POS0208 GENDER DIFFERENCES IN RESPONSE TO BIOLOGICALS. WOMEN FARE WORSE ACROSS INFLAMMATORY ARTHRITIS DISEASES - DATA FROM THE BIOREG

Background:Gender differences in prevalence and disease course are known in various rheumatic diseases; however, investigations of gender difference concerning therapeutical response have yielded variable results.Objectives:The aim of this retrospective study was to investigate, whether a gender difference in response rate to biological disease-modifying antirheumatic drugs (bDMARDs) and apremilast in bDMARD-naïve patients could be observed across the three most prevalent inflammatory arthritis diseases: rheumatoid arthritis (RA), spondylarthritis (SpA) and psoriatic arthritis (PsA). Additionally, a response to individual TNF blockers was investigated in this respect.Methods:Data from bDMARD-naïve RA-, SpA- and PsA-patients from Bioreg, the Austrian registry for biological DMARDs in rheumatic diseases, were used. Patients with a baseline (Visit 1=V1) and follow-up visits at 6 months (Visit 2=V2) and 12 months (Visit 3=V3) were included and response to therapy with TNF-inhibitors (TNFi), furthermore to therapy with rituximab, tocilizumab and apremilast was analyzed according to gender. The remaining bDMARDs were not analyzed due to small numbers. Key response-parameter for RA was disease activity score (DAS28), whereas for PsoA the Stockerau Activity Score for Psoriatic Arthritis (SASPA) and for SpA the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were employed; in addition, the Health assessment Questionnaire (HAQ) was used. Data were analyzed in R Statistic stratified by gender using Kruskal-Wallis and Wilcoxon tests.Results:354 women and 123 men with RA (n=477), 81 women and 69 men with PsA (n=150), 121 women and 191 men with SpA (n=312) were included. No significant differences in biometrics was seen between female and male patients at baseline in all diseases.In RA patients overall DAS28 decreased from baseline (V1) to V2 and V3 (DAS28: V1: male: 4.38 [3.66, 5.11], female: 4.30 [3.68, 5.03], p(m/f) = 0.905; V2: male: 2.66 [1.73, 3.63], female: 3.10 [2.17, 3.98], p(m/f) = 0.015; V3: male: 2.25 [1.39, 3.36], female: 3.01 [1.87, 3.87], p(m/f) = 0.002). For TNF inhibitors (n=311), there was a significant difference between genders at V2 (Fig.1a). Patients receiving Rituximab (n=41) displayed a significantly higher DAS28 at baseline in females, which diminished in the follow up: V1: (p(m/f) p=0.002; V2: p=0.019; V3: p=0.13); response to tocilizumab (n=63) did not show any gender differences.In PsA patients overall SASPA decreased from baseline (V1) to V2 and V3 (SASPA: V1: male: 4.00 [2.80, 5.20], female: 4.40 [2.80, 5.80], p(m/f) = 0.399; V2: male: 2.20 [1.20, 3.50], female: 3.40 [2.00, 5.00], p(m/f) = 0.071; V3: male: 1.80 [0.80, 2.70], female: 3.01 [2.35, 4.80], p(m/f) = 0.001). For TNF inhibitors (n=79), there was a significant difference between genders at V3 (Fig 1a). For Apremilast (n=39), there was a significant difference between genders at V2 (Fig.1c).In SpA patients overall BASDAI decreased from baseline (V1) to V2 and V3 (BASDAI: V1: male: 4.70 [2.88, 6.18], female: 4.80 [3.30, 6.20], p(m/f) = 0.463; V2: male: 3.05 [2.00, 4.60], female: 3.64 [2.62, 5.41], p(m/f) = 0.039; V3: male: 3.02 [1.67, 4.20], female: 3.65 [2.18, 5.47], p(m/f) = 0.016). In V3 a differential BASDAI in response to TNFi (n=299) was observed (Fig.1a).Possible differences of response to individual TNFi (etanercept, infliximab, other TNFi) measured by HAQ were investigated in all diseases together. The difference between male and females was significant at baseline for all 3 TNFi; whereas with the use of ETA the significant difference was carried through to V2 and V3, it was lost with the use of IFX and was variable with the other TNFi (Fig.1b)Figure 1.Conclusion:Female patients showed a statistically lower response to TNFi in all three disease entities (RA, SpA and PsoA) to a variable degree in our homogenous central european population. Interestingly, the difference was not uniform across individual TNFi when measured by HAQ. Gender differences were also seen in response to Apremilast.Disclosure of Interests:Elisabeth Loibner: None declared, Valentin Ritschl: None declared, Burkhard Leeb Speakers bureau: AbbVie, Roche, MSD, Pfizer, Actiopharm, Boehringer-Ingelheim, Kwizda, Celgene, Sandoz, Grünenthal, Eli-Lilly, Grant/research support from: TRB, Roche, Consultancies: AbbVie, Amgen, Roche, MSD, Pfizer, Celgene, Grünenthal, Kwizda, Eli-Lilly, Novartis, Sandoz;, Peter Spellitz: None declared, Gabriela Eichbauer-Sturm: None declared, Jochen Zwerina: None declared, Manfred Herold: None declared, Miriam Stetter: None declared, Rudolf Puchner Speakers bureau: AbbVie, BMS, Janssen, Kwizda, MSD, Pfizer, Celgene, Grünenthal, Eli-Lilly, Consultant of: AbbVie, Amgen, Pfizer, Celgene, Grünenthal, Eli-Lilly, Franz Singer: None declared, Ruth Fritsch-Stork: None declared

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FRI0284 EFFECTIVENESS AND SAFETY OF SECUKINUMAB IN NAÏVE OR TNF-INHIBITORS FAILURE PSORIATIC ARTHRITIS PATIENTS IN REAL LIFE: A 24-MONTHS PROSPECTIVE MULTICENTER STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3702 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 730.1-730

Author(s):

M. Lorenzin ◽

A. Carletto ◽

R. Foti ◽

M. S. Chimenti ◽

A. Semeraro ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Adverse Events ◽

Disease Activity ◽

Real Life ◽

Tnf Inhibitors ◽

Significant Difference ◽

Group A ◽

Group B

Background:Secukinumab (SEC) is a novel treatment for psoriatic arthritis (PsA),but data from real life are still missing.Objectives:1)to evaluate the effectiveness and safety of a wide cohort of PsA patients on SEC followed in 7 Italian rheumatologic centers for 24 months;2)to compare the features and disease activity indices of SEC-treated PsA patients subdivided in naïve biological drugs (group A) and in TNF-inhibitors (TNFi) failure patients (group B).Methods:Consecutive patients with moderate-severe PsA,who begun SEC treatment were evaluated prospectively.Data on disease characteristics,previous and ongoing treatments,comorbidities and duration of follow-up were collected.Disease activity,functional and clinimetric scores and biochemical values were recorded at baseline (t0),at 6 (t6),12 (t12),and 24 (t24) months.Anova (Kruskal Wallis) and generalized linear models were used to compare variables over time.Infections and adverse events were also collected.Results:PsA345patients [38.84% men;mean age 52.9 (11.27) years] were enrolled;mean treatment duration was 18.53 (9.97) years.SEC was prescribed as first line biologic treatment in 133 (38.55%) patients and as second or more line biological treatment in 212 (61.45%) patients. Enthesitis was present as a prominent manifestation in 61.44% of patients (Figure 1).In all population significant decrease in tender/swollen joints;Visual Analogue Scale of pain (VASp) and general health (VASgh);Psoriasis Area Severity Index (PASI);Leeds Enthesitis Index (LEI);number of dactylitis;Health Assessment Questionnaire modified for spondyloarthritis (HAQ-S);Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Bath Ankylosing Spondylitis Functional Index (BASFI);C-reactive protein (CRP) was achieved.Effectiveness of all PsA patients was associated to an improvement in Ankylosing Spondylitis disease activity score (ASDAS) [t0=3.45 (0.69) vs t24=1.48 (0.23);p<0.01] and in Disease Activity in PsA (DAPSA) [t0=29.52 (12.56) vs t24=11.41 (7.63);p<0.001].At t0group Bhad a more erosive (p=0.04) and polyarticular pattern (p=0.04),a longer disease duration (p=0.001),a greater prevalence (p=0.04) of psoriasis and dactylitis (p=0.01),a higher PASI score (p=0.01),while no significant difference was observed for uveitis,inflammatory bowel diseases,enthesitis.At t24group Ashowed better physical functioning and lower disease activity compared togroup B[HAQs A vs B=0.03 (0.16) vs 0.69 (0.73);BASDAI A vs B=2.37 (0.66) vs 4.27 (2.33);ASDAS A vs B=1.4 (0.62) vs 1.99 (0.86);CRP A vs B=2.03 (1.94) vs 3.11 (1.55) mg/L;DAPSA A vs B=7.03 (3.57) vs 12.41 (8.05)].After t24 of treatment 74.6% ofGroup Aand 72.8% ofGroup Barticular had an inactive\low disease activity (MDA),accordingly to ASDAS and DAPSA respectively.Forty-three patients (12.46%) stopped the treatment during the follow-up mainly because of primary or secondary loss of efficacy (29 and 24, respectively).Only 14 patients suspended SEC because of adverse events (of which 9 for reactions at site of injection).A low number of episodes of mild infections (16) occurred;SEC was instead permanently discontinued in 7 cases for:oral refractory mucositis (3);recurrent aphthosis (2);diverticulitis (2).The retention rate at t24 was good in the whole population.Interestingly no differences were found betweenGroup AandB(p=0.815).Conclusion:In a real life clinical setting,SEC was safe and effective in PsA. as shown by a significant decrease of DAPSA and ASDAS over a 24-months follow up.Disclosure of Interests:Mariagrazia Lorenzin: None declared, Antonio Carletto: None declared, Rosario Foti Consultant of: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Speakers bureau: lilly, sanofi, MSD, Janssen, Abbvie, BMS, celgene, roche, Maria Sole Chimenti: None declared, Angelo Semeraro: None declared, Luisa Costa: None declared, Leonardo Santo: None declared, Elena Fracassi: None declared, Ilaria Montanari: None declared, Mara Felicetti: None declared, Giulia Lavinia Fonti: None declared, Francesco Caso: None declared, Andrea Doria Consultant of: GSK, Pfizer, Abbvie, Novartis, Ely Lilly, Speakers bureau: UCB pharma, GSK, Pfizer, Janssen, Abbvie, Novartis, Ely Lilly, BMS, Augusta Ortolan: None declared, Roberta Ramonda Speakers bureau: Novartis, Celgene, Janssen, Pfizer, Abbvie, Lilly

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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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AB0741 IS THE THERAPEUTIC TARGET ACHIEVEMENT INCREASING OVER TIME IN PATIENTS WITH PSORIATIC ARTHRITIS STARTING BIOLOGICAL THERAPY? DATA FROM 15 YEARS.

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1710 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1666-1667

Author(s):

D. Benavent ◽

V. Navarro-Compán ◽

I. Monjo ◽

M. Novella-Navarro ◽

A. Balsa ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Biological Therapy ◽

Lower Percentage ◽

Tnf Inhibitor ◽

Medium Term ◽

Significant Difference ◽

One Year ◽

Over Time

Background:Treatment in Psoriatic Arthritis (PsA) has undergone a major revolution in recent years, with the development of new targets and molecules. Despite these advances, data from clinical practice demonstrating a change in management success are scarce.Objectives:To evaluate if the proportion of patients (pts) with PsA maintaining an acceptable medium-term control of the disease activity after starting a first biologic agent is increasing over time.Methods:Prospective cohort including 101 patients (pts) with PsA starting a 1st biologic (TNF inhibitor, anti-IL 17 inhibitor) in a tertiary hospital between 2002-2018. Demographic, clinical and laboratory data were collected at the beginning of treatment. Disease activity indexes (ASDAS for axPsA and DAPSA for pPsA) were collected before starting biologic, six and twelve months later (baseline, 6m and 12m visit, respectively). Low disease activity (LDA) was defined as ASDAS < 2.1 (axPsA) and DAPSA ≤14 (pPsA). Three groups were established according to biologic initiation date: period 1 (p1) (between 2002-2007), (p2) 2008-2013 and (p3) 2014-2018. Each period had a minimum follow-up of 1 year for every patient. For each interval, the percentage of pts achieving persistent (at both follow-up visits) LDA was determined, as a marker of acceptable medium-term control of the disease. All collected variables were compared between groups by ANOVA and Chi-Squared test.Results:Out of the 101 pts initiating biological therapy, 46 % were males and 57 % had peripheral PsA. At the biologic treatment start, mean ± SD age was 48.5 ± 12 years and disease duration was 9.9 ± 10 years. Biological therapies initiated included etanercept in 38 % of pts, infliximab in 24 %, adalimumab in 25 %, golimumab in 7 %, secukinumab in 3 % and certolizumab in 3 %.Stratified by time intervals, 36 (35.6%) pts started in p1, 36 (35.6%) in p2 and 29 (28.8%) in p3. Baseline characteristics of pts by periods are shown in Table 1. For patients in p3, compared to the previous intervals, a significant lower CRP (p=0.03) and ESR (p=0.004) were found at baseline, whereas there were no significant differences on baseline disease activity indices. Fifty-one (50%) pts achieved persistent-LDA after one year of starting biologic. Figure 1 reports the total number of patients that were in LDA in all the visits in the 1styear, stratified per period of time and predominant manifestation. A lower percentage of patients in LDA (33% in p1 vs, 67% in p2 vs 52% in p3, p = 0.02) was found in the first interval, in comparison to the most recent periods. The difference in response between p2 and p3 is mainly due to the group of patients with pPsA, whereas the improvement in the group of patients with axPsA remains constant in both periods.Table 1.Baseline patient’s characteristics by periods of timeFigure 1.Patients achieving persistent-LDA during the 1styear of biological therapy, stratified by period of time and by disease.* Statistically significant difference with respect to p1.Conclusion:The percentage of pts with PsA achieving LDA status after one year of initiating a biological therapy has substantially increased over time. A lower threshold of inflammation at biological therapy start and a broader spectrum of therapies might explain this better management on PsA.Disclosure of Interests:Diego Benavent: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Irene Monjo: None declared, Marta Novella-Navarro: None declared, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz, Chamaida Plasencia: None declared

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IL-33 Gene Polymorphisms as Potential Biomarkers of Disease Susceptibility and Response to TNF Inhibitors in Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis Patients

Frontiers in Immunology ◽

10.3389/fimmu.2021.631603 ◽

2021 ◽

Vol 12 ◽

Author(s):

Milena Iwaszko ◽

Joanna Wielińska ◽

Jerzy Świerkot ◽

Katarzyna Kolossa ◽

Renata Sokolik ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Rheumatic Diseases ◽

Inflammatory Arthritis ◽

Gene Polymorphisms ◽

Disease Susceptibility ◽

Tnf Inhibitors ◽

Inflammatory Rheumatic Diseases

ObjectiveRheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) belong to inflammatory rheumatic diseases, the group of conditions of unknown etiology. However, a strong genetic component in their pathogenesis has been well established. A dysregulation of cytokine networks plays an important role in the development of inflammatory arthritis. Interleukin 33 (IL-33) is a recently identified member of the IL-1 family. To date, the significance of IL-33 in inflammatory arthritis has been poorly studied. This research aimed to investigate the potential of IL-33 gene polymorphisms to serve as biomarkers for disease susceptibility and TNF inhibitor response in RA, AS, and PsA patients.Materials and MethodsIn total, 735 patients diagnosed with RA, AS, and PsA and 229 healthy individuals were enrolled in the study. Genotyping for three single nucleotide polymorphisms (SNPs) within the IL-33 gene, namely, rs16924159 (A/G), rs10975519 (T/C), and rs7044343 (C/T), was performed using polymerase chain reaction amplification employing LightSNiP assays.ResultsIn the present study, the IL-33 rs10975519 CC genotype was associated with a decreased risk of developing RA in females, while the IL-33 rs16924159 polymorphism was associated with the efficacy of anti-TNF therapy and clinical parameters for RA and AS patients. The IL-33 rs16924159 AA genotype correlated with higher disease activity and worse clinical outcomes in RA patients treated with TNF inhibitors, and AS patients carrying the IL-33 rs16924159 AA genotype had higher disease activity and a worse response to anti-TNF therapy. That indicates a deleterious role of the IL-33 rs16924159 AA genotype in the context of RA, as well as AS.ConclusionsThe obtained results suggest that IL-33 gene polymorphisms might be potential candidate biomarkers of disease susceptibility and anti-TNF treatment response in patients with inflammatory rheumatic diseases.

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P03 Effectiveness and tolerability of Benepali in patients switched from Enbrel with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthropathy

Rheumatology ◽

10.1093/rheumatology/keaa111.002 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Brandon Yeo ◽

Sarah Dyball ◽

Audrey Low

Keyword(s):

Rheumatoid Arthritis ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Retention Rate ◽

Cost Savings ◽

Rank Test ◽

Patient Records ◽

Axial Spondyloarthropathy ◽

Significant Difference

Abstract Background Benepali (SB4) is an etanercept biosimilar licensed for rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthropathy (AS) and is cheaper than Enbrel (ETN). We aimed to evaluate the effectiveness and tolerability of switching from ETN to SB4 and costs saved. Methods All patients on ETN were identified from pharmacy records and reviewed by consultants for clinical suitability to switch to SB4. Letters informing patients of the proposed switch were sent and replies collated. Patients were switched when prescriptions were due for renewal. Switching started in June 2018 and patients were prospectively followed at 3 and 6 months after switching. Anonymised demographic and clinical data were collected from patient records. DAS28 was calculated for RA and PsA due to availability of score components from patient records. The difference between disease activity scores prior to the switch, 3 months, and 6 months after switching was analysed using the Wilcoxon signed-rank test. Results 113 patients were prescribed ETN and 17 patients were clinically unsuitable to switch. Of the remaining 96 patients, 6 declined switching and 7 stopped ETN before switching. The remaining 83 patients were switched from ETN to SB4 over a year and analysed (Table 1). Comparing measures of disease activity prior to switching versus 3 months or 6 months of follow-up on SB4, there were no statistically significant differences in disease activity for patients with RA (Table). Missing data for PsA and AS precluded statistical comparisons. 5 patients switched back to ETN due to subjective worsening of joint symptoms. 3 patients switched back to ETN due to adverse effects (infections, dizziness and nausea, unknown). 1 patient switched from SB4 to abatacept due to high disease activity. 1 patient stopped SB4 due to incident lung cancer. Conclusion SB4 was generally well tolerated with a retention rate of 88% (73/83) over 6 months of follow-up. In RA there was no significant difference in patients’ disease activity when switching from ETN to SB4, at 3 or 6 months of follow-up. Assuming all 73 switched patients remained on SB4 for a year, this would equate to £56,000 cost savings per year. Disclosures B. Yeo None. S. Dyball None. A. Low None.

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AB0806 DOES VITAMIN D INFLUENCE THE ACTIVITY OF THE DISEASE IN PATIENTS WITH PSORIATIC ARTHRITIS?

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4625 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1704.1-1705

Author(s):

L. Montolio-Chiva ◽

A. V. Orenes Vera ◽

M. Aguilar-Zamora ◽

C. Vergara-Dangond ◽

I. Vázquez-Gómez ◽

...

Keyword(s):

Vitamin D ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Functional Capacity ◽

Inverse Correlation ◽

Hypovitaminosis D ◽

Joint Involvement ◽

Average Value ◽

Vitamin D Levels

Background:Several studies have shown an inverse relationship between vitamin D levels (25OHD) and disease activity in patients with rheumatoid arthritis (RA). However, the existing data in patients with psoriatic arthritis (PsA) are poor, and they use the DAS28 index as a peripheral joint activity marker by extrapolation with RA.Objectives:To analyze the relationship between 25OHD levels, disease activity and functional capacity in patients with PsA.Methods:Transversal, observational, descriptive study. We included PsA patients with peripheral joint involvement. We collected demographic variables (gender, age), clinical variables [follow-up, received treatments, TJC (68), SJC (68), VAS] and analytical variables (25OHD, CRP, ESR). We usedDisease activity in psoriatic arthritis(DAPSA) score to measure disease activity, and theHealth assessment questionnaire(HAQ) to determine functional capacity. Levels of 25 OHD <20 ng/ml and between 20-30 ng/ml were considered deficient and insufficient, respectively. Statistical analysis was made with SPSS 22.0. The descriptive analysis results were expressed as percentage and mean ± SD. We used Pearson’s correlation to assess the association between quantitative variables and T test to compare means between dichotomous variables.Results:125 patients were included, the majority women (60.8%), with an average age of 55.4 (SD 12.2) years. The average follow-up was 75.5 (SD 68.3) months. 97.6% of patients had received DMARDs and 40.8% biologics, and almost half of the patients (42.7%) took calcium and 25OHD supplements. The average value of 25OHD was 27.1 (SD 12.1) ng/ml, with 30% of patients having 25OHD deficit and 63.3% insufficiency. The majority of patients had an acceptable disease control, with a mean DAPSA of 10.5 (SD 7,9); and mean of CRP, ESR, TJC and SJC was 6.1 (SD 3.7) mg/l, 10.2 (SD 9.9) mm/h, 1.3 (SD 2.5) and 0.7 (SD 2.1), respectively. The average value of HAQ was 0.6 (SD 0.7). We observed an inverse correlation between 25OHD levels and joint counts, TJC (p=0.02) and SJC (p=0.03). On the other hand, patients with hypovitaminosis D presented a tendency to get higher scores in DAPSA index (P=0.07). We do not observe any relationship between 25OHD and HAQ.Conclusion:As can be seen in our sample, low values of 25OHD are related to increased disease activity in patients with PsA.Disclosure of Interests:L Montolio-Chiva: None declared, Ana V Orenes Vera: None declared, Marta Aguilar-Zamora: None declared, C Vergara-Dangond: None declared, I Vázquez-Gómez: None declared, Eduardo Flores: None declared, A Sendra-García: None declared, À Martínez-Ferrer: None declared, Elia Valls-Pascual Grant/research support from: Roche, Novartis, and AbbVie, Speakers bureau: AbbVie, Lilly, Pfizer, MSD, Novartis, Janssen, Bristol Myers Squibb, UCB Pharma, D Ybáñez-García Speakers bureau: Lilly, Roche, Sanofi, V Núñez-Monje: None declared, I Torner-Hernández: None declared, Juanjo J Alegre-Sancho Consultant of: UCB, Roche, Sanofi, Boehringer, Celltrion, Paid instructor for: GSK, Speakers bureau: MSD, GSK, Lilly, Sanofi, Roche, UCB, Actelion, Pfizer, Abbvie, Novartis

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THU0517 THE ROLE OF ULTRASOUND-DEFINED SYNOVITIS GRADE I IN PATIENTS PRESENTING WITH INFLAMMATORY ARTHRALGIA, A RETROSPECTIVE STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4886 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 497.2-497

Author(s):

J. Arroyo Palomo ◽

M. Arce Benavente ◽

C. Pijoan Moratalla ◽

B. A. Blanco Cáceres ◽

A. Rodriguez

Keyword(s):

Rheumatoid Arthritis ◽

Inflammatory Arthritis ◽

Statistical Tests ◽

Median Number ◽

Painful Joint ◽

Significant Difference ◽

The Mean ◽

Specialized Unit

Background:Musculoeskeletal ultrasound (MSUS) is frequently used in several rheumatology units to detect subclinical inflammation in patients with joint symptoms suspected for progression to inflammatory arthritis (IA). Synovitis grade I (EULAR-OMERACT combined score) is known to be a casual finding in healthy individuals, but studies headed to unravel its possible role on rheumatic diseases are sparse.Objectives:To investigate the correlation between synovitis grade I, and the diagnosis of IA made after a year follow-up period since MSUS findings, in patients of an MSUS-specialized unit of a Rheumatology Department.Methods:We conducted a descriptive, retrospective and unicentric study. 30 patients were selected from the MSUS-specialized unit of our Rheumatology Department from July-18 to January-19. Patients presenting synovitis grade 0 (exclusively), 2 and/or 3 on combined score were excluded. Data collection at baseline included age, sex, immunological profile and previous physical examination to the MSUS findings, as well as the diagnosis made by the rheumatologist in 1-year visit follow-up: dividing the patient sample into two groups: those who were diagnosed with IA and those not. Non-parametric statistical tests for comparing means were used.Results:The mean age was 51,6 years and 70% were females. 6 (20%) patients were diagnosed with inflammatory arthritis after a year follow-up: 2 (4,8%) psoriatic arthritis, 1 (3,3%) undifferentiated arthritis, 1 (3,3%) rheumatoid arthritis, 1 (3,3%) Sjögren’s syndrome. Non-inflammatory arthropathies were also found 24 (80%), of which, 12 (40%) were non-specific arthralgias and 8 (19%) osteoarthritis.In the group of patients who did not developed an IA the mean C-reactive protein (CPR) value was 3,12 mg/L and erythrocyte sedimentation rate (ESR) was 8,2 mm; all of them were rheumatoid factor (RF) positive and ACPA-negative except one patient. 5 (31,3%) patients presented low antinuclear antibodies (ANAs) levels. In those who HLA B-27 and Cw6 were tested (4,25%); both were negative except for one that was HLA B-27 positive. The median number of swollen and painful joint count was 0, and the mean of joints with MSUS involvement was 3,5; the mean involved metacarpophalangeal (MCP) joints was 1,83; proximal interphalangeal (PIP) joints was 1,48 and distal interphalangeal (DIP) joints 0,21.Among the group of patients that developed an IA the mean of CPR and ESR was 9,27 mg/L and 14,17 mm respectively; 2 (33%) patients were RF- positive, and 1 ACPA-positive. ANAs were positive in 3 cases (50%). The median of swollen joint count was 2 and for painful joint count was 0, the median of joints with MSUS involvement was 4,5. The mean of MSUS involvement was for MCP, PIP and DIP joints: 1,67, 2 and 0. Comparing the means of CPR values in the two groups with Student’s t-test we obtained a statistically significant difference (p=0,023). No other significant differences were found.Conclusion:Despite the limitations and possible statistical bias, the presence of MSUS-defined synovitis grade I and elevated CRP levels could be related to further diagnoses of inflammatory arthropathy. Besides, the absence of synovitis in DIP joints might have a diagnostic role. Normal physical exploration and normal levels of CRP might suggest low MSUS value. However, further research is needed to clarify the role of MSUS-defined synovitis grade I.References:[1]D’Agostino MA et al. Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: definition and development of a standardized, consensus-based scoring system. RMD Open. 2017;3(1):e000428.[2]Van den Berg R et al. What is the value of musculoskeletal ultrasound in patients presenting with arthralgia to predict inflammatory arthritis development? A systematic literature review. Arthritis Research & Therapy (2018) 20:228.Disclosure of Interests:None declared

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AB0115 COMPARISON OF ULTRASOUND FINDINGS BETWEEN TNF INHIBITORS AND NON-TNF INHIBITORS AT FIRST BIOLOGICS IN PATIENTS WITH RHEUMATOID ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1377 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1086.2-1087

Author(s):

T. Okano ◽

T. Koike ◽

K. Inui ◽

K. Mamoto ◽

Y. Yamada ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Disease Duration ◽

Power Doppler ◽

Tnf Inhibitors ◽

Tnf Inhibitor ◽

Significant Difference ◽

The Us ◽

Us Findings ◽

Improvement Ratio

Background:In rheumatoid arthritis (RA), biologics treatment is one of the effective treatment options. Usually, there is no difference in therapeutic effect regardless of which biologics is used, but the effect for joint synovitis is unknown. Recently, ultrasound (US) has played a role of sensitive imaging modality in the diagnosis and follow-up of patients with RA.Objectives:The aim of this study was to compare the improvement of US findings between TNF inhibitors and non-TNF inhibitors at first biologics in patients with RA.Methods:Fifty-four RA patients who started the first biologics from September 2016 to December 2018 were included in this longitudinal study (SPEEDY study, UMIN000028260). All the patients were performed clinical examination, blood test and US examination at baseline, 4, 12, 24, 36 and 52 weeks. A US examination was performed at the bilateral first to fifth metacarpophalangeal (MCP) joints, first interphalangeal (IP) and second to fifth proximal interphalangeal (PIP) joints, wrist joints (three part of radial, medial and ulnar) and first to fifth metatarsophalangeal (MTP) joints, by using HI VISION Ascendus (Hitachi Medical Corporation, Japan) with a multifrequency linear transducer (18-6 MHz). The gray scale (GS) and power Doppler (PD) findings were assessed by the semi-quantitative method (0-3). GS score and PD score (both 0-108 points) were defined as the sum of each score. The change of disease activity and US findings were compared between TNF group and non-TNF group.Results:Among 54 cases, 32 patients were used TNF inhibitor and 22 were non-TNF inhibitor. Age and duration of RA were significantly higher in the non-TNF group, and MTX dose was significantly lower in the non-TNF group. The baseline inflammatory markers tended to be higher in the non-TNF group and the disease activity was also higher in the non-TNF group. However, the US findings showed no significant difference in both GS and PD between two groups at baseline. US improvement ratio was no difference between TNF group and non-TNF group at 4, 12, 24, 36 and 52 weeks in both GS and PD score. Regardless of the type of biologics, patients with long-term disease duration tended to have poor improvement in US synovial fingings.Table 1.Baseline patient and disease characteristicsTNF (n=32)non-TNF (n=22)P valueFemale patients, n (%)21 (65.6)16 (72.7)0.767Age (years)63.5±15.471.0±9.00.030Disease duration (years)6.5±8.213.0±11.70.032CRP (mg/dl)1.8±2.53.0±3.20.170DAS28-ESR5.0±1.45.8±1.20.022GS score26.1±18.831.8±21.10.313PD score17.6±11.423.1±14.60.150Figure 1.GS and PD improvement ratio at 4, 12, 24, 36 and 52 weeksConclusion:There was no difference in the US findings improvement between patients with TNF inhibitor and non-TNF inhibitor at first biologics in patients with RA.References:[1]Grassi W, Okano T, Di Geso L, Filippucci E. Imaging in rheumatoid arthritis: options, uses and optimization. Expert Rev Clin Immunol. 2015;11:1131-46.[2]Nishino A, Kawashiri SY, Koga T, et al. Ultrasonographic Efficacy of Biologic andTargeted Synthetic Disease-ModifyingAntirheumatic Drug Therapy in RheumatoidArthritis From a Multicenter RheumatoidArthritis Ultrasound Prospective Cohort in Japan. Arthritis Care Res (Hoboken). 2018;70:1719-26.Acknowledgements:We wish to thank Atsuko Kamiyama, Tomoko Nakatsuka for clinical assistant, Setsuko Takeda, Emi Yamashita, Yuko Yoshida, Rika Morinaka, Hatsue Ueda and Tomomi Iwahashi for their special efforts as a sonographer and collecting data.Disclosure of Interests:None declared

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POS1021 THE PsABio STUDY IN ITALY: A REAL-WORLD COMPARISON OF THE PERSISTENCE, EFFECTIVENESS AND SAFETY OF USTEKINUMAB AND TUMOUR NECROSIS FACTOR INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.81 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 778-779

Author(s):

E. Gremese ◽

F. Ciccia ◽

C. Selmi ◽

G. Cuomo ◽

R. Foti ◽

...

Keyword(s):

Adverse Event ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Tumour Necrosis Factor ◽

Tumour Necrosis ◽

Research Support ◽

Treatment Persistence ◽

Low Disease Activity ◽

Necrosis Factor

Background:There are still unmet needs in the treatment of psoriatic arthritis (PsA), including in terms of treatment persistence, which is a function of effectiveness, safety and patient satisfaction. Ustekinumab (UST) was the first new biologic drug to be developed for the treatment of PsA after tumour necrosis factor inhibitors (TNFi).Objectives:To compare treatment persistence, effectiveness and safety of UST and TNFi in Italian patients within the PsABio cohort.Methods:PsABio (NCT02627768) is an observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. The current analysis set includes 222 eligible patients treated in 15 Italian centres, followed to Month 12 (±3 months). Treatment persistence/risk of stopping was analysed using Kaplan−Meier (KM) and Cox regression analysis. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation of effectiveness endpoints if treatment was stopped/switched before 1 year. Last observation carried forward data are reported.Results:Of patients starting UST and TNFi, 75/101 (74.3%) and 77/121 (63.6%), respectively, persisted with treatment at 1 year. The observed mean persistence was 410 days for UST and 363 days for TNFi. KM curves and PS-adjusted hazard ratios confirmed significantly higher persistence (hazard ratio [95% confidence interval (CI)]) for UST versus TNFi overall (0.46 [0.26; 0.82]; Figure 1). Persistence was also higher for UST than TNFi in patients receiving monotherapy without methotrexate (0.31 [0.15; 0.63]), in females (0.41 [0.20; 0.83]), and in patients with body mass index (BMI) <25 kg/m2 (0.34 [0.14; 0.87]) or >30 kg/m2 (0.19 [0.06; 0.54]). There was no significant difference in persistence between treatments in patients with BMI 25−30 kg/m2. While patients receiving 1st- and 3rd-line UST or TNFi showed similar risk of discontinuation (0.60 [0.27; 1.29] and 0.36 [0.10; 1.25], respectively), patients receiving 2nd-line UST showed better persistence than those receiving 2nd-line TNFi (0.33 [0.13; 0.87]). Other factors added to the PS-adjusted Cox model did not show significant effects. In patients with available follow-up data, the mean (standard deviation) baseline cDAPSA was 26.3 (15.4) for UST and 23.5 (12.3) for TNFi; at 1-year follow-up, 43.5% of UST- and 43.6% of TNFi-treated patients reached cDAPSA LDA/remission. MDA was reached in 24.2% of UST- and 28.0% of TNFi-treated patients, and VLDA in 12.5% of UST- and 10.2% of TNFi-treated patients. After PS adjustment (stoppers/switchers as non-responders), odds ratios (95% CI) at 1 year did not differ significantly between UST and TNFi groups for reaching cDAPSA LDA/remission (1.08 [0.54; 2.15]), MDA (0.96 [0.45; 2.05]) or VLDA (0.98 [0.35; 2.76]). In total, 23 (20.4%) patients reported ≥1 treatment emergent adverse event with UST and 30 (22.2%) with TNFi; 6 (5.3%) and 10 (7.4%) patients, respectively, discontinued treatment because of an adverse event.Conclusion:In the Italian PsABio cohort, UST had better overall persistence compared with TNFi, as well as in specific subgroups: females, patients on monotherapy without methotrexate, with BMI <25 or >30 kg/m2, and patients receiving UST as 2nd-line treatment. At 1 year, both treatments showed similar effectiveness, as measured by cDAPSA responses and MDA/VLDA achievement.Acknowledgements:This study was funded by Janssen. Contributing author: Prof. Piercarlo Sarzi-Puttini, ASST Fatebenefratelli-Sacco, University of Milan, ItalyDisclosure of Interests:Elisa Gremese: None declared, Francesco Ciccia Speakers bureau: AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Consultant of: Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Grant/research support from: Celgene, Janssen, Novartis, Pfizer, Roche, Carlo Selmi Speakers bureau: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Consultant of: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, Giovanna CUOMO: None declared, Rosario Foti Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Actelion, Biogen, Janssen, Lilly, Consultant of: Chemomab, Grant/research support from: MSD, Fabrizio Conti Consultant of: AbbVie, Bristol-Myers Squibb, Galapagos, Lilly, Pfizer, Enrico Fusaro Speakers bureau: AbbVie, Amgen, Lilly, Grant/research support from: AbbVie, Pfizer, Giuliana Guggino Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, Sandoz, Grant/research support from: Celgene, Pfizer, Florenzo Iannone Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Andrea Delle Sedie: None declared, Roberto Perricone: None declared, Luca Idolazzi Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Sandoz, Paolo Moscato: None declared, Elke Theander Employee of: Janssen, Wim Noel Employee of: Janssen, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Silvia Marelli Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche.

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AB0546 5 YEARS FOLLOW-UP OF PSORIATIC ARTHRITIS PATIENTS TREATED ACCORDING TREAT-TO-TARGET STRATEGY. PRELIMINARY RESULTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1985 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1306.1-1306

Author(s):

P. Tremaskina ◽

E. Loginova ◽

T. Korotaeva ◽

S. Glukhova ◽

A. Lila

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Standard Care ◽

Early Stage ◽

Treat To Target ◽

Moderate Activity ◽

Long Term Outcomes ◽

Mean Values

Background:The concept of treat to target (T2T) in psoriatic arthritis (PsA) has been established recently and already shown its benefits [1]. But the long-term outcomes of the T2T have not been studied yet.Objectives:To study 5 years (yrs) follow-up of PsA patients (pts) treated according to T2T strategy at the early stage.Methods:35 (M/F–17/18) PsA pts fulfilling CASPAR criteria, who were treated according to T2T strategy at the early stage (PsA duration≤2 yrs) within 24 months (mos) were analyzed. At the time of evaluation mean age is 42.7±11.2 yrs, median (Me) PsA duration 72 [60;95] mos, psoriasis duration 120 [88;180] mos. All pts underwent standard clinical examinations of PsA before started T2T therapy and at follow-up. Within 24 mos of T2T strategy all pts were taking Methotrexate (MTX) monotherapy in increasing dose up to 25 mg/wk and 18 out of 35 (51%) pts received MTX in combination with iTNF. When T2T study was stopped all pts were treated according to standard care with NSAIDs, bDMARDs, MTX, tsDMARDs based on PsA activity and physician decision. The number of pts achieved minimal disease activity (MDA, 5 of 7) and remission by DAPSA (≤4)/low disease activity (LDA)≤14) at the 24 mos of T2T strategy and at 5 yrs follow-up were calculated. The results are presented in the form of mean values, median, upper and lower quartiles.Results:Me duration of follow-up is 68 [53.5;81.5] mos. At 24 mos Me DAPSA 3.48 [0.45;21.76], remission by DAPSA (REM-DAPSA) were seen in 20 out of 35 (57%) pts, LDA-DAPSA in 4 (12%) pts, moderate activity (MoA) by DAPSA in 6 (17%) pts and high disease activity by DAPSA (HDA-DAPSA) in 5 (14%) pts. MDA was noted in 21 out of 35 (60%) pts. At 5 yrs Me DAPSA 7.4 [2.22;13.87], REM-DAPSA was noted in 12 (34%) pts, LDA-DAPSA in 14 (40%), MoA-DAPSA in 5 (14%), HDA-DAPSA in 4 (12%) pts. MDA was observed in 17 of 35 pts (49%). Among 20 pts who had REM-DAPSA at 24 mos only 6 pts (30%) remained in remission at 5 yrs follow-up and 12 out of 21 pts (57.14%) remained in MDA status.Conclusion:In early PsA pts remission and MDA are achievable goal of T2T strategy. But most pts lost remission/MDA after this strategy was changed to a standard care, despite being in remission/MDA status before change of therapy. Further investigations of the long-term outcomes of T2T strategy in PsA, including radiographic outcomes are needed.References:[1]Coates LC, Moverley AR, McParland L, et al. Lancet 2015; 386: 2489–98.Disclosure of Interests:None declared.

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