Consensus Statement by an Expert Panel on the Diagnosis and Management of Iron Deficiency Anemia in the Gulf Cooperation Council Countries.

BACKGROUND: Iron deficiency (ID) and ID anemia (IDA) are common in the member states of the Gulf Cooperation Council (GCC). The unique genetic and lifestyle factors of the patient population in the region have necessitated the development of recommendations to help educate health-care professionals on appropriate diagnosis and management of ID/IDA. METHODS: A panel of regional experts, including gastroenterologists and hematologists with expertise in the treatment of IDA, was convened to develop regional practice recommendations for ID/IDA. After reviewing the regional and international literature, the expert panel developed consensus recommendations for screening, diagnosis, and treatment of patients with IDA in the GCC region. RESULTS: The recommendations proposed were customized to the patient population keeping in view the increasingly recognized burden of coeliac disease, high fertility and obesity rates, high prevalence of alpha- and beta-thalassemia traits, and poor tolerance and low treatment compliance with oral iron therapy. CONCLUSIONS: This consensus statement proposes recommendations for screening, diagnosis, and treatment of IDA in the GCC region.

Alcohol-Related Liver Disease Is Rarely Detected at Early Stages Compared With Liver Diseases of Other Etiologies Worldwide.

BACKGROUND & AIMS: Despite recent advances in treatment of viral hepatitis, liver-related mortality is high, possibly owing to the large burden of advanced alcohol-related liver disease (ALD). We investigated whether patients with ALD are initially seen at later stages of disease development than patients with hepatitis C virus (HCV) infection or other etiologies. METHODS: We performed a cross-sectional study of 3453 consecutive patients with either early or advanced liver disease (1699 patients with early and 1754 with advanced liver disease) seen at 17 tertiary care liver or gastrointestinal units worldwide, from August 2015 through March 2017. We collected anthropometric, etiology, and clinical information, as well as and model for end-stage liver disease scores. We used unconditional logistic regression to estimate the odds ratios for evaluation at late stages of the disease progression. RESULTS: Of the patients analyzed, 81% had 1 etiology of liver disease and 17% had 2 etiologies of liver disease. Of patients seen at early stages for a single etiology, 31% had HCV infection, 21% had hepatitis B virus infection, and 17% had nonalcoholic fatty liver disease, whereas only 3.8% had ALD. In contrast, 29% of patients seen for advanced disease had ALD. Patients with ALD were more likely to be seen at specialized centers, with advanced-stage disease, compared with patients with HCV-associated liver disease (odds ratio, 14.1; 95% CI, 10.5-18.9; P < .001). Of patients with 2 etiologies of liver disease, excess alcohol use was associated with 50% of cases. These patients had significantly more visits to health care providers, with more advanced disease, compared with patients without excess alcohol use. The mean model for end-stage liver disease score for patients with advanced ALD (score, 16) was higher than for patients with advanced liver disease not associated with excess alcohol use (score, 13) (P < .01). CONCLUSIONS: In a cross-sectional analysis of patients with liver disease worldwide, we found that patients with ALD are seen with more advanced-stage disease than patients with HCV-associated liver disease. Of patients with 2 etiologies of liver disease, excess alcohol use was associated with 50% of cases. Early detection and referral programs are needed for patients with ALD worldwide.

Immunogenicity of Hepatitis B Vaccination in Patients with Ulcerative Colitis on Infliximab Is Attenuated Compared to Those on 5-Aminosalicylic Acid Therapies: A Prospective Observational Study.

INTRODUCTION: Hepatitis B virus (HBV) infection has been associated with chronic hepatitis and cirrhosis. Patients with inflammatory bowel disease (IBD) may be at a higher risk of HBV infection reactivation, especially those on biologic therapies. This study intends to compare the effectiveness of the HBV vaccine in patients with ulcerative colitis (UC) on infliximab (IFX) compared to those on 5-aminosalicylic acid (5-ASA). METHODS: Patients with UC aged >18 years old were prospectively enrolled in the study. The patients were divided into two groups: patients treated with 5-ASA (control group) and patients treated with IFX (study group). HBV vaccination was administered (20 mcg) following the standard regimen, and Hepatitis B serum antibody (HbsAb) titers were assessed three months after the final dose. The response to HBV vaccines was categorized as an 'adequate' immune response (≥10 IU/L) and 'effective' immune response (≥100 IU/L). RESULTS: In our final analysis of 118 patients with UC, 54.2% were male and 52.5% had extensive colitis. HBsAb titer levels were significantly higher in the 5-ASA group (126.7 ± 37.5) compared to the IFX group (55.5 ± 29.4). Stratifying HBsAb levels into two categories (≥10-99 IU/L and ≥100 IU/L) revealed a significantly greater proportion of subjects in the 5-ASA group with levels ≥100 IU/L compared to the IFX group (76.7% vs. 12.1%, p < 0.001). Logistic regression analysis demonstrated that patients with UC receiving 5-ASA were 23.94 times more likely to exhibit HBsAb levels ≥ 100 compared to those treated with IFX (OR = 23.94, 95% CI 8.89-64.49). CONCLUSION: The immune response to hepatitis B vaccination in patients with ulcerative colitis treated with IFX is attenuated compared to those treated with 5-ASA. Therefore, emphasizing the importance of HBV vaccination for patients with IBD before starting anti-TNF therapy, especially IFX, and advocating for screening is imperative in high-risk countries. Determining what levels of HBsAb provide protection and what happens to the levels over time after a booster dose are important clinical questions to be answered by follow-up studies.

Effectiveness of vedolizumab and ustekinumab as second biologic agent in achieving target outcomes in tumor necrosis factor antagonists experienced patients with inflammatory bowel disease (enroll-ex study).

Background: About a third of patients with inflammatory bowel disease (IBD) do not respond to anti-tumor necrosis factor (anti-TNF) therapy. In our study, we evaluated the effectiveness of vedolizumab and ustekinumab in achieving clinical and endoscopic outcomes in anti-TNF-experienced patients with IBD. Methods: We conducted a retrospective cohort study. Electronic medical records of patients with moderate to severe IBD, who were previously received anti-TNF therapies, were reviewed and evaluated retrospectively in a gastroenterology center. Outcomes of patients treated with ustekinumab or vedolizumab after failing one anti-TNF agent were evaluated. The primary outcomes were the percentage of hospitalization, surgery, mucosal healing and steroid-free remission. Mucosal healing was defined as a Mayo endoscopic score of 0 or 1 in ulcerative colitis (UC) and an SES-CD score of less than 3 in Crohn's disease (CD). Outcomes were quantified using descriptive analysis. Results: A total of 207 (130 CD: 77 UC) patients with IBD who had previously received one anti-TNF agent were included in the study. Of the total cohort, 62 (30.0%) patients were receiving vedolizumab, and 145 (70.0%) patients were on ustekinumab. 101 (77.6%) patients with CD who failed one anti-TNF therapy were on ustekinumab. Of these patients, 26 (19.7%) patients were hospitalized, and 12 (11.9%) patients had IBD-related surgery. 16 (16.1%) patients had at least one corticosteroid course. 60 (59.0%) patients with CD on ustekinumab achieved mucosal healing. 29 (22.3%) patients with CD who failed one anti-TNF therapy were receiving vedolizumab. Of those, 7 (25%) patients were hospitalized, and 11 (37.9%) patients had IBD-related surgery. 15 (51.0%) patients achieved mucosal healing. 44 (57.1%) patients with UC who failed one anti-TNF therapy were on ustekinumab. Of these 6 (14.1%) patients were hospitalized, 3 (7.0%) patients had IBD-related surgery and 13 (30%) patients had at least 1 corticosteroid course. 25 (57.0%) patients achieved mucosal healing. 33 (42.8%) patients with UC who failed one anti-TNF therapy were receiving vedolizumab. Of those, 6 (18.6%) patients were hospitalized, and 16 (49.6%) patients had at least 1 corticosteroid course. 17 (53.2%) patients achieved mucosal healing. Conclusion: Ustekinumab and vedolizumab were both effective in achieving clinical outcomes in patients with IBD after failing an anti-TNF agent. However, patients receiving ustekinumab had numerically higher percentages of reaching target outcomes than patients receiving vedolizumab. A prospective head-to-head trial is warranted to confirm these findings.

COVID-19 Vaccine Booster Dose Willingness among Patients with Inflammatory Bowel Disease on Infliximab and Vedolizumab: A Cross-Sectional Study.

BACKGROUND: Vaccination has been effective in preventing COVID-19 infections and related mortality. However, waning immunity after two-dose vaccination prompted health authorities to recommend a third dose of COVID-19 vaccine to boost immunity. The aim of our study was to assess willingness to receive a third (booster) dose among patients with inflammatory bowel disease (IBD). METHODS: A cross-sectional study was performed at an IBD tertiary care center. Patients were recruited at the infusion room from 1 January 2022 to 31 March 2022. The primary outcome was the prevalence of a third (booster) dose of the BNT162b2 vaccine in infliximab- or vedolizumab-treated patients with IBD. The secondary outcome evaluated whether the prevalence of a third (booster) dose of the BNT162b2 vaccine differed based on type of COVID-19 vaccine, gender, age, type of biologic therapy, and citizenship. RESULTS: In total, 499 patients with IBD were included in this study. The median age was 34.5 years, and 60% had ulcerative colitis (UC). Among the study participants, 302 (60.5%) patients were vaccinated with BNT162b2, and 197 (39.5%) were vaccinated with ChAdOx1 nCoV-19. Of the total number of participants, 400 (80.2%) were receiving infliximab, and 99 (19.8%) were receiving vedolizumab. Overall, 290 (58.1%) of the included patients were willing to receive the third (booster) dose. Patients vaccinated with BNT162b2 were more likely to be willing to receive a booster dose compared to patients vaccinated with ChAdOx1 nCoV-19 (201 (66.5%) vs. 103 (52.0%), p = 0.014). Infliximab-treated patients were more likely to be willing to receive a booster dose compared to patients receiving vedolizumab (310 (77.5%) vs. 62 (62.6%), p = 0.002). There was no statistical difference in willingness to receive a booster dose in terms of age, nationality, or gender. CONCLUSIONS: The percentage of patients with IBD willing to receive or having already received a third (booster) dose of BNT162b2 vaccine was lower compared to the general population. In addition, patients who received two doses of BNT162b2 vaccines were more likely to be willing to receive a third (booster) dose compared to patients who received ChAdOx1 nCoV-19. Patients treated with infliximab were more likely to be willing to receive a third (booster) dose of COVID-19 vaccine.

A Randomized Clinical Trial Comparing Triple Therapy versus Non-bismuth based Quadruple Therapy for the Eradication of Helicobacter Pylori in Kuwait.

Introduction: Helicobacter pylori-induced chronic infection is associated with peptic ulcer, chronic gastritis, gastric cancer, and increasing antibiotic resistance. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait. Methods: We enrolled a total of 603 treatment-naive dyspeptic patients with gastric biopsy-proven chronic gastritis secondary to H. pylori in a prospective, open-label, randomized study. Patients were randomized into two groups: a group received the standard triple therapy (omeprazole, amoxicillin, and clarithromycin) for 14 days and a group received quadruple therapy (omeprazole, amoxicillin, clarithromycin, and metronidazole) for 14 days. All patients were tested for the eradication of H. pylori by carbon-13 urea breath test 1 month after eradication therapy. Results: The overall eradication rate was 63.2%. The eradication rates in intention-to-treat (ITT) and per protocol (PP) population were 58.4% and 64.6%, respectively, in triple therapy group. In the quadruple therapy group, the eradication rates in ITT and PP population were 68.0% and 78.5%, respectively, with a statistically significant higher eradication rate in patients treated by quadruple therapy than the triple therapy (P < 0.01). Multivariate logistic regression analysis revealed that treatment regimen was the only significant predictor for successful H. pylori eradication. The most common adverse events were abnormal taste, headache, dizziness, and abdominal pain. Conclusion: Non-bismuth based quadruple therapy is more effective than standard clarithromycin-based triple therapy for eradicating H. pylori in patients with chronic gastritis.ClinicalTrials.gov Identifier: NCT04617613.

Impact of BNT162b2 mRNA Vaccination on the Development of Short and Long-Term Vaccine-Related Adverse Events in Inflammatory Bowel Disease: A Multi-Center Prospective Study.

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination has been effective in protecting against severe COVID-19 infections and related mortality. It is recommended for all individuals including patients with inflammatory bowel disease (IBD). However, safety data are lacking in this group of patients. Therefore, we aim to evaluate the short- and long-term vaccine related adverse events (AEs) in patients with IBD. Methods: This is a prospective, observational cohort study investigating short- and long-term AEs related to the BNT162b2 vaccine in patients with IBD (study group) after the first and second dose compared to healthy participants (control group). Patients were recruited at the time of attendance to the clinic or infusion rooms. Short term (<3 weeks) localized and systemic AEs were assessed via questionnaire. Follow-up phone-based survey was made to collect data on long term (up to 24 weeks) AEs. Results: A total of 408 patients answered the questionnaires, 204 patients in each group, the study and control group. No serious adverse events were reported in either the study or the control group after the first or the second dose. Participants in the control group reported more frequent pain at the injection site than those in the study group after the first dose [58 (57%) vs. 38 (37%) respectively, P = 0.005]. After the second dose, tiredness was reported more frequently in the control group [49 (48%)] compared to the study group [25 (24%) (P < 0.001)]. At 20-24 weeks post vaccination, 386 out of 408 (94.6%) patients were willing to participate in the follow-up phone based questionnaire [196 (96.1%) in the study group vs. 190 (93.1%) in the control group]. In both groups, none of the patients reported local, systemic, or severe adverse events (0 out of 386) at week 20-24 post second dose. Conclusion: The BNT162b2 vaccine is safe in patients with IBD. No severe or long-term adverse events were reported in our study. The frequency of local and systemic adverse events after the second dose was generally higher among healthy participants compared to patients with IBD. Further studies including a larger cohort with a longer follow-up duration are needed to assess for possible rare adverse events.

Impact of tumor necrosis factor antagonist combination and anti-integrin therapies on body mass index in inflammatory bowel disease: A cross-sectional study.

Background: The impact of biologic therapies on body mass index (BMI) in patients with inflammatory bowel disease (IBD) is unclear. This study investigates any associations between BMI, type of IBD, and the type of medications taken among patients with IBD with varying weight categories. Methods: A cross sectional study was performed in an IBD tertiary care center. Data was obtained from patients with IBD attending outpatient clinics from January 1st, 2021 until November 1st, 2021. Adult patients, older than 18 years, with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) were recruited. The primary outcome was the association between BMI and medication used in IBD. The secondary outcome was the association between BMI and disease type and location in patients with IBD. Results: The study included a total of 528 patients of which, 66.5% have CD. Patients with normal weight comprises 55.9% of the participants, while those who are underweight, overweight or obese are 3.4, 28.2, and 12.5%, respectively. None of the underweight patients had UC. Among the normal weight, overweight and obese BMI categories, 34.6% vs. 36.2% vs. 31.8% had UC, respectively. Patients who are on tumor necrosis factor inhibitors (anti-TNF) with an immunomodulator (anti-TNF combination), are more likely to be overweight or obese than patients who are not on anti-TNF combination (OR 2.86, 95% CI 1.739-4.711, p < 0.001). Patients on vedolizumab are twice as likely to be overweight or obese than patients not on vedolizumab (OR 2.23, 95% CI 1.086-4.584, p < 0.05). Patients with ileocolonic CD are more likely to be overweight or obese compared to other subtypes of CD (OR 1.78, 95% CI 1.14-2.77, p = 0.01). Conclusion: Many patients with IBD are either obese or overweight. Patients with IBD who are on anti-TNF combination therapy or vedolizumab monotherapy are more likely to be obese and overweight. In addition, patients will ileocolonic CD are more likely to be obese or overweight.

Immunogenicity of BNT162b2 Vaccine Booster Dose in Patients With Inflammatory Bowel Disease Receiving Infliximab Combination Therapy: A Prospective Observational Study.

Introduction: Few data exist regarding the immunogenicity of the third dose of BNT162b2 relative to the second dose in patients with inflammatory bowel disease (IBD) on different immunosuppressive therapies. We investigated the immunogenicity of BNT162b2 vaccine booster dose in patients with IBD on infliximab combination therapy. Method: This is a prospective single-center observational study conducted from January 1, 2022 to February 28, 2022. Patients were recruited at the time of attendance at the infusion center. Eligibility criteria included patients with a confirmed diagnosis of IBD who are receiving infliximab with azathioprine or 6-mercaptopurine. Patients who received two doses of BNT162b2 vaccine (second dose group) were compared to patients who had received three doses of BNT162b2 vaccine [third dose (booster) group]. Patients were excluded if they were infected or had symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) previously since the start of the pandemic or received other vaccines than the BNT162b2. Our primary outcome was the concentrations of SARS-CoV-2 antibodies Immunoglobulin G (IgG) and neutralizing antibodies 40-45 weeks from the first dose of BNT162b2 vaccine in patients with IBD receiving infliximab combination therapy. Medians with interquartile range (IQR) were calculated. Results: In total, 162 patients with IBD and receiving infliximab combination therapy were recruited, and the number of patients in both the second dose group and third dose (booster) group was 81. Mean age was 35 years old in both groups. Median (IQR) SARS-CoV-2 IgG levels were significantly lower after the second dose [125 BAU/ml (43, 192)] compared to patients who received the third booster dose [207 BAU/ml (181, 234)] (P = 0.003). Neutralizing antibody levels were also lower after the second dose [80% (21, 95)] compared to patients who received the third booster dose [96% (93, 99)] (P ≤ 0.001). The percentage of patients who achieved positive SARS-CoV-2 IgG levels in the third (booster) dose group was 96.3%, whereas it was 86.4% in the second dose group. The percentage of participants who received the third (booster) dose and achieved a positive SARS-CoV-2-neutralizing antibody level was 100%, whereas it was 88.9% in the participants who received the second dose only. Conclusion: Most patients with IBD on infliximab combination therapy had positive SARS-CoV-2 IgG and neutralizing antibody concentrations 40-45 weeks post BNT162b2 vaccination. However, SARS-CoV-2 IgG and neutralizing antibody concentrations were lower in patients who received two doses only compared to patients who received a third dose. A longer follow-up study is needed to evaluate decay in antibodies over time.

Effectiveness of inspectors' team in increasing compliance with personal protective equipment use and reducing COVID19 infection spread among healthcare workers.

BACKGROUND: Healthcare workers (HCW) were amongst the front-liners in the mission to tackle the COVID-19 pandemic and thus bore a huge risk of infection. Therefore, personal protective equipment (PPE) is of vital importance. There are several methods described in the literature to increase compliance with PPE use and reduce occupational infections. One of those methods is the institution of PPE inspectors that ensure proper adherence to PPE protocols and ultimately improve the outcomes of many HCWs. METHODS: A team of PPE inspectors was introduced in a tertiary care university hospital, where they randomly evaluated and reinforced PPE use in accordance with the guidelines set by the local health authority. The study period was from the 10th of May 2020 until the 31st of August 2020. The evaluations were divided into three categories; appropriate, missing, or unnecessary use of PPE and were compared to trends in healthcare workers' COVID-19 infection rates. RESULTS: A total of 720 HCWs were evaluated from the 10th of May 2020 until the 31st of August 2020. The appropriate use of PPE increased from 56% to 89% during the study period. Meanwhile, the incidence of COVID-19 infection among HCWs, which has peaked to 31 cases per day on the 18th of May 2020, has been declining to below 5 cases per day towards the end of the study period. CONCLUSION: PPE inspectors' team served a positive role in increasing compliance with PPE use and was associated with a reduction in the transmission of SARS-Cov-2 among HCWs.

COVID-19 Vaccine Hesitancy among Patients with Inflammatory Bowel Disease Receiving Biologic Therapies in Kuwait: A Cross-Sectional Study.

BACKGROUND: COVID-19 vaccinations have been shown to be effective in reducing risk of severe infection, hospitalization, and death. They have also been shown to be safe and effective in patients with inflammatory bowel disease (IBD) who are receiving biologic therapies. In this study, we aimed to evaluate the prevalence of vaccination among patients receiving biologic therapies for IBD. METHODS: A single-center prospective cross-sectional study conducted at a tertiary care inflammatory bowel disease center in Kuwait. Data from patients with inflammatory bowel disease (IBD) who attended the gastroenterology infusion clinic from 1 June 2021 until 31 October 2021 were retrieved. Patients who received infliximab or vedolizumab at least six weeks before recruitment were included. The primary outcome was prevalence of COVID-19 vaccination. The secondary outcome was to assess whether prevalence of COVID-19 vaccination differed based on sex, age, type of biologic therapy and nationality. RESULTS: The total number of inflammatory bowel disease (IBD) patients enrolled in the study was 280 (56.0% male and 44.0% female). Of the total, 112 (40.0%) patients were diagnosed with ulcerative colitis and 168 (60.0%) with Crohn's disease. The number of ulcerative colitis patients who were vaccinated was 49 (43.8%) and the number of Crohn's disease patients who were vaccinated was 68 (40.5%). The median age was 33.2 years and BMI was 24.8 kg/m2. With respect to the total number of patients, 117 (41.8%) were vaccinated with either BNT162b2 or ChAdOx1 nCoV-19 and 163 (58.2%) were not vaccinated. Female patients were more likely to receive the vaccine compared to male patients (83.0% vs. 63.8%, p < 0.001). In addition, patients above the age 50 were more likely to receive the vaccine than patients below the age of 50 (95.6% vs. 31.2% p < 0.001). Expatriates were more likely to receive the vaccine than citizens (84.8% vs. 25.0%, p < 0.001). There was no statistical difference between patients on infliximab and vedolizumab with regard to prevalence of vaccination (40.0% vs 48.0%, p = 0.34). CONCLUSION: The overall prevalence of COVID-19 vaccination among patients with inflammatory bowel disease (IBD) on biologic therapies was lower than that of the general population and world health organization (WHO) recom-mendation. Female patients, patients above the age of 50, and expatriates were more likely to receive the vaccine. Physicians should reinforce the safety and efficacy of COVID-19 vaccines among patients, especially IBD patients on biologic therapies, who express hesitancy towards them.

Relationship Between Patient Sex and Serum Tumor Necrosis Factor Antagonist Drug and Anti-drug Antibody Concentrations in Inflammatory Bowel Disease; A Nationwide Cohort Study.

Background: Anti-drug antibodies to infliximab (ATI) and adalimumab (ATA) are associated with loss of response to tumor necrosis factor antagonist (anti-TNF) therapy in inflammatory bowel disease (IBD). We evaluated the relationship between patient sex and serum TNF antagonist drug and antibody concentrations in inflammatory bowel disease. Methods: A nationwide multicenter retrospective cohort study was conducted by evaluating patients' charts from July 2018 until September 2021. The effect of patient sex on anti-drug antibodies and serum drug concentration in patients with IBD across seven hospitals was investigated. A subgroup analysis also investigated the effect of anti-TNF combination therapy. Geometric means were calculated, and multiple linear regression was used to estimate the adjusted ratio of geometric means (RoGM) and their 95% confidence intervals (CI). Results: In the total study sample (n = 1093), males receiving infliximab had higher anti-drug antibody concentrations (38.3 vs. 22.3 AU/ml; aRoGM = 1.72, 95% CI: 1.30-2.27, p < 0.001) compared to females. Additionally, infliximab serum drug concentrations among males were lower compared to females (2.6 vs. 4.1 ug/ml; aRoGM = 0.62, 95% CI: 0.44-0.88, p = 0.007). In the subgroup analysis (n = 359), male compared to female patients on combination therapy with infliximab and immunomodulators had similar anti-drug antibody concentrations (30.2 vs. 21.9 AU/ml; aRoGM = 1.38, 95% CI: 0.79-2.40, p = 0.254). There was no difference in the anti-drug antibody and serum drug concentrations among males and females on adalimumab. Conclusion: In patients receiving infliximab, anti-drug antibodies were higher in males than females. Consistent with this, serum drug concentrations were lower in males than females on infliximab. There was no difference in anti-drug antibody and serum drug concentrations among males and females on adalimumab. In addition, no difference in anti-drug antibodies between males and females receiving anti-TNF combination therapy was observed.

Serological Response to BNT162b2 and ChAdOx1 nCoV-19 Vaccines in Patients with Inflammatory Bowel Disease on Biologic Therapies.

Introduction: The immunogenicity of SARS-CoV-2 vaccines in patients with inflammatory bowel disease (IBD) on biologic therapies is not well studied. The goal of this study was to measure the serological response to BNT162b2 and ChAdOx1 nCoV-19 vaccines in patients with IBD receiving different biologic therapies. Methods: We performed a multi-center prospective study between 1 August 2021 and 15 September 2021. We measured the seropositivity of SARS-CoV-2 antibodies (SARS-CoV-2 IgG) and neutralizing antibody concentrations in patients with IBD receiving biologic therapies 4-10 weeks after their second dose or 3-6 weeks after their first dose of BNT162b2 or ChAdOx1 nCoV-19 vaccines. Results: A total of 126 patients were enrolled (mean age, 31 years; 60% male; 71% Crohn's disease, 29% ulcerative colitis). Of these, 92 patients were vaccinated with the BNT162b2 vaccine (73%) and 34 patients with the ChAdOx1 nCoV-19 vaccine (27%). In patients being treated with infliximab and adalimumab, the proportion of patients who achieved positive anti-SARS-CoV-2 IgG antibody levels after receiving two doses of the vaccine were 44 out of 59 patients (74.5%) and 13 out of 16 patients (81.2%), respectively. In contrast, of those receiving ustekinumab and vedolizumab, the proportion of patients who achieved positive anti-SARS-CoV-2 IgG antibody levels after receiving two doses of the vaccine were 100% and 92.8%, respectively. In patients receiving infliximab and adalimumab, the proportion of patients who had positive anti-SARS-CoV-2 neutralizing antibody levels after two-dose vaccination was 40 out of 59 patients (67.7%) and 14 out 16 patients (87.5%), respectively. On the other hand, the proportion of patients who had positive anti-SARS-CoV-2 neutralizing antibody levels were 12 out of 13 patients (92.3%) and 13 out of 14 patients (92.8%) in patients receiving ustekinumab and vedolizumab, respectively. Conclusions: The majority of patients with IBD who were on infliximab, adalimumab, and vedolizumab seroconverted after two doses of SARS-CoV-2 vaccination. All patients on ustekinumab seroconverted after two doses of SARS-CoV-2 vaccine. The BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines are both likely to be effective after two doses in patients with IBD on biologics. Larger follow-up studies are needed to evaluate if decay of antibodies occurs over time.

Immunogenicity of BNT162b2 Vaccine in Patients with Inflammatory Bowel Disease on Infliximab Combination Therapy: A Multicenter Prospective Study.

BACKGROUND: Vaccination is a promising strategy to protect vulnerable groups like inflammatory bowel disease (IBD) patients against COVID-19 and associated severe outcomes. COVID-19 vaccine clinical trials excluded IBD patients taking infliximab with azathioprine or 6-mercaptopurine (infliximab combination). Therefore, we sought to evaluate serologic responses to COVID-19 vaccination with the mRNA vaccine, BNT162b2, in patients with IBD receiving infliximab combination therapy compared with healthy participants. METHOD: This was a multicenter prospective study. Patients with IBD were recruited at the time of attendance at infusion center between 1 August 2021, and 15 September 2021. Our primary outcome were the concentrations of SARS-CoV-2 antibodies 4-10 weeks after vaccination with two doses of BNT162b2 vaccine in patients with IBD taking infliximab combination therapy (study group) compared with a healthy participants group (control group). Both study and control groups were matched for age, sex, and time-since-last-vaccine-dose using optimal pair-matching method. RESULTS: In total, 116 participants were recruited in the study, 58 patients in the study group and 58 in the control group. Median (IQR) IgG concentrations were lower in the study group (99 BAU/mL (40, 177)) than the control group (139 BAU/mL (120, 188)) following vaccination (p = 0.0032). Neutralizing antibodies were also lower in the study group compared with the control group (64% (23, 94) vs. 91% (85, 94), p < 0.001). The median IgA levels in the study group were also significantly lower when compared with the control group (6 U/mL (3, 34) vs. 13 U/mL (7, 30), p = 0.0097). In the study group, the percentages of patients who achieved positive IgG, neutralizing antibody and IgA levels were 81%, 75%, and 40%, respectively. In the control group, all participants (100%) had positive IgG and neutralizing antibody levels while 62% had positive IgA levels. CONCLUSION: In patients with IBD receiving infliximab combination therapy, SARS-CoV2 IgG, IgA, and neutralizing antibody levels after BNT162b2 vaccination were lower compared with healthy participants. However, most patients treated with infliximab combination therapy seroconverted after two doses of the vaccine.

Accelerating the elimination of hepatitis C in Kuwait: An expert opinion.

The hepatitis C virus (HCV) is estimated to affect 71 million people worldwide. In 2016, the World Health Organization adopted the first global health sector strategy to eliminate viral hepatitis as a public health threat by 2030. In December 2018, the European Association for the Study of the Liver, International Liver Foundation convened an expert panel to address the elimination of HCV in Kuwait. Several steps have already been taken to eliminate HCV in Kuwait, including free HCV treatment for Kuwait's citizens, high blood safety standards, and the implementation of screening and awareness programs. The expert panel made several recommendations aimed at accelerating the elimination of HCV in Kuwait: The development of a national strategy and action plan to guide all HCV elimination activities; the formation of a coordination mechanism to support collaboration between hepatitis working committees; the prioritization of micro-elimination at primary, secondary or tertiary facilities, in prisons and rehabilitation centers; and ensuring the involvement of multiple stakeholders - including relevant civil society groups - in all activities. Enhanced screening and linkage to care should be prioritized in Kuwait, with the expansion of the prescriber base to primary healthcare providers and nurse practitioners to be considered. Raising awareness and educating people about HCV infection also remain essential to achieve the goal of HCV elimination. Lastly, a national HCV registry should be developed to help monitor the implementation of viral hepatitis plans and progress towards achieving national and international targets.

Kuwait Recommendations on Vaccine Use in People with Inflammatory Rheumatic Diseases.

People with IRD are at increased risk of infection, and in 2011 EULAR made general recommendations for vaccination in these patients. Global and European perspectives are important, but they cannot accurately reflect the individual situations of patients in different countries and regions. Based on our clinical experience and opinions, we have sought to tailor the original EULAR recommendations to include advice for vaccination with new agents approved in the intervening years-including the new class of targeted synthetic disease-modifying antirheumatic drugs. We have also considered the specific demographic needs of patients in local populations in the Gulf region. The resulting 16 recommendations are grouped into four main categories covering general vaccination guidelines and best-practice for all patients with IRD, followed by a set of recommended vaccines against specific pathogens. The last two categories include recommendations for certain patient subgroups with defined risks and for patients who wish to travel.

Quadruple therapy versus standard triple therapy for eradication of Helicobacter pylori in Kuwait.

BACKGROUND AND STUDY AIMS: Chronic infection caused by Helicobacter pylori (H. pylori) is associated with chronic gastritis, peptic ulcer disease, and gastric cancer. Eradication of H. pylori reduces morbidity of chronic gastritis and incidence of gastric cancer in high-risk population. We aimed at testing the efficacy of clarithromycin-based triple therapy and bismuth-based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait. PATIENTS AND METHODS: A total of 218 dyspeptic patients from different countries who were proved to have chronic gastritis by endoscopy and gastric biopsy were enroled. All of them were naïve to H. pylori eradication therapy. They were randomised into two groups: group A, received triple therapy (omeprazole, amoxicillin, and clarithromycin) for 10days; and group B, received quadruple therapy (omeprazole, bismuth subcitrate potassium, tetracycline, and metronidazole) for 10days. All patients were tested for eradication of H. pylori by carbon-13 urea breath test 4weeks after treatment. RESULTS: Total response rate of eradication therapy in both groups was 77.5% (n=169). However, group B (n=100) had a higher eradication rate (88%) than group A (n=118) (68.6%). H. pylori eradication rate was significantly higher in males (84.2%) than females (70.2%) in both groups (p<0.01). There were no differences in eradication rates with regard to median age or nationality. CONCLUSION: Bismuth-based quadruple therapy is more effective as a first-line therapy than clarithromycin-based triple therapy for eradicating H. pylori in patients with H. pylori-related chronic gastritis in Kuwait.

Methotrexate in inflammatory bowel disease.

Over the past decade methotrexate has emerged as a new treatment for chronically active Crohn's disease. Although controlled trials to compare the relative efficacy and safety of azathioprine and methotrexate in therapy-resistant patients are desirable, these studies will be difficult, if not impossible, to conduct because of the relatively small differences in potency and tolerability between these agents. A more productive area for future investigations is to explore the use of these drugs in combination with infliximab and other biologic treatments.