Peptic ulcer disease.

Annual prevalence estimates of peptic ulcer disease range between 0·12% and 1·5%. Peptic ulcer disease is usually attributable to Helicobacter pylori infection, intake of some medications (such as aspirin and non-steroidal anti-inflammatory medications), or being critically ill (stress-related), or it can be idiopathic. The clinical presentation is usually uncomplicated, with peptic ulcer disease management based on eradicating H pylori if present, the use of acid-suppressing medications-most often proton pump inhibitors (PPIs)-or addressing complications, such as with early endoscopy and high-dose PPIs for peptic ulcer bleeding. Special considerations apply to patients on antiplatelet and antithrombotic agents. H pylori treatment has evolved, with the choice of regimen dictated by local antibiotic resistance patterns. Indications for primary and secondary prophylaxis vary across societies; most suggest PPIs for patients at highest risk of developing a peptic ulcer, its complications, or its recurrence. Additional research areas include the use of potassium-competitive acid blockers and H pylori vaccination; the optimal approach for patients at risk of stress ulcer bleeding requires more robust determinations of optimal patient selection and treatment selection, if any. Appropriate continuation of PPI use outweighs most possible side-effects if given for approved indications, while de-prescribing should be trialled when a definitive indication is no longer present.

Eosinophilic esophagitis: Current concepts in diagnosis and management.

ABSTRACT: Eosinophilic esophagitis is an antigen-mediated chronic inflammatory disorder that has risen in incidence and prevalence over the past 2 decades. The clinical presentation is variable and consists of mainly esophageal symptoms such as dysphagia, heartburn, food impaction, and vomiting. Current management relies on dietary elimination, proton-pump inhibitors, and topical corticosteroids with different response rates and relapses after treatment discontinuation. With a better understanding of the underlying pathophysiology, many molecules emerged recently as targeted treatment including dupilumab (IL4/IL13 blocker), as the first FDA-approved biological treatment, which has changed the management paradigm.

The Saudi Gastroenterology Association consensus on the clinical care pathway for the diagnosis and treatment of GERD.

ABSTRACT: Gastroesophageal reflux disease (GERD) is one of the most common problems encountered in outpatient general medicine and gastroenterology clinics. GERD may present with classic esophageal symptoms, extraesophageal symptoms, or mixed symptoms. The diagnosis and treatment of GERD are challenging due to the variety of symptoms and multifactorial pathophysiology. Since there is no consensus on the diagnosis and treatment of GERD in Saudi Arabia, the Saudi Gastroenterology Association established an expert group to formulate a consensus on the clinical care pathway for the diagnosis and treatment of GERD to update health-care providers in Saudi Arabia. The expert group reviewed the literature including recently published international guidelines, clinical trials, and expert opinion and conducted virtual and in-person meetings. A total of 22 statements on the definition, diagnosis, and treatment of GERD were formulated, and three algorithms for the clinical care of GERD were developed with a detailed description for each step. The expert group endorsed the new definition of GERD, the practical principles of interpretation of the diagnostic GERD evaluation, and the practical guidance for GERD treatment including medical, surgical, and endoscopic therapy. The expert group recommends further studies to investigate local data on the diagnosis and treatment of GERD.

Primary and Specialty Care Trainees' Perceptions About Proton Pump Inhibitor Use.

OBJECTIVE: Proton pump inhibitors (PPIs) are widely prescribed with proven efficacy in many indications, yet longstanding controversy about potential adverse events persists. We aimed to acquire knowledge about perceptions of outpatient PPI long-term prescribing (≥8 wk) among primary and specialty care trainees at 2 Canadian Universities. METHODS: Family medicine, internal medicine, and gastroenterology trainees completed a web-based survey that included 20 clinical scenarios assessing trainee knowledge about PPI efficacy. Contextual PPI prescribing decisions were also elicited, balancing possible PPI indications versus side effects. Management strategies were compared between junior and senior trainees, as well as across training programs. RESULTS: Over a 4-month period,163 trainees (age <26 y: 12%; age 26 to 45: 88%; 59% females) participated in the survey (family medicine: 51%, internal medicine: 44%, and gastroenterology: 5%); 83% were considered junior residents. Only 42% had received formal education on prescribing PPI long-term. Overall, 93% believed they would benefit from such teaching, with 98% stating they would follow related guidelines. No between-group differences were noted in knowledge of appropriate PPI indications nor possible side effects when comparing juniors to seniors, or among different specialties. Across different management scenarios, inappropriate PPI discontinuation was chosen by 14.3% to 67.2%, whereas inappropriate PPI continuation was reported in up to 57%. Trainee seniority and specialty did not differ in appropriate deprescribing rates. CONCLUSIONS: Training level and primary versus specialty care settings are associated with frequent inappropriate PPI prescribing and deprescribing. These findings highlight the need for and may inform future educational programs on PPI usage.

Review article: Advances in the management of lower gastrointestinal bleeding.

BACKGROUND: Lower gastrointestinal bleeding (LGIB) is a common emergency with substantial associated morbidity and mortality. Elective colonoscopy plays an essential role in management, with an even more important role for radiology in the acute setting. Recent advances in the management of patients with LGIB warrant review as the management has recently evolved. AIMS: To provide a comprehensive and updated overview of advances in the approach to patients with LGIB METHODS: We performed a comprehensive literature search to examine the current data for this narrative review supplemented by expert opinion. RESULTS: The incidence of LGIB is increasing worldwide, partly related to an ageing population and the increasing use of antithrombotics. Diverticulosis continues to be the most common aetiology of LGIB. Pre-endoscopic risk stratification tools, especially the Oakland score, can aid appropriate patient triage. Adequate resuscitation continues to form the basis of management, while appropriate management of antithrombotics is crucial to balance the risk of worsening bleeding against increased cardiovascular risk. Radiological imaging plays an essential role in the diagnosis and treatment of acute LGIB, especially among unstable patients. Colonoscopy remains the gold-standard test for the elective management of stable patients. CONCLUSIONS: The management of LGIB has evolved significantly in recent years, with a shift towards radiological interventions for unstable patients while reserving elective colonoscopy for stable patients. A multidisciplinary approach is essential to optimise the outcomes of patients with LGIB.

Cost-Consequence Analysis of Colon Cancer Screening among Patients with Long-Standing Ulcerative Colitis: 11 Years' Experience of Saudi Population.

Background: Clinical guidelines recommend that patients with long-standing ulcerative colitis (UC) should undergo periodic surveillance colonoscopy. However, the cost and clinical value of performing annual colonoscopy among high-risk patient populations is largely unknown in the Middle East. Therefore, this study aimed to examine the cost and consequence of annual colonoscopy among high-risk UC patients in Saudi Arabia. Methods: A retrospective cohort study was conducted on UC patients who had UC for ≥ 8 years or had primary sclerosing cholangitis (PSC) at any time during their disease,and underwent colonoscopy surveillance between 2010 and 2021 at a university-affiliated tertiary care center. Patients who underwent annual screening were considered adherent, and those who did not were considered non-adherent. The dysplasia detection rate (%) and the costs were expressed in United States Dollars (USD). To generate the 95 % confidence intervals for annual cost and clinical consequence, nonparametric bias-corrected accelerated bootstrapping with 10,000 simulations were conducted. Results: Two-hundred and sixty-one UC patients met the inclusion criteria and were included. Most of the patients 54 % (141 patients), were non-adherent to annual screening, and the patients' mean age and duration of illness were 45 years and 15 years, respectively. The mean annual direct medical costs were USD 10,210.6 for patients who adhered to the annual screening program and USD 6,191.77 for those who did not adhere. The mean rates of dysplasia detection were 1.66 % and 7.09 % for patients who adhered and patients who did not adhere to annual colonoscopy, respectively. The difference in costs and rates of dysplasia detections between those who adhered to the annual screening and those who did not were USD 4,018.88 (95 % CI: 3097.46 - 6,798.06) and -5.43 % (95 % CI: -10.019 - -1.58730), respectively, resulting in an incremental cost-effectiveness ratio (ICER) of USD 740.125 per 1 % reduction in the rates of dysplasia. According to the bootstrap cost effectiveness distributions, adherence to the annual screening for UC patients would result in higher cost and lower rates of dysplasia development with more than 99 % confidence level. Conclusion: Adherence to annual colonoscopy screening detects more dysplasia in UC patients but with an increased cost. Considering the low rate of progression to colorectal cancer among UC patients, the annual screening might not be cost effective.

Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy.

ABSTRACT: The management of inflammatory bowel disease (IBD) in pregnant women is challenging and must be addressed on a patient-by-patient basis. Optimal patient management requires a multidisciplinary team and clear evidence-based recommendations that cater to this subset of patients. In this article, we provide concise guidelines and clinical care pathway for the management of IBD in pregnant women. Our recommendations were developed by a multidisciplinary working group that includes experts from the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacology. All recommendations are based on up-to-date information following an extensive literature review. A total of 23 evidence-based expert opinion recommendations for the management of IBD in pregnant women are herein provided.

Pre-Endoscopic Scores Predicting Low-Risk Patients with Upper Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis.

BACKGROUND: Several risk scores have attempted to risk stratify patients with acute upper gastrointestinal bleeding (UGIB) who are at a lower risk of requiring hospital-based interventions or negative outcomes including death. This systematic review and meta-analysis aimed to compare predictive abilities of pre-endoscopic scores in prognosticating the absence of adverse events in patients with UGIB. METHODS: We searched MEDLINE, EMBASE, Central, and ISI Web of knowledge from inception to February 2023. All fully published studies assessing a pre-endoscopic score in patients with UGIB were included. The primary outcome was a composite score for the need of a hospital-based intervention (endoscopic therapy, surgery, angiography, or blood transfusion). Secondary outcomes included: mortality, rebleeding, or the individual endpoints of the composite outcome. Both proportional and comparative analyses were performed. RESULTS: Thirty-eight studies were included from 2153 citations, (n = 36,215 patients). Few patients with a low Glasgow-Blatchford score (GBS) cutoff (0, ≤1 and ≤2) required hospital-based interventions (0.02 (0.01, 0.05), 0.04 (0.02, 0.09) and 0.03 (0.02, 0.07), respectively). The proportions of patients with clinical Rockall (CRS = 0) and ABC (≤3) scores requiring hospital-based intervention were 0.19 (0.15, 0.24) and 0.69 (0.62, 0.75), respectively. GBS (cutoffs 0, ≤1 and ≤2), CRS (cutoffs 0, ≤1 and ≤2), AIMS65 (cutoffs 0 and ≤1) and ABC (cutoffs ≤1 and ≤3) scores all were associated with few patients (0.01-0.04) dying. The proportion of patients suffering other secondary outcomes varied between scoring systems but, in general, was lowest for the GBS. GBS (using cutoffs 0, ≤1 and ≤2) showed excellent discriminative ability in predicting the need for hospital-based interventions (OR 0.02, (0.00, 0.16), 0.00 (0.00, 0.02) and 0.01 (0.00, 0.01), respectively). A CRS cutoff of 0 was less discriminative. For the other secondary outcomes, discriminative abilities varied between scores but, in general, the GBS (using cutoffs up to 2) was clinically useful for most outcomes. CONCLUSIONS: A GBS cut-off of one or less prognosticated low-risk patients the best. Expanding the GBS cut-off to 2 maintains prognostic accuracy while allowing more patients to be managed safely as outpatients. The evidence is limited by the number, homogeneity, quality, and generalizability of available data and subjectivity of deciding on clinical impact. Additional, comparative and, ideally, interventional studies are needed.

Complementary and alternative medicine use and its association with medication adherence in inflammatory bowel disease and other gastrointestinal diseases.

Background: The use of complementary and alternative medicines (CAMs) has been embedded in populations for decades. In this study, we aimed to determine the rate of their usage among inflammatory bowel disease (IBD) patients and their association with adherence to conventional therapies. Methods: In this cross sectional, survey-based study, IBD patients' (n=226) adherence and compliance were evaluated using the Morisky Medication Adherence Scale-8. A control sample of 227 patients with other gastrointestinal diseases was included to compare trends of CAM use. Results: Crohn's disease represented 66.4% of those with IBD, with a mean age of 35 ± 13.0 years (54% males). The control group had either chronic viral hepatitis B, gastroesophageal reflux disease, Celiac disease, or other non-IBD diseases, with a mean age of 43.5 ± 16.8 years (55% males). Overall, 49% of patients reported using CAMs (54% in IBD group and 43% in the non-IBD group, P =0.024). Across both groups, the most used CAMs were honey (28%) and Zamzam water (19%). There was no significant association between the severity of the illness and use of CAMs. Patients who used CAMs had a lower adherence to conventional therapies vs. those who did not use CAMs (39% vs. 23%, P =0.038). Using the Morisky Medication Adherence Scale-8, low adherence to medications was reported in 35% of the IBD group vs. 11% of non-IBD group (P = 0.01). Conclusion: In our population, patients with IBD are more likely to use CAMs and are less adherent to medications. Furthermore, the use of CAMs was associated with a lower adherence rate to conventional therapies. Consequently, further studies assessing the causes associated with the use of CAMs and nonadherence to conventional therapies should be explored and interventions designed to mitigate nonadherence.

Comparative Evaluation of the ABC Score to Other Risk Stratification Scales in Managing High-risk Patients Presenting With Acute Upper Gastrointestinal Bleeding.

OBJECTIVE: The ABC risk score identifies patients at high risk of mortality in acute lower and upper gastrointestinal bleeding (UGIB). We aimed to externally validate the ABC score while comparing it to other prognostication scales when assessing UGIB patients at high risk of negative outcomes before endoscopy. METHODS: UGIB patients from a national Canadian registry (REASON) were studied, with mortality prediction as a primary outcome. Secondary endpoints included prognostication of rebleeding, intensive care unit (ICU) admission, ICU and hospitalization lengths of stay (LOS), and a previously proposed composite outcome measure. Univariable and areas under the receiver operating characteristic curve analyses compared discriminatory abilities of the ABC score to the AIMS65, Glasgow Blatchford Scale (GBS), and clinical Rockall score. RESULTS: The REASON registry included 2020 patients [89.4% nonvariceal; mean age (±SD): 66.3±16.4 y; 38.4% female]. Overall mortality, rebleeding, ICU admission, transfusion and composite score rates were 9.9%, 11.4%, 21.1%, 69.0%, and 67.3%, respectively. ICU and hospitalization LOS were 5.4±9.3 and 9.1±11.5 days, respectively. The ABC score displayed superior 30-day mortality prediction [0.78 (0.73; 0.83)] compared with GBS [0.69 (0.63; 0.75)] or clinical Rockall [0.64 (0.58; 0.70)] but not AIMS65 [0.73 (0.67; 0.79)]. Although most scales significantly prognosticated secondary outcomes in the univariable analysis except for ICU LOS, discriminatory abilities on areas under the receiver operating characteristic curve analyses were poor. CONCLUSIONS: ABC and AIMS65 display similar good prediction of mortality. Clinical usefulness in prognosticating secondary outcomes was modest for all scales, limiting their adoptions when informing early management of high-risk UGIB patients.

Topical hemostatic agents in the management of upper gastrointestinal bleeding: a meta-analysis.

Background and study aims Novel topical hemostatic agents have shown promising results in treating patients with non-variceal upper gastrointestinal bleeding (NVUGIB). However, data are limited even in published meta-analyses as to their role, especially compared to conventional endoscopic approaches. The aim of this study was to perform a highly comprehensive systematic review assessing the effectiveness of topical hemostatic agents in UGIB in different clinical settings. Methods We performed a literature search of OVID MEDLINE, EMBASE, and ISI Web of Knowledge databases through September 2021. Studies assessing the efficacy of topical hemostatic agents in UGIB were included. Main outcomes were immediate hemostasis and overall rebleeding. Results A total of 980 citations were identified and 59 studies with a total of 3,417 patients were included in the analysis. Immediate hemostasis was achieved in 93 % (91 %; 94 %), with similar results according to etiology (NVUGIB vs. variceal), topical agent used, or treatment strategy (primary vs. rescue). The overall rebleeding rate was 18 % (15%; 21 %) with the majority of rebleeds occurring in the first 7 days. Among comparative studies, topical agents achieved immediate hemostasis more often than standard endoscopic modalities (OR 3.94 [1.73; 8.96), with non-different overall rebleeding odds (OR 1.06 [0.65; 1.74]). Adverse events occurred in 2 % (1 %; 3 %). Study quality was overall low to very low. Conclusions Topical hemostatic agents are effective and safe in the management of UGIB with favorable outcomes when compared to conventional endoscopic modalities across a variety of bleeding etiologies. This is especially true in novel subgroup analyses that assessed immediate hemostasis and rebleeding among RCTs and in malignant bleeding. Due to methodological limitations of available data, additional studies are needed to ascertain their effectiveness more confidently in the management of patients with UGIB.

The Saudi Gastroenterology Association guidelines for quality indicators in gastrointestinal endoscopic procedures.

The quality and safety of gastrointestinal endoscopy varies considerably across regions and facilities worldwide. In this field, quality management has traditionally focused on individual performance of endoscopists, with most indicators addressing process measures and limited evidence of improvement in health outcomes. Indicators of quality can be classified according to their nature and sequence. The various professional societies and organizations have proposed many systems of indicators, but a universal system is necessary so that healthcare professionals are not overburdened and confused with a variety of quality improvement approaches. In this paper, we propose guidelines by the Saudi Gastroenterology Association pertaining to quality in endoscopic procedures aiming to improve the awareness of endoscopy unit staff toward important quality indications to enhance and standardize quality of care provided to our patients.

Role of the endoscopic Doppler probe in nonvariceal upper gastrointestinal bleeding: Systematic review and meta-analysis.

OBJECTIVES: The effectiveness of the Doppler endoscopic probe (DEP) remains unclear in nonvariceal upper gastrointestinal bleeding (NVUGIB). We thus performed a systematic review characterizing the effectiveness of DEP in patients with NVUGIB addressing this question. METHODS: A literature search was done until July 2021 using MEDLINE, EMBASE, and ISI Web of Science. A series of meta-analyses were performed assessing outcomes among observational and interventional studies for DEP signal positive and negative lesions as well as DEP-assisted versus standard endoscopies. The primary outcome was "overall rebleeding"; secondary outcomes included all-cause mortality, bleeding-related mortality, need for surgery, length of stay, intensive care unit stay, and angiography. RESULTS: Fourteen studies were included from 1911 citations identified. Observational studies compared bleeding lesions with DEP-positive versus DEP-negative signals (11 studies, n = 800 prehemostasis; five studies, n = 148 with posthemostasis data). Three interventional studies (n = 308) compared DEP-assisted to standard endoscopy management. DEP signal positive versus negative lesions either prior to or following any possible hemostasis were at greater risk of overall rebleeding (odds ratio [OR] 6.54 [2.36, 18.11] and OR 25.96 [6.74, 100.0], respectively). The use of DEP during upper endoscopy significantly reduced overall rebleeding rates (OR 0.27 [0.14, 0.54]). When removing outcomes analysis for which only one study was available, all evaluable outcomes were improved with DEP characterization of management guidance except for all-cause mortality. CONCLUSION: Although with low certainty evidence, DEP-related information improves on sole visual prediction of rebleeding in NVUGIB, with DEP-guided management yielding decreased overall rebleeding, bleeding-related mortality, and need for surgery.

Informing a cost-effectiveness threshold for Saudi Arabia.

BACKGROUND: Saudi Arabia's Vision 2030 aims to reform health care across the Kingdom, with health technology assessment being adopted as one tool promising to improve the efficiency with which resources are used. An understanding of the opportunity costs of reimbursement decisions is key to fulfilling this promise and can be used to inform a cost-effectiveness threshold. This paper is the first to provide a range of estimates of this using existing evidence extrapolated to the context of Saudi Arabia. METHODS AND MATERIALS: We use four approaches to estimate the marginal cost per unit of health produced by the healthcare system; drawing from existing evidence provided by a cross-country analysis, two alternative estimates from the UK context, and based on extrapolating a UK estimate using evidence on the income elasticity of the value of health. Consequences of estimation error are explored. RESULTS: Based on the four approaches, we find a range of SAR 42,046 per QALY gained (48% of GDP per capita) to SAR 215,120 per QALY gained (246% of GDP per capita). Calculated potential central estimates from the average of estimated health gains based on each source gives a range of SAR 50,000-75,000. The results are in line with estimates from the emerging literature from across the world. CONCLUSION: A cost-effectiveness threshold reflecting health opportunity costs can aid decision-making. Applying a cost-effectiveness threshold based on the range SAR 50,000 to 75,000 per QALY gained would ensure that resource allocation decisions in healthcare can in be informed in a way that accounts for health opportunity costs. LIMITATIONS: A limitation is that it is not based on a within-country study for Saudi Arabia, which represents a promising line of future work.

Healthcare in Saudi Arabia is undergoing wide-ranging reform through Saudi Arabia's Vision 2030. One aim of these reforms is to ensure that money spent on healthcare generates the most improvement in population health possible. To do this requires understanding the trade-offs that exist: funding one pharmaceutical drug means that same money is not available to fund another pharmaceutical drug. This is relevant whether the new drug would be funded from within the existing budget for healthcare or from an expansion of it. If the drugs apply to the same patient population and have the same price, the question is simply, "which one generates more health?" In reality, we need to compare pharmaceutical drugs for different diseases, patient populations, and at a range of potential prices to understand whether the drug in question would generate more health per riyal spent than what is currently funded by the healthcare system. This paper provides the first estimates of the amount of health, measured in terms of quality adjusted life years (QALYs), generated by the Saudi Arabian healthcare system. We find that the healthcare system generates health at a rate of one QALY produced for every 50,000­75,000 riyals spent (58­86% of GDP per capita). Using the range we estimate to inform cost-effectiveness threshold can aid decision-making.

Practice guidelines for the management of Helicobacter pylori infection: The Saudi H. pylori Working Group recommendations.

The eradication rates for Helicobacter pylori globally are decreasing with a dramatic increase in the prevalence of antibiotic resistant bacteria all over the world, including Saudi Arabia. There is no current consensus on the management of H. pylori in Saudi Arabia. The Saudi Gastroenterology Association developed these practice guidelines after reviewing the local and regional studies on the management of H. pylori. The aim was to establish recommendations to guide healthcare providers in managing H. pylori in Saudi Arabia. Experts in the areas of H. pylori management and microbiology were invited to write these guidelines. A literature search was performed, and all authors participated in writing and reviewing the guidelines. In addition, international guidelines and consensus reports were reviewed to bridge the gap in knowledge when local and regional data were unavailable. There is limited local data on treatment of H. pylori. The rate of clarithromycin and metronidazole resistance is high; therefore, standard triple therapy for 10-14 days is no longer recommended in the treatment of H. pylori unless antimicrobial susceptibility testing was performed. Based on the available data, bismuth quadruple therapy for 10-14 days is considered the best first-line and second-line therapy. Culture and antimicrobial susceptibility testing should be considered following two treatment failures. These recommendations are intended to provide the most relevant evidence-based guidelines for the management of H. pylori infection in Saudi Arabia. The working group recommends further studies to explore more therapeutic options to eradicate H. pylori.

Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease.

Optimal management of inflammatory bowel disease (IBD) relies on a clear understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This article provides concise guidelines for the management of IBD in adults, based on the most up-to-date information at the time of writing and will be regularly updated. These guidelines were developed by the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacy. After an extensive literature review, 78 evidence-and expert opinion-based recommendations for diagnosing and treating ulcerative colitis and Crohn's disease in adults were proposed and further refined by a voting process. The consensus guidelines include the finally agreed on statements with their level of evidence covering different aspects of IBD diagnosis and treatment.

The Long-Term Clinical Effectiveness of Ustekinumab in Antitumor Necrosis Factor-Experienced Crohn's Disease Patients.

Background Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) of unknown etiology. Ustekinumab (UST), an interleukin (IL)-12 and IL-23 antibody, has been approved in the recent years to treat IBD, both Crohn's disease and ulcerative colitis. This study clarifies the long-term effectiveness of ustekinumab (UST) in antitumor necrosis factor (anti-TNF) refractory Crohn's disease in Middle Eastern patients. Methods A retrospective review study, including 30 refractory or medication-intolerant patients with Crohn's disease, was conducted at a tertiary care center in Riyadh, Saudi Arabia. The patients were started on ustekinumab and followed up for at least 52 weeks. Follow-up was performed on weeks 12, 24, and 52. Data related to demographic and laboratory parameters, the dosing schedule of ustekinumab administration, and the Harvey-Bradshaw index (HBI) were collected. Clinical remission and response rates were assessed. Statistical analysis was performed using SPSS Statistics version 28.0 (IBM Corp., Armonk, NY, USA). A statistical significance threshold of p < 0.05 was adopted. Results The mean age of the study subjects was 34.2 ± 17.9 years (95% confidence interval (CI): 27.5-40.9), with a mean disease duration of 10.6 ± 4.9 years (95% CI: 8.8-12.5). Of our cohort, 56.7% failed two biologics during their disease course, and about 20% failed three different biologics. The percentage of patients who used thiopurines was 76.7%, while 6.7% used methotrexate. Concurrent immunomodulators were used by 58.6% of the patients. Corticosteroids were given to 13.3% of the patients. Intravenous induction of UST at 6 mg/kg was used for 90% of the patients, while only 10% used a 260 mg subcutaneous dose. At week 12, 73.3% of the patients had a clinical response, and 66.7% achieved clinical remission. Corticosteroid-free remission, clinical response, and clinical remission showed a decreasing percentage trend between weeks 12 and 24 compared to week 52 where a spike was observed in all aforementioned parameters. The clinical response rate at week 52 was 76.7%. The p-values from cross-tabulation were significant for clinical response and remission when comparing week 12 to weeks 24 and 52. Conclusion Ustekinumab presents a safe and effective treatment option in moderate to severe Crohn's disease patients with previous exposure to multiple biologics.

Predictors of Anti-TNF Therapy Failure among Inflammatory Bowel Disease (IBD) Patients in Saudi Arabia: A Single-Center Study.

BACKGROUND: The advent of monoclonal antibodies (mAbs) has revolutionized the management of many immune-mediated diseases such as inflammatory bowel disease (IBD). Infliximab and adalimumab were the first mAbs approved for the management of IBD, and are still commonly prescribed for the treatment of both Crohn's disease (CD) and ulcerative colitis (UC). Although mAbs have demonstrated high effectiveness rates in the management of IBD, some patients fail to respond adequately to mAbs, resulting in disease progression and the flare-up of symptoms. OBJECTIVE: The objective was to explore the predictors of treatment failure among IBD patients on infliximab (INF) and adalimumab (ADA)-as demonstrated via colonoscopy with a simple endoscopic score (SES-CD) of ≥1 for CD and a Mayo score of ≥2 for UC-and compare the rates of treatment failure among patients on those two mAbs. METHODS: This was a prospective cohort study among IBD patients aged 18 years and above who had not had any exposure to mAbs before. Those patients were followed after the initiation of biologic treatment with either INF or ADA until they were switched to another treatment due to failure of these mAbs in preventing the disease progression. Univariate and multiple logistic regressions were conducted to examine the predictors and rates of treatment failure. RESULTS: A total of 146 IBD patients (118 patients on INF and 28 on ADA) met the inclusion criteria and were included in the analysis. The mean age of the patients was 31 years, and most of them were males (59%) with CD (75%). About 27% and 26% of the patients had penetrating and non-stricturing-non-penetrating CD behavior, respectively. Patients with UC had significantly higher odds of treatment failure compared to their counterparts with CD (OR = 2.58, 95% CI [1.06-6.26], p = 0.035). Those with left-sided disease had significantly higher odds of treatment failure (OR = 4.28, 95% CI [1.42-12.81], p = 0.0094). Patients on ADA had higher odds of treatment failure in comparison to those on INF (OR = 26.91, 95% CI [7.75-93.39], p = 0.0001). CONCLUSION: Infliximab was shown to be more effective in the management of IBD, with lower incidence rates of treatment failure in comparison to adalimumab.