THU0230 Anti-TNF Alpha Drugs Retention Rate at Ankylosing Spondylitis and Axial Spondyloarthritis: HUR-BIO Real Life Results

2015 ◽  
Vol 74 (Suppl 2) ◽  
pp. 279.2-280
Author(s):  
U. Kalyoncu ◽  
H. Babaoglu ◽  
A. Erden ◽  
L. Kilic ◽  
M. Torgutalp ◽  
...  
2020 ◽  
Vol 20 (7) ◽  
pp. 813-821 ◽  
Author(s):  
Maria Sole Chimenti ◽  
Giulia Lavinia Fonti ◽  
Paola Conigliaro ◽  
Flavia Sunzini ◽  
Rossana Scrivo ◽  
...  

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.


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


Author(s):  
B. Serrano-Benavente ◽  
C.M. González Fernández ◽  
L. Valor ◽  
J.C. Nieto-González ◽  
R.D. González-Benítez ◽  
...  

2020 ◽  
Vol 2020 ◽  
pp. 1-5 ◽  
Author(s):  
Stefano Gentileschi ◽  
Donato Rigante ◽  
Jurgen Sota ◽  
Giuseppe Lopalco ◽  
Maria Grazia Giannotta ◽  
...  

Objectives. The primary aim of our study was to evaluate long-term efficacy of secukinumab (SCK) in patients with axial spondyloarthritis (axSpA); secondary aims were to evaluate drug retention rate and to identify differences in the clinical and laboratory assessment according to axSpA clinical features, dosage administered, and biologic treatment lines. Patients and Methods. We collected clinical, demographical, and treatment data from 39 patients affected by axSpA consecutively treated with SCK. Laboratory assessment was based on inflammation parameters; clinical assessment was performed with the Ankylosing Spondylitis Disease Activity Score- (ASDAS-) CRP and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Data were recorded at baseline and every 3 months for the first year and then every 6 months in the second year. Results. Twelve males and 27 females were enrolled; both BASDAI and ASDAS-CRP showed a statistically significant reduction during the observation period (p<0.0001 and p<0.0001, respectively). C-reactive protein significantly decreased (p=0.006), with significant reduction at the post hoc analysis between baseline and both 6-month evaluation (p=0.02) and 24-month visit (p=0.036). No statistical significance was observed in BASDAI and ASDAS-CRP improvement (p=0.482 and p=0.164, respectively) between different dosages administered. No significant differences emerged in the BASDAI and ASDAS-CRP variations between biologic-naïve patients and subjects previously failing to tumour necrosis factor (TNF) inhibitors (p=0.53 and p=0.148, respectively). At the end of our observation, 7 out of 39 patients discontinued SCK. The global retention rate at the end of the study period was 78.2%, without any significant differences between biologic-naïve and anti-TNF-failure patients (p=0.619) or between subjects administered with different SCK dosages (p=0.614). No adverse events were reported. Conclusions. In our cohort, SCK has proved a remarkable effectiveness regardless biologic treatment line and dosages employed. As suggested by the notable drug retention rate, SCK has been able to maintain its effectiveness over a considerable long period of treatment.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 726.1-726
Author(s):  
M. Lorenzin ◽  
A. Ortolan ◽  
M. S. Chimenti ◽  
A. Marchesoni ◽  
E. Lubrano ◽  
...  

Background:Axial Spondyloarthritis (axSpA) can be distinguished in radiographic axSpA (r-axSpA) and non-radiographic (nr-axSpA). Secukinumab (SEC) is a novel treatment for axSpA, but data from real-life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of axSpA patients on SEC followed in 8 Italian Rheumatologic centers for 24-months;2)to compare the features and disease-activity indices of SEC-treated axSpA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors failure patients (group B).Methods:Consecutive patients with active axSpA (diagnosis according Assessment of SpondyloArthritis International Society ASAS criteria), who started SEC treatment, were evaluated prospectively.Data on disease characteristics, previous/ongoing treatments and imaging were collected. Disease-activity/functional/clinical scores and biochemical values were recorded at baseline (T0), at 6 (T6), 12 (T12), and 24 (T24) months. Effectiveness was evaluated over-time with descriptive statistics. Anova (Kruskal Wallis) and generalized linear models were used to compare variables over-time. Infections,adverse events were collected.Results:One-hundred-seven patients [49.53% men; median age 49years; median treatment duration 18.5years] were enrolled;53(49.53%) had HLA-B27, 47.66% were r-axSpA and 52.34% nr-axSpA. Signs of sacroiliitis were present on MRI in 97 (90.65%) and X-rays in 51 (47.66%). SEC was prescribed as first line biologic treatment in 32 (29.9%) patients and as second or more line biological treatment in 75 (70.1%) patients (Figure 1). In all population significant decrease was achieved in:Visual Analogue Scale of pain and general-health; Leeds Enthesitis Index;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-s);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein. Bath Ankylosing Spondylitis Metrology Index and Erythrocyte-sedimentation-rate not significantly decreased. Effectiveness was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [T0=3.4 (2.9-3.9) vs T24=1.9 (1.2-2.7);p=0.02] and in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [T0=6.6 (5.0-7.8) vs T24=3.2 (2.0-5.0);p=0.03].At T0 group B had a longer disease duration (p=0.04),a greater prevalence of peripheral arthritis (p=0.02),enthesitis (p=0.04) and psoriasis (p=0.05) and was mostly male (p=0.05),while no significant difference was observed for functional and disease-activity indices and signs of sacroiliitis on MRI/X-rays. At T24 group A showed better physical functioning and lower disease activity compared to group B [HAQs A vs. B=0.1(0.0-0.5) vs 0.3(0.1-0.8); BASFI A vs B=1.6(0.8-4.8) vs 4.0(2.5-4.6); BASDAI A vs B=2.2(1.0-3.8) vs 3.9(2.7-5.0);ASDAS A vs B=1.3(1.0-2.2) vs 2.1(1.6-2.9)].After T24 of treatment 70.2% of Group A and 68.4% of Group B had a low disease activity,accordingly to ASDAS<2.1. Twenty-three patients (21.5%) stopped the treatment during the follow-up mainly because of primary (7) or secondary loss of efficacy (9).Only 7 patients suspended SEC because of adverse events.A low number of episodes of mild infections (19) occurred;SEC was instead permanently discontinued in 4 cases for:oral refractory mucositis (2);recurrent aphthosis (1);recurrent broncopneumoniae (1).The retention rate at t24 was good in the whole population (73%).Survival curves for Group A and B were similar (log-rank test=0.81;p=0.69).Conclusion:In a real-life clinical setting,SEC was safe and effective in axSpA, as shown by a significant decrease of BASDAI and ASDAS over a 24-months follow-up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Augusta Ortolan: None declared, Maria Sole Chimenti: None declared, Antonio Marchesoni Grant/research support from: AM has received honoraria and speaker fees from Abbvie, Pfizer, MSD, UCB, Novartis, Janssen, Eli-Lilly., Ennio Lubrano: None declared, Leonardo Santo Speakers bureau: Speaker from Jansen, Novartis, Pfizer, UCB, MSD, Sanofi, Angelo Semeraro: None declared, Carlo Salvarani: None declared, Nicolò Girolimetto: None declared, Emanuela Praino: None declared, Giulia Lavinia Fonti: None declared, Rosario Foti: None declared, Antonio Carletto: None declared, Andrea Doria Grant/research support from: ADhas received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen., Roberta Ramonda Grant/research support from: RR has received honoraria and speaker fees from Novartis, Abbvie, Pfizer, MSD, Janssen.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1613.2-1613
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  

Background:The advent of biologics targeting tumor necrosis factor-alpha (anti-TNF alpha) has revolutionized the treatment of spondyloarthritis (SpA). Their association with conventional synthetic disease-modifying antirheumatic drugs (cs-DMARD), although effective and used in clinical practice for the treatment of peripheral rheumatic diseases, is not clearly assessed in axial spondyloarthritis (ax-SpA).Objectives:The aim of this study was to assess the strategy of prescription of anti-TNF alpha in a population of ax-SpA and to compare patients treated with anti-TNF alpha on monotherapy with those who had combined therapy with cs-DMARDs.Methods:This is a retrospective descriptive study including 85 cases of ax-SpA diagnosed between January 2000 and October 2019 and treated with anti-TNF alpha.The clinical features, the erythrocyte sedimentation rate (ESR), the C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were compared between groups of anti-TNF alpha on monotherapy or combined therapy with csDMARDs.Results:Of 85 ax-SpA, 67 were males (78,8%) and the mean age was 44,4 ± 10,9 years. The mean period of evolution was 12,3 ± 9,1 years and 52,2% of patients were HLA-B27 positive. The ax-SpA was a pure axial form in 74,1% of patients, associated with peripheral arthritis, enthesitis and dactylitis in 17,6%, 17,6% and 1,2% respectively.The ant-TNFs were administrated with a men delay of 78 ± 70,8 months. The anti-TNFs used were: Infliximab (41,1%), Etanercept (32,9%), Adalimumab (23,5%) and Golimumab (2,3%). Fifty-nine patients (69,4%) were treated with anti-TNF alpha on monotherapy and 26 patients (30,6%) had combined therapy. The csDMARDs prescribed were the Salazopyrine (22,4%) and the Methotrexate (7,1%).While comparing the groups of anti-TNFs combined therapy and monotherapy, we noticed that the arthritis were present in 30,7% of patients from the group of combined therapy versus 11,8% of patients from the group of monotherapy (p=0,03). The psoriasis also was more present in the group of combined therapy (11,5% vs 1,6%; p=0,04).There was no statically significant difference between the two groups in the following parameters: age, gender, HLA B27, enthesitis, dactylitis, uveitis, inflammatory bowel diseases, ESR, CRP, BASDAI and BASFI.Conclusion:Our results suggest that the concomitant use of csDMARDs with anti-TNFs is frequent in clinical practice in ax-SpA, but mainly justified by the presence of arthritis or psoriasis.References:[1]Engel-Nitz NM, et al. Rheumatol Ther. 2015;2(2):127–39.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 718.2-719
Author(s):  
C. Baert ◽  
C. Mouafo Toukam ◽  
T. Sokolova ◽  
A. Nzeusseu Toukap

Background:Randomized-controlled trials (RCTs) done in axial spondyloarthritis (AxSpA) patients have shown that remission in AxSpA and nonradiographic axial SpA patients treated without biologics (BIOL) occurs infrequently (Ref 1, 2). Few are known about remission rate (RR) in daily clinical practice.Objectives:Our aim was to assess the remission rate (RR) in AxSpA patients in Real life, and to compare the RR in AxSpA patients on NSAIDs to RR for those on Biologics (TNFα blockers or IL-17A blockers).Methods:This cross-sectional study reviewed clinical data from a single center (St-Luc university hospitals, UCLouvain, Brussels) from 01/2013 to 03/2019. Last visit available for clinical assessment was evaluated. Disease activity was measured using the Bath Ankylosing Spondylitis disease activity index (BASDAI), and the Ankylosing Spondylitis disease activity score (ASDAS) using the C-reactive protein. Remission was defined as BASDAI < 4 and ASDAS < 1.3.Results:Data from 551 AxSpA patients were reviewed. 353 were men (64.3%). In the entire cohort, 478 BASDAI and 317 ASDAS were recorded. The RR according to the BASDAI was 46.7% (n = 223), and 17.3% for the ASDAS (n = 55). To look for the treatment-related RR, we stratified by the treatment (NSAIDs vs Biologics). We had 285 patients on NSAIDs (177 men, 62.5%) and 266 on BIOL (176 men, 66%). 245 BASDAI were available for NSAIDs and 233 for BIOL. 110 patients on NSAIDs (44.9%) and 113 on BIOL (48.5%) were in remission for BASDAI. Regarding ASDAS (table below), data from 172 patients on NSAIDs and 144 on BIOL were available. Out of them, 27 (15.7%) and 28 (19.4%) were in remission for NSAIDs and BIOL respectively. Chi-square test: p = 0.853.Table.Distribution of ASDAS values in both groups.ASDAS<1.3ASDAS≥ 1.3 < 2.1ASDAS≥ 2.1 < 3.5ASDAS> 3.5NSAIDs (n = 172)N = 27 (15.7%)N = 41 (23.8%)N = 70 (40.7%)N = 34 (19.8%)BIOL (n = 144)N = 28 (19.4%)N = 30 (20.8%)N = 57 (39.6%)N = 29 (20.1%)Conclusion:The real life RR in AxSpA seems to be higher on BIOL, even if compared to NSAIDs, the difference is not significant. However, many patients on NSAIDs achieve the remission.References:[1]Deodhar A. et al. Arthritis Rheumatol 2019 Jul;71(7):1101-1111. 2) Sieper J. et al. Rheumatology (Oxford) 2016 Nov; 55(11): 1946-1953.Disclosure of Interests:Charlotte Baert: None declared, Charlene MOUAFO TOUKAM: None declared, Tatiana Sokolova: None declared, Adrien Nzeusseu Toukap Grant/research support from: AbbVie, Celgene Corporation, Janssen, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Eli Lilly, Janssen, Novartis, UCB – consultant, Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, UCB – advisory board member


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