Correlation between physician- and patient-directed disease assessments in ulcerative colitis patients from Saudi Arabia and Kuwait: Data from ICONIC.

Background: The aim of the observational, prospective study was to validate a novel, nonverbal assessment tool for perceived disease burden-Pictorial Representation of Illness and Self-Measure (PRISM)-in ulcerative colitis (UC) against established patient health questionnaires. The cumulative burden of patients recently diagnosed (<3 years) with UC was also evaluated. Methods: "ICONIC" - Understanding the impact of ulcerative colitis and its associated disease burden on patients - was a noninterventional, multicountry, multicenter study performed in a 2-year follow-up format in adult patients with recently diagnosed UC in 33 countries, regardless of disease severity or treatment. Data collection consisted of five visits, scheduled at approximately 6-month intervals. For the current analysis, patient data from Saudi Arabia and Kuwait were evaluated. The collected data comprised demographics, disease-related data, UC treatment, and healthcare resources, as well as physician- and patient-assessed quality-of-life and disease burden questionnaires. Correlations between selected questionnaire scores were performed using Spearman's rho. Results: Disease severity at baseline and throughout the study was slightly less favorable in this country analysis compared with the global study cohort. Disease burden was assessed by PRISM and improved within 24 months. Conclusions: The detected moderate correlation between PRISM and other assessment methods supports the validity of PRISM. Differences in perceptions of UC-related burden between physician and patient may reflect to some degree insufficient patient-physician communication.

Pegylated interferon alfa-2b plus ribavirin for the treatment of chronic hepatitis C genotype 4 in adolescents.

BACKGROUND: Hepatitis C is endemic in the Middle East where genotype 4 accounts for most cases. Data regarding the safety and efficacy of peginterferon plus ribavirin for the treatment of chronic hepatitis C in children and adolescents, particularly those infected with genotype 4 is limited. Aim. To evaluate the efficacy and tolerability of peginterferon alfa-2b in combination with ribavirin in adolescents chronically infected with HCV genotype 4. PATIENTS AND METHODS: In an open-labeled, uncontrolled pilot study, 12 adolescents (range14-17 years) were treated with subcutaneous peginterferon alfa-2b at a dose of 1.5 mg/kg body weight once per week plus oral ribavirin (15 mg/kg/day) for 48 weeks. Patients were followed for 24 weeks post-treatment. All patients had biopsy proven hepatitis without cirrhosis. RESULTS: One patient withdrew from the study due to developing insulin dependent diabetes mellitus 4 months into treatment. The remaining patients received at least 80% of the prescribed dose of pegylated interferon and ribavirin. Sustained viral response was observed in 9 patients (75%). The most frequent side effect was flu like illness which was reported in all patients. Sixty seven percent had leucopenia, but only one individual required adjuvant therapy with hematologic growth factor. Four patients had anemia requiring ribavirin dose reduction. One patient developed hypothyroidism. CONCLUSION: Combination treatment of peginterferon alfa-2b with ribavirin appears to be efficacious and relatively safe in adolescents with chronic hepatitis C genotype 4.B.

Lymphocytic enterocolitis in systemic lupus erythematosus.

Microscopic colitis (MC) is a recognized cause of chronic watery diarrhea. It is characterized by subepithelial collagen deposition or intraepithelial lymphocytic infiltration of the colonic mucosa which, however, appears grossly normal on endoscopy. The term microscopic enterocolitis is applied when MC is associated with similar microscopic affection of the ileum and/or proximal small intestine. MC is reported to be associated with a variety of autoimmune conditions. Systemic lupus erythematosus (SLE) is rarely reported in association with MC. We report a female patient with microscopic enterocolitis as one of the presenting manifestations of SLE.

Peginterferon alpha-2b plus ribavirin with or without amantadine [correction of amantidine] for the treatment of non-responders to standard interferon and ribavirin.

BACKGROUND: A significant proportion of hepatitis C patients treated with unmodified interferon plus ribavirin fail to respond. The optimal therapy for these patients has not been established yet. The objective of this study was to assess the efficacy and safety of peginterferon plus ribavirin with or without amantidine in such patients. METHODS: In this open-label, prospective controlled trial, a total of 63 patients were randomly divided into groups A and B with a ratio of 1:2. Group A (21 patients) received weekly peginterferon alpha-2b, 1.5 microg/kg concomitantly with ribavirin 1000-1200mg per day. Group B (42 patients) received peginterferon and ribavirin as in group A, plus amantadine [corrected] 200 mg per day. RESULTS: At the completion of treatment, serum levels of hepatitis C virus RNA were undetectable in 14% and 12% of patients in groups A and B, respectively (P=NS). Hepatitis C virus RNA remained undetectable 24 weeks after the end of treatment in one patient (5%) in group A and three patients (7%) in group B (P=NS). Sustained viral clearance was associated with sustained normalization of serum alanine aminotransferase level. Both drug regimens had similar side effect profiles. CONCLUSION: Peginterferon plus ribavirin therapy with or without amantadine [corrected] is associated with a low sustained virological response in patients who failed interferon and ribavirin combination therapy.