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.
BackgroundThe Psoriatic arthritis UnclutteRed screening Evaluation (PURE-4), culturally adapted to Spanish language following the standardized methodology,[1]was recommended by experts due to the reduced number of items,[2]its high sensitivity/specificity and the feasibility to implement in clinical practice.ObjectivesTo confirm the presence/absence of psoriatic arthritis (PsA) according to rheumatologist criteria in patients (pts) with psoriasis (Pso) 1 year after having answered the PURE-4 questionnaire in the dermatology consultation.MethodsCross-sectional, observational, multicenter study conducted with primary data collection under conditions of routine clinical practice in Spain. Adult pts (≥18 years old) with Pso diagnosis that voluntarily accepted to participate. Two cross-sectional evaluations. Assessment I allowed to validate the Spanish version of the PURE-4 questionnaire and its results were previously communicated.[3]Data from assessment II (pts without PsA in assessment I were evaluated by the rheumatologist 1 year ±2 months later and performed the PsA diagnostic confirmation according to her/his criteria and collected clinical characteristics) are presented here.Results268 patients pts were included in assessment I, 223 (83.2%) of them without a PsA diagnosis. 219 pts were evaluable in assessment II, as they go to the second visit to rheumatologist: 56.2% male, with a mean (SD) age of 46.8 (12.5) years, a mean (SD) time from Pso diagnosis of 18.7 (12.8) years. Mean (SD) PURE-4 score was 2.4 (1.1) for pts with PsA and 1.2 (1.2) for pts without PsA diagnosis. Among pts who did assessment II, PsA diagnosis was confirmed in 12 (5.5%) pts. Area under the receiver-operating characteristic (ROC) curve was 0.7618 (95% CI: 0.6530, 0.8706) (n=217), confirming the good quality of the questionnaire (Figure 1). Using the Youden index, it was identified a score ≥2 indicative of a possible early presence of PsA, same as in assessment I. PURE-4 questionnaire showed a sensitivity of 75.0% and a specificity of 62.9%. In 63.6% of the cases, the PURE-4 questionnaire classified pts in the same way as the rheumatologist, with a negative predictive value of 97.7%.ConclusionAssessment II findings together with the assessment I results, demonstrate the good PsA screening properties of the PURE-4 questionnaire, starting with a ≥2 score, differing from the original questionnaire (≥1).[4]Questions of the PURE-4 questionnaire referring to dactylitis, both buttocks pain and peripheral joint pain with swelling (before age 50) were the most “discriminative” of PsA. The study reinforce the recommendation to assess annually, or ideally every 6 months, the possible PsA presence,[5]as early PsA identification thanks to simple tools such as PURE-4 could help to prevent irreversible joint damage of this disease.References[1]Belinchón I, et al. Actas Dermosifiliogr. 2020;111(8):655-64.[2]Urruticoechea-Arana A, et al. PLoS One. 2021;16(3): e0248571.[3]Queiro Silva R, et al. Ann Rheum Dis. 2022;81:862-3.[4]Audureau E, et al. J Eur Acad Dermatol Venereol. 2018;32(11):1950-3.[5]Belinchón I, et al. Actas Dermosifiliogr. 2020;111(10):835-46.Figure 1.Area under the ROC curve (assessment II)AUC, area under the curve; Se, sensitivity; Sp, specificity.AcknowledgementsThe authors thank IQVIA and Carmen Barrull and Marco Pinel for providing medical editorial assistance with this presentation.Disclosure of InterestsRubén Queiró Silva Grant/research support from: received honoraria as part of the scientific committee of the PURE-4 study, Isabel Belinchón Speakers bureau: consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen, Amgen, Leo-Pharma, Pfizer-Wyeth, BMS, UCB and MSD, Consultant of: consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen, Amgen, Leo-Pharma, Pfizer-Wyeth, BMS, UCB and MSD, Grant/research support from: consultant and/or speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including Janssen Pharmaceuticals Inc, Almirall SA, Lilly, AbbVie, Novartis, Celgene, Biogen, Amgen, Leo-Pharma, Pfizer-Wyeth, BMS, UCB and MSD, Anna Lopez-Ferrer Speakers bureau: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Grant/research support from: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Marta Ferran i Farrés Speakers bureau: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Grant/research support from: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Raquel Rivera Díaz Speakers bureau: consultant, researcher and/or speaker for AbbVie, Almirall, Celgene Corporation, GSK, Janssen-Cilag, Lilly, LEO Pharma, MSD, Novartis, Pfizer and UCB, Consultant of: consultant, researcher and/or speaker for AbbVie, Almirall, Celgene Corporation, GSK, Janssen-Cilag, Lilly, LEO Pharma, MSD, Novartis, Pfizer and UCB, Grant/research support from: consultant, researcher and/or speaker for AbbVie, Almirall, Celgene Corporation, GSK, Janssen-Cilag, Lilly, LEO Pharma, MSD, Novartis, Pfizer and UCB, David Vidal Sarro Speakers bureau: advisor and/or researcher and/or speaker for AbbVie, Janssen, Lilly, Novartis and UCB, Consultant of: advisor and/or researcher and/or speaker for AbbVie, Janssen, Lilly, Novartis and UCB, Grant/research support from: advisor and/or researcher and/or speaker for AbbVie, Janssen, Lilly, Novartis and UCB, lourdes rodriguez freire Speakers bureau: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, BMS, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer and UCB, Consultant of: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, BMS, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer and UCB, Grant/research support from: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, BMS, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer and UCB, Pablo de la Cueva Dobao Speakers bureau: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, BMS, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Consultant of: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, BMS, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Grant/research support from: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, BMS, Boehringer, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi, UCB, Jorge Santos Juanes Speakers bureau: speaker for, received scholarships, and participated in advisory sessions for Novartis, Lilly, Janssen, Abbvie, Amgen, and Sanofi, Consultant of: speaker for, received scholarships, and participated in advisory sessions for Novartis, Lilly, Janssen, Abbvie, Amgen, and Sanofi, Grant/research support from: speaker for, received scholarships, and participated in advisory sessions for Novartis, Lilly, Janssen, Abbvie, Amgen, and Sanofi, Vicenç Rocamora Duran Speakers bureau: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Consultant of: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Grant/research support from: advisor and/or researcher and/or speaker for Abbvie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, UCB, Guillermo Guinea Uzábal Employee of: Novartis employee, Víctor Martín Vázquez Employee of: Novartis employee, Lara Gómez Labrador Employee of: Novartis employee.
Background:Although the evidence that testifies to a higher prevalence of cardiometabolic risk factors in psoriatic disease is robust, there are not too many studies that have analyzed which disease traits are associated with these risk factors both in psoriasis and psoriatic arthritis1.Objectives:We aimed to analyze the frequency and disease-associated features of hyperlipidemia in psoriatic disease.Methods:Cross-sectional observational study that included 290 patients with psoriatic arthritis (mean age 54 ± 12 years, 54.8 % male, psoriasis average duration 21 ± 10 years) and 310 with psoriasis alone (mean age 53 ± 11.5 years, 52.9% male, psoriasis average duration 22 ± 11 years). We first analyzed the frequency of this comorbidity and then the factors associated with it using conditional logistic regression. The significant factors in this first model were introduced in a multivariate model using a backward stepwise approach.Results:Main disease features are depicted in Table 1. A total of 124 patients had hyperlipidemia (20.7%). Among arthritis patients, 82/290 (28.3%) had hyperlipidemia, compared with 42/310 (13.5%) of those with psoriasis alone (OR 2.5, 95%CI: 1.7–3.3, p < 0.001). Hyperlipidemia was independently associated with age [OR 1.07, 95%CI: 1.04–1.11, p < 0.001] and systemic therapy [OR 0.4, 95%CI: 0.17–0.89, p = 0.026].Conclusion:Hyperlipidemia is common in psoriatic disease, but much more among arthritis patients. This comorbid factor seems to go in parallel with increasing age. There is an inverse association between systemic treatment and hyperlipidemia that should be endorsed with well-designed longitudinal studies.References:[1]Puig L. Cardiometabolic comorbidities in psoriasis and psoriatic arthritis. Int J Mol Sci 2018; 19: 58.Table 1.Disease characteristics of both subpopulationsVariablePsAn = 290Psoriasisn = 310p-valuesAge (yr ± SD)54 ± 1253 ± 11.5NSAge at psoriasis onset (yr ± SD)32 ± 1631 ± 14.2NSAge at arthritis onset (yr ±SD)46 ± 14NSDuration of psoriasis (yr ± SD)21 ± 1022 ± 11NSDuration of arthritis (yr ± SD)11 ± 7.2NSMale gender (n, %)159 (54.8)164 (52.9)NSPrimary education (n, %)145 (50)148 (47.7)NSSecondary education (n, %)79 (27.2)87 (28.1)NSUniversity degree (n, %)66 (22.8)235 (24.2)NSPlaque psoriasis (n, %)250 (86.2)272 (87.7)NSNail disease (n, %)122 (42.1)110 (35.5)NSPsoriasis in ≥ 3 body areas (n, %)130 (45)155 (50)<0.05Family history of psoriasis (n, %)130 (45)136 (44)NSFamily history of PsA (n, %)44 (15.2)15 (4.8)PASI6.5 ± 4.36.8 ± 3.5Oligoarthritis (n, %)122 (42.1)Polyarthritis (n, %)81 (28)Axial disease (n, %)17 (5.8)Mixed pattern (n, %)70 (24.1)Dactylitis (n, %)87 (30)DIP joint disease (n, %)72 (24.8)Mutilating arthritis (n, %)5 (1.7)Erosive disease (n, %)58 (20)HAQ (mean ± SD)0.74 ± 0.32*BASDAI (mean ± SD)3.64 ± 2.12Pain VAS (mean ± SD)4.09 ± 2.64HLA-B*27 (n, %)52 (17.9)HLA-C*06 (n, %)112 (38.6)124 (40)NSNSAID (n, %)72 (24.8)47 (15.2)NSGlucocorticoids (n, %)34 (11.7)15 (4.8)NSMTX (n, %)189 (65.2)128 (41.3)<0.05Biologics (n, %)128 (44.1)132 (42.6)NSSD, standard deviation; PsA, psoriatic arthritis; PASI, psoriasis area and severity index; DIP, distal interphalangeal joint; HAQ, Health Assessment Questionnaire; BASDAI, bath ankylosing spondylitis disease activity index; VAS, visual analog scale; NSAID, non-steroidal anti-inflammatory drugs. MTX, methotrexate. *Only in patients with axial diseaseDisclosure 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
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