Background/Purpose: Poor control of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) can lead to the use of corticosteroids and non-steroidal anti-inflammatories (NSAIDs), which in turn can affect patients’ gastric mucosa and contribute to gastroesophageal reflux disease (GERD). GERD may be treated with acid-reducing agents including proton pump inhibitors (PPIs); PPIs are known to interact with a variety of drugs, potentially including investigational therapies in clinical trials. The prevalence of chronic PPI use in RA and SLE patients is not well-known, and therefore the potential for widespread drug-drug interactions in these patients is not well-understood. A better understanding of the details of concomitant medication use in these patient populations could guide more effective therapies in the future. We investigated the prevalence and type of chronic PPI use in RA and SLE populations, with the aim of helping clinicians and investigators to make appropriate treatment decisions, and to highlight the importance of PPI polypharmacy in clinical trial design.

Methods: A retrospective analysis of medication use in RA and SLE patients from 2012-2015 was done using Truven MarketScan® Claims Databases. Algorithms from the literature were used to identify RA and lupus cases, and to stratify by disease severity/line of treatment; these were pressure-tested using sensitivity analyses. Omnibus tests for between-strata differences in PPI use according to disease severity/line of treatment were carried out, followed by pairwise comparisons (n=15 for RA; n=3 for lupus) using Fisher’s exact test correction for multiple comparisons via false discovery rate (FDR).

Results: Roughly one-third of RA and lupus patients in a large claims database were chronic users of PPIs. For SLE patients, this proportion increased with our measure of disease severity. For RA patients, higher use was observed in TNF-IR and BIO-IR patients. Following significant results from our omnibus tests and FDR correction of pairwise comparisons, all but the following four remained significant for RA: csDMARD vs. bDMARD/JAKi; TNF-IR vs. no treatment; TNF-IR vs. multiple treatment; and BIO-IR vs. multiple treatment. For lupus, mild vs. moderate and mild vs. severe comparisons remained significant. Results are given in Table 1.

Conclusion: Chronic use of PPIs is widespread among RA and lupus patients in the MarketScan database. Because PPIs may interact with a number of other medications, providers who treat RA and lupus patients should take care to assess concomitant medication use in these patients, and researchers designing clinical trials should carefully assess the prevalence of PPI use in comparator versus treatment arms to ensure that results are not unduly influenced by PPI use. In each case, attention should be paid to the particular type of PPI used, as pharmacokinetic characteristics of each PPI vary.

Table 1. Chronic PPI Use Among RA and SLE Patients.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/widespread-chronic-use-of-proton-pump-inhibitors-and-potential-for-drug-drug-interactions-in-rheumatoid-arthritis-and-lupus-patients/