Use Of Biologic Therapies Research Articles

Availability of medical care for the rural population with diseases of the skin and subcutaneous tissue in the Republic of Bashkortostan

The morbidity rate of the rural population is lower than that of the urban population for all classes of diseases, which is due to the low availability of medical care (MC) for rural residents, including those with diseases of the skin and subcutaneous tissue (DSST). The purpose of our study was to study the accessibility of MP to the rural population of the Republic of Bashkortostan with DSST and determine ways to improve it.Materials and methods. An analysis was made of the incidence of the rural population of DSST, resource provision of dermatovenereological care and the volume of primary health care and specialized, including high-tech MC, based on reporting data for the Republic of Bashkortostan (RB) in comparison with the indicators of the Russian Federation (RF) and the Volga Federal District (VFD).Results. For the period 2013–2020 in the RB, there are high average annual incidence rates of the rural population with DSST, exceeding similar data for the RF and VFD. The provision of dermatovenerologists has decreased (the rate of decrease is 16.2 %), the number of dermatovenereological rooms has decreased (the rate of decrease is 9.3 %). In terms of the number of dermatological beds, the republic ranks frst among other regions of the VFD, and second in terms of the level of provision. The share of rural residents who received high-tech MC in 2020 amounted to 38.5 % of the total quota.Conclusion. As a result of the study, the need to increase the role of nursing staff of central district hospitals in conducting dispensary observation of patients with chronic dermatoses, creating algorithms for constant interaction between dermatovenereologists of the consultative and diagnostic department of the Republican dermatovenerologic dispensary and doctors and / or nurses of districts, creating a republican register of patients with chronic dermatosis, increase in the volume of high-tech medical care with the use of genetic engineering biological therapy. The priority in increasing the availability of medical care for the rural population with DSST is systematic work consisting in the development and implementation of a set of organizational solutions.

Residence in Peripheral Regions and Low Socioeconomic Status Are Associated With Worse Outcomes of Inflammatory Bowel Diseases: A Nationwide Study From the epi-IIRN.

Timely access to quality medical care impacts patient outcomes in inflammatory bowel disease (IBD). In a nationwide study from the epidemiology group of the Israeli IBD research nucleus we aimed to assess the impact of residence and socioeconomic status (SES) on disease outcomes. We utilized data from the 4 health maintenance organizations in Israel, representing 98% of the population. Regions were defined as central, northern and southern; SES was graded from lowest to highest (from 1 to 4) as per Israel Central Bureau of Statistics. The primary outcome was steroid dependency, with secondary outcomes of surgeries and biologic therapy use. A total of 28 216 IBD patients were included: 15 818 (56%) Crohn's disease (CD) and 12 398 (44%) ulcerative colitis; 74%, 12% and 14% resided in central, southern, and northern Israel, respectively (SES 1: 21%, SES 4: 12%). Lower SES was associated with steroid dependency (20% in SES 1 vs 12% in SES 4 in CD; P < .001; and 18% vs 12% in ulcerative colitis; P < .001), and higher surgery rates (12% vs 7%; P < .001, and 1.4% vs 0.7%; P = .115, respectively). There were higher steroid dependency and CD surgery rates in peripheral vs central regions. In multivariable models, both SES and peripheral region were independently associated with poorer outcomes. We found that lower SES and peripheral residence were associated with deleterious outcomes in IBD. This should be considered by policymakers and should encourage strategies for improving outcomes in populations at risk.

Biologics for Nasal Polyps: Synthesizing Current Recommendations into a Practical Clinical Algorithm.

Chronic rhinosinusitis with nasal polyps (CRSwNP) has been traditionally managed with a combination of topical and systemic medical therapy as well as endoscopic sinus surgery. The emergence of biologic therapies that target specific aspects of the inflammatory cascade has ushered in a potentially new paradigm in the management options available for CRSwNP. To summarize the current literature and recommendations supporting the use of available biologic therapies for CRSwNP and to develop an algorithm to aid clinical decision-making regarding treatment selection. A review of available literature and studies that demonstrated the clinical efficacy of biologic agents for the treatment of CRSwNP informing current CRSwNP consensus algorithms. Current biologic medications target immunoglobulin E, interleukins, or interleukin receptors implicated in the Th2 inflammatory cascade. Institution of biologic therapy is now an option for patients who have disease refractory to topical medical therapy and endoscopic sinus surgery, those who cannot tolerate surgery, or patients with other comorbid Th2 diseases. Response to treatment should be monitored at 4-6 months and 1 year after initiating therapy. Across multiple indirect comparisons, dupilumab appears to have the largest therapeutic benefit across multiple subjective and objective outcomes. The choice of therapeutic agent also depends on drug availability, patient tolerance, presence of comorbid illnesses, and cost. Biologics are emerging as an important option in the management of patients with CRSwNP. While more data is required to fully inform indications, treatment selection, and health economics related to their use, biologics may offer robust symptom relief to patients who have failed other interventions.

Incremental net monetary benefit of biologic therapies in moderate to severe asthma: a systematic review and meta-analysis of economic evaluation studies

Objectives This meta-analysis was conducted to quantitatively pool the incremental net benefit (INB) of using biologic therapies as an add-on treatment to standard therapy in patients with moderate to severe asthma. Methods We performed a comprehensive search in several databases published until April 2022. Studies were included if they were cost-effectiveness analyses reporting cost per quality-adjusted life-year or life-year on any biologic therapies as an add-on treatment for moderate to severe asthma in patients of all ages. Various monetary units were converted to purchasing power parity, adjusted to 2021 US dollars. The INBs were pooled across studies using a random-effects model, stratified by country income level (high-income countries (HICs) and low- and middle-income countries (LMICs)) and perspectives (health care or payer perspective (HCPP) and societal perspective (SP)) and age group (>12 years and 6–11 years). Heterogeneity was assessed using the I2 statistic. Results A total of 32 comparisons from 25 studies were included. Pooled INB indicated that the use of omalizumab as an add-on treatment to standard therapy in those aged >12 years was not cost-effective in HICs from the HCPP (n = 8, INB, −6,341 (95% CI, -$25,000 to $12,210), I2=86.18%) and SP (n = 5, -$14,000 (-$170,000 to $140,000), I2=75.64%). A similar finding was observed in those aged 6–11 years from the HCPP in LMICs (n = 2, -$45,000 (-$73,000 to $17,000), I2=00.00%). Subgroup analyses provided no explanations of the potential sources of heterogeneity. Conclusion The use of biologic therapies in moderate to severe asthma is not cost-effective compared to standard treatment alone.

P240 Low surgery rates first year after diagnosis in Crohn’s disease; results from a large population-based inception cohort - the IBSEN III study

Abstract Background Surgery rates in Crohn’s disease (CD) have declined during recent years, in parallel with the introduction and increased use of biological treatment. The aim of this study was to describe the use of first-line biologic therapy and to estimate the intra-abdominal surgery rate during the first year after the CD diagnosis. Methods The Inflammatory Bowel Disease in South-Eastern Norway III (IBSEN III) study is a population-based inception cohort with a prospective follow-up of newly diagnosed inflammatory bowel disease patients from the South-Eastern Health Region of Norway included in the period 2017 to 2019. Five hundred and seven patients ≥18 years were diagnosed with CD and those attending the one-year follow-up visit were included in this study. Clinical data, including Montreal classification, were registered at time of diagnosis. At the one-year follow-up, use of biologic therapy and need for CD-related intra-abdominal surgery since diagnosis were registered. Kaplan-Meier plots estimated the cumulative incidence of first-line biologic therapy and intra-abdominal surgery. Results A total of 431/507 (85%) CD patients attended the one-year follow-up and were included, 54.8% female, median age 37 years (range 18-80). At diagnosis 218 (50.6%) presented with ileal disease location, 76 (17.6%) colonic and 137 (31.8%) ileocolonic disease location, while 11 (2.6%) also had upper gastrointestinal involvement. The majority, 351 (81.4%), had a non-stricturing non-penetrating disease behavior, 70 (16.2%) a stricturing and 10 (2.3%) a penetrating disease behavior, while 17 (3.9%) also had perianal disease. Within one year of follow-up, 165 (38.7%) received at least one biologic therapy (60.6% infliximab, 35.8% adalimumab and 3.6% vedolizumab). Seven patients (1.6%) underwent perianal surgery and 21 (4.9%) had intra-abdominal surgery within the first year. Three of these were diagnosed during their primary surgery. Time from diagnosis to start of first-line biologic therapy and first intra-abdominal surgery is shown in Figure 1 and Figure 2, respectively. Figure 1: Kaplan-Meier plot showing cumulative incidence of first-line biologic therapy. Figure 2: Kaplan-Meier plot showing cumulative incidence of Crohn's related intra-abdominal surgery. Conclusion In the IBSEN III cohort, the rate of intra-abdominal surgery during the first year of disease was low (4.9%) compared to a previous population-based study from the same geographic area during the pre-biologic era, the IBSEN study, where the surgery rate was reported as 15.9 %.1 We hypothesize that a large preponderance of patients presenting with milder phenotypes at diagnosis combined with high use of biologicals contribute to the low surgery rates.

P353 Ulcerative Colitis in the IBSEN III study: Frequent use of biologics and low colectomy rates first year of disease.

Abstract Background Biological therapy of ulcerative colitis (UC) has become more common in recent years, and colectomy rates have declined during the same period. The aim of this study was to describe the use of first-line biologic therapy and to estimate the colectomy rate in a population-based inception cohort during first year of disease. Methods Inflammatory Bowel Disease in South-Eastern Norway III (IBSEN III) is a population-based inception cohort with a prospective follow-up of newly diagnosed patients with inflammatory bowel disease from the South-Eastern Health Region of Norway, including from 2017 to 2019. In this project, we studied patients≥ 18 years with a verified UC diagnosis at baseline and at one-year follow-up. Baseline characteristics, use of biological therapy, and need for surgery during the first year after diagnosis were analysed. Kaplan-Meier plot was used to estimate the time to first-line biologic therapy. Results A total of 889 UC patients (45.9% female, median age 36 years (range 18-84), 6.2% smokers) were included in the study and met for one-year follow-up. Totally 129 (14.5%) patients started on biological therapy due to UC, during the first year of disease. Time from diagnosis to start of first-line biologic therapy is depicted in Figure 1 (Kaplan-Meier plot). In addition, four patients received biologics due to other indications than UC (not depicted in Figure 1). The colectomy rate at one-year follow-up was 0.9% (8/889). Figure 1: Cumulative incidence of biologic therapy. Conclusion In this population-based inception cohort, colectomy rates during first year of disease were low compared to a prior population-based study from the same geographic area in the pre-biologic era (the IBSEN study)1, while the proportion starting on biological therapy was higher than reported in comparable inception cohorts2.

P459 Hospitalization, use of biologics and surgery rates in inflammatory bowel diseases: a single-center comparative analysis between public and private healthcare systems in a tertiary unit from Latin America

Abstract Background Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), characterized by chronic inflammation of the intestine, have a rising incidence and prevalence globally. The potential impact of socioeconomic inequality on health and mortality is well documented. In chronic diseases, the effect of inequality in assessment to healthcare can be associated with a higher frequency of complications and worse organ functionality in patients with social deprivation. In IBD, there are scarce studies comparing the differences between patients according to their socioeconomic status. Our aim was to comparatively evaluate hospitalizations, use of biologics and rates of surgery in patients with IBD between public and private healthcare systems. Methods single-center retrospective cohort study in patients with IBD from a tertiary referral unit from Latin America, between 2015 and 2021. CD and UC patients were classified into two subgroups: public and private healthcare systems. Main analyzed variables were age at diagnosis, gender, Montreal classification, new diagnoses or referred patients, smoking status, previous medications, need for IBD-related hospitalizations and abdominal surgery. Demographic characteristics, hospitalizations, need for surgery and biologics were compared between two subgroups: private and public healthcare systems. Results 500 patients were included, 322 with CD and 178 with UC. CD-related hospitalizations were frequently observed in both healthcare systems (76.28% in private and 67.46% in public). More than half of the patients had been submitted to one or more CD-related abdominal surgical procedure, with no significant difference between the subgroups. Although there was no difference in the rates of use of biological therapy in CD subgroups, infliximab was more used in the public setting (57.69% vs. 43.97%, p=0.014). There was no difference in UC-related hospitalizations between the subgroups (public 30.69% and private 37.66%, p=0.33) as well as the rates of colectomy (public: 16.83%, private: 19.48%, p=0.65). Biologics were used almost twice as often in private as compared to the public system (45.45% vs. 22.77%, p=0.001). Conclusion Patient demographics were overall similar between healthcare systems in IBD patients. There were no differences in the rates of hospitalization and abdominal surgery between the two subgroups in both diseases. In patients with UC, there was greater use of biological therapy in the private healthcare setting. Global data regarding the possible impact of social deprivation in IBD-related outcomes are warranted.

P386 Clinical presentation, management, and evolution of lymphomas in patients with Inflammatory Bowel Disease: an ENEIDA registry study.

Abstract Background An increased risk of lymphoma has been described in patients with Inflammatory Bowel Disease (IBD). The aims of our study were to determine the clinical presentation of lymphoma, previous exposure to immunosuppressive and biologic therapies, and the management and evolution of lymphomas in patients with IBD. Methods IBD patients with diagnosis of lymphoma from October 2006 to June 2021 were identified from the prospectively maintained ENEIDA registry of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU). Investigators at each participating centre provided additional information on lymphomas. Results We identified 52 patients with lymphoma in 18 centres following 21,740 patients with IBD (2.4 cases of lymphoma/1,000 patients with IBD; 95% CI 1.8-3.1). 35 were men (67%) and 27 (52%) had Ulcerative Colitis. Non-Hodgkin lymphoma was the most common lymphoma (65%). The median age at diagnosis of lymphoma was 59 years old (IQR 48-67). 31 patients (60%) received thiopurines, and 20 (38%) an anti-TNF drug (one of them had not received thiopurines) before lymphoma diagnosis. Age at diagnosis of lymphoma was lower in those patients treated with thiopurines (53 ± 17 years old) and anti-TNF drugs (47 ± 17 years old) than in those patients not treated with thiopurines nor anti-TNF drugs before the diagnosis of lymphoma (63 ± 12 years old; p&amp;lt;0.05 for both). The most common signs were adenopathy or mass (38%). Most of patients were treated with chemotherapy (77%). Median follow-up after lymphoma diagnosis was of 57 months (IQR 39-102 months). After diagnosis of lymphoma, IBD treatment was changed in 30 patients (58%), and 3 (5.8%) patients received thiopurines and 8 (15%) biologics during follow-up. Those patients who required to be treated with immunosuppressants or biologic therapies after lymphoma diagnosis had an IBD flare more frequently than those patients without these treatments (75% vs. 20%; p=0.01). 5 cases had relapse of lymphoma (incidence of 1.7 cases/100 patient-years; 95% CI 0.7-4.0), with a median of 38 months (IQR 23-84 months) from the diagnosis. 9 patients (17%) died after 19 months (IQR 0-48 months). Relapse and mortality were not related with the type of IBD or lymphoma, sex, smoking habit nor with the use and duration of thiopurines or biologic therapies. Conclusion Most IBD patients with lymphoma had been treated with thiopurines and/or anti-TNF agents before lymphoma diagnosis, and these patients were younger at diagnosis of lymphoma than those not treated with these drugs. IBD treatment was usually changed after a diagnosis of lymphoma. Relapse and mortality of lymphoma were not related to the use and duration of thiopurines or biologic therapies.

OP09 Long-term Colectomy rates of Ulcerative Colitis over 40-year of Different Therapeutic eras – Results from a Western Hungarian Population-based Inception Cohort between 1977–2020

Abstract Background Few population-based studies have investigated the long-term colectomy rates of ulcerative colitis (UC). The present study is a continuation of the Veszprem IBD population based cohort with a follow-up of the incidence and disease course for over 40 years. We aimed to assess the colectomy rates over 40 years of different therapeutic eras in a prospective population-based inception cohort from Veszprem Province, Western Hungary. Methods Patient inclusion lasted between January1,1977 and December31, 2018. Patient follow-up ended December 31,2020. Both in-hospital and outpatient records were collected and comprehensively reviewed at diagnosis and during clinical follow-up. Disease extension was evaluated based on the Montreal classification. Colectomy rates and disease course were examined in three different eras based on the time of UC diagnosis; cohort-A(1977-1995),cohort-B(1996-2008), and cohort C(2009-2018). Results Data of 1,370 incident UC patients were analyzed (male/female: 702/668; median age at diagnosis: 37 years(y) [IQR: 26-51]), with a median of 17y (IQR 9-24) follow-up. Table 1. The overall colectomy rate was 76/1,370 patients during the total follow-up. The proportion of extensive colitis at diagnosis increased over time (24.2% / 24.3% / 34.9% in cohorts A/B/C; p=0.001). Overall immunosuppressive therapy exposure was increasing in the cohorts (11.3% / 20.9% / 34.4%; p&amp;lt;0.001), as well as the probability of biological therapy initiation within 5 years of diagnosis (0.0±0% / 3.3±0.7% / 13.9±1.8%; pLogRank&amp;lt;0.001). Figure 1. There was no significant difference in the cumulative probability of proximal disease progression from proctitis (E1) to left-sided colitis/extensive colitis (E2/E3) or from left-sided colitis (E2) to extensive colitis (E3) over time in cohorts A, B, and C (Long-rank=0.482). Figure 2. The cumulative probability of colectomy in the total population was 4.1±0.6% after 10 years, 6.3±0.8% after 20 years, and 8.8±1.2% after 30 years. There were no statistically significant differences in the cumulative probability of colectomies between cohorts A/B/C: 1.7±0.7% / 2.2±0.6% / 3.7±1.0% after 5 years; 3.5±1.0% / 3.9±0.8% / 4.5±1.2% after 10 years; and 6.9±1.4% / 5.3±1.0% (cohorts A/B) after 20 years [pLogRank=0.447]. Figure 3. Extensive disease (HR 2.3;95%CI 21.60-3.37) and continuous uncontrolled disease activity (HR 6.89;95%CI 4.15-11.46) were independent predictors for colectomy. Table 2. Conclusion No differences in proximal disease progression and colectomy rates have been observed in the incident UC patients over 40 years despite increasing use of immunomodulators and biological therapies.

OP18 Disease course of Crohn’s disease during the first ten years following diagnosis in a prospective European population-based inception cohort – the Epi-IBD cohort

Abstract Background The Epi-IBD cohort is a prospective European population-based cohort of 1,390 patients diagnosed in 2010 and 2011 with inflammatory bowel disease (IBD) according to Copenhagen criteria in centres from Eastern and Western European countries. The study aims at describing differences in incidence, treatment strategies, disease course and prognosis of Crohn’s disease (CD) across Eastern and Western Europe. Methods CD patients were followed prospectively from the time of diagnosis until December 31st, 2020, death, emigration or loss of follow-up. Clinical data on surgery, hospitalizations, and medical treatment, were captured throughout the follow-up period and entered into a validated web-database, www.epi-ibd.org. Associations between surgery and covariates were analysed by multivariate Cox regression analyses. Results In total, 482 CD patients aged ≥15 years from 21 centres in 5 Eastern and 11 Western European countries were included. At 10-years follow-up, 101 (21%) patients underwent first intestinal resection and 11 out of these 101 patients (11%) underwent additional resections. Furthermore, 176 (37%) patients had at least one CD related hospitalization. Cancer was diagnosed in 21 (4%) patients, including 4 gastrointestinal cancers. The use of IBD medication was comparable between Eastern and Western European centres apart from 5-aminosalicylic acid agents (Table 1). During follow-up, 60 out of 360 patients (17%) progressed from non-stricturing-non-penetrating disease (B1) at diagnosis to stricturing or penetrating disease (B2 or B3) while 13 out of 83 patients (16%) with stricturing disease (B2) progressed to penetrating disease (B3). The median time to progression was 28 (IQR: 9-64) months from diagnosis. No patients from Eastern Europe were exposed to biological therapy prior to change in behaviour, compared to 23 out of 66 patients (35%) from Western Europe. Multivariate Cox regression analysis showed no difference in risk of surgery according to European region (Eastern vs. Western Europe, HR: 0.54, 95%CI: 0.24-1.21). Early intervention with biological therapy (within 6 months) did not influence the risk of surgery (HR:0.75, 95%CI: 0.31-1.83), however early introduction of immunomodulators reduced the risk significantly (HR:0.54, 95%CI: 0.30-0.98). Progression in behaviour from B1 was associated with higher risk of surgery (HR:7.62, 95%CI: 3.91-14.87). Conclusion After 10 years of follow-up, 21% underwent intestinal resection and 10% required additional resections. Despite the widespread use of immunomodulators and biological therapy, 16% of the patients had disease behavioural progression, which was associated with higher risk of surgery. Early introduction of immunomodulators was found to be beneficial.

PATIENT PERSPECTIVE OF BOWEL URGENCY AND BOWEL URGENCY-RELATED ACCIDENTS IN CROHN’S DISEASE

Abstract OBJECTIVE This study aimed to explore the Crohn’s disease (CD) patient experience of Bowel Urgency (BU) and BU-related accidents to identify what is most relevant and important to patients. METHODS Patients in the US were eligible to participate in this qualitative study if they were ≥18 years of age, had a diagnosis of moderate to severe CD for ≥6 months and had experienced BU in the last 6 months. Interviews were conducted to explore the signs, symptoms, and impacts related to BU and BU-related accidents. Specifically, patients were asked to describe BU and BU-related accident experiences of CD in their own words. Transcripts were coded and analyzed in ATLAS.ti 9 using a systematic thematic analysis. RESULTS A total of 15 patients participated; majority were female (53%), white (53%), receiving biologic and/or conventional therapy (87%), and mean age of 50 yrs. A majority of patients (80%) experienced BU at least once in the last week and 20% had experienced ≥1 BU-related accident in the last month. The time-sensitive need to use or be near the bathroom, uncertainty of BU, and fear of experiencing an accident were reported as the most bothersome aspects of the BU experience. Patients reported 16 signs and symptoms that co-occur with BU, with abdominal pain (87%), fatigue (87%), and abdominal cramping (53%) being most frequently reported (Table 1). Patients reported 36 BU-related impact concepts across 16 domains (Table 1). Impact domains most frequently reported were adaptive behaviors (93%), household chores (87%), and social activities (87%). Impact concepts most frequently reported were dietary changes (87%) and inability to participate in social activities (87%). Inability to participate in family activities, interrupted work activities, and inability to participate in social activities were reported as the most bothersome impacts to patients. All 15 patients reported ever experiencing BU-related accidents. Patients reported 12 signs and symptoms that co-occur with BU-related accidents, with abdominal pain (67%), fatigue (67%), and abdominal cramping (60%) being most frequently reported (Table 2). Patients reported 44 impacts of BU-related accidents across 16 domains (Table 2). Impact domains most frequently reported were adaptive behaviors (100%) and emotional functioning (87%). Impact concepts most frequently reported were dietary changes (80%) and embarrassment (60%). CONCLUSION This study revealed that the experience of BU and BU-related accidents is bothersome to patients with CD, impactful on their daily lives, and occurs despite the use of biologic and/or conventional therapy.

PATIENT PERSPECTIVES OF BOWEL URGENCY AND BOWEL URGENCY-RELATED ACCIDENTS IN ULCERATIVE COLITIS

Abstract OBJECTIVE This study aimed to explore the Ulcerative Colitis (UC) patient experience of Bowel Urgency (BU) and BU-related accidents to identify what is most relevant and important to patients. METHODS Patients in the US were eligible to participate in this qualitative study if they were ≥18 years of age, had a diagnosis of moderate to severe UC for ≥6 months and had experienced BU in the last 6 months. Interviews were conducted to explore the signs, symptoms, and impacts related to BU and BU-related accidents. Transcripts were coded and analyzed in ATLAS.ti 9 using a systematic thematic analysis. RESULTS 15 patients with moderate to severe UC participated; majority were female (53%), white (80%), receiving biologic and/or conventional therapy (80%), and had a mean age of 51.6 years. A majority of patients (80%) indicated that they had experienced BU at least once in the last week and 33% indicated that they had experienced at least 1 BU-related accident in the last month. Participants reported a total of 13 sign and symptom concepts that co-occur with BU, with abdominal pain (87%), fatigue (80%), abdominal cramping (67%), and diarrhea (33%) being the most frequently reported (Table 1). Abdominal pain (40%) and abdominal cramping (40%) were frequently reported as the most bothersome symptoms of BU to participants. A total of 32 BU-related impact concepts were reported by participants across 16 impact domains (Table 1). The impact domains most frequently reported by participants were adaptive behaviors (100%), emotional functioning (87%), and social activities (67%). The most frequently reported impact concepts were dietary changes (73%), inability to participate in social activities (67%), and difficulty running errands (60%). Inability to participate in social activities (27%) and bathroom mapping (20%) were frequently reported as the most bothersome impacts to participants. A total of thirteen (87%) participants reported experiencing BU-related accidents. Of the 7 signs and symptoms reported by participants to co-occur with BU-related accidents, the most frequently reported were abdominal pain (77%), gas (77%), and abdominal cramping (69%) (Table 2). A total of 30 impact concepts of BU-related accidents were reported by participants across 13 impact domains (Table 2). The domains most frequently reported by participants were adaptive behaviors (100%), emotional functioning (69), and social activities (62%). The most frequently reported impact concepts were bathroom mapping (62%), inability to participate in social activities (62%), and embarrassment (54%). CONCLUSION This qualitative study revealed that BU, BU-related accidents, and BU co-occurring symptoms are bothersome, impactful on participants’ daily lives, and occur despite the use of biologic and/or conventional therapy.

Self-medication in ophthalmologic problems. What is known about it?

Self-medication (SM) refers to any practice for curative purposes that is not prescribed by a physician. It includes the use of conventional or allopathic medicine (CM) and complementary and alternative medicine (CAM). In the case of ophthalmologic ailments, this division can also be seen, within CM, the use of anesthetics, analgesics and topical antibiotics, for the treatment of mainly traumatic pathologies, to save time and money, advised by their close circle, but always with the risk of not improving, abusing the medication, producing toxicity, masking the condition and giving an incorrect treatment. CAM highlights the use of biological therapies due to the variety of products that have been documented, such as chamomile, tea leaves, garlic, sage, etc. But also the use of mind-body therapies, manipulative and body-based methods; and energy therapies such as acupuncture; there are many more pathologies for which they are used compared to CM, and they resort to it precisely because of the lack of results of CM, the sources of information are usually similar and although they seem harmless, they are not innocuous. In general, it is a subject that is little addressed, but is relevant due to the risks involved. This manuscript seeks to provide an overview so that medical personnel remain expectant and in each intervention detect the areas of opportunity that reduce this practice.

Pediatric perianal Crohn's disease behavior in the era of biologic therapy.

To describe perianal Crohn's disease behavior and the role of biological therapy in a sample of pediatric patients. A retrospective study of pediatric patients with Crohn's disease (CD) treated in our institution from 2017 to 2021, with a minimum follow up period of 6 months, was conducted. Patients were divided whether they had perianal disease (PD) or not. Baseline characteristics, extension of disease, growth failure rate, aggressive pattern rate, use of biological therapy and need for surgery, among other variables, were compared between both groups. Clinical and/or radiological improvement in the last 6 months of follow up was considered good control of PD. Seventy eight pediatric patients with CD were included. Median age at diagnosis was 10.5 years, and median follow up time was 3.8 years. 64.1% patients were male. Of all, 15 (19.2%) had perianal disease, of which 10 had fistulizing findings and 5 had non fistulizing findings. PD was presented at diagnosis in 8 patients, and the rest developed it in a median time of 1 year from diagnosis. PD was associated with growth failure (p=0.003), use of biological therapies (p=0.005), and need for second line of biologics (p=0.005). Most patients (12/15, 80%) had good control of PD with the treatment received. CD patients with PD seem to need a more aggressive treatment, with biological therapies playing a key role for its handling nowadays. These patients require close nutritional evaluation that ensures proper development and growth.

Psoriasis Clearance Rates with Different Treatments – An In-depth Retrospective Chart Review

Abstract Background: Before the advent of biologics, psoriasis clearance was not a realistic goal of treatment. Purpose: This retrospective chart review aimed to compare the rates of psoriasis clearance associated with different modes of therapy in real-life practice. Methods: The study included 256 psoriasis patients who had &gt;2 Physician Global Assessment and body surface area scores and psoriasis treatments recorded during a 3-year period. Results: Injection biologics performed better than regimens including topical agents alone or in combination with topical and oral systemic therapy. Patients on injection regimens accounted for 90% of patients with disease clearance. Injection therapy alone had a larger decrease in psoriasis severity scores from baseline than injection therapy combined with other agents. Despite clinical trials being monotherapy studies, this study conducted at a large referral center aligns with the clearance rates reported in clinical trials. Conclusion: Our results suggest that monotherapy studies can be translated into community practice. Overall, this study adds to the growing body of evidence supporting the use of biologic therapy in psoriasis management and underscores the importance of patient education on the potential for complete clearance with modern therapies.

Canadian multidisciplinary expert consensus on the use of biologics in upper airways: a Delphi study

BackgroundChronic rhinosinusitis with nasal polyposis (CRSwNP) often coexists with lower airway disease. With the overlap between upper and lower airway disease, optimal management of the upper airways is undertaken in conjunction with that of the lower airways. Biologic therapy with targeted activity within the Type 2 inflammatory pathway can improve the clinical signs and symptoms of both upper and lower airway diseases. Knowledge gaps nevertheless exist in how best to approach patient care as a whole. There have been sixteen randomized, double-blind, placebo-controlled trails performed for CRSwNP targeted components of the Type 2 inflammatory pathway, notably interleukin (IL)-4, IL-5 and IL-13, IL- 5R, IL-33, and immunoglobulin (Ig)E. This white paper considers the perspectives of experts in various disciplines such as rhinology, allergy, and respirology across Canada, all of whom have unique and valuable insights to contribute on how to best approach patients with upper airway disease from a multidisciplinary perspective.MethodsA Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. A national multidisciplinary expert panel of 34 certified specialists was created, composed of 16 rhinologists, 7 allergists, and 11 respirologists who evaluated the 20 original statements on a scale of 1–9 and provided comments. All ratings were quantitively reviewed by mean, median, mode, range, standard deviation and inter-rater reliability. Consensus was defined by relative interrater reliability measures—kappa coefficient (kappa) value > 0.61.ResultsAfter three rounds, a total of 22 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with upper airway disease.ConclusionThis white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of upper airway disease from a multidisciplinary perspective, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.Graphical abstract

The prevalence of rheumatoid arthritis in Western Australia

BackgroundRheumatoid arthritis (RA) is the most common form of autoimmune arthritis, but the prevalence in Australia is unknown. We estimated RA period prevalence and identified factors associated with frequent RA hospitalisations, using linked administrative health and state-specific Australian Pharmaceutical Benefits Scheme (PBS) datasets in Western Australia (WA) from 1995 to 2014.MethodsThis was a longitudinal population-based cohort study using two independent datasets to identify prevalent RA patients. RA prevalence was calculated per 1000 hospital separations and biological therapy users. RA patients were identified in the WA linked health dataset using ICD codes 714.0–714.9 and M05.00–M06.99. Dispensing data on biological therapy for RA were obtained from PBS records and converted to defined daily doses /1000 population/day. Multivariable logistic regression was used to analyse factors associated with frequent RA hospitalisations (> 2/year), controlling for sex, age, and geographic locations. Potential interactions were assessed using logistic regression in a stepwise approach.ResultsA total of 17,125 RA patients had 50,353 hospital separations between 1995 and 2014, averaging three hospitalisations per patient over 20 years. The RA period prevalence was 3.4 per 1000 separations (0.34%; 95% CI 0.33–0.34), while the RA period prevalence based on biological therapy use was 0.36% (95% CI 0.35–0.37). The corrected RA prevalence based on biological therapy usage was 0.36% (95% CI 0.35–0.37) for the 2005–2009 and increased to 0.72% (95% CI 0.70–0.74) in 2010–2014 period. Associated factors for frequent RA hospitalisations were being female [1.21 (95% CI 1.15–1.26)], aged 60–69 years [4.45 (95% CI 3.74–5.30)], living in rural areas [1.12 (95% CI 1.02–1.24)]. The odd ratio of interaction between these associated factors was 1.34 (95% CI 1.16–1.55).ConclusionThe minimal prevalence of RA in Western Australia is 0.34–0.36%, which falls within the literature range. Older female RA patients in rural were more likely to be hospitalised, suggesting unmet primary care for needs.

Perceived stress and readiness to undertake biodebridement in the group of nurses undertaking prevention and treatment of chronic wounds.

Stress as the body's response to adverse stimulus is recognized as one of the key problems in basic and clinical neurological studies. Stress is an indispensable component of modern nursing with its low doses being desirable, however, prolonged stress is detrimental to health increasing the risk of chronic disease i.e., hypertension, cardiovascular diseases, electrolyte disturbances, occupational burnout, depression, anxiety disorders. The implementation of certain techniques and therapeutic methods may have a stressful effect from the point of view of practice and the patient's condition. The authors undertook the study to assess the intensity of the perceived stress in the group of nurses dealing with wound care in the perspective of implementing wound debridment using Lucilia sericata larvae. The study group consisted of 290 nurses specialized in chronic wounds undergoing training at the Postgraduate Training Center of Nurses and Midwives in Rzeszów, out of the entire group of 1.136 individuals participating in training courses organized in Poland in 2020-2021. The study used the diagnostic survey method, the research tool was a scientific research protocol consisting of tools (MDT perception questionnaire, perceived stress scale (PSS-10). Certain differences in the level of stress in the study sample were observed between age categories, but they were not statistically significant. The greatest differences between the levels of stress in the study sample were observed between people who completed treatment courses and those who did not complete these courses. The higher the stress level, the lower the willingness to undertake such therapy. The analysis of grouped data leads to interesting observations. There were statistically significant differences in the score in the MDT10 scale in the categories of people with different stress levels. The highest readiness to implement MDT was observed in the category of people with the lowest perceived level of stress. The level of professional experience related to postgraduate education increases opportunities addressing new professional challenges. The level of perceived stress may influence decisions related to the use of biological therapy. The higher the level of stress, the lower the readiness to undertake MDT.

Long-term Colectomy Rates of Ulcerative Colitis over 40 Years of Different Therapeutic Eras-Results from a Western Hungarian Population-based Inception Cohort Between 1977 and 2020.

Few populaion-based studies have investigated the long-term colectomy rates of ulcerative colitis [UC]. We aimed to assess the colectomy rates over 40 years of different therapeutic eras in a prospective population-based inception cohort from Veszprem Province, Western Hungary. Patient inclusion lasted between January1, 1977, and December31, 2018. Patient follow-up ended December 31, 2020. Colectomy rates and disease course were examined in three different eras based on the time of UC diagnosis; cohort A [1977-1995], cohort B [1996-2008], and cohort C [2009-2018]. A total of 1370 incident UC patients were included [male 51.2%, median age at diagnosis 37 years]. Median follow-up was 17 years (interquartile range [IQR] 9-24); 87 patients [6.4%] underwent colectomy. The cumulative probability of colectomy in the total population was 2.6% (95% confidence interval [CI] 2.2-3.0), 4.2% [95% CI 3.6-4.8], 7.0% [95% CI 6.2-7.8], and 10.4% [95% CI 9.1-11.7] after 5, 10, 20, and 30 years, respectively. The proportion of extensive colitis at diagnosis increased over time [24.2%/24.3%/34.9% in cohorts A/B/C, respectively, p = 0.001]. Overall exposure to immunomodulators [11.3%/20.9%/34.4% in cohorts A/B/C, respectively, p <0.001], as well as the probability for biologic therapy initiation increased over time (0%/3.3% [95% CI 2.6-4.0]/13.9% [95% CI 12.1-15.7], p <0.001). There were no statistically significant differences in the cumulative probability of colectomies between cohorts A/B/C: 1.7% [95% CI 1.0-2.4], 2.5% [95% CI 1.9-3.1], and 3.7% [95% CI 2.7-4.7] after 5 years; 3.5% [95% CI 2.5-4.5], 4.2% [95% CI 3.4-5.0], and 4.5% [95% CI 3.3-5.7] after 10 years; and 7.5% [95% CI 6.1-8.9] and 6.3% [95% CI 5.2-7.4] in cohorts A/B after 20 years [log-rank = 0.588]. Extensive colitis (hazard ratio [HR] 2.24, 95% CI 1.55-3.23) and continuous active disease activity [HR 6.36, 95% CI 3.46-11.67] were independent predictors for colectomy. No differences in colectomy rates have been observed in the incident UC patients over 40 years despite increasing use of immunomodulators and biologic therapies.

481. Risk Factors and Clinical Outcomes of Candidemia Associated with Severe Coronavirus Disease 2019 (COVID-19)

Abstract Background COVID-19 can cause serious illness requiring multimodal treatment of the viral infection and its associated complications, including the potential for secondary infections. Studies have suggested an increased risk of fungal infections, including candidemia following severe COVID-19 though understanding of risk factors and clinical outcomes remains unclear. Methods A multi-center, case-control study of patients with severe COVID-19 was conducted to evaluate risk factors and clinical outcomes in patients who developed candidemia between August 2020 to August 2021. Risk factors associated with candidemia and mortality were characterized using multivariate analyses. Results A total of 275 patients were enrolled in the study, including 91 patients with severe COVID-19 and subsequent candidemia and 184 patients with severe COVID-19 without candidemia. Most patients received antibiotics prior to candidemia episode (93%), while approximately one-quarter of all patients received biologic for COVID-19. In-hospital mortality was significantly higher in the case group compared to the control group (68% vs 40%, P &amp;lt; 0.01). Multivariable logistic regression revealed that the use of central lines, biologic and paralytic therapy were independent risk factors for candidemia. The presence of candidemia, older age, central line use, and intensive care unit admission were significantly associated with mortality. Demographics and Baseline Characteristics of Study Patients with SARS-CoV-2 Positive With or Without Candidemia Hospitalization Details and Outcomes Conclusion Clinicians should be aware of the possibility of development of candidemia in hospitalized older patients with severe COVID-19 and should closely monitor those patients at risk. Risk factors for developing candidemia in the setting of COVID-19 are largely consistent with classic risk factors previously identified. Disclosures Tanaya Bhowmick, MD, Gilead: Grant/Research Support|Shinogi: Advisor/Consultant Steven Smoke, PharmD, BCPS, BCIDP, Karius: Advisor/Consultant|Shionogi: Advisor/Consultant.