Background:Secukinumab is a human monoclonal antibody directed against IL-17A, approved for the treatment of psoriatic arthritis (PsA) and ankylosing spondylitis (AS). The safety profile of secukinumab was favourable in clinical studies, but there is still scarce evidence in clinical practice. Similarly, we currently have less data regarding the real survival of secukinumab compared to other biological therapies such as anti-TNF.Objectives:To analyze the retention rate and safety of secukinumab as well as the causes and factors associated with its survival in patients with ankylosing spondylitis and psoriatic arthritis in real clinical practice.Methods:we conducted a retrospective longitudinal observational multicenter study of all patients with PsA and Spondyloarthritis (SpA) who had received at least one dose of secukinumab. Adverse events and drug retention were considered the main variables. In addition, we collected variables predicting drug retention. We estimated the total adverse event rate, by severity and type of event, and drug retention (mean duration and retention at 6 months, 1 year and 2 years), all with 95% confidence intervals (95% CI). Survival was analyzed using Kaplan-Meier curves and predictive factors using Cox regression, with the Hazard Ratio (HR) as a measure of the association.Results:154 patients were included, 59 with PsA (38%) and 95 with SpA (62%), with a mean age of disease onset of 49 years (SD ± 11), being 55% men. The mean disease duration was 6.5 years (ICR 2-8). The median number of previous biologics was 2 (SD ± 1). Secukinumab was the first line of treatment in 13 patients (8%), the second line in 46 (30%), the third line in 54 (35%) and subsequent lines in 41 (27%). The median survival of secukinumab was 23 months (ICR 5-32), with a 1-year retention rate of 66% and a 2-year retention rate of 43%. The most frequent cause of discontinuation was inefficacy (59%) and the second one was adverse events (AE) (36%). Most patients who discontinued due to AEs (71%) did so during the first 6 months of treatment. Only 2 major cardiovascular events were collected, and 2 cases of Crohn’s disease occurred during the exposure. The factors identified as predictors of survival for secukinumab were: duration of disease (HR 0.96, 95% CI 0.93-0.99 p=0.012), number of previous biologics (HR 1.18, 95% CI 1.04-1.34 p=0.011), male gender (HR 0.63, 95% CI 0.43-0.90 p=0.013), obesity (HR 0.31, 95% CI 0.18-0.54 p=0.000) and depression (HR 2.54, 95% CI 1.64-3.94 p=0.000).Conclusion:In this study of real clinical practice, secukinumab showed a 66% retention rate at one year in a population mostly refractory to biological therapy. The main cause of discontinuation was lack of efficacy. The AAs that led to drug discontinuation occurred mainly in the first 6 months of treatmentAcknowledgments:Raquel Linge, Agnes Díaz and Juan CalatayudDisclosure of Interests:Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Sara Alonso Castro: None declared, Sabela Fernández: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Lilian Consuelo Charca Benavente: None declared, Marina Pino Martínez: None declared, Leyre Riancho-Zarrabeitia Grant/research support from: Yes, Speakers bureau: Yes, Isla Morante Bolado: None declared, Montserrat Santos Gómez: None declared, Anahy Brandy-Garcia: None declared, Elena Aurrecoechea: None declared, Loreto Carmona Grant/research support from: Novartis Farmaceutica, SA, Pfizer, S.L.U., Merck Sharp & Dohme España, S.A., Roche Farma, S.A, Sanofi Aventis, AbbVie Spain, S.L.U., and Laboratorios Gebro Pharma, SA (All trhough institution), Rubén Queiró Silva: None declared
Background:Currently available information on disease factors associated with a high life impact on axial spondyloarthritis (axSpA) is still very limited. Therefore, information on disease factors associated with a high life impact is crucial for the optimal management of this condition.Objectives:To define disease factors associated with a high disease impact (HDI) in axSpA.Methods:Post hoc analysis of a cross-sectional observational study conducted in 111 consecutive patients diagnosed with axSpA1. We defined the Assessment of SpondyloArthritis international Society-Health Index (ASAS HI) functioning and health status groups thresholds using the Ankylosing Spondylitis Disease Activity Score (ASDAS) as external anchor. To establish the ASAS HI cut-off, receiver operating characteristic (ROC) curves of the different activity categories of the ASDAS were constructed. A multivariate analysis was carried out to evaluate the disease factors associated with HDI.Results:Median ASDAS was 2.1 (IQR: 1.5-2.7). Average score for ASAS-HI was 5.4 ± 3.8 (IQR: 3-8). ASAS HI values > 6, area under the ROC curve 0.86 (95%CI: 0.78-0.92), identified the patients belonging to the groups of high-very high disease activity. Among the study population, 69 patients had an ASAS HI ≤ 6 while 42 showed an ASAS HI > 6 (Table 1). In the multivariate regression model, HLA-B27 [OR 0.15 (95%CI: 0.05-0.48), p=0.001], NSAID intake [OR 5.4 (95%CI: 1.2-23.3), p=0.023, and a family history of SpA [OR 3.1 (95%CI: 1.01-10.6), p=0.043] were independently related to HDI.Table 1.Disease features among patients with and without high disease impactFeatureASAS HI ≤ 6 (n: 69)ASAS HI > 6 (n: 42)P-valuesAge, yrs (SD)42.7 (11.2)44.3 (9.8)NSDisease duration, yrs (SD)7.6 (7.5)7.8 (5.2)NSMen, n (%)49 (71)25 (59.5)NSWomen, n (%)20 (29)17 (40.5)NSAS, n (%)47 (68.1)27 (64.3)NSFamily history, n (%)6 (8.7)10 (23.8)0.040HLA-B27, n (%)62 (89.9)26 (61.9)0.001Education level: -Primary, n (%)25 (36.2)18 (42.9)NS -Secondary, n (%)20 (29)14 (33.3) -University, n (%)24 (34.8)10 (23.8)CVRF: -Smoking, n (%)25 (36.2)19 (45.2)NS -Obesity, n (%)8 (11.6)10 (23.8) -Diabetes, n (%)3 (4.3)3 (7.1) -HBP, n (%)9 (13)5 (11.9) -Dyslipidemia, n (%)17 (24.6)9 (21.4)Radiographic features: -Bilateral SI, n (%)57 (82.6)30 (71.4)NS -Squaring, n (%)13 (18.8)9 (21.4) -Syndesmophytes, n (%)12 (17.4)9 (21.4)SpA-associated features: -Enthesitis, n (%)7 (10.1)1 (2.4)NS -Anterior uveitis, n (%)12 (17.4)2 (2.8)0.045 -IBD, n (%)2 (2.9)4 (9.5)NSFibromyalgia, n (%)0 (0)3 (7.1)0.052Depression, n (%)2 (2.9)6 (14.3)0.032Treatments: -NSAID, n (%)50 (72.5%)39 (92.9)0.013 -DMARDs, n (%)4 (5.8%)2 (4.8)NS -Biologic therapy, n (%)40 (58)27 (64.3)NSASAS HI: Assessment of SpondyloArthritis international Society-Health Index, yrs: years, SD: standard deviation, AS: ankylosing spondylitis, HLA: human leukocyte antigen, CVRF: cardiovascular risk factors, HBP: high blood pressure, SI: sacroiliitis, SpA: spondyloarthritis, IBD: inflammatory bowel disease, NSAID: non-steroidal anti-inflammatory drugs, DMARDs: disease modifying antirheumatic drugs.Conclusion:In this study, patients with regular NSAID intake and those with a positive family history of SpA were more likely to be in a high-impact category according to the ASAS HI. On the other hand, HLA-B27 carriers reduced that possibility by 85%. Our data may contribute to providing more personalized attention focused on patients` needs.References:[1]Alonso S, Pardo E, Charca L, et al. Performance of the ASAS health index for the evaluation of spondyloarthritis in daily practice. J Rheumatol 2020; 47: 1483-1489.Disclosure of Interests:None declared.
Background:Prognosis of non-infectious refractory uveitis has improved markedly with biologic therapy (BT) (1-5). Most data are with monoclonal anti-TNF drugs, especially Adalimumab (ADA) and Infliximab (IFX). However, there is not enough evidence for the use of Certolizumab Pegol (CZP).Objectives:To evaluate the efficacy and safety of CZP in refractory uveitis secondary to Immune-Mediated Inflammatory Diseases (IMID).Methods:Multicenter study of 71 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants. Efficacy was assessed with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, vitritis, macular thickness and presence of retinal vasculitis. These outcomes were compared between baseline, 1st week, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with IBM SPSS Statistics v.23.Results:71 patients/100 affected eyes (29 men/42 women) with mean age of 40.0±11.3 years were studied. Underlying IMIDs were: spondyloarthritis (n=38), Behçet (10), psoriatic arthritis (8), Crohn disease (3), sarcoidosis (2), JIA (1), reactive arthritis (1), rheumatoid arthritis (1), relapsing polychondritis (1), TINU (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (3). Uveitis pattern was anterior (n=55), posterior (6), panuveitis (6) and intermediate (4).Prior to CZP, patients had received: methotrexate (37), sulfasalazine (26), azathioprine (14), cyclosporine (10), leflunomide (3), mycophenolate mofetil (3) and cyclophosphamide (1). Previous BT was administered in 48 (67.6%) patients, with a mean of 1.4±1.3 drugs per patient as follows: ADA (n=56), IFX (27), golimumab (14), tocilizumab (5) and etanercept (3). Pregnancy was the reason for prescribing CZP in 19 patients. CZP was administered in monotherapy (n=39) or combined with conventional immunosuppressants (n=32).After a mean follow-up of 27.1±21.1 months, most of the ocular variables showed a rapid and significantly improvement (Table 1). A decrease in the median number [IQR] of flares of uveitis before and after CZP, (3 [1-4] vs. 0 [0-1], p<0.001) was observed. CZP was discontinued in 15 patients due to remission (n=2), ocular insufficient response (2) and incomplete response of extraocular manifestations (11). No serious adverse events were reported.Conclusion:CZP seems to be effective and safe in patients with refractory uveitis due to IMID.References:[1]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451. doi: 10.1016/j.ophtha.2018.02.020.[2]Atienza-Mateo B, et al. Arthritis Rheumatol 2019; 71:2081-2089. doi: 10.1002/art.41026.[3]Santos-Gómez M, et al. Clin Exp Rheumatol 2016; 34(6 Suppl 102):S34-S40. PMID: 27054359[4]Vegas-Revenga N, et al. Am J Ophthalmol 2019; 200:85-94. doi: 10.1016/j.ajo.2018.12.019[5]Calvo-Río V, et al. Clin Exp Rheumatol. 2014; 32 (4 Suppl 84):S54-7. PMID: 25005576Table 1.Baseline1stweek1stMonth6thMonth1styear2ndyearBCVA (mean±SD)0.68±0.270.72±0.27*0.79±0.25*0.84±0.24*0.85±0.25*0.87±0.22*Improvement in AC Cells, n (%)Patients with AC cells at baseline (n=48)-21 (43.7)30 (62.5)*41 (85.4)*48 (100)*48 (100)*Improvement in Vitritis, n (%)Patients with vitritis at baseline (n=13)-3 (23.1)8 (61.5)*11 (84.6)*13 (100)*13 (100)*OCT (µ) (mean±SD)292.5±47.7294±47.4286.7±41.9*274.7±38.7*272.8±38.9*266.31±36.2*Choroiditis; affected eyes, n, (%)3 (4.2)3 (4.2)2 (2.8)2 (2.8)1 (1.4)0 (0)Retinal Vasculitis; affected eyes, n, (%)2 (2.8)0 (0)1 (1.4)0 (0)0 (0)0 (0)*p<0.001Disclosure of Interests:None declared
Background:Although the MDA response and DAPSA remission are treatment objectives proposed by EULAR for a proper management of psoriatic arthritis (PsA), there is no clear consensus on which of the two is the most advisable in clinical practice. Some studies suggest that patients who reach a sustained MDA have less subclinical atherosclerosis, but whether the same applies to DAPSA remission is unknown at present.Objectives:To compare the frequency of subclinical atherosclerosis in patients with PsA that reach the MDA response versus those who achieve DAPSA remission.Methods:One hundred-forty consecutive patients with PsA (CASPAR criteria) treated with biological and non-biological systemic agents were included. SCORE risk charts were used to estimate cardiovascular risk (CVR). The presence of plaques and / or carotid intima-media thickness (cIMT) > 0.9 mm in carotid ultrasound defined subclinical atherosclerosis. These findings were analyzed in patients in MDA and in those in DAPSA remission.Results:According to the SCORE tables, 42.8%, 35.7% and 21.5%, had low, moderate and high-very high CVR, respectively. There was a linear association between cIMT values and the SCORE risk categories (p <0.0005). The best cut-off point to define a high CVR (by SCORE plus carotid plaques) corresponded to a cIMT > 0.63 mm, with an area under the ROC curve of 0.75 (0.66-0.82), sensitivity 85.7%, specificity 56.1% (Figure 1). Ninety-seven of the 140 patients (69.3%) were in MDA situation, while 60 (42.8%) were in DAPSA remission. The average value of the cIMT was 0.64 ± 0.12 mm. One in 4 patient had atheroma plaques, while 19 (13.6%) had a cIMT> 0.9 mm. There were no differences in cIMT values of patients with (0.66 ± 0.12 mm) and without (0.63 ± 0.12 mm) DAPSA remission. An identical percentage (25%) of patients with and without DAPSA remission had carotid atheroma plaques. On the other hand, there were differences between patients with (6.2%) and without (30.2%) MDA in terms of cIMT values > 0.9 mm, p <0.05. 32.6% of non-MDA and 23.7% of MDA patients had carotid plaques, p NS.Conclusion:Patients who achieve an MDA response show less subclinical atherosclerosis than those in DAPSA remission. These findings suggest that the MDA response better discriminates the presence of subclinical atherosclerosis, and therefore, it could be a more complete therapeutic target than DAPSA remission.Disclosure of Interests:None declared
Background:Patients with spondyloarthritis (SpA) suffer not only from pain or physical disability, but they are also affected in multiple facets of life due to this condition (disease impact). Recently, the ASAS group has proposed a new way of capturing the impact that SpA have on patients’ lives, based on the principles proposed by the International classification of functioning, disability and health (ICF). The tool obtained (ASAS-health index or ASAS-HI) includes 17 items that cover most ICF domains.Objectives:To analyze the performance of ASAS-HI in real clinical practice, by comparing it with other standard measures of evaluation of SpA. To assess whether ASAS-HI is able to identify disease activity states in these patients.Methods:This cross-sectional study included 111 consecutive patients with SpA (ASAS criteria). The correlation (Spearman’s rho) between ASAS-HI, BASDAI, ASDAS, and BASFI was analyzed. ROC curves were constructed to analyze ASAS-HI values that determined BASDAI remission, ASDAS inactive disease, and ASDAS low activity. A logistic regression was made to determine the ASAS-HI items with greater capability to discriminate the state of remission / inactive disease.Results:Seventy-four men and 37 women were included, mean age of 43.3 ± 10.6 years. The average duration of illness was 7.6 ± 6.8 years. Sixty percent of the series was under biological therapy. HLA-B27 was positive in 79.3%. The average value of ASAS-HI was 5.4 ± 3.8. There were significant correlations between ASDAS and BASDAI (rho: 0.89, p <0.0005), BASDAI and BASFI (rho: 0.86, p <0.0005), BASFI and ASDAS (rho: 0.78, p <0.0005), BASDAI and ASAS-HI (rho: 0.77, p <0.0005), ASDAS and ASAS-HI (rho: 0.70, p <0.0005). The optimal cut-off point of ASAS-HI for BASDAI remission (Table 1) corresponded to a value ≤ 2. As for the value of ASAS-HI to define ASDAS inactive disease (Table 2), this was ≤ 0. For ASDAS low activity, the value was ≤ 6 [area under the ROC curve 0.82 (95% CI: 0.73-0.89), Sen: 89.5%, Spe: 66.1). In the multivariate regression, the two ASAS-HI items associated with BASDAI non-remission were, “I often get frustrated” [OR 9.2 (95% CI: 1.2-69.4), p = 0.032], and “I sleep badly at night” [OR 7.7 (95% CI: 1.4-41.6), p = 0.018). As for ASDAS, the only question of ASAS-HI significantly associated with active disease was “pain sometimes disrupts my normal activities” [OR 8.7 (95% CI: 1.7-45.2), p = 0.010].Conclusion:ASAS-HI correlates well with most outcome measures in SpA. A cut-off point of ASAS-HI ≤ 6 identifies a low disease activity and could be considered a good treatment objective. The evaluation of SpA should include not only conventional measures (BASDAI / ASDAS) but also disease impact measures (ASAS-HI).Table 1.Area under the ROC curve (AUC)0.88395% CI0.809-0.936p-value<0.0001Optimal cut-off point≤2Sensitivity65.71Specificity96.05Table 2.Area under the ROC curve (AUC)0.87395% CI0.797-0.929p-value<0.0001Optimal cut-off point≤0Sensitivity58.82Specificity94.68Disclosure of Interests:None declared
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