Secukinumab is a novel anti-IL17 biologic treatment approved for the treatment of psoriatic arthritis (PsA). The purpose of the present study is to identify factors that can condition the retention rate of this drug in a real-world scenario. Methods: A multicentric retrospective study was conducted based on the registries of consecutive patients diagnosed with PsA who started secukinumab from January 2016 to December 2018. For purposes of Cox-regression analysis, the time spanning from the first administration of secukinumab until its interruption or the end of the follow-up was considered the independent variable. Variables of known relevance and those who demonstrated direct association with the drug retention rate were included in the model. Results: One hundred seventy-six registries were analyzed (average age at diagnosis 44.7 ± 12.1 years old, 114 females). The median retention rate of secukinumab was 636 days (95% confidence interval [CI] 542.4-729.5). Presence of peripheral arthritis (hazard ratio 0.424 [95% CI 0.213-0.847, P = .015]) and a time of evolution >6 years (hazard ratio 0.468 [95% CI 0.225-0.975, P = .043]) were the 2 variables that showed a significant influence on the drug retention rate. According to our results, patients who exhibit peripheral arthritis and those with a higher evolution time will have more probabilities of a larger secukinumab retention rate.

BackgroundIL-17 inhibition has been proved effective in patients with ankylosing spondylitis (AS) in clinical trials and it has been added to the most recent national and international treatment guidelines. However, real-world data of its use is still scarce.ObjectivesThis study aims to describe the axial spondyloartrhtitis (AxSpA) population receiving secukinumab therapy under non-experimental conditions.MethodsMulticentric observational, retrospective, longitudinal study conducted in 4 tertiary hospitals of the Madrid region. Patients over 18 y.o. With clinical diagnosis of axSpa and having received at least one dose of secukinumab were included. Medical records were reviewed to collect demographic and clinical data related to axSpA, its features and treatment. Descriptive statstic analysis with measures of central tendency and measures of variability was performed.Results143 patients, of which 68 women (47.6%) were included. Mean age was 50.6 y.o.(26-74) and average duration of the disease was 12.4 years (1-54). 105 aS patients (73.4%) and 38 non radiographic axSpA patients (26.6%). 85 of them were HLAB27 positive (62%)Observed comorbidities were hypertension (37pt, 25.8%), diabetes mellitus (12pt, 8.4%), dyslipidemia (43 pt,30.1%) and active smoking (41pt,28.7%) average BMI was 27.1 (15.8-43.4), with an obesity rate of 27.6% (29pt). Other comorbidities highlighted were ischemic heart disease (10pt, 7%), HBV infection (10pt, 7.5%), malignancy (14pt, 9.8%) and renal transplantation (2 pt, 1.4%). No HVC nor HIV infections were detected.In terms of axial disease, 97 (65.7%) patients showed grade 2 or higher sacroilitis. In sacroiliac joint MRI studies 35 patients (42.7%) had acute and chronic lesions, 13 (15.9%) had acute lesions, 17 (20.7%) had chronic lesions and 17 (20.7%) were normal. Syndesmophytes were present in 49 patients (34.5%) and hip arthropathy in 15 patients (11.4%).In addition, peripheral disease was present: 77 patients (53.8%) had arthritis, 80 patients (55.9%) had enthesitis and 9 patients (6.3%) showed dactilitis. Joint erosions in hand and feet X-rays were reported in 6 patients (6.8%).Extraarticular SpA features found were inflammatory bowel disease in 3 patients (2.1%), uveitis in 17 pts (11.9%) and psoriasis in12 pts (8.4%). 2 patients (1.4%) presented secondary amiloidosis.Regarding previous treatments, 97.2% had used NSAIDs and 38.5% glucocorticoids. 100 patients (84.1%) had received DMARDs, particularly sulfasalazine (84 pts, 58.7%). 38 patients were naïve to biologic therapy (26.6%); 36 (34.3%) had been exposed to one bDMARD, 39 (37.1%) to two and 30 (28.6%) to three or more. Besides all TNF inhibitors, 13 treatments with abatacept, tocilizumab, rituximab or ustekinumab were recorded.Average baseline BASDAI was 6.54 (0.4-12.8), and 5.01 (0-10) after 6 mo SCK therapy. Baseline BASFI was 5.8 (0.4-10) and 4.8 (0-9.6) at 6 months. Adverse events did not differ from those reported in clinical trials.ConclusionPopulation receiving SCK in real-world setting is different to clinical trials: mor...

BackgroundThe advent of biologic therapy (BT) in ankylosing spondylitis (AS) has substantially benefited patients with inadequate response to conventional therapy. However, it is known patients with inadequeate response to a 1st BT have worse response to 2nd and further lines.ObjectivesTo analyze the effectiveness of BT in biologic-naïve and biologic-experienced real-world AS patients, measuring response through change in activity indexes (ASDAS-CRP and BASDAI) and percentage of low activity and inactive disease at 12 months.MethodsData were obtained from BIOBADASER III, an ongoing observational longitudinal multicenter cohort of patients with rheumatic diseases treated with BT or targeted synthetic DMARDs. Patients were divided into 2 groups, according to their state before entering the study: BT-naïve (BTn) receiving their 1st BT, and BT-experienced (BTe) receiving their 2nd or further BT; regardless of the specific drug they received. Disease activity indexes (DAI) were collected at baseline and after 12 months of BT; mean and SD was calculated for each group and interpreted according to ASDAS disease activity states and, since not established, analogous categories previously used for BASDAI (<2 inactive, ≥2 <4 low, ≥4 <6 high, ≥6 very high)1. Clinical response was assessed by ASDAS improvement cut-offs (≥1.1 clinically important improvement (CII), ≥2 major improvement (MI)) and BASDAI CII (≥1.1)2, BASDAI change (Δ) ≥2 or BASDAI50.Results846 patients, (29.3% women, mean age 47.6 years) were included, 422 BTn and 424 BTe. Mean DAI results (table 1): at baseline, AS had high disease activity by BASDAI (>4) and ASDAS (>2.1 to <3.5). At 12 months, disease activity was low on both groups (BASDAI<4, ASDAS >1.3 to <2.1), reaching BASDAI CII; ΔBASDAI≥2 was only achieved in BTn. No group reached BASDAI50. ASDAS CII was reached in all groups, but MI was not seen. Percentage of patients achieving low disease activity and inactive disease are summarized at table 2, being overall higher for the BTn compared to the BTe group.Table 1 Mean disease activity indexes evolution Activity index Biologic-naïve (BTn ) B iologic-experienced (BTe) Baseline (SD) 12 months (SD) Δ Baseline (SD) 12 months (SD) Δ BASDAI 5.5 (2.0) n= 422 3.2 (1.0) n= 287 2.35.6 (2.3) n= 424 3.9 (2.3) n= 244 1.7 ASDAS-PCR 3.2 (1.4) n= 120 1.7 (1.0) n= 64 1.53.4 (1.5) n= 95 2.0 (0.9) n= 50 1.4Table 2 Percentage of low disease activity and inactive disease by BASDAI and ASDAS Disease activity states n,% achieved at 12 months on BTn n,% achieved at 12 months on BTe BASDAI low activity 120, 41.8%72, 29.5% BASDAI inactive disease 73, 25.4%58, 23.8% ASDAS low activity 21, 32.8%11, 22% ASDAS inactive disease 23, 35.9%15, 30%ConclusionThe mean disease activity on patients starting biologic therapy is high. A clinically important improvement is met after 12 months of therapy, irrespectively of the index used or the prior use of biologics. The delta in DAI is bigger in the biologic-naïve group who receive the 1st BT. The biologic-naïve group also reache...

BackgroundIL-17 inhibition has been proved effective in patients with ankylosing spondylitis (AS) in clinical trials and it has been added to the most recent national and international treatment guidelines. However, real-world data of its use is still scarce.ObjectivesThis study aims to analyze drug survival of secukinumab for axial spondyloarthritis (AxSpA) in a real world setting and identify response factors.MethodsMulticentric observational, retrospective, longitudinal study conducted in 4 tertiary hospitals of the Madrid region. Patients over 18 y.o. with clinical diagnosis of AxSpa and having received at least one dose of secukinumab between January 2016 and October 2018 were included. Medical records were reviewed to collect demographic and clinical data related to AxSpA, its features and treatment. Statistical analysis was performed including bivariate analisys (considering withdrawal of drug during study period or not) and survival analysis with Kaplan-Meier and Cox regression. Reasons for discontinuating therapy are described. To detect inffluential variables, demographic characteristics, HLA-B27 positivity, radiographic features, previous biologic therapies, comorbidities and extra-articular involvement were analyzed.ResultsOut of 143 patients included, 89 (62%) mantained secukinumab therapy at the end of the observation period (Dec 31, 2018), with an average drug survival time of 17 ± 8,2 months. 54 patients (38%) withdrawn therapy, due to primary ineffectiveness (26), secundary ineffectiveness (14), adverse events (7) and other reasons (7). Median time to withdrawal was 6 months (0-21). No significative differences were found between groups, but a tendency to higher number of female patients (55% vs 41%, p 0,07), non radiographic AxSpA (35% vs 27%, p 0,053) and lower HLA-B27 positivity (50% vs 65%, p 0,052) was noted in the group withdrawing therapy. Previous exposure to biologic therapy did not differ (75% vs 71%, p 0,37). Number of bDMARDs before Secukinumab therapy was also similar in both groups; the proportion of patients with previous exposure to 2 or more bDMARDs were 17% vs 22% (p 0.373). Neither differences were found in all other variables studied (demographic, hip arthropathy, syndesmophytes, extra-articular involvement -uveitis, psoriasis, inflammatory bowel disease- nor in comorbidities (tobacco exposure, hypertension, diabetes mellitus, dyslipidemia, ischemic heart disease, malignancy)ConclusionThis study assesing drug survival of secukinumab in real-world setting showed a trend to lower drug survival in comparison to clinical trial data. No differences were found in the treatment withdrawal group. Population in which secukinumab is prescribed in real-world setting differs from clinical trials, with higher previous exposure to bDMARDs and higher comorbidity.Disclosure of InterestsCarolina Merino Argumánez: None declared, Valentina Emperiale: None declared, María Martín: None declared, Marta Valero: None declared, Javier Bachiller-Corral: None declared, Beatriz Joven-Ibáñez Speakers burea...

Background:Systemic Sclerosis is a multisystem autoimmune disease characterized by fibrosis of the skin and internal organs and vascular damage. The diagnosis is usually made in the late stages, when irreversible damage has already occured. Recently, we have established new criteria to detect early cases of the disease. Performing capillaroscopy and its findings are crucial in the diagnosis of early systemic Sclerosis or “prescleroderma” and there may be changes seen in capillaries of patients without skin manifestations.Objectives:To analyze the nailfold capillaroscopy findings in patients with anti-centromere or anti-topoisomerase antibodies and evaluate their usefulness for the diagnosis of systemic sclerosis.Methods:Of a total of 255 capillaroscopy performed in our Rheumatology department, those patients with positive anti-centromere or anti-topoisomerase were selected. In all cases, capillaroscopy was performed in eight fingers, always by the same observer. The following findings were considered pathological or scleroderma pattern: Local or global capillary loss (> 20%), hemorrhages: two or more in at least two fingers and enlarged capillaries: two or more capillary with double or more caliber in at least two different fingers.Statistical analysis was performed with SPSS 19.0 program.Results:The study included 69 patients: 5 (7.2%) males and 64 (92.8%) women, 14 (20.3%) smokers, 47 (68.1%) non-smokers and 8 (11.6%) quitters. The characteristics of the patients included in the study were as follows: 20 patients (30%) were previously diagnosed of systemic sclerosis (19 limited and one diffuse), of which 4 patients had concomitant primary biliary cirrhosis Syndrome (Reynolds), 1 patient with primary biliary cirrhosis and positive anti-centomere without the presence of Raynaud, one patient diagnosed with Sjögren’s syndrome with positive anti-centromere without presence of Raynaud, 26 patients with suspected early systemic sclerosis and 21 patients with disease-specific autoantibodies in the absence of Raynaud. Nailfold capillaroscopy was normal in 32 patients (46.4%) and pathological (scleroderma pattern) in 37 patients (53.6%); we detected limited enlarged capillaries in 26.2%, generalized enlarged capillaries also in 26.2%, giant capillaries in 37.7%, local loss of capillaries in 27.9%, global loss of capillaries in 8.2%, hemorragies in small claims in 29.5% and abundant hemorrhagies in 9.8%. All patients previously diagnosed of systemic sclerosis had a pathological capillaroscopy except one. However, no changes were observed in capillaroscopy in patients who had only disease-specific autoantibodies in the absence of Raynaud’s phenomenon. While, the 26 patients who were referred for suspected systemic sclerosis (at least with the presence of Raynaud and autoantibodies) in 18 (69.9%) of these scleroderma pattern was observed with subsequent diagnosis of early systemic sclerosis or “prescleroderma”.Conclusion:Nailfod capillaroscopy is a useful and inexpensive tool for the diagnosis of systemic sclerosis. The scle...