P240 Can ultrasound alone predict the need to treat ACPA positive individuals without synovitis?

Abstract Background In anti-cyclic citrullinated peptide antibody-positive (ACPA+) individuals without clinical synovitis (at-risk), to define the critical ultrasound (US) features sufficiently predictive for inflammatory arthritis (IA) to enable logical initiation of therapy. Methods In a single centre prospective cohort, at risk ACPA+ individuals with a new musculoskeletal symptoms underwent an US scan of 38 joints and 18 tendons at first visit. The predictive value of US abnormalities (Power Doppler (PD), Grey Scale (GS), erosion or tenosynovitis (TSV)) for progression to IA was analysed and the best predictive joints determined by Multivariable Cox Regression, adjusted for confounders. The US results were combined with clinical symptoms/findings to produce predictive models. Results Consecutive at-risk ACPA+ individuals (n = 457, mean age 50.3 years old, 74.2% women) were followed up for median of 15.4 months (range 0.1-127.4), a complete dataset with follow-up of at least 6 months was available for 319 of them. 135 (29.5%) developed IA after a median of 11.3 months (range 0.1-111.7). The negative predictive value of a US scan without any abnormality was 82%. In multivariable Cox regression, both PD and TSV were predictive of progression, with respectively hazard ratios of 1.2 (9=0.026) and 1.13 (p = 0.025). All US abnormalities had a high specificity (spec) but only moderate sensitivity (sens), PD was the most specific with a spec/sens of 0.94/0.23, followed by TSV with a spec/sens of 0.91/0.26 but the best area under the curve (AUC) of 0.599 (P = 0.0015). The addition ACPA titre (high compared to low), but not GS, improved spec/sens up to 0.92/0.34 and AUC to 0.964 (p < 0.001). A selection of US and clinical data of 14 joints also improved prediction, with an AUC of 0.670 (p < 0.001) and a spec/sens of 0.65/0.62. A selection of the 34 most predictive features reached the same sens/spec as the ACR/EULAR 2010 classification criteria for RA, showing a spec/sens of 0.80/0.56. Conclusion In at-risk ACPA+ individuals, the presence of sub-clinical US abnormalities are highly specific for progression to IA. The only moderate sensitivity can be improved by using joints or features selection in combination with clinical examination. These results are the first step in providing guidance for which at-risk ACPA+ individuals to treat. Disclosures L.M. Duquenne None. K. Mankia None. L. Garcia Montoya None. A. Di Matteo None. J. Nam None. P. Emery None.

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Identification of a distinct imaging phenotype may improve the management of palindromic rheumatism

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2018-214175 ◽

2018 ◽

Vol 78 (1) ◽

pp. 43-50 ◽

Cited By ~ 9

Author(s):

Kulveer Mankia ◽

Maria-Antonietta D’Agostino ◽

Richard J Wakefield ◽

Jackie L Nam ◽

Waqar Mahmood ◽

...

Keyword(s):

At Risk ◽

High Frequency ◽

Power Doppler ◽

Musculoskeletal Symptoms ◽

High Resolution Imaging ◽

Palindromic Rheumatism ◽

Treatment Naïve ◽

Resolution Imaging ◽

Citrullinated Peptide ◽

New Onset

ObjectivesTo use high-resolution imaging to characterise palindromic rheumatism (PR) and to compare the imaging pattern observed to that seen in new-onset rheumatoid arthritis (NORA).MethodsUltrasound (US) assessment of synovitis, tenosynovitis and non-synovial extracapsular inflammation (ECI) was performed during and between flares in a prospective treatment-naive PR cohort. MRI of the flaring region was performed where possible. For comparison, the same US assessment was also performed in anticyclic citrullinated peptide (CCP) positive individuals with musculoskeletal symptoms (CCP+ at risk) and patients with NORA.ResultsThirty-one of 79 patients with PR recruited were assessed during a flare. A high frequency of ECI was identified on US; 19/31 (61%) of patients had ECI including 12/19 (63%) in whom ECI was identified in the absence of synovitis. Only 7/31 (23%) patients with PR had synovitis (greyscale ≥1 and power Doppler ≥1) during flare. In the hands/wrists, ECI was more prevalent in PR compared with NORA and CCP+ at risk (65% vs 29 % vs 6%, p<0.05). Furthermore, ECI without synovitis was specific for PR (42% PR vs 4% NORA (p=0.003) and 6% CCP+ at risk (p=0.0012)). Eleven PR flares were captured by MRI, which was more sensitive than US for synovitis and ECI. 8/31 (26%) patients with PR developed RA and had a similar US phenotype to NORA at progression.ConclusionPR has a distinct US pattern characterised by reversible ECI, often without synovitis. In patients presenting with new joint swelling, US may refine management by distinguishing relapsing from persistent arthritis.

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Comparison of power Doppler and thermography for the selection of thyroid nodules in which fine-needle aspiration biopsy is indicated

Radiologia Brasileira ◽

10.1590/0100-3984.2014.0111 ◽

2016 ◽

Vol 49 (5) ◽

pp. 311-315 ◽

Cited By ~ 11

Author(s):

Maria Lucia D'Arbo Alves ◽

Manoel Henrique Cintra Gabarra

Keyword(s):

Fine Needle Aspiration ◽

Predictive Value ◽

Thyroid Nodules ◽

Fine Needle Aspiration Biopsy ◽

Power Doppler ◽

Needle Aspiration ◽

Aspiration Biopsy ◽

Fine Needle ◽

Needle Aspiration Biopsy ◽

Selection Of

Abstract Objective: To compare two methods-power Doppler and thermography-for the analysis of nodule vascularization and subsequent selection of nodules to be biopsied. Materials and Methods: A total of 510 subjects with thyroid nodules were analyzed by power Doppler and submitted to fine-needle aspiration biopsy (FNAB). Thirty-seven patients were submitted to nodule excision (29 due to carcinoma or suspected carcinoma and 8 by patient choice). Among those patients, power Doppler had raised the suspicion of malignancy in 39 lesions, compared with 48 for FNAB. Another group, comprising 110 patients, underwent thermography, which raised the suspicion of malignancy in 124 thyroid nodules, as did FNAB. Malignant nodules were excised in all 110 of those patients (95 underwent nodulectomy and 15 underwent thyroidectomy), malignancy being confirmed by intraoperative examination of frozen biopsy samples. Results: In relation to the FNAB findings, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of power Doppler were 95.16%, 23.52%, 96.22%, 16.70%, and 89.51%, respectively, compared with 100%, 58.06%, 87.73%, 100%, and 89.51%, respectively, for thermography. Conclusion: Thermography was more precise than was power Doppler for the selection of thyroid nodules to be biopsied.

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SAT0045 DISTRIBUTION AND SEVERITY OF PERIODONTITIS PREDICTS PROGRESSION TO INFLAMMATORY ARTHRITIS IN ANTI-CCP POSITIVE AT-RISK INDIVIDUALS WITHOUT CLINICAL SYNOVITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5589 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 953-953

Author(s):

K. Mankia ◽

Z. Mustufvi ◽

J. Kang ◽

A. Tugnait ◽

R. Letton ◽

...

Keyword(s):

At Risk ◽

Clinical Trials ◽

Periodontal Disease ◽

Inflammatory Arthritis ◽

Cox Regression ◽

Musculoskeletal Symptoms ◽

Mucosal Inflammation ◽

Pocket Depth ◽

Periodontal Inflammation ◽

Total Burden

Background:The prevalence of periodontal disease and the citrullinating bacteriumPorphyromonas gingivalisare increased in anti-CCP positive individuals at-risk of rheumatoid arthritis (RA) (1). This suggests periodontal inflammation may have an important role in the initiation and development of RA. Despite significant interest in the role of the periodontium and other mucosal sites in the initiation of RA-related autoimmunity, the influence of mucosal inflammation on progression to inflammatory arthritis (IA) in at-risk individuals remains unclear.Objectives:To investigate the association between periodontitis and progression to inflammatory arthritis in anti-CCP+ at-risk individuals without synovitis.Methods:Anti-CCP positive individuals with musculoskeletal symptoms but no clinical synovitis (CCP+ at-risk) were recruited as part of a national prospective cohort study. Comprehensive periodontal examination was performed at baseline by a dentist; six sites per tooth were assessed for clinical attachment level (CAL), pocket depth (PD) and bleeding on probing (BOP). Periodontal disease sites (PDD) were defined as CAL ≥2mm and PD ≥4mm. The distribution of PDD was classified in line with recent guidelines (2). The severity i.e. total burden of periodontal inflammation, was quantified at patient level using the periodontal inflamed surface area (PISA) index(3). CCP+ at-risk were monitored for progression to IA. Multivariable Cox regression was used to assess the effect of PDD distribution and PISA on progression to IA.Results:126 CCP+ at-risk underwent full periodontal examination and were followed up for median 23.4 months (range 0.6 – 56.8 months). Mean age was 49 years, 86 (68%) were females. At baseline, 42(33%) subjects had no PDD, 51(40%) had localised PDD (<30% teeth with one or more PDD site) and 33 (26%) had generalised PDD (≥ 30% of teeth with one or more PDD site). Mean (SD) PISA for all subjects was 267(319)mm2. 31 subjects (25%) progressed to IA after median of 12.6 months (range 0.6 – 49.5 months). Progression to IA was significantly higher in subjects with localised PDD compared with those without PDD (33% vs 16%, HR (95% CI) 2.45 (1.02, 5.94) p=0.02), figure 1. Interestingly, this association was not seen in subjects with generalised PDD (19% progression, HR 0.68 (0.20, 2.32). In addition, severity (i.e. total burden) of periodontal inflammation (PISA) was not significantly predictive of progression to IA alone (HR 1.001 (0.999-1.002), p=0.08). However, when adjusting for distribution of PDD, PISA was significantly associated with progression to IA (HR 1.0016 (1.0003- 1.003), p=0.00163).Conclusion:Periodontal inflammation predicts progression to IA in CCP+ at-risk individuals without clinical synovitis. The severity (i.e. total burden) of periodontitis appears to be particularly predictive of progression to IA in patients with localised periodontitis. These data suggest periodontitis may be an important factor in the development of RA and provide rationale for periodontal intervention with the aim of arthritis prevention in at-risk individuals.References:[1] Mankia K et al, JAMA Network Open(2019)[2] Caton J et al, J Clin Periodontol(2018)[3] Nesse W et al, J Clin Periodontol(2008)Disclosure of Interests :Kulveer Mankia: None declared, Zhain Mustufvi: None declared, Jing Kang: None declared, Aradhna Tugnait: None declared, Robert Letton: None declared, Laurence Duquenne: None declared, Alastair Speirs: None declared, Val Clerehugh: None declared, Deirdre Devine: None declared, Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor)

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Bone Erosions Detected by Ultrasound Are Prognostic for Clinical Arthritis Development in Patients With ACPA and Musculoskeletal Pain

Frontiers in Medicine ◽

10.3389/fmed.2021.653994 ◽

2021 ◽

Vol 8 ◽

Author(s):

Michael Ziegelasch ◽

Emma Eloff ◽

Hilde B. Hammer ◽

Jan Cedergren ◽

Klara Martinsson ◽

...

Keyword(s):

At Risk ◽

Musculoskeletal Pain ◽

Cox Regression ◽

Power Doppler ◽

Multivariable Analysis ◽

Control Group ◽

Cox Regression Analysis ◽

Bone Erosions ◽

Clinical Arthritis ◽

Hands And Feet

Anti-citrullinated protein antibodies (ACPA) often precede onset of rheumatoid arthritis (RA) by years, and there is an urgent clinical need for predictors of arthritis development among such at-risk patients. This study assesses the prognostic value of ultrasound for arthritis development among ACPA-positive patients with musculoskeletal pain. We prospectively followed 82 ACPA-positive patients without clinical signs of arthritis at baseline. Ultrasound at baseline assessed synovial hypertrophy, inflammatory activity by power Doppler, and erosions in small joints of hands and feet. We applied Cox regression analyses to examine associations with clinical arthritis development during follow-up (median, 69 months; range, 24–90 months). We also compared the ultrasound findings among the patients to a control group of 100 blood donors without musculoskeletal pain. Clinical arthritis developed in 39/82 patients (48%) after a median of 6 months (range, 1–71 months). One or more ultrasound erosions occurred in 13/82 patients (16%), with none in control subjects (p < 0.001). Clinical arthritis development was more common among patients with baseline ultrasound erosions than those without (77 vs. 42%, p = 0.032), and remained significant in a multivariable Cox regression analysis that included previously described prognostic factors (HR 3.9, 95% CI 1.6–9.4, p = 0.003). Ultrasound-detected tenosynovitis was more frequent among the patients and associated with clinical arthritis development in a univariable analysis (HR 2.5, 95% CI 1.1–5.7, p = 0.031), but did not remain statistically significant in multivariable analysis. Thus, bone erosions detected by ultrasound are independent predictors of clinical arthritis development in an ACPA-positive at-risk population.Trial Registration: Regional Ethics Committee in Linköping, Sweden, Dnr M220-09. Registered 16 December 2009, https://etikprovningsmyndigheten.se/.

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Can power Doppler ultrasound of the entheses help in classifying recent axial spondyloarthritis? Data from the DESIR cohort

RMD Open ◽

10.1136/rmdopen-2018-000686 ◽

2018 ◽

Vol 4 (2) ◽

pp. e000686 ◽

Cited By ~ 2

Author(s):

Cecile Poulain ◽

Maria Antonietta D'Agostino ◽

Severine Thibault ◽

Jean Pierre Daures ◽

Salah Ferkal ◽

...

Keyword(s):

Predictive Value ◽

Axial Spondyloarthritis ◽

Clinical Symptoms ◽

Power Doppler ◽

Inflammatory Back Pain ◽

Power Doppler Ultrasonography ◽

Asas Criteria ◽

Asas Classification Criteria ◽

Diagnostic Management ◽

Additional Value

Early diagnosis of axial spondyloarthritis (axSpA) remains a challenge due to the lack of specificity of clinical symptoms and variable prevalence of axial imaging findings permitting a definite diagnosis. Power Doppler ultrasonography (PDUS) of the entheses has demonstrated to be a potential useful tool for the classification and diagnostic management of early SpA independently of the phenotype.Objectives To assess the classification value (sensitivity and specificity) of PDUS-defined enthesitis for identifying patients fulfilling Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA (ASAS+) in patients with recent inflammatory back pain (IBP) (the DESIR (DEvenir des Spondylarthropathies Indifférenciées Récentes) cohort).Methods Baseline PDUS was performed at eight entheseal sites, and PDUS enthesitis was defined by the presence of vascularisation at entheseal insertion.Results 402 patients from the DESIR cohort underwent a PDUS evaluation. PDUS enthesitis was detected in 58 (14.4%) patients of whom 40 (14.2%) belonged to the ASAS+ patients and 18 (17%) to the ASAS- patients. The sensitivity of PDUS enthesitis was 13.9% and the specificity was 83.5%, with a positive predictive value of 69% and 26.8% of negative predictive value for meeting ASAS criteria for axSpA. Of the 18 ASAS- patients with positive PDUS, 59% fulfilled Amor’s criteria, 88% European Spondyloarthropathy Study Group criteria and 59% both.ConclusionsIn a cohort of patients with recent IBP, the prevalence of PDUS enthesitis was low (14.4%); however, its specificity for classifying patients as axSpA according to ASAS criteria was high (83.5%). PDUS enthesitis might be of additional value for classifying as patients with axSpA IBP who do not fulfil ASAS criteria.

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VALUE OF COMBINATION OF HAP SCORE AND BISAP SCORE IN PREDICTING SEVERITY IN PATIENTS OF ACUTE PANCREATITIS

Journal of Medicine and Pharmacy ◽

10.34071/jmp.2019.1.15 ◽

2019 ◽

pp. 96-100

Author(s):

Thi Ngoc Suong Le ◽

Pham Chi Tran ◽

Van Huy Tran

Keyword(s):

Acute Pancreatitis ◽

Positive Predictive Value ◽

Roc Curve ◽

Predictive Value ◽

Prognostic Value ◽

Acute Inflammation ◽

Clinical Symptoms ◽

Mortality Rates ◽

Multiple Organ ◽

Central Hospital

Acute pancreatitis (AP) is an acute inflammation of the pancreas, usually occurs suddenly with a variety of clinical symptoms, complications of multiple organ failure and high mortality rates. Objectives: To determine the value of combination of HAP score and BISAP score in predicting the severity of acute pancreatitis of the Atlanta 2012 Classification. Patients and Methods: 75 patients of acute pancreatitis hospitalized at Hue Central Hospital between March 2017 and July 2018; HAP and BISHAP score is calculated within the first 24 hours. The severity of AP was classified by the revised Atlanta criteria 2012. Results: When combining the HAP and BISAP scores in predicting the severity of acute pancreatitis, the area under the ROC curve was 0,923 with sensitivity value was 66.7%, specificity value was 97.1%; positive predictive value was 66.7%, negative predictive value was 97.1%. Conclusion: The combination of HAP and BISAP scores increased the sensitivity, predictive value, and prognostic value in predicting the severity of acute pancreatitis of the revised Atlanta 2012 classification in compare to each single scores. Key words: HAPscore, BiSAP score, acute pancreatitis, predicting severity

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Serum alpha-fetoprotein and clinical outcomes in patients with advanced hepatocellular carcinoma treated with ramucirumab

British Journal of Cancer ◽

10.1038/s41416-021-01260-w ◽

2021 ◽

Author(s):

Andrew X. Zhu ◽

Richard S. Finn ◽

Yoon-Koo Kang ◽

Chia-Jui Yen ◽

Peter R. Galle ◽

...

Keyword(s):

Prognostic Factor ◽

Clinical Outcomes ◽

Predictive Value ◽

Survival Benefit ◽

Radiographic Progression ◽

Cox Regression ◽

Selection Criterion ◽

Alpha Fetoprotein ◽

Advanced Hepatocellular Carcinoma ◽

Clinical Trial Registration

Abstract Background Post hoc analyses assessed the prognostic and predictive value of baseline alpha-fetoprotein (AFP), as well as clinical outcomes by AFP response or progression, during treatment in two placebo-controlled trials (REACH, REACH-2). Methods Serum AFP was measured at baseline and every three cycles. The prognostic and predictive value of baseline AFP was assessed by Cox regression models and Subpopulation Treatment Effect Pattern Plot method. Associations between AFP (≥ 20% increase) and radiographic progression and efficacy were assessed. Results Baseline AFP was confirmed as a continuous (REACH, REACH-2; p < 0.0001) and dichotomous (≥400 vs. <400 ng/ml; REACH, p < 0.01) prognostic factor, and was predictive for ramucirumab survival benefit in REACH (p = 0.0042 continuous; p < 0.0001 dichotomous). Time to AFP (hazard ratio [HR] 0.513; p < 0.0001) and radiographic (HR 0.549; p < 0.0001) progression favoured ramucirumab. Association between AFP and radiographic progression was shown for up to 6 (odds ratio [OR] 5.1; p < 0.0001) and 6–12 weeks (OR 1.8; p = 0.0065). AFP response was higher with ramucirumab vs. placebo (p < 0.0001). Survival was longer in patients with an AFP response than patients without (13.6 vs. 5.6 months, HR 0.451; 95% confidence interval, 0.354–0.574; p < 0.0001). Conclusions AFP is an important prognostic factor and a predictive biomarker for ramucirumab survival benefit. AFP ≥ 400 ng/ml is an appropriate selection criterion for ramucirumab. Clinical Trial Registration ClinicalTrials.gov, REACH (NCT01140347) and REACH-2 (NCT02435433).

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EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-220884 ◽

2021 ◽

pp. annrheumdis-2021-220884

Author(s):

Kulveer Mankia ◽

Heidi J Siddle ◽

Andreas Kerschbaumer ◽

Deshire Alpizar Rodriguez ◽

Anca Irinel Catrina ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Risk Factors ◽

At Risk ◽

Clinical Trials ◽

Observational Studies ◽

Task Force ◽

Musculoskeletal Symptoms ◽

Subclinical Inflammation ◽

Consensus Statements ◽

Clinical Arthritis

BackgroundDespite growing interest, there is no guidance or consensus on how to conduct clinical trials and observational studies in populations at risk of rheumatoid arthritis (RA).MethodsAn European League Against Rheumatism (EULAR) task force formulated four research questions to be addressed by systematic literature review (SLR). The SLR results informed consensus statements. One overarching principle, 10 points to consider (PTC) and a research agenda were proposed. Task force members rated their level of agreement (1–10) for each PTC.ResultsEpidemiological and demographic characteristics should be measured in all clinical trials and studies in at-risk individuals. Different at-risk populations, identified according to clinical presentation, were defined: asymptomatic, musculoskeletal symptoms without arthritis and early clinical arthritis. Study end-points should include the development of subclinical inflammation on imaging, clinical arthritis, RA and subsequent achievement of arthritis remission. Risk factors should be assessed at baseline and re-evaluated where appropriate; they include genetic markers and autoantibody profiling and additionally clinical symptoms and subclinical inflammation on imaging in those with symptoms and/or clinical arthritis. Trials should address the effect of the intervention on risk factors, as well as progression to clinical arthritis or RA. In patients with early clinical arthritis, pharmacological intervention has the potential to prevent RA development. Participants’ knowledge of their RA risk may inform their decision to participate; information should be provided using an individually tailored approach.ConclusionThese consensus statements provide data-driven guidance for rheumatologists, health professionals and investigators conducting clinical trials and observational studies in individuals at risk of RA.

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Predictive value of small dense low-density lipoprotein cholesterol for cardiovascular events in Chinese elder diabetes mellitus patients

Diabetology & Metabolic Syndrome ◽

10.1186/s13098-021-00667-y ◽

2021 ◽

Vol 13 (1) ◽

Author(s):

Li Xu ◽

Xu Chen ◽

Jingfen Lu ◽

Yan Xu ◽

Honglin Yang ◽

...

Keyword(s):

Predictive Value ◽

Cardiovascular Events ◽

Cox Regression ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Lipoprotein Cholesterol ◽

Low Density ◽

Low Density Lipoprotein Cholesterol ◽

Type 2 Dm

Abstract Background As a subcomponent of low-density lipoprotein cholesterol (LDL-C), small dense LDL-C (sdLDL-C) has been suggested to be a better predictor of cardiovascular diseases (CVD). The aim of this research was to evaluate the predictive value of the sdLDL-C in cardiovascular events (CVs) in Chinese elderly patients with type 2 diabetes mellitus (DM). Methods A total of 386 consecutive type 2 DM patients were included into this study during December 2014 to December 2016. The serum sdLDL-C level of each subject was measured by homogeneous method. During a period of 48-month’s follow-up, the occurrence of CVs and associated clinical information were recorded. Receiver operating characteristic (ROC) curves were used to assess the predictive value of serum sdLDL-C to occurrence of major CVs. Results A total of 92 CVs occurred during the study period. The ROC curve analysis manifested that sdLDL-C in the study population had a matchable discriminatory power (AUC for sdLDL-C was 0.7366, P = 0.003). In addition, Kaplan-Meier event-free survival curves displayed an obvious increase of CVs risk for sdLDL‐C ≧ 26 mg/dL (log-rank = 9.10, P = 0.003). This phenomenon had analogous results in patients who received statins at baseline (log rank = 7.336, P = 0.007). Cox regression analysis revealed that the increase in HbA1c, glucose, LDL-C, sdLDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and apolipoprotein B (ApoB) and the decrease in apolipoprotein AI (ApoAI) were obviously interrelated with heightened CVs risk. Multiple Cox regression demonstrated that the increase of sdLDL-C and hemoglobin A1c (HbA1c) was significantly correlated with CVs. The results of the study indicated that high sdLDL-C level (> 10 mg/dL) was a risk factor for CVs in the multivariate model (HR 1.281, 95% CI 1.225–16.032; P < 0.01). Conclusion sdLDL-C level could be an effective predictor in predicting the future CVs for Chinese elderly patients with type 2 DM and dyslipidemia.

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381 Role of CT scans of abdomen and pelvis in management of patients with immunotherapy-induced colitis

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0381 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A406-A406

Author(s):

Juan Ibarra Rovira ◽

Raghunandan Vikram ◽

Selvi Thirumurthi ◽

Bulent Yilmaz ◽

Heather Lin ◽

...

Keyword(s):

Negative Predictive Value ◽

Clinical Diagnosis ◽

Predictive Value ◽

Clinical Symptoms ◽

Cytotoxic T Lymphocyte ◽

Checkpoint Inhibitors ◽

Ct Scans ◽

Wall Thickening ◽

Low Sensitivity ◽

Sensitivity Specificity

BackgroundColitis is one of the most common immune-related adverse event in patients who receive immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death-1 (PD-1). Although radiographic changes are reported on computed tomography such as mild diffuse bowel thickening or segmental colitis, the utility of CT in diagnosis of patients with suspected immune-related colitis is not well studied.MethodsCT scans of the abdomen and pelvis of 34 patients on immunotherapy with a clinical diagnosis of immunotherapy induced colitis and 19 patients receiving immunotherapy without clinical symptoms of colitis (control) were enrolled in this retrospective study. Segments of the colon (rectum, sigmoid, descending, transverse, ascending and cecum) were assessed independently by two fellowship trained abdominal imaging specialists with 7 and 13 years‘ experience who were blinded to the clinical diagnosis. Each segment was assessed for mucosal enhancement, wall thickening, distension, peri-serosal fat stranding. Any disagreements were resolved in consensus. The degree of distension and the spurious assignment of wall thickening were the most common causes for disagreement. The presence of any of the signs was considered as radiographic evidence of colitis.ResultsCT evidence of colitis was seen in 16 of 34 patients with symptoms of colitis. 7 of 19 patients who did not have symptoms of colitis showed signs of colitis on CT. The sensitivity, specificity, Positive Predictive Value and Negative Predictive Value for colitis on CT is 47%, 63.2%, 69.5% and 40%, respectively.ConclusionsCT has a low sensitivity, specificity and negative predictive value for the diagnosis of immunotherapy-induced colitis. CT has no role in the diagnosis of patients suspected of having uncomplicated immune-related colitis and should not be used routinely for management.Trial RegistrationThis protocol is not registered on clinicaltrials.gov.Ethics ApprovalThis protocol was IRB approved on: 11/16/2015 - IRB 4 Chair Designee FWA #: 00000363 OHRP IRB Registration Number: IRB 4 IRB00005015ConsentThis protocol utilizes an IRB approved waiver of consent.

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