Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background/Aims: Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis. Methods: In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events. Results: Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups.No significant difference was noted in the incidence of adverse drug reactions. Conclusions Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).

Background/Aims: We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. Methods: A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases. Results: In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences. Conclusions TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea

Background: Psoriasis is a chronic disease that can have accompanying comorbidities including arthritis, metabolic syndrome, and cardiovascular diseases. Patients with psoriasis tend to frequently visit medical institutions, and their economic burden for medical services is high. Objective: To investigate the economic burden of psoriasis in Korea. Methods: The Korean Society for Psoriasis conducted a multi-center field survey of the patients and analyzed the national insurance claim data. Also, we discussed the medical environment of psoriasis in Korea based on the results. Results: The economic burden of psoriasis patients is substantial and varied by the type of medical institute. Patients also paid the indirect and intangible medical costs. Biological agents, which is used in patients with severe psoriasis, led to an increase in the cost. Conclusion This is the first study to estimate the economic burden of psoriasis in Korea comprehensively. To improve the medical environment of psoriasis and alleviate the burden of patients, discussion on the more efficient health policy and medical insurance criteria for psoriasis would be needed.

Background/Aims: The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Background: Psoriasis is a chronic disease that can have accompanying comorbidities including arthritis, metabolic syndrome, and cardiovascular diseases. Patients with psoriasis tend to frequently visit medical institutions, and their economic burden for medical services is high. Objective: To investigate the economic burden of psoriasis in Korea. Methods: The Korean Society for Psoriasis conducted a multi-center field survey of the patients and analyzed the national insurance claim data. Also, we discussed the medical environment of psoriasis in Korea based on the results. Results: The economic burden of psoriasis patients is substantial and varied by the type of medical institute. Patients also paid the indirect and intangible medical costs. Biological agents, which is used in patients with severe psoriasis, led to an increase in the cost. Conclusion This is the first study to estimate the economic burden of psoriasis in Korea comprehensively. To improve the medical environment of psoriasis and alleviate the burden of patients, discussion on the more efficient health policy and medical insurance criteria for psoriasis would be needed.

Background: Non-alcoholic fatty liver disease (NAFLD) is the most frequent liver disease. Evidence supporting a strong relationship between psoriasis and NAFLD exists. NAFLD is significantly higher in psoriatic patients than in matched controls and psoriatic patients with NAFLD have more severe forms of psoriasis than those without NAFLD. Objective: To evaluate the prevalence and clinical features of NAFLD among Korean psoriatic patients with abnormal liver function tests. Methods: We evaluated the laboratory results of psoriatic patients who visited the Department of Dermatology, National Medical Center, between September 2012 and June 2017. Those who had abnormal liver function tests were consulted by a hepatologist to confirm the diagnosis of NAFLD using ultrasonography. Results: A total of 307 psoriatic patients underwent liver function tests (LFTs), and 46 patients (15.0%) had abnormal LFT values. A hepatologist consulted psoriatic patients with abnormal LFTs, and hepatic ultrasonography was performed; 34 patients (73.9%) were diagnosed with NAFLD. Among psoriatic patients with abnormal LFTs, those with a Psoriasis Area and Severity Index (PASI) ≥10 had a significantly higher rate of NAFLD than psoriatic patients with PASI ＜10 (87.5% vs 59.1%). Conclusion Among psoriatic patients with abnormal LFTs, 34 patients (73.9%) were diagnosed with NAFLD.Psoriatic patients with PASI ≥10 had a significantly higher rate of NAFLD than those with PASI ＜10.

Background: Non-alcoholic fatty liver disease (NAFLD) is the most frequent liver disease. Evidence supporting a strong relationship between psoriasis and NAFLD exists. NAFLD is significantly higher in psoriatic patients than in matched controls and psoriatic patients with NAFLD have more severe forms of psoriasis than those without NAFLD. Objective: To evaluate the prevalence and clinical features of NAFLD among Korean psoriatic patients with abnormal liver function tests. Methods: We evaluated the laboratory results of psoriatic patients who visited the Department of Dermatology, National Medical Center, between September 2012 and June 2017. Those who had abnormal liver function tests were consulted by a hepatologist to confirm the diagnosis of NAFLD using ultrasonography. Results: A total of 307 psoriatic patients underwent liver function tests (LFTs), and 46 patients (15.0%) had abnormal LFT values. A hepatologist consulted psoriatic patients with abnormal LFTs, and hepatic ultrasonography was performed; 34 patients (73.9%) were diagnosed with NAFLD. Among psoriatic patients with abnormal LFTs, those with a Psoriasis Area and Severity Index (PASI) ≥10 had a significantly higher rate of NAFLD than psoriatic patients with PASI ＜10 (87.5% vs 59.1%). Conclusion Among psoriatic patients with abnormal LFTs, 34 patients (73.9%) were diagnosed with NAFLD.Psoriatic patients with PASI ≥10 had a significantly higher rate of NAFLD than those with PASI ＜10.