Use Of Biologic Therapies Research Articles

Advances in Research on Stem Cell-Based Pulp Regeneration.

Although root canal therapy is the most common and widely used treatment at clinical presentation, there are still some postoperative complications. As cell biology and tissue engineering techniques advance rapidly, the use of biological therapy to regenerate dental pulp has become a new trend; Relevant literatures in recent five years were searched using key words such as "root canal therapy", "Dental pulp stem cells", "Dental pulp regeneration", and "Cell homing" in PubMed, Web of Science, etc; Dental pulp stem cells (DPSCs) have multi-differentiation potential, self-renewal capability, and high proliferative ability. Stem cell-based dental pulp regeneration has emerged as a new research hot spot in clinical therapy. Recently, dental pulp-like structures have been generated by the transplantation of exogenous DPSCs or the induction of homing of endogenous DPSCs. Studies on DPSCs are important and significant for dental pulp regeneration and dental restoration; In this review, the existing clinical treatment methods, dental pulp regeneration, and DPSC research status are revealed, and their application prospects are discussed.The stem cell-based pulp regeneration exerts promising potential in clinical therapy for pulp regeneration.

Endotypes of chronic rhinosinusitis: Relationships to disease phenotypes, pathogenesis, clinical findings, and treatment approaches.

Chronic rhinosinusitis (CRS) is a common clinical syndrome that produces significant morbidity and costs to our health system. The study of CRS has progressed from an era focused on phenotype to include endotype-based information. Phenotypic classification has identified clinical heterogeneity in CRS based on endoscopically observed features such as presence of nasal polyps, presence of comorbid or systemic diseases, and timing of disease onset. More recently, laboratory-based findings have established CRS endotype based upon specific mechanisms or molecular biomarkers. Understanding the basis of widespread heterogeneity in the manifestations of CRS is advanced by findings that the three main endotypes, Type 1, 2, and 3, orchestrate the expression of three distinct large sets of genes. The development and use of improved methods of endotyping disease in the clinic are ushering in an expansion of the use of biological therapies targeting Type 2 inflammation now and perhaps other inflammatory endotypes in the near future. The purpose of this review is to discuss the phenotypic and endotypic heterogeneity of CRS from the perspective of advancing the understanding of the pathogenesis and improvement of treatment approaches and outcomes.

Нестероидные противовоспалительные средства: современное представление о механизмах повреждения пищеварительного тракта, минусы препаратов патогенетического лечения и перспективы биологической терапии НПВС-индуцированной эзофагогастроэнтероколонопатии

Актуальность. Нестероидные противовоспалительные средства (НПВС) ежедневно применяют более чем 30 млн человек, а их арсенал насчитывает свыше 80 препаратов и около 1000 созданных на их основе лекарственных форм. Они широко используются во многих сферах медицины и являются одной из наиболее клинически значимых групп лекарственных средств. Однако при использовании НПВС достаточно часто могут возникать побочные реакции, наиболее распространенными из них являются повреждения желудочно-кишечного тракта. Цель: охарактеризовать со­временное представление о механизмах повреждения пищеварительного тракта НПВС, оценить недостатки существующих препаратов патогенетического лечения и перспективы биологической терапии НПВС-индуцированной эзофагогастроэнтероколонопатии криоконсервированным экстрактом плаценты человека. Материалы и методы. Проведен анализ работ, опубликованных в 2010–2020 гг., в которых освещались сведения об эпидемиологии, патогенезе, диагностике и тактике лечения поражений пищевода и желудочно-кишечного тракта, индуцированных НПВС, а также биологические свойства криоконсервированного экстракта плаценты человека как средства биологической терапии. Результаты. Лечение НПВС-индуцированной эзофагогастроэнтероколонопатии классически направлено на кислотосупрессивную терапию (ингибиторы протонной помпы, Н2-гистаминоблокаторы и др.), применение гастроцитопротекторов (де-нол, сукральфат и др.) и препаратов, восстанавливающих содержание простагландинов в слизистой оболочке (мизопростол, ребамипид и др.). Однако все указанные группы лекарственных средств недостаточно удовлетворяют клиницистов, поскольку направлены преимущественно на лечение НПВС-гастропатии и имеют побочные эффекты. Новым перспективным направлением повышения безопасности НПВС на сегодняшний день является применение средств биологической терапии, источниками которых выступают микроорганизмы, органы и ткани растительного или животного происхождения, клетки или жидкости (в том числе кровь и плазма) человеческого или животного происхождения и биотехнологические клеточные конструкции. Выводы. Использование НПВС значительно ограничивается присущими им побочными эффектами, наи­более распространенными являются нарушения со стороны желудочно-кишечного тракта. Криоконсервированный экстракт плаценты человека является перспективным средством биологической терапии ульцерогенных повреждений желудочно-кишечного тракта, индуцированных НПВС.

Real-World Satisfaction with Secukinumab in Clearing the Skin of Patients with Plaque Psoriasis through 24Months of Follow-Up: Results from US Dermatology Electronic Medical Records.

IntroductionInformation on the long-term treatment satisfaction with secukinumab for patients with plaque psoriasis in real-world settings is limited. The objective of this study was to describe real-world treatment satisfaction in patients with plaque psoriasis who initiated secukinumab using data from an electronic medical records-based dermatology database.MethodsPatients aged ≥ 18 years with plaque psoriasis in Modernizing Medicine Data Services’ affiliate’s database who received secukinumab 3/1/2018–1/21/2020 were included. Satisfaction with the treatment’s effectiveness in clearing the skin of psoriasis was evaluated using a 5-point Likert scale during the 12-month baseline period and at 6-, 12-, 18-, and 24-month postindex visits for the overall population and at 6-, 12-, and 18-month postindex visits for subgroups stratified by prior biologic and systemic therapy use. Additionally, satisfaction levels were assessed among patients who were unsatisfied with treatment at baseline.ResultsOverall, 82.3% agreed that secukinumab was effective in clearing their skin at 6 months, which was maintained through 12 (81.7%), 18 (83.3%), and 24 months (81.4%). Similar results were observed in biologic-experienced/naive and systemic-experienced/naive patients. Overall mean (SD) treatment satisfaction improved from 2.49 (1.36) at baseline to 1.77 (1.06) at 6 months, with similar improvements in satisfaction scores reported at each follow-up period up through 24 months. Of the patients who were not satisfied at baseline, 77.9% reported being satisfied with their treatment at 6 months, which continued through 12 (74.4%), 18 (82.8%), and 24 months (71.4%). Patients receiving secukinumab experienced meaningful changes in percent affected body surface area and Physician Global Assessment scores that were sustained through 24 months, regardless of prior treatment experience.ConclusionsThese real-world findings highlight the high level of sustained satisfaction with secukinumab treatment for improving and maintaining skin clearance in patients with moderate-to-severe disease, regardless of prior treatment experience.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-021-00599-5.

Current joint therapy usage in equine practice: Changes in the last 10years.

Osteoarthritis is a common clinical condition in the performance horse. In the last 10years, there has been substantial growth in understanding of the disease and in the development of novel therapies. To document changes in clinical use of joint therapies over the past 10years. We also aimed to understand how newly developed therapies have been added to routine clinical practice. Survey of veterinary professionals. We administered an electronic survey to members of the American Association of the Equine Practitioners. Questions from a similar survey in 2009 were repeated and new questions were added. The responses were tabulated, analysed and compared to those of the previous survey. A total of 407 completed surveys were returned. There were no significant differences between the current and previous surveys with respect to demographic parameters. Triamcinolone acetonide (TA) remained the most common corticosteroid used to treat high-motion joints. Methylprednisolone acetate (MPA) remained the most common corticosteroid to treat low-motion joints. The use of MPA for high-motion joints was significantly more common in 2009 than in 2019 (odds ratio [OR]: 2.38, 95% confidence interval [CI]: 1.66-3.42, P=.001). Biological therapies became more popular, and the likelihood of respondents reporting having used autologous conditioned serum was substantially higher in 2019 than in 2009 (OR: 4.24, 95% CI: 3.16-5.68, P<.001). Concomitant use of antibiotics with intra-articular medications became more common as well. This is a report of survey data and not directly measured treatments. There is a decrease in the use of MPA to treat high-motion joints. The use of biological therapies in joints has become more prevalent. There are clear differences in the use of joint therapies over time. While some differences agree with the scientific evidence, others are not fully concordant or are in direct conflict with the scientific literature.

Rheumatoid arthritis activity scores in patients with and without fibromyalgia syndrome.

BACKGROUND: Fibromyalgia syndrome (FM) is a systemic disease of unknown etiology, which can cause widespread musculoskeletal pain. In patients with rheumatoid arthritis (RA), FM can cause an additional symptom burden, which can affect some variables on the RA disease activity score 28 (DAS28), a tool that evaluates 28 joints in RA patients.OBJECTIVE: Compare the results of four different versions of the DAS28 and the parameters used to determine disease activity scores in RA patients with and without FM, and determine whether there are treatment differences between RA patients with and without FM.DESIGN: Retrospective, cross-sectional.SETTING: Tertiary hospital.PATIENTS AND METHODS: We identified patients diagnosed with RA between 1 September 2016 and 1 February 2020 and identified patients with and without FM.MAIN OUTCOME MEASURES: Differences between variables in the DAS28 calculations (tender joint count [TJC], patient global assessment [PGA], and others), between patients with and without FM, and differences between patients with and without FM who were using or not using biological agents.SAMPLE SIZE: 381, including 322 females (84.5%).RESULTS: The frequency of FM in RA patients was 25.7% (89 females, 24.6%). In RA patients with FM, the TJC and PGA median values were significantly higher than in patients without FM (P<.05). The use of corticosteroids and biological therapy in patients with FM was more frequent than in patients without FM (P<.05). Compared to patients without FM, patients with FM switched treatment more often because of non-response to treatment (P=.01) Median values of the DAS28 scores (calculated by four different versions of the instrument) in RA patients with FM were higher than in patients without FM (P<.05).CONCLUSION: The presence of FM in RA patients may affect the subjective variables in different versions of DAS28 scores, causing the disease activity to score higher on the instrument, erroneously indicating worse disease than is actually present.LIMITATIONS: A single center, retrospective study.CONFLICTS OF INTEREST: None.

The Relationship between Pre-Pandemic Interferon Gamma Release Assay Test Results and COVID-19 Infection: Potential Prognostic Value of Indeterminate IFN-γ Release Assay Results

Objective To reveal the relationship between interferon-gamma release assay (IGRA) test (Standard ETB-Feron ELISA (TBF)) results performed within 12 months before the COVID-19 pandemic and the frequency of COVID-19 infections and the severity of COVID-19. Methods The retrospective TBF test results and contact information of 684 patients aged over 18 years who underwent TBF testing between March 11th, 2019, and March 10th, 2020, were obtained. Of the 684 patients contacted by phone, 365 agreed to participate in the study and were enrolled. The patients were divided into three groups (TBF test positive, negative, and indeterminate). The data obtained from the questionnaire were compared statistically. Results According to the TBF test results, positive (n = 51, 14%), negative (n = 286, 78.3%), and indeterminate (n = 28, 7.7%) groups were compared. The frequency of COVID-19 infections in the indeterminate group was found significantly higher than that in the positive and negative groups (p=0.005). When the group with COVID-19 (n = 46, 12.6%) was compared with the group without (n = 319, 87.4%), no difference was found in terms of age, sex, body mass index, smoking history and number of cigarettes smoked, TB history, diabetes mellitus, hypertension, coronary artery disease, and biologic and corticosteroid therapy use. Only the frequency of obstructive pulmonary disease was significantly higher in the group without COVID-19 (p=0.033). Conclusion The frequency of COVID-19 infection was increased in patients with indeterminate TBF test results. Indeterminate TBF test results may be a guide in terms of risk stratification in groups at risk for COVID-19.

First-line biologic treatment of inflammatory bowel disease during the first 12 months after diagnosis from 2010 to 2016: a Norwegian nationwide registry study

Objectives The use of biologic therapy in inflammatory bowel disease (IBD) is likely to increase with lower costs and more biologics and biosimilars becoming available. Our aim was to estimate the trends in use of first-line biologics during the first year after diagnosis in a Norwegian IBD population from 2010 to 2016. Methods Data were collected from the Norwegian National Patient Registry and Norwegian Prescription Database. Patients defined as incident IBD cases between 2010 and 2016 were included and followed for 12 months. Patients were stratified by year of diagnosis to examine change over time. Chi-square test was used for calculations on proportions. Time from diagnosis to first biologic was calculated by Kaplan-Meier failure estimates. Results 14,645 patients were included, 5283 (36%) with Crohn’s disease (CD) and 9362 (64%) with ulcerative colitis (UC). In the 2010 and 2016 cohort, the proportion initiating biologics increased from 17% to 33% (p < .001) for CD and 7% to 13% (p < .001) for UC. The most frequently used first-line biologics were infliximab (CD: 64% and UC: 82%) and adalimumab (CD: 36% and UC: 15%). The highest registered use of adalimumab was in the 2012 cohort (CD: 56% and UC: 39%). In the 2014–2016 cohorts, infliximab was the most used first-line biologic for both CD and UC. Conclusions The proportion of IBD patients initiating biologics within 12 months after diagnosis increased between 2010 and 2016. The use of infliximab as first-line biologic increased after the approval of biosimilar infliximab in 2013.

Evaluation of Real-World Healthcare Resource Utilization and Associated Costs in Children with Juvenile Idiopathic Arthritis: A Canadian Retrospective Cohort Study.

IntroductionJuvenile idiopathic arthritis (JIA) is a chronic rheumatic disease, whose multifaceted care path can lead to significant expenditure for the healthcare system. We aim to assess the real-world healthcare resource use (HCRU) and associated cost for children with JIA in a single center in Canada.MethodsA single-center consecutive cohort of newly diagnosed patients with JIA attending the pediatric rheumatology clinic from 2011 to 2019 was identified using an administrative data algorithm and electronic medical charts. HCRU was estimated from six administrative health databases that included hospital admissions, emergency, outpatient care, practitioners’ visits, medication, and laboratory and imaging tests. Costs were assigned using appropriate sources. We reported the yearly overall and JIA-associated HCRU and costs 5 years prior to and 6 years after the first visit to the pediatric rheumatologist. The Zhao and Tian estimator was used to calculate cumulative mean costs over a 6-year timeframe. Results were stratified by disease subtype.ResultsA total of 389 patients were identified. The yearly total overall mean costs per patient ranged between $804 and $4460 during the 5 years prior to the first visit to the pediatric rheumatologist and $8529 and $10,651 for the 6 years after. Medication cost, driven by use of biologic therapies, and outpatient visits were the greatest contributor to the total cost. The overall cumulative mean cost for 6 years of care was $48,649 per patient, while the JIA-associated cumulative mean cost was $26,820 per patient. During the first year of rheumatology care, systemic onset JIA had the highest cumulative mean overall cost, while oligoarticular JIA had the lowest cumulative mean cost.ConclusionThe care pathway for children with JIA can be expensive, and complex—and varies by JIA subtype. Although the yearly total mean cost per patient was constant, the distribution of costs changes over time with the introduction of biologic therapies later in the care pathway. This study provides a better understanding of the JIA costs profile and can help inform future economic studies.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00331-x.

Retrospective analysis of the effectiveness of local corticosteroid therapy in children with oligoarticular juvenile idiopathic arthritis

Background . Despite the progress in diagnosis and treatment of chronic rheumatic diseases in children, the choice of anti-inflammatory drugs in case of the onset of oligoarticular juvenile idiopathic arthritis (JIA) still remains relevant. Till present, pediatric rheumatologists have not reached a consensus on this issue yet. The aim of this study was to search for predictors of early failure of local steroid therapy and assessment of its feasibility in patients with oligoarticular JIA. Materials and methods. In a retrospective study, 92 children aged 11 months – 9 years with chronic oligoarticular JIA without extra-articular manifestations were monitored. The features of the clinical, instrumental and laboratory diagnosis during the disease onset were studied, along with the dynamics of the articular syndrome and the effectiveness of intra-articular administration of corticosteroid drugs. Results and discussion. The data on 92 children with 164 active joints who received 218 local intra-articular injections of triamcinolone acetonide at the onset of the disease were analyzed. Intra-articular injections of triamcinolone acetonide at a dose of 20–40 mg were performed with an interval of 3, 6, and 12 months, depending on the intensity of the disease. In about one third of children with oligoarticular JIA, arthritis became inactive on average after two intra-articular injections of triamcinolone acetonide. The study did not reveal the predictors of early ineffective topical corticosteroid monotherapy in children. No clinical, instrumental, and laboratory signs were identified that would directly indicate the need for early therapy with methotrexate. Conclusion . Triamcinolone acetonide is an effective and safe drug for children with oligoarticular JIA. Despite the widespread use of biological, gene, and other innovative therapies, application of local corticosteroids as the firstline therapy in children with oligoarticular JIA should not be neglected.

Effect of first-line biologic initiation on glucocorticoid exposure in children hospitalized with new-onset systemic juvenile idiopathic arthritis: emulation of a pragmatic trial using observational data

BackgroundGlucocorticoid exposure is a significant driver of morbidity in children with systemic juvenile idiopathic arthritis (sJIA). We determined the effect of early initiation of biologic therapy (IL-1 or IL-6 inhibition) on glucocorticoid exposure in hospitalized patients with new-onset sJIA.MethodsWe emulated a pragmatic sequence of trials (“pseudo-trials”) of biologic initiation in children (≤ 18 years) hospitalized with new-onset sJIA utilizing retrospective data from an administrative database from 52 tertiary care children’s hospitals from 2008 to 2019. Eligibility window, treatment assignment and start of follow-up between biologic and non-biologic study arms were aligned for each pseudo-trial. Patients in the source population could meet eligibility criteria at several timepoints. Mixed-effects logistic regression was used to determine the effect of biologic initiation on in-hospital glucocorticoid exposure.ResultsFour hundred sixty-eight children met eligibility criteria, of which 19% received biologic therapy without preceding or concomitant initiation of immunomodulatory medications. This proportion significantly increased over time during the study period (p < 0.01). 1451 trial subjects were included across 4 pseudo-trials with 71 assigned to the biologic arm and 1380 assigned to the non-biologic arm. After adjustment, there was a trend toward decreased odds of glucocorticoid initiation in the biologic arm compared to the non-biologic arm (OR 0.39, 95% CI [0.13, 1.15]).ConclusionBiologic initiation in children hospitalized with new-onset sJIA significantly increased over time and may be associated with reduced glucocorticoid exposure. The increasing use of first-line biologic therapy may lead to clinically relevant reductions in treatment-related adverse effects of glucocorticoid-reliant therapeutic approaches.

Biologics in professional and Olympic sport: a scoping review.

The aim of this study was to prepare a scoping review to investigate the use of biologic therapies in the treatment of musculoskeletal injuries in professional and Olympic athletes. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews and Arksey and O'Malley frameworks were followed. A three-step search strategy identified relevant published primary and secondary studies, as well as grey literature. The identified studies were screened with criteria for inclusion comprising clinical studies evaluating the use of biologic therapies in professional and Olympic athletes, systematic reviews, consensus statements, and conference proceedings. Data were extracted using a standardized tool to form a descriptive analysis and a thematic summary. A total of 202 studies were initially identified, and 35 met criteria for the scoping review; 33 (94.3%) were published within the last eight years, and 18 (51.4%) originated from the USA. Platelet rich plasma was the most studied biologic therapy, being evaluated in 33 (94.3%) studies. Ulnar collateral ligament and hamstring injuries were the conditions most studied (nine (25.7%) studies and seven (20.0%) studies, respectively). Athletes most frequently participated in baseball, soccer, and American football. Only two (5.7%) studies were level 1 evidence, with interpretation and comparison between studies limited by the variations in the injury profile, biologic preparations, and rehabilitation protocols. There is diverse use of biologic therapies in the management of musculoskeletal injuries in professional and Olympic athletes. There is currently insufficient high-level evidence to support the widespread use of biologic therapies in athletes. Further research priorities include the development of condition/pathology-specific preparations of biologic therapies, and of outcome measures and imaging modalities sufficiently sensitive to detect differences in outcomes, should they exist. Cite this article: Bone Joint J2021;103-B(7):1189-1196.

Biologic Therapy and Severe Asthma in Children.

Severe asthma is a heterogeneous, complex and chronic disease widespread in the pediatric population. According to the recent findings about the different endotypes of asthma in children, each one characterized by specific intracellular molecular pathways, several innovative biologic therapies have been developed. Due to their precise ability to target specific inflammatory type 2 mediators, biologics have revolutionized the care of chronic allergic diseases in the pediatric and adult population. In this review, we aim to provide the latest evidence about the use, indications, efficacy and safety of biologic therapies to treat severe asthma in children and adolescents.

The risk of malignancy in patients with secukinumab‐treated psoriasis, psoriatic arthritis and ankylosing spondylitis: analysis of clinical trial and postmarketing surveillance data with up to five years of follow‐up

Data on the use of biologic therapy and malignancy risk are inconsistent due to limited long-term robust studies. To assess the malignancy risk in patients with secukinumab-treated psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS). This integrated safety analysis from both the secukinumab clinical trial programme and postmarketing safety surveillance data included any patient receiving at least one approved dose of secukinumab with a maximum of 5 years of follow-up. Safety analyses evaluated the rate of malignancy using exposure-adjusted incidence rates [EAIR; incidence rates per 100 patient treatment-years (PTY)]. Standardized incidence ratios (SIRs) were reported using the Surveillance, Epidemiology, and End Results Program (SEER) database as a reference population. Crude incidence of malignancy was also reported using postmarketing surveillance data. Safety data from 49 clinical trials with secukinumab-treated patients were included: 10 685 patients with psoriasis, 2523 with PsA and 1311 with AS. Across indications over a 5-year period, the EAIR of malignancy was 0·85 per 100 PTY [95% confidence interval (CI) 0·74-0·98] in secukinumab-treated patients, corresponding to 204 patients per 23 908 PTY. Overall, the observed vs. expected number of malignancies from secukinumab clinical trial data were comparable, as indicated by an SIR of 0·99 (95% CI 0·82-1·19) across indications. The estimated crude cumulative incidence reporting rate per 100 PTY for malignancy was 0·27 in the postmarketing surveillance data across indications with a cumulative exposure of 285 811 PTY. In this large safety analysis, the risk of malignancy was low for up to 5 years of secukinumab treatment. These data support the long-term use of secukinumab in these indications.

Resultados de gestión en una cohorte de pacientes con artritis reumatoide en una institución de atención integral especializada en Colombia

ObjectiveTo determine the management results in a cohort of patients with rheumatoid arthritis in a specialized integral healthcare institution for this disease in Colombia. Materials and methodsDescriptive cross-sectional study based on a cohort of rheumatoid arthritis patients according to ACR/EULAR 2010 criteria. The information was analysed based on consolidated data from clinical records and national reports in the period 2015 to 2018. Administrative records related to medication authorizations and prescriptions were considered. Sociodemographic variables, outcome indicators related to disease activity status and medication use percentage were evaluated. ResultsAs of June 30th 2018, 698 patients were identified, of which the female sex represented 83.8%, the general average age was 55.47 years, and the highest number of cases were in the 60 to 64 year age group. Of the patients, 68.3% were between remission and low disease activity. Seventy-three point one percent were managed with conventional disease-modifying antirheumatic drugs and a reduction in the use of biological therapy was recorded from 27.2% in 2016 to 17.8% at the end of the period. ConclusionsThis study presents the management results of a comprehensive care model for patients with rheumatoid arthritis in Colombia, which managed to maintain the highest proportion of patients in low activity and remission as they had a longer follow-up time, to decrease the percentage of biological DMARDs use, and establish conventional DMARDs as the main therapeutic alternative.

P653 Rheumatic extraintestinal manifestations in ulcerative colitis : Prevalence and predictive factors

Abstract Background Ulcerative colitis (UC) are an inflammatory condition affecting the gastrointestinal tract. They are considered as chronic disease with complex genetic, immune and environmental components. UC are not exclusive to the gastrointestinal system as they have been identified to be associated with extraintestinal manifestations (EIM) that encompass every other organ in the human body including musculoskeletal system. The aim of this study was to evaluate the prevalence and predictive factors of rheumatic EIM among patients with UC. Methods We carried out a retrospective study from January 2000 to December 2018 including all patients with UC. A complete rheumatologic examination, osteodensitometry,lumbosacral and sacroiliac X-rays were performed.The variables retrospectively analyzed were: gender, age,habits, location and extension of the disease, biochemical markers, other EIM, and previous immunosuppressive therapy. We investigated associations between rheumatic manifestations and clinical and biological criteria. Results Seventy eight patients were included in our study with an average age of 47,56 years [24–85 years]. Sex ratio M/F 0,85. Rheumatic manifestations of any type were present in 42,3%(33 of 78). Peripheral arthritis were observed in 3,8%. Axial involvement including sacroiliitis (SI), with or without spondylitis was noticed in 8,97%. Bone mineral loss was present in 25,6% with 13 cases of osteopenia and 7 cases of osteoporosis. Three patients (3,8%) had an association of SI and osteoporosis. No cases of enthesopathy have been reported. Otherwise, univariate and multivariate logistic regression methods testing for each predictor and their possible association with rheumatic manifestations among UC had shown a decreased risk for rheumatic manifestations with an age over 40 years (p=0,018), an hepatobiliary disorders such as the presence of hepatic cytolysis (p=0,034) and cholestasis (p=0,017) , the coexistence of dermatologic EIM (p=0,048). Forms complicated with an acute severe ulcerative colitis are likely to be correlated with rheumatologic manifestations (p=0,039) but location and extension of the disease had not shown any significant association. And finally, patients who underwent systemic corticosteroid treatment were highly associated with a decreased risk for rheumatic manifestations (p=0,044). Conclusion Predictive factors involved in the occurrence of rheumatic manifestations are: an advanced age, presence of other EIM, severe forms and the use of steroid. Regular screening for EIM and early use of biological therapies may prevent the development of musculoskeletal involvement . Medical care for patients with UC should be multidisciplinary involving the coordination between rheumatologists and gastroenterologists .

P630 Inflammatory bowel disease in immigrants to Spain: results of the EIIMIGRA study from GETECCU (ENEIDA registry)

Abstract Background Previous studies comparing inflammatory bowel disease(IBD) features between migrant and native patients have shown clinical phenotype differences. To date, no study has focused on IBD immigrants(MP) in Spain. The aim of this study was to explore the features of MP in Spain and to compare age of disease onset, IBD phenotype and therapeutic requirements with native-born IBD patients(NP). Methods This was an observational, multicentric and case-control study of the nationwide ENEIDA registry. We selected all IBD patients who were born outside of Spain and compared with a control cohort of NP. All included patients were diagnosed with IBD before 2015. Results A total of 13,524 patients were included(1864 MP and 11660 NP).The most prevalent ethnic migrant group was Caucasian(771, 41%), followed by Latin American(572, 31%) and Arabian(341,18%), whereas Asian represented only 6%. Table 1 summarizes the demographic and phenotypic features. 71% of MP were diagnosed with IBD in Spain. There was not a gender predisposition to IBD in the overall migrant group, however more female UC MP were detected compared to UC NP(52 % vs 45%, p&amp;lt;0.001). MP were younger at the onset of the disease and had a shorter disease duration compared to NP, in both UC and CD patients. Significantly more CD patients were diagnosed under 16 years(A1) among MP, and more patients over 40 years(A3) among NB. More NB patients had CD stricturing phenotype(24% vs 19%, p=0,002) compared to MP. Disease extension in CD and UC did not differ between groups. The overall proportion of abdominal or perianal surgery was similar in both groups but the use of biologic therapy was more common in MP(36% vs 30%, p=0,001). Conclusion In the largest cohort of migrant IBD patients in Spain, immigrants were younger, had a shorter disease duration and required a higher use of biologics than natives, pointing phenotypic differences in this population and a universal access to the healthcare system all over the country.

P246 Development of a new Inflammatory Bowel Disease Patient Identifier shortens time to clinic review and initiation of treatment

Abstract Background Timely diagnosis of inflammatory bowel disease (IBD) is important because earlier use of biologic therapies leads to mucosal healing, a reduction in hospitalisations and surgeries and improvements in quality of life. In the United Kingdom, general practitioners refer patients with symptoms suggestive of IBD to colorectal surgeons, emergency department physicians, gastroenterologists or directly for a lower gastrointestinal endoscopy. Consequently, there is variation in the time from endoscopic diagnosis of IBD to specialist review. We created an electronic tool that screens all endoscopy reports for a new diagnosis of IBD. These cases are then reviewed in our weekly complex multidisciplinary team (MDT) meeting and new patients are allocated an IBD specialist. We sought to determine whether our new patient identifier reduced the time to clinical review by an IBD specialist and initiation of IBD treatment. Methods We designed a retrospective observational cohort study comparing time from endoscopic diagnosis of IBD to initiation of treatment and IBD specialist review. Outcomes were compared in the 18 months before and after the introduction, in January 2018, of our new IBD patient identifier. Demographic, endoscopic and treatment outcome data were recorded from our electronic patient record. Categorical and continuous variables were summarised as frequencies (%) and median [IQR] and compared with Fisher’s exact and Mann Whitney U tests respectively. Results Between the 1st January 2018 and 30th June 2019, 116 new patients diagnosed with IBD were identified and reviewed in our MDT meeting. In the preceding 18 months, 111 patients were diagnosed with IBD. There were no significant differences between groups according to sex, age, age at diagnosis, disease type, or phenotype according to the Montreal classification (Table 1). Both the median time from endoscopic diagnosis to treatment initiation (0 days [IQR 0 – 14.2] vs 14 days [IQR 0 – 31.6], p=0.007) and specialist clinic review (21 days [IQR 7 - 25] vs 48 days [IQR 34 – 63], p&amp;lt;0.0001) were shorter following the introduction of the new IBD patient identifier screening tool (Figure 1). Conclusion Systematic electronic screening of endoscopic reports linked to MDT review reduces the time to first treatment and specialist review in newly diagnosed patients with IBD.

DOP48 Use of biologic therapies with different mechanisms of action (MOA) in the first-line (1L) treatment of Crohn’s Disease (CD) in the U.S

Abstract Background Anti-cytokine biologics (anti-TNF agents, anti-IL-12/23 agent) and gut-selective anti-lymphocyte trafficking agent (MAdCAM α4β7 blocker) are available treatment options for patients (pts) with moderate-to-severe CD. There are limited data on treatment persistence of these different MOA as 1L biologic treatment of CD in real-world setting. Methods This retrospective study used the Truven Health MarketScan administrative claims database to assess treatment patterns in a large U.S. insured population. Biologic naïve adult CD pts (CD diagnosed by using ICD 9 and 10 codes) who initiated (date of initiation defined as index date) 1L biologic treatment (adalimumab [ADA], infliximab [IFX], vedolizumab [VDZ] or ustekinumab [UST] between 09/2016 and 09/2019) with ≥6 months of continuous health benefits enrolment post biologics initiation were included. Treatment persistence was defined as time to index drug discontinuation with a pre-defined gap or switch to other biologic drugs. Results Overall, 2648 ADA, 1446 IFX, 474 VDZ, and 415 UST treated CD pts were identified. The mean age was highest for VDZ pts (45.5 y), followed by UST (42.2 y), ADA (40.1 y) and IFX (38.8 y). The use of corticosteroid in 12 months prior to 1L biologics was highest for ADA pts (74.3%), then UST (68.2%), VDZ (65.2%), and IFX (64.9%). Disease duration (time from the first observed CD diagnosis to 1L biologics initiation date) ≤ 2 yrs was found lowest in VDZ pts (48.1%), then UST (54.7%), ADA (59.6%), and IFX (67.6%). Fistulising condition in 12 months before 1L biologics was highest in IFX pts (11.9%), then UST (9.4%), ADA (7.7%), and VDZ (5.3%). Continuation on 1L biologics was highest in VDZ pts (59.1%), followed by IFX (58.0%), UST (57.6%), and ADA (50.8%). Treatment discontinuation was highest in UST pts (35.7%), then ADA (35.4%), VDZ (30.2%), and IFX (28.2%). Switch to 2L biologics was highest in IFX pts (13.9%), then ADA (13.8%), VDZ (10.8%) and UST (6.8%). Median treatment persistence was highest for VDZ pts (842 days), followed by IFX (770 days), UST (566 days) and ADA (507 days). VDZ pts showed higher treatment persistence than ADA pts (log-rank p-value=0.005) or UST pts (p=0.14). IFX pts had higher persistence than ADA pts (p&amp;lt;0.0001) or UST pts (p=0.07). The adjusted hazard ratio of treatment discontinuation, with VDZ as the reference group, was highest for ADA (1.36, p&amp;lt;0.0001), then UST (1.27, p=0.023) and IFX (1.07, p=0.45). Conclusion In biologic naïve CD pts, real-world evidence shows that VDZ is associated with longer treatment persistence when compared with any of the currently approved anti-cytokine biologics. With &amp;gt;2 years of treatment persistence, VDZ and IFX were significantly superior to both ADA and UST.

P609 Impact of accessibility of medical care and socioeconomic class on outcomes of IBD – a nationwide population study

Abstract Background Despite ongoing improvements in Inflammatory Bowel Disease (IBD) therapeutics, timely access to quality medical care likely impacts patient outcomes. Physical distance from specialty care and socioeconomic status (SES) may impact quality of care. In a nationwide population study we aimed to assess the impact of patient location and SES on IBD outcomes. Methods This Epi-IIRN project utilized a meta-database incorporating patient data of all four health maintenance organisations (HMO) in Israel, representing 98% of the population. All patients identified on the incidence cohort were followed from diagnosis until end of 2018. Regions in Israel were defined as central (coastal plain and Jerusalem corridor), northern region and southern region. SES class were defined by postcode as per Israel bureau of statistics data from SES 1 (lowest) to SES 4 (highest). Primary outcome was steroid dependency, with secondary outcomes of biologic therapy use during first year of diagnosis, surgery, gastroenterology visits, hospitalizations and mortality. Analysis was performed separately for Crohn’s disease (CD) and ulcerative colitis (UC). Results A total of 30,167 IBD patients (16,936 (56%) CD and 13,231 (44%) UC) were included: 74% of patients were in central region, 12% southern region and 14% northern region. 21% were in SES class 1 and 12% in SES 4. In CD, lower SES was associated with higher steroid dependency (37% vs 30%, p=0.002), higher surgery rates (21% vs 12%, p&amp;lt;0.001), more hospitalizations (2.4 vs 1.1, p&amp;lt;0.001), more emergency department (ER) visits (2.9 vs 1.9, p&amp;lt;0.001) and higher mortality (3.3% vs 2.5%, p=0.03). Regarding region, steroid dependency, hospitalization rate, ER visits and surgery rate were all lower in central regions compared to both northern and southern region (p&amp;lt;0.001 for both central vs northern, and central vs southern regions). Similarly, gastrointestinal specialized clinic visits were more frequent in central regions (p=0.01). In UC, lower SES was associated with lower frequency of gastrointestinal clinic visits (5.0 vs 8.5, p&amp;lt;0.001). This was associated with more hospitalizations (1.6 vs 0.7, p&amp;lt;0.001), ER visits (2.1 vs 1.6, p=0.002), surgeries (7.6% vs 5.0%, p=0.014) and higher mortality (5.1% vs 4.2%, p=0.026). By region, gastrointestinal clinic visits were more frequent, and ER visits, hospitalizations (all p&amp;lt;0.001) and surgeries (p=0.001) were all lower in central compared to both northern and southern regions. Conclusion In this nationwide analysis we show deleterious impact of both lower SES and peripheral residence on outcomes of CD and UC. Policy makers should consider these data to facilitate improved access to medical care and maximize IBD outcomes in a standardized way.