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ObjectiveThe objective is to analyze the association between therapeutic adherence and disease activity in SLE patients.MethodsAn observational, prospective study in SLE patients (SLICC/ACR criteria), treated whit subcutaneous Belimumab (200 mg/week) was made. Disease activity was measured by SLEDAI in three consecutive visits, and it was considered clinical worsening an increase of SLEDAI-score of ≥4 point. Persistence and adherence of Belimumab data during the follow-up were collected and were calculated based on the number of drug dispensing. Poor therapeutic adherence was established under the 95%.ResultsThirty-one prescriptions of Belimumab were registered (83.9% women) with a mean age of 48.1 (14.9) years. Time since the diagnosis was 12.5 (6.29) years and treatment period were 2.2 (1.4) years. Fifteen patients were considered as non-adherent (48.4%).Persistence and disease activity data in each group were showed in the table 1.Abstract P149 Table 1Poor adherence was secondary to clinical improvement (66.67%), recurrent infections (13.33%), surgery (6.67%), pregnancy (6.67%) and inability to drug collect due to COVID-19 pandemic (6.67%). Non-adherent group showed worse SLEDAI-score than adherent group in V0, despite of a similar SLEDAI-score at V2 in both groups was observed. There was an association between poor therapeutic adherence and high delta_SLEDAI (p=0.046).ConclusionsWe observed an association between poor therapeutic adherence and delta_SLEDAI. The high SLEDAI-score at the beginning of the study in non-adherent group would be due to clinical manifestations, despite of the similar serological activity in both groups.

ObjectiveWe aimed to analyze the association between inflammatory cytokine levels (IFN-a2, IFN-b, IFN-g, IL10 and BLyS) and disease activity for a 12 months of follow-up in SLE patients.MethodsA longitudinal, observational prospective study with evaluations at baseline and follow-up visits every 3 months in SLE patients (SLICC 2012 criteria) and 65 healthy controls was performed. In SLE patients complete laboratory test, clinical evaluation and SLEDAI score was carried out. We analyzed inflammatory cytokines serum levels by colorimetric methods in all cases.Results45 SLE patients (86.7% female) participated in the study, with a mean age at diagnosis of 32.8 (16.2) years and a mean time of disease evolution of 17.9 (11.4) years. The 28.9% of patients showed SLEDAI>6 at the basal visit. The 66.7% were under glucocorticoid treatment, 44.4% under immunosupressants (methotrexate, azatioprine, belimumab or mycophenolate) and 66.7% under antimalarials. SLEDAI and inflammatory cytokine levels during follow-up is shown in table 1.Abstract P9 Table 1 CONTROLS N=65 Mean (SD) SLE V0 N=45 Mean (SD) SLE V3 N=45 Mean (SD) SLE V6 N=45 Mean (SD) SLE V9 N=45 Mean (SD) SLE V12 N=45 Mean (SD) SLEDAI score --- 6.09 (5.38) 3.53 (3.41) 5.09 (4.06) 3.71 (2.87) 3.64 (2.61) IFN-alpha2 (pg/mL) 85.53 (104.72) 202.59 (608.11) 115.24 (219.33) 170.6 (634.44) 103.21 (194.39) 157.22 (523.12) IFN-beta (pg/mL) 38.49 (35.43) 74.61 (91.24) 72.65 (114.59) 76.2 (101.37) 77.23 (114.21) 74.55 (97.51) IFN-gamma (pg/mL) 150.95 (133.14) 257.18 (413.65) 293.62 (395.65) 334.26 (485.59) 289.19 (354.71) 370.53 (794.94) IL-10 (pg/mL) 5.66 (5.45) 14.35 (21.07) 15.48 (16.92) 11.79 (15.23) 11.02 (11.14) 11.86 (11.76) BLyS (pg/mL) 2576.86 (882.64) 3073.4 (2198.6) 6232.42 (4838.81) 4111.58 (3593.74) 4812.91 (3786.77) 5432.31 (4747.82) Statistical analysis showed significant association between SLEDAI score and IL-10 (P=0.014) and IFNa2 (0.009), as well as a tendency with IFN-beta (P=0.057), independently of the time of follow-up. Regarding to clinical activity biomarkers, we observed an association between high levels of antidsDNA and elevated IFN-beta (P=0.005) and IFN-gamma (P=0.038), and low levels of C3 and an increment in IL-10 (P=0.006).Patients under antimalarials treatment during follow-up exhibit low levels of IL-10 (P=0.012) and those under belimumab treatment showed high levels of BLyS (P<0.001). No influence of age at diagnosis, time of evolution, vitamin D levels, corticoids and tobacco use in cytokine levels was observed.SLE patients were categorized by normal or high level of the five cytokines, based on the cytokine level above 2 SD of the mean in healthy controls. Despite the fact that no specific cytokine profile associated with clinical activity was observed, those patients with high SLEDAI score had increased levels of IL10.ConclusionWe observed an association between IL-10, IFN-alpha2, IFN-beta and IFN-gamma levels with clinical activity, independently of the time of follow-up. IL-10 levels may be influenced by antimalarial treatment and BLyS levels by belimumab treatment.

ObjectiveSeveral drugs have been implicated in the development of de novo systemic lupus erythematosus (SLE), unmasking of quiescent SLE or causing an exacerbation of previously diagnosed SLE. Our aim is to describe the causative drugs, clinical and serological features of patients diagnosed of Drug-Induced lupus (DIL) in our Rheumatology Department.MethodsA total of 445 patients diagnosed with SLE treated in our Rheumatology Department from 2012 to 2023 were retrospectively screened for the fulfilment of DIL criteria through the search of medical electronic records. Demographic, clinical and laboratory data were summarised using descriptive statistics.ResultsWe identified 18 patients diagnosed with DIL, representing a prevalence of 4% among all SLE patients in our Department. There was a female preponderance and a young age at disease onset. Patients’ clinical and serological characteristics are shown in table 1. Only three drugs (infliximab, adalimumab and sulfasalazine) were identified as causative agents of DIL, anti-TNF being the most common. Most patients were treated for a condition different from a rheumatic disease, mainly inflammatory bowel disease (IBD). Median time to symptom onset after drug initiation ranged from 3 to 194 weeks (median 50.4). Peripheral arthritis and skin rash were the most frequent symptoms, with 4 patients (22%) presenting both at onset. Serologically, only 2 patients were ANA negative, but tested positive for anti-dsDNA. After drug withdrawal, ANA titre showed a slow decreasing trend over time, as well as anti-dsDNA antibodies. However, only 2 patients lost ANA-positivity through follow-up. Remarkably, more than half of the patients tested positive for antiphospholipid antibodies.ConclusionDIL showed a prevalence of 4% in our Rheumatology Department. Anti-TNF agents were the most common drugs causing DIL. ANA tend to decrease over time, but only become undetectable in a few patients. Antiphospholipid antibodies are common in our DIL patients. Age at onset is earlier than previously reported, probably because causative drugs are being used in younger populations.Abstract P28 Table 1Patients’ clinical and serological characteristics Age at onset (median years; IQR) 37.6 ± 19.6 Gender (n,%) Female 14 (78%) Male 4 (22%) Baseline diagnosis Inflammatory Bowel Disease 8 (44%) Inflammatory arthritis 4 (22%) Hidrosadenitis 3 (17%) Psoriasis 2 (11%) Nonspecific Orbital Inflammation 1 (6%) Drug Infliximab 12 (66%) Adalimumab 5 (28%) Sulfasalazine 1 (6%) Time to onset after drug initiation (median weeks, range) 50.4 (3 – 194) Symptoms at onset Peripheral arthritis 9 (50%) Skin rash 4 (22%) Peripheral arthritis AND skin rash 4 (22%) Inflammatory arthralgia 1 (6%) Autoantibodies profile ANA positivity 16 (89%) Median ANA titre 1/320 Low C3 and/or C4 5 (28%) Anti-Ro 1 (6%) Antihistone positivity 0 Anti-La 0 Anti-Sm 0 Antiphospholipid antibodies (AAF) 10 (55.5%) 1 AAF 5 (28%) 2 AAF 4 (22%) 3 AAF 1 (6%)