Purpose: GC1118 is a novel antibody targeting epidermal growth factor receptor (EGFR) with enhanced blocking activity against both low- and high-affinity EGFR ligands. A phase 1b/2a study was conducted to determine a recommended phase 2 dose (RP2D) of GC1118 in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) (phase 1b) and to assess the safety and efficacy of GC1118 plus FOLFIRI as a second-line therapy for recurrent/metastatic colorectal cancer (CRC) (phase 2a). Materials and Methods: Phase 1b was designed as a standard 3+3 dose-escalation study with a starting dose of GC1118 (3 mg/kg/week) in combination with biweekly FOLFIRI (irinotecan 180 mg/m2; leucovorin 400 mg/m2; 5-fluorouracil 400 mg/m2 bolus and 2,400 mg/m2 infusion over 46 hours) in patients with solid tumors refractory to standard treatments. The subsequent phase 2a part was conducted with objective response rate (ORR) as a primary endpoint. Patients with KRAS/NRAS/BRAF wild-type, EGFR-positive, recurrent/metastatic CRC resistant to the first-line treatment were enrolled in the phase 2a study. Results: RP2D of GC1118 was determined to be 3 mg/kg/wk in the phase 1b study (n=7). Common adverse drug reactions (ADRs) observed in the phase 2a study (n=24) were acneiform rash (95.8%), dry skin (66.7%), paronychia (58.3%), and stomatitis (50.0%). The most common ADR of ≥ grade 3 was neutropenia (33.3%). ORR was 42.5% (95% confidence interval [CI], 23.5 to 62.0), and median progression-free survival was 6.7 months (95% CI, 4.0-8.0). Conclusion GC1118 administered weekly at 3 mg/kg in combination with FOLFIRI appears as an effective and safe treatment option in recurrent/metastatic CRC.

Background: Patients with skin barrier dysfunction often coincides with pruritus, creating a ‘vicious cycle’ of dry skin and itching. Recently, Cynanchum atratum (CA) extract and its constituents have demonstrated effects on atopic dermatitis both in vivo and in vitro. Objective: This study aimed to assess the safety and efficacy of a moisturizer infused with CA extract in enhancing epidermal barrier function and reducing pruritus. Methods: A total 36 participants with skin barrier dysfunction with pruritus (mean age: 46.22±12.48 years) applied the CA-containing moisturizer topically twice daily for up to 4 weeks. Treatment efficacy was assessed by the investigator using the erythema scaling induration fissuring (ESIF) scale, transepidermal water loss (TEWL), skin hydration, visual analogue scale (VAS) for pruritus, and overall patient satisfaction assessed via questionnaire. Results: The CA-containing moisturizer demonstrated favorable tolerability, and yielded significant pruritus relief as evidenced by VAS scores after 2 and 4 weeks of application (p＜0.05). Significant decreases in TEWL (p＜0.05) and skin hydration (p＜0.05) were observed after 2 and 4 weeks, indicating enhanced skin barrier function. Moreover, significant relief from pruritus and reductions in ESIF were observed at 2 and 4 weeks of application (p ＜0.05), aligning with the high levels of patient satisfaction was high. Conclusion The CA-infused moisturizer emerged as a safe and effective intervention for restoring skin barrier function and providing itch relief.

BACKGROUND: Inflammatory bowel disease (IBD) is an incurable disease that negatively influences the quality of life of patients. Current and emerging therapies target proinflammatory cytokines and/or receptors to downregulate proinflammatory responses, but insufficient remission requires other therapeutic agents. Herein, we report that the synthetic antiinflammatory peptide 15 (SAP15) is capable of cell penetration and anti-inflammatory activity in human macrophages. METHODS: SAP15 was labeled with fluorescence and administered to human leukemia monocytic cells (THP-1) cells for cell penetration analysis. Using biolayer interferometry analysis, the binding affinity of SAP15 with histone deacetylase 5 (HDAC5) was measured. SAP15-treated THP-1 cells were analyzed by protein phosphorylation assay, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). In addition, in vivo analysis of the therapeutic effect on IBD was observed in a dextran sulfate sodium (DSS)-induced model. Samples from SAP15-treated mice were analyzed at both the macroscopic and microscopic levels using ELISA, myeloperoxidase (MPO) assays, and histological evaluations. RESULTS: SAP15 was internalized within the cytosol and nucleus of THP-1 cells and bound to the HDAC5 protein. SAP15-treated macrophages were assessed for protein phosphorylation and showed inhibited phosphorylation of HDAC5 and other immune-related proteins, which led to increased M2-like macrophage markers and decreased M1-like macrophage markers and tumor necrosis factor-a and interleukin-6 cytokine levels. The SAP15 treatment on IBD model showed significant recovery of colon length. Further histological analysis of colon demonstrated the therapeutic effect of SAP15 on mucosal layer. Moreover, proinflammatory cytokine levels and MPO activity from the plasma show that SAP15 is effective in reduced proinflammatory responses. CONCLUSION These findings suggest that SAP15 is a novel peptide with a novel cell-penetrating peptide with antiinflammatory property that can be used as a therapeutic agent for IBD and other inflammatory diseases.

Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.

Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.

BACKGROUND/AIMS: The eradication rates of Helicobacter pylori has been decreasing over the years and it is different among the regions. The aim of this study was to investigate the rates of first-line and the second-line eradication of H. pylori over the last 5 years in a single institute of Changwon and Gyeongsangnam-do, Korea. MATERIALS AND METHODS: Eradication rates of first-line triple regimen in 1,164 patients and second-line quadruple regimen in 223 patients who received H. pylori eradication treatment from January 2008 to December 2012 at Changwon Fatima Hospital were evaluated retrospectively. The patients for second-line quadruple therapy were divided into three groups according to the dosage of medications. RESULTS: The overall eradication rates of first-line and second-line therapy were 70.5% and 81.2%, respectively. There was no decreasing tendency in the eradication rate of first-line therapy for 5 years (P=0.573). However, annul eradication rates of second-line therapy significantly decreased (P=0.001, linear by linear association). In second-line therapy, patients treated with high dose bismuth and metronidazole had higher eradication rates than those treated with low dose bismuth and metronidazole (P=0.039). CONCLUSIONS: The effectiveness of the first-line and second-line therapy for H. pylori was suboptimal. In addition, there was a decreasing tendency in the eradication rates of second-line therapy over the past 5 years in Changwon and Gyeongsangnam-do province. Alternative regimens or high dose therapy should be considered for first-line and second-line therapy.
Bismuth ; Gyeongsangnam-do ; Helicobacter pylori* ; Helicobacter* ; Humans ; Korea ; Metronidazole ; Retrospective Studies

PURPOSE: The purpose of this study was to assess and compare the clinical and radiographic outcomes of guided tissue regeneration therapy for human periodontal intrabony defects using two different collagen membranes: a porous nonchemical cross-linking collagen membrane (NC) and a bilayer collagen membrane (BC). METHODS: Thirty subjects were randomly assigned and divided into the following 3 groups: a test group (NC+BM), in which a NC was used with xenograft bone mineral (BM), a positive control group (BC+BM), in which a BC was used with xenograft BM, and a negative control group (BM), in which only xenograft BM was used. The following clinical measurements were taken at baseline and 3 months after surgery: plaque index, gingival index, probing pocket depth, gingival recession, and clinical attachment level. Radiographic analysis was performed at baseline, 1 week and 3 months after surgery. RESULTS: Membrane exposure was not observed in any cases. Significant probing depth reduction, attachment-level gain and bone fill were observed for both test and control groups compared to baseline at 3 months after surgery (P<0.05). However, there were no statistically significant differences in clinical improvement and radiographic bone fill between treatment protocols (P>0.05). CONCLUSIONS: Within the limitations of this study, the results suggest that both NC and BC were comparable in terms of clinical and radiographic outcomes for the treatment of periodontal intrabony defects in human subjects.
Chronic Periodontitis ; Clinical Protocols ; Collagen* ; Gingival Recession ; Guided Tissue Regeneration* ; Heterografts ; Humans ; Membranes* ; Periodontal Index

Extrahepatic bile duct can be compressed by right hepatic artery (RHA) and cause a variety of hepatobiliary symptoms. This condition is referred to as RHA syndrome. A 20-year-old man was admitted because of jaundice. No stones or tumor were visible on CT scan and endoscopic retrograde cholangiopancreatography. However, RHA was seen traversing and compressing the mid common bile duct (CBD) with resultant upstream dilatation. The patient was diagnosed with obstructive jaundice due to compression of the CBD by variant RHA originating from gastroduodenal artery. After separation and mobilization of the variant RHA, obstructive jaundice was resolved. Herein, we report a case of a variant form of RHA syndrome that was successfully managed by surgery.
Arteries ; Bile Ducts, Extrahepatic ; Cholangiopancreatography, Endoscopic Retrograde ; Common Bile Duct* ; Dilatation ; Hepatic Artery* ; Humans ; Jaundice ; Jaundice, Obstructive* ; Tomography, X-Ray Computed ; Young Adult

Intraductal tubulopapillary neoplasm (ITPN) of the pancreas has been recently reported. It is very rare, therefore clinical behavior and prognosis has not yet been characterized. We experienced a case of ITPN of the pancreas which presented with acute pancreatitis and treated with Whipple's operation. Histopathologic finding showed papillary hyperplasia with carcinomatous change. The tumor recurred after 47 month of operation, and she underwent total pancreatectomy. Pathologic finding revealed tubulopapillary growth with high grade dysplasia. Immunohistochemial staining was not performed, however gross and microscopic findings were compatible with ITPN of the pancreas. We report a case of ITPN of the pancreas.
Hyperplasia ; Pancreas* ; Pancreatectomy ; Pancreatitis* ; Prognosis

Intraductal tubulopapillary neoplasm (ITPN) of the pancreas has been recently reported. It is very rare, therefore clinical behavior and prognosis has not yet been characterized. We experienced a case of ITPN of the pancreas which presented with acute pancreatitis and treated with Whipple's operation. Histopathologic finding showed papillary hyperplasia with carcinomatous change. The tumor recurred after 47 month of operation, and she underwent total pancreatectomy. Pathologic finding revealed tubulopapillary growth with high grade dysplasia. Immunohistochemial staining was not performed, however gross and microscopic findings were compatible with ITPN of the pancreas. We report a case of ITPN of the pancreas.
Hyperplasia ; Pancreas* ; Pancreatectomy ; Pancreatitis* ; Prognosis