scholarly journals AB0646 IS IT FEASIBLE TO ACHIEVE RECOMMENDED THERAPEUTICAL TARGET IN PATIENTS WITH AXIAL SPONDYLARTHRITIS IN CLINICAL PRACTICE? DATA FROM THE SpA-Paz COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1617.1-1618
Author(s):  
K. N. Franco Gomez ◽  
C. Plasencia ◽  
M. Novella-Navarro ◽  
D. Benavent ◽  
P. Bogas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Disease Activity ◽  
Biological Treatment ◽  
Biological Therapy ◽  
Hla B27 ◽  
Research Support ◽  
Low Disease Activity ◽  
Younger Age ◽  
Axial Spondylarthritis ◽  
Male Sex

Background:Current ASAS/EULAR recommendations for the management of patients with axial spondylarthritis (axSpA) establish that the therapeutic goal to achieve in clinical practice is remission, defined as the absence of both clinical and laboratory disease activity evaluated by BASDAI&CRP or preferably ASDAS and if this is not possible, low disease activity may be an alternative. Recently, ASDAS nomenclature has been modified, calling now low disease activity to what was previously called moderate activity. To this day we do not know if this target is feasible in clinical practice.Objectives:To analyze the frequency of patients with axSpA achieving maintained remission (R) or low disease activity (LDA) after receiving biological therapy. Secondary objectives included: i) to assess if the activity index used influences the frequency of maintained R/LDA, ii) analyze the prognostic factors for achieving maintained R/LDA.Methods:An observational, longitudinal study of a prospective cohort (SpA-Paz) including all patients with axSpA who initiated their first biological treatment between the years 2003-2017. Demographic, clinical and analytical data were collected at the beginning of treatment and clinical disease activity measured by BASDAI&CRP and ASDAS every 6 months for 2 years. Maintained R was defined as (BASDAI<2 & normal CRP and/or ASDAS <1.3) and maintained LDA (BASDAI <4 & normal CRP and/or ASDAS <2.1) on at least 3 consecutive visits. Statistical analysis: i) measures of central tendency and dispersion for quantitative variables and frequencies for qualitative variables; ii) univariate and multivariate analysis of binomial logistic regression model and calculation of OR and 95% CI.Results:Out of 186 patients with axSpA who started treatment during the study period, 63% were men with a mean age of 54 ± 14.1 years. 75.3% of the patients had radiographic axSpA and 74.7% were HLA-B27 positive. Other baseline characteristics (not shown due to space restrictions). Overall, 80% of the patients achieved ASDAS R/LDA (R36%/LDA44%) in at least one of the visits after 2 years of follow-up, but only 40% (R27%/LDA13%) fulfilled the maintained ASDAS R/LDA state. On the other hand, 73% of patients were classified as BASDAI&CRP R/LDA (R31%/LDA42%) in at least one of the visits, but only 31% (R21%/LDA10%) obtained the maintained BASDAI&CRP R/LDA state. In the multivariate analysis, we observed an independent statistically significant association with male sex (OR=3.19; 95% CI=1.46-6.99), younger age at the beginning of the biological treatment (OR=0.97; 95% CI=0.95-0.99) and the use of methotrexate (OR=3.07; 95% CI=1.39-6.78) in patients who achieved maintained BASDAI&CRP R/LDA and with male sex (OR=4.01; 95% CI=1.83-8.77), younger age at the beginning of the biological therapy (OR=0.96; 95% CI=0.94-0.99) and HLA B27 presence (OR=4.30; 95% CI=1.68-11.01) in patients who achieved maintained ASDAS R/LDA.Conclusion:Although the majority of patients with axSpA who initiate biological therapy achieve the recommended therapeutic goal in the first two years of treatment, the percentage of patients who manage to maintain the R/LDA status is limited. In our study, maintained R was more frequent than maintained LDA, being somewhat higher when measured by ASDAS. This fact may suggest that patients who achieve maintained R have a greater inhibition of their inflammatory activity and, therefore, it remains in time. Male sex and younger age at the beginning of the biological therapy were the main baseline predictors for achieving maintained R/LDA.Graphics:Disclosure of Interests:Karen Nathalie Franco Gomez: None declared, Chamaida Plasencia: None declared, Marta Novella-Navarro: None declared, Diego Benavent: None declared, Patricia Bogas: None declared, Romina Nieto: None declared, Irene Monjo: None declared, Laura Nuño: None declared, Alejandro Villalva: None declared, Diana Peiteado Grant/research support from: AbbVie, Lilly, MSD, and Roche, Speakers bureau: AbbVie, Roche, and MSD, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB

scholarly journals AB0670 AXIAL MANIFESTATIONS IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS: ARE THEY SIMILAR?

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1630.1-1630
Author(s):  
D. Benavent ◽  
V. Navarro-Compán ◽  
C. Plasencia ◽  
D. Peiteado ◽  
A. Villalva ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Clinical Features ◽  
Biological Therapy ◽  
Smoking Habit ◽  
Concomitant Treatment ◽  
Hla B27 ◽  
Biological Therapies ◽  
Concomitant Therapy

Background:Spondyloarthritis (SpA) is a group of heterogeneous diseases that includes axial SpA (axSpA), such as ankylosing spondylitis and axial non-radiographic SpA, and Psoriatic Arthritis (PsA) with peripheral and/or axial involvement (axPsA). Currently, it is not well known if the characteristics and burden of the disease in patients with axPsA are similar to that of patients with axSpA.Objectives:To compare the demographic, clinical and structural features between patients with axSpA and axPsA.Methods:Data from an observational prospective cohort including all patients with SpA initiating biological therapy because of predominant axial manifestations from 2002-2019 in a university hospital were analyzed. AxSpA and axPsA were defined in clinical practice according to the prescribing rheumatologist, based on clinical features and complementary examinations. Demographic information, laboratory tests, disease presentation, sacroiliitis according to modified New York criteria in the pelvis X-ray, disease activity indexes (ASDAS and BASDAI) and concomitant treatment before starting biological drug were collected from the electronic medical record and biologic database. In the statistical analysis, chi square or the exact Fisher’s test was used for categorical and t-student or U-Mann Whitney for continuous variables, according to the distribution of the data. Then, the association between demographic and clinical features and each disease was analysed using univariable and multivariable logistic regression models.Results:Out of 352 included patients, 287 (81.5%) had axSpA, and 65 had axPsA (18.5%). Baseline characteristics are shown in Table 1. Mean baseline ASDAS was 3.3±0.9 and 3.1±1.0 for axSpA and axPsA, respectively. Biological therapies initiated can be seen in Figure 1. No significant differences at baseline were observed between axSpA and axPsA for most of the characteristics including: gender, age at diagnosis, age at starting biologic, disease duration before biologic, smoking habit, CRP, disease activity, enthesitis, dactylitis, inflammatory bowel disease (IBD), patient global assessment and sulfasalazine use. However, there were differences between diseases in some relevant characteristics. AxSpA patients had less peripheral involvement (41.5 vs. 78.5 %, p=0.004), more uveitis (15.3 vs. 3.1 %, p=0.03) and were more frequently HLA-B*27 positive (72.3 vs 34.1 %, p<0.001), in comparison to axPsA patients. They also had better physician global assessments (PhGA) (37.4 vs 44.4, p=0.02), and a higher grade of radiographic sacroiilitis. AxSpA patients used less global baseline concomitant therapy (p=0.001), methotrexate (p<0.001) and prednisone (p<0.01), whereas they used more sulfasalazine (p=0.003) than axPsA patients in our cohort. After running multivariate analyses, the absence of peripheral manifestations (OR=4.7; p<0.001) and the positivity of HLA-B27 (OR=5.4; p<0.001) were independently associated with axSpA.Table 1. Baseline stratified characteristics. Results are shown as absolute numbers (percentages) or mean ± standard deviation.Conclusion:Despite being spondyloartrithis with many common traits, axSpA and axPsA present some differences in clinical practice. Whereas axSpA patients are more frequently HLA-B27 positive, axPsA have more peripheral involvement. These differences in clinical presentation between both diseases may contribute to variances in therapeutic management, such as increased use of baseline concomitant therapy in axPsA patients who initiate biological therapy.Figure 1.Biological therapies initiated in axSpA and axPsADisclosure of Interests:Diego Benavent: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Chamaida Plasencia: None declared, Diana Peiteado: None declared, Alejandro Villalva: None declared, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz

scholarly journals AB0542 EVALUATION OF APREMILAST USE IN THE ROUTINE CLINICAL PRACTICE IN PATIENTS WITH PSORIATIC ARTHRITIS NAÏVE TO BIOLOGICAL TREATMENTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1303.2-1304
Author(s):  
J. Gratacos-Masmitja ◽  
J. L. Álvarez Vega ◽  
E. Beltrán ◽  
A. Urruticoechea-Arana ◽  
C. Fito-Manteca ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Routine Clinical Practice ◽  
Wilcoxon Test ◽  
Psychiatric Disease ◽  
Biological Therapies ◽  
Research Support ◽  
Disease Evolution ◽  
Biological Treatments

Background:Apremilast is a non-biologic systemic agent approved for the treatment of plaque psoriasis, oral ulcers of Behcet’s disease and PsA with proven efficacy in clinical trials [1,2]. However, more real-world evidence of apremilast use and effectiveness is needed to identify the patient profile most likely to benefit from this treatment [3].Objectives:To evaluate the persistence of apremilast treatment in patients with PsA naïve to biological treatments in routine clinical practice and assess its effectiveness. Baseline clinical characteristics on patients who started apremilast were also evaluated.Methods:Observational, prospective, multicenter (20 centers) study including consecutive adult patients with PsA naïve to biological therapies who had started treatment with apremilast during the previous 5 to 7 months and were followed-up during 12 months. Variables recorded were persistence of treatment with apremilast at 6 months (6mo) and number of swelling joints, presence of enthesitis and dactylitis, and disease activity, measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score and Physician Global Assessment (PGA) of psoriasis, collected at baseline (BL) (i.e., apremilast treatment start) and 6mo; comorbidities were retrospectively collected at BL. Categorical and quantitative variables were compared using McNemar’s and Wilcoxon test, respectively. Data sets analyzed included all assessable patients.Results:Of the 60 patients recruited at the time of this interim analysis, 54 (90.0%) [mean (SD) age 53.4 (13.9) years] were assessable; 41 (75.9%) of these continued treatment with apremilast at 6mo. At BL, 34 (63.0%) patients had at least one comorbidity, the most frequent being cardiovascular disease (n=15, 27.8%), including hypertension (n=8, 14.8%), metabolic/endocrine disease (n=18, 33.3%), including obesity (n=8, 14.8%) and dyslipidemia (n=10, 18.5%). Psychiatric disease (i.e., depression) (n=5, 9.3%) and neoplasia (n=8, 14.8%) were also observed. The number of swelling joints decreased from median (Q1, Q3) 4.0 (2.0, 7.0) at BL to 1.5 (0.0, 4.0) at 6mo (p=0.0012). Patients with dactylitis and enthesitis decreased from 19 (35.2%) and 16 (29.6%) at BL to 10 (18.5%) and 9 (16.7%) at 6mo (p=0.0225 and p=0.0391), respectively. The distribution of patients in the different disease activity categories according to DAPSA scale changed between BL and 6mo, indicating a favorable disease evolution (Figure 1 next page). According to PGA, at BL (n=53), disease activity was categorized as mild in 18.0%, as moderate in 72.0%, and as severe in 10% of patients and, at 6mo (n=54), as mild in 70.6%, as moderate in 25.5%, and as severe in 3.9% of patients. Fifteen (27.8%) patients interrupted treatment permanently (n=13, 24.1%) or temporarily (n=2, 3.7%), due to no/partial response (n=8, 14.8%), tolerability issues leading to adverse events (n=3, 5.6%), patient decision (n=2, 3.7%), and other reasons (n=2, 3.7%) after a mean (SD) treatment of 3.05 (2.20) months.Conclusion:Forty-one (75.9%) patients with PsA naïve to biological therapies were treated with apremilast during ≥6 months. After treatment, the number of swelling joints, and dactylitis and enthesitis decreased and changes in disease activity according to DAPSA and PGA pointed to a favorable disease evolution. Apremilast treatment provides a clinical benefit to patients with PsA treated in clinical practice.References:[1]Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Feb 10;75(3):499 LP-510[2]Torres T and Puig L. Apremilast: A novel oral treatment for psoriasis and psoriatic arthritis. Am J clin Dermatol. 2018 Feb;19(1):23-32[3]Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015. Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol. 2016;68(5):1060– 71.Disclosure of Interests:Jordi Gratacos-Masmitja Speakers bureau: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., Consultant of: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., José Luis Álvarez Vega Speakers bureau: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Consultant of: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Grant/research support from: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, ANA URRUTICOECHEA-ARANA: None declared., C. Fito-Manteca: None declared., Francisco Maceiras: None declared., Joaquin Maria Belzunegui Otano Speakers bureau: Lilly, Amgen, Novartis, Abbvie, Janssen., J. Fernández-Melón Speakers bureau: Amgen SL, Eugenio Chamizo Carmona: None declared., Abad Hernández Speakers bureau: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Consultant of: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Grant/research support from: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Inmaculada Ros Consultant of: Amgen, Grant/research support from: MSD, Roche, Novartis, lilly, Pfizer, Amgen, Eva Pascual Shareholder of: Amgen, Employee of: Amgen, Juan Carlos Torre Speakers bureau: Amgen, Lilly, Novartis, Janssen, Pfizer, Consultant of: Amgen, Lilly, Novartis, Janssen, Pfizer, Grant/research support from: Amgen, Lilly, Novartis, Janssen, Pfizer.

scholarly journals OP0008 DEVELOPMENT AND VALIDATION OF AN ALTERNATIVE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE WHEN PATIENT GLOBAL ASSESSMENT IS UNAVAILABLE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Psychometric Properties ◽  
Global Assessment ◽  
Disease Activity Score ◽  
Validation Cohort ◽  
Patient Global Assessment ◽  
Activity Score ◽  
Research Support ◽  
Low Disease Activity

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV

scholarly journals POS1021 THE PsABio STUDY IN ITALY: A REAL-WORLD COMPARISON OF THE PERSISTENCE, EFFECTIVENESS AND SAFETY OF USTEKINUMAB AND TUMOUR NECROSIS FACTOR INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 778-779
Author(s):  
E. Gremese ◽  
F. Ciccia ◽  
C. Selmi ◽  
G. Cuomo ◽  
R. Foti ◽  
...  
Keyword(s):  
Adverse Event ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Research Support ◽  
Treatment Persistence ◽  
Low Disease Activity ◽  
Necrosis Factor

Background:There are still unmet needs in the treatment of psoriatic arthritis (PsA), including in terms of treatment persistence, which is a function of effectiveness, safety and patient satisfaction. Ustekinumab (UST) was the first new biologic drug to be developed for the treatment of PsA after tumour necrosis factor inhibitors (TNFi).Objectives:To compare treatment persistence, effectiveness and safety of UST and TNFi in Italian patients within the PsABio cohort.Methods:PsABio (NCT02627768) is an observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. The current analysis set includes 222 eligible patients treated in 15 Italian centres, followed to Month 12 (±3 months). Treatment persistence/risk of stopping was analysed using Kaplan−Meier (KM) and Cox regression analysis. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation of effectiveness endpoints if treatment was stopped/switched before 1 year. Last observation carried forward data are reported.Results:Of patients starting UST and TNFi, 75/101 (74.3%) and 77/121 (63.6%), respectively, persisted with treatment at 1 year. The observed mean persistence was 410 days for UST and 363 days for TNFi. KM curves and PS-adjusted hazard ratios confirmed significantly higher persistence (hazard ratio [95% confidence interval (CI)]) for UST versus TNFi overall (0.46 [0.26; 0.82]; Figure 1). Persistence was also higher for UST than TNFi in patients receiving monotherapy without methotrexate (0.31 [0.15; 0.63]), in females (0.41 [0.20; 0.83]), and in patients with body mass index (BMI) <25 kg/m2 (0.34 [0.14; 0.87]) or >30 kg/m2 (0.19 [0.06; 0.54]). There was no significant difference in persistence between treatments in patients with BMI 25−30 kg/m2. While patients receiving 1st- and 3rd-line UST or TNFi showed similar risk of discontinuation (0.60 [0.27; 1.29] and 0.36 [0.10; 1.25], respectively), patients receiving 2nd-line UST showed better persistence than those receiving 2nd-line TNFi (0.33 [0.13; 0.87]). Other factors added to the PS-adjusted Cox model did not show significant effects. In patients with available follow-up data, the mean (standard deviation) baseline cDAPSA was 26.3 (15.4) for UST and 23.5 (12.3) for TNFi; at 1-year follow-up, 43.5% of UST- and 43.6% of TNFi-treated patients reached cDAPSA LDA/remission. MDA was reached in 24.2% of UST- and 28.0% of TNFi-treated patients, and VLDA in 12.5% of UST- and 10.2% of TNFi-treated patients. After PS adjustment (stoppers/switchers as non-responders), odds ratios (95% CI) at 1 year did not differ significantly between UST and TNFi groups for reaching cDAPSA LDA/remission (1.08 [0.54; 2.15]), MDA (0.96 [0.45; 2.05]) or VLDA (0.98 [0.35; 2.76]). In total, 23 (20.4%) patients reported ≥1 treatment emergent adverse event with UST and 30 (22.2%) with TNFi; 6 (5.3%) and 10 (7.4%) patients, respectively, discontinued treatment because of an adverse event.Conclusion:In the Italian PsABio cohort, UST had better overall persistence compared with TNFi, as well as in specific subgroups: females, patients on monotherapy without methotrexate, with BMI <25 or >30 kg/m2, and patients receiving UST as 2nd-line treatment. At 1 year, both treatments showed similar effectiveness, as measured by cDAPSA responses and MDA/VLDA achievement.Acknowledgements:This study was funded by Janssen. Contributing author: Prof. Piercarlo Sarzi-Puttini, ASST Fatebenefratelli-Sacco, University of Milan, ItalyDisclosure of Interests:Elisa Gremese: None declared, Francesco Ciccia Speakers bureau: AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Consultant of: Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Grant/research support from: Celgene, Janssen, Novartis, Pfizer, Roche, Carlo Selmi Speakers bureau: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Consultant of: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, Giovanna CUOMO: None declared, Rosario Foti Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Actelion, Biogen, Janssen, Lilly, Consultant of: Chemomab, Grant/research support from: MSD, Fabrizio Conti Consultant of: AbbVie, Bristol-Myers Squibb, Galapagos, Lilly, Pfizer, Enrico Fusaro Speakers bureau: AbbVie, Amgen, Lilly, Grant/research support from: AbbVie, Pfizer, Giuliana Guggino Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, Sandoz, Grant/research support from: Celgene, Pfizer, Florenzo Iannone Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Andrea Delle Sedie: None declared, Roberto Perricone: None declared, Luca Idolazzi Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Sandoz, Paolo Moscato: None declared, Elke Theander Employee of: Janssen, Wim Noel Employee of: Janssen, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Silvia Marelli Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche.

scholarly journals Switching first-line targeted therapy after not reaching low disease activity within 6 months is superior to conservative approach: a propensity score-matched analysis from the ATTRA registry

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Lucie Nekvindová ◽  
Jiří Vencovský ◽  
Karel Pavelka ◽  
Pavel Horák ◽  
Zlatuše Křístková ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Targeted Therapy ◽  
Propensity Score ◽  
Disease Activity ◽  
Treatment Response ◽  
Daily Clinical Practice ◽  
Current Therapy ◽  
First Line ◽  
Treatment Target ◽  
Low Disease Activity

Abstract Background Treat-to-target (T2T) is a widely accepted strategy for patients with rheumatoid arthritis (RA). It recommends attaining a goal of at least low disease activity (LDA) within 6 months; otherwise, the current therapy should be modified. We aimed to investigate whether switching a first-line targeted therapy (TT) in patients not reaching LDA within 6 months leads to a higher probability of meeting LDA at the 12-month visit in daily clinical practice using data from Czech registry ATTRA. Methods We included patients with RA starting the first-line TT from 1 January 2012 to 31 January 2017 with at least 1-year follow-up. We created four mutually exclusive cohorts based on (1) switching to another TT within the first year and (2) reaching a treatment target (DAS28-ESR ≤ 3.2) at the 6-month visit. The primary outcome was the comparison of odds for reaching remission (REM) or LDA at the 12-month visit between patients switching and not switching TT after not reaching treatment target at 6 months. Before using logistic regression to estimate the odds ratio, we employed the propensity score to match patients at the 6-month visit. Results A total of 1275 patients were eligible for the analysis. Sixty-two patients switched within the first 5 months of the treatment before evaluating treatment response at the 6-month visit (C1); 598 patients reached the treatment target within 6 months of therapy (C2); 124 patients did not reach treatment response at 6-month visit and switched to another therapy (C3), and 491 patients continued with the same treatment despite not reaching LDA at the 6-month visit (C4). We matched 75 patients from cohort C3 and 75 patients from C4 using the propensity score. Patients following the T2T principle (C3) showed 2.8 (95% CI 1.4–5.8; p = 0.005) times increased likelihood of achieving REM/LDA at the 12-month visit compared to patients not following the T2T strategy (C4). Conclusions In daily clinical practice, the application of the T2T strategy is underused. Switching TT after not reaching REM/LDA within the first 6 months leads to a higher probability of achieving REM/LDA in RA patients at the 12-month visit.

scholarly journals AB0374 LUPUS LOW DISEASE ACTIVITY STATE AND MAINTAINING DRUG THERAPY: A RETROSPECTIVE INVESTIGATION

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1487.2-1487
Author(s):  
E. Gotelli ◽  
A. Sulli ◽  
G. Ferrari ◽  
G. Pacini ◽  
C. Schenone ◽  
...  
Keyword(s):  
Disease Activity ◽  
Hemolytic Anemia ◽  
Clinical Remission ◽  
Disease Onset ◽  
Treat To Target ◽  
Research Support ◽  
Low Disease Activity ◽  
Wide Range ◽  
Target Strategy ◽  
Activity State

Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune multisystemic disease, that can begin with a wide range of clinical manifestations, and requires immunosuppressive therapies (1). A treat-to-target strategy leads to a high rate of clinical remission among patients (2). Several “remission” definitions have been provided in the last years and Lupus Low Disease Activity State (LLDAS) seems one of the best tools to evaluate it in clinical practice (3).Objectives:To evaluate the prevalence of SLE signs and symptoms at onset and the drugs used to induce and maintain the clinical remission, evaluated by LLDAS, in a real-life cohort of SLE patients.Methods:Thirty female SLE patients (mean age 52±15 years; mean age at disease onset 34±16 years, mean disease duration 18±13 years) in clinical remission have been enrolled (EULAR/ACR 2019 criteria) (4). Remission was defined by LLDAS (SLEDAI-2K < 4 and no activity in major organ systems, no hemolytic anemia; no new features of activity compared with previous assessment, physician global assessment (PGA) ≤ 1, prednisone dose ≤7.5 mg/day, well tolerated and stable therapy with maintenance doses of immunosuppressive drugs). Clinical and serological manifestations, SLEDAI-2K and pharmacological treatments were recorded at baseline and during follow-up.Results:Mucocutaneous involvement (57%), arthritis (30%), serositis (30%), nephritis (27%), leukopenia (23%), thrombocytopenia (20%), hemolytic anemia (13%), antiphospholipid syndrome manifestations (16%), neuro-psychiatric lupus symptoms (6%) were present in various combinations at disease onset. Baseline mean SLEDAI-2K was 10.5±2.5. Patients were treated with different dosages of glucocorticoids (100%), hydroxychloroquine (HCQ, 73%), cyclofosfamide (20%), mycophenolate mofetile (MMF, 13%), azathioprine (AZA, 13%), methotrexate (MTX, 13%), cyclosporine A (CSA, 6%), rituximab (3%), abatacept (ABA, 3%). Glucocorticoids were prescribed together with a single DMARD in 50% of cases and with two DMARDs in the remaining 50% of patients. Patients reached LLDAS remission after a mean time of 14±12 years, with a mean remission duration of 4.2±3.2 years (mean SLEDAI-2K at last visit 1±1; Mean PGA 0.4±0.1). Maintenance therapies during remission were prednisone ≤ 5 mg/day and/or HCQ ≤ 400 mg/day and/or CSA ≤ 200 mg/day and/or MTX ≤ 10 mg/weekly and/or MMF ≤ 2 g/day and/or AZA ≤ 100 mg/day. In particular, only prednisone 7%, only HCQ 3%, prednisone + HCQ 53%, prednisone + single DMARD (different from HCQ) 7%, prednisone + HCQ + DMARDs 30%.Conclusion:After reaching the clinical remission by a treat to target strategy, the administration of low dose of prednisone and HCQ in the majority of SLE patients (63%) seems useful to prevent new SLE flares. The retrospective design and the absence of a control group of patients with active disease limit this study.References:[1]Lisnevskaia L et al. 2014.Lancet384(9957):1878-1888.[2]Van Vollenhoven RF et al. 2014.Ann Rheum Dis73(6): 958-967.[3]Franklyn K et al. 2016.Ann Rheum Dis. 75(9): 1615-21.[4]Aringer M et al. 2019.Arthritis Rheumatol.71(9): 1400-1412.Disclosure of Interests:Emanuele Gotelli: None declared, Alberto Sulli Grant/research support from: Laboratori Baldacci, Giorgia Ferrari: None declared, Greta Pacini: None declared, Carlotta Schenone: None declared, Massimo Patanè: None declared, Pietro Francesco Bica: None declared, Carmen Pizzorni: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Sabrina Paolino: None declared

THU0400 CLINICAL COURSE OF EARLY AXIAL SPONDYLOARTHRITIS OVER TEN YEARS: LONG-TERM RESULTS FROM THE GERMAN SPONDYLOARTHRITIS INCEPTION COHORT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 437-437
Author(s):  
D. Poddubnyy ◽  
V. Rios Rodriguez ◽  
M. Torgutalp ◽  
M. Verba ◽  
J. Callhoff ◽  
...  
Keyword(s):  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Clinical Course ◽  
Symptom Duration ◽  
Disease Course ◽  
Inception Cohort ◽  
Research Support ◽  
Low Disease Activity ◽  
Similar Disease

Background:Previous studies showed that patients with non-radiographic and radiographic axial spondyloarthritis (nr- and r-axSpA) have similar disease burden and similar response to anti-inflammatory therapy given similar level of inflammatory activity. Only little is known, however, about long-term disease course in patients with early axSpA.Objectives:To investigate the long-term (up to 10 years) clinical course of patients with early axSpA.Methods:In total, 525 patients with early axSpA (r-axSpA with symptom duration ≤10 years and nr-axSpA with symptom duration ≤5 years) from the German Spondyloarthritis Inception Cohort (GESPIC) were included. The final patient classification was based on central reading results in 458 patients with available pelvic X-rays, and on local rheumatologist judgement in 67 patients. A total of 251 patients were finally classified as r-axSpA and 274 as nr-axSpA. Clinical evaluation, which included disease activity (BASDAI, C-reactive protein – CRP, ASDAS) as well as therapy recording, was performed at baseline and every 6 months thereafter until year 2 and annually thereafter till year 10. Treatment was conducted at the discretion of the local rheumatologist.Results:Since the cohort has started prior to introduction of TNF inhibitors (TNFi), only 2% patients received TNFi at baseline that increased to 23% at year 10 (15% in nr-axSpA and 31% in r-axSpA) – Figure 1. The use of NSAIDs and csDMARDs decreased in both groups (Figure 1), while use of systemic steroids did not change substantially (9% at baseline, 8% at year 10). The proportion of patients with low disease activity according to BASDAI (<4) was higher in r-axSpA as compared to nr-axSpA at almost all time points, while the proportion of patients with low disease activity according to ASDAS (<2.1), as well as with ASDAS inactive disease (<1.3) was similar between nr-axSpA and r-axSpA (Figure 2). In the group of patients who completed year 10 (n=134 in total, 68 with nr-axSpA, 67 with r-axSpA) the same trends in therapy and disease activity were observed.Conclusion:Patients with nr-axSpA and r-axSpA showed a similar disease course in terms of disease activity on the group level. The drop-out rate in this observational cohort was overall high, but comparable between groups. The lower proportion of patients with nr-axSpA being treated with TNFi might reflect a later introduction of TNFi for this indication.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research as well as by Abbott, Amgen, Centocor, Schering–Plough, and Wyeth. From 2010 till 2019 GESPIC has been supported by Abbvie.Disclosure of Interests:Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Murat Torgutalp: None declared, Maryna Verba: None declared, Johanna Callhoff: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Judith Rademacher: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma

O24 Concomitant treatment with MTX does not increase the efficacy of ustekinumab or TFNi in PsA: results from the PsABio study

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Stefan Siebert ◽  
Elisa Gremese ◽  
Paul Bergmans ◽  
Kurt de Vlam ◽  
Beatriz Joven-Ibáñez ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Real World ◽  
Concomitant Treatment ◽  
Skin Involvement ◽  
Research Support ◽  
Real World Data ◽  
Low Disease Activity ◽  
Intention To Treat ◽  
Patient Reported

Abstract Background The additional benefit of methotrexate (MTX) as a concomitant treatment in PsA has not been fully elucidated for TNF inhibitors (TNFi) and no real-world data on this currently exist for ustekinumab (UST). We investigated the additive effect of MTX on the ability to reach composite treatment targets beyond monotherapy with UST or TNFi, and the ability to improve patient-reported outcomes in a real-world clinical setting in 8 European countries. Methods The PsABio study (NCT02627768) evaluates persistence, effectiveness and tolerability of 1st, 2nd or 3rd-line UST or TNFi in patients with PsA. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (LDA) or remission, as well as the patient acceptable symptom state (PASS; score ≤4) of the 12-item Psoriatic Arthritis Impact of Disease questionnaire (PsAID-12) were evaluated. Here we present 6-month follow-up data using intention to treat (ITT) analysis; patients who stopped/switched initial treatment were imputed as non-responders. The effect of MTX co-therapy was investigated within UST and TNFi cohorts, as well as between the cohorts, using multivariate logistic regression including interaction terms, and propensity score (PS) analysis to adjust for imbalanced, potentially prognostic, baseline covariates. Results Of 930 patients, data was available for 868 ITT patients, including patients who switched/stopped before 6 months (UST: n = 28/426 [6.6%], TNFi: n = 44/442 [10.0%]). At baseline there were no relevant differences in demographics and disease activity, however there were significant differences in skin involvement as well as csDMARD and NSAID exposure. Co-therapy with MTX did not increase the likelihood of achieving any of the outcomes in either the UST or TNFi cohorts (Table 1). After PS adjustment, co-treatment with MTX did not influence treatment effects differently when added to UST compared with TNFi. concomitant use of csDMARDs other than MTX yielded very similar results. Conclusion In a real-world setting, concomitant treatment with MTX in addition to UST or TNFi was not associated with enhanced effects across a broad variety of disease outcomes, including disease activity, disease impact, and skin involvement within or between treatment cohorts, after PS adjustment for baseline confounders. Disclosures S. Siebert: Consultancies; AbbVie, UCB, Pfizer, Janssen, Boehringer Ingelheim, Celgene, Novartis. Grants/research support; Pfizer, Janssen, BMS, Celgene, UCB, Boehringer Ingelheim. E. Gremese: Consultancies; AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, Pfizer. P. Bergmans: Shareholder/stock ownership; Johnson & Johnson. Other; Employee of Janssen. K. de Vlam: Consultancies; Johnson & Johnson. B. Joven-Ibáñez: Member of speakers’ bureau; Celgene, Novartis, MSD, Pfizer, AbbVie, Janssen. G. Katsifis: None. T.V. Korotaeva: Consultancies; Pfizer, MSD, Novartis, AbbVie, Celgene, Biocad, Janssen, UCB, Lilly, Novartis-Sandoz. W. Noël: Other; Employee of Janssen. C. Selmi: None. P.P. Sfikakis: None. P. Smirnov: Other; Employee of Janssen. E. Theander: Other; Employee of Janssen. M.T. Nurmohamed: Grants/research support; Pfizer, AbbVie, Roche, BMS, MSD, Mundipharma, UCB, Janssen, Menarini, Lilly, Sanofi, Celgene. L. Gossec: Honoraria; AbbVie, Celgene, Janssen, Lilly, Novartis-Sandoz, Pfizer, Sanofi, UCB. Grants/research support; Pfizer. J.S. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro, Celgene, Celtrion, GlaxoSmithKline, ILTOO Pharma, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB. Grants/research support; AbbVie, Janssen, Lilly, MSD, Pfizer, Roche.

scholarly journals Determinants and protective associations of the lupus low disease activity state in a prospective Chinese cohort

2021 ◽  
Author(s):  
Yanjie Hao ◽  
Shereen Oon ◽  
Lanlan Ji ◽  
Dai Gao ◽  
Yong Fan ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Serum Creatinine ◽  
Disease Activity ◽  
Protective Factor ◽  
Treat To Target ◽  
Low Disease Activity ◽  
Damage Accrual ◽  
Chinese Cohort ◽  
Activity State

Abstract Objective To investigate the frequency and determinants of achieving the lupus low disease activity state (LLDAS), and the effect of LLDAS attainment on disease flare and damage accrual in a prospective, single-center cohort of Chinese lupus patients. Methods Baseline and follow-up data from consecutive patients at the Peking University First Hospital were collected from January 2017 to June 2020. Results A total of 185 patients were enrolled, with median (range) disease duration at enrolment of 2.3 (0.8–7.7) years, and median follow-up of 2.2 (1.0–2.9) years. By the end of the study, 139 (75.1%) patients had achieved LLDAS at least once; 82 (44.3%) patients achieved LLDAS for ≥ 50% of observations. Multivariable logistic regression analysis showed that 24-h urinary total protein (UTP; per g) (OR = 0.447, 95%CI [0.207–0.968], p = 0.041), serum creatinine (Scr; per 10 µmol/L) (OR = 0.72, 95%CI [0.52–0.99], p = 0.040), and C3 level (per 100 mg/L) (OR = 1.60, 95%CI [1.18–2.17], p = 0.003) at recruitment had independent negative associations with achieving LLDAS for ≥ 50% of observations. Kaplan–Meier analyses showed a significant reduction in flare rate with increased proportion of time in LLDAS. Attainment of LLDAS in at least 50% of observations was an independent protective factor for damage accrual (OR = 0.19, 95%CI [0.04–0.99], p = 0.049). Conclusions In this prospective Chinese cohort, LLDAS was an attainable goal in clinical practice. Nephritis-related markers (UTP and Scr) and C3 level at recruitment negatively influenced achievement of LLDAS. LLDAS achievement was significantly protective from flare and damage accrual. Key points • Low disease activity status (LLDAS) is an achievable target during SLE treatment in China. Urine protein, serum creatinine, and C3 level at recruitment independently affect LLDAS achievement in this group of Chinese lupus patients. • As a treatment target, LLDAS achievement has a highly protective effect for preventing flare and damage accrual, especially in case of achieving LLDAS for ≥ 50% of observations. • The present results further highlight the practical significance of treat-to-target principle in SLE management (T2T/SLE) and the needs for promoting the application of T2T/SLE in clinical practice as well as exploring the concrete implement strategy.

Sign in / Sign up

Export Citation Format

Share Document