Background/Purpose: The increasing use of ESSDAI and patient reported outcomes (PROs) in primary Sjögren’s syndrome (pSS) clinical trials has pointed out that the performance of the single domains and scales of these indices may differ in the short term period. Objective of this study was to analyze the performance of single ESSDAI domains and ESSPRI scales in detecting changes of disease activity/PROs over a 12-month follow-up in real-life and to explore any eventual correlation between ESSDAI and ESSPRI.

Methods: This is a 12-month longitudinal single centre study including consecutive patients with pSS (AECG 2002). All the patients were evaluated at least twice during the study period. At each visit, patients completed the ESSPRI and the same researcher assessed the ESSDAI domains. Minimal clinically important improvement (MCII), defined as an improvement of at least three points of the ESSDAI, and the patient acceptable symptom state (PASS), defined as an ESSPRI<5 points, were calculated at the end of the follow-up. A ≥30% reduction of the patient’s dryness/fatigue/pain VAS was also evaluated as response outcome measure.

Results: We included 275 patients (267F: 8M) with pSS (mean age (DS): 57(13.6) yrs; mean follow-up (DS): 6(5) yrs. Out of them, at baseline: 14/275 (5.1%) presented a high disease activity (ESSDAI≥14), 69/275 (25.1%) a moderate disease activity (5≤ESSDAI≤13) and 192/275 (69.8%) a low disease activity (ESSDAI <5). Patients were treated according to the standard of care therapy for pSS. At the end of follow-up, MCII was reached by 17% of the patients. Levels of disease activity remained stable in the vast majority of the cases (79%) and worsened in 4% of the patients. Among the ESSDAI domains, those that showed the most significant tendency to improve were the “articular” and “cutaneous” domains (p<0.000), whereas “biological” domain tended to remain unchanged. The use of hydroxychloroquine and a high ESSDAI at baseline were associated to MCII (p=0.000 and p=0.002). An ESSPRI<5 was observed in 20.7% of the patients at the inclusion and in 22.2% at the end of the follow-up. ESSPRI remained unchanged in 80.8% of the patients, improved in 10.4% and worsened in 8.8%. A ≥30% reduction of the patient’s oral and ocular dryness/fatigue/pain VAS was observed in 17%, 15.6%, 14.1% and 20% of the cases. No correlation was detected between ESSDAI and ESSPRI.

Conclusion: This study highlights the general concept that pSS is a slowly progressive disease and that disease activity and PROs are not correlated. Some domains of the ESSDAI seem to capture changes of disease activity better than others in the short term and this may have a value when using ESSDAI in clinical trials.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinically-meaningful-improvement-of-essdai-and-esspri-in-patients-with-primary-sjogrens-syndrome-in-real-life-a-12-month-longitudinal-study/