ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2898

Anti-Reflux Medications in Diffuse Cutaneous Systemic Sclerosis:  Is Empiric Use of Proton Pump Inhibitors Supported?

Tracy M. Frech1, Ami A. Shah2, Monique Hinchcliff3, Flavia V. Castelino4, Shervin Assassi5, Elana J. Bernstein6, Robyn T. Domsic7, Jessica K. Gordon8, Victoria K. Shanmugam9,10, Virginia D. Steen11, Maureen Murtaugh12, Bernie LaSalle13, Dinesh Khanna14 and Faye N. Hant15, 1Division of Rheumatology, University of Utah, Salt Lake City, UT, 2Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 3Northwestern University, Feinberg School of Medicine Scleroderma Program, Chicago, IL, 4Rheumatology, Allergy, Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 5Department of Internal Medicine - Rheumatology, University of Texas-McGovern Medical School, Houston, TX, 6Department of Medicine, Division of Rheumatology, Columbia University, New York, NY, 7Medicine - Rheumatology, University of Pittsburgh, Pittsburgh, PA, 8Rheumatology, Hospital for Special Surgery, New York, NY, 9Rheumatology, George Washington University, Great Falls, VA, 10Division of Rheumatology, The George Washington University, Washington, DC, 11Rheumatology, Georgetown University Medical Center, Washington, DC, 12University of Utah, Salt Lake, UT, 13University of Utah, Salt Lake City, UT, 14University of Michigan, Ann Arbor, MI, 15Medicine/Rheumatology & Immunology, Medical University of South Carolina, Charleston, SC

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: ,

Session Information

Date: Tuesday, November 15, 2016

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: Empiric long-term use of proton pump inhibitors (PPI) are implicated in concomitant renal dysfunction (1) and small intestinal bacterial overgrowth (SIBO)(2). Yet, experts recommend daily empiric PPI even in the absence of reflux symptomatology in SSc patients (3). The Prospective Registry of Early Systemic Sclerosis (PRESS) cohort of early diffuse cutaneous systemic sclerosis (dcSSc) permits determination of the utility of empiric PPI administration in this patient population.

Methods:  The PRESS cohort includes dcSSc patients with < 2 years duration who are recruited at 11 United States Scleroderma Centers. Patients participate in detailed baseline and biannual clinical and laboratory assessments that permit examination of patient characteristics, PPI use, renal function and patient-reported clinical outcomes measures including the University of California Los Angeles Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 (GIT 2.0)(4).

Results:  As of May 2016, 166 PRESS patients were enrolled (Table 1). At baseline and 6 months, 132 and 67 patients had completed the GIT 2.0 respectively. Of the 88 patients taking a PPI at baseline, 6 had no reflux, 37 had mild reflux, 28 had moderate reflux and 15 had severe reflux. Five patients taking PPI had renal dysfunction at baseline (defined as reduced creatinine clearance). No patient taking a PPI developed renal dysfunction between baseline and 6 months. Only 11 of the 88 patients on PPI lacked bloating or distention at baseline. At 6 months, only 1 patient with a repeat GIT 2.0 was newly prescribed that PPI. This patient lacked renal insufficiency and bloating or distention.

Conclusion:  Most dcSSc patients take PPI. PPI use was not associated with incident renal dysfunction over 6 months follow-up. Bloating and distension are common symptoms in dcSSc patients and may be associated with PPI use. Due to recent associations of PPI with SIBO and renal dysfunction experts may consider changes in practice patterns. Cohorts such as PRESS provide the opportunity to understand gastrointestinal disease and renal dysfunction in the dcSSc patient population as well as the opportunity to study potential adverse effects of medications. Table 1: PRESS Patient Characteristics 

Characteristic (n=166) Number or mean
Female 116
Age 48.7
BMI (kg/m2) 25.7 ± 5.3
Ethnicity:

  • African American
  • Asian
  • White or Caucasian
  • Other
  • Hispanic

 25 7 125 8 20
ANA positive

  • Negative

Autoantibody in ANA positive patients:

  • RNA polymerase III
  • SCL70

 128 6 60 38
SCTC completed:

  • Baseline
  • 6 month Follow-up visit

 132 67
PPI use at baseline

  • No reflux SCTC GIT 2.0
  • Mild reflux SCTC GIT 2.0
  • Moderate reflux SCTC GIT 2.0
  • Severe-very severe reflux

 6 (23)* 37 (73) 28 (41) 15 (25)
PPI use at baseline:

  • No bloating/distention SCTC GIT 2.0
  • Mild bloating/distention SCTC GIT 2.0
  • Moderate distention/bloating SCTC GIT 2.0
  • Severe-very severe bloating SCTC GIT 2.0

 11(24) 36 (66) 8 (14) 12 (23)
PPI use and Renal function:

  • No hx SRC and serum creatinine < 1.3 mg/dL
  • Hx SRC and serum creatinine < 1.6 mg/dL
  • Hx SRC and serum creatinine between 1.7 and 2.9 mg/dL
  • Hx SRC and serum creatinine > 3.0 mg/dL
  • Hx SRC and dialysis required

 69 (137) 3 (4) 1 (1) 1 (3) 2 (3)

Disclosure: T. M. Frech, None; A. A. Shah, None; M. Hinchcliff, None; F. V. Castelino, None; S. Assassi, Boehringer Ingelheim, 5,Genentech and Biogen IDEC Inc., 2,Bayer HealthCare, 2; E. J. Bernstein, None; R. T. Domsic, Bayer Healthcare, 2,Biogen-Idec, 2; J. K. Gordon, None; V. K. Shanmugam, None; V. D. Steen, None; M. Murtaugh, None; B. LaSalle, None; D. Khanna, NONE, 2; F. N. Hant, None.

To cite this abstract in AMA style:

Frech TM, Shah AA, Hinchcliff M, Castelino FV, Assassi S, Bernstein EJ, Domsic RT, Gordon JK, Shanmugam VK, Steen VD, Murtaugh M, LaSalle B, Khanna D, Hant FN. Anti-Reflux Medications in Diffuse Cutaneous Systemic Sclerosis:  Is Empiric Use of Proton Pump Inhibitors Supported? [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/anti-reflux-medications-in-diffuse-cutaneous-systemic-sclerosis-is-empiric-use-of-proton-pump-inhibitors-supported/. Accessed .

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