ACR Meeting Abstracts

ACR Meeting Abstracts

  • Meetings
    • ACR Convergence 2024
    • ACR Convergence 2023
    • 2023 ACR/ARP PRSYM
    • ACR Convergence 2022
    • ACR Convergence 2021
    • ACR Convergence 2020
    • 2020 ACR/ARP PRSYM
    • 2019 ACR/ARP Annual Meeting
    • 2018-2009 Meetings
    • Download Abstracts
  • Keyword Index
  • Advanced Search
  • Your Favorites
    • Favorites
    • Login
    • View and print all favorites
    • Clear all your favorites
  • ACR Meetings

Abstract Number: 848

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

  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print
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 Serotonin (5-HT4) receptor agonists with only moderate affinity for the 5-HT4 receptors were however withdrawn due to cardiac toxicity.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 .
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-prucalopride-in-the-treatment-of-systemic-sclerosis-related-intestinal-involvement-results-from-an-open-label-cross-over-study/

Advanced Search

Your Favorites

You can save and print a list of your favorite abstracts during your browser session by clicking the “Favorite” button at the bottom of any abstract. View your favorites »

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM ET on November 14, 2024. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

Wiley

  • Online Journal
  • Privacy Policy
  • Permissions Policies
  • Cookie Preferences

© Copyright 2025 American College of Rheumatology