Efficacy of Prucalopride in the Treatment of Systemic Sclerosis-Related Intestinal Involvement: Results from an Open Label Cross-over Study

Barbara Vigone¹, Monica Caronni¹, Adriana Severino¹, Chiara Bellocchi², Anna Rita Baldassarri³, Gaia Montanelli⁴, Alessandro Santaniello¹ and Lorenzo Beretta¹, ¹Scleroderma Unit, Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy, ²Scleroderma Unit, Referral Center for Systemic Autoimmune Diseases,, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy, ³Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy, ⁴Scleroderma Unit, Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Milano, Italy

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Clinical research, Gastrointestinal complications and systemic sclerosis

Session Information

Date: Sunday, November 13, 2016

Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud's – Clinical Aspects and Therapeutics - Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: The gastrointestinal tract (GIT) is frequently affected in SSc patients as a consequence of a reduction in enteric propulsive forces. Due to intestinal involvement, patients may experience diarrhea, constipation, bloating, weight loss and a general reduction in well-being. The use of prokinetics proved effective in treating some SSc patients with GIT. Serotonin (5-HT4) receptor agonists with only moderate affinity for the 5-HT4 receptors were however withdrawn due to cardiac toxicity. Prucalopride is a high-affinity 5-HT4 receptor agonists with no major cardiac issues, whose efficacy in SSc has not been assessed yet.

Methods: Forty patients with self-reported mild-to-moderate enteric symptoms were enrolled in a cross-over 2 x 2 study. Subjects were given prucalopride 2 mg/day or no treatment for one month and vice versa after a 2 weeks washout period, according to the ABBA sequence. Before and after each sequence the patients compiled the UCLA GIT 2.0 questionnaire and Likert scales to rate the severity of GIT involvement or constipation; the number of complete intestinal movements and the number of used laxatives were also recorded. Mixed linear models, were used to compare responses correcting for the number of laxatives.

Results: Seven patients did experience side effects (headache and dizziness, diarrhea, abdominal pain) and 4 patients were not compliant to study procedures (inadequate drug intake); 29 subjects did complete the study. Baseline GIT parameters and main results are reported in the Table. Prucalopride treatment was ranked as moderately-to-extremely effective by 22 patients (72.4%).

Conclusion: The safety profile of Prucalopride in SSc is similar to what had already reported in the literature. In SSc patients with mild-to-moderate GIT problems, prucalopride may be effective in treating dismotility symptoms, increasing the number of complete bowel movements, partially reducing reflux disease and improving the patents’ well-being.

Variable	Baseline	*Change after prucalopride**	*Change after no drug**	p
Bowel movements	NA	26,96 ± 13,84**	15,63 ± 10,54**	5*10-6
Likert GIT	2,24 ± 0,74	-0,68 ± 0,72	0 ± 0,29	7.4*10-5
Likert Constipation	2,24 ± 0,64	-1,32 ± 0,9	0,19 ± 0,79	8.1*10-8
GIT	0,99 ± 1,28	-0,15 ± 0,39	0,02 ± 0,21	0.032
GIT Constipation	1,27 ± 0,67	-0,67 ± 0,76	0,08 ± 0,26	6.3*10-5
GIT Subscales Reflux Bloating Fecal soilage Diharrea Social activities Emotional well-being	1,01 ± 0,69 1,48 ± 0,9 0,51 ± 0,91 0,22 ± 0,41 0,72 ± 0,59 0,77 ± 0,78	-0,41 ± 0,57 -0,42 ± 0,47 -0,1 ± 0,91 0,36 ± 0,62 -0,12 ± 0,7 -0,22 ± 0,49	0,01 ± 0,39 -0,08 ± 0,43 0,08 ± 0,28 0,09 ± 0,24 0 ± 0,38 0,02 ± 0,46	0.003 0.010 0.346 0.053 0.388 0.041

*Negative values indicate improvement **Total number of spontaneous bowel movements/arm

Disclosure: B. Vigone, None; M. Caronni, None; A. Severino, None; C. Bellocchi, None; A. R. Baldassarri, None; G. Montanelli, None; A. Santaniello, None; L. Beretta, None.

To cite this abstract in AMA style:

Vigone B, Caronni M, Severino A, Bellocchi C, Baldassarri AR, Montanelli G, Santaniello A, Beretta L. Efficacy of Prucalopride in the Treatment of Systemic Sclerosis-Related Intestinal Involvement: Results from an Open Label Cross-over Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-prucalopride-in-the-treatment-of-systemic-sclerosis-related-intestinal-involvement-results-from-an-open-label-cross-over-study/. Accessed .

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