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How to Assess Treatment Efficacy in Sjo¨Gren's Syndrome?

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How to Assess Treatment Efficacy in Sjo¨Gren's Syndrome? REVIEW CURRENT OPINION How to assess treatment efficacy in Sjo¨gren’s syndrome? Arjan Vissinka, Hendrika Bootsmab, Frans G.M. Kroeseb, and Cees G.M. Kallenbergb Purpose of review This article critically reviews the current views and discusses the future challenges with regard to assessing disease progression and disease activity in Sjo¨gren’s syndrome, as a decrease of disease progression and activity is what an effective Sjo¨gren’s syndrome therapy aims for. This topic has recently gained renewed attention as targeted treatment modalities have become available in primary Sjo¨gren’s syndrome, while the lack of well established outcome parameters interferes with a straightforward comparison of the outcomes of the various trials. Recent findings Recent advances in how to assess changes in disease progression and activity objectively (via repeated biopsies of salivary glands, sialometry, sialochemistry, biomarkers, secretion and composition of tears, EULAR Sjo¨gren’s Syndrome Disease Activity Index: ESSDAI) and subjectively (EULAR Sjo¨gren’s Syndrome Patient Related Index: ESSPRI) have opened new ways to reliably assess the outcome of a particular treatment. Summary Newly applied tools are instrumental, both for clinical research and clinical practice, in reliably judging and comparing the value of well established and newly developed therapies in Sjo¨gren’s syndrome. Keywords biologicals, ESSDAI, ESSPRI, saliva, Sjo¨gren’s syndrome, tears, treatment efficacy INTRODUCTION studies which makes a proper comparison of results && & Sjo¨gren’s syndrome is an autoimmune inflamma- between studies difficult if even possible [7 ,8 ]. tory disorder of exocrine glands. It particularly Therefore, this study critically reviews the current affects the lacrimal and salivary glands. Dry mouth views and future challenges with regard to measur- and dry eyes are frequently proffered as presenting ing disease activity and disease progression in symptoms [1,2]. These symptoms are in many cases Sjo¨gren’s syndrome. accompanied by nonspecific symptoms, such as malaise and fatigue [3]. In addition, extraglandular PROGRESSION AND DISEASE ACTIVITY ¨ manifestations, like purpura, polyneuropathy, and IN PRIMARY SJOGREN’S SYNDROME arthritis, can be present, even as presenting signs of As mentioned in the introduction, the largest hurdle the disease [2]. Lymphomas develop in 5–10% of to be taken is to develop a reliable set of assessments Sjo¨gren’s syndrome patients [4,5]. Sjo¨gren’s syn- drome affects mainly women with a female/male a b ratio of 9 : 1 and can occur at all ages. Department of Oral and Maxillofacial Surgery and Department of In-vitro and in-vivo experimental data have Rheumatology and Clinical Immunology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands pointed to new immunopathogenic mechanisms Correspondence to Arjan Vissink, DMD, MD, PhD, Department of Oral in primary Sjo¨gren’s syndrome (pSS). The availabil- and Maxillofacial Surgery, University Medical Center Groningen, ity of targeted treatment modalities has opened new University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The ways to selectively target these mechanistic path- Netherlands. Tel: +31 50 3613840; fax: +31 50 3611136; e-mail: ways in vivo [6&]. A problem of all studies assessing [email protected] the efficacy of these new modalities is the large Curr Opin Rheumatol 2012, 24:281–289 variety of outcome parameters used in the various DOI:10.1097/BOR.0b013e3283524c37 1040-8711 ß 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins www.co-rheumatology.com Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Clinical therapeutics Activity Index (ESSDAI) [12&,13&,25&] as there are for KEY POINTS rheumatoid arthritis (RA) [26] and systemic lupus ESSPRI and ESSDAI are promising tools to assess erythematosus (SLE) [27]. disease activity and disease progression in pSS to With regard to pSS, studies are in progress to monitor treatment efficacy. assess the reliability and sensitivity to change of the ESSDAI and ESSPRI. Such studies are important as Salivary gland functioning in pSS patients is best the usefulness of instruments designed to measure assessed by measuring glandular secretions and should be included in monitoring progression and treatment change over time or after therapeutic intervention is efficacy of pSS. not only dependent on their validity and reliability, but also on their potential to detect clinically Tear osmolarity may evolve into a more potent tool for relevant changes [28–30]. Seror et al. [12&] retrospec- assessing the ocular component in pSS than lisamin tively investigated the sensitivity to change of the green and Schirmer tests. ESSDAI over time in 96 patient profiles and reported Proteomic and genomic approaches in saliva and tears that the internal and external responsiveness of are potent tools to facilitate diagnosis, to monitor the ESSDAI was large, and changes over time were effect of a particular treatment, and to contribute to detected more accurately than with other known understanding of pSS pathogenesis. indices. Meiners et al. [31&&] prospectively assessed Labial or parotid biopsies are needed for proper the internal and external responsiveness to change diagnosis, as they may indicate the likelihood of of ESSPRI and ESSDAI in pSS patients treated with developing MALT or NHL lymphoma and thus may rituximab. The latter study revealed that ESSPRI indicate which patient has to be closely monitored. and ESSDAI are, indeed, sensitive to measure the Repeated (parotid) salivary gland biopsies may show changes in disease activity after therapeutic inter- what the treatment effect is at a tissue level. vention, which supports the usefulness of these indices for future clinical trials. The promising results from the retrospective analysis of Seror et al. [12&] and the prospective intervention study by which the efficacy of a particular treatment by Meiners et al. [31&&] showed that, when validated, approach can be assessed, meanwhile allowing evi- application of both instruments for outcome dence-based comparison of the various treatment measurements in randomized controlled clinical approaches tested in pSS [6&,7&&,8&]. Such a set of trials should allow assessing all aspects of pSS assessments probably also can be used to rate disease (Fig. 1). activity and disease progression in pSS. Saliva EULAR Sjo¨ gren’s Syndrome Disease Activity Within the wide spectrum of clinical manifestations Index and EULAR Sjo¨ gren’s Syndrome of Sjo¨gren’s syndrome, salivary gland dysfunction is Patient Related Index considered to be a key manifestation [32]. Dysfunc- Evidence-based therapy for Sjo¨gren’s syndrome is tion of the salivary glands results in changes of the largely limited to treatments that improve sicca amount and composition of the saliva. The auto- features [7&&,9–11]. In addition, the variety of ad immune process itself is reflected by the presence of hoc outcome measures used to rate the effects of various components of the immune response, such both symptomatic and disease-modifying treat- as cytokines, chemokines, autoantibodies, in saliva. ments are mainly based on glandular symptoms As such, sialometry is not only of diagnostic but also [12&,13&]. Therefore, validated activity indexes are of prognostic importance. Moreover, as the amount needed to assess the effectiveness of (new) targeted and composition of saliva reflect the damage caused therapies [14–16]. For example, B-cell-targeted by the autoimmune process in the salivary glands, therapies have shown promising results for both sialochemistry may be valuable in diagnosis, assess- systemic [17–22] and glandular features ment of prognosis, and evaluation of treatment [17,21,23,24&&], but, again, a variety of outcome [17,24&&,33–36]. Thus, sialometry and sialochemis- measures has been used [7&&,8&]. To solve these short- try can be used as a diagnostic tool either by collect- comings, the European League against Rheumatism ing whole saliva (the combined secretions of all (EULAR) recently introduced a patient-administered salivary glands) [37] or by collecting glandular saliva questionnaire to assess patient symptoms (EULAR (gland-specific saliva) [33,34,38,39]. Although Sjo¨gren’s syndrome Patient Reported Index: ESSPRI) unstimulated whole saliva is a major criterion for and a systemic activity index to assess systemic the evaluation of salivary gland dysfunction in complications (EULAR Sjo¨gren’s Syndrome Disease Sjo¨gren’s syndrome [37], when Sjo¨gren’s syndrome 282 www.co-rheumatology.com Volume 24 Number 3 May 2012 Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Treatment efficacy in Sjo¨ grens syndrome Vissink et al. (a) Score 10 ESSPRI 9 ESSDAI 8 7 6 * ** * 5 4 3 2 ** * 1 0 0122436 48 60 Time (weeks) (b) Improvement 100 disease activity Constitutional 80 Glandular Articular 60 Haematological Biological 40 20 0 0 12 24 36 48 60 Time (weeks) FIGURE 1. Disease activity in primary Sjo¨gren’s syndrome patients treated with rituximab (median values). (a) ESSPRI and ESSDAI. (b) Disease activity for the ESSDAI domains showing the highest changes (percentage of patients with no disease activity in a particular domain is given). ÃIndicates significant (P < 0.05) change compared with baseline [31&&]. develops, not all major salivary glands may yet recent progress in proteomics and genomics has manifest dysfunction, rendering whole saliva
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