Longitudinal Assessment of Gastrointestinal Symptoms in the Prospective Registry of Early Systemic Sclerosis Cohort

Tracy M. Frech¹, Maureen Murtaugh², Jessica K. Gordon³, Robyn T. Domsic⁴, Ami A. Shah⁵, Faye N. Hant⁶, Shervin Assassi⁷, Monique E. Hinchcliff⁸, Elana J. Bernstein⁹, Virginia D. Steen¹⁰, Victoria K. Shanmugam^11,12 and Dinesh Khanna¹³, ¹Div of Rheumatology, University of Utah, Salt Lake City, UT, ²University of Utah, Salt Lake, UT, ³Rheumatology, Hospital for Special Surgery, New York, NY, ⁴Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, ⁵Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, ⁶Dept of Medicine, Medical University of South Carolina, Charleston, SC, ⁷Rheumatology, University of Texas Medical School at Houston, Houston, TX, ⁸Division of Rheumatology, Division of Rheumatology, Northwestern University, Feinberg School of Medicine, Chicago, IL, ⁹Columbia University, New Yory, NY, ¹⁰Rheumatology, Georgetown University Medical Center, Washington, DC, ¹¹Director, Division of Rheumatology, The George Washington University, Washington, DC, ¹²Division of Rheumatology, The George Washington University, Washington, DC, ¹³Division of Rheumatology, University of Michigan, Ann Arbor, MI

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: gastrointestinal complications, scleroderma and systemic sclerosis

Session Information

Date: Tuesday, November 10, 2015

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

Session Type: ACR Poster Session C

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

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). We previously reported that gastrointestinal tract
(GIT) symptoms are common at baseline in this cohort and are not associated
with the choice of immunosuppressant agent. The goal of this study was to
analyze the longitudinal assessment of GIT symptoms in early dcSSc as captured by the GIT 2.0.

Methods: PRESS data was collected longitudinally at
various SSc centers using REDCap, a NIH funded
database including demographics, disease characteristics, physical exam data,
and patient-reported outcomes. PRESS
patients who had a complete gastrointestinal tract questionnaire (GIT 2.0), a validated instrument for evaluation of patient-reported outcomes
involving the GIT, at baseline and at one and/or two-years were
included in this analysis. Statistical analysis was performed using SAS version 9.4.

Results:
A total of 83 of 92 PRESS patients had a GIT 2.0 completed at the
baseline visit. Thirty-seven of 15 and 12 of 15 had GIT 2.0 at one- and two-
year follow-up respectively. At
baseline, the mean age of this patient population was 48.9 (SD 15.1) years. Fifty-eight were women. The average BMI
was 25.9 (SD 4.8). At baseline, upper GIT
symptoms were more common than lower GIT symptoms. Medication use did not account for these
baseline GIT 2.0 severity differences (proton pump inhibitors p=0.47;
methotrexate p=1; or mycophenolate mofetil p=0.27). At
one-year follow-up, 13 had worse scores for total GIT 2.0, 2 remained the same
and 13 had improved scores. At
two-year follow-up 6 had worse scores for total GIT 2.0 and 7 had improved
total scores (Table 1). No
medication changes accounted for these changes. Soilage
was not present at baseline in our population, but developed in some patients
at the two-year follow-up (Table 2). No PRESS patients reported a complete
absence of GIT symptoms.

Conclusion: Gastrointestinal symptoms captured by
the GIT 2.0 are universal in early dcSSc. Variability in change of GIT 2.0 scores may
reflect variation in disease progression and GIT involvement; however the pathogenesis
of developing soilage in this population wants
further study.

Table 1: Severity of GIT Illness in the PRESS
Population

Total GIT 2.0	Baseline (n=83)	Year 1 (n=37)	Year 2 (n=12)
Mild to Moderate	58	28	10
Moderate	17	4	0
Severe to Very Severe	8	5	2

Table 2: PRESS patient gastrointestinal symptoms
captured as components of GIT 2.0 (median, Interquartile range*)

	Baseline (n=83)		Year 1 (n=37)		Year 2 (n=12)
Variable	Median	IQR*	Median	IQR	Median	IQR
Total GIT 2.0	0.32	0.45	0.19	0.33	0.26	0.34
Reflux	0.38	0.75	0.63	0.75	0.5	0.56
Distention/Bloating	0.5	1.25	0.75	0.75	0.63	0.63
Fecal Soilage	0	0	0	0	0	0.5
Diarrhea	0	0.5	0.0	0.5	0	0
Social Functioning	0	0.5	0.17	0.5	0	0.25
Emotional Well-being	0	0.22	0	0.22	0.06	0.22
Constipation	0	0.5	0	0.5	0	0.5

Disclosure: T. M. Frech, None; M. Murtaugh, None; J. K. Gordon, Bayer, 5; R. T. Domsic, Biogen-Idec, 5,Bayer, 5; A. A. Shah, None; F. N. Hant, None; S. Assassi, None; M. E. Hinchcliff, None; E. J. Bernstein, None; V. D. Steen, None; V. K. Shanmugam, None; D. Khanna, Bristol-Myers Squibb, 2,EMD Serono, 2,Genentech and Biogen IDEC Inc., 2,Bayer, 5,Biogen Idec, 5,Cytori, 5,EMD Serono, 5,Forward, 5,Genentech and Biogen IDEC Inc., 5,Gilead, 5,Lycera, 5,Seattle Genetics, 5.

To cite this abstract in AMA style:

Frech TM, Murtaugh M, Gordon JK, Domsic RT, Shah AA, Hant FN, Assassi S, Hinchcliff ME, Bernstein EJ, Steen VD, Shanmugam VK, Khanna D. Longitudinal Assessment of Gastrointestinal Symptoms in the Prospective Registry of Early Systemic Sclerosis Cohort [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/longitudinal-assessment-of-gastrointestinal-symptoms-in-the-prospective-registry-of-early-systemic-sclerosis-cohort/. Accessed .

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