IDDF2023-ABS-0032 Active inflammatory bowel disease is associated with severe covid-19: a systematic review and meta-analysis

IDDF2023-ABS-0032 Figure 1 IDDF2023-ABS-0032 Figure 2 IDDF2023-ABS-0032 Figure 3 IDDF2023-ABS-0032 Figure 4COVID-19 outcomes in moderate-severe vs mild or quiescent IBD[Figure omitted. See PDF]ConclusionsPatients with IBD, particularly UC had an increased risk of developing severe COVID-19. Active IBD is associated with adverse COVID-19 outcomes, and the risk is increased with the disease activity of IBD.

PLACEBO-CONTROLLED EFFICACY AND SAFETY OF UPADACITINIB THROUGH ONE YEAR IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

BackgroundUpadacitinib (UPA), a Janus kinase inhibitor, was effective and well tolerated in patients (pts) with non-radiographic axial spondyloarthritis (nr-axSpA) through 14 weeks (wks) of treatment.[1]ObjectivesThis analysis assessed the efficacy and safety of UPA vs placebo (PBO) through 1 year.MethodsThe SELECT-AXIS 2 nr-axSpA study included a 52-wk randomized, double-blind, PBO-controlled period. Enrolled adults had a clinical diagnosis of active nr-axSpA fulfilling the 2009 ASAS classification criteria, objective signs of inflammation based on MRI sacroiliitis and/or elevated C-reactive protein, and an inadequate response to NSAIDs. One-third of pts had an inadequate response to biologic DMARDs. Pts were randomized 1:1 to UPA 15 mg once daily or PBO. Concomitant medications, including NSAIDs, had to be kept stable through wk 52. The study protocol outlined that pts who did not achieve ASAS20 at any two consecutive study visits between wks 24 to 52 should receive rescue therapy with NSAIDs, corticosteroids, conventional synthetic/biologic DMARDs, or analgesics. Cochran-Mantel-Haenszel (CMH) test with non-responder imputation incorporating multiple imputation (NRI-MI) was used to handle missing data and intercurrent events for binary efficacy endpoints. Mixed-effect model repeated measures (MMRM) was used to assess continuous efficacy endpoints. NRI was used for binary endpoints after rescue and as observed analysis excluding data after rescue for continuous endpoints. Treatment-emergent adverse events (TEAEs) are reported through wk 52.ResultsOf the 314 pts randomized, 259 (82%;UPA, n=130;PBO, n=129) completed wk 52 on study drug. More pts achieved an ASAS40 response with UPA vs PBO from wks 14 to 52 with a 20% treatment difference at wk 52 (63% vs 43%;nominal P <.001;Figure 1). The proportion of pts achieving ASDAS inactive disease with UPA remained higher than PBO at wk 52 (33% vs 11%;nominal P <.0001;Figure 1). Consistent improvements and maintenance of efficacy were also seen across other disease activity measures. Between wks 24 and 52, fewer pts on UPA (9%) than PBO (17%) received rescue therapy. A similar proportion of pts in each treatment group had a TEAE (Table 1). Infections were the most common TEAE;the rates of serious infections and herpes zoster were higher with UPA vs PBO, although no new serious infections were reported from wks 14 to 52. COVID-19 events were balanced between treatment groups. No opportunistic infections, malignancy excluding non-melanoma skin cancer, adjudicated major adverse cardiovascular events, inflammatory bowel disease, or deaths were reported. Two pts (1.3%) on PBO had adjudicated venous thromboembolic events.ConclusionUPA showed consistent improvement and maintenance of efficacy vs PBO through 1 year across multiple disease activity measures. No new safety risks were identified with longer-term UPA exposure. These results continue to support the benefit of UPA in pts with active nr-axSpA.Reference[1]Deodhar A, et al. Lancet. 2022;400(10349):369–379.Table 1.Safety through week 52Event, n (%)PBO (n = 157)UPA 15 mg QD (n = 156)Any AE103 (66%)107 (69%)Serious AE6 (3.8%)6 (3.8%)AE leading to D/C4 (2.5%)6 (3.8%)COVID-19-related AE22 (14%)24 (15%)Deaths00Infection60 (38%)68 (44%) Serious infection1 (0.6%)2 (1.3%) Herpes zoster1 (0.6%)5 (3.2%)Malignancy other than NMSC00NMSC1 (0.6%)0Hepatic disorder7 (4.5%)6 (3.8%)Neutropenia1 (0.6%)8 (5.1%)MACE (adjudicated)00VTE (adjudicated)2 (1.3%)a0Uveitisb3 (1.9%)2 (1.3%)Inflammatory bowel disease00aBoth patients had non-serious events of deep vein thrombosis in the lower limb with risk factors including obesity and prior deep vein thrombosis in one patient and concomitant COVID-19 infection in the other patient.bThree events of uveitis occurred in each treatment group (among n = 3 patients in the PBO group and n = 2 patients in the UPA group);two events in the PBO group and one in the UPA group occurred in patients with a history of uveitis.AcknowledgementsAbbVie funded this study and participated in the study design, res arch, analysis, data collection, interpretation of data, review, and approval of the . All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Julia Zolotarjova, MSc, MWC, of AbbVie.Disclosure of InterestsFilip van den Bosch Speakers bureau: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Consultant of: AbbVie, Amgen, Galapagos, Janssen, Lilly, Merck, MoonLake, Novartis, Pfizer, and UCB., Atul Deodhar Consultant of: AbbVie, Amgen, Aurinia, BMS, Celgene, GSK, Janssen, Lilly, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, GSK, Lilly, Novartis, Pfizer, and UCB, Denis Poddubnyy Speakers bureau: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Consultant of: AbbVie, Biocad, BMS, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, MSD, Medscape, MoonLake, Novartis, Peervoice, Pfizer, Roche, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Lilly, MSD, Novartis, and Pfizer., Walter P Maksymowych Consultant of: AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, and UCB, Employee of: Director of Imaging Rheumatology BV, Tae-Hwan Kim Speakers bureau: AbbVie, Celltrion, Kirin, Lilly, and Novartis., Mitsumasa Kishimoto Consultant of: AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi Pharma, BMS, Chugai, Daiichi Sankyo, Eisai, Gilead, Janssen, Lilly, Novartis, Ono Pharma, Pfizer, Tanabe-Mitsubishi, and UCB., Xenofon Baraliakos Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, and UCB, Consultant of: AbbVie, BMS, Chugai, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie and Novartis, Yuanyuan Duan Shareholder of: AbbVie, Employee of: AbbVie, Kristin D'Silva Shareholder of: AbbVie, Employee of: AbbVie, Peter Wung Shareholder of: AbbVie, Employee of: AbbVie, In-Ho Song Shareholder of: AbbVie, Employee of: AbbVie.

VACCINATIONS IN PATIENTS WITH CHRONIC INFLAMMATORY DISEASES, PATIENT KNOWLEDGE AND AWARENESS: RESULTS FROM A NORDIC SURVEY

BackgroundPatients with chronic inflammatory diseases (CID) have an increased risk for contracting infections. For patients with rheumatic diseases EULAR recommends protecting them from vaccine-preventable diseases.ObjectivesTo assess the knowledge and awareness of common vaccinations and extent of immunization among patients with CID in Denmark, Finland, Norway, Sweden (Nordics), and to identify gaps between the existing EULAR vaccination recommendations and current practice as experienced by patients.MethodsA structured anonymous online survey for patients with CID ((rheumatological disease (RD), inflammatory bowel disease (IBD) and dermatological diseases (DD)) was conducted in 2022.The survey was answered by 1748 respondents (1031 patients with RD, 543 with IBD and 563 with DD).ResultsAmong respondents, 89% were female and 58% had disease duration of above 10 years. In total, 56% were treated in specialised and 32% in primary care. Majority had ongoing systemic immunosuppressive treatment (IT) (65%). Majority of RD (59%) and IBD (66%) patients were treated in specialised care whereas minority of DD patients (38%) were treated in specialised care.Forty-nine percent (49%) responded that their healthcare professional (HCP) did not inform them about the increased risk of infection – however, 55% of the respondents believed they are somewhat or much more likely to suffer from infections than those without CID or treatment, 33% thought there is no difference and 13% did not know there is a difference.In total 68% of respondents considered it important to get vaccinated due to CID or IT. The number was particularly high in RD group (74%), although 63% stated they had not received any information regarding vaccinations at the start of their treatment.Commonly recommended vaccinations by the HCP were COVID 19 (66%), influenza (63%) and pneumococcal (45%) vaccination. When comparing respondents ≥65 and <65 years, there was a difference in how often the influenza (71% vs. 57%) and pneumococcal (57% vs. 38%), but not COVID 19 vaccination (68% vs. 65%), were recommended. In addition, 74% and 75% of respondents receiving IT were recommended influenza and COVID 19 vaccination, respectively.In total, 22% had their vaccination status checked before initiating treatment;the lowest percentage was in DD (16%) and the highest in RD (25%). However, 44% of respondents received influenza vaccination before initiation of treatment. Moreover, 62% and 74% of respondents received influenza and COVID 19 vaccination while on treatment, respectively.Eighty-six percent (86%) did not receive a vaccination plan in relation to their CID and treatment. Moreover, 64% of the respondents (RD 57%;DD 71% and IBD 66%) did not have vaccination status assessed on a regular basis. Forty-three percent (43%) were dissatisfied with the follow-up of vaccination status by their HCP. Respondents of age ≥65 years were more satisfied than the younger ones (34% vs. 25% very satisfied) and respondents with RD were more satisfied than those with IBD or DD (33% vs. 25% vs. 20%).Forty-four percent (44%) responded that the information on vaccinations related to their CID and treatment was difficult to find and 71% would like to receive more information.The respondents with RD had different level of awareness regarding EULAR vaccination recommendations. The degree of awareness among patients with RD treated with IT are presented in Figure 1.ConclusionThis Nordic survey provides insights on patients' information needs, information sources and own experiences related to recommendations on vaccinations in relation to their CID and IT. The results confirm a gap between patients' expectations and needs vs. the information they actually receive. Our findings demonstrate a need for increased awareness among patients, providers and HCP regarding EULAR vaccination recommendations in patients with RD.Reference[1]Furer V, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis 2020;79: 9–52.Acknowledgements:NIL.Disclosure of InterestsMeliha C Kapetanovic Grant/research support from: Received independent research grants from Roche and Pfizer, Randeep Mandla Shareholder of: Pfizer, Employee of: Current employee of Pfizer Norway, Maria Seddighzadeh Shareholder of: Pfizer, Employee of: Current employee of Pfizer Sweden, Susanne Thiesen Gren Shareholder of: Pfizer, Employee of: Current employee of Pfizer Denmark, Maaria Palmroth Consultant of: Employee of MedEngine Oy and contractor for Pfizer Oy, Employee of: Contractor for Pfizer Oy, Finland, Dan Henrohn Shareholder of: Pfizer, Employee of: Current employee of Pfizer AB, Sweden, Anne Grete Frostrup Shareholder of: Pfizer, Employee of: Current employee of Pfizer Denmark, Anna-Maria Hiltunen Consultant of: Pfizer. Employee of Nordic Healthcare Group, Jussi Ranta Consultant of: Pfizer. Employee of Nordic Healthcare Group, Anna-Kaisa Asikainen Consultant of: Pfizer. Employee of Nordic Healthcare Group, Veli-Jukka Anttila Speakers bureau: Lectures for Pfizer, MSD, Astellas, Roche, GSK, BMS, Biogen, Sandoz, Gilead, Unimedic Pharma, Boehringer-Ingelheim, Astra-Zeneca, Consultant of: Consultant for Pfizer and MSD.

IMPACT OF CHRONIC KIDNEY DISEASE IN PATIENTS WITH AS USING BIOLOGIC AGENTS

BackgroundAlthough renal involvement is an rare extra-articular involvement in patients with ankylosing spondylitis (AS), medications and accopamyning comorbidities may adversly affect renal functions [1].ObjectivesTo determine the frequency and impact of CKD in patients with AS using biologic disease modyfying anti-rheumatic drugs (bDMARDs).MethodsBetween 2005 and November 2021, 3207 patients diagnosed with AS according to the modified New York criteria were enrolled in the Hacettepe University biological database (HUR-BIO). The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guideline was used for the definition of CKD to evaluate the renal function of patients. Glomerular filtration rate (GFR) was calculated with the MDRD (modified Modification of Diet in Renal Disease) formula, taking into account the creatinine value, age and gender parameters of the patients [2]. CKD was detected in 39 (1,2%) patients. Age-sex matched 41 non-CKD AS patients were selected as the control group. Demographic and clinical characteristics and mortality rates of AS patients with and without CKD were compared.ResultsOf 39 AS-CKD patients, 25 (64.1%) had CKD before the initation of bDMARD and and 14 (35.8%) developed CKD during follow-up after treatment was started. Patients with AS-CKD had longer duration of symptoms and disease (Table 1). Comorbidities such as hypertension, coronary artery disease and amyloidosis were more prevalent in patients with AS-CKD. At a median follow-up of 2.48(0.1-20.1) years, mortality was observed in 11(28.2%) patients in the AS-CKD group, while no mortality was observed in the age-sex matched AS-nonCKD group (p<0.001, Figure 1). The mortality rate in patients with AS-CKD was 12.6 per 1000 patient-years, and 4 (10.2%) of deaths were during the COVID-19 pandemia.Figure 1.Table 1.AS-CKD group (n=39)AS-nonCKD group (n=41)PTotal AS patients, (n=3207)Age, mean(SD), years68.2 (12.0)58.8(12.6)-47.9±(11.2)Male, n(%)27 (69.2)27(65.9)-1716(53.5)53.1)Symptom duration, years median (min-max)20 (5-42)11(2-30)0.0110(1-44)Disease duration, years median (min-max)14,5(5-42)7(1-29)0.046(1-37)HLA-B27 positivity, n(%)13(33.3)12(29.2)0.5826/2014(41.0)Uveitis, n(%)6/354/360.2339/2946(11.5)Inflammatory bowel disease, n(%)4/353/360.4135/2946(4.58)Smoking, ever, n(%)22/34 (64.7)20/36(55.5)0.31781/2942(60.5)BMI (kg/m2), mean(SD)28 (6.08)28.2(5.01)0.828.1(5.5)Amiloidosis, n(%)14/36(38.9)1(2.4)<0.00133/2949(1.11)Comotbidities n(%)• Diabetes Mellitus,7/34(20.6)4/36(11.1)0.2199/2949(6.7)• Hypertension27/34(79.4)9/36(25)<0.001442/2949(14.9)• CAD8/21(38.1)1/25(4)0.005110/1882(5.8)• COPD5/21(23.8)0/240.004117/1774(6.59)CRP, med(min-max)1.6(0.4-12.4)1.77(0.1-23.6)0.81.07(0.1-45)• at the initiation of bDMARDs, at the last visit,0.7(0.16-14)0.55(0.1-7.5)0.30.5(0.1-14)ESR, med(min-max)• at the initiation of bDMARDs,48(12-140)30(2-96)0.119(1-140)• at the last visit, med(min-max)25(3-93)15(2-70)0.113(1-110)BASDAI, mean (SD)• At the initiation of bDMARDs4.5(±2.1) 5.46(±2.07) 0.5 5.7(±2.04) • At the last vizit3.94(±2.35)2.95(±2.33)0.093.69(±2.5)CAD: Coronary artery disease, COPD: Chronic Obstructive pulmonary disease, BMI: Body mass index, BASDAI: Bath AS Disease Activity IndexConclusionBoth comorbid disease burden and mortality seem to be increased in patients with AS-CKD. Increased mortality was more pronounced during the COVID-19 pandemia.References[1]Coşkun, B.N., et al., Anti-TNF treatment in ankylosing spondylitis patients with chronic kidney disease: Is it effective and safe? Eur J Rheumatol, 2022. 9(2): p. 68-74.[2]Stevens, P.E. and A. Levin, Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med, 2013. 158(11): p. 825-30.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

DO PATIENTS ON SUPPRESSIVE THERAPY HAVE A DECREASED HUMORAL RESPONSE TO SARS-CoV2 VACCINATION?

BackgroundSARS-Cov2 vaccination has been shown to be effective against severe forms of SARS-Cov2 infection. Several studies investigated the humoral and cellular response to SARS-Cov2 vaccines in patients followed for autoimmune and inflammatory diseases under immunosuppressive or immunomodulatory treatments. It has been shown that patients on immunosuppressive or immunomodulatory therapies have a poor humoral response to the vaccine[1]ObjectivesThe aim of our study was to investigate the humoral response in patients under conventional immunosuppressive and biotherapies compared to healthy controls.MethodsPatients followed for immuno-inflammatory diseases under immunosuppressive or immunomodulatory drugs who received at least one dose of anti- SARS-Cov2 vaccines were included. Quantitative Anti- SARS-Cov2 antibodies (IgM and IgG assay) VIDAS ® were assessed for all patients. Patients were then compared with healthy controls.ResultsWe enrolled 93 blood samples (63 patients with autoimmune and inflammatory disease and 30 healthy controls), the median age was 52 years [Q1 43, Q3 56]. The immuno-inflammatory diseases were: Crohn's disease (n=28), Rheumatoid arthritis (n=9), Hemorrhagic rectocolitis (n=5), Behçet's disease (n=5), Systemic lupus erythematosus (n=4), Sjogren's syndrome (n=3), Sarcoidosis (n=2), Takayasu disease (n=1). All patients continued their treatment during and after vaccination. Nineteen patients were on biotherapies: Infliximab (n=12), Adalimumab (n=3), etanercept (n=2), Ustekinumab (n=1), tocilizimab (n=1). Forty-three patients were on conventional immunosuppressive: azathioprine (n=18), methotrexate (n=16), corticosteroids > 10 mg/d (n=12). All patients had received at least one dose of vaccine: the median number of doses in both groups was 2[1-4] with no statistically significant difference between the 2 groups (p=0.2). The vaccines received in the group of patients were mRNA vaccine (n=35) and other type of vaccine (n=28). In the healthy control group, type of vaccine were mRNA (n=13) other type vaccine (n=17). The patient had a lower mean level of Ig G against SARS-Cov2 antibodies (24.64 IU +/- 16.65) comparing to healthy controls (33.05+/- 10) with statically significant difference (p= 0.014). No difference between the 2 groups was noted in Ig G levels according to the history of SARS-Cov2 infection. No difference was found between conventional immunosuppressive drugs and biotherapies regarding to the level of antibodies.ConclusionOur study highlights that patients with autoimmune disease and under immunosuppressive therapy displayed a decrease of humoral response comparing to healthy controls. This finding was reported in several studies, Geisen et al[2] reported that patients with chronic inflammatory condition and receiving TNF alfa blockers had a decreased protection and a low level Ig A against spike. Based on these data, patients with autoimmune and inflammatory diseases have decreased humoral immunity to SARS-Cov2 and should be encouraged to receive a booster dose of SARS-COv2 vaccine.References[1]Prendecki M, Clarke C, Edwards H, et al. Humoral and T-cell responses to SARS-CoV-2 vaccination in patients receiving immunosuppression. Ann Rheum Dis 2021;80:1322–9. doi:10.1136/annrheumdis-2021-220626[2]Geisen UM, Sümbül M, Tran F, et al. Humoral protection to SARS-CoV2 declines faster in patients on TNF alpha blocking therapies. RMD Open 2021;7:e002008. doi:10.1136/rmdopen-2021-002008AcknowledgementsMrs Hajer Mediouni.Disclosure of InterestsNone Declared.

Facial ageing . . . and other stories

When high quality photographs of the faces of 2700 middle aged and older participants in a longitudinal study were assessed by a panel without knowledge of their chronological age and medical history, people whose perceived age was lower than their chronological age were less likely to have osteoporosis, chronic obstructive pulmonary disease, hearing loss, or cataracts. Energy expenditure and incident type 2 diabetes Data from 90 000 participants in the UK Biobank study who wore an accelerometer for seven days reveal a linear relation between the amount of energy expended during physical activity and the subsequent incidence of type 2 diabetes—even after adjusting for body mass index. A study using data for 1.5 million prescriptions of PPIs in UK general practice found an increased risk of diagnosis of an inflammatory bowel disease in the first two years after treatment started.

Vaccination against COVID-19 in patients with inflammatory bowel diseases

The novel coronavirus infection (COVID-19) is characterized by a high incidence of damage not only to the bronchopulmonary system, but also to the gastrointestinal tract. The problem of patients with bowel diseases was reviewed in this research the context of the COVID-19 pandemic and the importance of vaccination this group of patients was reflected and approaches to it were described. The analysis of biomedical literature data on the problem of vaccination of patients with intestinal diseases against COVID-19 was carried out.Copyright © 2022 Sorbtsionnye i Khromatograficheskie Protsessy. All rights reserved.

Development of indigestible IgA antibody for restoring microbiome balance

Dysbiosis, especially in the gut plays a crucial role in the pathogenesis of a wide variety of diseases, including inflammatory bowel disease, colorectal cancer, cardiovascular disease, obesity, diabetes and multiple sclerosis. At mucosal surfaces, mucosal polymeric immunoglobulin A（IgA）antibodies are known to be important to regulate the gut microbiota as well as to exclude infection induced by pathogenic bacteria or virus such as influenza and SARS-CoV-2（severe acute respiratory syndrome coronavirus 2）. Since the 1970s, oral administration of IgA or IgG antibodies has been performed against infectious enteritis caused by pathogenic Escherichia coli or Clostridioides difficile. However, none of them has been successfully developed as an antibody drug up to now. Although IgA is well known to modulate the gut commensal microbiota, the therapeutic IgA drugs to treat dysbiosis has not been developed. Here, we discuss the advantages of therapeutic IgA antibodies.Alternate :抄録Dysbiosisは、健康な微生物叢と比較した微生物組成の変化であり、腸内微生物多様性の減少および微生物分類群の変化を特徴とする。腸内のdysbiosisはまた、炎症性腸疾患、結腸直腸がん、心血管疾患、肥満、糖尿病および多発性硬化症を含むさまざまな疾患の病因において重要な役割を果たすと提唱されている。腸の多量体免疫グロブリンA（IgA）抗体は、腸内微生物叢を調節するだけではなく、病原性細菌、インフルエンザやSARS-CoV-2（重症急性呼吸器症候群コロナウイルス2）などのウイルス感染を粘膜部位から排除するのに重要であることが、多くのエビデンスから示されている。1970年代以降、治療用IgAまたはIgGの経口投与試験が、主に病原性大腸菌またはディフィシル菌によって引き起こされる感染性腸炎を治療するために行われてきた。しかし、現在まで臨床応用として開発に成功したものはない。腸内病原体に対する防御機能に加えて、IgAは腸内共生微生物叢を調節して共生に導くことがよく知られているが、dysbiosisを治療するためのIgA治療薬の開発も進んでいない。本稿では、治療用IgA抗体の利点とその開発について議論する。

Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A Brazilian Observational Multicentric Study.

Background: Ulcerative colitis (UC) is a chronic inflammatory bowel disease which affects the colorectal mucosa with a relapsing-remitting pattern. The therapeutic options currently available for the medical management of UC include many options. Tofacitinib is an oral small molecule, Janus kinase (JAK) inhibitor, more selective for JAK1 and JAK3, which reduces the inflammatory process involved in the pathogenesis of UC. Methods: Retrospective observational multicentric study of patients with UC who used tofacitinib in any phase of their treatment. Clinical remission and response (according to Mayo score), mucosal healing, primary and secondary loss of response, discontinuation of the drug with possible causes, and the need for dose optimization or switching to biologicals, need for surgery and adverse events were evaluated. Results: From a total of 56 included patients, clinical remission was observed in 43.6% at week 12, 54.5% at week 26, 57.9% at week 52, and 40% at the last follow-up visit. Clinical response was observed in 71.4%, 81.8%, 89.5%, and 61.8% at the same time periods, respectively. Mucosal healing rates were 50% and 17.8% needed colectomy. Conclusions: Tofacitinib was effective in induction and maintenance of clinical response and remission rates, compatible to other international real-word studies and meta-analyses.

Recommendations and algorithms to deal with gastroenterological procedures, inflammatory bowel diseases, liver diseases and transplantation during COVID-19 Pandemic: Review article and regional expert opinion

Coronavirus Disease 2019 (COVID-19) has emerged in Wuhan, China, in December 2019, then spread to become a worldwide pandemic with significant morbidity and mortality. This has left healthcare systems worldwide vulnerable to the surge in the number of patients. With the exponential spread of the disease and increasing demand for medical care, a significant proportion of medical procedures were canceled or delayed to decrease viral transmission. Most inflammatory bowel disease patients are on immunosuppressive agents, which are presumed to put them at a higher risk for acquiring the infection. However, some studies have shown that immunosuppressive agents did not increase mortality from COVID-19 at any age. Although most of the morbidity and mortality of this condition are related to respiratory manifestations, some patients develop extra-pulmonary manifestations including gastrointestinal and hepatic derangements. Studies have shown that liver chemistry abnormalities are common with COVID-19. There is currently no vaccine or effective treatment for COVID-19, so the only thing we can do is reduce the virus's transmission. In this review, we addressed the dilemma of how to deal with gastroenterological procedures in times of a spreading pandemic, to decide which procedures can or cannot be postponed based on current international available data. As well as, to ensure the continuation of the essential management of inflammatory bowel diseases (IBDs) patients, many of whom are on immunosuppressive and biologic agents, thus, making the decisions about which medications the patient can stay on to prevent disease attacks. Finally, studying the hepatic manifestations during the COVID-19 pandemic. We have also postulated local recommendations that can serve as a guide for managing liver diseases during COVID-19 and when to go to liver transplantation with the least risk possible for viral transmission. © 2022, An-Najah National University. All rights reserved.

Impact of covid-19 pandemic on gastroenterology: Chronic gastroenterological diseases, iatrogenesis and endoscopy.

The current article describes the course and treatment of chronic gastrointestinal diseases during the COVID-19 pandemic. We analyzed articles about iatrogenic harm to the gastrointestinal tract by etiological and pathogenetic therapy of the COVID-19. National and international recommendations for gastrointestinal endoscopy for infected and uninfected patients are analyzed.Copyright © A.M. SHCHIKOTA, I.V. POGONCHENKOVA, E.A. TUROVA, M.A. RASSULOVA, M.S. FILIPPOV.

Effect of COVID-19 on severity of signs and symptoms of autoimmune diseases

It is an observational cross-sectional study, the data collected by convenience sampling method from 33 patients in the Ranya General Hospital and private clinics for follow-up patient's autoimmune diseases state in the Ranya city from the 10th November 2020 to the 20th May 2021 and the study included all the patients had autoimmune diseases that recovered from the COVID-19 disease. For the study materials, the data was collected by a questionnaire form that included demographic and autoimmune disease questions also questions about the patient's intensity of their autoimmune disease's signs and symptoms before and after they recovered from COVID-19. Determine patient's autoimmune disease signs and symptoms intensity based on the prescribed drug for a treat the autoimmune diseases which are changed by special doctors. Furthermore, the data were analysed by SPSS software to produce descriptive statistic measures and to find the difference between dependent categorical variables Sign tests were used but the Chi-square test was used for the categorical independent variables with regarding 0.05 as a significant critical value. The result reveals that the range of their age started from 42 to 74 years old with mean..standard deviation (57.3 .. 8.06) and most of the cases 15(45.5%) were between (55-65) years old, followed by less than 55 years old 13(39.4%) and more than 65 years old age 5(3.8%) cases respectively. Rheumatoid arthritis was a major type 16 (48.5%) of the autoimmune disease compared to other types, Ankylosing Spondylitis 8(24.2%) cases, and Ulcerative Colitis 6(18.2%) cases respectively while Crohn's disease was the minimum 3(9.1%) cases and before the got COVID-19 most of the cases 25(75.8%) had moderate intensity signs and symptoms of their autoimmune diseases and 8(24.2%) cases had severe signs and symptoms but after they recovered from the COVID-19 disease the rate of their signs and symptoms changed to mild 19(57.6%) and moderate 14(42.4%) intensity while severe intensity signs and symptoms were zero with highly significant differences (P-value 0.0001). Despite the current study concluded autoimmune disease patients recovered from the COVID-19 their autoimmune diseases signs and symptoms intensity decreased significantly but still further studies are needed with a bigger sample size to determine and explain this association.

Effects of COVID-19 on axial spondyloarthritis disease flare

Aims: Rheumatological disease flares may occur after many infections. However, our knowledge of the post-Coronavirus disease-2019 (COVID-19) axial spondyloarthritis (SpA) flares and related factors is limited. Methods: We retrospectively assessed the axial SpA patients who had COVID-19. Demographic and clinical data were collected from the medical records. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was applied via telephone for pre- and post-COVID-19 SpA symptoms. An increase of 2 points in the BASDAI score or any new extra-articular manifestations were defined as SpA flares and SpA patients were grouped as flares and no-flare. Factors predicting SpA flare were also analyzed. Results: A total of 48 axial SpA patients were included in the study [age, mean+or-standard deviation (SD): 42.3+or-8.6 years;male: 65%]. Post-COVID-19 SpA flare was identified in 19 patients (40%), and new extra-articular manifestations were recorded in 6 patients (13%). Although the diagnosis of inflammatory bowel disease was more common in the flare group, the difference was not significant compared with that of the no-flare group. Other features of SpA and COVID-19 disease severity were similar between the flare and no-flare groups. In the flare group, the frequency of back pain (84% vs. 62%, p=0.091) and diarrhea (53% vs. 28%, p=0.080), and headache (84% vs. 52%, p=0.021) were higher than the no-flare group. No risk factor for a post-COVID-19 SpA flare could be identified. Conclusions: Post-COVID-19 flare was common in the axial SpA, and even new extra-articular manifestations could be reported. Although some clinical manifestations of COVID-19 were more common in patients with a flare, any predictive factor could not be identified among the study variables.

New Coronavirus Infection (COVID-19) and Digestive System

Aim. The study reviews current evidence on digestive system lesions provoked by the new COVID-19 coronavirus infection. Key points. Alongside the destructive impact on respiratory system, COVID-19 manifests itself in gastrointestinal symptoms (nausea, vomiting, diarrhoea) that may precede respiratory signs and prevail in the clinical picture of infection. Patients with chronic inflammatory bowel diseases receiving immunosuppressive therapy are at elevated risk of severe COVID-19 progression. The new coronavirus infection may induce liver damage with increased transaminase activity. Conclusion. Association of digestive system lesions with COVID-19 remains understudied and requires further research. © 2021 Journal of Refrigeration. All rights reserved.

Effects of SARS-CoV-2 vaccine (Vero cells) on disease activity in patients with inflammatory bowel disease in China: a multicenter study.

AIMS: To evaluate the impact of SARS-CoV-2 vaccine on IBD activity. METHODS: Adult IBD patients from five large IBD centers in China were enrolled and followed up for 6 months. Patients were divided into vaccinated and unvaccinated groups according to vaccination status. Demographic and clinical data were collected. RESULTS: A total of 280 individuals (213 UC and 67 CD patients) were enrolled in the study. The unvaccinated and vaccinated groups of UC patients were comparable for basic characteristics, including age (t = - 0.8, p = 0.425), sex (χ2 = 0.980, p = 0.322), course of disease (z = - 0.513, p = 0.608), surgical conditions (χ2 = 1.042, p = 0.838), disease extent (χ2 = 4.853, p = 0.088), or baseline drug therapy (χ2 = 7.784, p = 0.064). In the subgroup of UC patients, there was no association between vaccination and disease activities, according to the medium disease activity scores for two groups: unvaccinated patients having scores (IQR) 1(2.75), 1(2), 1(2), and 1(2) at baseline, 1, 3, and 6 months, respectively, whereas vaccinated patients having scores (IQR) 1(2), 1(2), 1(2), and 1(2). Similar conclusions were also derived in the subgroup of CD patients. There were also no statistically significant differences in age (t = - 1.48, p = 0.144), sex (χ2 = 0.003, p = 0.957), course of disease (z = - 0.074, p = 0.941), surgical conditions (χ2 = 0.613, p = 0.594), localization (χ2 = 6.261, p = 0.199), or baseline drug therapy (χ2 = 5.881, p = 0.114) between 2 groups of CD patients. The medium disease activity scores (IQR) of the unvaccinated group at baseline, 1, 3, and 6 months were 1(4), 1(3), 1(3), and 1(3), respectively, whereas those of vaccinated group were 2.5(3.75), 2.5(3.75), 3(2), and 2(2), respectively. Overall, very few participants in this study described worsening IBD disease activity requiring a change or addition of medication. CONCLUSIONS: SARS-CoV-2 vaccine has no adverse effect on disease activity in IBD population. IBD patients should be recommended to receive SARS-CoV-2 vaccine in time.

Application and development of fecal microbiota transplantation in the treatment of gastrointestinal and metabolic diseases: A review.

Fecal microbiota transplantation (FMT) restores a balanced intestinal flora, which helps to cure recurrent Clostridium difficile infections (RCDI). FMT has also been used to treat other gastrointestinal diseases, including inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), and chronic constipation, as well as a variety of non-GI disorders. The purpose of this review is to discuss gut microbiota and FMT treatment of GI and non-GI diseases. An imbalanced gut microbiota is known to predispose one to Clostridium difficile infections (CDI), IBD, and IBS. However, the complex role of the gut microbiota in maintaining health is a newer concept that is being increasingly studied. The microbiome plays a major role in cellular immunity and metabolism and has been implicated in the pathogenesis of non-GI autoimmune diseases, chronic fatigue syndrome, obesity, and even some neuropsychiatric disorders. Many recent studies have reported that viral gastroenteritis can affect intestinal epithelial cells, and SARS-CoV-2 virus has been identified in the stool of infected patients. FMT is a highly effective cure for RCDI, but a better understanding of the gut microbiota in maintaining health and controlled studies of FMT in a variety of conditions are needed before FMT can be accepted and used clinically.

Vaccination against COVID-19 in patients with inflammatory bowel diseases

The novel coronavirus infection (COVID-19) is characterized by a high incidence of damage not only to the bronchopulmonary system, but also to the gastrointestinal tract. The problem of patients with bowel diseases was reviewed in this research the context of the COVID-19 pandemic and the importance of vaccination this group of patients was reflected and approaches to it were described. The analysis of biomedical literature data on the problem of vaccination of patients with intestinal diseases against COVID-19 was carried out. © 2022 Sorbtsionnye i Khromatograficheskie Protsessy. All rights reserved.

Outcomes of budesonide multimatrix prescriptions in the COVID-19 pandemic

Background: Budesonide multimatrix is prescribed to treat forms of inflammatory bowel disease (IBD) during periods of relapse, and it is licensed to treat mild-to-moderate ulcerative colitis (UC). However, during the COVID-19 pandemic, there was a rise in the use of budesonide multimatrix to treat all forms of IBD after fears that systemic corticosteroid use, such as prednisolone, could increase the risk of COVID-19 severity. Methods: This audit included records of all patients who were prescribed the budesonide multimatrix Cortiment (9 mg once a day) over a year in NHS Lothian. Patients were grouped by disease activity at the point of prescription (Partial Mayo Score (PMS) less than 5 showed milder disease and above 5 showed more severe disease) and disease phenotype. The primary endpoint was response at 8 weeks from start of treatment, grouped into full response, partial response, no response and escalation. Results: The full response rate to budesonide multimatrix was 52% among all patients, but 80% in those with PMS ≤4 and only 15% in those with a PMS ≥5. By phenotype, response rates were 41% in Crohn's disease, 50% in IBD unclassified, 56% in proctitis, 56% in left-sided colitis and 51% in pancolitis. Conclusions: Budesonide multimatrix is effective to treat mild disease but is not effective in patients who are having a moderate-to-severe flare of IBD. This medication was 80% effective if the PMS was below 5, suggesting that it is very effective in mild disease.

Preferences for COVID-19 Vaccination in People With Chronic Immune-Mediated Inflammatory Diseases.

OBJECTIVE: To understand how people with chronic immune-mediated inflammatory diseases (IMIDs) trade off the benefits and risks of coronavirus disease 2019 (COVID-19) vaccine options. METHODS: We conducted an online discrete-choice experiment in people with IMIDs to quantify the relative importance (RI) of attributes relevant to COVID-19 vaccination. Participants were recruited between May and August 2021 through patient groups and clinics in Canada, and completed 10 choices where they selected 1 of 2 hypothetical vaccine options or no vaccine. The RI of each attribute was estimated and heterogeneity was explored through latent class analysis. RESULTS: The survey was completed by 551 people (89% female, mean age 46 yrs) with a range of IMIDs (inflammatory bowel disease [48%], rheumatoid arthritis [38%], systemic lupus erythematosus [16%]). Most had received 1 (94%) or 2 (64%) COVID-19 vaccinations. Across the ranges of levels considered, vaccine effectiveness was most important (RI = 66%), followed by disease flare (21%), rare but serious risks (9%), and number/timing of injections (4%). Patients would accept a risk of disease flare requiring a treatment change of ≤ 8.8% for a vaccine with a small absolute increase in effectiveness (10%). Of the 3 latent classes, the group with the greatest aversion to disease flare were more likely to be male and have lower incomes, but this group still valued effectiveness higher than other attributes. CONCLUSION: Patients perceived the benefits of COVID-19 vaccination to outweigh rare serious risks and disease flare. This supports COVID-19 vaccine strategies that maximize effectiveness, while recognizing the heterogeneity in preferences that exists.

SARS-CoV-2 Infection and Outcomes in Children with Inflammatory Bowel Diseases: A Systematic Review.

The impact of COVID-19 on pediatric patients with inflammatory bowel disease (PIBD) is still not clear and the knowledge acquired over the last 2 years is still evolving. This study aims to investigate the risk and clinical outcomes of COVID-19 in patients with PIBD. A systematic search of PubMed and Scopus databases was conducted to identify studies published up until September 2022. Out of the 475 articles screened, 14 studies were included in the review. Of the 4006 children with PIBD included, 390 (9.7%) tested positive for COVID-19. Among those with COVID-19, 5.9% (0-16.7%) needed hospitalization, 0.6% (0-1%) were admitted to the pediatric intensive care unit (PICU), and no deaths were reported. Among the included studies, only four presented details regarding patients' symptoms, with 21% (0-25%) presenting gastrointestinal (GI) symptoms. An association between PIBD activity or specific treatment and COVID-19 outcome could not be established. The prevalence of COVID-19 in patients with PIBD was low; therefore, the initial concerns regarding higher infection risk and worse prognosis in this population are not supported by the currently available data. Further research is needed to determine the natural history of the infection and the optimal treatment for these patients. Much is still unclear and additional studies should be performed in order to optimize prevention and care for this special group of patients.