Background: The EULAR Systemic Sclerosis Impact of Disease (ScleroID) questionnaire is a comprehensive and easy to perform PRO able to capture the overall impact by ten domains, Raynaud’s phenomenon, hand function, upper and lower gastrointestinal (GI) tract symptoms, pain, fatigue, body mobility, life choices limitation, breathlessness, and digital ulceration in patients with Systemic sclerosis (SSc).

Objectives: The aim of this study is to assess the sensitivity to change of ScleroID and its associated domain questions over a 12-month period in patients with stand of care immunosuppressive treatment (IS).

Methods: Patients who were fulfilling the 2013 ACR/EULAR SSc classification criteria from the observational cohort STRIKE (Stratification for Risk of Progression in Systemic Sclerosis) between January 2022 and 2024 and who had at least two (12±3 months) ScleroID questionnaires were included in the study. IS, vasodilatator (VD), and proton pump inhibitors (PPI) treatments were recorded. The difference between 12-month follow-up and baseline scores was defined as change (Δ). The modified version of the EUSTAR Disease Activity Index (mDAI) was used for assessing disease activity. The differences between the two visits were analysed with using Wilcoxon-signed rank test. To determine significant factors for follow-up ScleroID score, multivariable linear regression was used.

Results: Among 97 SSc patients with at least two ScleroID questionnaires in 12 month time, 69 patients who had treatment data were included in the study. There were 59 female with a mean age of 57.1 ±13.3 years. Limited cutaneous SSc was observed in 47 (68.1%) patients, and diffuse cutaneous SSc was observed in 22 (31.9%) patients. The demographic and clinical characteristics of the study population are given in Table 1. The median (IQR) score of total ScleroID was 4.1 (4.3) at baseline and 3.8 (4.5) at 12 ^th month. The median (IQR) subitem scores at baseline and follow-up were 3 (5) and 4 (6) for Raynaud’s, 4 (6) and 4 (5) for hand function, 3 (6) and 4 (7) for upper GI, 4 (6) and 4 (6) for pain, 6 (6) and 5 (6) for fatigue, 5 (8) and 5 (7) for lower GI, 5 (7) and 5 (7) for life choices limitation, 4 (7) and 3 (8) for body mobility, 3 (5) and 3 (6) for breathlessness, and 0 (3) and 0 (3) for digital ulcer. Thirty-five (52.2%) patients were on stable immunosuppressive treatment throughout the 12 months observation. The median (IQR) duration of immunosuppressive treatment at baseline was 4 (59.5) months. PPI was used in 59 (85.5%), VD was used in 47 (68.1%), and antifibrotic was used in 3 (4.3%) patients. Raynaud’s, hand function, upper GI, pain, fatigue, body mobility, life choices limitation, breathlessness, and total score were significantly higher at baseline in the IS group compared to the non-IS group; however, at the end of 12 months, only upper GI was higher in the IS-using group (Table 2). On the other hand, there was a significant change in ScleroID fatigue subitem in 12-month time among patients using immunosuppressives (z=-2.32, p=0.02). In multivariable linear regression analysis for ScleroID total score at the end of 12-month, lower ScleroID total score was associated with using immunosuppressives (Beta:-0.569, p=0.009) and baseline lower ScleroID total scores (Beta: 0.767, CI 95%: 0.515-1.113, p<0.001).

Conclusions: ScleroID scores show sensitivity to change over 12 months, particularly in patients on IS. Larger studies to assess the impact of IS treatment on ScleroID subitems will inform better approaches to capture impact on how patients feel and function in clinical trial design.

REFERENCES: NIL.

Acknowledgments: NIL.

Disclosure of Interests: None declared.