Background: We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data. Methods: RA patients referred to three Italian tertiary Centers who started Upadacitinib were enrolled as per ACR/EULAR classification criteria and prospectively reviewed. The primary aim of this study was to assess changes in clinimetric and ultrasonographic scores through time (at baseline, after 1 month, 3 months, and 6 months from the beginning of the therapy). Secondary aims were to: (i) estimate the impact of biologic lines of treatment and concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; and (iii) find potential predictive factors associated with response to therapy. Results: Seventy-one patients (49 Females and 22 Males) were included. Clinimetric scores, including the Disease Activity Score (DAS28-CRP) and Simplified Clinical Disease Activity Index (SDAI), and US findings (synovial hypertrophy and power Doppler) significantly improved (p = 0.029, p = 0.001, p = 0.001, p = 0.001, respectively). Regression analysis revealed a significant association between the concomitant csDMARDs therapy at baseline and the lack of improvement in synovial hypertrophy [OR −4.824, p = 0.010] as well as with DAS28-CRP [OR −0.690, p = 0.045], whereas the presence of increased ESR or CRP at baseline was able to predict a significant improvement in SDAI [OR 8.481, p = 0.003]. No adverse events, such as deep venous thrombosis, pulmonary embolism, or herpes zoster virus infection, were reported during this study observation. Conclusion: Our real-life experience confirms the efficacy of Upadacitinib in terms of clinical and ultrasonographic improvement, as well as displaying a good safety profile.

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)

Population Medicine considers the following types of articles:• Research Papers -reports of data from original research or secondary dataset analyses.• Review Papers -comprehensive, authoritative, reviews within the journal's scope.These include both systematic reviews and narrative reviews.• Short Reports -brief reports of data from original research.• Policy Case Studies -brief articles on policy development at a regional or national level.• Study Protocols -articles describing a research protocol of a study.• Methodology Papers -papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.• Methodology Papers -papers that present different methodological approaches that can be used to investigate problems in a relevant scientific field and to encourage innovation.

Background Rheumatoid Arthritis (RA) is associated with increased cardiovascular (CV) morbidity and mortality and osteometabolic alterations risk, associated with chronic inflammation, the use of glucocorticoids (GC) and the reduced physical exercise.[1] Objectives The objective of the study is to cross-sectionally estimate cardiovascular risk and osteometabolic status in patients (pts) with RA and to evaluate the association with some disease parameters such as positivity of autoantibodies, disease activity and steroid therapy. Methods At the current time, 61 consecutive pts with diagnosis of RA, admitted to the Rheumatology Unit of the University Hospital of Turin, were prospectively recruited and assessed for cardiometabolic risk by the Endocrinology Unit, by undergoing laboratory and instrumental tests. Results The following prevalences were observed: arterial hypertension (52%), type 2 diabetes mellitus (7%), dyslipidemia (56%), osteoporosis (42%), and vertebral fracture (30%). At the univariate analysis, the enrolled pts were divided according to serodiagnosis, GC therapy and disease remission. No statistically significant results were highlighted stratifying population by serodiagnosis. Pts with high disease activity showed lower bone mineral density (BMD) values [BMD femoral trochanter: 0.53± 0.08 vs 0.60 ± 0.08 (g/m2), p=0.031] and T-score value on bone densitometry [T-score Femoral total: -1.88 ± 0.53 vs -1.07 ± 0.83, p=0.005], higher percentage of osteoporosis [67% vs 27%, p=0.047] and vertebral fractures [60% vs 12%, p=0.001], and higher sarcopenia score [SARC-F: 5 (3-7) vs 2 (2-4), p=0.020], in comparison with pts with remission disease. These differences were not confirmed when the population was divided according to the use of GC therapy. For CV risk factors, disease activity group showed a trend of higher prevalence compared to remission group, but without reaching statistical significance. At the multivariate analysis, advanced age (p=0.001), GC therapy (p=0.021) and copeptin (p=0.002) showed an inverse association and lumbar T-score (p=0.002) a direct one with lumbar trabecular bone score (TBS). Moreover, male gender (p=0.001) revealed a direct and significant association, while copeptin (p=0.086) an inverse and not significant one with percentage of lean mass on total densitometry, correcting for advanced age, duration of disease, GC therapy, and disease activity. In the last model, advanced age (p<0.001) and copeptin (p<0.001) showed a direct and significant association with HeartSCORE, correcting for parameters of disease while serodiagnosis, duration of disease, GC therapy, and disease activity. Conclusion At univariate analysis osteometabolic alterations were associated with disease activity, but not with GC therapy and serodiagnosis. At the multivariate analysis, the association of disease activity and TBS values, did not reach the statistical significance, probably for the loss of statistical power. However, GC therapy, as well as advanced age, low lumbar T-score and high value of copeptin, remained independently associated with lower TBS value. Disease parameters were not associated with lower percentage of lean mass at total body densitometry and higher HeartSCORE values, while advanced age and copeptin were associated with bone health and cardiovascular risk. Reference [1] Mackey RH et al. Rheum Dis Clin North Am 2018. Acknowledgements: NIL. Disclosure of Interests None Declared.Table 1Multivariate linear regression analysisCovariates associated with lumbar TBSB-coefficientCI 95%p-valueAge-0.005(-0.007- -0.002)0.001GC-0.068(-0.125- -0.011)0.021T-Score0.049(0.020-0.079)0.002Copeptin-0.014(-0.023- -0.006)0.002Covariates associated with HeartSCORE cardiovascular risk scoreB-coefficientCI 95%p-valueAge0.242(0.180-0.304)<0.001Duration of disease-0.045(-0.099-0.008)0.096RF and/or ACPA +-0.224(-1.855-1.407)0.782GC0.840(-0.454-2.135)0.195Copeptin0.345(0.172-0.518)<0.001Remission0.502(-0.848-1.853)0.454

Giant cell arteritis (GCA) is the most common primary systemic vasculitis in western countries, prevalently affecting elderly people. Both early diagnosis and regular monitoring are necessary for the correct management of GCA. Following the outbreak of the COVID-19 pandemic, government decisions aiming at reducing the contagion led to reductions in health activities, limiting them to urgent cases. At the same time, remote monitoring activities have been implemented through telephone contacts or video calls carried out by specialists. In line with these deep changes affecting the worldwide healthcare system and in consideration of the high risk of GCA morbidity, we activated the TELEMACOV protocol (TELEmedicine and Management of the patient affected by GCA during the COVID-19 pandemic) in order to remotely monitor patients affected by GCA. The aim of this study was to evaluate the effectiveness of telemedicine in the follow-up of patients already diagnosed with GCA. This was a monocenter observational study. Patients with a previous diagnosis of GCA admitted to the Rheumatology Unit of the University Hospital “Città della Salute e della Scienza” in Turin were monitored every 6–7 weeks by means of video/phone calls from 9 March to 9 June 2020. All patients were asked questions concerning the onset of new symptoms or their recurrence, exams carried out, changes in current therapy, and satisfaction with video/phone calls. We performed 74 remote monitoring visits in 37 GCA patients. Patients were mostly women (77.8%) and had a mean age of 71.85 ± 9.25 years old. The mean disease duration was 5.3 ± 2.3 months. A total of 19 patients received oral glucocorticoids (GC) alone at the time of diagnosis with a daily dose of 0.8–1 mg/kg (52.7 ± 18.3 mg) of prednisone, while 18 patients were treated with a combination of oral steroids (at the time of diagnosis, the prednisone mean dose was 51.7 ± 18.8 mg) and subcutaneous injections of tocilizumab (TCZ). During the follow-up, patients additionally treated with TCZ reduced their GC dose more than patients treated with GC alone (p = 0.03). Only one patient, who was treated with GC alone, had a cranial flare and needed to increase the dosage of GC, which led to rapid improvement. Furthermore, all patients proved very adherent to the therapies (assessed by Medication Adherence Rating Scale (MARS)) and considered this type of monitoring very satisfactory according to a Likert scale (mean score 4.4 ± 0.2 on a 1–5 range). Our study shows that telemedicine can be safely and effectively used in patients with GCA under control as a possible alternative, at least for a limited period of time, to traditional visits.

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.

Background Upadacitinib (UPA), a JAK inhibitor engineered for a greater selectivity towards JAK1, has demonstrated a favourable benefit-to-risk profile in rheumatoid arthritis (RA) patients with an inadequate response to cDMARDs and biologic agents in randomized clinical trials. However, real-life data on its efficacy and safety are limited. We herein provide the first prospective multicentre experience on UPA efficacy and safety profile in RA in a real-life context, focusing on clinimetric and ultrasonographic (US) data. Objectives The primary aim of the study was to assess changes in clinimetric and US scores between different time point observations (baseline, 1 month, 3 months and 6 months). Secondary aims were to: (i) estimate the impact of biologic line of treatment and of concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; (iii) find potential predictive factors associated with response to therapy. Methods Medical records of consecutive RA patients treated with UPA and referred to three Italian tertiary Centers were prospectively reviewed. Adult patients meeting ACR/EULAR classification criteria for RA were enrolled. Results Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation. An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time.In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs.Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice. Conclusion Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation.An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time.In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs.Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests None Declared.Figure 1Table 1Changes in clinimetric and ultrasonographic scores throughout the study period and significance levels (p values) for single comparisons between different observations in time.EndpointOverall significanceT0 vs T1T0 vs T3T0 vs T6T1 vs T3T1 vs T6T3 vs T6Synovitis grade< 0.0010.8040.090<0.001< 0.001< 0.001< 0.001PD signal grading0.0290.9140.3200.0260.0290.0090.066Tenosinovitis grading0.0120.9680.3700,0310,0180,0090,059DAS28-CRP0.0050.014< 0.001< 0.0010.2200.0150.035SDAI index< 0.0010.003< 0.001< 0.001< 0.001< 0.001< 0.001List of abbreviation: DAS28-CRP Disease Activity Score 28 – C-reactive protein, PD power Doppler, SDAI Simplified Clinical Activity Index, T0 baseline, T1 1 month evaluation, T3 3 month evaluation, T6 6 month evaluation

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 Sjogren's syndrome (SSj) is a systemic disease with autoimmune pathogenesis, with prevalent involvement of the lacrimal and salivary exocrine glands, classified as primary or secondary on the basis of the association with other rheumatic diseases.The epidemiological data in the literature are variable due to the heterogeneity of the populations examined and the different classification criteria used.In a recent systematic review by Baodon Qin et al. In a recent systematic review by Baodon Qin et al. the average incidence rate was 7 cases every 100,000 people/year (range 5-9) with higher values in the Caucasian and Asian populations, with a women/men ratio of 9.3 (95% CI 3.35 to 13.18), while the prevalence rate was 61 cases per 100,000 inhabitants (range 10-90) with a female/male ratio of 10.7 (95% CI 7.35-15.62). Objectives The aim of the study was to estimate the prevalence rate of primary SSj in real-life, through analysis of administrative data. Methods An epidemiological research was carried out as at 31 December 2020, through the analysis of all adult patients residing in Piedmont (northwest of Italy) with exemption code (EC) for SSj (code 030) and any association with other ECs for rheumatological pathologies or for pathologies considered according to the 2016 EULAR/ACR classification criteria; specifically, the EC were considered for rheumatoid arthritis, ulcerative colitis and Crohn's disease, chronic hepatitis (active), HIV infection, affected subjects from malignant neoplastic pathologies, tumors of uncertain behavior, systemic lupus erythematosus, Hashimoto's thyroiditis, undifferentiated connective tissue disease; mixed cryoglobulinemia, antiphospholipid antibody syndrome (primary form), primary and familial amyloidosis, hereditary/familial autoinflammatory syndromes, microscopic polyangiitis, polyarteritis nodosa, sarcoidosis, dermatomyositis, polymyositis, mixed connective tissue disease, progressive systemic sclerosis. Results There were 3889 patients with EC for SSj as at 31 December 2020, of which 2611 with active EC.The number of assisted people alive with the aforementioned exemption was 2601, while those with other exemptions in the list were 1020. Of these patients, 1581 had only the exemption from code 030 as at 31 December 2020; the distribution of the other pathologies analyzed is shown in the tables below (Table 1).Of the total number of patients with active exemption, 2442 were female, while 159 were male, with a female/male ratio of 15.3; the distribution by gender is shown in Figure 1.Considering that the Piedmont population on 31 December 2020 was 4 274 945 inhabitants (ref: National Institute of Statistics), the estimated prevalence rate was 4.7 cases per 10 000 inhabitants. Conclusion This research has some limitations, including the retrospective design and the use of administrative data which may be affected by the aforementioned difficulty of classification as well as incorrect attributions of exemption, both for SSj and for associated pathologies.Our research highlights a number of patients with primary SSj lower than the prevalence figure that defines a rare disease, i.e. a prevalence of less than 5 cases per 10,000 inhabitants.Further studies are needed to confirm these preliminary data. Reference [1]Baodong Qin et al. Ann Rheum Dis. 2015 Nov;74(11):1983-9. Acknowledgements: NIL. Disclosure of Interests None Declared.Figure 1Distribution by gender of patients residing in Piedmont with exemption for Sjogren's Syndrome. F: Female; M: MaleTable 1Distribution of EC in patients residing in Piedmont as at 31/12/2020Diseases with ECN of patientsRheumatoid Arthritis250Ulcerative colitis and Crohn's disease18chronic hepatitis52HIV infection2Systemic Lupus Erythematosus122Subjects affected by malignant neoplastic pathologies330Hashimoto's thyroiditis280Undifferentiated Connective Tissue Sisease86Mixed Cryoglobulinemia6Antiphospholipid Antibody Syndrome8Primary And Familial Amyloidosis3Hereditary/Familial Autoinflammatory Syndromes1Microscopic Polyangiitis2Polyarteritis Nodosa1Sarcoidosis5Dermatomyositis2Polymyositis5Mixed connective tissue disease25Progressive systemic sclerosis56

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 In real-life setting, a greater number of elderly rheumatoid arthritis (RA) patients with impaired glomerular filtration rate (GFR) needs treatment with biologic or target synthetic disease-modifying anti-rheumatic drugs (b/tsDMARD) to achieve disease control and reduce NSAIDs intake. Long-term observational data from the real-life on the use of b/tsDMARD in these patients are scarce. Objectives The aim of this study was to evaluate the retention rate of b/tsDMARD in RA patients with impaired GFR in real-life setting. Methods Data of RA patients treated with at least one b/tsDMARD were retrospectively analyzed form the national Italian GISEA registry from January 2016 to December 2021. Estimated-GFR (eGFR) was calculated with the Cockcroft-Gault equation at the time of any b/tsDMARD prescription. For the purpose of this study, patients were divided in two groups, patients with impaired GFR (eGFR ≤60) and patients with normal GFR (eGFR >60). The retention rate was calculated by the Kaplan-Meier method and compared between these two groups by a log-rank test. Results The study population included 2443 treatment-line with b/tsDMARD from 1888 patients (female 80.4%, age 57±12 years, mean baseline CDAI 17±12, FR/ACPA+ 69.5%) who started a new b/tsDMARD. Disease characteristics are shown in Table 1. 288 treatments with b/tsDMARD were started in patients with impaired eGFR and 2155 in patients with normal eGFR. Compared to patients with eGFR >60, patients with eGFR ≤60 showed higher HAQ-DI (1.3±0.8 vs 1±0.8, p<0.001) at the start of b/tsDMARD treatment. Glucocorticoids were more prescribed in patients with impaired eGFR (80.2% vs 72.8%, p<0.01), while csDMARDs were more prescribed in association with b/tsDMARD in patients with normal eGFR (83.1% vs 76.4%, p<0.01). Of note, CTLA4-Ig treatment was more prescribed in patients with impaired eGFR (26% vs 17.1%, p<0.05), while no difference in b/tsDMARD prescription was observed for other mechanism of actions. Drug survival was similar between RA patients with impaired eGFR [58.2%, mean survival time 35 months (CI95% 31-39)]and RA patients with normal eGFR [55%, mean survival time 34.4 months (CI95% 33-36), log rank: 0.88] (Figure 1). Cox regression model adjusted for age, sex and b/tsDMARD showed no impact of eGFR on drug survival [HR: 0.9 (CI95%: 0.7-1.2). Conclusion Our data show that impaired eGFR seems to not influence the persistence of b/tsDMARD treatment in RA patients. Disclosure of Interests None declared

Background Patients with autoimmune systemic diseases (ASDs) can be counted among frail populations as regards the predisposition to COVID-19 due to the frequent visceral organ involvement and comorbidities, as well as the ongoing immunomodulating treatments. Objectives Our long-term multicenter telephone survey prospectively investigated the prevalence, prognostic factors, and outcomes of COVID-19 in Italian ASD patients during the first 3 pandemic waves. Methods A large series of 3,918 ASD patients (815 M, 3103 F; mean age 59±12SD years) was consecutively recruited at the 36 referral centers of COVID-19 & ASD Italian Study Group. In particular, ASD series encompassed the following conditions: rheumatoid arthritis (n: 981), psoriatic arthritis (n: 471), ankylosing spondylitis (n: 159), systemic sclerosis (n: 1,738), systemic lupus (172), systemic vasculitis (n: 219), and a miscellany of other ASDs (n: 178). The development of COVID-19 was recorded by means of telephone survey using standardized symptom-assessment questionnaire (1). Results A significantly increased prevalence of COVID-19 (8.37% vs 6.49%; p<0.0001) was observed in our ASD patients, while the cumulative death rate revealed statistically comparable to the Italian general population (3.65% vs 2.95%; p: ns). In particular, among the 328 ASD patients complicated by COVID-19, 57 (17%) needed hospitalization, while mild-moderate manifestations were observed in the large majority of individuals (83%). In addition, 12/57 hospitalized patients died due to severe interstitial pneumonia and/or cardiovascular manifestations. Interestingly, a significantly higher COVID-19-related death rate was observed in systemic sclerosis patients compared to the Italian general population (6.29% vs 2.95%; p=0.018). Other adverse prognostic factors to develop COVID-19 were the patients’ older age, male gender, pre-existing ASD-related interstitial lung involvement, and chronic steroid treatment. Conversely, patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) showed a significantly lower prevalence of COVID-19 compared to those without (3.58% vs 46.99%; p=0.000), as well as the chronic administration of low dose aspirin in a subgroup of SSc patients (with 5.57% vs without 27.84%; p=0.000). Conclusion The cumulative impact of COVID-19 on ASD patients after the first 3 pandemic waves revealed less severe than that observed during the first phase of pandemic (1), especially with regards to the death rate that was comparable to the Italian general population in spite of the increased prevalence of complicating COVID-19 in the same ASD series. Ongoing long-term treatments, mainly csDMARDs, might usefully contribute to generally positive outcomes of in this frail patients’ population. Of note, a significantly increased COVID-19-related mortality was recorded in only SSc patients’ subgroup, possibly favored by pre-existing lung fibrosis. Among different ASD, SSc deserves special attention, since it shares the main pathological alterations with COVID-19, namely the interstitial lung involvement and the endothelial injury responsible for diffuse microangiopathy. Besides SSc, the patients’ subgroups characterized by older age, chronic steroid treatment, pre-existing interstitial lung disease, and/or impaired COVID-19 vaccine response (1-3), may deserve well-designed prevention and management strategies. References [1]Ferri C, et al. Ann Rheum Dis. 2020 Oct 14 doi: 10.1136/annrheumdis-2020-219113. [2]Ferri C et al. J Autoimmun. 2021 Dec;125:102744. doi: 10.1016/j.jaut.2021.102744. [3]Visentini M et al. Ann Rheum Dis. 2021 Nov 24. doi: 10.1136/annrheumdis-2021-221248 Disclosure of Interests None declared

Background AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars. However, there is lack of data on the switch between biosimilars. The current evidence on the safety, efficacy, and immunogenicity of switching multiple times from a biosimilar to another biosimilar comes from a limited number of randomized-controlled trials and real world evidence studies. Objectives The aim of our work was to evaluate the disease activity trend after multiple switching from ADA originator-Humira (oADA) to its biosimilars (bsADA; ABP 501 and SB5 subsequently) in a cohort of inflammatory arthritis patients. Methods In this real-life study, we selected patients with clinical diagnosis of rheumatoid Arthritis (RA), psoriatic Arthritis (PsA) and ankylosing spondylitis (AS). Patients had been previously treated with oADA and switched to the bsADA (first ABP 501 and then SB5). At each outpatient visit, we recorded demographic features (age, sex, and time since diagnosis) and the following disease activity measures: DAS28, DAPSA, BASDAI and the HAQ. Rheumatoid factor (RF), anti-citrullinated protein antibody (ACPA), C-reactive protein (CRP) and HLAB27 were also measured over the observational period (visits 0, 12, 24 and 36 months). The disease activity was evaluated during the year before the introduction of the bsADA, and then evaluated in the following 36 months during the first and the second bsADA treatment. We also examined whether some baseline characteristics, such as the duration of ADA treatment, concomitant therapy, comorbid disease and baseline disease activity, could influence the bsADA discontinuation. Results We evaluated the 3-year drug survival and efficacy of the multiple switch of bsADA in RA, PsA and AS patients, previously treated with oADA in 127 patients (Table 1). All the patients enrolled underwent a first switch lasting one year and then a second switch with a follow up of one year too. The 1-year retention rate for ABP501 was 84.4%, 78% and 76% in AS, RA and PsA patients, respectively. The 1-year retention rate for SB5 was 82.1%, 78,7% and 77,5% in AS, RA and PsA patients, respectively. Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years (Figure 1). Comorbid disease (HR: 3.04, p < 0.001) and HAQ at baseline (HR: 2.12, p = 0.001) significantly increased the risk of ADA discontinuation, while previous ADA duration was positively associated with bsADA retention rate (HR: 0.83, p = 0.0024). 27.4% patients left the study due to the interruption of the bsADA, 76.5% discontinued due to inefficacy and 23.5% due to adverse events. Table 1. Baseline characteristics of RA, PsA and AS patients Characteristics Total cohort N=127 RA N=41 PsA N=52 AS N=34 Female gender (%) 75 (60) 35 (85) 31 (59) 9 (26) Age (years) 61.7±12.78 60.5±12.64 61.55±11.6 56.3±10.71 Disease duration (years) 15.86±9.49 17.23±10.64 13.75±6.57 14.92±9.50 Comorbidities, (%) 17,8 (14) 5,7 (14) 9,8 (19) 2 (6) ACPA+, n (%) - 25 (63.3) - - RF+, n (%) 24 (62.5) HLAB27+, n (%) - - 8 (15) 17 (50) CRP (mg/L) 1.65±2.27 2.31±1.90 0.42±0.27 1.36±1.91 DAS 28 - 2.65±0.75 DAPSA - 8.25±3.69 BASDAI - 3.23±1.58 HAQ 0.73±0.57 0.72±0.55 0.73±0.52 0.76±0.69 Prednisone, n (%) 46 (36) 23 (55) 20 (44) 3 (13) Combo Therapy 65 (51) 29 (68) 25 (48) 11 (32) oADA duration (months) 49.74±40.75 56.43±41.27 25.00±13.67 40.08±37.78 ABP501 duration (months) 12.42±2.41 12.77±2.34 12.82±1.49 12.49±2.95 SB501 duration (months) 11.92±1.41 12.47±1.74 12.72±1.49 12.41±1.95 ABP501 (Adalimumab biosimilar, Amgevita), SB501 (Adalimumab biosimilar, Imraldi) Conclusion No difference was found between oADA and bsADA in terms of efficacy. This real-life study confirms the similar efficacy profile of multiple switch bsADA with long-term retention and a good safety profile in inflammatory arthritis patients. References [1]Feagan BG et al. Adv Ther. 2020 Nov;37(11):4491-4518. doi: 10.1007/s12325-020-01472-1. Epub 2020 Sep 10. Disclosure of Interests None declared

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