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.