AB0229 A NATIONAL, MULTICENTER, SECONDARY DATA USE STUDY EVALUATING EFFICACY AND RETENTION OF FIRST-LINE BIOLOGIC TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-LIFE SETTING FROM TURKBIO REGISTRY

Background:Tocilizumab (TCZ) is a human anti-interleukin (IL)-6 receptor antibody approved in Turkey for the treatment of rheumatoid arthritis (RA).Objectives:In this study our purpose was to describe the disease activity, quality of life (QoL), and retention rate in RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting.Methods:Anonymized patient registry of TURKBIO was used based in a national, multicenter, and retrospective context. We conducted a search in the registry between years 2013 and 2020 and included adult RA patients who were prescribed with TCZ as their first-line biologic treatment with a post-TCZ follow-up of at least 6 months. CDAI, DAS28-(ESR), and HAQ-DI scores in 6, 12, and 24 months were obtained. Pairwise comparison was carried out for survey scores across baseline and timepoints. Subgroup analysis for route of TCZ administration was performed. EULAR response criteria were used for response evaluation. Retention of TCZ was evaluated by Kaplan-Meier analysis.Results:Overall,130 patients with a mean RA duration of14 years were included in the study. 87.7% of the patients were female and mean age was53 (SD; 15.0). Median duration of follow-up was 18.5 months. Majority (90.8%) of patients were given tocilizumab via intravenous route at baseline. Number of patients with ongoing TCZ treatment and follow-up at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (<2.8) and DAS28-(ESR) (<2.6) scores were 61.5%, 44.6%, 30%, and 54.6%, 40.8%, 27.7%, respectively. CDAI, DAS28-(ESR) and HAQ-DI survey scores significantly improved at 6, 12 and 26 months, respectively (p<0.001) (Table 1) in both IV and SC TCZ subgroups. At 6, 12 and 24months 74.8%, 82.5% and 86.4% of patients achieved a EULAR good response respectively. Twenty-three patients (17.6%) discontinued TCZ at 24 months. Of these, 19 patients discontinued due to unsatisfactory response. Retention rates of TCZ at 6, 12, and 24 months were 93%, 84.3%, and 72.2%, respectively (Figure 1).Conclusion:TCZ as a first-line biologic treatment was found to be clinically effective in this real-world study with a high retention rate. These results are in line with the results gathered from previous TCZ controlled and real-life studies in which TCZ was found clinically safe and effective.References:[1]Haraoui B, Casado G, Czirjak L, Taylor A, Dong L, Button P, Luder Y, Caporali R. Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies. Rheumatol Ther. 2019 Jun;6(2):231-243.[2]Favalli EG, Raimondo MG, Becciolini A, Crotti C, Biggioggero M, Caporali R. The management of first-line biologic therapy failures in rheumatoid arthritis: Current practice and future perspectives. Autoimmun Rev. 2017 Dec;16(12):1185-1195.[3]Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results from an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec; 5(2): 551–565.Disclosure of Interests:Ayten Yazici Speakers bureau: PFIZER, AbbVie, NOVARTIS, Özlem Özdemir Işik: None declared, Ediz Dalkiliç Speakers bureau: AbbVie, UCB Pharma, PFIZER, Roche, MSD, NOVARTIS, Süleyman Serdar Koca Speakers bureau: MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, SANOFİ, Yavuz Pehlivan Speakers bureau: PFIZER, NOVARTIS, MSD, CELLTRION, Consultant of: PFIZER, Soner Şenel: None declared, Nevsun Inanc Speakers bureau: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Paid instructor for: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Consultant of: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Grant/research support from: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Servet Akar Speakers bureau: LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, Paid instructor for: LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB, AMGEN, Grant/research support from: PFIZER, Sema Yilmaz: None declared, Özgül Soysal Gündüz: None declared, Ayse Cefle Speakers bureau: UCB Pharma, PFIZER, MSD, AbbVie, AMGEN, NOVARTIS, Fatos Onen Speakers bureau: AbbVie, LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Paid instructor for: AbbVie, LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Grant/research support from: PFIZER

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AB0330 HIGH REMISSION RATES IN RA – REAL LIFE DATA FROM BARITICINIB

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5263 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1463.2-1464

Author(s):

S. Bayat ◽

K. Tascilar ◽

V. Kaufmann ◽

A. Kleyer ◽

D. Simon ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Cox Regression ◽

Real Life ◽

Inadequate Response ◽

Research Support ◽

Das 28 ◽

Patient Reported ◽

One Year

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB

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AB0337 TOFACITINIB MONOTHERAPY OR COMBINED WITH METHOTREXATE IN PATIENTS WITH RHEUMATOID ARTHRITIS SHOW SIMILAR RETENTION OVER FOUR YEARS. REPORT FROM RHUMADATA ®

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2479 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1467.1-1467

Author(s):

D. Choquette ◽

L. Bessette ◽

L. Choquette Sauvageau ◽

I. Ferdinand ◽

B. Haraoui ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Real World ◽

Treatment Initiation ◽

Retention Rate ◽

Janus Kinase ◽

P Value ◽

Research Support ◽

Medication Discontinuation ◽

Kaplan Meier

Background:Since the introduction of biologic agents around the turn of the century, the scientific evidence shows that the majority of agents, independent of the therapeutic target, have a better outcome when used in combination with methotrexate (MTX). In 2014, tofacitinib (TOFA), an agent targeting Janus kinase 1 and 3, has reached the Canadian market with data showing that the combination with MTX may not be necessary [1,2].Objectives:To evaluate the efficacy and retention rate of TOFA in real-world patients with rheumatoid arthritis (RA).Methods:Two cohorts of patients prescribed TOFA was created. The first cohort was formed of patients who were receiving MTX concomitantly with TOFA (COMBO) and the other of patients using TOFA in monotherapy (MONO). MONO patients either never use MTX or were prescribed MTX post-TOFA initiation for at most 20% of the time they were on TOFA. COMBO patients received MTX at the time of TOFA initiation or were prescribed MTX post-TOFA initiation for at least 80% of the time. For all those patients, baseline demographic data definitions. Disease activity score and HAQ-DI were compared from the initiation of TOFA to the last visit. Time to medication discontinuation was extracted, and survival was estimated using Kaplan-Meier calculation for MONO and COMBO cohorts.Results:Overall, 194 patients were selected. Most were women (83%) on average younger than the men (men: 62.6 ± 11.0 years vs. women: 56.9 ± 12.1 years, p-value=0.0130). The patient’s assessments of global disease activity, pain and fatigue were respectively 5.0 ± 2.7, 5.2 ± 2.9, 5.1 ± 3.1 in the COMBO group and 6.2 ± 2.5, 6.5 ± 2.6, 6.3 ± 2.8 in the MONO group all differences being significant across groups. HAQ-DI at treatment initiation was 1.3 ± 0.7 and 1.5 ± 0.7 in the COMBO and MONO groups, respectively, p-value=0.0858. Similarly, the SDAI score at treatment initiation was 23.9 ± 9.4 and 25.2 ± 11.5, p-value=0.5546. Average changes in SDAI were -13.4 ± 15.5 (COMBO) and -8.9 ± 13.5 (MONO), p-value=0.1515, and changes in HAQ -0.21 ± 0.63 and -0.26 ± 0.74, p-value 0.6112. At treatment initiation, DAS28(4)ESR were 4.4 ± 1.4 (COMBO) and 4.6 ± 1.3 (MONO), p-value 0.5815, with respective average changes of -1.06 ± 2.07 and -0.70 ± 1.96, p-value=0.2852. The Kaplan-Meier analysis demonstrated that the COMBO and MONO retention curves were not statistically different (log-rank p-value=0.9318).Conclusion:Sustainability of TOFA in MONO or COMBO are not statistically different as are the changes in DAS28(4)ESR and SDAI. Despite this result, some patients may still benefit from combination with MTX.References:[1]Product Monograph - XELJANZ ® (tofacitinib) tablets for oral administration Initial U.S. Approval: 2012.[2] Reed GW, Gerber RA, Shan Y, et al. Real-World Comparative Effectiveness of Tofacitinib and Tumor Necrosis Factor Inhibitors as Monotherapy and Combination Therapy for Treatment of Rheumatoid Arthritis [published online ahead of print, 2019 Nov 9].Rheumatol Ther. 2019;6(4):573–586. doi:10.1007/s40744-019-00177-4.Disclosure of Interests:Denis Choquette Grant/research support from: Rhumadata is supported by grants from Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Consultant of: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Speakers bureau: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Loïc Choquette Sauvageau: None declared, Isabelle Ferdinand Consultant of: Pfizer, Abbvie, Amgen, Novartis, Speakers bureau: Pfizer, Amgen, Boulos Haraoui Grant/research support from: Abbvie, Amgen, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, and UCB, Consultant of: Abbvie, Amgen, Lilly, Pfizer, Sandoz, UCB, Consultant of: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Merck, Pfizer, Roche, and UCB, Speakers bureau: Pfizer, Speakers bureau: Amgen, BMS, Janssen, Pfizer, and UCB, Frédéric Massicotte Consultant of: Abbvie, Janssen, Lilly, Pfizer, Speakers bureau: Janssen, Jean-Pierre Pelletier Shareholder of: ArthroLab Inc., Grant/research support from: TRB Chemedica, Speakers bureau: TRB Chemedica and Mylan, Jean-Pierre Raynauld Consultant of: ArthroLab Inc., Marie-Anaïs Rémillard Consultant of: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Paid instructor for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Diane Sauvageau: None declared, Édith Villeneuve Consultant of: Abbvie, Amgen, BMS, Celgene, Pfizer, Roche, Sanofi-Genzyme,UCB, Paid instructor for: Abbvie, Speakers bureau: AbbVie, BMS, Pfizer, Roche, Louis Coupal: None declared

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SAT0134 COMPARATIVE RISK OF CANCER ASSOCIATED WITH FIRST-LINE DMARDS USE IN RHEUMATOID ARTHRITIS: REAL WORLD EVIDENCE FROM THE OHDSI NETWORK

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3866 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1004.1-1004

Author(s):

T. Duarte-Salles ◽

M. Recalde ◽

J. Weaver ◽

E. Burn ◽

K. Marinier ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Cancer Risk ◽

Full Time ◽

First Line ◽

Research Support ◽

Site Specific ◽

Hazard Ratios ◽

Comparative Risk ◽

Risk Of Cancer

Background:Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) are recommended as first line treatment for rheumatoid arthritis (RA) patients, but limited information exists on the comparative risk of cancer associated with their use.Objectives:To compare the risk of incident overall (excluding non-melanoma skin) and site-specific cancers (colorectal, lung, lymphoma, leukaemia) associated with first-line use of csDMARDs in patients with RA.Methods:We conducted a multinational cohort study informed by data from 7 healthcare databases including claims and electronic medical records from 4 countries (SIDIAP-Spain, MDCR-US Optum-US, CCAE-US, IQVIA AMBEMR-US, IQVIA-Germany, THIN-UK) part of the Observational Health Data Sciences and Informatics (OHDSI) network. All patients aged ≥18 years who initiated methotrexate (MTX), hydroxychloroquine (HCQ), sulphasalazine (SSZ), or leflunomide (LEF) as first-line monotherapy after a diagnosis of RA between 2005 to 2018 were eligible. Individuals with a prior diagnosis of another inflammatory arthropathy or cancer, or <1 year of follow-up were excluded. Patients were followed from 1-year after treatment initiation to the earliest of incident cancer, loss to follow-up, or 5-years. Cox proportional-hazard models for MTX against each other csDMARD were performed after propensity score stratification. A large set of negative control outcomes were analysed to calibrate hazard ratios (cHRs). Estimates were pooled where homogeneity across sources was adequate (I2<0.4).Results:Across the databases, 127,547 RA patients initiating csDMARD therapy were included in the analyses (MTX: 73,996, HCL: 36,381 SSZ: 9,383 LEF: 7,787). The pooled incidence rate of overall cancer for MTX was 22.8 per 1,000 person years. The pooled summary and source-specific estimated cHRs for overall cancer are shown below in Figure 1. While little difference was seen for HCQ and SSZ compared to MTX, LEF was consistently associated with a reduced cancer risk: pooled cHR (95% CI) 0.67 (0.59 to 0.76) and cHRs ranged from 0.53 (0.36 to 0.80) in CCAE-US to 0.84 (0.58 to 1.22) in SIDIAP-Spain. There were insufficient cases to look site-specific cancers within data sources, although pooled results suggest little risk difference in leukemia, lymphoma, colorectal, or lung cancers.Figure 1.Calibrated hazard ratios (cHRs) of overall cancer risk with their respective confidence intervals (95%CI) by study database. Database estimates not reported where adequate covariate balance not attained. Meta-analysis results not reported where I2>0.4.Conclusion:Compared to MTX users, patients treated with LEF had a lower risk of overall cancer. Risk of four specific cancers did not differ by first line csDMARD exposure.Disclosure of Interests: :Talita Duarte-Salles: None declared, Martina Recalde: None declared, James Weaver Shareholder of: J&J Shares, Grant/research support from: Full-time employment salary from Janssen, Consultant of: Janssen employee, Employee of: Janssen, Paid instructor for: Janssen employee, have instructed at conferences, Speakers bureau: Janssen employee, have spoken at conferences, Edward Burn: None declared, Karine Marinier Employee of: Servier, Yesika Díaz: None declared, Ben Illingens: None declared, David Vizcaya Employee of: Bayer, Katerina Chatzidionysiou Consultant of: AbbVie, Pfizer, Lilly., Patrick Ryan: None declared, Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen

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Twelve-Year Retention Rate of First-Line Tumor Necrosis Factor Inhibitors in Rheumatoid Arthritis: Real-Life Data From a Local Registry

Arthritis Care & Research ◽

10.1002/acr.22788 ◽

2016 ◽

Vol 68 (4) ◽

pp. 432-439 ◽

Cited By ~ 41

Author(s):

Ennio Giulio Favalli ◽

Francesca Pregnolato ◽

Martina Biggioggero ◽

Andrea Becciolini ◽

Alessandra Emiliana Penatti ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Tumor Necrosis Factor ◽

Tumor Necrosis ◽

Retention Rate ◽

Real Life ◽

Tumor Necrosis Factor Inhibitors ◽

First Line ◽

Life Data ◽

Real Life Data ◽

Necrosis Factor

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Real-Life Retention Rates and Reasons for Switching of Biological DMARDs in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

Frontiers in Medicine ◽

10.3389/fmed.2021.708168 ◽

2021 ◽

Vol 8 ◽

Author(s):

Vandana Bhushan ◽

Susan Lester ◽

Liz Briggs ◽

Raif Hijjawi ◽

E. Michael Shanahan ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Real Life ◽

Treatment Retention ◽

Cox Proportional Hazards Model ◽

Retention Rates ◽

Published Data ◽

Retention Data

Aims: To determine real-life biologic/targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) retention rates in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), explore reasons for switching and to compare results to previously published data.Methods: Time-to-event analysis for mean treatment duration (estimated as the Restricted Mean Survival Time), b/tsDMARD failure, and b/tsDMARDs switching was performed for 230 patients (n = 147 RA, 46 PsA, 37 AS) who commenced their first b/tsDMARD between 2008 and 2018. Patients were managed in a dedicated “biologics” clinic in a tertiary hospital; the choice of b/tsDMARD was clinician driven based on medical factors and patient preferences. The effect of covariates on switching risk was analysed by a conditional risk-set Cox proportional-hazards model. Treatment retention data was compared to a historical analysis (2002–2008).Results: The proportions remaining on treatment (retention) were similar, throughout follow-up, for the first, second and third b/tsDMARDs across all patients (p = 0.46). When compared to RA patients, the risk of b/tsDMARD failure was halved in PsA patients [Hazard Ratio (HR) = 0.50], but no different in AS patients (HR = 1.0). The respective restricted mean (95%CI) treatment durations, estimated at 5 years of follow-up, were 3.1 (2.9, 3.4), 4.1 (3.7, 4.6), and 3.3 (2.8, 3.9) years, for RA, PsA, and AS, respectively. Age, gender, disease duration, smoking status and the use of concomitant csDMARDS were not associated with the risk of bDMARD failure. The most common reasons for switching in the first and subsequent years were secondary (n = 62) and primary (n = 35) failure. Comparison with historical data indicated no substantive differences in switching of the first biologic for RA and PsA.Conclusion: Similar retention rates of the second and third compared to the first b/tsDMARD in RA, PsA, and AS support a strategy of differential b/tsDMARDs use informed by patient presentation. Despite greater availability of b/tsDMARDs with differing mechanisms of action, retention rates of the first b/tsDMARD remain similar to previous years.

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Conventional Synthetic Dmards in Psoriatic Arthritis: Changing Practice in Biologic Era; Real-Life Results from HURBIO-PsA Registry

Acta Medica ◽

10.32552/2021.actamedica.623 ◽

2021 ◽

pp. 1-7

Author(s):

Emre Bilgin ◽

Umut Kalyoncu

Keyword(s):

Psoriatic Arthritis ◽

Survival Data ◽

Retention Rate ◽

Treatment Options ◽

Real Life ◽

Biological Database ◽

Biologic Treatment ◽

Changing Practice ◽

Disease Modifying

Objectives: Psoriatic arthritis is a chronic musculoskeletal disorder which may affect skin, joints, bone and enthesis. Conventional synthetic disease modifying anti-rheumatic drugs are first-line treatment options and biologic disease modifying anti-rheumatic drugs are recommended in psoriatic arthritis patients who are intolerant/not controlled well with conventional synthetic disease modifying anti-rheumatic drugs. Although survival data of the conventional synthetic disease modifying anti-rheumatic drugs without concomitant biologic disease modifying anti-rheumatic drugs are available, the effect of biologic disease modifying anti-rheumatic drugs on the retention of conventional synthetic disease modifying anti-rheumatic drugs is still a question of interest. Materials and Methods: Psoriatic arthritis patients who received at least 1 dose of biologic disease modifying anti-rheumatic drugs, using at least 1 conventional synthetic disease modifying anti-rheumatic drugs (methotrexate, leflunomide, hydroxychloroquine and sulfasalazine) at the time of biologic disease modifying anti-rheumatic drugs starting visit and registered in the Hacettepe University BIOlogical Database-Psoriatic Arthritis were included in this retrospective longitudinal analysis. Demographic and disease-specific data at first and last follow-up visit were collected. Unadjusted retention rate of each conventional synthetic disease modifying anti-rheumatic drugs was assessed. Overall prescription of conventional synthetic disease modifying anti-rheumatic drugs at first and last follow-up visit were compared. Results: A total of 266 (191(71.8%) female) patients was included. Median follow-up duration under biologic treatment was 43.4 (19.4-80.1) months. Median retention duration of each conventional synthetic disease modifying anti-rheumatic drugs were similar. Between the first and last visit; there was a 29.3% decrease in methotrexate use (61.7% vs. 43.6%; p<0.001), 8.4% decrease in leflunomide use (31.2% vs. 28.6%; p=0.30), 30.0% decrease in sulfasalazine use (11.3% vs. 7.9%; p=0.05), 31.1% decrease in hydroxychloroquine use (16.9% vs. 11.7%; p=0.001), 12.5 % decrease in glucocorticoids use (51.1% vs. 44.7%; p=0.015). At last visit, 59 (22.2%) patients were conventional synthetic disease modifying anti-rheumatic drugs -free: 20 (7.5%) patients were using only glucocorticoids, 39 (14.7%) patients were conventional synthetic disease modifying anti-rheumatic drugs + glucocorticoid-free. Conclusion: Although conventional synthetic disease modifying anti-rheumatic drugs were significantly discontinued in an important percent of patients after the initiation of biologic disease modifying anti-rheumatic drugs, percentage of patients using glucocorticoids at last visit was still high. Studies aiming to demonstrate when, in whom and how to discontinue conventional synthetic disease modifying anti-rheumatic drugs are needed.

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AB0315 RETENTION RATE OF ABATACEPT MONOTHERAPY IN AN ITALIAN MULTICENTRIC RHEUMATOID ARTHRITIS COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.5780 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1456.1-1457

Author(s):

D. Iacono ◽

I. Pantano ◽

D. Birra ◽

G. Scalise ◽

M. A. Coscia ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Median Duration ◽

Retention Rate ◽

Real Life ◽

Physician Global Assessment ◽

Low Disease Activity ◽

Baseline Activity ◽

Disease Modifying

Background:EULAR recommendations focus the importance of Methotrexate (MTX) therapy as a key element in the treatment of patients with Rheumatoid Arthritis (RA), alone as first line therapy and in combination with biological Disease Modifying Anti-rheumatic Drug (bDMARDs). Abatacept (CTLA4-Ig) in Europe is approved for the treatment of moderate to severe active RA in combination with MTX. Several patients, however, discontinue MTX for intolerance, side effects or contraindications, and real-life data demonstrate how, even in patients receiving therapy with MTX, compliance could be suboptimal. The only data on the use of abatacept in monotherapy come from the ORA-Registry, where a worse performance is observed in monotherapy patients.Objectives:To evaluate a multicenter cohort of RA patients treated with Abatacept in patients underwent combined MTX therapy vs monotherapy.Methods:We retrospectively evaluated RA patients, referring to 2 Italian rheumatology centers, treated with Abatacept monotherapy or in combination with MTX. We compared both persistence in therapy and the rate of remission/low disease activity according to Clinical Disease Activity Index (CDAI) between the 2 groups.Results:We enrolled 147 patients, out of them 66 patients were on monotherapy with Abatacept due to intolerance or controindications and 81 in therapy with Abatacept plus MTX. The two cohorts appeared homogeneous in age, gender, disease duration and baseline activity indexes, with the only difference being higher baseline Physician Global assessment (PhGA) values in monotherapy patients. During the follow-up (median duration 24±14 months), the retention rate of Abatacept treatment was 71.2% in MTX patients (median duration 27–15.6 months) and 62.1% in monotherapy patients (median duration 25.2–17.5; p=ns). No differences between the two groups in terms of retention rate, low-disease activity and CDAI remission (log rank p=ns), Breslow p=ns) were detected.Conclusion:In patients with RA with intolerance or contraindication to MTX use, Abatacept monotherapy could be an efficient and safe option even in the long term follow-up.References:[1]Abatacept monotherapy compared with abatacept plus disease-modifying anti-rheumatic drugs in rheumatoid arthritis patients: data from the ORA registry.Truchetet ME et al. Arthritis Res Ther. 2016 Mar 30;18:72.Disclosure of Interests:DANIELA IACONO Speakers bureau: PFIZER, BRISTOL MAYERS SQUIBB, SANOFI, Ilenia Pantano: None declared, domenico birra: None declared, GIUSEPPE SCALISE: None declared, Melania Alessia Coscia: None declared, VALENTINA MESSINITI: None declared, Gabriella Loi: None declared, Anna Merchionda: None declared, Paolo Moscato: None declared, francesco ciccia Grant/research support from: pfizer, novartis, roche, Consultant of: pfizer, novartis, lilly, abbvie, Speakers bureau: pfizer, novartis, lilly, abbvie

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Treatment patterns and achievement of the treat-to-target goals in a real-life rheumatoid arthritis patient cohort: data from 1317 patients

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x20937132 ◽

2020 ◽

Vol 12 ◽

pp. 1759720X2093713

Author(s):

Konstantinos Thomas ◽

Argiro Lazarini ◽

Evripidis Kaltsonoudis ◽

Alexandros Drosos ◽

Ioannis Papalopoulos ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Real Life ◽

Treatment Patterns ◽

Treat To Target ◽

Number Of Patients ◽

Co Morbidity ◽

Male Sex ◽

Morbidity Index

Background: Data regarding the real-life predictors of low disease activity (LDA) in rheumatoid arthritis (RA) patients are limited. Our aim was to evaluate the rate and predictors of LDA and treatment patterns in RA. Methods: This was a multicenter, prospective, RA cohort study where patients were evaluated in two different time points approximately 12 months apart. Statistical analysis was performed in order to identify predictors of LDA while patterns of disease-modifying anti-rheumatic drug [DMARDs; conventional synthetic (csDMARD) or biologic (bDMARD)] and glucocorticoid (GC) use were also recorded. Results: The total number of patients included was 1317 (79% females, mean age: 62.9 years, mean disease duration: 10.3 years). After 1 year, 57% had achieved LDA (DAS28ESR<3.2) while 43% did not (34%: moderate disease activity: DAS28ESR ⩾3.2 to <5.1, 9%: high disease activity, DAS28ESR ⩾5.1). By multivariate analysis, male sex was positively associated with LDA [odds ratio (OR) = 2.29 p < 0.001] whereas advanced age (OR = 0.98, p = 0.005), high Health Assessment Questionnaire (HAQ) score (OR = 0.57, p < 0.001), use of GCs (OR = 0.75, p = 0.037) or ⩾2 bDMARDs (OR = 0.61, p = 0.002), high co-morbidity index (OR = 0.86, p = 0.011) and obesity (OR = 0.62, p = 0.002) were negative predictors of LDA. During follow-up, among active patients (DAS28ESR >3.2), 21% initiated (among csDMARDs users) and 22% switched (among bDMARDs users) their bDMARDs. Conclusion: In a real-life RA cohort, during 1 year of follow-up, 43% of patients do not reach treatment targets while only ~20% of those with active RA started or switched their bDMARDs. Male sex, younger age, lower HAQ, body mass index and co-morbidity index were independent factors associated with LDA while use of GCs or ⩾2 bDMARDs were negative predictors.

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AB0234 SURVIVAL OF ABATACEPT IN RHEUMATOID ARTHRITIS PATIENTS: A REAL-LIFE STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3689 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1143.1-1143

Author(s):

E. Molteni ◽

F. Ceccarelli ◽

C. Castellani ◽

F. Giardina ◽

C. Alessandri ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

T Cell Activation ◽

Cell Activation ◽

Disease Duration ◽

Retention Rate ◽

Real Life ◽

Standard Of Care ◽

Median Disease Duration ◽

Drug Survival

Background:Abatacept (ABA) is a biological drug approved for the treatment of rheumatoid arthritis (RA) patients that, by working on CTLA4, can inhibit T-cell activation. Randomized controlled trials have demonstrated both the efficacy and a good safety profile, characterized by a lower infectious risk in comparison with other biological DMARDs, in RA patients. In a real-life setting, the drug retention rate could be considered as a surrogate of drug effectiveness. Data from the literature reported a retention rate of ABA ranging from 55 to 76% at 12 months and from 54 to 64% at 24 months (1-3).Objectives:In the present longitudinal analysis, we evaluated the retention rate of ABA in a large monocentric RA cohort.Methods:We enrolled consecutive RA patients starting treatment with intravenous (IV) or subcutaneous (SC) ABA according to the standard of care. All the patients fulfilled the 2010 ACR/EULAR classification criteria for RA. For each patient, we collected demographic parameters, serological status, previous and concomitant treatments, and disease activity by DAS28 with C reactive protein (DAS28-CRP). All the patients were assessed at baseline, and after 4 and 12 months (T4 and T12, respectively). The reasons for withdrawal of treatment were registered and classified as primary or secondary inefficacy or adverse events (AEs). Kaplan-Meier statistical analysis has been done to evaluate the survival of the treatment in patients with at least 12 months follow-up.Results:We evaluated 161 patients [M/F 21/140; median age 67 years (IQR 21.7), median disease duration 180 months (IQR 161)]. RF was positive in 70.3% of patients, ACPA in 66.4%. ABA was the first biological DMARD in 66 patients (41%). At baseline, the median DAS28-CRP was 4.3 (IQR 1.6) and ABA was administered in association with MTX in 96 patients (59.6%). One hundred-eleven patients (68.9%) started SC ABA [M/F 16/95; median age 64.5 years (IQR 21.5), median disease duration 156 months (IQR 132)], the remaining 50 IV ABA [M/F 5/45, median age 71 years (IQR 60.2), median disease duration 187 months (IQR 157)]. Median age and disease duration were significantly higher in patients receiving IV in comparison with SC ABA (p=0.008 and p=0.03, respectively). We found a significant reduction of DAS28-CRP values during the follow-up in comparison with baseline [4 months: median 3.5 (IQR 1.9), p<0.0001; 12 months: median 3.2 (IQR 1.4), p<0.0001]. Seven patients were lost to follow-up, in the remaining 154 patients a median treatment duration of 33 months (IQR 49) was registered. Data on drug survival are reported in Figure 1A: at 12 months, 92% of patients persisted on treatment; this percentage decreased to 78.2% at 24 months and to 67.9% at 36 months. Furthermore, we did not find any differences in drug survival either with respect to SC vs IV administration (12 months: 93.7% versus 88.6%; 24 months 78.9% versus 72.6%; 36 months 63.7% versus 72.6%; Figure 1B) or according to the association with MTX. Concerning the withdrawal reasons, 46 patients (29.9%) stopped ABA due to inefficacy (primary in 28, secondary in 18), 11 patients (7.1%) due to AEs, and 7 for inadequate adherence (4.5%). Finally, 10 patients switched from IV to SC administration, due to patient’s preference.Conclusion:In our monocentric RA cohort, we have observed a high retention rate of ABA at both 12 and 24 months, confirming the good profile of this drug in terms of effectiveness and safety, irrespective of the route of administration and association with MTX.References:[1]Cagnotto, Arthritis Res Ther 2020; (2) Salmon, J Clin Med 2020; Westhovens, Rheumatol Int 2020.Acknowledgements:I would like to acknowledge Dr. F. Ceccarelli, for her patience.Disclosure of Interests:None declared

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O32 Serious infection with tocilizumab compared to TNF-inhibitors and other bDMARDS in rheumatoid arthritis patients: does line of therapy matter?

Rheumatology ◽

10.1093/rheumatology/keab246.031 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Kim Lauper ◽

Lianne Kearsley-Fleet ◽

Rebecca Davies ◽

Kath Watson ◽

Mark Lunt ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Disease Duration ◽

Tnf Inhibitors ◽

World Population ◽

Research Support ◽

Serious Infection ◽

Number Of Patients ◽

Serious Infections ◽

Line Of Therapy

Abstract Background/Aims In the real-world, tocilizumab is prescribed to a population of patients different from those prescribed TNF-inhibitors, often older with longer disease duration, worse functional status and more previous b- or tsDMARDs. The aim of this study was to evaluate if and how the risk of serious infection on tocilizumab and other bDMARDs differs when stratifying by line of therapy in a real-world population of rheumatoid arthritis patients. Methods We included patients registered in the BSRBR-RA treated with tocilizumab, etanercept, adalimumab, infliximab, certolizumab, abatacept or rituximab, including biosimilars. Primary outcome was the occurrence of a serious infection (defined as infection requiring hospitalisation, intravenous antibiotics or resulting in death). Primary covariate of interest was line of therapy (from first to fifth line of therapy). Every change to another b- or tsDMARD was considered a new line of therapy, but not a change between a bio-original and a biosimilar. Hazard ratios (HR) of serious infections were estimated using an inverse probability weighted Cox regression, based on a propensity score including baseline patient and disease characteristics, and adjusting for time in study (see table). The reference group was etanercept, which included the highest number of patients. Treatment exposure was analysed without and with stratification by line of therapy. Results A total of 33,916 treatment courses were included (Table) contributing to 62,532 years of follow-up. Compared to etanercept, participants starting abatacept, tocilizumab and rituximab were older, had more previous bDMARDs, longer disease duration and more comorbidities. The crude HR of serious infections were higher with infliximab and adalimumab, lower with certolizumab and rituximab, and not significantly different for abatacept and tocilizumab compared to etanercept. After adjustment, HR of serious infections were higher with tocilizumab, adalimumab and infliximab. However, when stratified by line of therapy, HR were no longer significantly different compared to etanercept for tocilizumab, adalimumab and infliximab for most lines of therapy. Conclusion Whilst initially there appears to be a difference in rates of serious infections between biologic therapies, line of therapy may be a confounding factor when comparing the risk of serious infections between bDMARDs. Disclosure K. Lauper: Honoraria; Gilead-Galapagos. Grants/research support; AbbVie. Other; AbbVie, Pfizer. L. Kearsley-Fleet: None. R. Davies: None. K. Watson: None. M. Lunt: None. K.L. Hyrich: Honoraria; AbbVie. Grants/research support; Pfizer, BMS.

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