patients treated with intravenous TCZ in 
      open-label prescription conditions. The first 5 infusions (4 months) were 
      assessed. The primary endpoint was the percentage of patients with variation of 
      the FACIT fatigue scale from inclusion to 4 months, above the minimal clinically 
      important difference (MCID) of 4 points. Fatigue was also assessed by the patient 
      acceptable symptom state for fatigue (PASS) question. Variables related with 
      fatigue and with fatigue improvement including other patient reported outcomes, 
      depression and anxiety, and disease activity, were assessed before and after 
      treatment. ANALYSES: univariate and multivariate logistic regressions. RESULTS: 
      Of 719 patients, 610 had evaluable data: mean age 56+/-13 years, disease duration 
      12+/-10 years, 490 (81%) women. At baseline, fatigue levels were high: 73% patients 
      had unacceptable fatigue. At 4 months, 378 patients (62%) reached MCID 
      improvement for fatigue. Fatigue reduction was rapid, seen as early as after 2 
      weeks. Fatigue was mainly related to functional status (HAQ score), depression 
      and anxiety, both before and after TCZ treatment. Moderate predictors of fatigue 
      improvement were evidenced. CONCLUSIONS: In these long-standing RA patients, 
      fatigue levels were high and mainly explained by HAQ and psychological distress 
      but improved with treatment indicating a link with disease activity. The 
      pathophysiological basis of RA fatigue should be further explored.
FAU - Gossec, Laure
AU  - Gossec L
AD  - Sorbonne Universites, UPMC Univ Paris 06, Institut Pierre Louis d'Epidemiologie 
      et de Sante Publique, and AP-HP, Pitie Salpetriere Hospital, Department of 
      rheumatology, Paris, France. laure.gossec@aphp.fr.
FAU - Steinberg, Ghislaine
AU  - Steinberg G
AD  - Medical Department, Roche, France.
FAU - Rouanet, Stephanie
AU  - Rouanet S
AD  - eXYSTAT, Paris, France.
FAU - Combe, Bernard
AU  - Combe B
AD  - Rheumatology Department, Lapeyronie Hospital, Montpellier CHRU, and Universite 
      Montpellier I, Montpellier, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT01667458
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150907
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - I031V2H011 (tocilizumab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Arthritis, Rheumatoid/complications/diagnosis/*drug 
      therapy/physiopathology/psychology
MH  - Drug Administration Schedule
MH  - Fatigue/diagnosis/*etiology/physiopathology/psychology
MH  - Female
MH  - France
MH  - Humans
MH  - Infusions, Intravenous
MH  - Linear Models
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Prospective Studies
MH  - Remission Induction
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2015/09/08 06:00
MHDA- 2015/12/19 06:00
CRDT- 2015/09/08 06:00
PHST- 2015/01/08 00:00 [received]
PHST- 2015/03/13 00:00 [accepted]
PHST- 2015/09/08 06:00 [entrez]
PHST- 2015/09/08 06:00 [pubmed]
PHST- 2015/12/19 06:00 [medline]
AID - 9059 [pii]
PST - ppublish
SO  - Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7.