Relationship between shoulder ultrasound findings and disease activity in patients with rheumatoid arthritis: A pilot study

Objectives: The aim of this study was to investigate whether shoulder ultrasound (US) findings were associated with disease activity and pain level in rheumatoid arthritis (RA) patients. Patients and methods: Between April 2019 and November 2019, a total of 60 shoulders of 30 female patients with RA (mean age: 53.8±12.0 years; range, 30 to 65 years) were included. The patients were questioned about shoulder pain and their Disease Activity Score-28 (DAS28) was estimated. After clinical examination with shoulder impingement tests, both shoulders were evaluated by US. Results: Of 60 shoulders examined by shoulder US, the most common shoulder pathology was supraspinatus tendinopathy (n=33, 55%). The prevalence of subdeltoid bursitis on US was significantly higher in the group with moderate disease activity, compared to the group with low disease activity (p<0.05). There were no significant differences in the physical examination findings of patients with low and moderate disease activity. In terms of US findings, subscapularis tendinopathy, glenohumeral joint and acromioclavicular joint degeneration, and subacromial bursitis were more common in shoulders with a history of pain, compared to non-painful shoulders. Conclusion: Shoulder US may be useful for demonstrating shoulder involvement in patients with RA, independent of the presence of shoulder pain.

Effectiveness and Safety of Subcutaneous Abatacept in Biologic-Naïve RA Patients at Week 52: A Japanese Multicenter Investigational Study (ORIGAMI Study)

Objectives To evaluate the effectiveness and safety of abatacept over 52 weeks in biologic-naïve rheumatoid arthritis (RA) patients with moderate disease activity in the prospective, 5-year, observational study (ORIGAMI study) in Japan. Methods Abatacept 125 mg was administered subcutaneously once a week. Clinical outcomes included Simplified Disease Activity Index (SDAI) remission at Week 52 (primary endpoint), Japanese Health Assessment Questionnaire (J-HAQ), EuroQol 5-Dimension (EQ-5D), treatment retention, and safety. Results were compared with those of csDMARD controls from the ongoing Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry. Results Overall, 325 patients were enrolled, with a mean age of 66.9±12.7 years. The proportion of patients achieving SDAI remission (≤3.3) at Week 52 was 18.9% (95% CI: 14.3–23.6) and low disease activity (≤11) was 53.3% (95% CI: 47.4–59.1). A significant improvement was observed in J-HAQ and EQ-5D over 52 weeks in both the abatacept and csDMARD groups. The probability of abatacept treatment retention at Week 52 was 69.9% (95% CI: 64.7–75.5). AEs and serious AEs were reported in 50.0% and 12.1% of patients, respectively. Conclusions Abatacept significantly improved disease activity, physical disability, and quality of life for up to 52 weeks in RA patients in a real-world setting.

AB0272 CAN NONSTEROIDAL ANTI-INFLAMMATORY DRUGS CONTROL THE SYMPTOMS OF MODERATE RHEUMATOID ARTHRITIS?

Objectives:to evaluate the efficacy of long-term pain therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with rheumatoid arthritis (RA) with an initially moderate disease activity (DAS 28 <5,1).Methods:the study included 404 RA patients, disease duration was more than 1 year, mean DAS 28 3.7±1.6, mean age 58.6±10.0 years, 69% women, 76,7% RF “+”, 81,5% ACPA “+”. 91,2% of the patients received conventional DMARDs (methotrexate), 8,8% - biological agents. All patients received NSAIDs (aceclofenac) to control their symptoms. Тhe follow-up period was 6 months. We evaluated the dynamics of the DAS 28 index, the level of pain and patient global health on a 100- mm visual analog scale (VAS).Results:the level of pain (VAS) decreased from 63,1 ± 15,4 to 46,3± 8,3 (p=0,001) by 3 months of follow-up and up to 39,5± 11,2 (p= 0,001) by 6 months of follow-up. The patient global health (VAS) also improved from 58,2 ± 13,4 at baseline to 40,3 ± 11,2 (p=0,001) at 3 months and to 35,5 ± 9,7 (p=0,001) at 6 months of follow up. The mean DAS 28 remained within the moderate disease activity and decreased from 3,7±1,5 to 3,4 ±1,1 (p=0,01) after 3 months, and to 3,1± 0,9 (p=0,01) after 6 months.Conclusion:long-term NSAID therapy allows to control the disease activity in patients with moderate RA. This should be taken into account when planning therapy, including deciding whether to “switch” DMARDs and prescribing biological agents.Disclosure of Interests:None declared

OP0298 ARE PATIENTS WITH PSORIATIC ARTHRITIS BEING TREATED OPTIMALLY ACROSS THE WORLD? DISPARITIES IN HEALTH CARE FOR PATIENTS WITH PSORIATIC ARTHRITIS ACROSS COUNTRIES WITH DIFFERENT GDP’S, AN ANALYSIS OF 429 PATIENTS FROM 13 COUNTRIES

Background:In psoriatic arthritis (PsA), EULAR recommendations are to aim for remission or low disease activity(1). Many treatments are now available, though some are costly and not widely available in all countries. Country of patient care, and in particular Gross Domestic Product (GDP) may be linked to PsA outcomes(2). Although patients with high disease activity are eligible for targeted therapies such as biologic disease-modifying anti-rheumatic drugs (bDMARDs), they may not be able to get the benefits from these efficacious treatments in all countries equally.Objectives:The objective was to explore the rate of PsA patients with high to moderate disease activity, not receiving bDMARDs across countries, and to assess the consequences on functional incapacity.Methods:This was a cross-sectional analysis of an observational study (ReFlap, NCT03119805)(3), which included adult patients with PsA with ≥ 2 years disease duration from 14 countries. One country was excluded from this analysis since only 7 patients were included. We explored the rate of patients with significant disease activity (i.e based on DAPSA > 14) and no ongoing bDMARD prescription. Countries of inclusion were analysed separately, and classified into tertiles by GDP/capita (lowest tertile: Brazil, Turkey, Russia, Romania, Estonia; middle tertile: Spain, Italy, UK, France; highest tertile: Canada, Germany, USA and Singapore). The rate of no bDMARDs - DAPSA > 14 patients was analysed by country and compared between the 3 tertiles of GDP/capita by parametric tests. Functional capacity (HAQ) was compared between no bDMARDs - DAPSA > 14 patients and the other patients (pooling patients with moderate or high disease activity with bDMARD, low disease activity and remission with or without bDMARD). There was no imputation of missing data.Results:Of the 459 patients, 429 had complete data available and were analysed: mean age 52.3 (SD 12.6) years, mean disease duration 10.2 (SD 8.2) years, 215 (50.1%) males. The rate of no bDMARDs - DAPSA > 14 patients was 18.4% (76/414). The rate ranged from 7.4% (UK and Spain) to 40% (Russia): Figure 1. A link was seen with the country and the tertiles of countries according to GDP/capita, with higher rate of no bDMARDs - DAPSA > 14 patients in the lowest GDP/capita countries (28.8%, 15.3% and 14.3% in the 3 GDP/capita tertiles, respectively, p=0.005; Figure 1). Of note, 40/76 no bDMARDs - DAPSA > 14 patients received a treatment intensification during the visit. Among no bDMARDs - DAPSA > 14 patients, functional incapacity was higher than in the other patients, as expected (mean HAQ 0.96 (SD 0.64) vs 0.57 (SD 0.63), p<0.001).Figure 1.The size of the bubbles represent the number of patients per country (range, 13 to 89). The horizontal lines represent the mean proportion of patients with no bDMARDs – DAPSA > 14 for each tertiles of countries by GDP/capita.Conclusion:In this exploratory comparison of disease patterns and treatments choices in 13 countries, we observed that more PsA patients with high or moderate disease activity and living in low GDP/capita countries were less likely to be treated with bDMARDs. As a consequence, no bDMARDs – DAPSA > 14 patients had worse functional incapacity. Equitable access to bDMARDs should be aimed for all patients regardless of their country of origin.References:[1]Gossec L et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712.[2]Gossec L et al. Are There Country Differences in Disease Activity and Life Impact of Psoriatic Arthritis? An Analysis of 436 Patients from 14 Countries [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).[3]Gorlier C et al. Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries. Ann Rheum Dis. 2019 Feb;78(2):201-208.Disclosure of Interests:None declared.

Clinical course and seroprevalence of COVID-19 in children with rheumatic diseases. Cross-sectional study from a reference centre in Spain.

Background Patients with rheumatic diseases have been considered at risk of COVID-19. A significant percentage of infections in children are asymptomatic or mild and can go unnoticed. This study aims to describe the seroprevalence of SARS-CoV-2 in a cohort of children with rheumatic diseases and assess possible risk factors. Methods: A cross-sectional study was performed in a pediatric rheumatology unit from a reference hospital in Madrid, from September 2020 to February 2021. Serology of SARS-CoV-2 was performed at the same time as their routine laboratory tests, and a specific questionnaire was completed by parents. Demographics, treatment and disease activity from laboratory-confirmed COVID-19 patients were compared to the data of patients without laboratory-confirmed COVID-19.Findings A total of 105 children were included. SARS-CoV-2 infection was demonstrated in 27 patients (25.7%): 6 PCR and 21 positive IgG serology. The mean age was 11.8 years , and the majority of the patients were females (72.4%). Most of the children were diagnosed with juvenile idiopathic arthritis (JIA) (70.3%; 19/27), followed by PFAPA (11.1%; 3/27). Immunosuppresive treatment was given in 88% of cases (24/27). Overall, 44.4% (12/27) of infected patients were asymptomatic. Three patients required hospital admission because of COVID-19, however none of them required oxygen supplementation. A total of 66.7% (18/27) of patients did not require any treatment or medical assistance. The seroprevalence in our cohort was 20% in contrast to the 7.7% population seroprevalence observed during the same study period in Spanish children. SARS-CoV-2 confirmed children with positive IgG or PCR were less frequently in remission (52% vs 72%; p 0.014). Moderate disease activity and treatment with oral corticosteroids were associated with higher risk for COVID-19 (OR 5.05; CI 95%: 1.56 - 16.3 and OR 4.2; CI 95%: 1.26 - 13.9 respectively). Conclusions In a cohort of pediatric patients with rheumatic disease and immunosuppressive therapy, moderate disease activity and oral corticosteroids were associated with COVID-19 positive patients. Seroprevalence was significantly higher compared to the same age healthy population. The clinical manifestations were mild and there were no severe infections among the patients.

P127 Treating rheumatoid arthritis patients with moderate disease activity: an analysis of the upadacitinib SELECT Phase III randomised studies

Background/Aims Some health systems restrict use of advanced therapies for rheumatoid arthritis (RA) to patients with high disease activity (DAS28&gt;5.1). Upadacitinib (UPA), a selective JAK inhibitor, has demonstrated significant improvement in patients with moderate-to-severe RA. We aimed to explore the efficacy and safety of UPA in RA patients with moderate disease activity. Methods This was a post-hoc, subgroup analysis from three phase 3 registrational trials evaluating once daily UPA 15mg versus placebo (PBO) in patients with moderate (DAS28(CRP)&gt;3.2, ≤5.1) and high (DAS28(CRP)&gt;5.1) disease activity. Patients had prior inadequate response to csDMARDs (SELECT-COMPARE and SELECT-NEXT integrated analysis) or bDMARDs (SELECT-BEYOND). Clinical and functional outcomes were analysed at the studies primary endpoint (Week12). Missing data were handled using non-responder imputation for binary endpoints and mixed-effect model repeat measurement for continuous variables. Results Across all three studies mean baseline DAS28(CRP) was ∼4.5 and ∼6.2 in moderate and severe patients, respectively. At Week 12 significantly greater proportions of csDMARD-inadequate responder (IR) and bDMARD-IR patients receiving UPA 15 mg achieved ACR20, low disease activity (DAS28(CRP)≤3.2) and remission (DAS28(CRP)&lt;2.6) compared to PBO in both disease severity subgroups (Table 1). Improvement in physical function assessed by Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ-DI) and pain visual analogue scale (VAS) were significantly greater with UPA 15mg vs PBO for severe csDMARDs-IR and bDMARD-IR populations and numerically greater in moderate bDMARD-IR patients. Across all IR populations higher proportions of patients with moderate disease treated with UPA 15mg achieved DAS28(CRP)≤3.2 and DAS28(CRP)&lt;2.6 compared to those with severe disease. The safety profile of UPA in moderate and severe patients was comparable and consistent with previously published data. Conclusion UPA 15mg was effective in improving clinical, functional, and patient reported outcomes in patients with either moderate or severe RA. P127 Table 1:Baseline characteristics and efficacy endpoints at week 12 from SELECT-NEXT, -COMPARE and -BEYONDTimepointKey EndpointscsDMARD IR (SELECT COMPARE and SELECT NEXT integrated)ModerateSevereUPA 15mg (n = 209)PBO (n = 195)UPA 15mg (n = 649)PBO (n = 671)BaselineAge (yrs; Mean ± SD)53.7 ± 12.654.5 ± 12.454.9 ± 11.654.1 ± 12.3Duration since diagnosis (yrs; Mean ± SD)7.5 ± 7.47.3 ± 6.78.0 ± 7.98.2 ± 8.2DAS28(CRP) (Mean ± SD)4.6 ± 0.44.6 ± 0.46.2 ± 0.76.1 ± 0.7HAQ-DI (Mean ± SD)1.2 ± 0.61.2 ± 0.61.7 ± 0.61.7 ± 0.6Pain VAS (0-100) (Mean ± SD)52.5 ± 21.448.4 ± 21.669.8 ± 18.268.9 ± 17.9Week 12ACR20 (% response, 95% CI)63.6 (57.1, 70.2)***33.8 (27.2, 40.5)71.2 (67.7, 74.7)***37.0 (33.3, 40.6)DAS28 (CRP) ≤3.2, (% response, 95% CI)61.7 (55.1, 68.3)***28.7 (22.4, 35.1)40.7 (36.9, 44.5)***10.3 (8.0, 12.6)DAS28 (CRP) ≤2.6, (% response, 95% CI)41.4 (34.5, 47.8)***14.9 (9.9, 19.9)25.1 (21.8, 28.5)***4.6 (3.0, 6.2)ΔHAQ-DI (mean, 95% CI)-0.43 (-0.51, -0.35)***-0.23 (-0.32, -0.15)-0.67 (-0.72, -0.61)***-0.31 (-0.36, -0.25)Δ Pain VAS (0-100) (% response, 95% CI)-25.0 (-28.6, -21.4)***-7.0, (-10.6, -3.2)-32.8 (-35.1, -30.5)***-16.1 (-18.4, -13.8)TimepointKey EndpointsbDMARD IR (SELECT-BEYOND)ModerateSevereUPA 15mg (n = 39)PBO (n = 38)UPA 15mg (n = 124)PBO (n = 128)BaselineAge (yrs; Mean ± SD)56.1 ± 11.157.7 ± 13.456.4 ± 11.557.6 ± 10.9Duration since diagnosis (yrs; Mean ± SD)13.6 ± 10.014.7 ± 9.411.9 ± 9.214.6 ± 9.3DAS28(CRP) (Mean ± SD)4.7 ± 0.34.4 ± 0.56.2 ± 0.86.2 ± 0.7HAQ-DI (Mean ± SD)1.4 ± 0.71.1 ± 0.51.8 ± 0.61.7 ± 0.6Pain VAS (0-100) (Mean ± SD)58.1 ± 22.449.8 ± 22.271.3 ±74.5 ±Week 12ACR20 (% response, 95% CI)61.5 (46.3, 76.8)*36.8 (21.5, 52.2)66.1 (57.8, 74.5)***26.6 (18.9, 34.2)DAS28 (CRP) ≤3.2, (% response, 95% CI)64.1 (49.0, 79.2)**28.9 (14.5, 43.4)36.3 (27.8, 44.8)***9.4 (4.3, 14.4)DAS28 (CRP) ≤2.6, (% response, 95% CI)43.6 (28.0, 59.2)*21.1 (8.1, 34.0)24.2 (16.7, 31.7)***6.3 (2.1, 10.4)ΔHAQ-DI (mean, 95% CI)-0.24 (-0.41, -0.07)-0.12 (-0.30, 0.05)-0.47 (-0.56, -0.37)***-0.18 (-0.28, -0.08)Δ Pain VAS (0-100) (% response, 95% CI)-16.8 (-25.4, -8.1)-5.4 (-14.3, 3.4)-28.7 (-33.5, -24.0)***-12.2 (-17.0, -7.3)*p ≤ 0.05;**p ≤ 0.01;***p ≤ 0.001 for comparison of UPA versus PBO. Disclosure P.G. Conaghan: Other; P.C. has been a consultant or speaker for AbbVie, BMS, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer. K. Pavelka: Other; K.P. has received honoraria for consultations and lectures from AbbVie, Roche, Pfizer, MSD, Sanofi, UCB and Amgen. S. Hsieh: None. T. Bonnington: Other; T.B. is an employee at AbbVie Limited. T.C. Kent: Other; T.C. is an employee at AbbVie Limited. C.J. Edwards: Other; C.E. has received honoraria, advisory boards, speakers bureau, research support from AbbVie, BMS, Biogen, Fresenius, Gilead Janssen, Lilly, Pfizer, MSD, Novartis, Roche, Samsung, Sanofi, UCB.

Serum progranulin level is associated with disease activity following orthopedic surgery in rheumatoid arthritis patients

Background Few studies have focused on the ability of progranulin to predict postoperative disease activity in rheumatoid arthritis (RA) patients who have undergone surgery. This study evaluated serum progranulin levels in active RA patients and analyzed its relationship with postoperative disease activity. Methods One hundred thirty-two patients with active RA and 72 healthy subjects were included in this study. Serum progranulin was measured, and clinical data were collected. The postoperative 1-year Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) scores was evaluated as an indicator of disease activity. The predictive value of progranulin in postoperative 1-year disease activity in RA patients was also analyzed. Results Serum progranulin was significantly associated with the postoperative 1-year RA disease activity. The mean serum progranulin level in patients with a high disease activity was significantly higher than that of RA patients with low-to-moderate disease activity (54.2 ± 10.6 ng/mL vs. 46.7 ± 8.8 ng/mL). Serum progranulin was also evaluated as an independent predictive factor for postoperative 1-year RA disease activity in multivariate analysis (odds ratio [OR], 2.21; 95% confidence interval [CI], 1.02–8.85). Conclusions Serum progranulin levels may be a promising indicator of postoperative disease activity in RA patients who underwent orthopedic surgery.

Factors associated with disability in patients with rheumatoid arthritis with persistent moderate disease activity: a retrospective cohort study

Background Many patients with rheumatoid arthritis (RA) do not attain remission/low disease activity, remaining in a moderate disease activity state (MDAS) with ongoing disability and impaired quality of life (QoL). If patients in persistent MDAS with poor future outcomes could be prospectively identified, they could arguably be treated more intensively. We evaluated baseline factors predicting function (Health Assessment Questionnaire-Disability Index [HAQ-DI] scores) and QoL (3-level EuroQol-5 dimensions questionnaire [EQ-5D-3L] index scores) at 12 months in patients with RA in persistent MDAS in a real-world setting. Methods Patients with persistent MDAS (Disease Activity Score for 28-joint count based on erythrocyte sedimentation rate [DAS28-ESR] 3.2–5.1 on at least two consecutive outpatient appointments over 12 months) were identified retrospectively from Guy’s Hospital RA Centre and analysed in two groups: (1) biologic naïve at baseline or (2) receiving/ever received biologics. The baseline timepoint was the second-visit MDAS DAS28-ESR score; the endpoint was the closest visit to 12 months. Linear regression analyses evaluated relationships between baseline variables and (1) 12-month HAQ-DI scores, (2) 12-month rank-transformed EQ-5D-3L index scores, (3) 12-month changes in HAQ-DI scores, and (4) 12-month changes in EQ-5D-3L index scores. Results The analysis included 207 biologic-naïve and 188 biologic-experienced patients. All patients had moderate disability (mean HAQ-DI 1.21 and 1.46) and impaired QoL (mean EQ-5D-3L index scores 0.52 and 0.50). Many reported moderate/severe pain (93 and 96%) and showed little change in HAQ-DI and EQ-5D-3L index scores over 12 months. In both biologic-naïve and biologic-experienced groups, multivariate analysis revealed a significant association between baseline HAQ-DI scores and endpoint HAQ-DI scores (β = 0.67, P < 0.001 and β = 0.76, P < 0.001, respectively), 12-month changes in HAQ-DI scores (both β = − 0.21, P < 0.001), and 12-month EQ-5D-3L index scores (β = − 0.57, P < 0.001 and β = − 0.29, P = 0.004, respectively). Baseline EQ-5D-3L index scores were significantly associated with 12-month changes in EQ-5D-3L index scores in both groups (β = − 0.73, P < 0.001 and β = − 0.40, P = 0.003, respectively). Conclusions Patients with RA in persistent MDAS experience substantial ongoing physical disability, poor QoL, and pain. HAQ-DI is an important predictor of future disability and reduced QoL, supporting current national recommendations to measure HAQ-DI in routine care.

Rheumatoid arthritis patients on persistent moderate disease activity on biologics have adverse 5-year outcome compared to persistent low-remission status and represent a heterogeneous group

Background The long-term outcome of rheumatoid arthritis (RA) patients who in clinical practice exhibit persistent moderate disease activity (pMDA) despite treatment with biologics has not been adequately studied. Herein, we analyzed the 5-year outcome of the pMDA group and assessed for within-group heterogeneity. Methods We included longitudinally monitored RA patients from the Hellenic Registry of Biologic Therapies with persistent (cumulative time ≥ 50% of a 5-year period) moderate (pMDA, 3.2 < DAS28 ≤ 5.1) or remission/low (pRLDA, DAS28 ≤ 3.2) disease activity. The former was further classified into persistent lower-moderate (plMDA, DAS28 < 4.2) and higher-moderate (phMDA, DAS28 ≥ 4.2) subgroups. Five-year trajectories of functionality (HAQ) were the primary outcome in comparing pRLDA versus pMDA and assessing heterogeneity within the pMDA subgroups through multivariable mixed-effect regression. We further compared serious adverse events (SAEs) occurrence between the two groups. Results We identified 295 patients with pMDA and 90 patients with pRLDA, the former group comprising of plMDA (n = 133, 45%) and phMDA (n = 162, 55%). pMDA was associated with worse 5-year functionality trajectory than pRLDA (+ 0.27 HAQ units, CI 95% + 0.22 to + 0.33; p < 0.0001), while the phMDA subgroup had worse 5-year functionality than plMDA (+ 0.26 HAQ units, CI 95% 0.18 to 0.36; p < 0.0001). Importantly, higher persistent disease activity was associated with more SAEs [pRLDA: 0.2 ± 0.48 vs pMDA: 0.5 ± 0.96, p = 0.006; plMDA: 0.32 ± 0.6 vs phMDA: 0.64 ± 1.16, p = 0.038]. Male gender (p = 0.017), lower baseline DAS28 (p < 0.001), HAQ improvement > 0.22 (p = 0.029), and lower average DAS28 during the first trimester since treatment initiation (p = 0.001) independently predicted grouping into pRLDA. Conclusions In clinical practice, RA patients with pMDA while on bDMARDs have adverse long-term outcomes compared to lower disease activity status, while heterogeneity exists within the pMDA group in terms of 5-year functionality and SAEs. Targeted studies to better characterize pMDA subgroups are needed, in order to assist clinicians in tailoring treatments.