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تدور الرواية حول حكاية غريق أمضى عشرة أيام عائما على متن زورق دون طعام أو شراب. ونصب بطلا قوميا، ثم تهاوت عليه قبلات ملكات الجمال ؛ فأصبح ثريا بفضل ما قام بتصويره من إعلانات. وعقب نشر تفاصيل الحكاية تفجرت الفضيحة ؛ حيث كان الفوز والتكريم والثروة من نصيب الغريق، أما الصحفي الذي أخذ على عاتقه جمع أطراف الحكاية، فقد كان مصيره النفي والتشريد.

Background:Systemic diseases most frequently associated with uveitis are spondyloarthritis (SpA). Differences in the presentation of uveitis have been described in each type of SpA, however, this information is contradictory and scarce in the literature. The differentiation of these associated inflammatory processes has important therapeutic and prognostic implications and may condition the treatment of the underlying disease in Ophthalmology/Rheumatology Ocular Inflammation Interdisciplinary Units.Objectives:The aim of the study is to analyze the characteristics of non-infectious ocular inflammation in the different types of spondyloarthritis in a multidisciplinary ocular inflammation practice.Methods:Descriptive observational study including data from patients with a non-infectious inflammatory ocular process secondary to SpA evaluated in a multidisciplinary ocular inflammation consultation from January 2012 to January 2024. Demographic, ocular involvement, sequelae, and therapy data are comparatively analyzed. Quantitative variables were described as median and interquartile range (IQR) or mean and standard deviation (SD), and frequencies were used for the qualitative variables. Comparative analysis was performed using the IBM SPSS 21.0 program and the comparison of proportions using the chi-square test. P-values <0.05 were considered statistically significant.Results:From our “Inflammatory ocular process Registry” at La Paz University Hospital with a total of 564 patients included, we collected data from 147 patients with SpA (26%). Table 1 shows clinical characteristics in the global sample and in the different types of spondyloarthritis. In the comparative analysis, according to the type of spondyloarthritis, significant differences were found in the percentage of positive HLAB27 (p<0.01); being more frequent in ankylosing spondylitis (AS) and axial spondyloarthritis (AxSpA) than in the rest of the groups. The age of onset was significantly higher in AS and psoriatic arthritis (PsA) than in others (p<0.01). Regarding the ocular involvement, significant differences were found (p<0.01) in the pattern and course. Recurrent acute anterior uveitis (RAAU) pattern and the recurrent acute course were predominant in AS, axSpA and PsA. Bilateral acute anterior uveitis (BAAU) pattern and chronic forms were more frequent in peripheral spondyloarthritis (pSpA) and inflammatory bowel disease associated with spondyloarthritis (IbdSpA). Concerning the ophthalmological examination, significant differences (p<0.05) were found in the presence of keratic precipitates (more frequent in AS, axSpA and PsA), vitritis (higher proportion in PsA) and cataract (more frequent in AS, IbdSpA and PsA). No differences were found in sex, location/laterality of the uveitis (anterior and unilateral involvement are predominant in all cases), neither in complications such as visual impairment, synechiae, cystic macular edema, glaucoma, retinal vasculitis, epiretinian membrane or papilitis. Regarding therapy, there were significant differences (p<0.05) in the use of systemic corticosteroids; most commonly used in pSpA and PsA. The use of disease-modifying anti-rheumatic drugs (DMARDs) was also more frequent in pSpA and PsA without reaching statistical significance (p=0.056). There were no significant differences in the use of biological therapy.Conclusion:This study reveals differences in the inflammatory ocular involvement regarding the type of spondyloarthritis. Bilateral and chronic forms of uveitis were more frequently observed in IbdSpA o pSpA. Additionally, the use of systemic steroids and DMARDs was most common in pSpA and PsA.Table 1.REFERENCES:NIL.Acknowledgements:To the Ophthalmology/Rheumatology Ocular Inflammation Interdisciplinary Unit of La Paz University Hospital.Disclosure of Interests:None declared.

Background:Capillaroscopy (CP) is a non-invasive technique that allows observation of the capillaries in the nail bed, being a widely used tool in patients with Raynaud’s phenomenon (RP) for the diagnosis of certain rheumatological diseases. On the other hand, one of the main causes of mortality in connective tissue diseases is heart disease and many patients have cardiovascular risk factors (CVRF): tobacco (TOB), diabetes (DM), alcohol (ALC), dyslipidemia (DL), arterial hypertension (HTA) and obesity.Objectives:The objective is to study whether there are characteristic capillaroscopic alterations in patients with CVRF and if cardiovascular risk can be a confounding factor when correctly classifying patients.Methods:Multicenter descriptive retrospective study based on clinical records from two public hospitals in the community of Madrid between 2015 and 2018. CP was performed with a 200x videocapillaroscope (Dinolite). Images were analyzed with DinoXcope software version 1.15. The variables were collected: CVRF, RP, pathologies and complications, laboratory data and autoimmunity, drug intake and alterations in CP (tortuosities, ramifications, dilations (>20µm), giant capillaries (>50µm) and hemorrhages). The statistical analysis consisted of parametric and non-parametric studies, obtaining statistical significance with p<0.05.Results:340 medical records were reviewed, 286 women and 54 men, with a middle age of 52.36 ± 16.971 years; 264 patients with RP (77.6%), 85 with triphasic color change of the digits (25%). We divide the patients into 3 groups: 155 healthy patients/primary RP (45.6%), 123 patients with sclerodermiform pathology (36.2%) and 62 patients with other non-sclerodermiform pathologies (18.2%). 212 patients (62.4%) had CVRF: 108 DL (31.8%), 62 HTA (18.2%), 59 exTOB (17.4%) and 49 TOB (14.4%), 20 DM (5.8%), 8 ALC (2.4%). Regarding changes in CP, a statistically significant association was observed in all groups between CVRF and tortuosity 99.5% (p<0.001), especially with HTA 100% (p<0.001), taking antihypertensives 100% (p<0.001) and hypercholesterolemia (p=0.006). We also observed association between tortuosities and hyperemia 99.6% (p<0.001) and the onset´s age of RP (p=0.008). Concerning the ramifications, there is an association in all groups with CVRF 86.8% (p<0.001), especially HTA 82.3% (p<0.001), TOB (p<0.001) and hyperemia (p<0.001). About dilations we found also an association in all groups with CVRF (p<0.001), HTA (p=0.019) and TOB (p=0.004). Regarding giant capillaries, there is an association with TOB (p=0.034) and hyperemia (p<0.001). In respect of hemorrages, there is an association with CVRF (p<0.001), HTA (p= 0.008), TAB (p=0.002), hyperemia (p<0.001) and antihypertensives (p=0.002). Concerning capillary loss, there is an association with HTA and antihypertensives intake. However, the visibility of the venous plexus did not present an association with CVRF.Conclusion:This study reveals the association between alterations in CP and CVRF. CP is a technique very used in Rheumatology but there is a limited literature regarding the alterations that can produce CVRF in CP. Prospective studies are needed to confirm the results of this study and see its applicability in clinical practice.REFERENCES:[1] Standardisation of nailfold capillaroscopy for the assessment of patients with Raynaud’s phenomenon and systemic sclerosis. Smith V et al, Autoimmun Rev 2020 Mar;19(3):102458.Acknowledgements:Rheumatology medical team at Severo Ochoa Hospital.Disclosure of Interests:None declared.

Background Hypophosphatasia (HPP) is a rare and underdiagnosed condition characterized by deficient bone and teeth mineralization. The aim of this study was first, to evaluate the diagnostic utility of employing alkaline phosphatase (ALP) threshold levels to identify adults with variants in ALPL among individuals with persistently low ALP levels and second, to determine the value of also including its substrates (serum pyridoxal-5′-phosphate—PLP—and urinary phosphoetanolamine-PEA) for this purpose in order to create a biochemical algorithm that could facilitate the diagnostic work-up of HPP. Results The study population comprised 77 subjects with persistent hypophosphatasaemia. They were divided into two groups according to the presence (+GT) or absence (−GT) of pathogenic ALPL variants: 40 +GT and 37 −GT. Diagnostic utility measures were calculated for different ALP thresholds and Receiver Operating Characteristic (ROC) curves were employed to determine PLP and PEA optimal cut-off levels to predict the presence of variants. The optimal threshold for ALP was 25 IU/L; for PLP, 180 nmol/L and for PEA, 30 µmol/g creatinine. Biochemical predictive models were assessed using binary logistic regression analysis and bootstrapping machine learning technique and results were then validated. For ALP < 25 UI/L (model 1), the area under curve (AUC) and the 95% confidence intervals (CI) was 0.68 (95% CI 0.63–0.72) and it improved to 0.87 (95% CI 0.8–0.9), when PEA or PLP threshold levels were added (models 2 and 3), reaching 0.94 (0.91–0.97) when both substrates were included (model 4). The internal validation showed that the addition of serum PLP threshold levels to the model just including ALP improved significantly sensitivity (S) and negative predictive value (NPV) − 100%, respectively- with an accuracy (AC) of 93% in comparison to the inclusion of urinary PEA (S: 71%; NPV 75% and AC: 79%) and similar diagnostic utility measures as those observed in model 3 were detected when both substrates were added. Conclusions In this study, we propose a biochemical predictive model based on the threshold levels of the main biochemical markers of HPP (ALP < 25 IU/L and PLP > 180 nmol/L) that when combined, seem to be very useful to identify individuals with ALPL variants.

BackgroundInflammatory back pain (IBP) is the core symptom in patients with axial spondyloarthritis (axSpA). For its assessment, experts recommend using the Assessment of SpondyloArthritis International Society (ASAS) criteria. Advances in telemedicine and online screening strategies require to evaluate whether self-reported perform equally to physicians’ assessment.ObjectivesTo assess the agreement and correlation between self-reported and physician´s assessments of ASAS IBP criteria and evaluate their performance compared with rheumatologist´s judgement for IBP.MethodsThe “Strategy for a Hospital Early Referral in Patients with Axial Spondyloarthritis” (SHERPAS) is a prospective ongoing study recruiting young patients (18 to 40 years) with chronic back pain asked to undergo an MRI of the spine by other specialists different than rheumatologists in a tertiary hospital, starting in September 2021. After inclusion, an additional MRI of the sacroiliac joints (SIJ), followed by a rheumatology visit and eligible blood tests were performed. IBP was assessed in 3 different independent ways: i) ASAS criteria asked verbatim by the rheumatologist (ASAS-IBP-phy criteria), ii) ASAS criteria embedded in a self-reported questionnaire (ASAS-IBP-self reported), and iii) according to rheumatologist judgement in the interview (IBP-rheumatologist). Dataset for this interim analysis was locked in October 2022. Kappa statistic (κ) and tetrachoric correlation coefficient (rt) were calculated to assess the agreement and correlation between ASAS-IBP-phy criteria and ASAS-IBP-self reported. Overall accuracy, sensitivity, specificity, positive and negative predictive values for each IBP assessment method were calculated, using IBP-rheumatologist as gold standard.ResultsAmong 152 recruited patients, 85 (55.9%) were female; mean (SD) age was 34.2 (5.3) years. 66/152 (43.4%) patients reported IBP by at least one of the three assessments, and 24 (15.8%) patients presented back pain as assessed by the three methods altogether. Venn diagrams representing the overlap between the different IBP assessments are shown in Figure 1. A moderate agreement (κ =0.48) and strong correlation (rt=0.7) were found between ASAS-IBP-self reported and ASAS-IBP-phy criteria. While ASAS-IBP-phy criteria showed a strong level of agreement and very strong correlation with IBP- rheumatologist (κ = 0.74, rt= 0.94), ASAS-IBP-self reported showed a moderate agreement and moderate correlation with this outcome (κ = 0.44, rt=0.67). ASAS-IBP-phy criteria showed better performance than ASAS-IBP-self reported for capturing IBP- rheumatologist [accuracy of 0.89 (95%CI 0.83- 0.94) vs 0.77 (95%CI 0.70- 0.84)] (Table 1).ConclusionASAS criteria to define IBP show higher level of agreement and correlation with IBP rheumatologist overall judgement when assessed by physician as compared to a self-reported assessment. These results call for caution when extrapolating use of experts IBP criteria from clinical to online setting and suggest that clinicians should prioritize physician assessment over self-report to define this.Figure 1.Number of patients showing IBP by each method of assessment[Figure omitted. See PDF]Table 1.Utility measures for each IBP assessment method to capture IBP according to rheumatologist judgementASAS-IBP-phy criteriaASAS-IBP-self reportedAccuracy0.890.78Sensitivity0.890.81Specificity0.920.66Negative Predictive Value0.730.54Positive Predictive Value0.970.87AcknowledgementsThe SHERPAS study has been conducted thanks to an unrestricted grants from Novartis.Disclosure of InterestsDiego Benavent Speakers bureau: Abbvie, Janssen, and Galapagos., Grant/research support from: Novartis, Mar Tapia-Viñé: None declared, Daniel Bernabeu: None declared, Victor Muley: None declared, Chamaida Plasencia Speakers bureau: from Pfizer, Abbvie, Lilly, Sandoz, Sanofi, Biogen, Roche, Novartis, Grant/research support from: Pfizer and Abbvie, Alejandro Balsa Speakers bureau: from Pfizer, Abbvie, Lilly, Galapagos, BMS, Sandoz, Nordic Pharma, Gebro, Roche, Sanofi, UCB, Consultant of: Pfizer, Abbvie, Lilly, Galapagos, BMS, Nordic Pharma, Sanofi, UCB, Grant/research support from: Pfizer, Abbvie, BMS, Nordic Pharma, Gebro, Roche, UCB, Victoria Navarro-Compán Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie and Novartis.

BackgroundChronic back pain (CBP) is one of the major causes for medical consultation among young people. Given the limited sources, it is relevant knowing the characteristics associated with a higher burden in order to prioritize the performance of imaging exams.ObjectivesTo identify factors associated with sick leave in a cohort of young patients with CBP awaiting an MRI of the spine.MethodsThe project “Strategy for a Hospital Early Referral in Patients with Axial Spondyloarthritis” (SHERPAS) is a prospective ongoing study recruiting young patients (18 to 40 years) with CBP that are requested an MRI of the spine by other specialists different than rheumatologists in a tertiary hospital. The study period started in September 2021, and the dataset for this interim analysis was locked in October 2022. Patients completed a questionnaire concerning work status, including sick leave due to CBP (at-visit or prior to this). Besides, socio-demographic and clinical characteristics were collected. Patient-reported outcomes (PROs) for fatigue, Patient Global Assessment (PGA), physical function (Bath Ankylosing Spondylitis Functional Index -BASFI), and overall health (Assessment of Spondyloarthritis international Society Health Index -ASAS HI) were also evaluated. A logistic regression analysis was performed to evaluate the association of patients’ characteristics with sick leave.ResultsOf 152 recruited patients, 123 (80.9%) were actively employed, 22 (14.5%) were unemployed and 7 (4.6%) were students. Among the employed patients (52.8% female; mean age 33.8(4.8) years; 57.0 (54.0) months CBP duration), 65 (52.8%) patients had been on sick leave at some point (50 prior to visit and 15 at the study visit). Baseline characteristics are shown in Table 1. Night pain was more frequent in patients on sick leave (56.9 % vs 36.2%, p=0.02), and PROs on fatigue, PGA, physical function and overall health and functioning showed worse results in these patients, as compared to patients who had never been in sick leave. Additionally, patients on sick leave had more frequently pharmacological treatment. After multivariable analysis, being male (OR 2.3, 95%CI 1.0-5.6), having night pain (OR=2.4, 95%CI 1.0-5.8) and reporting higher PGA (OR=1.1, 95%CI 1.0-1.4) were associated independently with being on sick leave.ConclusionOne out of two young patients with CBP awaiting an MRI of the spine are on sick leave at some point. These patients have poorer quality of life and use more pharmacological treatment than active patients with CBP. Male sex and night pain are associated with being on sick leave due to CBP and therefore could be used to prioritize the use of spinal MRI aiming to optimize health resources.Table 1.Characteristics of employed patients by work statusTotal employedn=123No sick leaven=58Ever sick leaven=65p-valueDemographicsAge33.8 (4.8)33.6 (5)34.1 (4.8)0.6Symptoms (months)57.0 (54.0)54.8 (54.1)59.0 (54.3)0.7BMI25.4 (4)25.4 (4.2)25.4 (3.7)0.9Female65 (52.8)33 (56.9)32 (49.2)0.5EducationPrimary/secondaryUniversity66 (52.8)56 (45.5)27 (46.5)30 (51.7)38 (58.4)26 (40.0)0.2Type of workSendentary/ not activePhysically active33 (26.8)76 (61.8)19 (32.8)38 (65.5)14 (21.5)38 (58.5)0.5Characteristics of back painButtock pain42 (34.2)17 (29.3)25 (38.4)0.4Night pain58 (47.1)21 (36.2)37 (56.9)0.02Inflammatory pain29 (23.6)14 (24.1)15 (23.1)1Flares of back pain87 (70.7)42 (72.4)45 (69.2)0.8Sudden onset72 (58.5)29 (50.0)43 (66.1)0.1Morning stiffness76 (61.8)32 (55.1)44 (67.7)0.2PROsFatigue (0-10)4.9 (3)4 (3.1)5.7 (2.7)0.002PGA (0-10)4.7 (2.9)3.7 (2.9)5.7 (2.6)<0.001Physical function (BASFI)3.2 (2.6)2.4 (2.3)4 (2.6)<0.001Overall health (ASAS-HI)6.7 (3.8)5.6 (3.6)7.8 (3.8)0.002TreatmentsNSAIDs109 (88.6)52 (89.6)57 (87.7)0.2Muscular relaxants88 (71.5)33 (56.9)55 (84.6)<0.001Opioids45 (36.6)11 (18.9)34 (52.3)<0.001Antidepresants19 (15.5)4 (6.9)15 (23.1)0.01AcknowledgementsThe SHERPAS study has been conducted thanks to an unrestricted grant from Novartis.Disclosure of InterestsDiego Benavent Speakers bureau: Janssen, Roche, Galapagos, Abbvie, Grant/research support from: Novartis, Mar Tapia-Viñé: None declared, Daniel Bernabeu: None declared, Victor Muley: None declared, Chamaida Plasencia Speakers bureau: Pfizer, Abbvie, Lilly, Sandoz, Sanofi, Biogen, Roche, Novartis, Grant/research support from: Pfizer and Abbvie, Alejandro Balsa Speakers bureau: Pfizer, Abbvie, Lilly, Galapagos, BMS, Sandoz, Nordic Pharma, Gebro, Roche, Sanofi, UCB, Consultant of: Pfizer, Abbvie, Lilly, Galapagos, BMS, Nordic Pharma, Sanofi, UCB, Grant/research support from: Pfizer, Abbvie, BMS, Nordic Pharma, Gebro, Roche, UCB, Victoria Navarro-Compán Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, Pfizer, UCB, Grant/research support from: AbbVie and Novartis.

ObjectivesColor Doppler ultrasound (CDUS) of the temporal arteries (TA) is becoming the first test to be performed for suspected giant cell arteritis (GCA). Our aim was to assess the added value of including CDUS of large vessels (LV) in the diagnosis of GCA.MethodsWe performed an observational and retrospective study of consecutive patients with suspected GCA. Baseline CDUS of the TA and LV (axillary, subclavian, and carotid) were conducted. We defined the CDUS finding as positive if the halo sign was present.ResultsOf 198 patients with suspected GCA, 87 were eventually diagnosed with GCA: 45 (51.7%) had a cranial pattern exclusively, 31 (35.6%) had both a cranial and an LV pattern, and 11 (12.6%) had an isolated LV pattern. CDUS of the TA had a sensitivity of 83.9%, specificity of 97.3%, and positive and negative predictive values (PPV, NPV) of 96.1% and 88.5%, respectively. When LV was added, sensitivity increased to 96.6% and NPV to 98.2%. Specificity was 97.3% and PPV was 96.6%. As for LVs, the axillary, subclavian, and carotid arteries were involved in 87.8%, 77.4%, and 34.4%, respectively. Isolated axillary examination resulted in a loss of 12.2% of patients with LV involvement; however, inclusion of the axillary and subclavian arteries retained 100% of patients with LV involvement.ConclusionsDetection of GCA by ultrasound should routinely include examinations of the TA and LV (at least the axillary and subclavian arteries) to improve diagnostic accuracy. More than 12% of patients in our cohort had isolated LV involvement. Key Points• Extracranial involvement in GCA is very common: half of patients have extracranial vasculitis and more than 12% isolated LV involvement that can be demonstrated with CDUS.• Adding a CDUS examination of LV to TA increased sensitivity (from 83.9 to 96.6%) and the negative predictive value (from 88.5 to 98.2%) for diagnosis of GCA.• In our cohort, if we only examined the axillary arteries, 12.2% of the CGA with LV involvement would not have been diagnosed.• We propose a CDUS protocol that includes examination of the TA and LV (at least the axillary and subclavian arteries) routinely in cases of suspected GCA.

Background:At present, there are limited data on characteristics of non-responders to antirheumatic treatments for rheumatoid arthritis (RA).Objectives:To characterize patients who were responders/non-responders to assigned treatment for RA.Methods:RA-BE-REAL is a 3-year, multinational, prospective, observational study of adult patients with RA. Patients initiated treatment with baricitinib (cohort A) or any biologic (b) disease-modifying antirheumatic drug (DMARD) or any other targeted synthetic (ts), namely tumour necrosis factor inhibitors (TNFi) or other mechanism of action (OMA) (cohort B), for the first time. This analysis concerns a European subpopulation. [1]. Primary non-response was defined as no remission/ low disease activity (LDA) (based on CDAI) at both 3 months (M) and 6M; response as remission/LDA at both 3M/6M. Baseline characteristics for both groups are presented here descriptively; no comparative testing was conductedResults:68.7%, 56.2% and 63.3% of patients treated with baricitinib, TNFi, and OMA were responders at both 3M and 6M. More responders than non-responders were naïve to b/tsDMARDs with numerically lower HAQ and disease activity at baseline.31.3% of baricitinib treated patients, 43.8% of TNFi patients and 36.7% of those on OMA were non responders at both 3 and 6M (Table 1). Primary non-responders had numerically higher CDAI, higher HAQ-DI, lower quality of life (QoL) and a higher percentage of patients - with pain assessment >20mm reported pain at baseline than responders, and previously failed more often 2 or more b/tsDMARDs. These findings were applicable to all three cohorts (Table 1).Conclusion:We found that primary non-responders were mostly patients who had higher disease severity and physical limitations and had more treatment failures. This subgroup of patient warrants more careful follow-up and earlier intensification of treatment to allow them to achieve early remission/LDA.REFERENCES:[1] Alten R, Burmester GR, Matucci-Cerinic M, et al. Comparative Effectiveness, Time to Discontinuation, and Patient-Reported Outcomes with Baricitinib in Rheumatoid Arthritis: 2-Year Data from the Multinational, Prospective Observational RA-BE-REAL Study in European Patients. Rheumatol Ther. 2023 Dec;10(6):1575-1595.Table 1. Baseline demographics, treatment history, clinical characteristics, and quality of life information for patients who were responders and primary non-responders at six months.Only patients with data on response/ non-response were included in the study.All data are presented as n (%) unless otherwise stated.DMARD, disease-modifying anti-rheumatic drug; bDMARD, biological DMARD; BMI, body mass index; CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic DMARD; HAQ-DI, Health Assessment Questionnaire-Disability Index; RA, rheumatoid arthritis; TNFi, tumour necrosis factor inhibitor; tsDMARD, targeted synthetic DMARD; VAS, visual analogue scale (mm)Acknowledgements:Medical writing support was provided by Mr. Alan Ó Céilleachair, an employee of Eli Lilly and Company Ltd.Disclosure of Interests:Alejandro Balsa has been a speaker for Eli Lilly and Company, UCB, AbbVie, Pfizer, Galapagos, Sanofi, Nordic Pharma, Sandoz, and Gebro, Alejandro Balsa has received consulting fees from Eli Lilly and Company, UCB, AbbVie, Pfizer, Galapagos, Sanofi, Nordic Pharma, Sandoz, and Gebro and has particpated on advisory boards for Eli Lilly and Company, UCB, and Sanofi, Alejandro Balsa has received grants from AbbVie, Pfizer, and UCB, Ennio Giulio Favalli has been paid as a speaker by Galapagos, Pfizer, and Novartis, Ennio Giulio Favalli has received consulting fees from AbbVie, Galapagos, Pfizer, and Eli Lilly and Company Limited., Kei Ikeda has been a paid speaker for AbbVie, Ashai-Kasei, Eisai, Eli Lilly and Company, Gilead, and Novartis, Kei Ikeda has received grants from Mitsubishi-Tanabe, Mart van de Laar has been paid as a speaker for Eli Lilly and Company and Galapagos, Mart van de Laar has been paid as a consultant for Eli Lilly and Company and Galapagos, Mart van de Laar has received grant support from Eli Lilly and Company and Galapagos, Hendrik Schulze-Koops has been paid as a speaker by Eli Lilly and Company, Hendrik Schulze-Koops has participated on advisory boards for Eli Lilly and Company, Ewa Haladyj is a minor shareholder in Eli Lilly and Company Ltd., Ewa Haladyj is an employee of Eli Lilly and Company Ltd., Walid Fakhouri is a minor shareholder in Eli Lilly and Company Ltd., Walid Fakhouri is an employee of Eli Lilly and Company Ltd., Samuel Ogwu is a minor shareholder in Eli Lilly and Company Ltd., Samuel Ogwu is an employee of Eli Lilly and Company Ltd., Cedric Laedermann is a minor shareholder in Eli Lilly and Company Ltd., Cedric Laedermann is an employee of Eli Lilly and Company Ltd., Axel Finckh has been a paid speaker for Astra-Zeneca, AbbVie, Eli Lilly and Company, Pfizer, and MSD, Axel Finckh has received consulting fees from AbbVie, Astra-Zeneca, Eli Lilly and Company Ltd., and Pfizer, Axel Finckh’s institution has received grants from AbbVie, BMS, Eli Lilly and Company Ltd., Galapagos, and Pfizer.

Background:Giant cell arteritis (GCA) is a large-vessel granulomatous vasculitis [1,2]. It is characterized by the presence at the inflamed arterial walls, of activated PD-1+ CD4 T cells [1,2]; this contrasts with observations indicating that a defect of PD-1 signaling is implicated in the pathogenesis of GCA [2]. A population of CD4+CXCR5-PD-1 cells, termed Tph cells, has been described at the inflamed synovium and peripheral blood of patients with Rheumatoid Arthritis [3], and seem to play a pathogenic role in this condition [3].Objectives:To study the frequencies of circulating total Tph (cTph) and activated ICOS+Tph (cICOS+Tph) cells in the peripheral blood of patients with newly diagnosed GCA (nGCA) and examine whether they are related with the clinical outcome.Methods:This is a prospective non-interventional study performed on consecutive patients referred to our ultrasound (US) GCA fast track clinic, in whom newly diagnosed GCA (nGCA) was clinically confirmed (2022 ACR/EULAR criteria) over a period of 18 months. Peripheral blood was drawn immediately upon confirmation and after obtaining written informed consent. For each patient, an age and gender-matched healthy control (HC) was also studied. PBMCs isolated by Ficoll- Hypaque gradient were stained with antibodies to CD3, CD4, CD45RA, CD45RO, CXCR5, ICOS, PD-1, and examined by flow cytometry. Patients were treated with standard therapy according to clinical response.Results:A total of 60 nGCA patients were included (mean age 82 years, 58 % female). As compared with HC, nGCA patients presented at baseline with an increased frequency of cTph and ICOS+cTph cells. Among the 37 patients who could be followed up for 12 months (the remaining 23 have been diagnosed less than 12 months ago), 15 (40.5%) experienced a relapse (2018 EULAR recommendations; symptoms plus: elevation of acute phase reactants and/or positive US). Interestingly, the baseline frequency of cTph and ICOS+cTph cells had been significantly lower in patients who relapsed as compared with those who did not.Conclusion:Newly diagnosed GCA patients demonstrate an increased frequency of cTph and ICOS+cTph cells. Lower basal proportions of cTph and cICOS+cTph cells are associated with relapse.REFERENCES:[1] Weyand CM, Berry GJ & Goronzy JJ. J Leukoc Biol. 2018.[2] Zhang H, et al. Proc Natl Acad Sci U S A. 2017.[3] Rao DA, et al. Nature. 2017.Acknowledgements:NIL.Disclosure of Interests:Maria-Eugenia Miranda-Carus Gebro Pharma, BMS, Beatriz Nieto-Carvalhal: None declared, Irene Monjo-Henry: None declared, Mariela del Carmen Uyaguari Morocho: None declared, Irene Casado-Juárez: None declared, Alejandro Balsa BMS, Eugenio De Miguel: None declared.

Background:Difficult-to-manage (D2M) axial spondyloarthritis (axSpA) is an emerging concept, whose definition is yet to be established. The characterisation of these subgroup of patients is relevant, as it may contribute to a broader understanding of the reasons behind treatment failure and to the development of new therapeutic strategies [1].Objectives:To develop a predictive model to forecast patients from the early stages of treatment with b/tsDMARDs.Methods:We analysed data from an observational prospective cohort from La Paz Hospital between 2004-2019 which included patients diagnosed of axSpA initiating a b/tsDMARD, and who fulfilled one of these two definitions: a) D2M: failure to at least 2 b/tsDMARDs, b) good responders (GR): patients remaining their first bDMARD for at least 3 years or withdrawing it because of sustained disease control. Clinical, laboratory, therapy-related information and disease activity measures prior to starting the first b/tsDMARD (baseline), as well as disease activity measures 6-months after initiating it, were collected. Delta-ASDAS was estimated as the difference between baseline and 6-month ASDAS. After excluding the variables with the greater number of missing values, all the variables associated with D2M-axSpA in the univariable regression analyses were selected in order to create Classification And Regression Tree (CART) models. The cohort was randomly split into two independent groups: a training set (80%) and a validation set (20%). Later on, the CART model inputted the most associated factors with D2M-axSpA selecting an optimal cut-off point for classification. Subsequent splits were made, using the Gini index, to divide the population into two branches, until the terminal node. Finally, the model’s performance was assessed using the validation set.Results:Among the 101 patients included in the cohort, 41 (41.6%) were classified as D2M, 59 (58.4%) were male with a mean age of 43 years old. D2M patients were less frequently HLA-B27 positive, had more peripheral manifestations (enthesitis), extra-musculoskeletal manifestations (IBD), comorbidities, and scored higher in composite disease activity indices 6 months after starting a first bDMARD (but did not in baseline indices). Two different CART models were obtained, with a lesser number of patients included in the second model because of the missing values. These 2 models with their cut-off points and the probability of D2M axSpA after each step are shown in Figure 1. The first model (Figure 1, model a) had a pre-test probability of D2M of 44%, and identified BASDAI (cut-off point < 4) after 6 months of therapy with the first bDMARD and age at the beginning of the first bDMARD (cut-off point ≥ 44 years old) as the most relevant factors. The second model (Figure 1, model b) had a pre-test probability of D2M of 47%. It used delta-ASDAS (cut-off point ≥ 1.1) as the variable for the first step, and tender joint count (cut-off point < 1) after 6 months of therapy with the first bDMARD and baseline age (cut-off point ≥ 53) for the second step. After validation, the CART models achieved an AUC of 0.94 (95% CI 0.87-1) and 0.83 (95% CI 0.67-1), respectively, and both of them classified properly 83% of the patients.Conclusion:This study identified two predictive models, which may be applied using everyday information, and could identify D2M-axSpA patients only after the first 6 months of bDMARD therapy. Next step will involve further validation in an external cohort.REFERENCES:[1] Wendling D, Verhoeven F, Prati C. Is the Difficult-to-Treat (D2T) concept applicable to axial spondyloarthritis? Joint Bone Spine. 2023;90(3):105512.Figure 1.CART models predicting D2M-axSpA. The value at each node represents the most frequently expected outcome (D2M in red or GR in green).GR: good responders, D2M: difficult-to-manage, BASDAI: Bath Ankylosing Spondylitis Disease Activity, ASDAS: Ankylosing Spondylitis Disease Activity Score, TJC: tender joint count.Acknowledgements:NIL.Disclosure of Interests:Manuel Juárez: None declared, Diego Benavent Eli Lilly, Janssen and UCB Pharma, Victoria Navarro-Compán Eli Lilly, Janssen, MSD, Novartis, Pfizer and UCB Pharma, AbbVie, Eli Lilly, Galapagos, Moonlake, MSD, Novartis, Pfizer and UCB Pharma, AbbVie and Novartis, Mariana Díaz-Almirón: None declared, Marta Novella-Navarro UCB, Lilly, Galapagos and Janssen, Diana Peiteado: None declared, Alejandro Villalba Janssen, Irene Monjo-Henry Roche, Novartis, UCB and Gedeon Richter, Laura Nuño: None declared, Alejandro Balsa AbbVie, Amgen, Pfizer, Galapagos, Novartis, Gilead, BMS, Nordic, Sanofi, Sandoz, Lilly, UCB and Roche, Chamaida Plasencia-Rodríguez AbbVie, Pfizer, Novartis, Lilly and Roche.