Search

BackgroundSecukinumab (SCK) is a fully human monoclonal antibody that selectively inhibits IL-17A indicated for both axial and peripheral spondyloarthritis (SpA) and psoriatic arthritis (PsA). In this paper we present our experience with SCK since its approval, in a tertiary hospital.ObjectivesTo describe the efficacy, survival and safety of SCK treatment in real clinical practice in patients with SpA and PsA.MethodsWe performed a descriptive, retrospective analysis of patients diagnosed with SpA according to ASAS criteria and PsA according to CASPAR criteria. For this purpose, data were collected from the medical records of 75 patients treated with SCK in the rheumatology service.To evaluate efficacy in the Spa group, analytical variables (C-reactive protein (CRP)), the Ankylosing Spondylitis Disease Activity Score (ASDAS) scale and the patient’s visual analog scale (VAS) were analyzed. In the PA group, VAS and CRP were assessed at baseline and at 12 months. Survival was evaluated with respect to the causes of drug discontinuation and its association with individual baseline characteristics, such as metabolic syndrome. Safety was evaluated by analyzing intercurrent infections or neoplasms requiring discontinuation.ResultsSeventy-five patients with spondyloarthritis included in treatment with SCK were analyzed, 40 had Spa and 34 had PAs. The mean age at diagnosis was 45.1 years (SD 11.3) and the median time from diagnosis to onset of SCK was 4.5 years (IQR 1-10) (Table 1).Table 1.Baseline characteristicsSpAAPsTotalAge at diagnosis45.1 (SD11.8)44.9 (SD10.9)45.1 (SD11.3)Age at begging of SCK53.5 (SD 9.3)52.2 (SD 10)52.9 (9.6DE)Hypertension10 (25.0%)10 (29.4%)20 (27.0%)Dyslipidaemia17 (42.5%)17 (51.5%)34 (46.6%)Diabetes mellitus5 (12.5%)6 (17.6%)11 (14.9%)Body Mass Index27.9 (SD4.4)30.5 (SD8.4)29.2 (SD6.7)Tobacco14 (35.0%)10 (29.4%)24 (32.4%)Cardiovascular disease5 (12.5%)2 (5.9%)7 (9.5%)Previous sDMARD-Methotrexate13 (32.5%)24 (70.6%)37 (50%)-Leflunomide1.7% (15%)12 (35.3%)18 (24.2%)Initial corticosteroids7 (18.4%)15 (44.1%)22 (30.6%)Fifty-seven patients (76%) were on treatment with anti-TNF prior to SCK initiation. The mean number of anti-TNF prior to SCK was 1.8 (SD 1.2). Twenty-six patients (35.1%) received were on treatment with SCK at a dose of 150 mg and 48 (64.9%) with 300 mg every 4 wk. The mean CRP before starting SCK was 8.46 mg/L (SD 18.38) and VAS 4.83 (SD 2.99).Statistically significant improvement was observed in both pathologies in VAS (-2.1 SD 3.1) (p 0.003). Despite the improvement in CRP, in both groups of -3.7 mg/L (SD 15) was not statistically significant. Regarding ASDAS, in the Spa group, 2 patients (5.3%) showed great improvement (>3.1), 9 patients (23.7%) clinical improvement (>1.1), 17 patients (42.5%) improvement (The overall drug survival to date is 19.41 months (SD 13.76), 20.6 months (SD 14.8) in the Spa group and 18 (SD 12.6) in the AP group (Figure 1).Figure 1.Secukinumab survival in both groups17 patients (23%) discontinued treatment, with a median duration of 12 months (SD 4.66). 12 (70.6%) due to ineffectiveness, 1 (5.9%) by their own decision, 3 (17.6%) due to persistent mechanical pain and 1 (5.9%) due to neoplasia (gastric adenocarcinoma). The clinical variables of metabolic syndrome were evaluated (Table 1) none of these characteristics had a statistically significant association as a cause of drug discontinuation. No patient presented infections that required discontinuation of the drug. No association was detected between drug discontinuation or the development of metabolic syndrome.ConclusionIn our cohort, SCK showed a statistically significant improvement in the VAS scale in both groups. A 23.7% of patients with Spa showed clinical improvement according to ASDAS values, 5.3% showed great improvement and 42.5% showed mild improvement. The overall drug survival to date is 19.41 months (SD 13.76) slightly longer in the SpA group than in APs. SCK seems to be a safe drug as none of our patients presented infections during its use.Disclosure of InterestsNone declared

BackgroundSpondyloarthritis (SpA) is a group of inflammatory arthropathies of unknown aetiology that share several clinical, pathophysiological, serological and radiological features. In many cases the initial symptoms are insidious, leading to a delay in diagnosis and initiation of treatment. The time between the onset of symptoms and treatment is of vital importance for the prognosis of the disease.ObjectivesTo describe the clinical characteristics of the SpA cohort, to analyse the number of months from symptom onset to referral to the rheumatology department and diagnosis of SpA, as well as differences according to the referring department.MethodsRetrospective descriptive study of patients with a diagnosis of PsA according to the ASAS criteria and CASPAR criteria for the psoriatic arthritis subgroup (PsA), in a single hospital centre.We collected demographic variables separated by subgroups of peripheral and axial SpA and PsA, age at diagnosis, time from symptom onset to referral to the rheumatology department and to diagnosis, as well as differences according to the department making the referral.ResultsSeventy-five patients with SpA were analysed, 40 had peripheral and axial SpA and 35 (46.66%) PsA. Thirty-six patients (49.3%) were female (Table 1). Patients with peripheral and axial SpA had a higher mean age at diagnosis than patients with PsA. 45.1 years (SD 11.3) was the mean age at diagnosis. 73.6% of patients were referred from primary care (PC), 9.4% from traumatology, 9.4% from rehabilitation (RH), 3.8% from dermatology and 3.8% from the emergency department. The median time from first symptom to referral to rheumatology was 31.4 (SD 57.2), 7.1 (SD 38.5), 21.7 (SD 51.4) months in peripheral and axial SpA, PsA and total respectively (Table 2). The service with the longest time between symptom onset and referral to rheumatology is PC and rehabilitation for all groups. The median time from first symptom to diagnosis was 43.1 (SD 55.1), 34.4 (SD 65.8) and 39.2 (SD 59.7) months for peripheral and axial SpA, PsA and total respectively (Table 2). The time from referral to rheumatology to diagnosis of peripheral and axial SpA was 12.2 (SD 19.4), PsA 17 (SD 39.3) and total 14.3(SD 29.5) months.Table 1.Demographic characteristics and time in months according to type of SpA.Peripheral and axial SpAPsATotalAge at diagnosis45.1 (SD11.8)44.9 (SD10.9)45.1 (SD11.3)Female20 (51.3%)16 (47.1%)36 (49.3%)Hypertension10 (25.0%)10 (29.4%)20 (27.0%)Dyslipidaemia17 (42.5%)17 (51.5%)34 (46.6%)Diabetes mellitus5 (12.5%)6 (17.6%)11 (14.9%)Body Mass Index27.9 (SD4.4)30.5 (SD8.4)29.2 (SD6.7)Cardiovascular disease5 (12.5%)2 (5.9%)7 (9.5%)Cerebrovascular disease2 (5.0%)2 (5.9%)4 (5.4%)Depression1 (2.5%)1 (2.9%)2 (2.7%)Renal insufficiency1 (2.5%)1 (3.0%)2 (2.7%)Liver failure3 (7.5%)5 (14.7%)8 (10.8%)Time in months from 1st symptom to referral31.4 (SD57.2)7.1 (SD38.5)21.7 (SD51.4) 1Primary care30.9(SD10.9)7.01(SD34.1)21.07(SD35.2) 1Traumatology5 (SD1.25)5 (SD2.82)5 (SD1.48) Rehabilitation36 (SD29.14)1927.5 (SD24.75) 7Dermatology13 (SD1.41)13 (SD1.41) 3Emergency service111Time from referral to diagnosis12.2 (SD19.4)17.0 (SD39.3)14.3 (SD29.5)Time from 1st symptom to diagnosis43.1 (SD55.1)34.4 (SD65.8)39.2 (SD59.7)ConclusionIn our cohort, patients are referred to rheumatology mainly from PC, which in turn is the service with the longest delay, especially in the peripheral and axial SpA group. Patients with PsA take less time to be referred than patients with peripheral and axial SpA. Once referred to rheumatology, peripheral and axial SpA patients take less time to be diagnosed than those in the PsA group.Disclosure of InterestsNone declared

Background:Biosimilar drugs has supposed a huge savings in our health systems and there are data that conclude that they work as original molecules when we making these switchings. There are limited studies that analize these patients across the time (1-3).Objectives:Long term follow up of patients after switching from original etanercept to biosimilar drug.Methods:We reviewed 187 patients who started Etanercept original in Rheumatology department at Navarra Hospital Complex and their switch to Etanercept biosimilar with a follow-up of 18 months.Results:The switch was performed in 176 patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) and psoriatic arthritis (PsA).At 18 months of follow-up 26,1% discontinued treatment; 13% at 6 months, 9,1% at 12 months and 4% patients at 18 months. The median time in etanercept original drug before switching was 52 months.There were 46 withdrawal patients with etanercept biosimilar: 34 inefficacy, 3 skin reaction, 2 malignancies (lymphoma and GIST), 1 injection site reaction, 1 headache, 1 diarrhea, 1 recurrent urinary infection, 1 heart failure and 2 deaths. 25 patients returned to Etanercept original but 3 did not achieve good response; all of them in RA group.Conclusion:In our series 50 % of withdrawal happened at 6 months of follow-up. 73,9% had a good response with etanercept biosimilar at 18 months. The main reason to stop biosimilar drug was inefficacy.Longer-term follow-up and greater number of patients are necessary to ratify these data.References:[1]Selmi C, et al. BENEFIT: real-world effectiveness of SB4 after transition from reference etanercept in rheumatoid arthritis and axial spondyloarthritis. Clin Exp Rheumatol. 2020 Jun 30. Epub ahead of print.[2]Glintborg B, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019 Feb;78(2):192-200.[3]Tweehuysen L, et al. Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study. Arthritis Rheumatol. 2018 Sep;70(9):1408-1418.Table 1.WITHDRAWAL (months)BACK TO ENBREL (n)CONTINUEENBREL (n)TIME TO SWITCH (months)REASON FOR WITHDRAWALInefficacyA.event*CancerDeathRA2211853 14521PsA166653,515001SpA888455300TOTAL4625225234822*Infections (1), Heart failure (1), skin reaction (3), injection point reaction (1)RA: rheumatoid arthritis; PsA: psoriatic artrhritis; SpA: spondyloarthritisDisclosure of Interests:None declared

Background:The Remitting Seronegative Symmetrical Synovitis with Pitting Edema Syndrome (RS3PE) is a rare rheumatological disease, considered a benign process.Objectives:This study aims to describe its clinical features and serological markers, and also to analyze its possible association with neoplasms.Methods:An observational retrospective study was performed to assess demographic and clinical characteristics of patients diagnosed from RS3PE at a reference hospital amongst the Rheumatology and Internal Medicine departments, from 2010 to 2021.Results:Twenty-seven patients were included, with a mean age of 82.74 y.o. (IC95% 80.45-85.04; range 66 to 93), and a 51.85% proportion of males. Only 22.22% were from rural areas.All patients presented bilateral hand edema although some associated feet edema (40.74%) or morning stiffness (70.37%). Blood tests demonstrated anemia in 44.44% of patients. Inflammatory markers were elevated, such as C-Reactive Protein (29.23 mg/L, IC95% 18.17-40.29), erythrocyte-sedimentation rate (33.74 mm/hour, IC95% 24.22-43.26) and fibrinogen (531.6 mg/dL, IC95% 482.91-580.30). Only a few patients presented any autoimmune serological marker such as antinuclear antibodies (18.18%) or rheumatoid factor (8.70%).X-ray screening was realized to 22 patients. 14 showed of osteoarthritis radiologic presentation, 4 had radiological findings of chondrocalcinosis and one of them presented both. Only one patient had bone erosion.Malignancy screening was performed at diagnosis in only 29.63% of patients (all negative). During follow-up only two tumors were detected (mean accumulated follow-up: 40.37 months, IC95% 26.70-54.04; range 1 to 122) and there were adenocarcinoma primary neoplasms.All but one patient received low-dose corticosteroids, with a good and rapid response in all cases. Three patients received treatment with methotrexate (2) or leflunomide (1).Conclusion:RS3PE must be contemplated in elderly patients presenting with bilateral hand pitting edema and articular symptoms. No specific biomarkers have been described, but inflammatory reaction is often found in the absence of rheumatoid arthritis biomarkers. Rapid response to corticosteroids is prevalent. Only two neoplasms were detected during follow-up.References:[1]Paira S, Graf C, Roverano S, Rossini J. Remitting seronegative symmetrical synovitis with pitting oedema: a study of 12 cases. Clin Rheumatol. 2002 May;21(2):146-9. doi: 10.1007/pl00011218. PMID: 12086166.[2]Cobeta García JC, Martínez Burgui J. RS3PE syndrome or benign edematous polysynovitis in the elderly. Study of 8 cases. Rev Clin Esp. 1999 Dec;199(12):785-9. Spanish. PMID: 10687410.[3]Moreno Obregón F, Del Castillo Madrigal M, Díaz Narváez F, Pérez Delgado FJ. RS3PE syndrome with positive rheumatoid factor. Reumatol Clin. 2019 Nov-Dec;15(6):e168-e169. English, Spanish. doi: 10.1016/j.reuma.2017.11.009. Epub 2017 Dec 15. PMID: 29254743Disclosure of Interests:None declared

Background:With the arrival of biosimilar drugs and savings policies to make the health system sustainable, hospital managers have chosen to make changes from original molecules to biosimilar drugs.Objectives:This work aims to reflect what happens when making these switchings.Methods:We reviewed 235 patients who started Etanercept original in Rheumatology at Navarra Hospital Complex and Henares University Hospital and their switch to Etanercept biosimilar with a follow-up of 6 months.Results:The switch was performed in 174 patients with psoriatic arthritis (PsA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), juvenile idiopathic arthritis, SAPHO and spondyloarthritis.9.8% discontinued treatment: 6 RA (8.1%), 5 PsA (9.8 %) and 6 AS (20.7%); all of them in the injection presentation. 12 patient stopped treatment due to ineffecacy, 2 due to reaction at the injection site, 2 due to diarrhea and 1 due to headache. Among 88.2% of patients who returned to Etanercept original, 28.6% did not achieve good response and had to change of treatment. The median time from Etanercept original beginning until the moment of switching was 54 (40-87) months.Conclusion:In our series, approximately 10% of switching patients failed after a 6-month of follow-up; when trying to return to Etanercept original 28.6% did not achieve response.The median persistence time in the original molecule and the percentage of failures observed in AS could be two conditions to consider before switching.A longer-term follow-up and a greater number of patients are necessary to ratify these data.Table 1DISEASESTOPPED CAUSEBACK TO Etanercept originalCONTINUE Etanercept originalTIME UNTIL SWITCH (meses)ASReaction at the injection siteYesYes28ASHeadacheYesYes54ASIneffecacyYesYes126RAIneffecacyYesNo25ASDiarrheaYesYes87RAIneffecacyYesYes37PsAIneffecacyNoNo43RAIneffecacyYesYes54PsAIneffecacyYesNo93PsAIneffecacyNoNo132PsAIneffecacyYesYes62RAIneffecacyYesYes142RAReaction at the injection siteYesYes51RAIneffecacyYesNo56PsAIneffecacyYesNo40ASIneffecacyYesYes26ASDiarrheaYesYes48Disclosure of Interests:Vicente Aldasoro Speakers bureau: Roche, Abbvie, MSD, UCB, Pfizer, Menarini, Grunenthal, Gebro, Novartis, Janssen, Javier Mendizabal: None declared, Sara Perez Garcia: None declared, Guillen Sada Urmeneta: None declared, Juliana Restrepo Vélez: None declared, Natividad del Val del Amo: None declared, Inmaculada Paniagua Zudaire: None declared, Ricardo Gutiérrez Polo: None declared, Loreto Horcada: None declared, Laura Garrido Courel: None declared, C. Fito-Manteca: None declared

Objectives To describe patients with Systemic Lupus Erythematosus (SLE) treated with Belimumab (BLM). Material and methods Review of patients with SLE treated with BLM from 2012 to 2017. Results We enrolled 18 patients, 16 women and 2 men. The median age at of SLE diagnose was 34.3 (IQR 27–45.7) years and the median age at BLM start was 2.2 (IQR 38.9–47) years. The received sDMARDs median number was 2.5 (IQR 2–4). Before starting BLM 7 patients had received rituximab, 4 cyclophosphamide, 1 abatacept and 1 one efalizumab. At BLM begin 17 patients were taking prednisone, 13 hydroxycloroquine, 7 methotrexate, 1 azatioprine, 1 mycophenolate and 1 leflunomide (table 1). The median BLM bolus received was 8.5 (IQR 2–32.7) and it was stopped in 4 patients due to lack of efficacy; this 4 patients had persistence of arthritis and non of them had received bDMARD before. 13 patients had at least one antiphospholipid autoantibody positive and 4 developed antiphospholipid syndrome. The median titer of antinuclear antibodies (ANA) was 1/360 (IQR 1/160–1/1280). All patients but one had ANA positive; among them 9 patients were antiRo positive, 4 antiLa, 4 antiSm and 4 antiRNP positive antibodies. 9 patients were antiDNA positive and 5 were positive for rheumatoid factor (RF) able 1 shows SLEDAI, C3 and C4, antiDNA levels. At BLMin 5 patients had renal involvement; 3 of them improved after 3 months of treatment. Among 14 patients with joint involvement, 3 improved by month 3, 2 by month 6 and 1 by month 7 after treatment beginning. 3 patients had heart and lung disease; no one of them improved with BLM. Among 9 patients with skin disease only one showed improvement after 12 months of treatment. 9 patients had haematological disorders: 1 improved by month one, 1 by month 3, one by month 5 and 2 my month 6 of treatment. Conclusion In this series BLM improved SLEDAI and complement levels allowing sparing of maintenance corticosteroid in SLE patients.