Objective Measures Of Disease Activity Research Articles

B-051 Clinical Validation of Vectra® DA: A Multi-Biomarker Based Test for the Objective Measurement of Disease Activity in Patients with Rheumatoid Arthritis

Abstract Background The Vectra® DA test measures serum levels of 12 protein biomarkers associated with rheumatoid arthritis (RA) and uses these levels in an algorithmic calculation to generate a numeric score that represents RA disease activity where established categories are low for scores 1 to 29, moderate for 30 to 44, and high for 45 to 100. LabCorp Specialty Lab in Calabasas, CA completed the quantitative analytical validations of 12 Vectra biomarkers (SAA, CRP, VCAM-1, IL-6, TNF-RI, EGF, VEGF-A, Leptin, Resistin, MMP-1, MMP-3, and YKL-40) and the clinical verification of the Vectra score algorithm. Methods The Vectra test consists of the quantitative measurements of EGF, Leptin, MMP-1, TNF-R1, VEGF, MMP-3, Resistin, VCAM, YKL-40, CRP, SAA and IL-6 using multiplex immunoassay platforms. The data acquired from each biomarker assay is processed through an algorithm where a composite Vectra score adjusted based on age, gender, and adiposity of the patient is computed. Analytical parameters validated for each biomarkers include sensitivity, precision, accuracy, specificity and stability. Precision was validated using pooled human serum controls at low, moderate, and high Vectra score levels. Method comparison was performed using 584 clinically defined serum samples. Quantitatively measured analyte values and computed Vectra scores by the Labcorp Vectra assay were compared with Vectra data produced by Myriad laboratory. Results Intra- and inter-assay sample precision of the final Vectra score was <13% and <18%, respectively. Sample stability using freshly collected serum subject to ambient and refrigerated temperature up to 14 days and frozen up to 364 days and up to 6 freeze-thaw cycles were acceptable. Of 584 clinical Vectra data compared, Labcorp vs Myriad, 96% of data were comparable within the acceptable criteria. Correlation of Vectra score from Labcorp and Myriad was excellent. A linear least square model resulted in a correlation coefficient (R) of 0.981 and a Deming slope of 1.009. Qualitative method comparison of Vectra scores resulted in excellent agreement of risk of radiographic progression and rheumatoid arthritis disease activity. A 91% agreement of risk category match between Labcorp and Myriad and 100% agreement of Vectra scores within 1 risk category was achieved. Conclusions We validated the Vectra® DA multiplex assay for measuring serum levels of 12 protein biomarkers associated with RA. Vectra combines biomarker levels into a personalized disease score that represents a patient’s RA inflammation and predict their risk of radiographic progression. High Vectra® DA scores (> 44) have been associated with a 20% 1-year risk of radiographic progression while low scores (< 30) carry only a 1% risk. Thus, the Vectra score provides an objective measurement of RA disease activity that can be used in combination with existing assessment tools to aid physicians to manage patients with RA.

Quantitative Magnetic Resonance Imaging (qMRI) of the Small Bowel in Crohn's Disease: State-of-the-Art and Future Directions.

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract in which repeated episodes of acute inflammation may lead to long-term bowel damage. Cross-sectional imaging is used in conjunction with endoscopy to diagnose and monitor disease and detect complications. Magnetic resonance imaging (MRI) has demonstrable utility in evaluating inflammatory activity. However, subjective interpretation of conventional MR sequences is limited in its ability to fully phenotype the underlying histopathological processes in chronic disease. In particular, conventional MRI can be confounded by the presence of mural fibrosis and muscle hypertrophy, which can mask or sometimes mimic inflammation. Quantitative MRI (qMRI) methods provide a means to better differentiate mural inflammation from fibrosis and improve quantification of these processes. qMRI may also provide more objective measures of disease activity and enable better tailoring of treatment. Here, we review quantitative MRI methods for imaging the small bowel in CD and consider the path to their clinical translation. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: Stage 2.

Skin Homeostasis is Impaired in Hidradenitis Suppurativa Lesions: A Comparative Study

IntroductionHidradenitis suppurativa (HS) is a chronic skin disease whose impact on skin homeostasis has not been adequately studied at present. Knowledge about how skin function changes in these patients, and could be of interest not only to improve the topical management of the disease, but also as an objective measure of disease activity. The aim of this study was to compare skin homeostasis and the epidermal barrier function in lesional and healthy skin areas of patients with HS. MethodsWe conducted a cross-sectional study. Skin homeostasis and the epidermal barrier function of lesions were assessed in HS patients using validated tools. A healthy perilesional skin control was assigned to each lesion to compare skin homeostasis parameters. ResultsA total of 43 patients were included: 22 nodules, 10 abscesses and 25 draining tunnels were measured. The male-to-female ratio was 20:23, and the mean age, 35.95 years (SD, 14.82). Increased transepidermal water loss (TEWL) and erythema were found in nodules, abscesses and draining tunnel vs healthy skin. A direct association was observed between inflammatory nodules TEWL and IHS4 stage. In draining tunnels, a direct association was observed between TEWL and smoking. A trend of increasing TEWL values was observed as a function of Hurley stage. ConclusionHS lesions exhibit epidermal barrier dysfunction that depends on the severity of inflammatory activity. These results could be useful to develop objective classification systems for the severity and degree of involvement of HS or help in the development of vehicles for specific drugs, antiseptics and dressings for the management of this disease.

Food-Related Quality of Life and Its Predictors in Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) is associated with dietary restrictions and food- and drink-driven daily life limitations. Food-related quality of life (FR-QoL) is still an under-addressed issue in IBD. We aimed to study determinants of FR-QoL in an IBD cohort, namely objective measures of disease activity. A cross-sectional case-control study was conducted in a Tertiary Hospital, including adult patients with IBD (cases) and blood donors or subjects referred for colorectal polypectomies (controls). Participants answered an anonymous multimodal questionnaire including sociodemographic and clinical data, the validated FR-QoL-29, and the SIBDQ tools. Patients' disease activity was previously assessed by a physician using symptom-based scores and biomarkers (Harvey-Bradshaw index, partial Mayo score, fecal calprotectin). A total of 239 patients with IBD and 126 controls were included. Patients with active disease had poorer FR-QoL than patients in remission (80.0 [56.0-99.0] vs. 103.5 [81.0-129.9], p < 0.001). Still, patients with IBD had significantly lower FR-QoL compared with controls (99.0 [76.0-126.0] vs. 126.0 [102.8-143.0], p < 0.001), irrespective of disease activity. FR-QoL correlated with health-related quality of life, measured by SIBDQ (r = 0.490, p < 0.001), and was significantly impaired by patients' depressive humor (84.0 [61.0-112.0] vs. 108.0 [88.0-130.5], p < 0.001). Globally, FR-QoL compromise was mostly related to persistent worries about food, concerns about food-related symptoms, and life disruption due to eating and drinking. Patients with IBD showed significant FR-QoL impairment, irrespective of disease type and activity. Related psychosocial factors, such as the patient's affective status and fear around eating, warrant a need for a multidisciplinary approach to IBD, including tailored nutritional counseling.

Safety and Efficacy of Various Doses of Tofacitinib among Patients with Active Seronegative Spondyloarthritides – A Retrospective Observational Study

Introduction: Seronegative spondyloarthritides (SpA) are a family of various joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Treatment goals for SpA are reducing symptoms, decreasing complications associated with the disease, and reducing functional limitations. Aim of the study: The purpose of this study is to find efficacy and safety of various doses of Tofacitinib, an oral Janus kinase inhibitor, compared with placebo in different stages of the treatment in patients with active Seronegative Spondyloarthritides. Methods: This retrospective observational study was carried out in the Popular Medical College Hospital, Bangladesh. Total 203 subjects of both sexes, aged more than 18 years were selected during the period of May 2023 to November 2023. In this 6 months study duration, patients received 16 weeks treatment (12-week treatment, 4-week washout) and were under follow up session for 8 weeks. Study patients with active SpA phase II were grouped to receive (N=25, 25, 25, 25, respectively) placebo or Jakloc (Tofacitinib) 5 mg and Jakloc (Tofacitinib) XR 11 mg manufactured by Popular Phermaceuticals PLC and Tofacitinib 2 mg or 10 mg (manufactured by other phermaceuticals) twice daily. Jakloc (Tofacitinib) XR 11 mg was used for adult patients with inadequate response or intolerance to methotrexate (3 patients). The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine after follow up session for 8 weeks. Safety was monitored. Result: The Emax model analysis of the primary endpoint predicted a Jakloc (Tofacitinib) 10 mg twice daily ASAS20 response rate of 67.4%, which ........

OA16 Identification of surrogate serum proteomic biomarkers associated with ultrasound power Doppler in psoriatic arthritis

Abstract Background/Aims An area of key unmet need in psoriatic arthritis (PsA) is the identification of biomarker(s) which predict those likely to respond to a specific therapy; in order to achieve that, an objective measure of disease activity would be ideal. Ultrasound power Doppler (PD) is a semi-quantitative measure of inflammation. However, ultrasound is time-consuming and requires specific expertise, whereas a blood-based surrogate biomarker of PD would be easier to apply clinically, and could serve as an objective outcome measure of response. Our aim is to identify proteomic biomarkers associated with PD in PsA patients. Methods Twenty-six patients with PsA (fulfilling CASPAR criteria) were recruited prospectively. All underwent 66-joint ultrasound examination and presence of PD was recorded. There were 7 patients without PD(-) and 19 with PD(+) detectable in at least 1 joint. Proteomics data for 1,073 proteins were generated using sequential window acquisition of all theoretical fragment ion spectra mass spectrometry (SWATH MS). Proteins with high levels of missing data were filtered (&amp;gt;30%) followed by random forest analysis. Differentially expressed proteins (DEPs) based on PD status were identified. Protein-protein interaction network analysis was performed using the search tool for retrieval of interacting genes (STRING), Kyoto Encyclopedia of Genes and Genomes (KEGG) and gene ontology (GO). Results Following pre-processing, 553 proteins were available for analysis. Seventeen DEPs were identified (p-values &amp;lt;0.05) (Table 1). Among these, ERAP2, an enzyme involved in MHC-I ligand processing and a known risk factor for inflammatory diseases, had the largest fold change (-0.64 95%CI -1.20 to -0.07, p = 0.03). Network analysis revealed that the 17 DEPs were significantly enriched (p &amp;lt; 0.001) in the PD+ group. KEGG pathway analysis identified the association of the DEPs in leukocyte transendothelial migration (strength 1.5 FDR=0.04). GO analysis of the DEPs revealed involvement in immunoglobulin receptor binding (strength 2.28 FDR=0.03). Conclusion We identified several potential serum proteomic biomarkers correlated with disease activity, as assessed by the presence of PD, in PsA; these provide insights into the biological mechanisms underlying synovitis in PsA. Validation in a larger cohort and functional studies are required to determine the role of these proteins in mediating inflammation in PsA. Disclosure R.M. Hum: None. N. Nair: None. S.F. Ling: None. A. Barton: None. P. Ho: None. D. Plant: None.

P548 Efficacy outcomes of placebo maintenance treatment in patients with moderate to severe Crohn’s disease who responded to placebo induction therapy: Post-hoc analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Risankizumab Studies

Abstract Background In the risankizumab (RZB) phase 3 clinical programme, Crohn’s disease (CD) patients who responded to RZB intravenous (IV) induction were re-randomised to RZB or placebo (PBO) (withdrawal PBO subcutaneous [SC] in maintenance (FORTIFY), while responders to PBO induction continued receiving PBO. Patients in the withdrawal (PBO SC) arm of FORTIFY who received IV RZB induction achieved high rates of clinical response/remission at Week (Wk) 52 likely due to the prolonged PK/PD effect of RZB and robust efficacy during induction.1 Here, we describe disease activity outcomes in non-randomised patients who received PBO during both induction and maintenance. Methods: This post-hoc analysis included patients who received PBO IV in the induction study (ADVANCE or MOTIVATE), achieved clinical response (definition in Figure footnote) at Wk 12, and continued on PBO SC during FORTIFY.1,2 Subjective measures of disease activity (clinical remission [per CD Activity Index (CDAI)] and per stool frequency [SF] and abdominal pain score [APS], CDAI clinical response, and SF/APS enhanced clinical response), as well as objective measures of biomarkers (high sensitivity C-Reactive Protein and faecal calprotectin) levels and endoscopic outcomes (response, remission, and ulcer-free endoscopy), during FORTIFY were evaluated (endpoint definitions in Figure footnotes) at Wk 52. Biomarkers were additionally evaluated at induction baseline. For reference only, previously reported data from patients who were clinical responders to RZB IV induction and were re-randomised in FORTIFY are presented alongside data from the continuous PBO patients subgroup.1,2 Results In the 104 patients who received PBO during both induction and maintenance, clinical response and remission rates decreased steadily during FORTIFY (Figure), while biomarker levels were relatively unchanged from induction baseline to FORTIFY Wk 52. In contrast, a slower rate of loss of response per clinical response/remission and lower biomarker levels over time were observed in RZB IV induction responders re-randomised to PBO in FORTIFY. Although already low, endoscopic response rates in the continuous PBO group decreased from FORTIFY Wk 0 to Wk 52, whereas endoscopic remission and ulcer-free endoscopy rates remained unchanged. Conclusion The symptomatic improvement achieved in patients clinically responding to PBO during induction was not maintained with continued PBO treatment in maintenance, unlike that observed in patients withdrawn from RZB, underscoring the durability of RZB induction response.1 Most objective measures of disease activity in patients receiving continuous PBO were relatively unchanged over time, with biomarkers remaining elevated and endoscopic rates of response low.

Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry

ObjectiveSuccessful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA),...

The Impact of Disease Activity on Sexual and Erectile Dysfunction in Patients With Inflammatory Bowel Disease.

Increased disease activity may be a risk factor for sexual dysfunction (SD) in patients with inflammatory bowel disease (IBD). This study investigated associations between objective measures of disease activity and sexual function. Adults with IBD undergoing ileocolonoscopy were prospectively recruited. Demographic, sexual function (Female Sexual Function Index and International Index of Erectile Function), disease activity (endoscopic, biomarker, and symptoms), psychological symptoms, and quality-of-life data were collected. Rates of SD and erectile dysfunction (ED) were compared between patients with active and inactive inflammation and symptoms using the Fisher's exact test. Logistic regression examined associations between SD and ED, and disease characteristics and psychological symptoms. A total of 159 participants were included, 97 had Crohn's disease and 85 were women. SD was reported in 36 of 59 and 13 of 59 sexually active women and men, respectively and ED in 22 of 59 sexually active men. Rates of SD and ED were similar between individuals with active and inactive IBD based on endoscopic indices (P > .05) and biomarkers (P > .05). Women with active IBD symptoms experienced significantly higher rates of SD (P < .05), but men did not (P > .05). Multivariable logistic regression identified that symptoms of severe depression (odds ratio, 5.77; 95% confidence interval, 1.59-20.94) were associated with SD in women, and severe anxiety (odds ratio, 15.62; 95% confidence interval, 1.74-140.23) was associated with ED in men. Objective measures of disease activity are not associated with SD or ED in patients with IBD. Clinicians should consider concomitant psychological symptoms contributing to the sexual health of patients with IBD.

P187 Major Depression in patients with Ulcerative Colitis and its relationship with clinical activity

Abstract Background In the last decade, there has been an increase in manuscripts published around the world related to psychological aspects in patients with IBD, suggesting a relationship between depression and IBD. Depressive symptoms seem to be able to aggravate ulcerative colitis (UC)¹, however there is a need for a clearer characterization of the sample and disease activity²,³. The aim of the study is to estimate the prevalence of major depression (MD) in patients with UC and to evaluate its relationship with the clinical activity and other diseases characteristics. Methods From October 2020 to May 2021, 299 patients with UC were evaluated using the Patient Health Questionnaire-9 (PHQ-9) scale, where absent depressive symptoms range from 0–4 points, mild depressive symptoms 5–9, moderate depressive symptoms 10–14, moderately-severe depressive symptoms 15–20, severe depressive symptoms greater than 20. MD was defined by PHQ-9 ≥10. Data were prospective analyzed,regarding socio-demographic characteristics, surgeries, current treatment; clinical activity and extent of disease were assessed by montreal classification. The association of characteristics with the MD risk was verified using chi-square tests or Fisher’s exact tests or likelihood ratio, and quantitative characteristics were compared according to MD risk categories using Student’s t-tests or Mann-Whitney tests. All statistical tests were performed with a 5% significance level. Results The prevalence of MD in UC patients was 35.8%. The main socio-demographic characteristics and MD risk are described in Figure 1. Figure 2 shows that, separately, sex, disease activity, hemoglobin and hematocrit statistically influenced the risk of MD (p &amp;lt; 0.05). There was no association between disease extension, surgeries performed along the disease course or current drug treatment with MD (p &amp;gt; 0.05). Together, gender influenced the MD risk in UC patients, regardless of the other characteristics evaluated, with female patients having a 2.63 times the chance of MD than male patients (Odds Ratio [OR] 2.63. 95% confidence interval [CI] 1, 41–4.89; p 0.002). Conclusion Our study confirms the high risk of MD among UC patients and is significantly related to the disease clinical activity. Psychological assessment of UC patients, in addition to objective measures of disease activity as an integral part of IBD care, is necessary, aiming to help improve the quality of life and maintain remission.

The influence of disease activity on fatigue in patients with ulcerative colitis – a longitudinal study

Objective The relationship between the disease activity of ulcerative colitis and fatigue is unclear. We investigated how reaching deep remission versus remaining in active disease influenced the severity of fatigue. Materials and methods We included 149 consecutive patients in a longitudinal study. Patients were re-examined after 3 months of conventional treatment and dichotomized into A: Active disease or B: Deep remission. The Partial Mayo Score (PMS) was recorded in all patients. Fatigue was rated using the fatigue visual analog scale (fVAS), Fatigue Severity Scale (FSS), and Short Form-36 Vitality Subscale (SF-36vs). A control group of 22 age and sex-matched healthy subjects were included as controls for patients reaching deep remission. Results After 3 months there were no significant differences in fVAS, FSS and SF-36vs scores in patients with active disease compared to patients reaching deep remission, when adjusting for baseline fatigue scores. Patients in remission based on MES-UC scores had no significant reduction in fatigue scores, whereas patients in remission based on PMS had all three fatigue scores reduced. However, patients reaching deep remission still had higher fVAS and lower SF-36vs scores compared to healthy control subjects. Conclusions After 3 months of conventional treatment there were no differences in fatigue severity in patients reaching deep remission compared with patients still having active disease. Fatigue was more pronounced in patients in deep remission than in healthy subjects, and was associated with subjective and not objective measures of disease activity. This indicates that other potent factors than inflammation influence fatigue in UC.

Is There a Correlation Between Patient-Reported Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score and MRI Findings in Axial Spondyloarthropathy in Routine Clinical Practice?

BackgroundThe Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is the patient-reported outcome (PRO) that is routinely used in clinical practice to monitor and measure disease activity in axial spondyloarthropathy (axSpA). BASDAI scores greater than four are thought to indicate active disease and require better control. Magnetic resonance imaging (MRI) is the most objective measure of disease activity in axSpA with its ability to pick up active inflammation both in the spine and sacroiliac joints. Previous studies have shown conflicting correlations between BASDAI and MRI, and therefore, there is the question of whether BASDAI is the best tool to monitor disease activity when it is subjective and potentially influenced by other patient factors. We, therefore, conducted a retrospective study to investigate the correlation between BASDAI and MRI in axSpA patients.MethodologyData were collected by retrospective analysis of axSpA patients attending University of Leicester (UHL) axSpA services. BASDAI scores were done within a year and closest to the time of MRI spine + sacroiliac joints were collected. The results prior to the initiation of biologic therapy were used. Data of one hundred and forty-nine patients were collected on their MRI results and BASDAI scores. Data were analysed using Statistical Package for the Social Sciences (SPSS) software and Pearson’s chi-squared applied to assess the correlation between BASDAI and MRI findings.ResultsOut of one hundred and forty-nine patients, 61.7% had active sacroiliitis on their MRI, 57.7% had chronic sacroiliitis, 53% had active spinal inflammation, and 17.4% had other MRI findings of active disease. There was a significant correlation between active sacroiliitis and BASDAI (p=0.014), but similar results were not found with other radiological features. A significant correlation was also found with males having higher BASDAI scores compared to females (p=0.027).ConclusionThis study demonstrates a statistically significant correlation between BASDAI and active sacroiliitis with those having higher scores more likely to have active disease on their MRI.

Sex Impacts Disease Activity But Not Symptoms or Quality of Life in Adults With Eosinophilic Esophagitis

Eosinophilic esophagitis has a strong male predominance that appears at least partially due to genetic susceptibility. However, data regarding sex-related differences in patients with EoE are scarce. We analyzed prospectively collected data from adults enrolled into the Swiss Eosinophilic Esophagitis Cohort Study. Patients with and without dilation in the past 12 months completed patient-reported Eosinophilic Esophagitis Activity Index (EEsAI) and EoE-specific quality of life in adults (EoE-QoL-A) and underwent endoscopy with biopsies. We used linear regression with EEsAI or EoE-QoL-A as the outcome, eosinophils per high power field, rings and strictures, current therapy use, and disease duration as predictors. A total of 266 patients (77% male, median age at diagnosis 35.8 years, median disease duration 10.4 years) were seen during 408 visits. Men had a longer diagnostic delay (62 months vs 36 months; P= .022), higher endoscopic disease activity (median endoscopic reference score 3.0 [interquartile range, 1.0-6.0] vs 2.0 [interquartile range, 0.0-4.0]; P= .010), more microabscesses (25% vs 13%; P= .025), and more often fibrosis of the lamina propria (mild/moderate 74.7% vs 61.5%, severe 9.1% vs 5.8%; P= .047) than women. When adjusting for objective measures of disease activity, disease duration, and current therapy use, we did not observe differences in EEsAI or EoE-QoL-A between women and men. Male EoE patients had higher endoscopic and histologic disease activity than female patients. When adjusting for biologic activity and therapy use, we did not identify differences in symptom severity or EoE-QoL between male and female eosinophilic esophagitis patients.

Advancing Mechanistic Understanding and Biomarker Development in Amyotrophic Lateral Sclerosis

Introduction Proteomic analysis has contributed significantly to the study of the neurodegenerative disease amyotrophic lateral sclerosis (ALS). It has helped to define the pathological change common to nearly all cases, namely intracellular aggregates of phosphorylated TDP-43, shifting the focus of pathogenesis in ALS towards RNA biology. Proteomics has also uniquely underpinned the delineation of disease mechanisms in model systems and has been central to recent advances in human ALS biomarker development. Areas covered The contribution of proteomics to understanding the cellular pathological changes, disease mechanisms and biomarker development in ALS are covered. Expert opinion Proteomics has delivered unique insights into the pathogenesis of ALS and advanced the goal of objective measurements of disease activity to improve therapeutic trials. Further developments in sensitivity and quantification are expected, with application to the presymptomatic phase of human disease offering the hope of prevention strategies.

The impact of disease activity on psychological symptoms and quality of life in patients with inflammatory bowel disease-results from the Stress, Anxiety and Depression with Disease Activity (SADD) Study.

Disease activity may be a risk factor for psychological illness in patients with inflammatory bowel disease (IBD). To correlate objective measures of disease activity with psychological symptoms. Adult patients with IBD undergoing ileocolonoscopy were prospectively recruited. Demographic, psychological symptoms (depression, anxiety, stress), disease activity (symptoms, biomarkers, endoscopy), and quality of life (QoL) data were collected. One-way ANOVA and multivariable analyses examined the associations between disease activity and symptoms of psychological illness, and identified other predictors of mental illness and reduced QoL. A total of 172 patients were included, 107 with Crohn's disease (CD) and 65 with ulcerative colitis (UC). There was no significant association between objective disease activity (endoscopic scores, faecal calprotectin or C-reactive protein) and depression, anxiety or stress scores (P>0.05 for all comparisons). Gastrointestinal symptoms were significantly associated with symptoms of depression, anxiety and stress in patients with CD and UC (P<0.05). On multivariable analysis, only gastrointestinal symptoms were associated with severe symptoms of depression (OR 20.78 [6.71-92.37], P<0.001) and anxiety (OR 4.26 [1.70-12.25], P=0.004). Anti-TNF and corticosteroid use, the presence of severe depressive, moderate-severe stress and gastrointestinal symptoms, and endoscopically active IBD were associated with a reduced QoL (P<0.05). Longer duration of IBD predicted an improved QoL (P<0.05). Objective measures of disease activity are not associated with symptoms of psychological illness in patients with IBD. Clinicians should consider underlying mental illness in patients with IBD with active gastrointestinal symptoms.

P235 Major Depression in patients with Crohn’s disease and its relationship with clinical activity and disease’s phenotype

Abstract Background Crohn’s disease (CD) has a considerable impact on quality of life and contributes to the onset of depressive symptoms¹. It has been demonstrated that depression is more prevalent in inflammatory bowel disease (IBD) patients compared to the general population². However, whether depression affects IBD course or the onset of IBD triggers psychological disorders remains to be elucidated. The aim of the study is to estimate the prevalence of major depression in patients with CD and to evaluate its relationship with the clinical activity and phenotype of the disease. Methods From November 2019 to February 2020, 283 patients with CD were evaluated using the Patient Heath Questionnaire-9 (PHQ-9). Major depression (MD) was defined by PHQ-9 ≥ 10 (0–4: absent depressive symptoms / 5–9: mild depressive symptoms / 10–14: moderate depressive symptoms / 14- 27: severe depressive symptoms). Data regarding socio-demographic characteristics, disease phenotype, clinical activity were prospective collected. Disease phenotype was characterized according to the Montreal classification and clinical activity was assessed using the Harvey-Bradshaw index (HBI). Statistical tests were performed with a 5% significance level. Results The prevalence of MD in CD patients was 41.7% (Table 1). Female patients were more susceptible to MD (Table 2). Other socio-demographic characteristics did not increase the risk of MD. Disease activity was significantly associated with an increased risk of MD (Odds Ratio [OR] 795.97, 95% confidence interval [CI] 133.7–4738.78, p &amp;lt;0.001) (Table 2). Regarding disease phenotype, the stenosing and penetrating behaviour were associated with a lower risk of MD (OR 0.8, 95%CI 0.01-.5 and OR 0.03, 95%CI 0.00–0.18), respectively, as compared with the inflammatory behaviour. No association was observed between location of the disease and MD. Conclusion Our study shows a high prevalence of MD among CD patients, which is significantly affected by disease phenotype and clinical activity. Given that the ultimate therapeutic goals for CD should include restoration of quality of life, this study shed light on the need of the inclusion of psychological assessment besides the objective measures of disease activity as an integral part of IBD care.

Chronic pain in patients with inflammatory bowel disease.

Crohn’s disease and ulcerative colitis (“inflammatory bowel disease” [IBD]) are chronic relapsing intermittently acute conditions, characterised by pathological changes in gut tissue, symptoms of diarrhoea, blood loss, and abdominal pain, long-term complications (fistulae, abscesses, and strictures), extra-abdominal manifestations such as arthritis, and systemic illness. Symptoms dominate IBD disease activity indices,39,42 but the primary target for treatment is inflammation of the gut mucosa. This treatment has significantly improved over the past decade, notably through the use of immunomodulator and biologic drugs. However, the pattern, severity, impact, and prognosis of symptoms still vary substantially from patient-to-patient. Clinicians caring for people with IBD focus on controlling the active bowel disease. Objective measures of disease activity, using endoscopy and imaging or surrogates such as faecal calprotectin, provide targets for disease-modifying drugs in trials and the clinic. However, there is a discrepancy between measures of gut inflammation and the extent and severity of patients' symptoms,30 and neither are straightforwardly related to measures of the overall impact on patients' lives.30 Early mucosal healing defined by endoscopy is associated with long-term improvements in symptom severity, but one-third of patients with healed mucosa do not achieve clinical remission.76,77 In particular, abdominal pain that persists beyond flares, despite optimal treatment of the gut disease, presents a common, disabling, and unresolved problem,64,101 affecting patients' quality of life (QoL) and psychological well-being58,75 and posing challenges for management.66,87 For clinicians, this means disease-targeted treatment alone may not resolve the patient's pain and pain-related distress. The result is that chronic abdominal pain may dominate patients' lives—underrecognised in both specialist and primary care settings, poorly assessed, and inadequately treated. In this Topical Review, we consider evidence about chronic abdominal pain in people with IBD. Our aim was to identify the extent to which general principles of modern chronic pain management92 should have equal place in the IBD clinic and consultation alongside the clinician's concern for diagnosing and treating underlying gut pathology, to ensure that pain in all patients with IBD is properly recognised, formally assessed, and treated safely and effectively.

Being overweight is associated with not reaching low disease activity in women but not men with psoriatic arthritis.

To assess sex differences in disease activity parameters and health-related quality of life in PsA, and to assess whether determinants associated with not reaching treatment target differed between men and women. Routine practice data of 855 PsA patients, who were all tightly monitored and treated, was used. Sex differences including, but not limited to, PsA Disease Activity Score (PASDAS), skin/nail disease, SF-12 PCS/MCS, and inflammatory back pain (IBP) were assessed. Multivariate analyses were used to examine determinants associated with not reaching treatment target (PASDAS ≤ 3.2) in men and women. Women had worse scores for-among others-swollen and tender joints, CRP, enthesitis and function (all P < 0.001). Higher PASDAS scores were found for women [3.5 (1.5)] than men [2.7 (1.5), P < 0.001]. Likewise, women were more often not at PASDAS treatment target (OR = 2.03, P < 0.001). No difference in current medication use was found. Nail disease, IBP, number of DMARDs used (past and current), and BMI were associated with not reaching treatment target in the overall sample. For women, but not men, BMI was associated with not reaching PASDAS low disease activity (LDA) (OR between 2.41 and 3.43, P < 0.001). Women with PsA in a tightly monitored and treated setting have more severe disease than men. This is demonstrated by worse scores for women in both subjective and objective disease activity measures, in addition to women less often reaching the treatment target. Notably, being overweight is associated with higher disease activity in women, but not men.

Defining Endpoints and Biomarkers in Inflammatory Bowel Disease: Moving the Needle Through Clinical Trial Design

Defining Endpoints and Biomarkers in Inflammatory Bowel Disease: Moving the Needle Through Clinical Trial Design

Does autoimmune thyroid disease affect rheumatoid arthritis disease activity or response to methotrexate?

ObjectiveTo investigate if autoimmune thyroid disease (AITD) impacts rheumatoid arthritis (RA) disease activity or response to methotrexate.MethodsA nationwide register-based cohort study of 9 004 patients with new-onset RA from the...