THU0312 Physical Fatigue Is Very Important as Clinical Outcome for Improvement by Treatment According To Patients with Primary Sjögren's Syndrome
Authors: S. Arends, P.M. Meiners, F.G. Kroese, E. Brouwer, F.K. Spijkervet, A. Vissink, H. Bootsma
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> Besides ocular and oral dryness, fatigue is a prominent symptom in patients with primary Sjögren9s syndrome (pSS). <h3>Objectives</h3> To investigate the importance of fatigue in relation to other symptoms and to evaluate the effect of rituximab treatment on fatigue in pSS patients with active disease. <h3>Methods</h3> The present analysis was based on data from our follow-up study of treatment with rituximab.(1) Twenty-eight pSS patients were treated with rituximab (1000 mg at days 1 and 15) and evaluated for 60 weeks. Subjective symptoms of dryness, physical fatigue, and limb pain were scored on a scale of 0–10 according to the ESSPRI. Mental fatigue was also scored on a scale of 0–10. Patients were asked to rank their symptoms of dryness, physical fatigue, pain, and mental fatigue in order of importance; from most to least eligible for improvement. In addition, the importance for improvement of each symptom was scored on a scale of 0–10. Fatigue was assessed in more detail with the Multidimensional Fatigue Inventory (MFI). Systemic disease activity was assessed with the ESSDAI. <h3>Results</h3> At baseline, 24 of the 28 (86%) pSS patients reported physical fatigue as most eligible for improvement, followed by pain and dryness. Mental fatigue was ranked as least eligible for improvement by 50% of the patients. However, for all these 4 domains, patients found it very important to get rid of their symptoms, reflected by median scores of importance of 8 or higher. The highest scores were given for physical fatigue (median 10, IQR 9–10). Rituximab treatment resulted in a significant improvement in all clinical assessments. At 16 and 24 weeks of follow-up, physical fatigue showed 31% and 25% improvement in median values at group level, pain 36 and 29%, dryness 29% and 36%, and mental fatigue 36% and 9%, respectively. Regarding MFI domains, most improvement was reported in general (25% and 25%) and physical (19% and 16%) fatigue. In comparison, systemic disease activity assessed with ESSDAI improved 73% at group level. At 60 weeks of follow-up, all clinical assessments had returned to baseline values. Before rituximab treatment, 18% of the patients had physical fatigue score &lt;5, representing patient-acceptable symptom state (PASS). At 16–24 weeks, this proportion of patients increased to 21–36%. The proportion of patients with low disease activity according to ESSDAI increased from 29% at baseline to 75–79% at 16–24 weeks. <h3>Conclusions</h3> Fatigue is a very important symptom in pSS patients with active disease, which particularly concerns physical fatigue. Rituximab treatment resulted in a significant improvement of all patient-reported symptoms. However, the large majority of patients still experienced physical fatigue above the cut-off value for the PASS. Therefore, clinical attention for this prominent symptom is warranted in future clinical trials in pSS. <h3>References</h3> Meiners et al. Ann Rheum Dis. 2012;71(8):1297–302. <h3>Disclosure of Interest</h3> None declared