Background/Purpose: The EULAR Sjögren’s syndrome (SS) disease activity index (ESSDAI) and EULAR SS Patient-Reported Index (ESSPRI) have been validated as disease activity and outcome measures for primary SS. However, there has been few studies on longitudinal ESSPRI and ESSDAI changes. We therefore aimed to prospectively investigate their temporal changes and to analyze the clinical features associated with a favorable course of ESSPRI in pSS patients.

Methods: A total of 115 pSS patients were evaluated using the ESSPRI, ESSDAI, EQ5-D, Fatigue Severity Score (FSS), Beck Depression Inventory (BDI), EULAR Sicca Score (ESS), Xerostomia Inventory (XI), patient’s global assessment (PGA) for pSS, and visual analog scale (VAS) scores for symptoms. After a median 3 (range 3.0-3.2) years, 100 patients repeatedly completed the questionnaires. The favorable course was defined as an improvement in ESSPRI (from baseline ESSPRI≥5 to follow-up ESSPRI< 5) or maintenance of ESSPRI< 5, and the unfavorable course as worsening of ESSPRI (from baseline ESSPRI< 5 to follow-up ESSPRI≥5) or maintenance of an unsatisfactory symptom status (ESSPRI≥5). The minimal clinically important improvement (MCII) was defined as decreased at least one point or 15% of ESSPRI in patients with ESSPRI≥5.

Results: The ESSPRI remained stable over 3 years although VAS scores for arthralgia, myalgia, anxiety, and PGA were significantly reduced (all P< 0.001). Serum IgG levels (P< 0.01) and ESSDAI scores (P< 0.05) were significantly reduced but clinical ESSDAI scores were unchanged during the follow-up. Fourteen (28.0%) showed the worsening of ESSPRI among patients with baseline ESSPRI< 5 (n=50) and 16 (36.0%) showed the improvement of ESSPRI among those with baseline ESSPRI≥5 (n=50). Only 8 (16.0%) achieved MCII in ESSPRI in patients with unsatisfactory symptom status at the baseline and 52 (52.0%) had a favorable course in total patients. Patients with MCII had higher total and clinical ESSDAI scores (all P< 0.001) and more lacrimal flow (P< 0.05) at the diagnosis than those without MCII. Patients with favorable course had lower scores of ESS, FSS, BDI, and XI and VAS levels for oral or eye dryness, myalgia, anxiety, and PGA. On the contrary, they showed higher ESSDAI scores than those with unfavorable course. Unexpectedly, the use of bupropion increased in patients with favorable course (19.2% vs 8.3%) and in patients with an improvement of unsatisfactory ESSPRI (50.0% vs 11.8%, p=0.01), when compared to those without, respectively. Multivariate analysis revealed that the favorable course was significantly associated with low levels of anxiety (OR 5.6), low ESS scores (OR 8.0), moderate-to-high ESSDAI (OR 7.1), bupropion use (OR 7.9), and baseline ESSPR< 5 (OR 5.8).

Conclusion: This study suggests that baseline ESSPRI provides a prognostic value for its longitudinal change, and the presence of extra-glandular features and more residual exocrine function could be associated with a favorable outcome in pSS. Additionally, bupropion may have beneficial effect on temporal changes in ESSPRI.

ACR_Table_SS_ESSPRI_F

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/baseline-eular-sjogrens-syndrome-patient-reported-index-has-a-significant-impact-on-the-longitudinal-course-of-sjogrens-syndrome/