Background/Purpose: The Prospective Registry of Early Systemic Sclerosis

(PRESS) is a multicenter incident cohort study of patients with early diffuse cutaneous systemic sclerosis (dcSSc; < 2 years duration).  Gastrointestinal tract (GIT) symptoms are common in this patient population. The goal of this study was to analyze whether immunosuppressant choice differentially impacts GIT symptoms in early dcSSc.

Methods: There are currently 71 patients enrolled in the PRESS study at various centers in the United States. Data is collected longitudinally using REDCap, an NIH funded database including demographics, disease characteristics, physical exam data, and patient reported outcomes.  PRESS patients who had both a complete gastrointestinal tract questionnaire (SCTC UCLA GIT 2.0) and immunosuppressant regimen recorded were included in this analysis. Statistical analysis was performed using SAS version 9.4.  Fisher’s exact was to examine associations between two categorical variables and unpaired t-test or Wilcoxin ranked sum was used for continuous variables.  Significance was assigned at p< 0.05.

Results: A total of 37 PRESS patients had the presence or absence of an immunosuppressant at the baseline visit/ and a complete GIT 2.0 recorded.  In this subgroup of PRESS patients, the most common immunosuppressant used was mycophenolate mofetil (n=17) followed by methotrexate (n=5) and cyclophosphamide (n=3). The mean age of this patient population was 52 years (12.8) and 24 were women. The average BMI was 25.2 (17.8-40.5).  Fifteen patients reported > 5 kg of weight loss over the past year; 5 of those patients had > 20 kg of weight loss.  In these 15 patients with weight loss there were significantly worse scores for total GIT 2.0 (p=0.03), soilage (p=0.01), social function (p=0.05) and emotional well-being (p=0.04).  

There were no significant differences in the GIT 2.0 total and component scores between different immunosuppressive regimens (Table 1).  No PRESS patients reported a complete absence of gastrointestinal tract symptoms.

Conclusion: Gastrointestinal symptoms captured by the GIT 2.0 are common in early dcSSc.  In patients with weight loss, scores for soilage, social, and emotional well-being are significant aspects of GIT involvement. In the PRESS cohort specific immunosuppressant exposure was not a strong driver of GIT symptoms, however, further longitudinal study in this patient population is planned.

Table 1: PRESS patient immunosuppressant use and gastrointestinal symptoms captured as components of GIT 2.0 (mean, standard deviation)

	Cyclophosphamide		Mycophenolate Mofetil		Methotrexate
	Yes N=3	No N=34	Yes N=17	No N=20	Yes N=5	No N=32
Reflux	0.94 0.5-1.38	0.58 0-2.63	0.44 0.-2.0	0.73 0-2.3	0.75 0-2.62	0.57 0-2.0
Bloating	0.94 1.5-2.5	0.74 0-2.5	0.72 0-2.25	0.88 0-2.5	0.95 0.25-2.0	0.78 0-2.5
Diarrhea	1.25 0.5-1.38	0.31 0-1.5	0.29 0-1.5	0.43 0-1.5	0.61 0-1.50	0.34 0-1.5
Social Function	0.42 0.-1.0	.29 0.-2.17	0.15 0-1.3	0.42 0-2.2	0.6 0-2.17	0.24 0-1.33
Soil	0.50    0-1.0	0.06 0-2.0	0	0.15 0-2.0	0.4 0-2.0	0.03 0-1
Emotional	0.23 0.23-0.56	0.24 0-1.88	0.20 0.-1.78	0.59 0-1.88	0.64 0-1.89	0.18 0-1.78
Constipation	0.5 0- 0.56	1.36 0-7.0	1.13 0-7	1.47 0-7.0	2.0 0-4.0	1.22 0-7.0
Total GIT 2.0	5.38 4.8-5.9	2.2 0-12.2	1.79 0.13-7.74	2.87 0-12.2	3.84 0.38-12.2	2.15 0-7.74

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/association-of-gastrointestinal-symptoms-with-immunosuppressant-use-in-the-prospective-registry-of-early-systemic-sclerosis-cohort/