ObjectivesTo evaluate survival in the first 4 years of treatment with Baricitinib (BARI) vs anti-TNF (TNFi), as the first biological drug (BIO-1), in patients with rheumatoid arthritis (RA).MethodsRetrospective study of patients with RA, treated with the first BIO-1, with BARI or TNFi, from September-2017 to December-2021.General data (current age, at diagnosis of RA and at the start of BIO-1) were collected; RA: evolution time, RF, ACPA; type of BIO-1: dose received, time in treatment, reason for withdrawal. Univariate analysis of drug survival was performed using Kaplan-Meyer curves and the Long Rank test to differentiate by groups. For the multivariate study, Cox regression with proportional hazards.ResultsThe study includes 96 patients with RA, who have started treatment for > 1 month with BIO-1: BARI (n: 63/66% patients) or TNFi (33/34% patients): women: 82 (96%), current mean age (SD): 62 (1) years, at diagnosis: 51 (1) years and at the start of BIO-1: 59 (1) years. 36 (37%) patients are ≥65 years old, the mean time in AR is 7.6 years and the time in BIO-1: 1.34 (2.2) years. BIO-1 was withdrawn in 34 (40%) patients: Inefficacy: 17 (18%) patients, Complications: 14 (15%) [Cardiovascular/thrombosis: 2 (2%), rash: 2 (2%), infection-neoplasia-immunogenicity: 1 (1%) patient in each], loss to follow-up: 5 (5%) and others: 2 (2%).When comparing the BARI vs. TNFI group, no differences were detected between the general data, the percentage of patients >65 years of age, or the mean time in treatment or the reasons for drug withdrawal (Table 1). However, survival in the BARI group was significantly superior to TNFi throughout the period (p=0.04; HR: 0.47, 95% CI: 0.24-0.91, p=0.026) (Figure 1A).Table 1.Characteristics of patients who receive Baricitinib (BARI) or anti-TNF as first BIO-1 (TNFi).AllN: 96BARIN: 63 (66%)TNFiN: 33 (34%)PFemale, n (%)82 (85%)56 (89)26 (79)0.2Current age, mean (SD)62 (4.2)63 (6)59 (11)0.057Age at diagnosis RA, mean (SD)51 (4.9)52.5 (7.8)48.6 (15.5)0.17Age at start of BIO-1, mean (SD)59 (2.1)60 (4.9)55.9 (9.9)0.23≥ 65 years, n (%)36 (37)27 (43)9 (27)0.39RF positive, n (%)77 (80)54 (86)23 (70)0.1ACPA positive, n (%)74 (77)50 (79)24 (73)0.56Average time in BIO-1, years (DE)1.34 (2.2)1.85 (0.5)1.32 (2.4)0.21BARI 2 mg, n (%)-23 (36)--Withdrawal of BIO-1, n (%):38 (40)20 (32)18 (55)0.15- Complication14 (15)7 (13)7 (21)-- Loss of efficacy17 (18)8 (13)9 (27)-- Loss of follow up5 (5)5 (8)--- Other2 (2)-2 (6)-Figure 1.Survival probability in patients with rheumatoid arthritis who receive the first BIO-1. A. Between TNFi drug vs Baricitinib. B. Between TNFi vs Baricitinib 2 mg or 4 mg.In patients <65 years, the greatest survival of BARI is maintained (p=0.05), being significant in the first 24 months of treatment (p=0.02). In patients ≥65 years, significance was not reached throughout the overall period (p=0.5) and in the first 24 months of treatment (p=0.06).When comparing the BARI 2 mg (n: 23/36%) and 4 mg (n: 40/64%) groups, the 2 mg group is significantly older at RA diagnosis (73 [SD: 2] years vs 56 [SD: 3] years; p<0.0001) and at the start of BIO-1 (72 [SD: 1.4] years vs 54 [SD: 2.8] years; p<0.0001). However, survival in the BARI 2 mg group was significantly higher in the first 24 months (p=0.003;) (Figure 1B): BARI 2 mg HR: 0.14, 95% CI; 0.04-0.56, p=0.005, HR BARI 4 mg: 0.44 (95% CI; 0.20-0.96, p=0.038).Conclusion1. Survival of BARI is superior to TNFi during the first 4 years of treatment, especially during the first 24 months of treatment. 2. There are no differences between the cause that causes drug withdrawal. 3. The use of the 2 mg dose of BARI predominates in patients older than 65 years, with survival being greater than TNFi, especially in the first 24 months of treatment.AcknowledgementsThe study was supported by a research grant from the Marina Baixa Association for Research in Rheumatology (AIRE-MB).Disclosure of InterestsNone declared

ObjectivesTo analyze the impact of the serum level of hydroxychlroquine (OHCLQ) on the QTc interval of the ECG, in patients with rheumatic systemic autoimmune diseases (SARD), treated with this drug for a long timeMethodsRetrospective study, among patients with SARD, treated with OHCLQ ≥ 1 year, dose 200-400 mg/day. Serum OHCLQ level was measured by liquid chromatography and QTc interval by ECG (Welch Allyn 200; SF, N York, USA). Two control groups for QTc are included: Group-1: patients with SARD not treated with OHCQ; Group-2: healthy subjects without SARD. In both, weight and current treatment and an ECG were recorded.In patients with SARD was collected: 1) Epidemiological data: age, sex, weight, concomitant diseases, current treatment. 2) SARD: diagnosis, year of diagnosis, disease evolution time, clinical and autoimmunity data, treatment and dose. 3) OHCLQ: time in treatment, toxicity, symptoms (dizziness, syncope) and serum level. 4) ECG; QTc and heart rate (HR).Results65 patients treated with OHCLQ, mean 10.8 (6.5) years are included, diagnosed with SLE: 43 (66%) patients, RA: 15 (23%), palindromic rheumatism: 4 (6%), SS1º: 2 (3 %) and PsA: 1 (1%). 63 (97%) patients are women, with a mean age (SD): 58 (14.7) years, weight: 69 (15) kg. Mean dose of OHCLQ: 221 mcg/L (64), 3.24 (1) mg/kg/day.Mean serum OHCLQ level: 166 mcg/L (6.5): 18 (28%) patients with level <100 mcg/L (mean: 63 [0.7] mcg/L) and 47 (72%) with level >100 mcg/L L (mean 195 mg/XX [94]). On ECG, mean HR: 69 bpm (10) and mean QTc interval: 429.7 (84) ms, prolonged (>440 ms) in 23 (35%) of the patients.12 (18%) patients reported dizziness at some time and 29 (45%) were being treated with a drug related to the risk of QTc prolongation: Possible (P: at authorized doses no risk of TdP): 1 (2%) patient, Conditional (C: risk under excessive dose, interactions): 13 (20%), P+C: 4 (8%), C+C: 11 (17%).When comparing the mean QTc result of the group with OHCLQ and the control groups without OHCLQ (n: 41), the QTc is higher (p=0.062) than the group of healthy subjects (n: 23) and without differences with the control group EASR (n: 18), not treated with OHCLQ (p=0.70). Among patients with OHCLQ level >100 mcg/L (n: 47) vs <100 mcg/L (n: 18), patient weight (p=0.012), level (p<0.0001), and dose in mg /kg (p=0.03), is significantly higher at levels >100 mcg/L. No relationship was observed between the OHCLQ level and the QTc result.In 6 (9%) patients the OHCLQ dose is >3 mg/kg (mean: 5.35 [1] mg/kg, HR: 73 [14] bpm, OHCLQ dose: 367 [71] mcg/L), no detected significant differences in QTc (1 patient presented QTC >440). In patients with QTc >440 ms, older patient age, QTc result, and heart rate were significant. However, the dose in mg/kg of OHCLQ was lower in the group with QTc <440 ms (p=007).ConclusionIn patients with SARD treated with maintenance doses of OHCLQ of about 3 mg/kg/day, 1) The serum level of OHCLQ is not associated with QTc prolongation on the ECG. 2) QTc is significantly related to age and heart rate. 3) The EASR per se does not affect the QTc result.Table 1.Characteristics of patients with QTc greater than or less than 440 ms and with an OHCLQ level greater than or less than 100 mcg/L.QTc >440 ms N: 23 (35%)QTc ≤440 ms N: 42 (65%)pAge, mean (SD)64 (15)56 (14.5)0.007Female, n (%)22 (96)40 (95)0.85QTc, mean (SD)454 (23.9)416 (23.7)0.0001Symptoms, n (%)4 (17)4 (10)0.77Heart rate, mean (SD)74 (10.3)67 (10.3)0.016Weight, mean (SD)69 (15.1)67 (15.6)0.61Risk factors QTc prolongation Concomitant disease, n (%)4 (17)4 (10)0.77 Drugs, n (%)14 (61)15 (36)0.18OHCLQ;Dosis, mean (SD)209 (64.5)229 (15.8)0.15Mg/kg OHCLQ, media (SD)2.91 (1.06)3.43 (1.08)0.07Years in treatment, mean (SD)9.3 (6.6)10.5 (6.5)0.48OHCLQ serum level, media (SD)174.27 (94.6)162,4 (80)0.51OHCLQ >100 mcg/LOHCLQ ≤100 mcg/LN: 47 (72%)N: 18 (28%)pOHCLQ serum level, mean (SD)166 (94)63 (96.5)0.0001QTc, mean (SD)430 (24)431 (23)0.87Dosis mg, mean (SD)221 (65)208 (66.5)0.48Mg/kg OHCLQ, mean (SD)3.32 (1.1)2.65 (1.08)0.03Years in OHCLQ, mean (SD)10.8 (6.8)11.5 (6.9)0.71Weight, mean (SD)69 (15.3)80 (15.2)0.012AcknowledgementsEl estudio fue apoyado con una beca de investigación de la Asociación para la Investigación en Reumatología de la Marina Baixa (AIRE-MB).Disclosure of InterestsNone declared

ObjectivesTo analyze the characteristics of postmenopausal women referred for the first bone densitometry (BMD), with normal results in the lumbar spine.MethodsRetrospective study of postmenopausal women, for a first BMD, at a rheumatology FLS, during February/2010-December/2021.General patient data (age, gender), osteoporosis (OP) risk factors were collected: age at menopause, parental hip fracture, body mass index (BMI), smoking and alcohol habit, drugs and potentially osteopenizing diseases, low-impact fractures in adulthood (fractures of osteoporotic origin included: vertebral, hip, humeral head and distal radius and pelvis), current treatment for OP and FRAX index.Results2.930 postmenopausal women with normal lumbar BMD are included: 505 (17%) had suffered an OP fracture: mean age (SD): 63.2 years (8.5) and of menopause 48 years (10). Among the OP risk factors: early menopause: 818 (28%) women, active smoking: 521 (18%), alcohol > 3 units: 84 (2%), parents hip fracture: 310 (11%). Among osteopenizing diseases: rheumatoid arthritis/chronic arthritis: 112 (4%) patients, inflammatory bowel disease: 44 (2%), arteritis/polymyalgia rheumatica: 35 (1%) and the rest <1%. Among the osteopenizing drugs: omeprazole: 967 (33%) patients, thyroxine: 354 (12%), oral or inhaled corticosteroids: 261 (9%) and aromatase inhibitors: 168 (6%).427 (15%) patients had had a previous OP fracture: distal radius: 188 (6%), vertebral: 146 (5%), humeral head: 46 (2%) and hip: 47 (2%). 808 (28%) patients were receiving treatment for OP: oral bisphosphonates: 518 (18%), SERM: 136 (5%), strontium ranelate: 75 (3%), denosumab: 51 (2%), teriparatide: 16 (0.7%) and zoledronate: 12 (0.5%) (Table 1).Table 1.Characteristics of patients with normal lumbar spine BMD.TOTAL BMD LS NormalN: 2.930Normal BMD LS WITH fractureN: 505 (17%)Normal BMD LS WITHOUT fractureN: 2.425 (83%)pAge in BMD, years, mean (SD)63,270.5 (7.78)60.6 (26)0.0001Menopausal age, years, mean (SD)48 (8.4)45 (5.46)48 (8.48)0.0001Early menopause, n (%)814 (28)171 (34)643 (27)0.07BMI, kg/m2, media (SD)29,1 (10.3)29.5 (17.03)28,9 (10.3)0.44Active tobacco, n (%)521 (18)40 (8)481 (20)0.06Alcohol ≥ 3 units, n (%)84 (2)10 (2)74 (3)0.85Parent hip fracture, n (%)310 (11)60 (12)250 (10)0.65Ostepenizing drug, n (%):1.750289 (57)1.461 (60)0.34  Omeprazole967 (33)178 (35)789 (33)0.60  Thyroxine354 (12)53 (10)301 (12)0.67  Corticosteroids261 (9)42 (8)219 (9)0.83  Aromatasa Inhibitor168 (6)16 (3)152 (6)0.62Treatment, n (%):808 (34)226 (48)582 (24)0.0001  Oral bisphosphonate518 (18)127 (25)391 (16)  SERM136 (5)24 (5)112 (5)0.02  Strontium ranelate75 (3)20 (4)55 (2)1  Denosumab51 (2)31 (6)20 (0.8)0.35  Zoledronate12 (0.5)10 (2)2 (<0.1)0.84  Teriparatide16 (0.7)14 (3)2 (<0.1)0.84BMD, mean Tscore (SD):  Lumbar spine0.890.04 (1.49)0.05 (1.49)0.89  Femoral neck0.70-1.3 (1.06)-0.54 (1.06)0.0001   Osteoporosis, n (%)108 (4)51 (10)57 (2)0.07    Osteopenia, n (%)981 (33)247 (49)734 (30)0.0001  Total hip-0.31-0.8 (1.12)-0.17 (1.12)0,0001FRAX with BMD, mean (SD):  Mean fracture5.2310.6 (5.79)3.99 (5.78)0.0001  Hip fracture1.543.7 (3.58)1.09 (3.58)0.0001The group with OP fractures, are significantly (Table 1): older (p<0.0001), with lower mean age of menopause (p<0.0001), receive more treatment (p<0.0001), especially oral bisphosphonates (p=0.02), have worse results in hip BMD (p<0.0001), with a higher percentage of osteopenia (50% vs 30%, p<0.0001) and worse result in FRAX of major fracture (p<0.0001) and of hip (p<0.001).ConclusionAmong the patients referred to BMD, although the result of lumbar spine is normal, 17% have suffered an OP fracture, presenting this group: 1) Older age, 2) Osteopenia in hip BMD 50%, with high risk of fracture due to FRAX and they followed treatment for OP, especially oral bisphosphonates. 3) It is advisable to simultaneously perform BMD at the lumbar and hip levels, especially in older subjectsAcknowledgementsThe study was supported by a research grant from the Marina Baixa Association for Research in Rheumatology (AIRE-MB).Disclosure of InterestsNone declared