scholarly journals POS0243 WHAT DOES REMISSION IN AXIAL SPONDYLOARTHRITIS MEAN FOR CLINICIANS? AN EXPLORATORY STUDY OF 200 FRENCH RHEUMATOLOGISTS BASED ON A VIGNETTE EXERCISE INCLUDING 36 CASES AND PRIORITY RATINGS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 343.1-343
Author(s):  
K. Aouad ◽  
D. Wendling ◽  
A. Baglin ◽  
M. Breban ◽  
S. Dadoun ◽  
...  

Background:Treat-to-target in axial spondyloarthritis (axSpA) aims to achieve and maintain clinical remission/inactive disease or alternatively, low disease activity [1]. However, there is no consensual definition of remission in axSpA: the T2T international task force has proposed Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, but this definition is not widely accepted [1, 2].Objectives:To explore rheumatologists’ perception of remission in axSpA, using vignette cases and a priority exercise.Methods:A steering group of 7 rheumatologists designed a national cross-sectional survey during two face-to-face meetings in 2019-2020. The survey comprised 36 vignette cases: fixed elements included the clinical picture (34 year-old-male with confirmed axSpA, normal C-reactive protein (CRP), without synovitis, enthesitis, dactylitis or extra-articular manifestations) and there were 3 varying parameters (axial pain (0-10) [ranging 2 to 5], fatigue (0-10) [2 to 8], and morning stiffness [<15 minutes, 30 minutes or 1 hour]. For each vignette, the rheumatologist answered binarily: “do you consider this patient in remission: yes/no”. The second part of the survey comprised a priority rating (0-10 priority and 4 top items) of elements important to consider for remission, from a list of 12 items (BASDAI, ASDAS, elements of BASDAI and ASDAS including CRP, NSAIDs use, extra-articular manifestations, and other explanations for the symptoms e.g., fibromyalgia). The analysis was descriptive.Results:Overall, 200 French rheumatologists participated between June and September 2020. Out of 2,400 vignette evaluations (mean of 66 evaluations per vignette), 463 (19%) were classified as remission by rheumatologists. Six vignette cases constituted 56% of all remission cases (Figure 1): these comprised a short duration of morning stiffness (<15 minutes), a low VAS axial pain (2 or 3) but with varying levels of VAS fatigue. When the duration of morning stiffness increased from 15 to 30 minutes and VAS axial pain increased from 2-3 to 4-5 independently, classification as remission decreased from 42% to 12% and from 28-33% to 5-11%, respectively. However, when VAS fatigue increased, it impacted less remission.In priority ratings, 4 items were selected as important by 68-75% of rheumatologists: morning stiffness and axial pain (both included in the vignettes), as well as extra-articular manifestations and NSAID use, whereas only 18% selected fatigue. BASDAI was cited as the 1st priority criteria by 24% of rheumatologists and ASDAS as the 2nd by 16% of rheumatologists.Figure 1.Frequencies of the declared remission states by rheumatologists for each of the 36 vignette casesConclusion:Morning stiffness, axial pain, NSAIDs use, and extra-articular manifestations seem to impact the physicians’ perception of remission in axSpA, whereas fatigue has less impact on remission for rheumatologists. Consensus is needed on remission in axSpA.References:[1Smolen JS et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis 2018;77:3–17.[2]Wendling D et al. 2018 update of French Society for Rheumatology (SFR) recommendations about the everyday management of patients with spondyloarthritis. Joint Bone Spine 2018;85:275–84.Funding:This study was funded and organized by Novartis FranceDisclosure of Interests:Krystel Aouad: None declared, Daniel Wendling: None declared, Anne BAGLIN Employee of: Novartis, Maxime Breban: None declared, sabrina DADOUN: None declared, Christophe Hudry: None declared, Anna Moltó: None declared, Edouard Pertuiset: None declared, Laure Gossec: None declared

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 342.1-342
Author(s):  
F. Proft ◽  
J. Schally ◽  
H. C. Brandt ◽  
J. Brandt-Juergens ◽  
G. R. Burmester ◽  
...  

Background:According to international recommendations, the Ankylosing Spondylitis Disease Activity Score (ASDAS) is the preferred score for assessing disease activity in axial spondyloarthritis (axSpA) [1]. However, routine determination of C-reactive protein (CRP) to calculate ASDAS values takes hours to days. This limits the use of ASDAS in clinical routine and clinical trials and hinders the implementation of treat-to-target approaches in axSpA. Whereas quick quantitative CRP (qCRP) tests allow CRP assessment within a few minutes. In a pilot project the performance of qCRP-based ASDAS assessment (ASDAS-qCRP) was already investigated in a single center study of 50 newly diagnosed, bDMARD-naïve axSpA patients with promising results [2].Objectives:To validate the ASDAS-qCRP in a prospective, multicenter study of axSpA patients in a typical axSpA cohort with an appropriate sample size.Methods:The study was conducted in five centers in Germany. Consecutive adult (≥ 18 years) axSpA patients were included. In addition to a rheumatological assessment, including patient reported outcomes (PROs), routine CRP and erythrocyte sedimentation rate (ESR) were measured in the local labs. Additionally, a qCRP testing with the „QuikRead go instrument“ (Aidian Oy, Finland) was performed at the study center (measurement range 0.5 - 200 mg/l for hematocrit concentrations of 40 – 45%). Statistical analysis included descriptive statistics, cross tabulation and weighted Cohen´s kappa comparing disease activity categories, Bland-Altman plots and intraclass correlation coefficient (ICC) for ASDAS-CRP and ASDAS-qCRP.Results:In this study 251 axSpA patients were included between January and September 2020 (mean age: 38.4 years; mean disease duration: 6.2 years, 159 patients (63.3%) were male, 211 (84.1%) HLA-B27 positive and 195 (77.7%) were classified as radiographic axSpA). 143 patients (57.0%) were treated with bDMARDs. CRP and qCRP showed mean values of 2.12 and 2.17 mg/l, respectively. With the ASDAS-qCRP, 242 patients (96.4%) were assigned to the same disease activity category as compared to the ASDAS based on the conventional lab CRP measurement (Table 1). Weighted Cohen´s kappa was 0.966 (95%CI: 0.943; 0.988). ICC for ASDAS-CRP- and ASDAS-qCRP-values was 0.997 (95%CI: 0.994; 0.999). The agreement of ASDAS-qCRP and ASDAS-CRP is shown in a Bland-Altman plot (Figure 1).Table 1.Disease activity categories by ASDAS-qCRP vs. ASDAS-CRPASDAS-qCRP (n = 251)Inactive Disease(< 1.3)Low Disease Activity (1.3 - < 2.1)High Disease Activity (2.1 - 3.5)Very high Disease Activity (> 3.5)ASDAS-CRPInactive Disease(< 1.3)56 (22.3%)2 (0.8%)Low Disease Activity (1.3 - < 2.1)62 (24.7%)7 (2.8%)High Disease Activity (2.1 - 3.5)97 (38.6%)Very high Disease Activity (> 3.5)27 (10.8%)The fields highlighted in red indicate that disease activity categories do not match.ASDAS = Ankylosing Spondylitis Disease Activity Score, CRP = C-reactive protein, qCRP = quick quantitative CRPConclusion:The ASDAS-qCRP and ASDAS-CRP showed an almost perfect agreement on the assignment to disease activity categories (96%) with the important advantage of time. With ASDAS-qCRP, rheumatologists could base their clinical decision-making on a disease activity measurement by using a composite score immediately. ASDAS-qCRP, therefore, can be integrated in clinical routine and clinical trials in the future and may facilitate implementation of the treat-to-target concept in axial SpA.References:[1]Smolen JS, et al. Ann Rheum Dis. 2018 Jan; 77(1):3-17.[2]Proft F, et al. Joint Bone Spine. 2019 Jul 29.Figure 1.Bland-Altman plot for ASDAS-qCRP and ASDAS-CRPAcknowledgements:The authors would like to deeply thank Braun T, Doerwald C, Deter N, Höppner C, Lackinger J, Lorenz C, Lunkwitz K, Mandt B, Sron S and Zernicke J for their practical support and coordinating the study.Funding statement: The AQUA study was supported by an unrestricted research grant from Novartis. Testing kits were provided free of charge from Aidian Oy, Finland.Disclosure of Interests:None declared


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S467-S467
Author(s):  
A Srinivasan ◽  
D R van Langenberg ◽  
R Little ◽  
M P Sparrow ◽  
P De Cruz ◽  
...  

Abstract Background Virtual clinics (VC) represent a novel model-of-care which promote quality use of biologics and facilitate a treat-to-target (T2T) approach. We aimed to evaluate the clinical and process-driven outcomes of intensified anti-TNF therapy for secondary loss of response (SLoR) in a VC compared with standard outpatient care (SoC). Methods A retrospective multicenter, parallel observational cohort study of patients with Crohn’s disease (CD) who underwent anti-TNF dose intensification to address SLoR with up to 2-years of follow-up was undertaken. Objective assessments of disease activity and anti-TNF trough levels at SLoR then during subsequent 6-month semesters were compared longitudinally between VC and SoC groups. ‘Anti-TNF escalation success’ was the primary endpoint, defined as achieved when two consecutive 6-month semesters of objective assessment demonstrated inactive disease. Dose intensification was defined as ‘appropriate’ if there was both objective evidence of disease activity, plus anti-TNF trough levels at or below the lower limit of the therapeutic range prior to intensification. ‘Treatment escalation failure’ was defined by the occurrence of one or more of biologic switching, discontinuation or further intensification; recommencement of corticosteroids, or IBD-related surgery. Results 149 patients (69 VC vs. 80 SoC) underwent infliximab (n = 94) or adalimumab (n = 55) dose intensification with similar baseline patient, disease and treatment characteristics between cohorts. The median duration of follow-up post dose-intensification was 1.9 and 1.5 years for the SoC and VC cohorts respectively (p = 0.37). There were higher rates of appropriate dose intensification (82.6 vs. 40.0%, p &lt; 0.01) across the VC cohort. Higher proportions of anti-TNF escalation success (60.9 v 35.0%, p &lt; 0.01), biomarker remission (i.e., C-Reactive Protein (&lt;5mg/l) and faecal calprotectin (&lt;150 μg/ml) normalisation, log-rank tests, p = 0.06 and p &lt; 0.01 respectively), tight disease monitoring (84.1 vs. 28.8%, p &lt; 0.01) and de-escalation of intensified therapy (21.3 vs. 10.0%, p = 0.03) were also achieved by the VC cohort following dose-intensification. Conclusion This study favoured a VC-led model of care over standard outpatient-based IBD care in facilitating an effective T2T approach to CD management. A VC model of care improved quality use of intensified anti-TNF therapy through processes that promoted appropriate dose intensification and encouraged more frequent anti-TNF dose de-escalation. Moreover, tight semester-based monitoring using a T2T-based strategy facilitated by the VC was associated with improved treatment outcomes.


2017 ◽  
Vol 45 (2) ◽  
pp. 195-201 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Maria Manara ◽  
Salvatore D’Angelo ◽  
Olga Addimanda ◽  
...  

Objective.The aim of this study was to evaluate the influence of sex on response to treatment and disease remission in patients with axial spondyloarthritis (axSpA).Methods.In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria for axSpA, and treated with adalimumab, etanercept, golimumab, or infliximab, were studied. We compared clinical characteristics, patient-reported outcomes, disease activity, function, and response to treatment in male and female patients with this disease.Results.Three hundred forty patients with axSpA (270 with ankylosing spondylitis, 19 with psoriatic arthritis with axial involvement, and 51 with nonradiographic axSpA) were studied. Male subjects had a significantly higher prevalence of grade IV sacroiliitis, higher levels of serum C-reactive protein, lower Maastricht Ankylosing Spondylitis Enthesitis Score, and fatigue when compared with females. Further, Kaplan-Meier survival curves showed that the rate of partial remission, ASAS40 response, and Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement, but not ASDAS inactive disease, were significantly lower in female patients.Conclusion.Our data suggest that female sex was associated with a lower rate of response to treatment and of disease remission in patients with axSpA treated with antitumor necrosis factor-α drugs.


RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001280
Author(s):  
Brigitte Michelsen ◽  
Ulf Lindström ◽  
Catalin Codreanu ◽  
Adrian Ciurea ◽  
Jakub Zavada ◽  
...  

ObjectivesTo explore 6-month and 12-month secukinumab effectiveness in patients with axial spondyloarthritis (axSpA) overall, as well as across (1) number of previous biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs), (2) time since diagnosis and (3) different European registries.MethodsReal-life data from 13 European registries participating in the European Spondyloarthritis Research Collaboration Network were pooled. Kaplan-Meier with log-rank test, Cox regression, χ² and logistic regression analyses were performed to assess 6-month and 12-month secukinumab retention, inactive disease/low-disease-activity states (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <2/<4, Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3/<2.1) and response rates (BASDAI50, Assessment of Spondyloarthritis International Society (ASAS) 20/40, ASDAS clinically important improvement (ASDAS-CII) and ASDAS major improvement (ASDAS-MI)).ResultsWe included 1860 patients initiating secukinumab as part of routine care. Overall 6-month/12-month secukinumab retention rates were 82%/72%, with significant (p<0.001) differences between the registries (6-month: 70–93%, 12-month: 53–86%) and across number of previous b/tsDMARDs (b/tsDMARD-naïve: 90%/73%, 1 prior b/tsDMARD: 83%/73%, ≥2 prior b/tsDMARDs: 78%/66%). Overall 6-month/12-month BASDAI<4 were observed in 51%/51%, ASDAS<1.3 in 9%/11%, BASDAI50 in 53%/47%, ASAS40 in 28%/22%, ASDAS-CII in 49%/46% and ASDAS-MI in 25%/26% of the patients. All rates differed significantly across number of previous b/tsDMARDs, were numerically higher for b/tsDMARD-naïve patients and varied significantly across registries. Overall, time since diagnosis was not associated with secukinumab effectiveness.ConclusionsIn this study of 1860 patients from 13 European countries, we present the first comprehensive real-life data on effectiveness of secukinumab in patients with axSpA. Overall, secukinumab retention rates after 6 and 12 months of treatment were high. Secukinumab effectiveness was consistently better for bionaïve patients, independent of time since diagnosis and differed across the European countries.


Rheumatology ◽  
2020 ◽  
Vol 60 (1) ◽  
pp. 263-268 ◽  
Author(s):  
Marwa Mahmoud Abdelaziz ◽  
Rania M Gamal ◽  
Nadia M Ismail ◽  
Raghda A Lafy ◽  
Helal F Hetta

Abstract Objectives This study was designed to evaluate the role of anti-CD74 antibodies in diagnosis of axial spondyloarthritis (axSpA) and their relationship to disease duration and disease activity. Methods Fifty patients with axSpA, 15 patients with RA and 15 healthy subjects were included in the study. Clinical examination and laboratory tests were done. The ESR, CRP level and ASDAS were measured as markers of the disease activity. Quantitative determination of human CD74 IgG antibodies was done. Results The mean age of the patients was 38.22 (S.D.12.20) years. The level of CD74 autoantibodies was significantly higher in axSpA in comparison to control groups. Most patients with positive articular and extra-articular manifestations were positive for CD74 autoantibodies. In patients with inactive disease, 33.3% were positive for CD74 autoantibodies, as were 83% with active disease. High percentages of patients with early and late axSPA were CD74 autoantibody positive. The majority of patients with positive disease activity in early and late axSpA were CD74 autoantibody positive. CD74 autoantibodies had 80% sensitivity vs both control groups with 87% specificity vs the healthy control group and 80% vs the RA control group in the diagnosis of axSpA. Conclusions The frequency of positive anti-CD74 IgG antibodies was as high in patients with early axSpA as in those with late axSpA, with no significant differences. There was a significant difference in the frequency of positive anti-CD74 IgG antibodies between patients with positive and negative disease activity. Based on the sensitivity and specificity of anti-CD74 IgG, this is a promising diagnostic tool to support the clinical diagnosis of axSpA.


2020 ◽  
pp. 24-30
Author(s):  
D. Capelusnik ◽  
L. L. Macías Oviedo ◽  
J. M. Sevillano Gutiérrez ◽  
G. Citera

Background: One of the premises of the Treat to Target (T2T) is the shared treatment decision between the rheumatologist and the patient. For this reason, patient preferences play a fundamental role in the success of treatment in the short and long term. The aims of this study were to evaluate the treatment preferences of patients with Axial Spondyloarthritis (axSpA) and to identify the factors associated with their choice. Material and methods: Cross sectional study. Patients ≥18 years old that fulfilled the ASAS 2009 criteria for axSpA were included. Sociodemographic data, comorbidities, disease characteristics, and treatments received were recorded. A specially designed questionnaire in both, multiple choice modality and response mode listed in order of priority of the statements was administered. Statistical analysis: Descriptive statistics. Student’s T-test, Chi2 test and multiple logistic regression analysis. A value of p <0.05 was considered significant. Results: Seventy patients were included with a median age (m) of 46.5 years (IQR: 38-57), 55 males (78.6%) and a median disease duration of 13.5 years (IQR: 7.75-23.25). The relevant aspects for choosing a treatment were: the ability to improve the quality of life (32.9%), followed by improvement in joint inflammation (22.9%), pain (21. 4%) and physical function (14.3%). The chosen administration routes in decreasing order of frequency were: oral (51.4%), subcutaneous (SC) (41.4%), intramuscular (IM) 4.3% and intravenous (IV) 2.9%. The preferred frequency of oral administration was one tablet per week (61.1%) and SC administration, once a month (34.5%). The choice of oral route was associated with: preference for self-administration, preference for receiving the medication at home and higher level of education. The choice of the SC route was independently associated with the type of axSpA (AS) and a lower educational level. The patients under biological SC treatment and with lower disease activity, showed higher level of treatment satisfaction. Conclusion: The most preferred way of administration by patients with axSpA was the oral route. Lower disease activity and SC biological treatment were associated with treatment greater compliance.


2018 ◽  
Vol 46 (1) ◽  
pp. 38-42 ◽  
Author(s):  
Laura C. Coates ◽  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Paul Emery ◽  
Philip G. Conaghan ◽  
...  

Objective.Recommendations regarding “treat to target” in psoriatic arthritis (PsA) have stated that the target should be remission or inactive disease. Potential definitions include very low disease activity (VLDA), PsA Disease Activity Score (PASDAS) near remission, Disease Activity Index for PsA (DAPSA) or clinical DAPSA (cDAPSA) remission. Our aim was to investigate the proportion of patients who fulfill these definitions and how much residual active disease remained.Methods.This analysis used 2 datasets: first, trial data from the Tight Control of PsA (TICOPA) study, which included 206 patients with recent-onset (< 2 yrs) PsA receiving standard and biological disease-modifying antirheumatic drugs (DMARD); and second, an observational clinical dataset from Italy of patients receiving biological DMARD. Proportions achieving each of the 4 potential targets were calculated in each dataset and comparisons between treatment groups were performed in the TICOPA dataset. Levels of residual disease were established for key clinical domains of PsA.Results.All measures could differentiate the TICOPA trial treatment groups (p < 0.03). Lower proportions of patients fulfilled the VLDA criteria compared to DAPSA or cDAPSA remission. PASDAS results were different between the cohorts. Residual active disease was low across all definitions although higher levels were seen in DAPSA and cDAPSA compared to VLDA, particularly for psoriasis. In all measures, the proportion with elevated C-reactive protein was similar and low.Conclusion.VLDA appears the most stringent measure. It ensures that significant active arthritis, enthesitis, and psoriasis are not present, in contrast with DAPSA and PASDAS, in which composite scores can “hide” active disease in some domains.


2016 ◽  
Vol 43 (8) ◽  
pp. 1541-1546 ◽  
Author(s):  
Ennio Lubrano ◽  
Fabio Massimo Perrotta ◽  
Maria Manara ◽  
Salvatore D’Angelo ◽  
Olga Addimanda ◽  
...  

Objective.The aim of this study was to evaluate rate and predictive factors of loss of remission and disease flare in patients with axial spondyloarthritis (axSpA) receiving antitumor necrosis factor (anti-TNF) treatment.Methods.In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria, treated with adalimumab, etanercept, or infliximab with a minimum followup of 12 months and satisfying the ASAS partial remission criteria and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease were studied. Disease flare was defined as a Bath Ankylosing Spondylitis Disease Activity Index score > 4.5 or ASDAS score > 2.5 on at least 1 occasion.Results.One hundred seventy-four patients with axSpA were studied. After a median [interquartile range (IQR)] followup of 4 years (2–6), 37 patients (21.2%) experienced a loss of remission and 28 (16.1% of the whole study group) a disease flare. Median (IQR) duration of remission in patients who lost this status was 1 year (0.625–2). Higher median erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values, continuous nonsteroidal antiinflammatory drug (NSAID) use, and an ASDAS-CRP ≥ 0.8 during the remission period were significantly associated with both loss of remission and disease flare. At the multivariate analysis, continuous NSAID intake (OR 4.05, 95% CI 1.4–11.74, p = 0.010) and ESR > 15 (OR 2.90, 95% CI 1.23–6.82, p = 0.015) were the only factors predictive of disease reactivation.Conclusion.In this study, loss of remission and disease flares occurred, respectively, in about 21% and 16% of the patients with axSpA who achieved a state of remission while receiving anti-TNF therapy. Residual disease activity was associated with disease reactivation.


2016 ◽  
Vol 76 (6) ◽  
pp. 1036-1041 ◽  
Author(s):  
Anna Molto ◽  
Sophie Tezenas du Montcel ◽  
Daniel Wendling ◽  
Maxime Dougados ◽  
Antoine Vanier ◽  
...  

BackgroundDisease activity may change over time in axial spondyloarthritis (axSpA). The objectives were to identify patterns of disease activity evolution in patients with early axSpA.MethodsPatients from the prospective early axSpA cohort (DEvenir des Spondyloarthrites Indifférenciées Récentes (DESIR)) who fulfilled the Assessment in SpondyloArthritis Society (ASAS) criteria for axSpA at baseline and with at least three Ankylosing Spondylitis Disease Activity Score (ASDAS) values available over the 3 years of follow-up were analysed. Statistical analyses: trajectories were estimated by group-based trajectory modelling; predisposing baseline factors for such trajectories were identified by univariate and multivariable multinomial (logit) regression; work disability over time was compared between the trajectories by Cox hazard model.ResultsIn all, 370 patients were analysed: mean disease duration was 1.6 (±0.9) years. The five distinct trajectories of disease activity over the 3 years were (t1) ‘persistent moderate disease activity’ (n=134 (36.2%)); (t2) ‘persistent inactive disease’ (n=66 (17.8%); (t3) ‘changing from very high disease activity to inactive disease’ ((n=29 (7.8%)); (t4) ‘persistent high disease activity’ (n=126 (34.1%)) and (t5) ‘persistent very high disease activity’ (n=15 (4.1%)). After adjustment for other characteristics, t2 was associated with a white-collar job (OR=2.6 (95% CI 1.0 to 6.7)) and t3 with male gender (OR=7.1 (1.6 to 32.2)), higher education level (OR=9.4 (1.4 to 63.4)) and peripheral joint involvement (OR=6.2 (1.23 to 31.32)). Patients from (t4) and (t5) were more often declared work disabled over follow-up (HR=5.2 (1.5 to 18.0) and HR=8.0 (1.3 to 47.9), respectively).ConclusionsTrajectory modelling of disease activity was feasible in early axSpA: more than 30% patients (141/370) were in a trajectory with a persistent high disease activity. Persistent high disease activity trajectories were significantly associated with consequences on work.Trial registration numberNCT01648907.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 722.1-723
Author(s):  
E. G. Favalli ◽  
A. Marchesoni ◽  
S. Balduzzi ◽  
C. Montecucco ◽  
C. Lomater ◽  
...  

Background:Observational data on the use of secukinumab for the treatment of spondyloarthritides are still lacking. Large population-based registries that allow long-term follow-up have been increasingly used to investigate the performance of biologic drugs in a real life setting.Objectives:The aim of this study is to evaluate the effectiveness and the retention rate of secukinumab in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients in a real-life setting over a 3-year follow-up period.Methods:Data of all PsA and axSpA patients (diagnosed according to CASPAR and ASAS criteria, respectively) treated with secukinumab were prospectively collected in the Italian multicentric LORHEN registry. Effectiveness was measured as the mean change from baseline of Disease Activity in PSoriatic Arthritis score (DAPSA) in PsA and Ankylosing Spondylitis Disease Activity Score (ASDAS) in axSpA patients. Rates of DAPSA remission and ASDAS inactive disease were also computed. The 3-year retention rate was calculated by the Kaplan-Meier method and compared between PsA and axSpA by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 195 PsA (55.4% females, mean age 50.7 [±11.8] years, mean disease duration 10 [±7.8] years, mean baseline DAPSA 23.12 [±12.3]) and 94 axSpA (61.7% males, mean age 49.1 [±12.7] years, mean disease duration 10.4 [±9.4] years, mean baseline ASDAS 3.41 [±1.1]) patients who received secukinumab as first (26.5 and 33%, respectively) or subsequent biologic agent. Compared with baseline, the 3-, 6- and 12-month mean values of both DAPSA (12.6 [±9], 11.2 [±10.5] and 9.3 [±7.5], respectively) and ASDAS (2.23 [±0.9], 2.15 [±0.9], and 1.84 [±0.9], respectively) were significantly decreased (p<0.001 for all the timepoints). The 3-, 6-, and 12-month rates of remission/inactive disease were 15.5, 25.4, and 30.5% in PsA and 18, 23.7, and 28.6% in axSpA group, respectively. One- and 3-year retention rate (figure 1) were respectively 79.4% and 66.6% in PsA and 72.3% and 70.1% in axSpA patients, with no significant difference between the two groups (p=0.517). The most frequent reason for withdrawal was inefficacy in both PsA (n=41) and axSpA (n=20), whereas only 8 PsA and 6 axSpA patients discontinued secukinumab because of adverse events.Conclusion:Our data confirmed in a real-life setting the 1-year clinical efficacy and the 3-year survival of secukinumab in both PsA and axSpA. The safety profile of secukinumab was very favorable for both the indications. No significant differences were observed in the performance of secukinumab between ax-SpA and PsA.References:[1]Deodhar A, et al. Arthritis Research & Therapy; 2019.[2]Mease PJ, et al. RMD Open. BMJ Specialist Journals; 2018;4(2):e000723.[3]Baraliakos X, et al. Clin Exp Rheumatol. 2018 Jan;36(1):50–5.Disclosure of Interests:Ennio Giulio Favalli Consultant of: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Speakers bureau: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Antonio Marchesoni Speakers bureau: Abbvie, Pfizer, UCB, Novartis, Celgene, Eli Lilly, Silvia Balduzzi: None declared, Carlomaurizio Montecucco: None declared, Claudia Lomater Consultant of: Advisory board for Sanofi, Novartis, Abbvie, Gloria Crepaldi Consultant of: Advisory board for Sanofi and Celgene, Speakers bureau: BMS, MSD, Silvia Talamini: None declared, Chiara Bazzani: None declared, Enrico Fusaro: None declared, Marta Priora: None declared, Aurora Iannello: None declared, Giuseppe Paolazzi: None declared, Roberto Caporali Consultant of: AbbVie; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme; Celgene; Bristol-Myers Squibb; Pfizer; UCB, Speakers bureau: Abbvie; Bristol-Myers Squibb; Celgene; Lilly; Gilead Sciences, Inc; MSD; Pfizer; Roche; UCB


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