Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study

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.

Endoscopic Treatment of Gastric and Duodenal Neuroendocrine Tumors: Present and Future

Gastric and duodenal neuroendocrine tumors (NETs) are not common; however, there is an increase in the incidence due to increased use of endoscopy. Endoscopic treatment has been applied to treat small NET G1 in the stomach and duodenum. For the endoscopic treatment of NETs, it is necessary to evaluate tumor size, depth of invasion, and lymphatic and distant metastasis. This article will review the current knowledge concerning the endoscopic treatment of gastric and duodenal neuroendocrine tumors.

A case report of a patient presented with skin ulcer after treatment of lenvatinib

A 60-year-old man diagnosed with unresectable hepatocellular carcinoma (HCC) presented to the hospital with pain in the perineal region. He had been taking lenvatinib every day for 2 months after he was diagnosed with HCC with metastases to the lymph node, small bowel mesentery, and retroperitoneal space. Enhanced abdominal computed tomography revealed mild elevation in intensity in the perineal subcutaneous tissue with subcutaneous emphysema. The patient was diagnosed with Common Terminology Criteria for Adverse Events grade 3, skin ulceration of stage IV with full-thickness skin loss and tissue necrosis in the muscular layer. The patient was taken off the medication with prescription of antibiotics, and after 3 weeks, the skin has fully recovered. This is the first report of an HCC patient who presented with a skin ulceration of stage IV after lenvatinib treatment. We recommend stopping the medication immediately and changing to alternative treatments with appropriate supportive care.

Endoscopic Treatment of Gastric and Duodenal Neuroendocrine Tumors: Present and Future

Gastric and duodenal neuroendocrine tumors (NETs) are not common; however, there is an increase in the incidence due to increased use of endoscopy. Endoscopic treatment has been applied to treat small NET G1 in the stomach and duodenum. For the endoscopic treatment of NETs, it is necessary to evaluate tumor size, depth of invasion, and lymphatic and distant metastasis. This article will review the current knowledge concerning the endoscopic treatment of gastric and duodenal neuroendocrine tumors.

A case report of a patient presented with skin ulcer after treatment of lenvatinib

A 60-year-old man diagnosed with unresectable hepatocellular carcinoma (HCC) presented to the hospital with pain in the perineal region. He had been taking lenvatinib every day for 2 months after he was diagnosed with HCC with metastases to the lymph node, small bowel mesentery, and retroperitoneal space. Enhanced abdominal computed tomography revealed mild elevation in intensity in the perineal subcutaneous tissue with subcutaneous emphysema. The patient was diagnosed with Common Terminology Criteria for Adverse Events grade 3, skin ulceration of stage IV with full-thickness skin loss and tissue necrosis in the muscular layer. The patient was taken off the medication with prescription of antibiotics, and after 3 weeks, the skin has fully recovered. This is the first report of an HCC patient who presented with a skin ulceration of stage IV after lenvatinib treatment. We recommend stopping the medication immediately and changing to alternative treatments with appropriate supportive care.

First-line Helicobacter pylori Eradication Rate of the 10-day Hybrid Therapy

Background/Aims@#To improve the eradication rate of a first-line therapy for Helicobacter pylori infection, alternate regimens such as sequential, concomitant, and hybrid therapies have been tried. The aim of this study was to evaluate the eradication rate of the 10-day hybrid therapy as a first-line therapy. @*Materials and Methods@#This retrospective study enrolled 124 patients from the Korea University Ansan Hospital between April 2016 and December 2019. The 10-day hybrid therapy comprised 5 days of dual therapy (proton pump inhibitor [PPI] standard dose and amoxicillin 1 g, twice daily) followed by 5 days of quadruple therapy (PPI, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, twice daily). We compared the 10-day hybrid therapy with the 10-day concomitant therapy comprising PPI, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, twice daily. Eradication was assessed by a 13C-urea breath test or gastroscopic biopsy at least 4 weeks after treatment completion. @*Results@#The eradication rates of the 10-day hybrid and concomitant therapies were 74.2% (46/62) and 67.7% (42/62), respectively, in the intention-to-treat (ITT) analysis and 88.5% (46/52) and 82.4% (42/51), respectively, in the per-protocol (PP) analysis. There was no significant difference in the eradication rates between the two groups in the ITT (P=0.429) and PP analysis (P=0.380). Adverse events developed in 75.0% and 70.6% of patients in the hybrid and concomitant groups, respectively, but there was no significant difference (P=0.615). @*Conclusions@#The 10-day hybrid therapy can be an option for a first-line therapy of Helicobacter pylori infection.

First-line Helicobacter pylori Eradication Rate of the 10-day Hybrid Therapy

Background/Aims@#To improve the eradication rate of a first-line therapy for Helicobacter pylori infection, alternate regimens such as sequential, concomitant, and hybrid therapies have been tried. The aim of this study was to evaluate the eradication rate of the 10-day hybrid therapy as a first-line therapy. @*Materials and Methods@#This retrospective study enrolled 124 patients from the Korea University Ansan Hospital between April 2016 and December 2019. The 10-day hybrid therapy comprised 5 days of dual therapy (proton pump inhibitor [PPI] standard dose and amoxicillin 1 g, twice daily) followed by 5 days of quadruple therapy (PPI, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, twice daily). We compared the 10-day hybrid therapy with the 10-day concomitant therapy comprising PPI, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, twice daily. Eradication was assessed by a 13C-urea breath test or gastroscopic biopsy at least 4 weeks after treatment completion. @*Results@#The eradication rates of the 10-day hybrid and concomitant therapies were 74.2% (46/62) and 67.7% (42/62), respectively, in the intention-to-treat (ITT) analysis and 88.5% (46/52) and 82.4% (42/51), respectively, in the per-protocol (PP) analysis. There was no significant difference in the eradication rates between the two groups in the ITT (P=0.429) and PP analysis (P=0.380). Adverse events developed in 75.0% and 70.6% of patients in the hybrid and concomitant groups, respectively, but there was no significant difference (P=0.615). @*Conclusions@#The 10-day hybrid therapy can be an option for a first-line therapy of Helicobacter pylori infection.

Self-reported Sleep Impairment in Functional Dyspepsia and Irritable Bowel Syndrome

BACKGROUND/AIMS: Sleep impairment is a common complaint among patients with irritable bowel syndrome (IBS) and functional dyspepsia (FD). This study aimed to evaluate the prevalence of sleep impairment in FD or IBS patients, and to determine whether IBS-FD overlap induced more sleep disturbance than FD or IBS alone. METHODS: A population-based cohort in South Korea including 2251 subjects was asked about gastrointestinal symptoms including IBS and dyspepsia-related symptoms. In addition, sleep disturbance was measured using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale questionnaires. One-way ANOVA and logistic regression were used to assess differences among the 4 groups (healthy subjects, IBS alone, FD alone, and IBS-FD overlap). RESULTS: Of 2251 subjects who were surveyed by questionnaire, 2031 responded (92.5% response rate) and were analyzed. The prevalence of IBS, FD, and IBS-FD overlap was 8.0% (95% confidence interval [CI], 6.8–9.2%), 4.8% (95% CI, 3.9–5.8%), and 1.8% (95% CI, 1.2–2.4%), respectively. FD alone, but not IBS alone, was significantly associated with a poorer sleep quality index (OR, 2.68; 95% CI, 1.43–5.01) and more daytime sleepiness (OR, 2.21; 95% CI, 1.14–4.30), compared to healthy subjects. IBS-FD overlap had the greatest likelihood of a poorer sleep quality index (OR, 3.88; 95% CI, 1.83–8.19), daytime sleepiness (OR, 2.47; 95% CI, 1.01–5.67), and insomnia (OR, 2.84; 95% CI, 1.39–5.82), compared to healthy subjects. CONCLUSION: A correlation between functional gastrointestinal disorders and sleep disturbance was demonstrated, which was significantly pronounced in the context of IBS-FD overlap.

Trephine Transverse Colostomy Is Effective for Patients Who Have Previously Undergone Rectal Surgery

PURPOSE: Colostomy creation is an essential procedure for colorectal surgeons, but the preferred method of colostomy varies by surgeon. We compared the outcomes of trephine colostomy creation with open those for the (laparotomy) and laparoscopic methods and evaluated appropriate indications for a trephine colostomy and the advantages of the technique. METHODS: We retrospectively evaluated 263 patients who had undergone colostomy creation by trephine, open and laparoscopic approaches between April 2006 and March 2016. We compared the clinical features and the operative and postoperative outcomes according to the approach used for stoma creation. RESULTS: One hundred sixty-three patients (62%) underwent colostomy surgery for obstructive causes and 100 (38%) for fistulous problems. The mean operative time was significantly shorter with the trephine approach (trephine, 46.0 ± 1.9 minutes; open, 78.7 ± 3.9 minutes; laparoscopic, 63.5 ± 5.0 minutes; P < 0.001), as was the time to flatus (1.8 ± 0.1 days, 2.1 ± 0.1 days, 2.2 ± 0.3 days, P = 0.025). Postoperative complications (<30 days) were not different among the 3 approaches (trephine, 4.3%; open, 1.2%; laparoscopic, 0%; P = 0.828). In patients who underwent rectal surgery, a trephine colostomy was feasible for a diversion colostomy (P < 0.001). CONCLUSION: The trephine colostomy is safe and can be implemented quickly in various situations, and compared to other colostomy procedures, the patient's recovery is faster. Previous laparotomy history was not a contraindication for a trephine colostomy, and a trephine transverse colostomy is feasible for patients who have undergone previous rectal surgery.

The Effect of Helicobacter pylori Infection on Recurrence of Gastric Hyperplastic Polyp after Endoscopic Removal / 대한소화기학회지

BACKGROUND/AIMS: Several previous studies suggest that eradication of Helicobacter pylori (H. pylori) leads to the disappearance of gastric hyperplastic polyps. However, little is known about the effect of H. pylori status and eradication on the recurrence of gastric polyps after endoscopic removal. Here, we investigated the recurrence of gastric polyps according to the final H. pylori status in patients who underwent endoscopic removal of gastric hyperplastic polyps. METHODS: Between January 2011 and December 2016, patients who underwent endoscopic removal of gastric hyperplastic polyps and were followed-up for more than two months were enrolled. The success of H. pylori eradication was assessed by histology and rapid urease test or urea breath test, at least 4 weeks after the completion of eradication treatment. At follow-up, the recurrence of gastric polyp was evaluated via esophagogastroduodenoscopy. RESULTS: Seventy-nine patients were enrolled. During the mean follow-up period of 16.4 months, the recurrence rate of gastric polyp was 25.3%. Among those who received H. pylori eradication therapy, the H. pylori persistent group showed a higher recurrence of polyp than the H. pylori eradicated group; but there was no statistical significance (42.9% vs. 21.7%, p=0.269). Regarding the final H. pylori infection status, the recurrence rate of gastric polyps was significantly higher in the H. pylori positive group than in the H. pylori negative group (42.9% vs. 18.9%, p=0.031). In multivariate analysis, the final H. pylori infection status was a significant risk factor for gastric polyp recurrence after endoscopic removal. CONCLUSIONS: The final positive H. pylori infection status is significantly associated with higher recurrence of gastric hyperplastic polyps after endoscopic removal.

Indication and Clinical Outcomes of Percutaneous Endoscopic Gastrostomy: A Single-center Retrospective Analysis

BACKGROUND/AIMS: Percutaneous endoscopic gastrostomy (PEG) is performed to provide enteral nutrition to patients who require tube-feeding support due to impaired oral intake. As life expectancy increases, the need for, and use of PEG also tend to increase. We aimed to evaluate the indications and complications of PEG insertion, and to investigate any differences in the complication group. MATERIALS AND METHODS: We conducted a retrospective analysis of 109 patients who received a PEG procedure between April 2011 and April 2016 in the Korea University Ansan Hospital. We reviewed the indications and complications related to PEG insertion and time interval of tube change. RESULTS: Among 109 patients who underwent a PEG procedure, 71.6% were male, and the mean age was 68.2 years. The most common indications for PEG were central nervous system diseases, including stroke (33.9%), cerebral hemorrhage (29.4%), and hypoxic brain damage (8.3%). The overall complication rate was 14.7%, and the most common complication was peristomal infection (7.3%). Most of the complications occurred within 10 days in 14 of 16 patients (87.5%). The patients with complications were older than those without complications (74.6±11.1 vs. 67.1±14.0 years, P=0.043). The mean time interval for gastrostomy tube change was 7.3 months. CONCLUSIONS: The most common indication of PEG was brain disease, and the complication rate cannot be ignored. Careful attention is needed after a PEG procedure especially in elderly patients.

Endoscopic Treatment of Jejunal Heterotopic Gastric Mucosa that Caused Recurrent Intussusception

Heterotopic gastric mucosa (HGM) is a rare anomaly in the small bowel and may be the cause of intussusception when it gets a lead point in the jejunum. All cases of intussusception due to intestinal HGM have been treated with surgical resection. A 5-year-old girl presented with chief complaints of vomiting and abdominal pain for 2 weeks. A computed tomography scan of the abdomen showed intussusception at the proximal jejunal loops. Three air reductions and one saline reduction were attempted without success. She continued to be symptomatic, and endoscopic evaluation was performed. Enteroscopy revealed some variable-sized polypoid mucosal lesions with erosions on the proximal jejunum. Endoscopic mucosal resection was performed using a snare. The resected tissues histologically showed a hyperplastic polyp arising from the HGM. Her symptoms did not recur within 1 year after the treatment. Our case showed that enteroscopy could be useful for the diagnosis and management of jejunal intussusception caused by HGM.

Is the AIMS 65 Score Useful in Prepdicting Clinical Outcomes in Korean Patients with Variceal and Nonvariceal Upper Gastrointestinal Bleeding?

BACKGROUND/AIMS: Various clinical scoring systems, including the Glasgow-Blatchford score (GBS), Rockall risk score (RS), and AIMS65 score (AIMS65), have been validated to predict the clinical outcomes in patients with upper gastrointestinal bleeding (UGIB). We compared the performance of these three scoring systems in predicting clinical outcomes in patients with UGIB in Korea. METHODS: We retrospectively evaluated 286 patients with UGIB who visited emergency department. The primary outcome was the need for clinical intervention (endoscopic, radiologic, or surgical) and blood transfusion. RESULTS: The causes of UGIB were esophageal/gastric varices in 64 patients, peptic ulcer in 168, Mallory-Weiss tear in 32, malignancy of UGI tract in eight, and unknown in 14. One hundred seventy-four (61%) patients required blood transfusion, 166 (58%) required endoscopic intervention, and 10 (3.5%) required surgical intervention. The GBS outperformed the RS and AIMS65 in predicting the need for endoscopic intervention. CONCLUSIONS: The GBS and RS were more accurate than AIMS65 in predicting the need for clinical interventions and transfusion patients with UGIB, regardless of variceal or nonvariceal bleeding. The AIMS65 may not be optimal for predicting clinical outcomes of UGIB in Korea.

The antibacterial effect of fatty acids on Helicobacter pylori infection

Eradication of Helicobacter pylori is recommended for the management of various gastric diseases, including peptic ulcers and mucosa-associated lymphoid tissue lymphoma. Because of the increasing prevalence of antibiotic resistance, the eradication rates of antibiotic-based therapies have decreased. Therefore, alternative treatments should be considered. The antibacterial properties of fatty acids (FAs) have been investigated in various organisms, including H. pylori. Some FAs, particularly polyunsaturated FAs, have been shown to have bactericidal activity against H. pylori in vitro; however, their antibacterial effects in vivo remain controversial. Poor solubility and delivery of FAs may be important reasons for this discrepancy. Recently, a series of studies demonstrated the antibacterial effects of a liposomal formulation of linolenic acid against H. pylori, both in vitro and in vivo. Further research is needed to improve the bioavailability of FAs and apply them in clinical use.

Feasibility of single-incision laparoscopic appendectomy in a small hospital

PURPOSE: This study aimed to compare clinical outcomes for single-incision laparoscopic appendectomy (SILA) and conventional laparoscopic appendectomy (CLA) for the treatment of acute appendicitis and to assess the feasibility of performing SILA in a small hospital with limited surgical instruments and staff experience. METHODS: Retrospective record review identified 133 patients who underwent laparoscopic appendectomy from December 2013 to April 2015. Patients were categorized according to the type of appendectomy performed (SILA or CLA). Patient characteristics and surgical outcomes were compared between the 2 groups. Postoperative complication rates were compared using the Clavien-Dindo classification. Postoperative pain was assessed using a visual analog scale immediately postsurgery; at 12, 24, 36, and 48 hours postoperatively, and at 7 days postoperatively. RESULTS: Record review identified 38 patients who had undergone SILA and 95 patients who had undergone CLA. No significant differences in clinical characteristics were found between the 2 groups. There were no significant differences in operation time, time to flatus, or length of hospital stay. Overall complication rates were not significantly different between the 2 groups. No complications worse than grade IIIa occurred in the SILA group. Postoperative pain scores were not significantly different between the 2 groups at any time point. CONCLUSION: We found comparable surgical outcomes for SILA compared to CLA. Even in a small hospital with limited surgical instruments and staff experience, SILA may be a feasible and safe technique.

Esophageal Hemangioma Treated by Endoscopic Mucosal Resection: A Case Report and Review of the Literature / 대한소화기학회지

Hemangioma of the esophagus is a rare form of benign esophageal tumor. It usually presents as a single lesion located in the lower third of the esophagus and is mostly asymptomatic. However, it may occasionally cause hematemesis and/or obstruction. Surgical resection is the conventional treatment modality for managing esophageal hemangioma, but less invasive approaches such as endoscopic therapy are recently becoming more widely employed. Herein, we report a case of a 54-year-old man who presented with an esophageal hemangioma that was successfully treated by endoscopic mucosal resection without any complications.

A Case of Necrotizing Colitis Presenting with Hepatic Portal Venous Gas and Pneumatosis Intestinalis / 대한소화기학회지

Hepatic portal venous gas is a very rare radiologic sign which is characterized by gas accumulation in the portal venous circulation. Pneumatosis intestinalis is also very rare and is characterized by multiple air cysts in the serosal or submucosal layers of the gastrointestinal tract walls. These two findings are caused by various pathological conditions and can develop individually or simultaneously. The latter is clinically more significant because it is frequently related to bowel ischemia or necrosis, and represents a poor prognosis. However, prognosis is more influenced by the severity of underlying disease rather than hepatic portal venous gas or pneumatosis intestinalis itself. If bowel ischemia or necrosis is the primary cause, emergency operation is very important to improve patient's prognosis. Herein, we report a case of necrotizing colitis presenting as hepatic portal venous gas and pneumatosis intestinalis which was successfully managed by early surgery.

Is propofol safe when administered to cirrhotic patients during sedative endoscopy?

BACKGROUND/AIMS: In patients with liver cirrhosis, drugs acting on the central nervous system can lead to hepatic encephalopathy and the effects may be prolonged. Recently, misuse of propofol has been reported and the associated risk of death have become an issue. Propofol is commonly used during sedative endoscopy; therefore, its safety in high-risk groups must be further investigated. We performed a pilot study of the safety and efficacy of propofol during endoscopy in Korean patients with cirrhosis. METHODS: Upper gastrointestinal endoscopy was performed under sedation with propofol along with careful monitoring in 20 patients with liver cirrhosis and 20 control subjects. The presence or development of hepatic encephalopathy was assessed using the number connection test and neurologic examination. RESULTS: Neither respiratory depression nor clinically significant hypotension were observed. Immediate postanesthetic recovery at 5 and 10 minutes after the procedure was delayed in the cirrhotic patients compared with the control group; however, at 30 minutes, the postanesthetic recovery was similar in both groups. Baseline psychomotor performance was more impaired in cirrhotic patients, but propofol was not associated with deteriorated psychomotor function even in cirrhotic patients with a minimal hepatic encephalopathy. CONCLUSIONS: Sedation with propofol was well tolerated in cirrhotic patients. No newly developed hepatic encephalopathy was observed.

Two Cases of Uncommon Complication during Percutaneous Endoscopic Gastrostomy Tube Replacement and Treatment / 대한소화기학회지

We presented two interesting cases of gastrocolocutaneous fistula that occurred after percutaneous endoscopic gastrostomy (PEG) tube placement, and its management. This fistula is a rare complication that occurs after PEG insertion, which is an epithelial connection between mucosa of the stomach, colon, and skin. The management of the fistula is controversial, ranging from conservative to surgical intervention. Endoscopists should be aware of the possibility of gastrocolocutaneous fistula after PEG insertion, and should evaluate the risk factors that may contribute to the development of gastrocolocutaneous fistula before the procedure. We reviewed complications of gastrostomy tube insertion, symptoms of gastrocolocutaneous fistula, and its risk factors.

Incidences of Serious Infections and Tuberculosis among Patients Receiving Anti-Tumor Necrosis Factor-alpha Therapy

PURPOSE: Anti-tumor necrosis factor-alpha (TNF-alpha) medications represent a major advancement in the management of chronic inflammatory diseases. However, these agents are associated with increased risks of tuberculosis (TB) and other serious infections. The aim of this study was to evaluate the incidences of such disease among tertiary hospitals in Korea. MATERIALS AND METHODS: We retrospectively studied patients who received anti-TNF-alpha therapy; we reviewed serious infections including TB that developed within 6 months after initiation of anti-TNF-alpha therapy. Data concerning patient demographics, types of anti-TNF-alpha agents, concomitant immunosuppressive drugs use, and infection details were collected. RESULTS: A total 175 patients treated with infliximab (n=72) or adalimumab (n=103) with the following conditions were enrolled: Crohn's disease, 34 (19.4%); ulcerative colitis, 20 (11.4%); ankylosing spondylitis, 82 (46.9%); and rheumatoid arthritis, 39 (22.2%). There were 18 cases (6.0%) of serious infections. The most common site of serious infection was the intra-abdomen (n=6), followed by TB (n=3), skin and soft tissue (n=3), bone and joints (n=2), ocular neurons (n=2), lower respiratory tract (n=1), and urinary tract (n=1). Of the 175 patients, only 3 cases showed development of TB. Furthermore, of all those who developed TB, none had taken anti-TB chemoprophylaxis prior to treatment with an anti-TNF agent due to negative screening results. CONCLUSION: Serious infections with anti-TNF-alpha therapy were uncommon among tertiary hospitals in Korea; TB was the second most frequent infection. Nevertheless, there were no TB reactivations after anti-TB chemoprophylaxis. Accordingly, physicians should be aware of TB in subjects undergoing anti-TNF-alpha therapy, especially in countries with a high prevalence of TB.