POS0196 DISEASE BURDEN AND IMPACT OF FECAL INCONTINENCE IN SYSTEMIC SCLEROSIS - DATA FROM THE RANDOMIZED ReSScue TRIAL

Background: Patients with systemic sclerosis (SSc) report loss of bowel control as one of the most distressing gastrointestinal (GI) manifestations of their disease. Nevertheless, despite the pivotal aspect of fecal incontinence (FI) care, our understanding of its prevalence and true impact on SSc patients remains elusive. Objectives: The study had three aims; (i) assess prevalence and burden of FI symptoms by two different patient-reported outcome measures, (ii) identify potential associations between FI symptoms and baseline SSc characteristics, and (iii) determine predictive factors for worsening of FI-related quality of life over time in SSc patients with lower GI disease. Methods: In the 20-week multicenter randomized clinical trial (ReSScue) 1 FI symptoms were assessed in 67 SSc patients with moderate to severe lower GI symptoms at baseline, 12 and 20 weeks using the Fecal Incontinence Quality of Life (FIQL) scale and University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 (UCLA GIT) scale. Patients reporting presence of FI symptoms at all three timepoints were defined as having "severe FI". Using multivariable logistic regressions, we assessed associations between baseline FI and frequency of FI with patient characteristics. Next, we assessed associations between FI, by UCLA GIT fecal soilage score and FIQL subscales, as well as ScleroID, HAQ-DI, EuroEQ-5D, patient and physician global assessment and VAS fatigue scale, using Pearson's correlation analysis. Linear mixed-effect models were applied to unveil predictors of FIQL score behavior over time. Results: In the entire cohort, 72% (48/67) reported FI on the FIQL scale, in contrast to 33% (22/67) using the UCLA GIT. Altogether, 14 SSc patients met the definition of "severe" FI. Compared to the patients with no FI, the patients who reported FI symptoms were more often anti-centromere positive and had lower Body Mass Index (Table 1 and Figure 1A). We found that "severe" FI associated with Modified Rodnan Skin Score (Figure 1B), while recurrent FI episodes associated with digital ulcers (DU), loose stools and diarrhea (Figure 1C). Age and disease duration predicted FI worsening over time in all and the severe FI patients (Figure 1D), with no associations between baseline FI severity and score changes in either cohort. The FIQL subdomains, particularly coping (r=-0.74, pConclusion: In SSc patients with moderate to severe lower GI disease, reported prevalence of fecal incontinence symptoms is high. In this study, the FIQL scale identified more FI cases than the UCLA GIT score, probably indicating higher sensitivity of the FIQL scale. Recurrent FI episodes are associated with more severe SSc-related GI involvement. Although we have identified significant associations with various aspects of FI, early FI assessment appears key to prevent the considerable life restrictions patients face daily. REFERENCES: 1 Hoffmann-Vold AM, Fretheim HH, Sarna VK, Barua I, Carstens MN, Distler O, et al. Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial. BMJ Open. 2021 Jun;11(6): e048541. Acknowledgements: NIL. Disclosure of Interests: Cristina Nita: None declared, Håvard Fretheim Boehringer Ingelheim, Bayer, Torhild Garen: None declared, Imon Barua: None declared, Maylen N Carstens: None declared, Henriette Didriksen: None declared, Vikas K. Sarna: None declared, Knut EA Lundin Takeda and Thermofisher, Takeda, Topas, Chugai, Alimentiv and GSK, Oliver Distler Boehringer Ingelheim, Janssen, Medscape, CITUS AG, 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Argenx, Arxx, AstraZeneca, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, Horizon, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Orion, Prometheus, Redxpharma, Roivant, Topadur and UCB., Dinesh Khanna: None declared, Elizabeth Volkmann Boehringer Ingelheim, GSK, Boehringer Ingelheim, Prometheus, Horizon, Øyvind Midtvedt: None declared, Tore Midtvedt: None declared, Alvilde Dhainaut: None declared, Anna-Kristine H Halse: None declared, Gunnstein Bakland: None declared, Inge C. Olsen: None declared, Maiju E Pesonen: None declared, Øyvind Molberg: None declared, Anna-Maria Hoffmann-Vold Boehringer Ingelheim, Boehringer Ingelheim, Janssen, Medscape, Merck Sharp & Dohme, Novartis and Roche, ARXX, BMS, Boehringer Ingelheim, Genentech, Janssen, Medscape, Merck Sharp & Dohme and Roche, Boehringer Ingelheim, Janssen.