ABSTRACT
INTRODUCTION: Inflammatory bowel disease (IBD), consists of two primary types: Ulcerative Colitis (UC) and Crohn's Disease (CD). Infliximab (IFX) and Adalimumab (ADA) are frequently utilized in the management of moderate to severe cases of IBD. AIM: This study aimed to assess the efficacy and safety of IFX and ADA in individuals diagnosed with moderate to severe IBD. METHOD: This study is a prospective open-labeled randomized parallel study that included moderate to severe IBD patients treated with either IFX or ADA. A total of 56 patients participated, with 34 patients received IFX and 22 patients received ADA. Various measures, including Crohn's Disease Activity Index (CDAI), Mayo Score/ Disease Activity Index (DAI), and C-reactive protein (CRP) levels, were taken at baseline and week 14 to assess the efficacy of the treatments. In addition, the levels of drugs and sTREM-1 were measured at 14 weeks. Patient safety was monitored throughout the study period. RESULTS: In the group received IFX, there was a notable decrease in CDAI (P = 0.045), DAI (P = 0.026), and CRP (P = 0.023 for CD, and P = 0.021 for UC) levels. In addition, the group received ADA experienced a significant reduction in CDAI (P = 0.001), DAI (P = 0.032), and CRP (P < 0.018 for CD and P = 0.003 for UC) levels. Responders had higher drug concentrations than non-responders, notably IFX concentration was higher in responders with CD (P = 0.001) and UC (P < 0.001). ADA concentration was higher in UC (P <= 0.001) and all CD patients responded to the treatment. The same trend was observed for sTREM-1 levels in CD and UC patients (P = 0.042, and P = 0.015, respectively) in the IFX group. In UC patients treated with ADA, the level of sTREM-1 was significantly low (P = 0.002). CONCLUSION: Both IFX and ADA have a good safety profile and deliver a beneficial clinical and laboratory response in moderate-severe IBD patients. CLINICAL TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov under the identifier NCT05291039. (You can access the study at https://clinicaltrials.gov/study/NCT05291039 (First Posted: March 22, 2022).
ABSTRACT
BACKGROUND AND AIM: After a decrease of COVID-19 cases in summer, Europe faced the appearance of a COVID-19 second wave. IBD patients are more vulnerable to various emotional and psychological stresses than normal individuals. The aim of this study explored the emotional state, perception, and coping strategies of patients with IBD during the COVID 19 pandemic period. METHODS: A cross-sectional study was conducted between 15 November and 15 December 2020. Patients presented to IBD Study Group Clinic, Department of Tropical Medicine, Ain Shams University Hospitals. The study included 105 IBD patients. A predesigned questionnaire was used that focused on patients' knowledge of the COVID-19 pandemic, and how it influenced patient care. Patient demographics, disease characteristics, and medication type were analyzed. RESULTS: We found 10.5% of patients stopped or delayed their medications owing to the COVID-19 pandemic second wave and 61% reported that their clinic visits were affected. Seven patients were tested, and two patients reported having been diagnosed with COVID-19, and 18 patients reported having relatives diagnosed with COVID-19. CONCLUSION: A considerable number of patients with IBD had an interruption to their care because of the second wave COVID-19 pandemic. So, patients with IBD should take attention before, during, and after such pandemics to avoid undesirable disease-related outcomes.