Efficacy and safety of rituximab treatment in early primary Sjögrens syndrome: a prospective, multi-center, follow-up studyReport as inadecuate




Efficacy and safety of rituximab treatment in early primary Sjögrens syndrome: a prospective, multi-center, follow-up study - Download this document for free, or read online. Document in PDF available to download.

Arthritis Research and Therapy

, 15:R172

First Online: 30 October 2013Received: 10 July 2013Accepted: 09 October 2013

Abstract

IntroductionPrimary Sjögren’s syndrome pSS is an autoimmune disorder affecting exocrine glands; however, a subgroup of pSS patients experience systemic extra-glandular involvement leading to a worsening of disease prognosis. Current therapeutic options are mainly empiric and often translated by other autoimmune diseases. In the last few years growing evidence suggests that B-cell depletion by rituximab RTX is effective also in pSS. Patients with early active disease appear to be those who could benefit the most from RTX. The aim of this study was to investigate the efficacy and safety of RTX in comparison to disease modifying anti-rheumatic drugs DMARDs in early active pSS patients.

MethodsForty-one patients with early pSS and active disease EULAR Sjogren’s syndrome disease activity index, ESSDAI ≥ 6 were enrolled in the study. Patients were treated with either RTX or DMARDs in two different Rheumatology centers and followed up for 120 weeks. Clinical assessment was performed by ESSDAI every 12 weeks up to week 120 and by self-reported global disease activity pain, sicca symptoms and fatigue on visual analogic scales, unstimulated saliva flow and Schirmer’s I test at week 12, 24, 48, 72, 96, and 120. Laboratory assessment was performed every 12 weeks to week 120. Two labial minor salivary gland MSG biopsies were obtained from all patients at the time of inclusion in the study and at week 120.

ResultsOur study demonstrated that RTX treatment results in a faster and more pronounced decrease of ESSDAI and other clinical parameters compared to DMARDs treatment. No adverse events were reported in the two groups. We also observed that RTX is able to reduce glandular infiltrate, interfere with B-T compartmentalization and consequently with the formation of ectopic lymphoid structures and germinal center-like structures in pSS-MSGs.

ConclusionsTo our knowledge, this is the first study performed in a large cohort of early active pSS patients for a period of 120 weeks. We showed that RTX is a safe and effective agent to be employed in pSS patients with systemic, extra-glandular involvement. Furthermore, our data on pSS-MSGs provide additional biological basis to employ RTX in this disease.

AbbreviationsBAFFB-cell activating factor

DMARDDisease-modifying anti-rheumatic drug

ESSDAIEULAR Sjögren’s syndrome disease activity index

FLSFocal lymphocytic sialadenitis

GCGerminal center

HR-QoLHealth-related quality of life

LTLymphotoxin

MSGMinor salivary gland

pSSPrimary Sjögren’s syndrome

RTXRituximab

VASVisual analogic scales.

Electronic supplementary materialThe online version of this article doi:10.1186-ar4359 contains supplementary material, which is available to authorized users.

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Author: Francesco Carubbi - Paola Cipriani - Alessandra Marrelli - Paola Di Benedetto - Piero Ruscitti - Onorina Berardicurti - Ile

Source: https://link.springer.com/







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