Background/Purpose: Esophageal involvement is one of the most frequent organ manifestations in patients with systemic sclerosis (SSc). Gastroesophageal reflux disease (GERD) is associated with reflux esophagitis, resulting in impaired quality of life and increased risk for esophageal stricture and cancer. Continuous use of proton pump inhibitors (PPIs) is recommended as the primary treatment for SSc-associated GERD and leads relief of the symptoms. However, some patients experience reflux esophagitis refractory to the maximum dose of conventional PPIs. Vonoprazan is a novel potassium-competitive acid blocker, and is shown to have several advantages over conventional PPIs, including long duration of acid suppression. Several clinical trials have consistently demonstrated superiority of vonoprazan over conventional PPIs in terms of achieving healing of mucosal breaks and maintaining the healing. The present study investigated the efficacy of vonoprazan for treating PPI-resistant reflux esophagitis in SSc patients.

Methods: This study enrolled SSc patients with PPI-resistant reflux esophagitis, who were selected from SSc database of Nippon Medical School Hospital, composing of 228 patients who visited our clinic after August of 2014. Patients eligible for this study included i) fulfillment of 2013 ACR/EURAR classification criteria for SSc; ii) reflux esophagitis proved by endoscopy on treatment of PPIs; iii) medication switch from PPIs to vonoprazan; and iv) endoscopic and patient-reported outcome evaluations available before and after switch to vonoprazan. Vonoprazan was started orally at a dosage of 20mg or 10mg daily, and the dosage was adjusted if necessary. Reflux esophagitis was graded using Los Angeles (LA) classification, and patient-reported outcomes were assessed using a frequency scale for the symptoms of GERD (FSSG) questionnaire. Safety was also evaluated by retrospective chart review.

Results: Of 13 patients with endoscopy-confirmed reflux esophagitis resistant to PPI treatment, PPIs were switched to vonoprazan in 12 patients. Complete before-and-after data were available in 7 patients, and follow-up evaluations were conducted after an interval of 3.4 ± 2.7 months. All the patients were female, mean age at study entry was 62 ± 13 years, mean disease duration from non-Raynaud’s symptom was 13 ± 8 years. Baseline LA classification was A in one, B in 3, C in 2, and D in one, but follow-up endoscopic evaluation revealed that reflux esophagitis was completely healed in 6 of 7 (86%) patients after switching to vonoprazan. Total FSSG score significantly improved from 18.4 ± 9.9 to 11.3 ± 14.2 (P = 0.04). The acid reflux component of the FSSG score improved significantly (12.0 ± 6.2 to 7.0 ± 7.9; P = 0.03), whereas the dysmotility component did not change (6.4 ± 4.7 to 4.3 ± 6.6). Vonoprazan has been continuously used for 18.7 ± 9.4 months without any adverse events. One patient had vonoprazan-resistant reflux esophagitis based on lack of improvement of the endoscopic findings, but symptomatic improvement was somewhat observed by the FSSG score.

Conclusion: This pilot study suggests that vonoprazan is beneficial for PPI-resistant reflux esophagitis in patients with SSc. A randomized clinical trial is warranted.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/vonoprazan-a-novel-potassium-competitive-acid-blocker-for-treatment-of-proton-pump-inhibitor-resistant-reflux-esophagitis-in-patients-with-systemic-sclerosis/