THU0063 Does biologic treatment modify the relationship of the variables associated with fatigue in patients with rheumatoid arthritis? The peps study of tocilizumab in real life:
Authors: L. Gossec, S. Rouanet, G. Steinberg, B. Combe
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Fatigue is an important domain of health in rheumatoid arthritis (RA), however it seems to be associated with patient-related variables (eg, depression) as much as disease-related variables (eg, disease activity). Biologics are efficacious on disease activity: do they modify the relationship between fatigue and other variables, eg psychological status? Fatigue is an important domain of health in rheumatoid arthritis (RA), however it seems to be associated with patient-related variables (eg, depression) as much as disease-related variables (eg, disease activity). Biologics are efficacious on disease activity: do they modify the relationship between fatigue and other variables, eg psychological status? <h3>Objectives</h3> To define variables related with fatigue in a population of RA patients starting a biologic, tocilizumab (TCZ), and to assess whether the treatment modifies the relationship between fatigue and these associated variables. <h3>Methods</h3> PEPS is a multicenter non-interventional study assessing fatigue in real life in patients starting TCZ. <i>Patients:</i> RA patients requiring TCZ according to their physician. <i>Treatment:</i> TCZ as prescribed in real life. Follow-up duration =4 months (first 5 infusions). <i>Endpoint:</i> Fatigue (FACIT-fatigue scale, 0-52, higher results indicate less fatigue, ref 2). <i>Covariates:</i> Variables possibly associated with fatigue levels at baseline then after 4 months of treatment. Variables analyzed were HAQ, patient global, sleep numeric rating scale, anxiety and depression by HADS, swollen joint count, and haemoglobin. <i>Analysis:</i> Multiple linear regression at both time points (no imputation of missing data). <h3>Results</h3> 719 pts were included; 610 had analyzable data; mean age 56±13 yrs, disease duration 12±10 yrs, 490 (81%) women, 463 (81%) rheumatoid factor or ACPA positive, 84% biologic insufficient responders. Mean (±SD) baseline DAS28 and FACIT-fatigue were respectively 5.3±1.1 and 24±10. At 4 months, TCZ reduced disease activity: mean DAS28 was 2.9±1.3, and improved fatigue; mean FACIT-fatigue was 33±11.The relationships between fatigue and the tested variables were not modified by the introduction of a biologic. <h3>Conclusions</h3> Fatigue levels were high in these long-standing active RA patients. Fatigue was mainly associated with HAQ and psychological status, rather than swollen joint count. Treatment with TCZ improved fatigue levels but did not modify the relationship between fatigue and the elements associated with fatigue. Fatigue is a patient-relevant aspect of RA and should continue to be further assessed as an outcome measure. <h3>References</h3> Gossec L et al, Arthritis Rheum 2011;63 Suppl 10: poster 1243. Cella D et al, J Rheumatol. 2005; 32:811-9. <h3>Disclosure of Interest</h3> L. Gossec Grant/Research support from: Honoraria from Roche Chugai as principle investigator, S. Rouanet Employee of: Roche Employee, G. Steinberg Employee of: Roche Employee, B. Combe Grant/Research support from: Honoraria from Roche Chugai as principle investigator