Prevalence of Classical Extraintestinal Manifestations among Inflammatory Bowel Disease Patients in Saudi Arabia: A Single Tertiary Center Experience.

Background: Patients with inflammatory bowel disease (IBD) may also experience extraintestinal manifestations (EIMs), which can affect various organ systems, and their occurrence is based on disease activity. Objectives: To determine the prevalence of EIMs and their most common types among IBD patients from Saudi Arabia. Materials and Methods: This retrospective study included all IBD patients aged 14-80 years who visited the Gastroenterology and Hepatology clinics at King Fahad Medical City, Riyadh, between February 2017 and December 2022. The collected data included demographic characteristics, disease characteristics, EIMs, and treatment. Results: The study included 578 IBD patients, of which 65 (11.2%) had at least one EIM, with primary sclerosing cholangitis (46.2%) and sacroiliitis (16.9%) being the most common. Patients with ulcerative colitis were more likely to have EIMs than those with Crohn's disease (15.1% vs. 9%; P = 0.026). Patients with ileocolonic (L3) Crohn's disease reported a higher prevalence of EIMs (7.5%) than those with other disease locations (P = 0.012), while in patients with ulcerative colitis, those with extensive colitis (E3) reported higher prevalence of EIMs (19.2%) (P = 0.001). Patients receiving 6 MP had a significantly high prevalence of EIMs (P = 0.014). Conclusion: The prevalence of extraintestinal manifestations among IBD patients in Saudi Arabia is 11.2%. These findings suggest the need for clinicians to screen for EIMs and manage them early. Further research is needed to understand the mechanisms underlying EIMs for the development of more effective treatments.

Prevalence and Risk Factors of Cytomegalovirus Colitis in Inflammatory Bowel Disease Patients in Riyadh, Saudi Arabia: A Tertiary Center Experience.

Background: Patients with inflammatory bowel disease (IBD) are at a higher risk of cytomegalovirus (CMV) colitis because of their immunocompromised status. There are no studies from Saudi Arabia regarding the prevalence of CMV colitis in patients with IBD. Objective: To determine the prevalence, characteristics, and risk factors of CMV colitis in patients with IBD in Riyadh, Saudi Arabia. Materials and Methods: This retrospective study included patients with a confirmed diagnosis of IBD (aged 14-75 years) who were followed up at King Fahad Medical City, a referral care center in Riyadh, between January 2016 and December 2021; patients with indeterminate colitis or incomplete medical records were excluded. Results: A total of 341 patients with IBD were included, of which 236 (72.2%) had Crohn's disease (CD) and 105 (27.8%) had ulcerative colitis (UC). Qualitative CMV PCR was done for 192 patients (60 UC and 132 CD patients), of which 14 patients were positive for CMV colitis (7.3%), and all positive CMV colitis cases were among UC patients (23.3%). However, the hematoxylin and eosin (H and E) stain and immunohistochemistry were negative for all patients. Most patients with CMV colitis were on steroids (71.4%), had at least one flare-up (64.3%), and were on biologic treatment (71.4%). Significant predictors of CMV colitis were hemoglobin (OR: 0.7; 95% CI: 0.51-0.96), albumin (OR: 0.88; 95% CI: 0.78-0.98), and C-reactive protein (OR: 1.03; 95% CI: 1.01-1.06) levels. Conclusion: This study found that the prevalence of CMV colitis was 7.3% among patients with IBD, and no case was diagnosed in patients with CD. In addition, as all cases diagnosed using qualitative CMV PCR were negative on H and E stain and immunohistochemistry, there is need for large-scale studies to improve the diagnosis of CMV colitis.

The efficacy of Elbasvir/Grazoprevir fixed-dose combination for 8 weeks in HCV treatment and health-related quality of life (HRQoL) in treatment-naïve, non-cirrhotic, genotype 4-infected patients (ELEGANT-4): A single-center, single-arm, open-label, phase 3 trial.

Background: Cost, adverse events, and long treatment duration can be significant obstacles in treating hepatitis C virus (HCV)-infected individuals. Shortening the treatment regimen can minimize these barriers, thereby enhancing adherence and increasing medication availability to more patients. Methods: This is a single-centre, single-arm, open-label, phase 3 clinical trial on treatment naïve, non-cirrhotic, HCV genotype 4 patients. The study aimed to evaluate an 8-week course of Elbasvir (ELB)/Grazoprevir (GZR) in this population. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment (SVR-12). The secondary endpoints were SVR-4, adverse events, and changes in health- and hepatitis-related quality of life (HRQoL). Results: Of the 30 patients who were enrolled, 29 (97%) achieved SVR-12 and SVR-4 (95% CI: 90-100%). No patients experienced serious or life-threatening adverse events (AEs), but mild/moderate AEs were reported by 16 (53%). The most commonly reported AEs were itching/skin rash (20%), headache (16.7%), abdominal/epigastric pain and decreased appetite (13.3% each), and nausea/vomiting (10%). Marked improvements in HRQoL were reported between the first (baseline) and third (SVR-12) timepoints. HRQoL score improvements involved the physical, mental, and hepatitis-specific indices, and ranged between 6 and 42 points (out of 100, P ≤0.003). Conclusion: The trial provides empirical evidence that HCV genotype 4-infected patients can achieve viral eradication with an 8-week-regimen of ELB/GZR. Further, this course of treatment is associated with a minimal adverse event profile and potentially significant improvements in quality of life. (ClinicalTrials.gov number, NCT03578640).

Peroral endoscopic myotomy (POEM) for the treatment of achalasia: A multicenter Middle Eastern experience.

BACKGROUND: Peroral endoscopic myotomy (POEM) was proposed in 2010 as a minimally invasive procedure for the treatment of achalasia. In this article, we describe the Middle Eastern experience with the procedure in terms of efficacy, length of admission, and short- and long-term complications. METHODS: A retrospective analysis of our prospectively collected data on patients who underwent a POEM procedure was conducted between March 2019 and May 2020. The primary outcome was clinical success rate, defined as a postprocedure Eckardt score ≤3 at ≥3 months. Secondary outcomes included the length of hospital stay, presence of reflux symptoms or need for proton pump inhibitors (PPIs) ≥3 months, and adverse events. RESULTS: During the study period, 67 patients (35 females) underwent the procedure for achalasia. The participants' ages ranged from 11 to 80 years (mean 41 ± 18 years). Eckardt scores before the treatment ranged between 4 and 12 (mean 8.85 ± 1.75). Sixty-four patients (95.5%) achieved Eckardt scores of ≤3 at ≥3 months after the procedure (95% confidence interval [CI]: 91%-100%). The difference between pre- and post-procedural Eckardt scores averaged around -8 points (95% CI: -7.5 to -8.5 P < 0.0001). Adverse events were reported in 24 patients (35.8%) and included pneumoperitoneum (32.8%), reflux symptoms at 3 months (29.9%), and surgical emphysema (3%). Six patients had adverse events that led to prolongation of admission; 3% of whom had aspiration pneumonia, 3% had pneumoperitoneum, 1.5% had both, and 1.5% had an esophageal tear. CONCLUSIONS: POEM is a promising procedure for the treatment of achalasia with a high clinical success rate, short hospital admission, and a reassuring safety profile.

Week 2 Adalimumab Levels Predict Short-term Clinical Remission in Patients With Inflammatory Bowel Disease.

BACKGROUND AND GOALS: The role of early proactive therapeutic drug level monitoring for anti-tumor necrosis factor therapies is unclear. We aimed to determine whether a week 2 serum trough level in patients with inflammatory bowel disease (IBD) using adalimumab may predict clinical outcomes. MATERIALS AND METHODS: This was a retrospective study of consecutive IBD patients with a week 2 serum adalimumab level available. Receiver operating characteristic curve analysis was conducted to determine an optimal week 2 threshold level for adalimumab. Patients above the threshold were compared for the primary outcome of week 12 clinical remission (CR) and the secondary outcome of short-term endoscopic healing. Multivariate logistic regression analysis was performed to evaluate the relationship between week 2 adalimumab level and CR. RESULTS: Forty-six patients had a week 2 adalimumab level performed. Receiver operating characteristic curve analysis suggested an optimal adalimumab level of 11.9 mcg/mL based on the area under the curve. Patients with week 2 adalimumab levels >11.9 mcg/mL had higher odds of week 12 CR than those with levels below or equal to this threshold (odds ratio=3.34, 95% confidence interval: 1.01-12.11, P =0.04). Other covariates were not found to have a significant association with the primary outcome. The rate of short-term endoscopic healing was numerically higher in patients with adalimumab week 2 levels above 11.9 mcg/mL; however, was not statistically significant (71.4% vs. 28.5%, P =0.11). CONCLUSIONS: Serum adalimumab levels at week 2 appears to be a predictor of short-term CR. Further research should explore whether patients with a week 2 adalimumab level equal to or below 11.9 mcg/mL benefit from early dose optimization.

Infliximab-induced autoimmune hepatitis requiring liver transplantation.

Autoimmune hepatitis is an infrequent but significant side effect of infliximab treatment. Diagnosis of autoimmune hepatitis is based on clinical, laboratory, and histological findings. Initial treatment involves cessation of infliximab and trial of prednisone. We present a rare case of infliximab-induced autoimmune hepatitis leading to liver failure requiring transplantation.