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.

Download Full-text

FRI0273 EFFECTIVENESS AND RETENTION RATE OF SECUKINUMAB FOR PSORIATIC ARTHRITIS AND AXIAL SPONDYLOARTHRITIS: REAL-LIFE DATA FROM THE ITALIAN LORHEN REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3197 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 722.1-723

Author(s):

E. G. Favalli ◽

A. Marchesoni ◽

S. Balduzzi ◽

C. Montecucco ◽

C. Lomater ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Disease Duration ◽

Axial Spondyloarthritis ◽

Retention Rate ◽

Real Life ◽

Advisory Board ◽

Inactive Disease ◽

Real Life Setting

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

Download Full-text

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

Download Full-text

AB0742 CONVENTIONAL SYNTHETIC DMARDS IN PSORIATIC ARTHRITIS - CHANGING PRACTICE IN BIOLOGIC ERA: REAL-LIFE RESULTS FROM HURBIO-PsA REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4735 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1667.1-1667

Author(s):

E. Bilgin ◽

E. Duran ◽

E. C. Bolek ◽

B. Farisoğullari ◽

G. K. Yardimci ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Demographic Data ◽

Treatment Options ◽

Certolizumab Pegol ◽

Real Life ◽

Daily Practice ◽

Biologic Drugs ◽

Initiation Rate ◽

Biologic Dmards ◽

Changing Practice

Background:Conventional synthetic disease modifiying anti-rheumatic drugs (csDMARDs) are recommended as the first-line treatment options for most of the psoriatic arthritis (PsA) patients. In the last two decades, biologic drugs become more accessible and their percentage in the daily practice is increasing continuously. However, how they influenced the utilization of csDMARDs still remains unknown, yet.Objectives:To determine the utilization rates of PsA patients before, after and at the starting of biologic DMARDsMethods:We analyzed all patients who received at least 1 dose of biologic DMARDs, registered to HURBIO-PsA database, and who have complete data regarding csDMARD use before (ever), after (at last control visit) and at the starting of biologic DMARD. Methotrexate, leflunomide and sulphasalasine were the csDMARDs recorded. Demographic data of these patients were also recorded.Results:A total of 426 (70% female) PsA patients was included. Mean age and mean PsA disease duration were 48±12.4 and 9.3±8.3 years, respectively. Mean duration of csDMARD utilization before bDMARDs was 5.8±5.1 years, and mean follow-up duration under bDMARDs was 3.7±2.5 years. Distribution of the bDMARDs that ever-prescribed as follows: adalimumab 273 (64.2%), etanercept 125 (29.3%), certolizumab pegol 103 (24.2%), infliximab 102 (24.0%), secukinumab 63 (14.8%), golimumab 55 (12.9%), ustekinumab 24 (5.6%) and tofacitinib 11 (3.4%). Percentage of each csDMARDs used before (ever used), after (at last control visit) and at the starting of biologic DMARDs were given inFigure. Also the percentage of patients using csDMARD as monotherapy and combination therapy were given inFigure.Conclusion:csDMARDs particularly sulphasalazine and methotrexate were important treatment options before bDMARD period, however they (particularly SSZ) were usually discontinued after bDMARD initiation. Rate of concomitant csDMARDs use remains relatively stable after starting the bDMARDs. Besides, rate of concomitant mono/csDMARD use is significantly higher after bDMARD initiation, in contrast to pre-bDMARD period.Figure.Percentage of each csDMARDs, and mono or combination of csDMARDs used before (ever used), after (at last control visit) and at the starting of biologic DMARDs (com/csDMARD: combination csDMARD; mono/csDMARD: monotherapy of csDMARD; csDMARD: conventional synthetic disease modifying antirheumatic drug)Disclosure of Interests:Emre Bilgin: None declared, Emine Duran: None declared, Ertugrul Cagri Bolek: None declared, Bayram Farisoğullari: None declared, Gözde Kübra Yardimci: None declared, Levent Kiliç: None declared, Ali Akdoğan: None declared, Şule Apraş Bilgen: None declared, Omer Karadag: None declared, Ali İhsan Ertenli: None declared, Sedat Kiraz: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB

Download Full-text

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.2928 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1140-1141

Author(s):

A. Yazici ◽

Ö. Özdemir Işik ◽

E. Dalkiliç ◽

S. S. Koca ◽

Y. Pehlivan ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Retention Rate ◽

Real Life ◽

Retention Rates ◽

First Line ◽

Research Support ◽

Biologic Treatment ◽

Number Of Patients

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

Download Full-text

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.

Download Full-text

FRI0362 COMPARATIVE EFFECTIVENESS OF USTEKINUMAB (UST) AND TNF INHIBITORS (TNFI) IN PATIENTS WITH PSORIATIC ARTHRITIS (PSA) IN THE REAL-WORLD, MULTINATIONAL PSABIO STUDY: 12-MONTH FOLLOW-UP

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2755 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 778-779

Author(s):

J. S. Smolen ◽

S. Siebert ◽

T. Korotaeva ◽

P. Bergmans ◽

K. De Vlam ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Activity Index ◽

Treatment Options ◽

Disease Activity Index ◽

Rapid Screening ◽

Research Support ◽

Real World Data

Background:Among treatment options for PsA, IL-12/23 inhibition with UST was the first new biologic mode of action after TNFi. Few real-world data comparing UST with TNFi are available.Objectives:Comparison of UST and TNFi treatment effectiveness within the prospectively followed PsABio cohort at 12-month (mo) follow-up.Methods:The PsABio study (NCT02627768) evaluates effectiveness, tolerability and persistence of 1st, 2nd or 3rd-line UST or TNFi in PsA. Proportions of patients (pts) reaching MDA/very low disease activity (VLDA) and clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) LDA/remission are described. Comparison across UST and TNFi cohorts was done on last observation carried forward up to 12 (±3) mo, with non-response imputation for pts who had stopped/switched initial treatment. Logistic regression analysis was used, including propensity score (PS) analysis to adjust for imbalanced prognostic baseline (BL) covariates: country, age, sex, BMI, smoking (yes/no), comorbidities (cardiovascular/metabolic syndrome), PsA type (axial, polyarticular, oligoarticular), psoriasis body surface area (BSA), disease duration, cDAPSA, 12-item PsA Impact of Disease (PsAID-12), dactylitis, enthesitis, Fibromyalgia Rapid Screening Tool (FiRST) score, line of biologic (b)DMARD, synthetic DMARD use, and steroid or NSAID use.Results:Of 929 eligible pts, 893 had evaluable data at BL and at follow-up; 438 (95.6%) were treated with UST and 455 (96.6%) with TNFi (including stoppers/switchers). UST and TNFi groups had BL differences in mean age (51.0 vs 48.5 years, respectively), concurrent comorbidities (68.7% vs 60.9%), time since diagnosis (7.5 vs 6.2 years), line of treatment (1st-line 45.0% vs 55.2%; 3rd-line 20.5% vs 12.1%), NSAID use (54.8% vs 68.8%), concomitant MTX use (29.9% vs 42.0%) and psoriasis skin involvement (BSA >10% in 26.6% vs 14.8%).In 714 pts with available data, mean (standard deviation) BL cDAPSA was 30.6 (20.2; n=358) for UST and 29.3 (18.6; n=356) for TNFi. Observed data showed differences in proportion of pts achieving MDA/VLDA and cDAPSA LDA/remission in favour of TNFi, but after PS adjustment for BL differences (such as line of therapy, skin psoriasis, concomitant conventional DMARD, etc.), odds ratios for reaching targets at 12 mo did not significantly differ between UST and TNFi groups (Fig. 1).Comparison of 6- and 12-mo unadjusted data showed sustained MDA/VLDA responses with both UST (21.8%) and TNFi (29.5%), with comparable proportions of additional pts achieving these targets between 6 and 12 mo (17.0% and 20.3%, respectively). Sustained efficacy became lower with successive lines of treatment (data not shown).Conclusion:Various factors, including patient characteristics such as comorbidities, influence the physician’s selection of treatment modality for patients needing a bDMARD. Our real-world results demonstrate differences in observed clinical effectiveness between UST and TNFi. However, after PS adjustment for a number of BL differences, clinical results at 12 mo were comparable between UST and TNFi groups. Data at 12 mo also show sustained response with both UST and TNFi treatment, as well as a similar rate of pts achieving targets after 6 to 12 mo of treatment.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Wim Noel Employee of: Janssen Pharmaceuticals NV, Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

Download Full-text

One-year effectiveness, retention rate, and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a real-life multicenter study

Expert Opinion on Biological Therapy ◽

10.1080/14712598.2020.1761957 ◽

2020 ◽

Vol 20 (7) ◽

pp. 813-821 ◽

Cited By ~ 3

Author(s):

Maria Sole Chimenti ◽

Giulia Lavinia Fonti ◽

Paola Conigliaro ◽

Flavia Sunzini ◽

Rossana Scrivo ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Multicenter Study ◽

Retention Rate ◽

Real Life ◽

One Year

Download Full-text

Need for Improvement in Current Treatment of Psoriatic Arthritis: Study of an Outpatient Clinic Population

The Journal of Rheumatology ◽

10.3899/jrheum.160973 ◽

2017 ◽

Vol 44 (4) ◽

pp. 431-436 ◽

Cited By ~ 12

Author(s):

Brigitte Michelsen ◽

Andreas P. Diamantopoulos ◽

Hege Kilander Høiberg ◽

Dag Magnar Soldal ◽

Arthur Kavanaugh ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Disease Activity Score ◽

Activity Index ◽

Real Life ◽

Disease Activity Index ◽

Activity Score ◽

Psoriatic Skin ◽

Biologic Treatment ◽

Remission Criteria

Objective.To explore the burden of skin, joint, and entheses manifestations in a representative psoriatic arthritis (PsA) outpatient cohort in the biologic treatment era.Methods.This was a cross-sectional study of 141 PsA outpatients fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria and examined between January 2013 and May 2014. Selected disease activity measures were explored including Disease Activity index for PSoriatic Arthritis (DAPSA), Composite Psoriatic Disease Activity Index (CPDAI), Psoriatic Arthritis Disease Activity Score (PASDAS), Disease Activity Score for 28 joints (DAS28), Simplified Disease Activity Index (SDAI), and Psoriasis Area Severity Index (PASI). Dermatology Life Quality Index (DLQI), minimal disease activity (MDA), and remission criteria were assessed.Results.Median (range) DAPSA was 14.5 (0.1–76.4), CPDAI 5 (1–11), PASDAS 3.1 (2.1–4.2), DAS28-erythrocyte sedimentation rate (ESR) 3.2 (0.6–6.4), SDAI 8.6 (0.1–39.5), PASI 1.2 (0.0–19.7), and DLQI 2.0 (0–17). The MDA criteria were fulfilled by 22.9% of the patients. DAPSA ≤ 4, CPDAI ≤ 2, PASDAS < 2.4, DAS28-ESR < 2.4, SDAI < 3.3, and Boolean’s remission criteria were fulfilled by 12.1, 9.3, 7.8, 26.2, 21.3, and 5.7% of patients, respectively. The number of satisfied patients was similar regardless of whether the group was treated with tumor necrosis factor inhibitors.Conclusion.Our real-life data indicate that there is still a need for improvement in today’s treatment of PsA. Musculoskeletal inflammatory involvement was more prominent than psoriatic skin involvement. Only a few patients fulfilled the DAPSA, PASDAS, and CPDAI remission criteria, and about a quarter fulfilled the MDA criteria. Considerably fewer patients fulfilled PsA-specific remission criteria versus non-PsA specific remission criteria. Still, patient satisfaction was good and PASI and DLQI were low.

Download Full-text

The 12-item Psoriatic Arthritis Impact of Disease Questionnaire: Construct Validity, Reliability, and Interpretability in a Clinical Setting

The Journal of Rheumatology ◽

10.3899/jrheum.160924 ◽

2016 ◽

Vol 44 (3) ◽

pp. 279-285 ◽

Cited By ~ 37

Author(s):

Marco Di Carlo ◽

Andrea Becciolini ◽

Valentina Lato ◽

Chiara Crotti ◽

Ennio Giulio Favalli ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Construct Validity ◽

Disease Activity ◽

Convergent Validity ◽

Activity Index ◽

Multivariable Analysis ◽

Real Life ◽

Life Quality ◽

Biologic Treatment ◽

Patient Reported

Objective.To study, in a real-life setting, the construct validity, the reliability, and the interpretability of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire in patients with psoriatic arthritis (PsA).Methods.In 144 consecutive patients with PsA (81 men and 63 women, mean age of 51.4 ± 12.8 yrs, and 77 receiving biologic treatment), the PsAID-12 and other patient-reported outcomes (PRO) were collected, such as the Dermatology Life Quality Index. Each patient underwent articular and skin assessment.Results.Construct validity: Factor analysis revealed a 2-factor result defined as the PsAID Symptom Score and the PsAID Skin Score. In determining convergent validity, significant correlations were found between the PsAID-12 and the clinical Disease Activity index for Psoriatic Arthritis (cDAPSA; ρ = 0.867, p < 0.0001). Multivariable analysis showed that the PsAID-12 is determined by the articular disease activity (cDAPSA, p < 0.0001), severity of psoriasis (PsO; physician’s global assessment, p < 0.0001), and the presence of a coexisting fibromyalgia (FM; p < 0.0001). Reliability: Cronbach’s alpha coefficient was 0.93 for the total PsAID-12. Interpretability: Applying the cDAPSA categorization of disease activity states, the PsAID-12 cutoff values resulted in 1.4 between remission and low disease activity (LDA), 4.1 between LDA and moderate disease activity (MDA), and 6.7 between MDA and high disease activity.Conclusion.The PsAID-12 is an excellent PRO to evaluate the effect of PsA. It should be carefully handled in patients with coexisting FM.

Download Full-text