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 Recently, the new class of drugs, namely targeted synthetic (ts) DMARDs, has broadened the possibilities of treating rheumatoid arthritis (RA). In particular, Janus Kinase inhibitors (JAKi) are used in RA and are currently represented by four drugs: baricitinib, tofacitinib, upadacitinib and filgotinib. One of the first to be used in Italy was baricitinib, a JAKi acting on JAK1 and JAK2. Objectives The aim of this study was to evaluate the clinical efficacy of baricitinib in a real-life setting in a cohort of RA patients. Methods This multicenter retrospective observational study included patients from 25 rheumatology centers diagnosed with RA and treated with baricitinib. The following were recorded for each patient: gender; age; duration of disease; presence of rheumatoid factor and anti-citrulline antibodies; concomitant treatment with conventional synthetic (cs) DMARDs; previous treatments with biological (b) or ts DMARDs. In order to evaluate the clinical efficacy, the retention rate was evaluated, calculated by means of the Kaplan-Meier method. The variables under examination were reported as frequencies and median with relative interquartile range. Results We included 478 patients of which 380 (79.5%) were female. 286 (60.1%) patients tested positive for rheumatoid factor (RF) and 264 (55,2%) for anti-citrulline antibody (ACPA). The parameters analyzed are shown in Table 1. 105 (22.0%) patients were treated with baricitnib as first line (after csDMARD), the remaining patients had failed at least one bDMARD and 9 (1.9%) also failed a tsDMARD. In 34,7% of cases baricitinib was used as monotherapy, the most frequently used csDMARD was methotrexate (29.2%). The median period of therapy was 674 days (298-1087).The survival rate at 6 months was 94.6%, at 12 months it was 87,9%, at 24 months was 81.7% and at 48 months was 53.4% (Figure 1).The main causes that led to the discontinuation of baricitinib therapy were: primary ineffectiveness (7,3%), secondary ineffectiveness (4.2%) and adverse events (3,7% 5 TEP/DVT). The concomitant steroid therapy seems to be a negative prognostic factor (HR 1,65 95% CI 1.03-2.63; p=0.035) as well as the line of therapy (HR 1.35 95% CI 1.15-1.58; p=0.000). Conclusion The efficacy of baricitinib in the treatment of RA in a real-life context appears consistent with what was reported by the pivotal studies. Furthermore, from this preliminary experience, seropositivity and combo therapy seems to not correlate with a better retention rate, while concomitant steroid therapy and line of treatment are a negative prognostic factor. References [1] Guidelli GM et al. Clin Exp Rheumatol. 2021 Jul-Aug;39(4):868-873.[2] Spinelli FR et al. Clin Exp Rheumatol. 2021 May-Jun;39(3):525-531. Acknowledgements: NIL. Disclosure of Interests None Declared.Figure 14 year retention rate of baricitinibTable 1CharacteristicsValueM:F98:380Age, median [IQR] yrs60 [51-70]Smokers, n (%) (**)YesFormerNo84 (18,8)76 (17,0)288 (64,2)Body Mass Index, median [IQR] kg/m^2 (*)24,8 [23,0-27,0]Disease Duration, median [IQR], months78 [32-163]RF positivity, n (%)286 (60,1)ACPA positivity, n (%)264 (55,2)SJC, median [IQR]5 [3-8]TJC, median [IQR]8 [4-12]ESR, median [IQR], mm/h33 [20-46]CRP, median [IQR], mg/dl1,3 [0,5-2,9]VAS Patient (0-100), median [IQR]70 [50-80]DAS28, median [IQR]5,4 [4,8-6,1]Line of treatment, [IQR]2 [2-3]Concomitant csDMARDs use, n (%)MTXLFNSSZHCQ140 (29,2)11 (2,3)3 (0,6)12 (2,5)Concomitant steroids use, n (%)237 (49,6)Steroids dose (PDN-Eq), median, mg/die5 [4-5]Prior bDMARDs use, n (%)TNFiIL6iIL1iCD20iCD80i164 (34,3)84 (17,6)08 (1,7)54 (11,3)Prior tsDMARDs use, n (%)Tofacitinib9 (1,9)Concomitant relevant disease, n (%)DiabetesHypercholesterolemiaMACEArterial HypertensionCancer36 (7,5)119 (24,9)28 (5,9)179 (37,4)24 (5,0)

The human leukocyte antigen (HLA)-B*27 family of alleles is strongly associated with ankylosing spondylitis (AS), a chronic inflammatory disorder affecting the axial and peripheral joints, yet some HLA-B*27 variants not associated with AS have been shown. Since no major differences in the ligandome of associated compared to not-associated alleles have emerged, a plausible hypothesis is that the quantity rather than the quality of the presented epitopes makes the difference. In addition, the Endoplasmic Reticulum AminoPeptidases (ERAPs) 1 and 2, playing a crucial role in shaping the HLA class I epitopes, act as strong AS susceptibility factors, suggesting that an altered peptidome might be responsible for the activation of pathogenic CD8+ T cells. In this context, we have previously singled out a B*27:05-restricted CD8+ T cell response against pEBNA3A (RPPIFIRRL), an EBV peptide lacking the B*27 classic binding motif. Here, we show that a specific ERAP1/2 haplotype negatively correlates with such response in B*27:05 subjects. Moreover, we prove that the B*27:05 allele successfully presents peptides with the same suboptimal N-terminal RP motif, including the self-peptide, pDYNEIN (RPPIFGDFL). Overall, this study underscores the cooperation between the HLA-B*27 and ERAP1/2 allelic variants in defining CD8+ T cell reactivity to suboptimal viral and self-B*27 peptides and prompts further investigation of the B*27:05 peptidome composition.

Objective. To compare etanercept and adalimumab biosimilars (SB4 and ABP501) and respective bioriginators in terms of safety and efficacy in a real-life contest. Methods. We consequently enrolled patients affected by rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, treated with SB4, and ABP501, or with corresponding originators, belonging to the main biological prescribing centers in the Lazio region (Italy), from 2017 to 2020. Data were collected at recruitment and after 4, 8, 12, and 24 months of therapy. Results. The multicenter cohort was composed by 455 patients treated with biosimilars [SB4/ABP501 276/179; female/male 307/146; biologic disease-modifying anti-rheumatic drug (b-DMARD) naïve 56%, median age/ interquartile range 55/46-65 years] and 436 treated with originators (etanercept/adalimumab 186/259, female/ male 279/157, b-DMARD naïve 67,2%, median age/interquartile range 53/43-62 years). No differences were found about safety, but the biosimilar group presented more discontinuations due to inefficacy (p<0.001). Female gender, being a smoker, and being b-DMARD naïve were predictive factors of reduced drug survival (p=0.05, p=0.046, p=0.001 respectively). The retention rate at 24 months was 81.1% for bioriginators and 76.5% for biosimilars (median retention time of 20.7 and 18.9 months, respectively) (p=0.002). Patients with remission/low disease activity achievement at 4 months showed a cumulative survival of 90% to biosimilar therapy until 24 months (p=0.001); early adverse reactions instead represented a cause of subsequent drug discontinuation (p=0.001). Conclusions. Real-life data demonstrated a similar safety profile between biosimilars and originators, but a reduced biosimilar retention rate at 24 months. Biosimilars could be considered a valid, safe, and less expensive alternative to originators, allowing access to treatments for a wider patient population.

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 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 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 The assessment of joint disease in psoriasis (PsO) patients is paramount, particularly where consensus among dermatology and rheumatology specialists is necessary. Objectives To evaluate the prevalence of psoriatic arthritis (PsA) in PsO patients and assess how a novel 16-item visual instrument (PsA-Disk) correlates with the disease and its clinical manifestations. Methods Data were prospectively collected from 8 dermatological/rheumatological centres across Italy. During their first dermatological visit, patients completed both PEST (Psoriasis Epidemiology Screening Tool) and PsA-disk questionnaires. Rheumatological visit was performed in order to confirm presence/absence of PsA. Clinimetric and disease activity variables were recorded. Results From a total of 239 PsO patients, 120 (50.2%) patients were diagnosed with PsA. More PsA-positive patients had nail PsO (54.2% vs. 42%, p=0.05) and a PEST score ≥3 vs. PsA-negative patients (77.5% vs. 37.8%, p<0.001). PsA-positive patients presented with significantly higher ESR (21.9±17.1 vs. 15.9±10.2 mm/h, p=0.041), NAPSI-feet (10.2±9.7 vs. 3.9±7.8, p=0.002), NAPSI-(hands+feet; 9.3±6.8 vs. 4.6±7.9, p=0.007), and PsA-Disk scores (73.9±32.1 vs. 58.1±39.8, p<0.001) vs. PsA-negative patients. PsA-patients with axial involvement had higher PsA-Disk scores (86.7 vs. 72.5, p=0.088) as well as patients with knee arthritis (98.4 vs. 71.5, p=0.006). PsA-Disk scores were also positively correlated with number of swollen (r=0.2, p<0.05) and tender joints (r=0.24, p=0.021), patient- (r=0.4, p<0.001) and physician-pain-VAS (r=0.33, p<0.001), PGA-VAS (r=0.23, p=0.025), physician-HAQ (r=0.38, p=0.011), DAS-44 (r=0.25, p=0.023) and DAPSA scores (r=0.31, p=0.005) (figure 1A). Examples of the powerful visual use of this instrument can be seen in figure 1B. Conclusions PsA-Disk is a novel instrument helping both dermatologist and rheumatologist in the rapid assessment PsA, facilitating in the timely therapeutic management of these patients. Disclosure of Interest None declared