AB0809 HOW WELL ARE BIOLOGICS RETAINED IN PSORIATIC ARTHRITIS - A REAL WORLD STUDY

Background:Biologics have led to a sea change in the management of psoriatic arthritis (PsA) with unprecedented improvement in the signs, symptoms and radiographic damage, resulting in improvement in functionality and quality of life. However longitudinal data for their retention and tolerability is sparse.Objectives:Our objective was to evaluate real-world biologic therapy duration and reasons for discontinuing treatment.Methods:We conducted a retrospective analysis of our PsA electronic register from 1994 up to and including April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management.Results:335 patients were identified with PsA. 58% of them were female with mean age of 46 yr (13-81). 113 (33.7%) patients had been treated with a biologic with 105 (93%) continuing at the time of analysis. 60 individuals were prescribed combination therapy with DMARDs. Mean age was 43.3 years (13-81) with 56% women. The biologics sample was ethnically diverse including 80% White Caucasian patients, 17% Asian and others (3%). Significant co-morbidities included cardiovascular disease (18.6%) and diabetes (4.4%). Eight different biologics were in use with adalimumab being the most prescribed (67%).35 (30.9%) patients had stopped biologics at some point with 76 episodes of cessation. 6% of our sample had discontinued two or more biologic treatments. The mean duration before biologic therapy was discontinued was 18.2 months (8 days to 9.5 years), which was almost twice as long as the average period before discontinuing a DMARD (9.9 months). Main reasons for stopping treatment included 23% each due to GI symptoms, neurological causes, cutaneous symptoms and other side effects. The remaining 8% reported fatigue as the reason for stopping therapy.Conclusion:To our knowledge this is the first dedicated retrospective review of a large real world PsA cohort comparing drug survival and tolerability of biologics against DMARDs. Biologic therapies are well tolerated in psoriatic arthritis. There is no significant difference amongst various modes of action. Over a quarter of the patients discontinue the drug owing to intolerance with mean drug survival of 18 months. In contrast nearly two-thirds were intolerant of DMARDs and stopped within ten months. Thus both the rate and duration of biologic retention is significantly better than conventional DMARDs. This has significant economic impact as NICE guidelines require an adequate trial of two DMARDs for six months prior to advanced therapy. However, this approach is unlikely to be cost effective as the disease progresses whilst patients struggle with DMARDs prescription and thus delay biologics which are more likely to be tolerated and retained longer. Hence there is an urgent need to review NICE guidelines to allow earlier employment of biologics in the treatment paradigm with significant benefits to both patients and the health economy.Disclosure of Interests:Issrah Jawad: None declared, Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Consultant of: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB

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EP43 Biologic retention in psoriatic arthritis: a real world study

Rheumatology ◽

10.1093/rheumatology/keaa109.042 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Issrah Jawad ◽

Muhammad K Nisar

Keyword(s):

Psoriatic Arthritis ◽

Real World ◽

Biologic Therapy ◽

Health Economy ◽

Nice Guidelines ◽

Drug Survival ◽

Advanced Therapy ◽

Gi Symptoms ◽

Conventional Dmards ◽

Significant Difference

Abstract Background Biologics have led to a sea change in the management of psoriatic arthritis (PsA) with unprecedented improvement in the signs, symptoms and radiographic damage, resulting in improvement in functionality and quality of life. However longitudinal data for their retention and tolerability is sparse. Our objective was to evaluate real-world biologic therapy duration and reasons for discontinuing treatment. Methods We conducted a retrospective analysis of our PsA electronic register from 1994 up to and including April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management. Results 335 patients were identified with PsA. 58% were female with mean age 46 yr (13-81). 113 (33.7%) patients had been treated with a biologic with 105 (93%) continuing at the time of analysis. 60 individuals were prescribed combination therapy with DMARDs. Mean age was 43.3 (13-81) with 56% women. The biologics sample was ethnically diverse including 80% White Caucasian patients, 17% Asian and others (3%). Significant co-morbidities included cardiovascular disease (18.6%) and diabetes (4.4%). Eight different biologics were in use with adalimumab being the most prescribed (67%). 35 (30.9%) patients had stopped biologics at some point with 76 episodes of cessation. 6% of our sample had discontinued two or more biologic treatments. The mean duration before biologic therapy was discontinued was 18.2 months (8 days to 9.5 years), which was almost twice as long as the average period before discontinuing a DMARD (9.9 months). Main reasons for stopping treatment included 23% each due to GI symptoms, neurological causes, cutaneous symptoms and other side effects. The remaining 8% reported fatigue as the reason for stopping therapy. Conclusion To our knowledge this is the first dedicated retrospective review of a large real world PsA cohort comparing drug survival and tolerability of biologics against DMARDs. Biologic therapies are well tolerated in psoriatic arthritis. There is no significant difference amongst various modes of action. Over a quarter of the patients discontinue the drug owing to intolerance with mean drug survival of 18 months. In contrast nearly two-thirds were intolerant of DMARDs and stopped within ten months. Thus both the rate and duration of biologic retention is significantly better than conventional DMARDs. This has significant economic impact as NICE guidelines require an adequate trial of two DMARDs for six months prior to advanced therapy. However, this approach is unlikely to be cost effective as the disease progresses whilst patients struggle with DMARDs prescription and thus delay biologics which are more likely to be tolerated and retained longer. Hence there is an urgent need to review NICE guidelines to allow earlier employment of biologics in the treatment paradigm with significant benefits to both patients and the health economy. Disclosures: I. Jawad: None. M.K. Nisar: None.

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P272 How well are conventional DMARDs tolerated in PsA: a real-world study

Rheumatology ◽

10.1093/rheumatology/keaa111.265 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Issrah Jawad ◽

Muhammad K Nisar

Keyword(s):

Side Effects ◽

Real World ◽

Retention Rate ◽

Cost Effective ◽

University Teaching ◽

Duration Of Treatment ◽

Real World Data ◽

Nice Guidelines ◽

Gi Symptoms ◽

Conventional Dmards

Abstract Background NICE guidelines recommend the first line use of DMARDs in psoriatic arthritis (PsA). However, studies show that many conventional treatments like methotrexate are poorly tolerated. There is hitherto no published real-world data addressing the tolerability of DMARDs in PsA. Our objective was therefore to assess the drug management in PsA with focus on tolerability and the reasons for therapy cessation. Methods We conducted a retrospective analysis of all PsA patients enrolled in electronic database up to April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management. Results 335 patients were identified with a formal diagnosis of PsA. Mean age of the cohort was 46 years (13-81) and 58% were female. 9% of the individuals had diabetes and 18% had concurrent cardiovascular disease. 1/10th reported to be current smokers and 8% had a diagnosis of depression. 48% of the group had clinically active disease. Same percentage were taking a single DMARD. 10% had trialled 3 or more drugs. 62% of patients had discontinued one or more DMARDs prior. The mean duration before discontinuing a DMARD was 9.9 months. Methotrexate was the best tolerated and on average discontinued after 13.4 months (range: 4 days to 10.9 years). Sulfasalazine and hydroxychloroquine were discontinued after an average of 8.4 (11 days to 4.27 years) and 12.5 months (1.3 months to 2.88 years) respectively. Leflunomide was the least tolerated DMARD and stopped after an average of 5.5 months (7 days to 2.53 years). The main reason for stopping a medication was gastro-intestinal symptoms which accounted for 42% of all the reported side effects. This applied to both methotrexate (43%) and sulfasalazine (46%) discontinuation. The leading reasons for discontinuing hydroxychloroquine were jointly GI symptoms and other side effects at 43% each. Leflunomide was stopped in 50% of cases due to neurological symptoms. Conclusion To our knowledge, this is the first report confirming poor retention rate of oral DMARDs in a real world PsA cohort managed over 20 years. In the context of chronic disease, the median duration of treatment is short. Our analysis did not include patients who suffer from side effects but continue therapy thereby impacting treatment adherence and hence the true scale of the issue is likely higher. Though NICE guidelines stipulate the need of an adequate trial of minimum two DMARDs prior to therapy escalation, these drugs are not well tolerated and thus pose a challenge to clinicians. One potential solution is earlier adoption of biological therapies, which are increasingly cost effective and have been shown to be better tolerated. Disclosures I. Jawad None. M.K. Nisar None.

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FRI0280 COMPARATIVE DRUG SURVIVAL OF TNF INHIBITORS AND SECUKINUMAB IN BIOLOGIC NAÏVE PATIENTS WITH ANKYLOSING SPONDYLITIS AND PSORIATIC ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4969 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 727.2-728

Author(s):

M. Cheila ◽

K. Douglas ◽

C. Koutsianas

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Duration ◽

Cox Regression ◽

Biologic Therapy ◽

Tnf Inhibitors ◽

Phase Iii ◽

Drug Survival ◽

Significant Difference

Background:Secukinumab (SEC) was approved for treating ankylosing spondylitis (AS) and psoriatic arthritis (PsA) in the UK in 2016/17 respectively, providing an alternative mechanism of action to TNF inhibitors (TNFi), which were, until that time, the most frequently prescribed biologic therapies for these rheumatic conditions. SEC’s efficacy and safety has been shown in clinical trials1, 2, but real world data on its survival remains scarce.Objectives:This study aimed to compare SEC and TNFi drug survival in AS and PsA biologic naïve patients.Methods:Observational retrospective study of consecutive biologic naïve patients attending the Dudley Group NHS Foundation Trust (DGFT) with a clinical diagnosis of AS (fulfilling ASAS criteria) or PsA (fulfilling CASPAR criteria) who received at least one dose of biologic therapy between 01/07/2017 and 30/09/2019, with a follow-up period until December 31st, 2019. The biologics database, patient medical records and investigations were reviewed and data on demographics, disease characteristics, previous cDMARD therapy and reasons for discontinuation of biologic were collected. Analysis was performed using descriptive statistics, Kaplan-Meier plots and Cox regression on SPSS version 23.Results:We identified 153 AS or PsA patients starting biologic therapy in this time interval. 103 (68.7%) were biologic naïve, commencing either TNFi (38, 36.9%), SEC (63, 61.1%) or Ixekizumab (2, 1.9% -excluded from analysis) for AS (45.5%) and PsA (54.5%). The patients were evenly distributed in terms of sex (female 50.5%), had a mean (±SD) age of 45 (±13.8) years and a median (IQR) disease duration of 5 (7.7) years. The median (IQR) follow up time was 13 (13) months.The overall 1 and 2-year drug survival was 86.8% and 79.3% respectively for TNFi and 81.5% and 77.4% for SEC treated patients. There was no statistically significant difference between the estimated means for drug survival time for the two treatment modalities (TNFi: 24.4 vs SEC:22.9 months,log rank:0.991) (Figure 1). The analysis of SEC’s drug survival in AS in comparison to PsA did not show statistically significant difference (21.8 vs 22.0 months respectively,log rank: 0.419). We observed a trend for worse TNFi survival in AS compared to PsA, but this did not reach statistical significance (18.9 vs 26.1 months respectively,log rank: 0.09).Figure 1.Comparative cumulative drug survival (months) in biologic naïve AS and PsA patientsNo significant difference in reasons for discontinuation between treatments was observed. Age, sex, disease duration, previous DMARD use and extra-articular manifestations were variables that were not associated with drug survival on Cox regression analysis.Conclusion:The estimated 1 year drug survival for TNFi and SEC was 86.8% and 81.5% respectively. Data from our cohort of real-life previously biologic naïve patients with AS and PsA showed no difference in drug survival and reasons for discontinuation between TNFi and SEC. Age, sex, previous DMARD use and extra-articular manifestations were not predictors for drug survival.References:[1]Kavanaugh et al. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355.[2]Braun et al. Effect of secukinumab on clinical and radiographic outcomes in ankylosing spondylitis: 2-year results from the randomised phase III MEASURE 1 study. Ann Rheum Dis. 2017 Jun;76(6):1070-1077Disclosure of Interests:None declared

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AB0810 IMPACT OF TOLERABILITY ON RETENTION OF cDMARDs IN PSORIATIC ARTHRITIS - IS IT A CONCERN?

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1973 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1706.2-1707

Author(s):

I. Jawad ◽

M. K. Nisar

Keyword(s):

Clinical Trials ◽

Psoriatic Arthritis ◽

Side Effects ◽

Real World ◽

Retention Rate ◽

Cost Effective ◽

University Teaching ◽

Duration Of Treatment ◽

Real World Data ◽

Gi Symptoms

Background:Most guidelines recommend the first line use of DMARDs in Psoriatic Arthritis (PsA). However, studies show that many conventional treatments like methotrexate are poorly tolerated. There is hitherto no published real-world data addressing the tolerability of DMARDs in PsA.Objectives:Our objective was therefore to assess the drug management in PsA with focus on tolerability and the reasons for therapy cessation.Methods:We conducted a retrospective analysis of all PsA patients enrolled in electronic database up to April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease managementResults:335 patients were identified with a formal diagnosis of PsA. Mean age of the cohort was 46 years (13-81) and 58% were female. 48% of the group had clinically active disease. Same percentage were taking a single DMARD. 10% had trialled 3 or more drugs. 62% of patients had discontinued one or more DMARDs prior. The mean duration before discontinuing a DMARD was 9.9 months. Methotrexate was the best tolerated and on average discontinued after 13.4 months (range: 4 days to 10.9 years). Sulfasalazine and Hydroxychloroquine were discontinued after an average of 8.4 (11 days to 4.27 years) and 12.5 months (1.3 months to 2.88 years) respectively. Leflunomide was the least tolerated DMARD and stopped after an average of 5.5 months (7 days to 2.53 years). The main reason for stopping a medication was gastro-intestinal symptoms which accounted for 42% of all the reported side effects. This applied to both methotrexate (43%) and sulfasalazine (46%) discontinuation. The leading reasons for discontinuing Hydroxychloroquine were jointly GI symptoms and other side effects at 43% each. Leflunomide was stopped in 50% of cases due to neurological symptoms.Conclusion:To our knowledge, this is the first report confirming poor retention rate of oral DMARDs in a real world PsA cohort managed over 20 years. In the context of chronic disease, the median duration of treatment is short. Our analysis did not include patients who suffer from side effects but continue therapy thereby impacting treatment adherence and hence the true scale of the issue is likely higher. Though NICE guidelines stipulate the need of an adequate trial of minimum two DMARDs prior to therapy escalation, in reality these drugs are not well tolerated and thus pose a challenge to clinicians. One potential solution is earlier adoption of biological therapies, which are increasingly cost effective and have been shown to be better tolerated.Disclosure of Interests:Issrah Jawad: None declared, Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Consultant of: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB

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SAT0398 PERSISTENCE OF USTEKINUMAB (UST) OR TNF INHIBITOR (TNFI) TREATMENT IN PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE LARGE, PROSPECTIVE, MULTINATIONAL, REAL-WORLD PsABio COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2127 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1149-1150

Author(s):

L. Gossec ◽

S. Siebert ◽

P. Bergmans ◽

K. De Vlam ◽

E. Gremese ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Real World ◽

Treatment Effect ◽

Cox Model ◽

Tnf Inhibitor ◽

Skin Involvement ◽

Research Support ◽

Treatment Persistence ◽

Kaplan Meier ◽

Significant Difference

Background:Several biologic DMARDs (bDMARDs) exist for PsA, TNFi and UST being the earliest on European markets. When bDMARDs are insufficiently effective, later-line bDMARDs typically have shorter persistence. Treatment persistence reflects a mix of effectiveness and adverse events (AEs), and persistence data are limited in PsA.Objectives:Comparative analysis of 1-year persistence of UST and TNFi within the prospective PsABio cohort.Methods:PsABio is an observational, multinational study of PsA patients (pts) treated with 1st to 3rd line UST or TNFi at their rheumatologist’s discretion.1Treatment persistence (up to 15 months of follow-up) was defined as time between start of first bDMARD treatment in PsABio, and either stop or switch to another bDMARD, or withdrawal.Persistence of UST and TNFi is shown by Kaplan-Meier curves and compared using Cox regression analysis, with propensity score (PS) to adjust for baseline imbalanced demographic and disease-related covariates (age, sex, bDMARD line, BMI, Clinical Disease Activity index for PSoriatic Arthritis [cDAPSA], 12-item PsA Impact of Disease [PsAID-12], Fibromyalgia Rapid Screening Tool [FiRST] score, co-treatments with MTX, NSAIDs, glucocorticoids, cardiovascular/metabolic comorbidities, dactylitis, enthesitis and body surface area [BSA]). Factors including concomitant MTX use and skin involvement: <3%, 3–10% and >10%, were added to the Cox model to investigate their impact on the PS-adjusted treatment effect.Results:Of 438 and 455 pts who started UST and TNF, respectively, 121 (28%) and 134 (29%) stopped or switched treatment before Month 15, with differences (as expected) according to treatment line (Fig. 1a, b). Reasons for stop/switch were related to safety/AEs in 12% (UST) and 28% (TNFi), and effectiveness (joints, nails or skin) in 77% (UST) and 69% (TNFi) of pts.The observed mean time on drug was 397 days for UST and 385 days for TNFi pts (1st line 410/397 days, 2nd 390/382 days, 3rd 381/338 days). Fig. 1b shows similar persistence for all drugs and treatment lines, except for lower persistence in TNFi 3rd line vs 1st/2nd. In PS-adjusted Cox analysis, no statistically significant difference between UST and TNFi persistence was seen; hazard ratio (HR; 95% CI) for stop/switch bDMARD (UST vs TNFi) was 0.82 (0.60, 1.13). In the model, bDMARD monotherapy (without MTX) and extensive skin involvement (BSA >10%), showed significantly better persistence for UST (HR 0.61 [0.42, 0.90] and 0.41 [0.19, 0.89] respectively; unadjusted Kaplan-Meier graphs shown in Fig. 1c, d). MTX co-therapy and low BSA did not affect the PS-adjusted treatment effect. Other factors added to the PS-adjusted Cox model did not show significant effects.Conclusion:In this real-world PsA cohort undergoing bDMARD treatment, persistence was generally comparable for UST and TNFi, but some clinical situations led to better drug persistence with UST compared to TNFi – particularly monotherapy, more extensive skin involvement, and in 3rd-line treatment. Our data emphasise the importance of skin involvement for pts with PsA.References:[1]Gossec L, et al.Ann Rheum Dis. 2018;77(suppl 2):Abstract AB0928Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, 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, 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, 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, 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, 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

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AB0760 DRUG SURVIVAL AND EFFICACY OF USTEKINUMAB AND SECUKINUMAB IN PSORIATIC ARTHRITIS: A REAL-WORLD MULTICENTRIC COHORT OF 186 PATIENTS

10.1136/annrheumdis-2019-eular.3279 ◽

2019 ◽

Author(s):

Jean-Guillaume Letarouilly ◽

Jeremie Sellam ◽

Pascal Richette ◽

Philippe Dieudé ◽

Pascal Claudepierre ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Real World ◽

Drug Survival

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Prevalence of Psoriatic Arthritis Patients Achieving Minimal Disease Activity in Real-world Studies and Randomized Clinical Trials: Systematic Review with Metaanalysis

The Journal of Rheumatology ◽

10.3899/jrheum.190677 ◽

2019 ◽

Vol 47 (6) ◽

pp. 839-846

Author(s):

Mariele Zardin-Moraes ◽

André Luis Ferreira Azeredo da Silva ◽

Carla Saldanha ◽

Charles Lubianca Kohem ◽

Laura C. Coates ◽

...

Keyword(s):

Clinical Trials ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Randomized Clinical Trials ◽

Data Extraction ◽

Cochrane Library ◽

Minimal Disease Activity ◽

Cross Sectional ◽

Minimal Disease

Objective.To estimate the frequency of patients with psoriatic arthritis (PsA) achieving minimal disease activity (MDA) status in real-world studies and randomized controlled trials (RCT).Methods.A systematic literature search for 2009–2017 was performed in PubMed, Embase, Cochrane Library, and LILACS. Study selection and data extraction were performed by 2 independent researchers. Random-effects single-arm metaanalyses were performed and heterogeneity was assessed using I2.Results.A total of 405 records were identified and 45 studies were analyzed: 39 (86.7%) observational studies and 6 (13.3%) RCT; they included 12,469 patients. The overall prevalence of MDA in cross-sectional studies was 35% (95% CI 30%–41%, I2 = 94%), varying from 17% (95% CI 7%–34%) in patients taking synthetic disease-modifying antirheumatic drugs (DMARD) to 57% (95% CI 41%–71%) in those taking biological DMARD. Prevalence of MDA in cohort studies increased with longer followup time, ranging from 25% (95% CI 15%–40%) with 3- to 4-month followup to 42% (95% CI 38%–45%) with > 24-month followup. Patients with PsA receiving biological DMARD in a real-world context and RCT had similar prevalence of MDA at 6-month followup: 30% (95% CI 21%–41%, I2 = 85%) versus 32% (95% CI 26%–39%, I2 = 79%), respectively.Conclusion.Patients with PsA included in real-world studies had similar prevalence of MDA compared to those in controlled clinical trials. This finding suggests that MDA is a useful treatment target for PsA in the real-world setting.

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AB0785 DRUG SURVIVAL OF SECUKINUMAB FOR PSORIATIC ARTHRITIS IN A REAL-WORLD SETTING

10.1136/annrheumdis-2019-eular.395 ◽

2019 ◽

Author(s):

Marta Valero ◽

Beatriz Joven-Ibáñez ◽

María Martín ◽

Jose Campos Esteban ◽

Carolina Merino Argumánez ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Real World ◽

Drug Survival ◽

Real World Setting

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SAT0520 CONTROVERSY ON DIAGNOSIS AND TREATMENT OF ADULT PATIENTS WITH SAPHO SYNDROME: MULTI-DISCIPLINARY INTERNATIONAL SURVEY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6390 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1216.1-1216

Author(s):

V. Furer ◽

M. Kishimoto ◽

S. Tsuji ◽

Y. Taniguchi ◽

Y. Ishihara ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Diagnostic Criteria ◽

Biologic Therapy ◽

Treatment Approach ◽

Sapho Syndrome ◽

Diagnosis And Treatment ◽

Conventional Dmards ◽

Inflammatory Drugs ◽

Disease Modifying ◽

Anti Inflammatory

Background:Synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) is a rare disease involving skin and skeleton, with a potentially complicated and severe course, optimal management of which seems to require a collaborative rheumatology and dermatology care. Diagnostic criteria for SAPHO remain preliminary and lack validation. There are no evidence-based treatment algorithms in SAPHO due to lack of clinical trials in this rare medical condition.Objectives:This study aimed to investigate the current practice in the diagnosis and treatment of SAPHO syndrome among the international rheumatology and dermatology communities.Methods:We conducted a survey among the members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) combining international rheumatologists and dermatologists as well as members of the Japanese and Israeli Societies of Rheumatology.Results:A total of 78 physicians participated in the survey: rheumatologists (83%, n=65), dermatologists (11.5%, n=9), and orthopedics (3.8%, n=3). SAPHO was considered a subtype of spondylarthritis by 48.7% (n=38), a subtype of psoriatic arthritis by 19.2% (n=15), a separate entity by 25.6% (n=20), and a subtype of reactive arthritis by 6.4% (n=5). Palmoplantar pustulosis was the most prevalent cutaneous manifestation (n=44, 56.4%) and anterior chest pain - the most prevalent osteoarticular manifestation (n=66, 84.6%). The majority (84.6%, n=66) voted for the update of the present diagnostic criteria by Khan 1994. Magnetic resonance imaging was considered the preferred imaging modality for the diagnosis of SAPHO by 41% (n=32). Conduction of bone biopsy for diagnosis of non-infectious osteitis was supported only by 10.3% (n=8). Patient-reported outcomes were considered the most appropriate measure for the assessment of disease activity by 47.4% (n=37). The treatment approach was overall similar among the rheumatology and dermatology communities, including non-steroidal anti-inflammatory drugs, bisphosphonates, conventional disease-modifying anti-inflammatory drugs, and biologics (Table 1).Table 1.Preferences in the treatment choice of SAPHOTreatment% of respondersNSAIDs76.6%Glucocorticoids32.5%Conventional DMARDs57.1%Bisphosphonates48.1%Anti-TNF biologic therapy75.3%Other biologic therapy20.8%Antibiotic14.3%Tonsillectomy5.1%Isotretinoin5.2%Topical therapy10.4%Intra-articular steroid injection7.8%Legend: NSAIDs – non-steroidal anti-inflammatory drugs; DMARDs – disease modifying anti-rheumatic drugsConclusion:Our study underlines the controversy on diagnosis and treatment of SAPHO syndrome among specialists in rheumatology and dermatology and emphasizes an unmet need for update and validation of diagnostic criteria and treatment approach.Acknowledgments:GRAPPA, Japanese Society of Rheumatology, Israeli Society of RheumatologyDisclosure of Interests:Victoria Furer: None declared, Mitsumasa Kishimoto: None declared, Shigeyoshi Tsuji Grant/research support from: Eli Lilly, Speakers bureau: AbbVie, Asahi Kasei, Chugai, Daiichi Sankyo, Eli Lilly, Eisai, Mitsubishi Tanabe, Celgene, and Novartis Pharma K.K., Yoshinori Taniguchi: None declared, Yoko Ishihara: None declared, Tetsuya Tomita Consultant of: Eli Lilly and Company, Ori Elkayam Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Novartis, Jansen

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PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

BMJ Open Diabetes Research & Care ◽

10.1136/bmjdrc-2020-001507 ◽

2020 ◽

Vol 8 (1) ◽

pp. e001507

Author(s):

Antonio Carlo Bossi ◽

Valentina De Mori ◽

Carlotta Galeone ◽

Davide Pietro Bertola ◽

Margherita Gaiti ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Repeated Measures ◽

Long Term Results ◽

Italian Population ◽

Drug Survival ◽

Kaplan Meier ◽

Significant Difference

IntroductionSitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population.Research design and methodsWe evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment.ResultsAt baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m2) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon.ConclusionPatients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events.

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