Preliminary safety and efficacy profile of prucalopride in the treatment of systemic sclerosis (SSc)-related intestinal involvement: results from the open label cross-over PROGASS study

Table 2 Demographics and baseline clinical characteristics

Variable	Patients with SSc (n = 29)	Arm 1 (drug first, n = 16)	Arm 2 (drug after, n = 13)
Age, years	54.4 ± 10.5	59 ± 9.2	48.8 ± 9.5*
Disease duration, years	12.3 ± 8.7	13.7 ± 9.9	10.7 ± 7.1
lcSSc, n (%)	22 (75.8)	12 (75%)	10 (79.6)
Autoantibody, n (%)
ANA ACA Topo I	27 (93.1) 18 (62.1) 9 (31)	15 (93.7) 11 (68.8) 4 (25)	12 (92.7) 7 (53.8) 5 (38.5)
Likert GERD (0–4)	2.24 ± 0.74	2.25 ± 0.68	2.23 ± 0.83
Likert constipation (0–4)	2.24 ± 0.64	2.44 ± 0.63	2 ± 0.58
UCLA GIT 2.0	0.99 ± 1.,28	1.23 ± 1.65	0.69 ± 0.49
UCLA GIT 2.0 constipation	1.27 ± 0.67	1.31 ± 0.68	1.21 ± 0.68
UCLA GIT 2.0 subscales
Reflux Bloating Fecal soilage Diarrhea Social activities Emotional wellbeing	1.01 ± 0.69 1.48 ± 0.9 0.51 ± 0.91 0.22 ± 0.41 0.72 ± 0.59 0.77 ± 0.78	1 ± 0.76 1.5 ± 0.97 0.61 ± 1.02 0.34 ± 0.47 0.83 ± 0.68 0.86 ± 0.85	1.02 ± 0.63 1.46 ± 0.85 0.38 ± 0.77 0.08 ± 0.28 0.59 ± 0.44 0.67 ± 0.71

Values expressed as mean ± standard deviation except where otherwise indicated. SSc systemic sclerosis, lcSSc limited cutanoeus SSc, ANA antinuclear antibodies, ACA anticentromere antibodies, Topo I anti-Topomerase I antibodies, GERD gastroesophageal reflux disease, UCLA GIT University of California Los Angeles gastrointestinal tract questionnaire
*p < 0.05 vs Arm 1

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