Exploring treatment of inflammatory bowel disease with infliximab in the Middle East and Northern Africa: An analysis of the HARIR observational cohort study.

Background: In 2017, inflammatory bowel disease, including Crohn's disease (CD) and ulcerative colitis (UC) affected more than 6.8 million people worldwide, with increased incidence in newly industrialized countries. Although treatment options were previously limited to symptom reduction, current approaches benefit from disease-modifying biologics. In this study, we aimed to explore disease characteristics, treatment, and outcomes of patients with CD or UC treated with infliximab or golimumab in routine clinical practice in the Middle East and Northern Africa. Methods: HARIR was a prospective, observational, multicenter study (NCT03006198), in patients who were treatment naïve or who received two or fewer biologic agents. Observed data from routine clinical practice were presented descriptively. Results: Data from 86 patients enrolled from five countries (Algeria, Egypt, Kuwait, Qatar, and Saudi Arabia) were analyzed, 62 with CD and 24 with UC. All patients received infliximab. Clinically meaningful efficacy data were observed only for the CD group (up to Month 3) due to limited patient numbers. Crohn's Disease Activity Index (CDAI) scores at Month 3 indicated a positive response to treatment (reduced score of ≥70 and ≥25% compared with baseline) for 14/48 (29.2%) patients; notably, 28/52 (53.8%) patients had CDAI score <150 at baseline. Rates of serious and severe adverse events (AEs) were low in both groups. The most common AEs were gastrointestinal disorders. Conclusion: Infliximab treatment was well tolerated in this Middle Eastern and Northern African population, and a clinical response was observed for 29.2% of CD patients. Limited accessibility to biologics and concomitant treatments restricted study conduct.

Characterization of Crohn's disease patients in Egypt: Risk factors for postoperative recurrence (A cohort study).

BACKGROUND: The aim of study to identify the characterizations of Crohn's disease in Egyptian patients and to determine its predictors for postoperative recurrence. METHODS: We conducted a retrospective observational cohort study on 15 patients diagnosed as Crohn's disease with surgical interventions. Different characteristics of studied patients were analyzed to determine the risk factors for postoperative recurrence such as age at diagnosis, gender, smoking, main presenting symptom, Montreal classification, perianal disease, laboratory findings and protocol of management including surgical characteristics like age at operation, surgical indication, preoperative medication, surgical approach, and operative findings. RESULTS: Nine of the studied patients (60%) suffered from clinical postoperative recurrence with mean duration of 23.5 ± 40.6 months. In comparison the demographic, clinical, operative, and medical treatment data between patients with postoperative recurrence of Crohn's disease and those without recurrence, age at diagnosis (mean age 42.9 years) and age at operation (mean 44.7 years) were found statistically significant in postoperative recurrence group (p-value = 0.001). According to Montreal classification of Crohn's disease, patients >40 years were significantly found in postoperative recurrence group, while patients between 17 and 40 years were significantly found in postoperative non-recurrence group (p-value=0.007) and ileal location of Crohn's disease was found significantly in postoperative recurrent group (p-value=0.044). Postoperative biological therapy significantly decreased the incidence of postoperative recurrence in the current study (p-value= 0.041). CONCLUSIONS: Age at diagnosis, age at operation, ileal location of Crohn's disease can significantly predict postoperative recurrence. Also, postoperative biological therapy can significantly decrease the incidence of postoperative recurrence.

Comparative study of IgG binding to megakaryocytes in immune and myelodysplastic thrombocytopenic patients.

Immune thrombocytopenia (ITP) is a disorder in which autoantibodies are responsible for destruction and decreased production of platelets. In the meantime, thrombocytopenia is frequent in patients with myelodysplastic syndromes (MDS) and immune clearance of megakaryocytes could be a reason. The aim of the present study is to evaluate and compare IgG binding to megakaryocytes in bone marrow of ITP and MDS patients to determine megakaryocytes targeting by autoantibodies in vivo as a mechanism of platelet underproduction in these disorders. The study was carried out on 20 ITP (group I) patients, 20 thrombocytopenic patients with (MDS) (group II), and 20 non-ITP patients as a control (group III) who were admitted to Minia University Hospital. Serial histological sections from bone marrow biopsies were stained for IgG. All patients in group I and 50% of group II patients showed bleeding tendency and the difference was significant (p < 0.001). No patient experienced fatigue in group I while 35% of patients in group II complained of easy fatigability, and the difference was significant (p < 0.008). High IgG antibody binding was found in ITP and MDS compared to the control group but no significant difference between ITP and MDS patients (14/20 (70%) vs. 13/20 (65%)) (p value = 0.736). Antibody binding to megakaryocytes in a proportion of MDS patients suggests that immune-mediated mechanism underlies platelet underproduction in those patients.

Comparative study between bowel ultrasound and magnetic resonance enterography among Egyptian inflammatory bowel disease patients.

BACKGROUND: Bowel ultrasound and magnetic resonance enterography (MRE) are decisive medical imaging modalities for diagnosing and locating bowel lesions with its extramural extent and complications. They assess the degree of activity, help clinicians to identify patients in need of surgery, and can be used for patient follow-up. AIM: To compare the role of MRE and bowel ultrasound in diagnosis and follow-up of inflammatory bowel disease (IBD) patients in Egypt. METHODS: The study was conducted on 40 patients with IBD. All patients were subjected to clinical assessment, laboratory investigations, bowel ultrasound, MRE, and colonoscopy up to the terminal ileum with biopsies for histopathological examination. RESULTS: This study was conducted on 14 patients (35%) with ulcerative colitis and 26 patients (65%) with Crohn's disease; 34 (85%) of these patients had active disease. Bowel ultrasound detected different bowel lesions with the following accuracies: ileum (85%), large bowel (70%), fistula (95%), stricture and proximal dilatation (95%) and abscesses (100%). Also, it showed that statistically significance of bowel ultrasound in differentiation between remission and activity of IBD in comparison to MRE and colonoscopy. CONCLUSION: In comparison to MRE, bowel ultrasound is a useful, non-invasive, and feasible bedside imaging tool for the detection of inflammation, detection of complications, and follow-up of IBD patients when performed by the attending physician.

Can zinc levels predict response to pegylated-interferon and ribavirin therapy in hepatitis C genotype 4 infected Egyptian patients?

BACKGROUND AND AIMS: Zinc has been found to be low in chronic hepatitis patients. Its level was correlated with response to Interferon/ribavirin therapy in patients infected with hepatitis C genotype 1. In Egypt, inexpensive predictors to treatment response in Hepatitis C genotype 4 infected patients are desperately needed. We aim to explore if pretreatment zinc serum levels correlate with response to pegylated- interferon and ribavirin therapy in Egyptian patients. METHODS: This is an observational prospective study where 57 treatment naive hepatitis C genotype 4 infected patients that were Hepatitis B and Human Immunodeficiency virus negative were recruited in a hospital setting. The study was performed from October 2010 till June 2012. Patients had Liver biopsy and basic biochemical profiles were performed pretreatment for all patients. Treatment consisted of 48 weeks of pegylated-interferon-alpha2a and ribavirin therapy. Blood samples were withdrawn from 21 healthy subjects to compare zinc levels and other biochemical markers. Patients were followed up to 72 weeks. RESULTS: Pretreatment serum zinc levels were significantly lower in hepatitis C infected patients compared to healthy volunteers (p < 0.05). Moreover, zinc levels correlated to sustained virological response in treated patients (p = 0.00). CONCLUSION: Serum zinc levels can be used as an inexpensive predictor to effective Pegylated-interferon/ribavirin therapy in Egyptian patients infected with Hepatitic C genotype 4.

Helicobacter Pylori Infection in a Group of Egyptian Children With Upper Gastro-Intestinal Bleeding.

BACKGROUND: Upper gastrointestinal bleeding is a life threatening condition in children. Common sources of upper gastrointestinal bleeding in children include mucosal lesions and variceal hemorrhage. Helicobacter pylori (H. pylori) is a Gram negative spiral-shaped bacterium that is found in the gastric mucous layer or adherent to the epithelial lining of the stomach. It causes more than 90% of duodenal ulcers and up to 70-80% of gastric ulcers. The relationship between H. pylori infection and upper GIT bleeding in children is still un-clear. This study aimed to estimate the incidence of H. pylori infection in children presented with upper GIT bleeding and correlation between H. pylori infection and endoscopic findings of the cause of bleeding. METHODS: The study included 70 children presented with upper GIT bleeding indicated for upper gastrointestinal endoscopy admitted in pediatric department, Minia University Hospital, Egypt during the period from February 2010 to December 2012. Thirty healthy children were included as a control group with age and sex matched. After medical history taking and physical examination all children were exposed for laboratory investigations (CBC, prothrombin time and concentration, liver function tests, hepatitis viral markers, blood urea and serum creatinine and Helicobacter pylori stool antigen test). Upper endoscopy was done for patients only. Patients were classified into variceal and non variceal groups according to upper endoscopy. RESULTS: Helico-pylori infection was significantly higher in children with non-variceal bleeding than controls (P = 0.02) and children with variceal bleeding (P = 0.03) with no significant difference between children with variceal bleeding and controls (P = 0.9). Both weights and BMIs centile were significantly lower in variceal and non-variceal groups than controls (P = 0.01 & 0.001 and 0.01 & 0.001 respectively). AST, ALT and direct bilirubin levels were significantly higher in variceal group than controls (P = 0.001, 0.004 & 0.001 respectively). Prothrombin concentration and albumin levels were significantly lower in variceal group than controls (P = 0.001 & 0.01 respectively). Hemoglobin levels were significantly lower in variceal and non-variceal groups than controls (P = 0.01 & 0.001 respectively). No significant differences were present as regards age, sex, height or platelets count between cases (variceal and non-variceal) and controls. CONCLUSIONS: H. pylori infection is significantly higher in children with non-variceal bleeding than controls. No significant difference between children with variceal bleeding and controls. Triad of increased ALT, decreased albumin levels and negative H. pylori infection could be a significant triad in predicting variceal bleeding as a cause of upper GIT bleeding in children.