Can We Expect Any Effect of Rituximab on Fatigue in Primary Sjögren Syndrome?: A Systematic Review and Critical Appraisal.

INTRODUCTION: Fatigue is a major determinant of impaired quality of life in primary Sjögren syndrome (pSS) patients. Effective therapeutic strategies are lacking. OBJECTIVES: To review the potential benefit of rituximab, a chimeric anti-CD20 antibody, in the treatment of fatigue in pSS. METHODS: A systematic review on the effect of rituximab on fatigue-related outcome measures was conducted, retrieving evidence from CENTRAL (Cochrane Central Register of Controlled Trials), MEDLINE (via PubMed), EMBASE, and Scopus. RESULTS: No benefit of rituximab over placebo on any fatigue-related outcome measure could be demonstrated in the included trials. Significant effects were only observed when compared with baseline, but not when compared with placebo. CONCLUSIONS: The use of rituximab for the treatment of pSS-related fatigue cannot be supported by the currently available evidence.