Background: Since 2022 clinicians have been consistently aware by the European Medical Agency (EMA) of prescribing Jak-inhibitors (JAKi) after assessing a risk/benefit ratio, especially in patients with rheumatoid arthritis (RA)1. Nevertheless, during the last years, uptake of selective JAKis has consistently increased, although limited data regarding differences between selective and unselective JAKis are available to date. Objectives: To assess differences between selective and unselective JAKIs in terms of discontinuation's rate. Methods: In this retrospective study, all patients with RA treated with JAKis were prospectively enrolled from 22 Italian centres since 2017. Selective JAKi included filgotinib and upadactinib, whereas unselective JAKIs included tofacitinib and baricitinib. Reasons of discontinuation rates were: primary and secondary inefficacy, remission, adverse events [deaths, infections, onset of major cardiovascular events-(MACEs)-, deep vein thrombosis-(DVT)-, pulmonary embolism-PE, cancers]. The following variables were collected at JAKi's first prescription: sex, age, disease duration (years), smoking, BMI, comorbidities (diabetes, hypertension, dyslipidaemia, cancer, major cardiovascular events-MACEs), positive RF/ACPA, associated cDMARDs, prednisone and prednisone dosage (mg/day), previous use of JAKi, time to discontinuation (days), reasons of discontinuation, discontinuation rates for each JAKi, line of treatment, DAS28-ESR, b/tsDMARDS naïve patients. Results: 693 patients were included in study. 395 (57%) patients received baricitinib, 150 (21.7%) tofacitinib, 94 (13.6%) upadacitinib and 54 (7.8%) filgotinib. The majority of patients were treated with unselective JAKi (78.6% vs 21.4% of selective JAKi). 157 (22.7%) patients discontinued JAKI after a median time of 334 days (IQR 152-869). Details of discontinuation rates for each drug are reported in Table 1. Reasons of discontinuation were primary inefficacy (n=55, 7.9%), secondary inefficacy (n=29, 4.2%), infections (n=9, 1.3%), PE/DVT (n=6, 0.9%), cancer (n=6, 0.9%), deaths (n=2, 0.3%), and other causes (n=7, 3.5%) including remission status in 1 patient. No MACEs were observed in this cohort during the follow up period, although 348 patients (50.2%) had at least one comorbidity at baseline. Notably, both VZV infection (n=3) and DVT/PE (N=6) occurred in patients on treatment with baricitinib. Among 157 patients who discontinued JAKi, a statistical difference between selective and unselective JAKIs was found (15.9% on selective JAKi vs. 84.1% on unselective JAKI, p value <0.001 at log-rank test, Figure 1). Finally selective JAKi were withdrawn before unselective JAKi (median 173 days, IQR 129-22 vs median 401.5 days, IQR 173.5-981). Conclusion: In this real-world cohort, only a minority of patients discontinued JAKi (22.7%). Primary and secondary inefficacy were the most common reasons of JAKi's withdrawal. All TVP/PE and VZV infections occurred in the baricitinib group, probably due to different overall time of drug's exposition. Finally, selective JAKis were discontinued earlier than unselective JAKi. REFERENCES: [1] Smolen JS, et al. Ann Rheum Dis 2023. Acknowledgements: NIL. Disclosure of Interests: Maddalena Larosa UCB, ABBVIE, AMGEN, Dario Camellino AStrazeneca, Boerhinger Ingelheim GSK, and Janssen, Andrea Becciolini: None declared, Eleonora Di Donato: None declared, Giuditta Adorni: None declared, Gianluca Lucchini: None declared, Daniele Santilli: None declared, Eugenio Arrigoni: None declared, Elena Bravi: None declared, Ilaria Platè: None declared, Alessandra Bezzi: None declared, Alessandra Bezzi: None declared, Maria Cristina Focherini: None declared, Fabio Mascella: None declared, Vincenzo Bruzzese: None declared, Palma Scolieri: None declared, Simone Parisi: None declared, Maria Chiara Ditto: None declared, Enrico Fusaro: None declared, Viviana Ravagnani: None declared, Guido Rovera: None declared, Alessia Fiorenza: None declared, Rosetta Vitetta: None declared, Antonio Marchetta: None declared, Alessandro Volpe: None declared, BERND RAFFEINER: None declared, Eleonora Celletti: None declared, Myriam Di Penta: None declared, Emanuela Sabatini: None declared, Francesco Cipollone: None declared, Francesca Ometto: None declared, Cecilia Giampietro: None declared, Valeria Nucera: None declared, Aurora Ianniello: None declared, Francesca Serale: None declared, Marta Priora: None declared, Dilia Giuggioli: None declared, Carlo Salvarani: None declared, Gilda Sandri: None declared, Federica Lumetti: None declared, FRANCESCO MOLICA COLELLA: None declared, Veronica Franchina: None declared, Aldo Molica Colella: None declared, Patrizia Del Medico: None declared, Rosalba Caccavale: None declared, Marino Paroli: None declared, Giulio Ferrero: None declared, Natalia Mansueto: None declared, Romina Andracco: None declared, Matteo Colina: None declared, Simone Bernardi: None declared, Francesco Girelli: None declared, Antonella Farina: None declared, Roberta Foti: None declared, Francesco De Lucia: None declared, Giorgio Amato: None declared, Rosario Foti: None declared, Alberto Lo Gullo: None declared, Mirco Magnani: None declared, Olga Addimanda: None declared, Massimo Reta: None declared, Alarico Ariani AMGEN, JANSSEN.
Background: After the publication of the ORAL Surveillance trial1, the European Medical Agency (EMA) recently recommended prescribing JAK inhibitors (JAKi) in patients with rheumatoid arthritis (RA) only after an adequate risk/benefit assessment. Indeed, according to EMA recommendations, patients ≥65 year-old, former or current smokers, at high risk of developing major cardiovascular events (MACEs), thromboembolic events or cancers should receive JAKi only when other treatments, such as TNF-inhibitors, are not appropriate. Unlike randomised controlled trials, real-world data seem to be reassuring promising and, in fact, the prescription rate of JAKi has dramatically risen in the last years. Objectives: The primary objective was to assess whether being at high risk according to EMA recommendations can impact JAKi's discontinuation rate. The secondary aim was to find out other possible predictors of JAKi's discontinuation. Methods: This was a retrospective Italian study carried out in 22 Italian centres since 2017. All patients with RA on treatment with JAKi were included in the dataset. This cohort was subdivided into two groups: "high risk patients" and "low risk" according to EMA recommendations. The first group included patients ≥65 year-old, past or current smokers and having at least one cardiovascular or neoplastic comorbidity. The following variables were collected at baseline: sex, age, disease duration (years), smoking habit, BMI, comorbidities (diabetes, hypertension, dyslipidaemia, cancer, previous MACEs), positive RF/ACPA, associated conventional DMARDs, concomitant use of prednisone and dosage (mg/day), previous use of JAKi, discontinuation reasons, time to discontinuation (days), b/tsDMARDS naïve patients, DAS28-ESR at baseline. Results: A total of 693 patients were enrolled. 48 patients were excluded due to missing data. Overall features of our cohort are summarised in Table 1 (N=645). 372 (57.7%) patients received baricitinib, 135 (20.9%) tofacitinib, 86 (13.3%) upadacitinib and 52 (8.11%) filgotinib. 21 (3.2%). 141 (21.9%) patients discontinued JAKi after a median time of 366 days (IQR 155-914). "High-risk patients according to EMA" were the majority of our cohort (n=384, 59.5%) vs 261 "low-risk patients" (40.5%). Reasons for discontinuation were primary inefficacy (n=48, 7.4%), secondary inefficacy (n=25, 3.9%), infections (n=8, 1.2%), pulmonary embolism/deep venous thrombosis (n=6, 0.9%), cancer (n=5, 0.8%), deaths (n=2, 0.3%), and other causes (n=21, 3.3%) including remission status in 1 patient. Notably, VZV infection determined JAKi's withdrawal in 3 patients and pulmonary embolism/deep venous thrombosis in 6 patients (all treated with baricitinib). At multivariate stepwise Cox analysis, predictors of discontinuation were: prednisone dosage [Hazard Ratio -(HR)- 1.1, 95% confidence interval- (CI)- 1.05-1.17], use of selective JAKis(HR 4.1, 95% CI 1.80-9.10), and absence of RF/ACPA (HR 0.46, 95% CI 0.26-0.83). Finally, being classified as "high risk" according to EMA was not statistically associated with JAKIs' withdrawal (HR 1.96, 95% CI 0.96-4-01). Conclusion: Our study shows that only a minority of patients discontinued JAKi (21.9%). Notably, among discontinuation's causes, no MACE's were found. Being classified at "high-risk" according to EMA was not associated with JAKi's discontinuation. Conversely, higher prednisone dosages, treatment with selective JAKi and absence of RF/ACPA were predictors of JAKi's withdrawal. REFERENCES: [1] Ytterberg SR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. New Engl J Med 2022;386(4):316-326. Acknowledgements: NIL. Disclosure of Interests: Maddalena Larosa UCB, ABBVIE, AMGEN, Andrea Becciolini: None declared, Simone Parisi: None declared, Eleonora Di Donato: None declared, Dario Camellino Astrazeneca, Boerhringer INgelheim, GSK, Janssen, Giuditta Adorni: None declared, Gianluca Lucchini: None declared, Daniele Santilli: None declared, Enrico Fusaro: None declared, Maria Chiara Ditto: None declared, Alberto Lo Gullo: None declared, Marino Paroli: None declared, Rosalba Caccavale: None declared, Alessandro Volpe: None declared, Antonio Marchetta: None declared, Bernd Raffeiner: None declared, Eleonora Celletti: None declared, Myriam Di Penta: None declared, Emanuela Sabatini: None declared, Francesco Cipollone: None declared, Massimo Reta: None declared, Olga Addimanda: None declared, Mirco Magnani: None declared, Elisa Visalli: None declared, Rosario Foti: None declared, Giorgio Amato: None declared, Francesco De Lucia: None declared, Roberta Foti: None declared, Antonella Farina: None declared, Francesco Girelli: None declared, Simone Bernardi: None declared, Matteo Colina: None declared, Romina Andracco: None declared, Natalia Mansueto: None declared, Giulio Ferrero: None declared, Patrizia Del Medico: None declared, Aldo Molica Colella: None declared, Veronica Franchina: None declared, Francesco Molica Colella: None declared, Federica Lumetti: None declared, Gilda Sandri: None declared, Carlo Salvarani: None declared, Dilia Giuggioli: None declared, Marta Priora: None declared, Francesca Serale: None declared, Aurora Ianniello: None declared, Valeria Nucera: None declared, Francesca Ometto: None declared, Cecilia Giampietro: None declared, Elena Bravi: None declared, Ilaria Platè: None declared, Eugenio Arrigoni: None declared, Fabio Mascella: None declared, Maria Cristina Focherini: None declared, Alessandra Bezzi: None declared, Palma Scolieri: None declared, Vincenzo Bruzzese: None declared, Viviana Ravagnani: None declared, Guido Rovera: None declared, Alessia Fiorenza: None declared, Rosetta Vitetta: None declared, Alarico Ariani Amgen, Janssen.
Background Janus kinase (JAK) inhibitors have been approved for the treatment of Rheumatoid Arthitis (RA) and other systemic or organ-specific autoimmune diseases. Sustained remission or low disease activity are target treatments recomended by European League Against Rheumatism (EULAR) in RA patients [1]. Upadacitinib (UPA), a reversible, oral JAK inhibitor, has been engineered to have a greater selectivity for JAK1 vs JAK2, JAK3, and tyrosine kinase. In the Phase 3 SELECT clinical trial program, UPA has been shown to be effective and well tollerate in patients with RA [2]. However, data on the use of UPA in real-world clinical practice are limited. Objectives To evaluate UPA effectiveness in RA patients and to report the main reasons of suspension and the most relevant factor related to treatment persistence. Methods In 25 Italian rheumatological referral centers, all RA consecutive patients who received UPA were enrolled. Anamnestic data, treatment history and RA disease activity at baseline were recorded.The 6 and 12 months UPA retention rate was assessed with the Kaplan-Meier curve methods. The Cox analysis investigated the effect of age, sex, smoke habit, ACPA/RF presence, disease duration, DAS28-CRP, line of treatment, concomitant csDMARD treatment on UPA retention rate. A p-value < 0.05 was considered statistically significant. Results The one-hundred-eleven enrolled patients median age 57 (IQR 50-65 yrs); M:F 28:83; disease duration 78 (IQR 40-170 months). The median observation period was 6.1 (IQR 3.2-10.2) months. The observation lasted 812 patients-months. The majority of patients (54.0%) were in mono-therapy and received steroids (respectively 54.0% and 58.6%) (Table 1).The UPA retention rate at 6, 12 months was, respectively 90.4% and 74.7% (Figure 1). The main discontinuation reason was lack of efficacy (42% of interruptions), cancer onset and infections (both 11%). No thromboembolic events were reported.According to the Cox analysis, no one of the above mentioned parameters were associated to high risk of treatment interruption. Conclusion UPA effectiveness appears to be confirmed. The safety profile of UPA 15 mg in real-world practice is consistent with data from Phase 3 SELECT trials, with no new safety signals. References [1]Smolen JS, et al. Ann Rheum Diseases 2023;82:3-18.[2]Burmester GR et al.Lancet 2018; 23;391(10139):2503-2512 Acknowledgements: NIL. Disclosure of Interests None Declared.Figure 1Table 1Baseline characteristics UPACharacteristicsValueM:F28:83Age, median [IQR] yrs58 [50-65]Smokers, n (%) (**)YesFormerNo16 (16,5)17 (17,5)64 (66,0)Body Mass Index, median [IQR] kg/m^2 (*)24,7 [22,4-27,7]Disease Duration, median [IQR], months78 [40-170]RF positivity, n (%)72 (64,9)ACPA positivity, n (%)68 (61,3)SJC, median [IQR]4 [3-8]TJC, median [IQR]8 [5-11]ESR, median [IQR], mm/h32 [20-53]CRP, median [IQR], mg/dl1,2 [0,5-3,3]VAS Patient (0-100), median [IQR]70 [50-80]DAS28, median [IQR]5,5 [4,9-5,9]Line of treatment, [IQR]3 [2-4]Concomitant csDMARDs use, n (%)MTXLFNSSZHCQ41 (36,9)3 (2,7)1 (0,9)5 (4,5)Concomitant steroids use, n (%)65 (58,6)Steroids dose (PDN-Eq), median, mg/die5 [5-6]Prior bDMARDs use, n (%)TNFiIL6iIL1iCD20iCD80i53 (47,7)13 (11,7)02 (1,8)11 (9,9)Prior tsDMARDs use, n (%)BaricitinibTofacitinib9 (8,1)2 (1,8)Concomitant relevant disease, n (%)DiabetesHypercholesterolemiaMACEArterial HypertensionCancer12 (10,8)23 (20,7)5 (4,5)34 (30,6)4 (3,6)
Background The recent EULAR recommendations [1,2] suggest using JAK-inhibitors (JAKis) for treating RA patients. These drugs include both selective (upadactinib and filgotinib) and unselective (tofacitinib and baricitinib) JAKis. Objectives To describe JAKis' discontinuation rate and to determine predictors of JAKIs' discontinuation in a real life setting. Methods All patients with RA treated with JAKis were prospectively followed up for at least 12 months in this multicentric study carried out on 23 Italian centres. For each patient, the following variables were collected: sex, age, disease duration, smoking, BMI, comorbidities (diabetes, hypertension, hypercholesterolemia, cancer, major cardiovascular events), positive RF/ACPA, cDMARDs at baseline, prednisone at baseline, previous use of JAKis, discontinuation, time to discontinuation, JAKis line of treatment, DAS28-ESR at baseline, 6 and 12 months. Statistical analyses were performed using R (2022.12.0). Results 864 patients were included (Table 1). 487 (55.2%) received baricitinib, 213 (24.6%) tofacitinib, 111 (12.8%) upadacitinib and 62 (7.2%) filgotinib. 192 (22.2%) patients discontinued JAKis after a median time of 334 days (IQR 154.5-879.5). Among them, a statistical difference was found between selective-JAKis and other JAKis (p=0.03, 14.6% of selective JAKis vs 85.4% of other JAKis); finally unselective JAKis were discontinued later than selective JAKis (p<0.001, median 401.5 days, IQR 197.5-976 for unselective JAKis vs median 74 days, IQR 129-212 for selective JAKis). Discontinuation's causes are reported in Figure 1. Notably, VZV infection determined JAKis withdrawal in 4 patients and pulmonary embolism/deep venous thrombosis in 6 patients (both with baricitinib). Regarding discontinuations' causes, no differences between selective JAKis and other JAKis were found with factor logistic regression model. At multivariate analysis, predictors of discontinuation were prednisone at baseline (OR 1.48, p=0.03), treatment with unselective JAKis (OR 1.79, p=0.01), and line of treatment (OR 1.29 p<0.001). Conclusion Our study showed that only a minority of patients discontinued JAKis. Among discontinuation's causes, no differences between selective JAKis and other JAKis were found. Predictors of JAKis discontinuation were prednisone at baseline, treatment with unselective JAKis and line of treatment (with more advanced lines of treatment associated with a higher risk of discontinuation). References [1] Smolen JS, et al. Ann Rheum Dis 2020.[2] Smolen JS, et al. Ann Rheum Dis 2023. Acknowledgements: NIL. Disclosure of Interests Maddalena Larosa: None declared, Alarico Ariani: None declared, Dario Camellino Speakers bureau: Abiogen, GSK, Paid instructor for: Mylan, Andrea Becciolini: None declared, Gerolamo Bianchi: None declared, Eleonora Di Donato: None declared, Giuditta Adorni: None declared, Daniele Santilli: None declared, Gianluca Lucchini: None declared, Massimo Reta: None declared, Olga Addimanda: None declared, Alberto Lo Gullo: None declared, elisa visalli: None declared, Rosario Foti: None declared, Giorgio Amato: None declared, Francesco De Lucia: None declared, antonella farina: None declared, Francesco Girelli: None declared, Simone Bernardi: None declared, Giulio Ferrero: None declared, Romina Andracco: None declared, Marino Paroli: None declared, Natalia Mansueto: None declared, rosalba caccavale: None declared, Patrizia Del Medico: None declared, Aldo Molica Colella: None declared, Veronica Franchina: None declared, Francesco Molica Colella: None declared, Federica Lumetti: None declared, Gilda Sandri: None declared, Carlo Salvarani: None declared, Marta Priora: None declared, Aurora Ianniello: None declared, Valeria Nucera: None declared, Francesca Ometto: None declared, Ilaria Platé: None declared, eugenio arrigoni: None declared, Alessandra Bezzi: None declared, Maria Cristina Focherini: None declared, Fabio Mascella: None declared, Vincenzo Bruzzese: None declared, Palma Scolieri: None declared, Simone Parisi: None declared, Maria Chiara Ditto: None declared, Enrico Fusaro: None declared, Viviana Ravagnani: None declared, Rosetta Vitetta: None declared, Alessia Fiorenza: None declared, Guido Rovera: None declared, Alessandro Volpe: None declared, Antonio Marchetta: None declared, Matteo Colina: None declared, Elena Bravi: None declared.Table 1General features of 864 RA patientsVariableN (%)Mean age at baseline (SD) (N=863)58.79 (12.84)Females678 (78.47)Mean BMI (Kg/cm2) at baseline (SD) (N=626)25.19 (3.79)Smoking (N=799)Yes151 (18.89)No504 (63.01)Former144 (18.02)Positive RF (N=809)533 (65.88)Positive ACPA (N=796)498 (61.56)Diabetes (N=770)70 (9.09)Hypertension (N=771)302 (39.17)Hypercholesterolemia (N=769)196 (25.49)Previous MACE (N=768)47 (6.12)Previous cancer (N=770)42 (5.45)Disease duration (months), (median, IQR) (N=855)77 (30-157)Mean DAS28-ESR at baseline (SD) (N=746)5.29 (1.06)cDMARDs at baseline (N=781)287 (36.75)PDN at baseline (N=780)444 (56.92)Median dosage (IQR) of PDN (mg/day)5.00 (4.00-5.00)JAKis naïve (N=853)731 (85.70)Line of JAKis treatment1^247 (26.59)2^211 (24.42)3^181 (20.64)4^111 (12.84)5^65 (7.52)6^29 (3.35)7^12 (1.39)8^3 (0.35)9^2 (0.23)10^3 (0.35)Patients who discontinued JAKis192 (22.2)Time to discontinuation (days), (median, IQR) (N=863)334 (154.5-879.5)Legends to Table 1: RA: rheumatoid arthritis; SD: standard deviation; BMI: Body Mass Index; RF: Rheumatoid Factor; ACPA: Autoantibodies against citrullinated peptides/proteins; MACE: Major cardiovascular events; PDN: prednisone; IQR: interquartile range; DAS28-ESR: Disease Activity Score-28 for Rheumatoid Arthritis with ESR; cDMARDs: conventional Disease-modifying antirheumatic agents; JAKis: JAK inhibitors.
Background Psoriatic arthritis (PsA) is an inflammatory rheumatic disease characterized by different phenotypes in terms of joint involvement. Apremilast, PDE4 competitive inhibitor, has been introduced in the treatment of adult psoriatic arthritis (PsA) with moderate disease activity. Musculoskeletal ultrasound (MUS) is useful in the assessment of disease, treatment response and follow up in PsA patients. Choosing an effective and safe treatment over time is an increasingly urgent goal given the greater availability of indicated drugs. Objectives The aim of this study is to evaluate if MUS assessment before apremilast treatment can improvement its retention rate. Methods We enrolled consecutive patients affected by PsA (according to the CASPAR Criteria) from 15 rheumatology centers. The following data were recorded for each patient: age, gender, duration of disease, DAPSA; smoke, comorbilities; concomitant treatment; duration of therapy with apremilast; reason of sospensione, PsA phenotype (poliarticular or oligoarticular) (Table 1). All patients were divided in two subset according to the presence of a MUS assessment before apremilast treatment. The differentes between two groups were calculated by means of the Mann-Whitney and Chi-quadro tests. The Kaplan Meier curve and Cox analysis assessed the retention rate and associated factors. P values < 0.05 were considered statistically significant. Results ON Three hundred and fifty patients (m/f: 198/152; median age 60 years, IQR 52-67 years), 40% received MUS examination. In the MUS group there was a moderate disease (medium 22,9 IQR 18,2-29 vs 26,9 IQR 20,3-33,9; p=0,0006) and a prevalence of the oligoarticular pattern (73% vs 44%, p<0,0001). The retention rate was statistically higher in MUS group (Figure 1) (HR 0,57 IC95% 0,35-0,95; p=0,03). Conclusion In PSA patients treated with apremilast, MUS assessment at baseline was associated with an higher retetion rate. MUS could be useful in the PsA treatment algorithm in order to better identify those patients whose characteristics are favourable to apremilast response. References [1]\Ramona Lucchetti et al. IMAJ 2021 JULY;23(7): 412-415. [2]\Fulvia Ceccarelli et al. Clin Rheumatol. 2019 Nov;38(11):3145-3151 Acknowledgements: NIL. Disclosure of Interests None Declared.
Introduction: Enthesitis and dactylitis are difficult-to-treat features of psoriatic arthritis (PsA), leading to disability and affecting quality of life. Objective: The aim of this study is to evaluate enthesitis (using the Leed enthesitis index (LEI)) and dactylitis at 6 and 12 months in patients treated with apremilast. Methods: Patients affected by PsA from fifteen Italian rheumatological referral centers were screened. The inclusion criteria were: (a) enthesitis or dactylitisphenotype; (b) treatment with apremilast 30 mg bid. Clinical and treatment history, including PsA disease activity, were recorded. Mann–Whitney and chi-squared tests were used to assess the differences between independent groups, and Wilcoxon matched pairs signed-rank test assessed the differences between dependent samples. A p-value of <0.05 was considered statistically significant. Results: The Eph cohort consisted of 118 patients (median LEI 3); the Dph cohort included 96 patients with a median dactylitis of 1 (IQR 1–2). According to an intention to treat analysis, 25% and 34% of patients with enthesitis achieved remission (i.e., LEI = 0) in T1 and T2. The remission of dactylitis was 47% in T1 and 44% in T2. The per protocol analysis (patients observed for at least 12 months) showed that both dactylitis and LEI significantly improved in T1 (median LEI 1 (IQR 1–3)) and T2 (median LEI 0 (IQR 1–2)). Conclusion: Eph and Dph PsA patients treated with apremilast experienced a significant improvement in enthesitis and dactylitis activity. After 1 year, enthesitis and dactylitis remission was achieved in more than one-third of patients.
Background Current and previous EULAR recommendations (1,2) suggest using JAK-inhibitors (JAKis) for treating Rheumatoid Arthritis (RA). However, little is known about differences of patients who are JAK-inhibitors (JAKis) naïve and patients who have already experienced at least one JAKi. Objectives To analyse differences between JAK-naïve and JAKis not naive patients in a real life setting. Methods All patients with RA on JAKis were prospectively followed up for 12 months in this multicentric study conducted in 23 centres. For each patient, the following variables were recorded: sex, age, disease duration at JAKi prescription, smoking, BMI, comorbidities, positive RF/ACPA, DAS28-ESR at baseline, 6 and 12 months, cDMARDs and prednisone at baseline, JAKis discontinuation, JAK-naïve. Statistics were performed by R (2022.12.0). Results 864 patients were included (Table 1). Among them, 731 (84.60%) were JAKis naïve, whereas 122 (14.12%) were not naïve (missing data in 11-1.27%-patients). 473 (55.22%) patients were treated with baricitinib (JAK-naïve were 412, 87.3%), 213 (24.6%) with tofacitinib (JAKis-naïve 187, 87.79%), 111 (12.84%) with upadacitinib (JAKis-naïve 78.37%) and 62 (7.17%) with filgotinib (JAKis-naïve 72.58%). Significant differences between JAKis-naïve and not naïve were found for hypercholesterolemia (p=0.04), hypertension (p=0.02), previous cancer (p<0.001), disease duration (p<0.001), line of treatment (p<0.001). No difference was found for JAKis discontinuation (p=0.13) (Table 1). Conclusion Our data suggest that line of treatment and disease duration result higher in JAKis not naive compared to naïve ones. Notably, JAKis naïve and not naïve did not differ regarding drug discontinuation, suggesting a similar retention rate irrespective of previous JAKis. References [1] Smolen JS, et al. Ann Rheum Dis 2020.[2] Smolen JS, et al. Ann Rheum Dis 2023. Acknowledgements: NIL. Disclosure of Interests Maddalena Larosa: None declared, Andrea Becciolini: None declared, Elena Bravi: None declared, Dario Camellino Speakers bureau: Abiogen, GSK, Paid instructor for: Mylan, Ilaria Platé: None declared, eugenio arrigoni: None declared, Francesca Ometto: None declared, Eleonora Di Donato: None declared, Giuditta Adorni: None declared, Gianluca Lucchini: None declared, Daniele Santilli: None declared, Alessandra Bezzi: None declared, Maria Cristina Focherini: None declared, Fabio Mascella: None declared, Vincenzo Bruzzese: None declared, Palma Scolieri: None declared, Simone Parisi: None declared, Enrico Fusaro: None declared, Maria Chiara Ditto: None declared, Viviana Ravagnani: None declared, Gilda Sandri: None declared, Carlo Salvarani: None declared, Marta Priora: None declared, Marino Paroli: None declared, rosalba caccavale: None declared, Romina Andracco: None declared, Natalia Mansueto: None declared, Matteo Colina: None declared, Massimo Reta: None declared, Olga Addimanda: None declared, Alberto Lo Gullo: None declared, elisa visalli: None declared, Rosario Foti: None declared, Giorgio Amato: None declared, Francesco De Lucia: None declared, antonella farina: None declared, Francesco Girelli: None declared, Patrizia Del Medico: None declared, Aldo Molica Colella: None declared, Veronica Franchina: None declared, Francesco Molica Colella: None declared, Federica Lumetti: None declared, Aurora Ianniello: None declared, Valeria Nucera: None declared, Rosetta Vitetta: None declared, Alessia Fiorenza: None declared, Guido Rovera: None declared, Alessandro Volpe: None declared, Giulio Ferrero: None declared, Antonio Marchetta: None declared, Simone Bernardi: None declared, Gerolamo Bianchi: None declared, Alarico Ariani: None declared.Table 1Differences between JAKis naïve and not naïve patientsTotalTotal (N=864)JAKis naive (N=731)JAKis not naïve (N=122)P valueN (%)N (%)N(%)Mean age at baseline (SD) (N=852)58.83 (12.87)58.54 (12.92)60.61 (12.45)0.10Females (N=853)668 (78.31)564 (77.15)104 (85.25)0.05Mean BMI (Kg/cm2) (SD) (N=616)25.15 (3.77)25.18 (3.62)25.02 (4.46)0.68Smoking (N=788)0.13Yes150 (19.03)135 (19.97)15 (13.39)No496 (62.94)425 (62.87)71 (63.39)Former142 (18.02)116 (17.16)26 (23.31)Positive RF (N=800)527 (65.89)444 (64.91)83 (71.55)0.16Positive ACPA (N=787)491 (62.39)411 (61.43)80 (67.80)0.19Diabetes (N=760)68 (8.95)56 (8.78)12 (9.84)0.71Hypertension (N=761)297 (39.03)238 (37.25)59 (48.36)0.02Hypercholesterolemia (N=759)195 (25.36)155 (24.29)40 (33.06)0.04Previous MACE (N=758)47 (6.20)39 (6.13)8 (6.56)0.86Previous cancer (N=760)42 (5.52)39 (6.10)3 (2.48)<0.001Disease duration (months), (median, IQR) (N=844)76 (29-155)71 (24-142.50)142 (69-226)<0.001Mean DAS28-ESR at baseline (SD) (N=736)5.29 (1.06)5.27 (1.09)5.40 (0.89)0.22cDMARDs at baseline (N=771)280 (36.31)235 (36.21)45 (36.89)0.88PDN at baseline (N=438)438 (50.69)368 (57.38)70 (56.79)0.90Median dosage (IQR) of PDN (mg/day) (N= 438)5 (4.00-5.00)2.50 (0.00-5.00)4.00 (0.00-5-00)0.08Line of JAKis treatment (N=853)<0.0011^244 (28.60)244 (33.38)0 (0.00)2^211 (24.74)207 (28.32)4 (3.28)3^175 (20.63)172 (23.53)(3.28)4^109 (12.78)56 (7.66)53 (3.44)5^65 (7.62)32 (4.38)33 (27.05)6^28 (3.28)12 (1.64)6 (13.11)7^12 (1.41)6 (0.82)6 (4.92)8^3 (0.35)1 (0.14)2 (1.64)9^2 0.23)1 (0.14)1 (0.82)10^3 (0.35)0 (0.00)(2.46)Patients who discontinued JAKis (N=853)192 (22.51)158 (21.61)34 (27.87)0.13SD: standard deviation; BMI: Body Mass Index; RF: Rheumatoid Factor; ACPA: Autoantibodies against citrullinated proteins; MACE: Major cardiovascular events; PDN: prednisone; IQR: interquartile range; DAS28-ESR: Disease Activity Score-28 for Rheumatoid Arthritis with ESR; cDMARDs: conventional Disease-modifying antirheumatic agents; JAKis: JAK inhibitors.
ObjectivesThe persistence in therapy of rheumatoid arthritis drugs and particularly bDMARD is a limiting factor for their long-term use. The randomized controlled trials (RCTs) may not reflect real-world contexts due to strict inclusion and exclusion criteria. Baricitinib, which targets both JAK1 and JAK2, has been used in Italy for several years. The aim of this multi-center study is to assess the real world persistence on therapy of baricitinib in RA patients and to identify predictive factors of baricitinib's survival rate.MethodsThis is a retrospective, multicentric, Italian, longitudinal study. All patients were enrolled according to the following criteria: a) age ≥ 18 years old; b) diagnosed with RA according 2010 ACR/EULAR classification criteria; c) treated with baricitinib. In order to describe baricitinib clinical efficacy, the survival rate was evaluated by The Kaplan–Meier curve. Then, predictive factors of drug retention rate were assessed by performing the Cox analysis, identifying which risk factors influenced treatment persistence.ResultsOverall, we included 478 patients treated with baricitinib. Among them, 380 (79.5%) were females. Baricitinib's survival rate was 94.6% at 6 months, 87.9% at 12 months, 81.7% at 24 months and 53.4% at 48 months. The Cox analysis regression showed that a higher bDMARDs/tsDMARD line of therapy seems to be a negative prognostic factor for the drug retention rate (HR 1.26 CI 95% 1.07–1.49, p = 0.006.ConclusionReal-life study confirms baricitinib effectiveness up to 4 years, but previous treatment with bDMARDs was a negative prognostic factor for its survival rate.
Background Apremilast, an inhibitor of the phosphodiesterase 4, is indicated for Psoriatic Arthritis (PsA) treatment. The 3 years retention rate, an outcome indirectly related to efficacy, observed in clinical trials [1] is 55,5%. A single subsequent real world setting study [2] suggested a lower efficacy as it reported that the six months retention rate was about 57%. Objectives The main aim of this retrospective observational study is the assessment of apremilast 3 years retention rate in a real world PsA patients’ cohort. Moreover, the secondary objective is reporting the reasons of apremilast suspension and the most relevant factor related to treatment persistence. Methods In thirteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history and PsA disease activity (DAPSA) at baseline and after 6 and 12 months were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant. Results The three-hundred-twenty-four enrolled patients (median age 60 [InterQuartile Range IQR 52-67] yrs; female prevalence 57,0%) median observation period was 17 [IQR 7-36] months (6848 patients-months). The apremilast retention rate at 6, 12 and 36 months was, respectively, 95%, 86% and 66% (Figure 1). The main discontinuation reasons were: primary inefficacy (40% of interruptions), secondary inefficacy (18%) and gastro-intestinal intolerance (17%%). The oligo-articular onset was the only factor associated to apremilast persistence (Hazard ratio 0.57 IQR 0.34-0.96). Sex, age, and sever comorbidities (cancer, chronic infections etc) were not related to treatment discontinuation. The basal DAPSA (24.1, IQR 18.5-32.0) decreased after 6 and 12 months (respectively 14.5, IQR 10.1-22.6 and 10.5, IQR 8,0-15.2). Remission or minimal disease activity (DAPSA < 15) was achieved after 12 months in 38.0% of patients. Conclusion Almost two third of PsA patients receiving apremilast were still in treatment after 3 years. The study’s data, confirmed its efficacy and safety profile. Apremilast appear a good treatment choice in patients with oligo articular PsA or burdened by severe comorbidities. References [1]Mease et al. ACR Open Rheumatology (2020) [2]Favalli et al Clin Exp Rheum (2020) Disclosure of Interests Alarico Ariani Speakers bureau: Zentiva, Consultant of: Boeringher, Amgen, Bristol-Meyers-Squibb, Novartis, Sanofi, Novo Nordisk, Lilly, Janssen, Bruno Farmaceutici, Simone Parisi: None declared, Patrizia Del Medico: None declared, antonella farina: None declared, elisa visalli: None declared, Aldo Molica Colella: None declared, Federica Lumetti Consultant of: Amgen, rosalba caccavale: None declared, Palma Scolieri: None declared, Romina Andracco: None declared, Francesco Girelli: None declared, Elena Bravi: None declared, Matteo Colina: None declared, Veronica Franchina: None declared, Ilaria Platé: None declared, eleonora Di Donato Consultant of: Novartis, Giorgio Amato: None declared, Carlo Salvarani: None declared, Francesco De Lucia: None declared, Daniele Santilli Consultant of: Novartis, eugenio arrigoni: None declared, Flavio Mozzani Consultant of: Novartis, Abbvie, Rosario Foti: None declared, Gilda Sandri: None declared, Vincenzo Bruzzese: None declared, Marino Paroli: None declared, Enrico Fusaro: None declared, Andrea Becciolini: None declared
Background: Enthesitis is one of the typical pathological signs of spondyloarthritis such as psoriatic arthritis (PsA) and it seems to be the Primum movens of the disease. Clinical assessment of enthesitis showed to be less sensitive, compared to ultrasound (US) evaluation, in identifying enthesitis in patients with PsA [1]. OMERACT defined US enthesitis as: “hypoechoic and/or thickened insertion of the tendon close to the bone (within 2 mm from the bony cortex), which exhibits Doppler signal if active and that may show erosions, enthesophytes/calcifications as a sign of structural damage” [3] The reported prevalence of subclinical enthesitis in psoriasis (PsO) patients in different countries ranges between 7% and 20% [2]. Objectives: The main objective of this study was to estimate, by US evaluation, the prevalence of subclinical enthesitis in PsO patients without any clinical signs of enthesitis. Secondary objectives were to analyze differences, in terms of age, sex, BMI, PsO onset and diagnosis, among patients with enthesitis (active or not active), enthesopathy and without any alteration of enthesis. According to the OMERACT definition of ultrasound enthesitis, patients were divided into 4 groups: patients with active enthesitis (AE) defined as the presence of power-Doppler signal in a hypoechoic and/or thickened insertion of the tendon close to the bone; patient with enthesitis (En) defined as hypoechoic and/or thickened insertion of the tendon close to the bone without PD signal; patients with enthesopathy (Ep) defined as the presence of structural damage (erosions, enthesophytes/calcifications); patients without any alteration of enthesis (WE). Methods: Patients with at least 18 years and a diagnosis of PsO made by a Dermatologist were included. Exclusion criteria were the presence of clinical symptoms or signs of articular or entheseal involvement, diagnosis of arthritis and therapy with bDMARDs or tsDMARDs. All patients underwent US examination on grey scale and Power Doppler (PD) ultrasonography of 6 sites (Achilles, quadriceps, distal and proximal patellar, plantar fascia and triceps enthesis) bilaterally. Ultrasound was performed by an experienced sonographer, using a Logiq P9 equipped with 6-12 MHz broad band linear transducer. Data were reported as frequencies and median with interquartile range. To check differences among these four groups, we used chi-square test or Kruskall-Wallis test. P-value ≤ 0.05 is considered statistically significant. Results: We enrolled 124 consecutive psoriasis patients (47 [37.9%] female) with median age 57.7 (45.3-66.5) years, median disease duration 20.4 (10.1-30.8) years, median BMI 27 [24-29]. Patients with AE, En, Ep were 20.2% (25/124), 49.2% (61/124) and 18.5% (23/124), respectively. Patients WE (12.1%, 15/124) showed significantly lower BMI, younger age and shorter diagnostic delay compared to the other patients. All signs of enthesopathy/enthesitis were more frequently observed at Achilles (33.1%, 41/124), triceps (23.4%, 29/124), quadriceps (20.2%, 25/124), distal patellar (18.5%, 23/124) and proximal patellar (4.8%, 6/124) enthesis. Conclusion: Subclinical enthesitis is quite common in PsO patients, and about 20% showed active enthesitis. The enthesopathy seems to be more frequent in patients with increased delay in PsO diagnosis, older age and higher BMI. References: [1]Bandinelli F. et al. Ultrasound detects occult entheseal involvement in early psoriatic arthritis independently of clinical features and psoriasis severity. Clin Exp Rheumatology. Mar-Apr 2013;31(2):219-24. [2]Zuliani F. et al. Ultrasonographic detection of subclinical enthesitis and synovitis: a possible stratification of psoriatic patients without clinical musculoskeletal involvement. Clin Exp Rheumatol Jul-Aug 2019;37(4):593-599. [3]Balint P. V. et al. Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative. Ann Rheum Dis 2018 Dec;77(12):1730-1735. Disclosure of Interests: None declared.
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint inflammation and progressive disability when inflammation cannot be sufficiently controlled. Despite treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs), up to 30% of RA patients do not reach or fail to maintain a good response over time. The recent introduction of Janus kinase inhibitors (JAKis) has widened the rheumatologist's armamentarium. Filgotinib, a selective JAK1 inhibitor, has been approved by the European Medicines Agency (EMA) for treatment of RA. Phase II and III studies highlighted filgotinib safety and efficacy in RA patients naive to DMARDs or with inadequate response to csDMARDs and bDMARDs. Filgotinib is administered orally at 200 mg every day. For patients older than 75 years or with moderate to severe renal impairment, a dose of filgotinib 100 mg every day is recommended.
Background: Systemic sclerosis (SSc) is a chronic disease with frequent lung involvement. As mucociliary clearance is impaired, mucus retention and frequent pulmonary infections, increase morbidity and mortality (1). Airway clearance techniques (ACT) enhance removal of mucus from the airways. Expiratory flow accelerator (EFA) is a new technology that promotes deep and gentle drainage of the bronchial secretions, through the Venturi effect. No respiratory effort is required and no negative pressure is generated, avoiding risk of bronchial collapse (2). Objectives: The aim of this study was to describe the effectiveness of EFA in improving pulmonary symptoms in SSc patients. Methods: SSc patients with daily productive cough, frequent pulmonary exacerbations, exertional dyspnea and/or reduced physical activity were selected. All of them underwent a home-based ACT program with EFA. A Respiratory Physiotherapist (RT) trained each patient to use the device 3 times a day, 15 minutes each session. Every subject compiled the Saint George’s Respiratory Questionnaire (SGRQ) and scleroderma Health Assessment Questionnaire (SHAQ) at baseline, 30, 90 and 180 days from the beginning. Statistical analysis has been carried out with General linear model for repeated measures. A value of p<0.05 was considered statistically significant. Results: 8 patients were enrolled (M:F=1:7), median age 54 (IC95% 46-69) years. Interstitial lung disease affected the majority of them (7/8). SGRQ total score and SHAQ domain for respiratory symptoms decreased over time (p= 0.003 and p= 0.005). In particular, there was an improvement in two SGRQ domains: activities (p= 0.013) and symptoms (p= 0.005) (fig.1). Figure 1 Conclusion: This is the first study to investigate the effect of EFA technology on airway clearance in SSc patients. The observations suggest the importance of a daily ACT program with EFA in improving respiratory symptoms. This technology appear to be extremely promising in SS patient management as it is well tolerated and it has the potential to slow down the pulmonary disease progression by limiting bronchial infections. References: [1]Tyndall AJ et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis 2010;69:1809–15. [2]Zampogna E, et al. Expiratory Flow Accelerator (EFA) technique on mucus hypersecretion of COPD patients with reduced cough efficiency after a severe exacerbation. Int Clin Med 2019;3:1-6. Disclosure of Interests: Silvia faverzani: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, ernesto crisafulli: None declared, filippo nocera: None declared, eleonora di donato: None declared, Flavio Mozzani: None declared, michele riva: None declared, Daniele Santilli: None declared, lorenza monica: None declared, annalisa barbieri: None declared, lissette barone: None declared, maurizio marvisi: None declared, veronica alfieri: None declared, annalisa frizzelli: None declared, Alfredo Chetta: None declared, ALARICO ARIANI: None declared
Background: Interstitial lung disease (ILD) is the main cause of death in Systemic Sclerosis (SSc). Chest CT is the gold standard in detecting ILD although it is not easy to understand its prognostic value. ILD qualitative assessment is almost worthless. Goh et al. semi quantitative score of ILD extent is related to mortality risk but it is burdened by relevant inter/intra-readers variability. An operator independent algorithm based on voxel-wise analysis proved to identify SSc patients with an increased risk of mortality according to prediction models. Objectives: To verify if quantitative analysis of chest CT (QCT) predict 10 years-mortality in SSc patients. Methods: SSc patients with availability of a chest CT were enrolled in 13 different centers. The CT voxel-wise analysis with a free software ( www.horosproject.com ) provided QCT indexes: kurtosis, skewness, mean lung attenuation and standard deviation. Patients characteristics, autoimmune profile and pulmonary function test were collected. The follow-up interval lasted from the date of chest CT to the one of the last visit or death. Each QCT index cutoff, established in a previous study (1), clustered patients in two groups. Kaplan-Meier analysis estimated and compared survival in the above mentioned groups. p < 0.05 was considered statistically significant. Results: Five hundred sixty three SSc patients were enrolled (35938 patient-months); 52.4% had ILD detectable at CT scan. For each QCT index cutoff the cohort was split in two subgroups without differences in terms of sex, age, disease duration, autoimmune profile. All QCT indexes’ cutoff selected subgroups with statistically different survival rate (e.g in Figure 1). Figure 1 Conclusion: QCT can arise as the new gold standard in identifying SSc patients with poor prognosis. The real possibility to stratify SSc subjects according mortality risk will have a pivotal role in ILD treatment decisional process with the incoming anti-fibrotic drugs. References: [1]Ariani A et al. Rheumatology 2017 Disclosure of Interests: Alarico Ariani: None declared, Elena Bravi: None declared, Maria De Santis: None declared, Vanessa Hax: None declared, Simone Parisi: None declared, Federica Lumetti: None declared, Francesco Girelli: None declared, Marta Saracco: None declared, Fabio De Gennaro: None declared, Alessandro Giollo: None declared, Masen Abdel Jaber: None declared, Francesco Bozzao: None declared, Mario Silva: None declared, Maria Chiara Ditto: None declared, Claudia Lomater: None declared, Flavio Mozzani: None declared, Daniele Santilli: None declared, eleonora Di Donato: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Francesco Pucciarini: None declared, Lorenzo Canziani: None declared, Flavio Cesare Bodini: None declared, eugenio arrigoni: None declared, M Bredemeier: None declared, Rafael Mendonça da Silva Chakr: None declared, Amelia Spinella: None declared, Luca Idolazzi: None declared, Roberto Bortolotti: None declared, Paola Tomietto: None declared, Elisa Baratella: None declared, Saverio Tollot: None declared, Dilia Giuggioli: None declared, Fabio Fischetti: None declared, Enrico Fusaro: None declared, Nicola Sverzellati: None declared, Carlo Alberto Scirè: None declared
Material and Methods: We studied 4 patients with diffuse systemic sclerosis (3 with recent alveolitis and 1 with chronic alveolar fibrosis) who received mycophenolate mofetil(MMF) and low dose (<=10 mg/d) corticosteroids. At the beginning of their treatment and at predetermined points during the study, patients except from clinical evaluation, were submitted to pulmonary function tests (Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) and Forced Vital Capacity (FVC) and HighResolution Computed Tomography (HRCT)
Background: Interstitial Lung Disease (ILD) is the main cause of death in Systemic Sclerosis (SSc). Serious lung involvement increase the hospitalization rate and sometimes oxygen therapy is required. An prompt treatment in ILD-SSc patients is essential, but nowadays there is not a feasible method to identify patients with poor prognosis. Although chest Computed Tomography (CT) is the gold standard to detect ILD, there is no standardized assessment of its severity. Quantitative CT (QCT) is an innovative and operator independent method to assess ILD-SSc extent and severity. An increasing number of evidences confirm that QCT is extremely useful for detecting SSc-ILD with the worst prognosis. However is not well established if QCT can predict death or comorbidity associated to ILD. Objectives: The main aim of this study is to verify if QCT predict 8-years mortality or clinical worsening (i.e. hospitalization for respiratory complications or chronic oxygen therapy) in SSc. Methods: Consecutive SSc patients (according to ACR/EULAR classification criteria) from ten different centers underwent a chest CT. Their clinical history was carefully recorded in the following 96 months. A rheumatologist post-analyzed every CT with an open source DICOM viewer in order to obtain QCT indexes. Patients were clustered in two subgroups: according to QCT indexes’ cutoff previously found (see Ariani et al., 2017). The survival time of each patient was considered the time interval between the CT date and death, hospitalization related to lung worsening, beginning of chronic oxygen therapy or last medical examination Results: We enrolled 342 patients; during the 8-years follow-up 15.5% (53/342) died and 4,4% (15/342) had a clinical worsening. The Kaplan-Meier survival analysis demonstrates a worse survival in patients with QCT indexes above or below the previously observed cutoffs. (p<0.01). In particular the QCT index cutoff which the best performance was total lung kurtosis (tKurt) equal to 4.89 (p<0.0001). References: The QCT indexes’ cutoffs previously found (see Ariani, et al., 2017) identify the SSc-ILD subjects with an high risk of 8-years mortality and comorbidity. These findings suggest that QCT could became a pivotal assessment in SSc management because its role in identifying patients with poor prognosis and who deserve an early aggressive treatment. Disclosure of Interest: None declared
Background The interstitial lung disease (ILD) is the most frequent form of lung damage in Sjögren9s syndrome (SjS). The diagnosis is still nowadays challenging: there are not specific test -autoantibodies, pulmonary function test- or symptoms. Chest CT is the gold standard. Semiquantitative (SQCT) assessment (such Taouli or Goh visual scores) could estimate ILD severity or burdened by relevant inter-rater variability. Quantitative chest CT (QCT) is a promising method to assess primary or secondary ILD, but there are not studies focused on SjS-ILD. Objectives Herein we designed a study to evaluate if QCT indexes might assess differences in SjS-ILD. Methods We conducted a multicenter, cross-sectional, and retrospective study, identifying subjects affected of SjS (per modified American-European consensus criteria) and with a thorax CT ordered by local physician by any reason. We enrolled 52 cases, splitted in two cohorts according to the presence/absence of ILD on chest CT. A centralized SQCT assessment was carried out to calculate both Goh and Taouli scores. A DICOM-viewer open-source software (Horos) was used to analyse, blindly and anonymously, all CT images and to calculate QCT indexes (pulmonary (p) and total (t) kurtosis, standard deviation, skewness and mean lung attenuation). QCT indexes and SQCT scores were compared using the Spearman rank and Mann-Whitney tests. ROC curves were calculated to assess the sensibility and specificity of the QCT indexes to detect ILD. Results Median age was 70.5 (95% CI 65.47–73.0); 96.2% were female. 9 cases have ILD, and 41 were not affected - two patients not assessable. The disease duration (till CT thorax) have a median of 21 (95% CI -6 – 42.41) months. 42.3% have secondary SjS and 57.7% a primary SjS. All QCT scores, except tSDev, were statistically different in ILD comparing those without ILD; the most relevant were: pKurt 2.05 (IQR 0.389 – 3.78) vs 4.34 (IQR 2.74- 6.0), p=0.008; pSdev (105.6 (IQR 101.4 - 122.95) vs 96.4 (IQR 92.38 to 104.94), p=0.006); pSkew (1.49 (IQR 0,49 -1,94) vs 2.01 (IQR 1.59 – 2.38), p=0.011); tKurt 7.62 (IQR 3.35 – 9.31) vs 10.00 (IQR 8.60 – 11.42),p=0,012 and tSkew 2.52 (1.63 – 2.85) vs 3.04 (2.81- 3.29), p=0.005). ROC analysis showed that tSkew could best discriminate ILD and those without: 0.8 (95% CI 0.66–0.9), cut off point ≤2.89; sensitivity 88.89% (95% CI 51.8–99.7), specificity 65.85% (95% CI 49.4–79.9), p<0.001. The correlation coefficients for QCT and Goh and Taouli9s score ranges around ±0.4. Conclusions QCT indexes identified some differences between SjS-ILD and those not. These parameters could be useful both to improve imaging diagnosis and also the decision to treat those cases. This innovative tool migh open up a potential research area to be developed in SjS. Moreover, the operator independence of QCT makes it a time-saving method extremely suitable for multi-centre trials. Our pilot study have some handicaps: small sample, low number of events, different reasons for CT performing, no smoking identification, and biological differences between primary and secondary SjS. However, it could be point out that QTC could be a useful tool to identify and quantify ILD in SjS, and further data are need to ascertain this hypothesis. Disclosure of Interest None declared