AB0706 Ankylosing spondylitis patients with uveitis had better adalimumab retention rate: hur-bio real life results

Background:Secukinumab (SEC) is the first interleukin-17A inhibitor showing efficacy in both ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in randomised trials, but real-life data are lacking.Objectives:In this prospective observational study, we evaluated the effectiveness and safety of SEC in patients with AS and PsA in a real-life setting.Methods:From September 2018 to September 2019, data were collected from 168 consecutive outpatients at baseline (T0) and at 6 (T6) and 12 months (T12) after starting SEC (39 AS, 23%; 129 PsA, 77%).Results:Significant improvement was seen at T6 and T12 for all clinical variables, including TJC, SJC, ESR, CRP, DAPSA, ASDAS-CRP, and BASDAI, as well as in patient-reported outcomes such as VAS-pain. By multivariable regression analysis, in AS patients high BASDAI at T0 correlated with diagnostic delay (R2=0.4; p=0.009) and peripheral joint involvement (R2=0.4; p=0.04). During follow-up, reduction of BASDAI positively correlated with high ESR (R2=0.65; p=0.04). ASDAS-CRP at T0 positively correlated with high ESR (R2=0.34; p=0.004). Reduction of ASDAS-CRP from T0 to T6 correlated with current smoking status (R2=0.42; p=0.0005). In PsA patients, reduction of DAPSA score from T0 to T12 negatively correlated with the presence of metabolic syndrome (R2=0.41; p= 0.0025). Retention rate showed good drug survival and an influence of female sex (Figure 1) in the survival curve in only AS patients, but no differences based on BMI, gender and lines of treatment were observed (Figure 2). SEC was well tolerated: Eleven patients discontinued treatment for non-severe adverse events.Conclusion:We demonstrated the effectiveness and safety of SEC in patients with AS and PsA in a real-life setting for the first time. No gender differences were observed; however, less clinical improvement was seen in smokers and in patients with metabolic syndromeReferences:No references.Disclosure of Interests:Maria Sole Chimenti: None declared, giulia lavinia fonti: None declared, Paola Conigliaro: None declared, flavia sunzini: None declared, Rossana Scrivo: None declared, luca navarini: None declared, paola triggianese: None declared, giusy peluso: None declared, Palma Scolieri: None declared, rosalba caccavale: None declared, Andrea Picchianti-Diamanti: None declared, erica de martino: None declared, simonetta salemi: None declared, domenico birra: None declared, Alessio Altobelli: None declared, marino paroli: None declared, Vincenzo Bruzzese: None declared, Bruno Laganà: None declared, Elisa Gremese Speakers bureau: Abbvie, BMS, Celgene, Jannsen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB, fabrizio conti Speakers bureau: BMS, Lilly, Abbvie, Pfizer, Sanofi, Antonella Afeltra: None declared, Roberto Perricone: None declared

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POS0675 THE COMPARATIVE 3-YEAR RETENTION RATE OF TARGETED-SYNTHETIC AND BIOLOGIC DRUGS FOR RHEUMATOID ARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN GISEA REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3557 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 582.1-582

Author(s):

E. G. Favalli ◽

F. Iannone ◽

E. Gremese ◽

R. Gorla ◽

R. Foti ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Adverse Events ◽

Retention Rate ◽

Large Population ◽

Real Life ◽

Mechanisms Of Action ◽

Biologic Drugs ◽

Real Life Setting ◽

Study Population ◽

Targeted Drug

Background:Long-term observational data on the real-life use of JAK inhibitors (JAKis) for rheumatoid arthritis (RA) and their comparison with biological drugs are still very limited. Large population-based registries have been increasingly used to investigate the performance of targeted drugs in a real-life setting.Objectives:The aim of this study is to evaluate and compare the 3-year retention rate of JAKis, TNF inhibitors (TNFis) and biologic drugs with other mechanisms of action (OMAs) in the large cohort of RA patients included in the Italian national GISEA registry.Methods:Data of all RA patients treated with targeted synthetic or biologic drugs were prospectively collected in the Italian multicentric GISEA registry. The analysis was limited to patients who started a first- or second-line targeted drug in the period after the first JAKi was marketed in Italy (1st December 2017). The 3-year retention rate was calculated by the Kaplan-Meier method and compared between different drug classes by a log-rank test. A descriptive analysis of reasons for discontinuation was performed.Results:The study population included 1027 RA patients (79.8% females, mean age [±SD] 56.9 [±13.5] years, mean disease duration 9.8 [±9] years, mean baseline SDAI 17.5 [±11.9], ACPA positive 67.4%, RF positive 62.7%) who received JAKis (baricitinib or tofacitinib, n=297), TNFis (n=365), or OMAs (n=365) as first or second targeted drug. Main baseline characteristics of study population were overall well balanced between treatment groups. Retention rate was numerically but not statistically higher (p=0.18) in patients treated with JAKis compared with TNFis or OMAs (80.6, 78.9 and 76.4% at 1 year and 73, 56.8 and 63.8% at 3 years, respectively) (Figure 1). Drug survival was significantly higher in patients receiving concomitant methotrexate (MTX) compared with monotherapy only in TNFis (66.8 vs 47.1%, p=0.04) but not in JAKis (76.1 vs 70.1%, p=0.54) and OMAs (66.1 vs 61.9%, p=0.41) group. Therapy was discontinued in a total of 211 patients because of ineffectiveness (n=107), adverse events (n=88), or compliance/other reasons (n=16). The most frequent reason for treatment withdrawal was ineffectiveness in both JAKis (n=30 out of 56) and TNFis (n=45 out of 74) groups, whereas OMAs were discontinued more frequently because of adverse events (n=41 out of 81).Conclusion:Our data confirmed in a real-life setting a favorable 3-year retention rate of all available targeted mechanisms of action for RA therapy. As expected, concomitant MTX significantly impacted persistence on therapy of TNFis only. Discontinuations of JAKis for adverse events were infrequent overall, confirming the safety profile observed in randomized clinical trials.Figure 1.Three-year retention rate by treatment groupDisclosure of Interests:None declared

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AB0292 EFFICACY AND SAFETY OF TWO BIOSIMILAR ETANERCEPT AFTER THE SWITCH FROM THEIR CORRESPONDING ORIGINATOR IN THE TREATMENT OF PATIENTS WITH AUTOIMMUNE ARTHRITIS; A RETROSPECTIVE ANALYSIS IN A REAL LIFE SETTING

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2364 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1445.1-1445

Author(s):

F. Girelli ◽

A. Ariani ◽

M. Bruschi ◽

A. Becciolini ◽

L. Gardelli ◽

...

Keyword(s):

Regression Analysis ◽

Disease Duration ◽

Retention Rate ◽

Real Life ◽

Autoimmune Arthritis ◽

Proportional Hazard ◽

Hazard Regression ◽

Cox Proportional Hazard ◽

Real Life Setting ◽

Cox Proportional Hazard Regression

Background:The available biosimilars of etanercept are as effective and well tolerated as their bio originator molecule in the naive treatment of chronic autoimmune arthritis. More data about the switching from the bio originator are needed.Objectives:To compare the clinical outcomes of the treatment with etanercept biosimilars (SB4 and GP2015) naïve and after the switch from their corresponding originator in patients affected by autoimmune arthritis in a real life settingMethods:We retrospectively analyzed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of etanercept (originator or biosimilar) in our Rheumatology Units from January 2000 to January 2020. We stratified the study population according to biosimilar use. Descriptive data are presented by medians (interquartile range [IQR]) for continuous data or as numbers (percentages) for categorical data. Drug survival distribution curves were computed by the Kaplan-Meier method and compared by a stratified log-rank test. A Cox proportional hazards regression analysis stratified by indication, drug, age, disease duration, sex, treatment line, biosimilar use and prescription year was performed. P values≤0.05 were considered statistically significant.Results:477 patients (65% female, median age 56 [46-75] years, median disease duration 97 [40.25-178.75] months) treated with etanercept were included in the analysis. 257 (53.9%) were affect by rheumatoid arthritis, 139 (29.1%) by psoriatic arthritis, and 81 (17%) by axial spondylarthritis. 298 (62.5%) were treated with etanercept originator, 97 (20.3%) with SB4, and 82 (17.2%) with GP2015. Among the biosimilars 90/179 (50.3%) patients were naïve to etanercept treatment. Among the 89 switchers we observed 8 treatment discontinuations: one due to surgical infection complication, three due to disease flare, two due to subjective worsening and one due to remission. The overall 6- and 12-month retentions rate were 92.8% and 80.2%. The 6- and 12-month retention rate for etanercept, SB4 and GP2015 were 92.7%, 93.4% and 90.2%, and 82%, 74.5% and 88.1% respectively, without significant differences among the three groups (p=0.374). Patients switching from originator to biosimilars showed and overall higher treatment survival when compared to naive (12-month retention rate 81.2% vs 70.8%, p=0.036). The Cox proportional hazard regression analysis highlighted that the only predictor significantly associated with an overall higher risk of treatment discontinuation was the year of prescription (HR 1.08, 95% CI 1.04 to 1.13; p<0.0001).Conclusion:In our retrospective study etanercept originator and its biosimilars (SB4 and GP2015) showed the same effectiveness. Patients switching from originator to biosimilar showed an significant higher retention rate when compared to naive. The only predictor of treatment discontinuation highlighted by the Cox proportional hazard regression analysis was the year of treatment prescription.Disclosure of Interests:Francesco Girelli: None declared, Alarico Ariani: None declared, Marco Bruschi: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Lucia Gardelli: None declared, Maurizio Nizzoli: None declared

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Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

RMD Open ◽

10.1136/rmdopen-2020-001519 ◽

2021 ◽

Vol 7 (1) ◽

pp. e001519

Author(s):

Roberta Ramonda ◽

Mariagrazia Lorenzin ◽

Antonio Carriero ◽

Maria Sole Chimenti ◽

Raffaele Scarpa ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Adverse Events ◽

Disease Activity ◽

Biological Treatment ◽

Retention Rate ◽

Real Life ◽

Drug Retention ◽

Group A ◽

Group B ◽

Drug Retention Rate

ObjectivesTo evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) diﬀerences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.MethodsConsecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.Results608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).ConclusionsIn a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.

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Real Life Experience of First Course of Anti-TNF Treatment in Ankylosing Spondylitis Patients in Brazil

Rheumatology and Therapy ◽

10.1007/s40744-016-0026-2 ◽

2016 ◽

Vol 3 (1) ◽

pp. 143-154 ◽

Cited By ~ 2

Author(s):

Marina Amaral de Ávila de Machado ◽

Alessandra Maciel Almeida ◽

Adriana Maria Kakehasi ◽

Francisco de Assis Acurcio

Keyword(s):

Ankylosing Spondylitis ◽

Life Experience ◽

Real Life

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AB0466 RETENTION RATE AND EFFECTIVENESS OF SECUKINUMAB VERSUS TNF INHIBITOR SWITCHING IN ANKYLOSING SPONDYLITIS PATIENTS WITH A HISTORY OF TNF INHIBITOR TREATMENT: DATA FROM A KOREAN NATIONWIDE REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1489 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1260.1-1260

Author(s):

H. K. Min ◽

K. Y. Kang

Keyword(s):

Ankylosing Spondylitis ◽

Clinical Efficacy ◽

Retention Rate ◽

Drug Discontinuation ◽

Tnf Inhibitor ◽

Drug Retention ◽

Treatment Data ◽

Adjusted Logistic Regression ◽

Efficacy Parameters

Background:The choice of second-line biologics for ankylosing spondylitis (AS) patients previously treated with a tumour necrosis factor inhibitor (TNFi) remains unclearObjectives:Here, we compared drug retention and clinical efficacy between AS patients who switched biologics to secukinumab and those who switched to a different TNFi.Methods:AS patients enrolled in the Korean College of Rheumatology BIOlogics registry were included. Patients with previous TNFi exposure were divided into the secukinumab group and the TNFi switching group. Drug retention and clinical efficacy (BASDAI50, ASAS20, ASAS40, ASDAS <2.1, ASDAS clinically important improvement, and ASDAS major improvement) were assessed at the 1 year follow-up. Propensity score (PS)-matched and covariate-adjusted logistic regression analyses were performed.Results:246 had available 1 year follow-up data. Secukinumab as third- or later-line biologics was more frequent than alternative TNFi (54% vs. 14%). PS-matched and multiple covariate-adjusted analyses showed that the odds ratio (OR) for drug discontinuation was comparable between the secukinumab and TNFi switching groups (OR=1.136; 95% CI, 0.843–1.531 and OR=1.000; 95% CI, 0.433–2.308, respectively). The proportion of patients who achieved BASDAI50 was also comparable between the two groups (OR=0.833; 95% CI, 0.481–1.441 in PS-matched analysis). Other clinical efficacy parameters were also comparable. In the subgroup analysis of AS patients with previous TNFi discontinuation due to ineffectiveness, all clinical efficacy parameters were comparable between the two groups.Conclusion:In AS patients with previous exposure to a TNFi, switching biologics to secukinumab and switching to an alternative TNFi resulted in comparable drug retention and clinical efficacy.References:[1]Micheroli R, Tellenbach C, Scherer A, et al. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis 2020;79:1203-9.Disclosure of Interests:None declared.

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