Initiation Of Biologic Treatment Research Articles

Should the Dermatological Assessment of Patients with Inflammatory Bowel Disease Become Standard during Qualifications for Biological Treatment? A Retrospective, Single-Center Experience from a Tertiary Center

Background: Oncological anxiety associated with biological therapy is a particular challenge in inflammatory bowel disease (IBD), and it has raised questions about the need for the dermatological assessment of the skin before starting biological therapy. Methods: The aim of this study was to assess the frequency of dermal lesions, including cutaneous malignancies, in IBD patients. This retrospective, single-center study evaluated 805 IBD patients who qualified for biological treatment and were subjected to a dermatological assessment. Results: Dermal lesions (DLs) were found in 15.5% (125) of IBD patients. A risk factor for DLs was higher with body mass index (OR = 1.08, 95% CI [1.02; 1.14], p = 0.007). Surprisingly, there was no effect of thiopurines between the groups with and without DLs (90.4% vs. 84.6%, MD = 0.06, 95% CI [0.01; 0.12], p = 0.118). Moreover, cutaneous malignancies were diagnosed in 9 cases (1.1%), including 4 basal cell carcinomas, 4 squamous cell carcinomas, and 1 melanoma skin cancer. Only 13.4% of patients complied with our strict policy of skin surveillance every 6–8 months. Conclusions: DLs, including cutaneous malignancies, are common in patients with IBD, making skin monitoring at the initiation of biological treatment an extremely useful tool. The lack of effect of the drugs used suggests that skin surveillance is necessary in all IBD patients. The low compliance of skin monitoring among immunosuppressed patients indicates the need for better education on the prevention of cutaneous malignancies.

Predictors of initiating biologics in the treatment of psoriasis.

Biologics are among the most effective therapies for psoriasis. However, many patients are only introduced to them at advanced stages of the disease course. Our aim was to identify predictors of initiating biologic therapy in patients with psoriasis and compare patients initiating biologics early versus late in their disease course. Kaplan-Meier curves visualized time to biologic initiation, while Cox regression models further explored variables as predictors of biologic initiation. Mann-Whitney U and chi-squared tests compared patients who started biologics early with those who began biologics later in the disease course. Our primary analysis included 233 psoriasis patients. Cox regression showed that age at diagnosis (P = 0.007), general physical well-being (P = 0.02), and nail psoriasis severity (P = 0.02) were significantly associated with time to biologic initiation. Our secondary analysis, the comparisons between patients starting biologics early versus later in the disease course, included a total of 378 patients. The median (interquartile range [IQR]) age at diagnosis was 34.5 (25.0-51.2) years for patients initiating biologics within 5 years, compared to 22.0 (15.0-32.8) years for patients initiating biologics later (P < 0.0001). The median (IQR) age at initiation was 37.0 (27.0-53.2) and 45.0 (36.0-55.0) years for patients initiating biologics earlier versus later than 5 years (P = 0.04). Age at diagnosis, general well-being, and severity of nail psoriasis significantly predicted future initiation of biologic treatment. Patients initiating biologics early in their disease course were generally older at diagnosis but younger at the time of biologic initiation compared to patients initiating biologics later in their disease course.

Factors Associated with Delays in Initiating Biologic Therapy in Patients with Inflammatory Bowel Disease.

Expeditious initiation of biologic therapy is important in patients with inflammatory bowel disease (IBD). However, initiation of biologics in the outpatient setting may be delayed by various clinical, social, and financial variables. To evaluate the delay in initiation of an advanced therapy in IBD and to identify factors that contributed to this delay. This was a multi-center retrospective study. Outpatients who were initiated on a biologic therapy from 3/1/2019 to 9/30/20 were eligible for the study. Univariate and multivariate linear regression analyses were performed to identify variables associated with a delay in biologic treatment initiation. Delay was defined as the days from decision date (prescription placement) to first infusion or delivery of medication. In total 411 patients (Crohn's disease, n = 276; ulcerative colitis, n = 129) were included in the analysis. The median [interquartile range-(IQR)] delay for all drugs was 20 [12-37] days (infliximab, 19 [13-33] days; adalimumab, 10 [5-26] days; vedolizumab, 21 [14-42] days; and ustekinumab, 21 [14-42] days). Multivariate linear regression analysis identified that the most important variables associated with delays in biologic treatment initiation was self-identification as Black, longer distance from treatment site, and lack of initial insurance coverage approval. There may be a significant delay in biologic treatment initiation in patients with IBD. The most important variables associated with this delay included self-identification as Black, longer distance from site, and lack of initial insurance coverage approval.

The role of chest X-rays when screening for latent tuberculosis infection in patients with inflammatory bowel disease before starting biologic treatment

Background Guidelines generally recommend a combination of immunological assays and chest X-ray imaging (CXR) when screening for latent tuberculosis infection (LTBI) prior to biologic treatment in inflammatory bowel disease (IBD). Objective To investigate whether CXR identify patients with suspected LTBI/TB who were not identified with QuantiFERON tests (QFT) when screening for LTBI/TB before starting biologic treatment in IBD patients. Methods Single-center, retrospective cohort study of patients with inflammatory bowel disease who had a QFT and a CXR prior to initiation of biologic treatment in a 5-year period (October 1st, 2017 to September 30th, 2022). Results 520 patients (56% female, mean age 40.1 years) were included. The majority had none or few risk factors for TB (as reflected by the demographic characteristics) but some risk factors for having false negative QFT results (concurrent glucocorticoid treatment and inflammatory activity). QFT results were positive in 8 patients (1.5%), inconclusive in 18 (3.5%) and negative in 494 (95.0%). Only 1 patient (0.19%) had CXR findings suspicious of LTBI. This patient also had a positive QFT and was subsequently diagnosed with active TB. All patients with negative or inconclusive QFT had CXR without any findings suggesting LTBI/TB. One patient developed active TB after having initiated biologic treatment in spite of having negative QFT and a normal CXR at screening. Conclusion In a population with low risk of TB, the benefits of supplementing the QFT with a CXR are limited and are unlikely to outweigh the cost in both patient test-burden, radioactive exposure, and economic resources.

Treatment Impact on the Long-Term Ocular Outcomes in Behçet’s-Related Uveitis

ABSTRACT Purpose To examine the demographic characteristics, findings and complication rates in patients with Behçet’s uveitis (BU) and to investigate the effect of early biological therapy on the development of complications. Methods Medical records of 94 patients with BU were retrospectively reviewed. Demographic data, ocular findings and complications at presentation, complications during follow-up, and treatments received during follow-up were analyzed. Patients who were followed for at least 24 months were divided into two groups according to the time of presentation as Group 1 (between 2009 and 2015) and Group 2 (between 2016 and 2021). Complications at the time of presentation and during follow-up, and treatments were compared. Results We enrolled 94 patients with a male-to-female ratio of 1.94 with a mean age of 30 ± 12 years. Median follow-up was 58.1(12–163) months. There were 35 patients (66 eyes) in Group 1 and 33 patients (61 eyes) in Group 2. At the time of presentation, end-stage disease, cataract, epiretinal membrane, and optic atrophy were significantly more common in Group 1 than in Group 2 (p < 0.05). A significantly higher proportion of eyes in Group 1 developed macular edema, cataract, epiretinal membrane, and macular atrophy during-follow-up (p < 0.05). Median time to initiation of biological treatment was 17.29 months in Group 1 and 3.33 months in Group 2 (p < 0.001). The overall complication rate was significantly lower in Group 2. Conclusions Prognosis of BU is improved after the introduction of biological treatment. Early use of biological agents in BU is effective in decreasing sight-threatening ocular complications.

Comparison of the Efficacy of Omalizumab and Mepolizumab in Non-Steroidal Anti-Inflammatory Drug-Exacerbated Respiratory Disease

Introduction: Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD) is heterogeneous in both phenotypes and endotypes. Due to insufficient head-to-head comparison studies, it is hard to decide which biological to initiate. This study aimed to compare the efficacy of omalizumab and mepolizumab which can be used in the treatment of patients with severe eosinophilic asthma diagnosed with N-ERD. Methods: The population of this observational, cross-sectional study comprised of N-ERD patients who received omalizumab or mepolizumab for at least 6 months for severe asthma. Outcomes included the asthma control test (ACT), and sino-nasal outcome test scores (SNOT-22), blood eosinophil counts at initiation of biological treatment (T0, baseline) and at the end of 6th months (T6). Adverse effects related to biological treatment and changes of oral corticosteroids dose was recorded. Results: The study included a total of 22 patients, of whom 11 received mepolizumab and 11 received omalizumab. The change in ACT, SNOT-22, eosinophil counts, and adverse effects related to biologicals were similar at T6 (p = 0.606, p = 0.168, p = 0.05, p = 0.053, respectively). However, when examining the SNOT-22 and ACT based on the cumulative distribution curve (SUCRA), mepolizumab (SUCRA value: 0.61, 0.72, respectively) demonstrated greater efficacy compared to omalizumab (SUCRA value: 0.19, 0.35, respectively). The oral corticosteroids discontinuation rate was similar between the two groups (p = 0.05). Conclusion: We found both omalizumab and mepolizumab to be effective in treatment; however, we determined that mepolizumab may have a potential superiority in efficacy.

Socioeconomic equality in initiation of biologic treatment in Danish patients with inflammatory bowel disease.

Low socioeconomic status is associated with disadvantages in health outcomes and delivery of medical care in patients with Inflammatory Bowel Disease (IBD). Inequality in the utilisation of biologic treatment is largely unexplored. To explore the potential association of socioeconomic status and time to first biologic treatment in apopulation-based IBD cohort. All 37,380 IBD incidences between 2000 and 2017 from the Danish National Patient Register were identified and linked to socioeconomic information including educational level, income and occupational status at diagnosis. Hazard ratios for receiving biologic treatment among socioeconomic groups were estimated using Cox proportional hazard regression. No difference in time between diagnosis and biologic treatment initiation was found comparing patients with upper secondary, vocational, or academic education to those with lower secondary education in patients with IBD. Patients with Crohn's disease in the two highest income quartiles received biologic treatment earlier (HR 1.16; 95% CI: 1.04; 1.30 & HR 1.15; 95% CI: 1.03; 1.30). An elevated treatment rate was found for persons with "other" occupational status (unspecified source of income) compared to employed persons in patients with ulcerative colitis (HR 1.36; 95% CI: 1.11; 1.66), but not in patients with Crohn's disease. This study revealed equal initiation of biologic treatment among patients with IBD across different educational background, income and occupational status. However, results are limited to asetting with free universal healthcare coverage and treatment needs should be considered and addressed in future research.

Quality of Life Improvements with Biologic Initiation Among Subspecialist-Treated US Patients with Severe Asthma.

Patients living with severe asthma (SA) experience multiple health-related quality of life (HRQoL) impairments. This study examined HRQoL changes after biologic treatment initiation among a large, real-world cohort of patients with SA. CHRONICLE is an ongoing observational study of subspecialist-treated adults with SA who receive biologics or maintenance systemic corticosteroids or are uncontrolled on high-dosage inhaled corticosteroids with additional controllers. Patients enrolled February 2018-February 2023 were asked to complete the St. George's Respiratory Questionnaire (SGRQ) every 6 months (total score range of 0-100 [0=best possible health], meaningful change threshold is a 4-unit reduction in the total score). Changes in SGRQ responses from 6 months before initiation to 12 to 18 months after initiation were summarized. A total of 76 patients completed the SGRQ 0 to 6 months before and 12 to 18 months after biologic initiation. The mean (SD) SGRQ total score decreased from 52.2 (20.6) to 41.9 (23.8), with improvement across the symptoms (-14.5), activity (-11.0), and impacts (-8.3) components. For specific impairments reported by ≥50% of patients before biologic initiation, fewer reported each impairment after biologic initiation; the largest reductions were for "Questions about what activities usually make you feel short of breath these days [Walking outside on level ground]" (67% to 43%), "Questions about other effects that your respiratory problems may have on you these days [I feel that I am not in control of my respiratory problems]" (55% to 34%), and "Questions about your cough and shortness of breath these days [My coughing or breathing disturbs my sleep]" (63% to 45%). In this real-world cohort of adults with SA, biologic initiation was associated with meaningful improvements in asthma-related HRQoL. These data provide further insight into the burden SA places on patients and the benefits of biologic treatment.

The need for surgery in pediatric patients with inflammatory bowel disease treated with biologicals

PurposeInflammatory bowel disease (IBD) in childhood often presents with a more extensive and more aggressive disease course than adult-onset disease. We aimed to evaluate if biological treatment started in childhood decreases the need for intestinal surgery over time.MethodsThis was a retrospective, single-center, cohort study. All pediatric patients with IBD initiated to biological therapy at the Children’s Hospital, were included in the study and followed up to the first surgical procedure or re-operation in their adulthood or until 31.12.2021 when ≥ 18 of age. Data were collected from the pediatric registry of IBD patients with biologicals and medical charts.ResultsA total of 207 pediatric IBD patients were identified [150 with Crohn´s disease (CD), 31 with ulcerative colitis (UC), 26 with IBD unclassified (IBDU)] of which 32.9% (n = 68; CD 49, UC 13, IBDU 6) underwent intestinal surgery. At the end of a median follow-up of 9.0 years (range 2.0-25.9), patients reached a median age of 21.4 years (range 18–36). Patients who had intestinal surgery in childhood were more likely to have IBD-related surgery also in early adulthood. The duration of the disease at induction of the first biological treatment emerged as the only risk factor, with a longer duration in the surgical group than in patients with no surgery.ConclusionDespite initiation of biological treatment, the risk of intestinal surgery remains high in pediatric IBD patients and often the need for surgery emerges after the transition to adult IBD clinics.

Baseline characterization of a cohort of colombian patients with chronic rhinosinusitis with nasal polyps

To present the baseline clinical and demographic characteristics of CRSwNP patients over the age of 18 enrolled in a Patient Support Program (PSP) prior to biologic treatment. Descriptive, cross-sectional study performed in a Colombian CRSwNP asthma PSP sponsored by Sanofi from Aug-2021 to Jul-2022. Data was collected from CRSwNP patients, prior to the start of Dupilumab treatment, who consented to the use of their data. The following information was reported: Age, reporting city, treating medical specialty, comorbidities, and persistence of treatment. 339 patients were included, 171 (50,4%) were women and 168 (49,6%) were men. The mean age at Dupilumab treatment initiation was 52,4 years. 62,8% began treatment during adulthood (26-59y), while 34.1% started at elderly (+60y) and 3.1% were young adults (18-25y). Most cases (29,7%) were included in Bogotá, followed by Antioquia (19%), Valle del Cauca (7,3%) and the remaining 44% nationwide. Comorbidities were present in 67,1% of the patients, with diagnosis of allergic rhinitis, atopic dermatitis, asthma, and other non-type 2 inflammatory diseases. Nasal surgical history was present in 89,6% of the patients, most of them with one to three previous surgeries. Continuous treatment was observed in 70,3% of patients for 6 to 12 months, in 21,3% for more than 12 months and in 8,4% for less than six months. The most frequently treating medical specialty was otorhinolaryngology (79,6%), followed by allergology (16%) and other medical professionals (4,4%). There is concordance with the literature on a higher presentation of the disease in women than in men. There is a large proportion of patients with nasal surgical history and type 2 inflammatory comorbidities by the moment of biologic treatment initiation. The care and identification of CRSwNP colombian patients is mainly provided by otorhinolaryngologists, followed by allergologists.

Beyond diagnosis: investigating hospital referral impact on biological treatment initiation, hospital admission, and surgery patterns in inflammatory bowel disease – a Danish population based study

Objectives Early biological treatment in patients with inflammatory bowel disease (IBD) is important in disease control. Previous studies have suggested that patients with IBD from Non-Academic Hospitals were less likely to receive biologics. The aims of this study were (1) to use the granular data in the clinical database, GASTROBIO, to study detailed differences in time from IBD diagnosis to first administration of biologics, hospital admission, and surgery in patients referred to Academic Hospitals versus to Non-Academic Hospitals, and (2) to explore differences in disease extent, behavior, and indication for biological treatment. Material and methods This was a retrospective cross-sectional descriptive population-based quality study of patients with IBD initiating biologics in the North Denmark Region between 2016 and 2018. Data from GASTROBIO were extracted, namely demographic data, time of diagnosis, biological treatments with indications, hospital admission, and surgery. Results Of the 146 patients included, 84 were from the Academic and 62 from the Non-Academic Hospitals. No significant differences in median time from diagnosis to (1) treatment, (2) hospital admission or (3) IBD surgery between the groups were observed. A higher percentage of patients with luminal Crohn’s disease were treated with biologics at the Academic Hospital (78% and 66%). Conclusions Based on the findings of this population-based study, we found no evidence that the referral area had a significant impact on the duration from diagnosis to the initiation of biological treatment, hospital admissions, or surgery. However, the data suggested that fewer patients with luminal Crohn’s disease were referred to biologics from Non-Academic Hospitals.

P297 Differences in disease characteristics and treatment exposures between pediatric- and adult-onset Ulcerative Colitis

Abstract Background previous studies highlighted differences between pediatric-onset ulcerative colitis (pUC) and adult-onset UC (aUC), showing a more severe phenotype in pUC. However, most studies lacked prolonged follow-up, and some were conducted prior to the biologic era. We utilized a large cohort database to compare disease characteristics and treatment exposures between pUC and aUC. Methods Single-center IBD registry from the Sheba Medical Center was used and included aUC (age ≥ 18 years) and pUC (age ≥ 6 and &amp;lt; 18 years) patients diagnosed between 2000 and 2022. Data were retrieved from the medical record to a computerized and periodically updating registry in a unified manner. Retrieved data included demographics, clinical disease characteristics and phenotype, and prescribed treatments during routine clinical follow-up. We used descriptive statistics, T-test, and chi-square test for between-group analyses. Results This study included 1332 UC patients, of them 682 were females (51.2%, Table 1). The cohort comprised 1058 aUC and 274 pUC patients. The median (IQR) age at diagnosis for pUC was 14.9 (12.5-16.8) years and 31.7 (23.6-48.9) years for aUC. Disease duration and the interval from diagnosis to last follow-up were similar between pUC and aUC, with a median (IQR) disease duration of 8.9 years (4.6-14.2) in pUC and 8.5 (4.5-14.1) in aUC, and a median interval from diagnosis to last follow-up of 7.3 years (3.5-12.3) in pUC and 7.3 years (3.4-13.0) in aUC. Significantly more pUC presented with pancolitis: 59.1% vs. 39.4% in aUC (p&amp;lt;0.00001), (Table 1). During long-term follow-up, treatment exposures also varied significantly between pUC and aUC (Figure 1); 61.3% of pUC were treated with systemic steroids vs. only 42.4% in the aUC group. Thiopurines were used in 40.5% of pUC vs. only 16.7% of aUC, and biological therapy was used in 46.0% of pUC vs. 34.1% of aUC. Time to initiation of biologic treatment was shorter in pUC with a median (IQR) of 33.0 months (15.0-71.3) vs. 36.6 months (15.8-96.1) in aUC (p=0.04). Finally, the number of biologics lines used was also higher in pUC vs. aUC ((mean of 2.1±1.4 vs. 1.8±1.0, p=0.01). Limiting the comparison to only UC patients who presented with pancolitis included 163 pUC and 417 aUC. Within this more severe UC phenotype, exposure to steroids and thiopurines was still significantly higher in pUC vs. pUC, but exposure to a biologic was similar with 54.6% of pUC vs. 50.1% of aUC. Conclusion pUC presents with more pancolitis, considered a more severe form of UC. This more aggressive presentation at diagnosis likely leads to a higher rate of exposure to systemic steroids, thiopurines, and biologics during a median of ~7 years of follow-up.

P775 Disease activity and treatment patterns of newly diagnosed adult patients with Crohn's disease in Japan: Interim analysis of inception cohort registry study of patients with Crohn's disease (iCREST-CD)

Abstract Background Biologics are commonly used for the treatment of Crohn’s disase (CD); however, the proportion of biologics used and their initiation time from diagnosis differs widely between different regions. There is limited information about the patient characteristics and the treatment persistence of each initial biologics, and the treatment persistence of top-down and step-up therapy. iCREST-CD is a prospective, non-interventional, longitudinal, observational registry study conducted at 19 tertiary centres to understand the characteristics of CD treatments in actual clinical settings in Japan. We conducted an interim analysis (cutoff date: 30 June 2022) of iCREST-CD to mainly evaluate the indication and outcomes of initial biologic therapy. Methods Patients newly diagnosed with CD after June 2016 based on the diagnostic criteria of the Japanese Guidelines, aged ≥16 years at the time of informed consent with no prior exposure to biologics were enrolled. Patient demographics, clinical data, disease activity and medical treatment were recorded. Biologic use without prior steroid use was defined as top-down and biologic use with prior steroid use was defined as step-up. Results A total of 672 eligible patients (68.2% male) with mean age (±SD) of 29.4 (13.1) years were analysed. Cumulative proportion of patients prescribed 5-aminosalicylic acid, steroids, immunomodulators, and biologics at 6- and 12-months from diagnosis were 71.3%, 40.6%, 31.4%, and 47.5%; and 75.0%, 43.6%, 36.0%, and 59.7%, respectively (Figure 1). A total of 498 patients received biological therapy—infliximab (IFX; 121 [24.3%]), adalimumab (ADA; 244 [49.0%]), ustekinumab (UST; 107 [21.5%]), and vedolizumab (VDZ; 26 [5.2%]). The mean age (±SD) at the initiation of biologic treatment was IFX: 28.2 (11.3), ADA: 26.6 (10.8), UST: 30.4 (14.1), and VDZ: 36.2 (17.4), and the mean (±SD) levels of C-reactive protein (CRP) (mg/L) was IFX: 25.9 (26.8), ADA: 18.9 (26.0), UST: 13.5 (17.9), and VDZ: 9.5 (19.0) (Table.1). The initial biologic treatment persistence rates of IFX, ADA, UST and VDZ at 36-months were 77.5%, 75.8%, 79.8%, and 49.0%, respectively (Figure 2). Patients receiving top-down and step-up therapy were 284 (57.0%) and 214 (43.0%), respectively. The treatment persistence rate of initial biologics by top-down and step-up therapy at 36-months from diagnosis was 81.6% and 66.9%, respectively (P=0.001) (Figure 3). Conclusion This registry study that demonstrated the treatment persistence rate of initial biologic therapy was significantly higher in the top-down than the step-up approach.

P581 Early biological therapy within the first 12 months after diagnosis leads to higher clinical, endoscopic, and transmural remission in Crohn’s disease: European multicentre study with a propensity-score matched analysis

Abstract Background Transmural healing (TH) is emerging as a potential treatment target for Crohn′s Disease (CD). While post-hoc analyses of RCTs and observational studies have shown that early introduction of biological therapy leads to higher rates of clinical (CR) and endoscopic remission (ER), no data is available for TH. Our goal was to assess the impact of early biologic introduction (defined as &amp;lt;12 months since diagnosis) in CR, ER, and TH rates. Methods Multicentre retrospective study including 5 European centres. Patients with CD with a baseline (±3 months) either computed tomography enterography (CTE) or magnetic resonance enterography (MRE) with signs of active disease before starting biologics were included. We assessed CR (PRO2&amp;lt;8), ER (SES-CD&amp;lt;3 and no ulcers), and TH (complete normalization of MRE) at 12±3 months following the introduction of biologics. All radiological examinations were read locally after a consensus meeting to list and define clinically relevant lesions and outcomes. Multivariate logistic regression with propensity-score matching also adjusted for previous biologic use was conducted (propensity-score covariates: gender, age at diagnosis, disease location, disease behavior, perianal disease, extra-intestinal manifestations, smoking history, and previous surgery). Results We included 168 patients (51% females), with a median age at diagnosis of 25 years old (IQR 19-34). Median follow-up time after treatment initiation was 73 (IQR 42-98) months and median disease duration was 120 (IQR 76-237) months. Most patients (93%) had ileal involvement (L1 or L3) and an inflammatory phenotype (50%). Overall, 79% were bio naïve and of those 46% were started on early biological treatment. Most patients were started on anti-TNF (89%), 10% on ustekinumab, and 1% on vedolizumab; 58% were on combination therapy (table 1). CR was achieved in 76% (119/157), ER in 52% (64/124), and TH in 32% (30/95). In the multivariate logistic regression model, early initiation of biological treatment was significantly associated with increased probability of achieving CR (OR 4.3, 95%CI 1.6-11.5, p=0.003), ER (OR 2.9, 95%CI 1.2-7.1, p=0.02) and TH (OR 2.7, 95%CI 1.002-7.1, p=0.049). The presence of a stricture in endoscopy was a negative independent factor to predict ER (table 2) and the presence of a stricture and extensive disease in cross-sectional imaging were negative independent factors to predict TH (table 3). Conclusion Introducing biological treatment within the first 12 months after diagnosis was associated with an increased probability of achieving CR, ER, and TH. The presence of a stricture both in endoscopy and in cross-sectional imaging and the radiological extension of the disease may limit the achievement of ER and TH, respectively.

Cost of Illness, Quality of Life, and Work Productivity in Axial Spondyloarthritis Patients Receiving Biological Treatments in Greece.

To estimate the cost of illness, quality of life and work productivity in patients with Axial Spondyloarthritis (Axial SpA) under biological treatment in Greece. We conducted a prospective study of 12-month duration, of patients with Axial SpA from a tertiary hospital in Greece. Adult patients fulfilling the Assessment of SpondyloArthritis international Society (ASAS) criteria were enrolled at the beginning of biological treatment due to active disease [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4] and failure of first line treatment. All participants completed questionnaires about quality of life, financial costs and work productivity at the same time with the disease activity assessment. 74 patients of whom 57 (77%) with a paid job, were included in the study. The total annual cost for Axial SpA patients is € 9,012.40 while the average cost of acquisition and administration of the drugs is € 8,364. The mean BASDAI in the 52 weeks of follow-up, was decreased from 5.74 to 3.2 and the mean Health Assessment Questionnaire (HAQ) also from 1.13 to 0.75. Work productivity of these patients as measured with the Work Productivity and Activity Impairment Questionnaire (WPAI), was significantly impaired at the baseline and improved after the initiation of biological treatment. The cost of illness in patients receiving biological treatments in Greece is high. However, these treatments except from the well-established positive effect on disease activity, can improve remarkably the work productivity and quality of life of Axial SpA patients.

HSD66 The Association Between Patients’ Socio-Demographic Characteristics and Biologic Treatment Initiation: Real-World Evidence From a 14-Year Cohort of Ulcerative Colitis Patients in Israel

HSD66 The Association Between Patients’ Socio-Demographic Characteristics and Biologic Treatment Initiation: Real-World Evidence From a 14-Year Cohort of Ulcerative Colitis Patients in Israel

CLINICAL OUTCOMES IN PATIENTS WITH SEVERE ASTHMA WHO HAD OR HAD NOT INITIATED BIOLOGIC THERAPY: RESULTS FROM THE CLEAR STUDY

CLINICAL OUTCOMES IN PATIENTS WITH SEVERE ASTHMA WHO HAD OR HAD NOT INITIATED BIOLOGIC THERAPY: RESULTS FROM THE CLEAR STUDY

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

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

Prevalence of antinuclear antibodies in inflammatory bowel disease and seroconversion after biological therapy.

Background:Estimates of detectable antinuclear antibodies (ANA) prevalence vary widely, from 6% in healthy populations to 50–80% in patients with autoimmune disease. However, there is a lack of evidence about the overall prevalence in inflammatory bowel disease (IBD) and ANA seroconversion after the beginning of biological therapy.Objectives:The aim of the study was to investigate the overall prevalence of ANA in IBD patients, their relationship with different treatments, clinical outcomes and the seroconversion rate of ANA in patients treated with biological therapy.Methods:Ambispective observational study including all consecutive IBD patients was carried out. Information about the presence of ANA, disease phenotype, duration, activity, complications, and past and current treatments were transversally collected. Retrospectively, in patients with detectable ANA, data regarding previous ANA detection and the diagnosis of lupus-like syndrome (LLS) was gathered.Results:A total of 879 IBD patients were included. We observed a detectable ANA prevalence of 13.6%. The presence of ANA was frequently associated with biological therapy (36/118) and decreased when immunomodulators were combined to this therapy (7/32). Of 78 patients with ANA prior to the beginning of biological therapy, a seroconversion rate of 28.8% was observed after a mean of 3.14 years. Only 1 patient suffered LLS.Conclusion:Our study showed a prevalence of detectable ANA higher than the expected in healthy population. The presence of ANA was lower when immunomodulator therapy is associated. The ANA seroconversion rate is relevant after the initiation of biological treatment nevertheless, the risk of LLS appeared to be marginal.

Expert Opinion on Biological Treatment of Chronic Rhinosinusitis with Nasal Polyps in the Gulf Region.

Chronic rhinosinusitis (CRS) is defined as the inflammation of nose and paranasal sinuses, affecting the patients’ quality of life and productivity. Chronic rhinosinusitis with nasal polyps (CRSwNP) is a principal clinical entity confirmed by the existence of chronic sinonasal inflammation and is characterized by anterior or posterior rhinorrhea, nasal congestion, hyposmia and/or facial pressure or facial pain. Several epidemiologic studies have revealed wide variations in the incidence of CRS among regions globally ranging from 4.6% to 12%. The Gulf countries are also witnessing an unprecedented burden of CRSwNP. According to the current clinical guidelines, glucocorticosteroids and antibiotics are the principal pharmacotherapeutic approaches. Endoscopic sinus surgery is recommended for those who have failed maximal pharmacotherapy. Recently, biologics are considered as an alternative best approach due to the complications associated with medical therapy and surgery. However, precise data on the clinical position of biologic agents in the management of CRSwNP in the Gulf region is not available. The present review article addresses the current diagnostic and management approaches for CRSwNP and also emphasizes the role of emerging biologics in the current treatment strategies for CRSwNP in the Gulf region. Further, a consensus protocol was convened to rationalize the guideline recommendations, strategize the best practices with biologics, and develop clinical practice guidelines for all primary-care specialists in the Gulf region. The consensus-based report will be a useful reference tool for primary-care physicians in primary-healthcare settings, regarding the appropriate time for the initiation of biological treatment in the Gulf region.