COVID-19 outcomes in patients with inflammatory bowel diseases in Latin America: Results from SECURE-IBD registry.

BACKGROUND AND AIM: One of the most impacted regions by the pandemic globally, Latin America is facing socioeconomic and health-care challenges that can potentially affect disease outcomes. Recent data suggest that inflammatory bowel disease (IBD) patients do not have an increased risk of the development of COVID-19 complications. However, the impact of COVID-19 on IBD patients living in least developed areas remains to be fully elucidated. This study aims to describe the outcomes of IBD patients diagnosed with COVID-19 in countries from Latin America based on data from the SECURE-IBD registry. METHODS: Patients from Latin America enrolled in the SECURE-IBD registry were included. Descriptive analyses were used to summarize clinical and sociodemographic characteristics. The studied outcomes were (i) a composite of need for intensive care unit admission, ventilator use, and/or death (primary outcome) and (ii) a composite of any hospitalization and/or death (secondary outcome). Multivariable regression was used to identify risk factors of severe COVID-19. RESULTS: During the study period, 230 cases (Crohn's disease: n = 115, ulcerative colitis: n = 114, IBD-unclassified [IBD-U]: n = 1) were reported to the SECURE-IBD database from 13 different countries. Primary outcome was observed in 17 (7.4%) patients, and the case fatality rate was 1.7%. In the adjusted multivariable model, the use of systemic corticosteroids (odds ratio [OR] 10.97; 95% confidence interval [CI]: 3.44-34.99) was significantly associated with the primary outcome. Older age (OR 1.03; 95% CI: 1.00-1.05), systemic corticosteroids (OR 9.33; 95% CI: 3.84-22.63), and the concomitant presence of one (OR 2.14; 95% CI: 0.89-5.15) or two (OR 10.67; 95% CI: 1.74-65.72) comorbidities were associated with the outcome of hospitalization or death. CONCLUSION: Inflammatory bowel disease patients with COVID-19 in Latin America appear to have similar outcomes to the overall global data. Risk factors of severe COVID-19 are similar to prior reports.

Safety considerations with biologics and new inflammatory bowel disease therapies.

PURPOSE OF REVIEW: The safety profile of therapies is an important issue that should always be shared with patients when choosing their treatment. The introduction of biologics over the past 2 decades represented a breakthrough in the management of inflammatory bowel diseases (IBDs). With better understanding of the pathophysiology of the disease, emerging therapies targeting different mechanisms of action have been developed including targeted monoclonal antibodies and small molecules. However, increasing concerns about the safety and side effects of these drugs have been challenging clinicians in clinical practice. RECENT FINDINGS: Comparative safety data between different therapies are lacking in the literature. Most safety recommendations are based on adverse events reported in clinical trials and register-based cohorts. An extensive literature review addressing the risk of infections, malignancies, immunogenicity, and metabolic disorders was performed for biologics and new IBD therapies based on reported adverse events in pivotal trials, long-term extension trials and real-world studies. SUMMARY: In this article, we summarize the most recent data on safety of biologics and new IBD therapies and propose hierarchical positioning of drugs regarding safety based on expert opinion recommendations.

Peroral endoscopic myotomy (POEM): a comparative study between Chagasic and idiopathic achalasia.

Background and study aims Achalasia can be classified as either primary (idiopathic) achalasia or secondary achalasia, which is a consequence of another systemic disease. Peroral endoscopic myotomy (POEM) is an effective and safe treatment for achalasia. We evaluated the efficacy and safety of POEM in patients with Chagasic achalasia compared to idiopathic achalasia. Patients and methods We evaluated POEM procedures performed at a single institution from November 2016 to January 2018. Demographic data, Eckardt score, lower esophageal sphincter (LES) pressure, body mass index, post-operative erosive esophagitis, adverse events, length of hospital stay, and procedure-related parameters were analyzed. Results Fifty-one patients underwent POEM as a treatment for achalasia in this period (20 patients with Chagasic and 31 with Idiopathic etiology). The overall clinical success rate was 92.1 %, with no statistical difference between groups (90 % in the Chagasic group vs. 93.5 % in the Idiopathic group, P  = 0.640). Both groups had significant reduction in Eckardt score and in LES pressure, and increase in bodey mass index (BMI) at 1-year follow-up. There was no statistical difference between groups regarding Eckardt score ( P  = 0.439), LES pressure (p = 0.507), BMI ( P  = 0.254), post erosive esophagitis (35 % vs. 38.7 %, P  = 0.789), adverse events (30 % vs. 12 %, P  = 0.163,) length of hospital stay (3.75 days vs. 3.58 days, P  = 0.622), and operative time (101.3 min vs. 99.1 min, P  = 0.840). Conclusion POEM is an effective and safe treatment for patients with achalasia. There is no difference in POEM outcomes for those patients with Chagasic or Idiopathic achalasia.