POS1067 BASELINE VITAMIN D LEVELS AND DISEASE ACTIVITY AND RESPONSE IN PORTUGUESE PATIENTS WITH PSORIATIC ARTHRITIS UNDER bMDARD: DOES IT MAKE A DIFFERENCE?

Background:There is growing evidence that vitamin D [25(OH)D]) plays an important role in maintaining skeletal health and modulating the immune system. Epidemiological data indicate that vitamin D deficiency is common in immune-mediated rheumatic diseases, especially in rheumatoid arthritis, but there is little data regarding its association with disease activity and response to therapy in patients with psoriatic arthritis (PsA) under bDMARD therapy.Objectives:We aimed to assess whether 25(OH)D basal levels correlate with disease activity and clinical response to the first bDMARD, at 6 and 12 months of therapy, in a monocentric cohort of patients with PsA.Methods:This retrospective study was carried out on PsA patients from a Rheumatology department of a tertiary hospital, fulfilling CASPAR criteria and registered in our national database (Reuma.pt), who started the first bDMARD since 2008. Demographic, clinical and laboratory criteria were evaluated at 0, 6 and 12 months of biologic therapy. Disease activity was assessed using CDAI, SDAI, DAS28(4V), BASDAI, ASDAS, DAPSA and the response was measured using the EULAR, BASDAI50, ASDAS, ASAS, ACR and PsARC responses. Correlations were made between absolute serum levels of 25(OH)D and continuous variables, as well as associations between different vitamin D cutoffs and disease activity measures and response criteria. Multiple linear and logistic regression analyses were performed to determine whether vitamin D is a predictor of disease activity and therapeutic response.Results:We included 81 patients, 41 (50.6%) females; with a mean age of 48.0±11.7 years, a mean disease duration of 9.5±7.4 years and a mean body mass index of 28.4±5.2 kg/m2. Thirteen (16.0%) were smokers. The mean 25(OH)D basal level was 25.5±13.2 ng/ml, 21 (25.9%) had 25(OH)D basal levels ≥30 ng/mL and 31 (38.3%) ≤20 ng/mL. Sixty-two patients (76.5%) were under csDMARD therapy. Golimumab (29, 35,8%), etanercept (28, 34.6%) and adalimumab (10, 12.3%) were the most frequently prescribed bDMARDs. There were only very weak, albeit positive, correlations between 25(OH)D levels and measures of disease activity. The BASDAI50 response at 6 months was associated with higher basal 25(OH)D levels (29.5±14.5 vs 21.5±10.2 ng/mL, p = 0.013); the ASAS20 (33.9±15.9 vs 24.2±12.8 ng/mL; p = 0.023), ASAS40 (31.9±14.6 vs 25.0±13.8 ng/mL; p = 0.023) and ASAS70 (47.0±4.2 vs 26.6±14.2; p = 0.027) responses at 12 months were associated with higher basal levels of 25(OH)D; basal 25(OH)D levels were ≥ 30ng/mL in a significantly higher proportion of patients who achieved CDAI (38.9% vs 10.5%; p = 0.027) and SDAI (38.9% vs 7.7%; p = 0.008) remission and ASDAS disease inactive (29.4% vs 7.3%; p = 0.040) at 1 year. In the regression models, basal levels of 25(OH)D were found to be predictors of good EULAR responders (OR 1.315, 1.017-1.213 95% CI; p = 0.037) at 6 months. Basal levels of 25(OH)D were not significantly different in patients who discontinued bDMARD and no significant correlations or associations were identified regarding more specific PsA activity measures, such as DAPSA and PsARC, nor were they predictive of these responses.Conclusion:We can conclude that there is a global trend for an association between higher levels of vitamin D and lower measures of disease activity and better therapeutic responses to the first biologic. It was possible to find statistically significant associations with some disease activity measures and response criteria that, although primarily designed for other rheumatic diseases, are often used in PsA.Disclosure of Interests:None declared.

POS0188 DISEASE ACTIVITY OUTCOME MEASURES ARE ONLY AVAILABLE IN HALF OF THE ELECTRONIC MEDICAL FILES OF PATIENTS WITH AXIAL SPONDYLOARTHRITIS FOLLOWED IN AN OUTPATIENT CLINIC: THE RESULTS OF AN AUDIT OF A TERTIARY-CARE RHEUMATOLOGY DEPARTMENT.

Background:Current recommendations for management of patients with axial Spondylarthritis (axSpA) include regular collection of validated disease activity outcomes.Objectives:This study aimed at evaluating the proportion of patients for whom the elements allowing the calculation of the validated outcome measures were available on the visits reported on the electronic medical records (EMR) and the factors associated with the presence of such information on the EMR.Methods:This was a cross-sectional and monocentric observational study conducted in a tertiary-care rheumatology department, EULAR center of excellence and ASAS center. We performed a systematic electronic search among all patients with a SpA diagnosis code who attended an outpatient visit between February 1st, 2018 and February 28th, 2019. Thereafter, a manual search was performed in order to check whether disease activity outcome measures (or the elements allowing its calculation): BASDAI individual questions, Disease activity Global, CRP, BASDAI and ASDAS) were reported on EMR. Patient’s and physician’s demographics disease characteristics (including treatment) and whether the patient had participated in a systematic review were also collected. A descriptive analysis of the percentage of EMR with available outcomes was performed, and the characteristics of patients in whom these measures were available/were not available evaluated by univariable and multivariable analysis (including only variables with p < 0,10 on the univariate)Results:320 EMR of axSpA patients seen in the outpatient clinic were screened and selected. Among them, 178 (55.6%) had at least one disease activity outcome measure reported, while 144(45%) and 123 (38.4%) had a BASDAI and an ASDAS reported, respectively. The most frequently reported disease activity items were duration of morning stiffness (n=230, 72%) and CRP (n=224, 70%).Only previous participation on an educational program for self-assessment was found to be independently associated with a reported disease activity outcome: among the patients participating in such program, 93.1% (n=27/29) had a disease activity measure available, compared to 51.9% (n=151/291) in those who did not participate in such program (p<0.001) (Table 1)Conclusion:Implementation of recommendations with regard to regularly collecting disease activity outcome measures is not optimal. The participation in educational programs including self-assessment educational programs might be one of the keys to improve such implementation.References:[1]Smolen JS, Braun J, Dougados M, Emery P, Fitzgerald O, Helliwell P, et al. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force. Ann Rheum Dis 2014;73:6–16. https://doi.org/10.1136/annrheumdis-2013-203419.[2]van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis 2017;76:978–91. https://doi.org/10.1136/annrheumdis-2016-210770.Figure 1.Frequency of disease activity measures reporting in the Electronic Medical Record of patients with axial Spondyloarthritis, followed in a tertiary care rheumatology department outpatient clinicTable 1.Factors associated with the presence of a reported disease activity measures on the electronic medical file of patients with axial SpADisclosure of Interests:Elodie Portier: None declared, Maxime Dougados: None declared, Christian Roux: None declared, Anna Moltó Consultant of: Abbvie, BMS, MSD, Pfizer, Lilly, UCB Novartis, Grant/research support from: Pfizer

POS0086 ANALYSIS OF DISEASE ACTIVITY MEASURES IN THE CONTEXT OF A METHOTREXATE WITHDRAWAL STUDY AMONG PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH TOFACITINIB 11 MG ONCE DAILY + METHOTREXATE: POST HOC ANALYSIS OF DATA FROM ORAL SHIFT

Background:The Phase 3b/4 study ORAL Shift demonstrated sustained efficacy and safety of tofacitinib modified-release (MR) 11 mg once daily (QD) following methotrexate (MTX) withdrawal that was non-inferior to continued tofacitinib + MTX use (per DAS28-4[ESR]), in patients (pts) with rheumatoid arthritis (RA) who achieved CDAI-defined low disease activity (LDA) with tofacitinib + MTX at Week (W)24.1Objectives:To assess the performance of alternative disease activity measures at W24 (randomisation) and W48 (study endpoint) in ORAL Shift.Methods:ORAL Shift (NCT02831855) enrolled pts aged ≥18 years with moderate to severe RA and an inadequate response to MTX. Pts received open-label tofacitinib MR 11 mg QD + MTX for 24 weeks. Achievement of CDAI LDA (≤10) at W24 was set as the criteria for entry to the 24-week double-blind MTX withdrawal phase, with pts randomised 1:1 to receive tofacitinib MR 11 mg QD + placebo (PBO) (ie blinded MTX withdrawal) or continue tofacitinib + MTX. In this post hoc analysis, efficacy analyses were performed in 8 subgroups defined by achievement of various disease activity criteria at W24: DAS28-4(ESR) remission (<2.6) or LDA (≤3.2); DAS28-4(CRP) <2.6 or ≤3.2; RAPID3 remission (≤3) or LDA (≤6); CDAI remission (≤2.8); and SDAI remission (≤3.3). For each subgroup, the proportion of pts who achieved the corresponding disease activity criterion at W48 was calculated, with a 95% confidence interval (CI) estimated using the normal approximation to the binomial distribution. The change (Δ) from W24 to W48 in least squares (LS) mean DAS28-4(ESR) and DAS28-4(CRP) was also calculated in each subgroup, with a 95% CI for the difference between treatment groups estimated using a mixed model with repeated measures. Nominal p values were calculated and are presented with no formal statistical hypothesis testing formulated.Results:Overall, 694 pts entered the open-label phase of ORAL Shift, and 530 were randomised and received treatment in the double-blind phase; 264 and 266 pts received tofacitinib + PBO and tofacitinib + MTX, respectively (Figure 1a). Considering those pts who were randomised and treated, the proportion of pts achieving each disease activity criterion at W24 varied, but was similar between treatments within each subgroup (Figure 1a). Among pts who met each disease activity criterion at W24, generally the majority of pts in both treatment groups also met the same criterion at W48 (Figure 1b). Numerically more pts receiving tofacitinib + MTX vs tofacitinib + PBO continued to meet the corresponding criterion at W48. Regardless of the disease activity criterion met at W24, differences between treatment groups in LS mean ΔDAS28-4(ESR) (Figure 1c) and ΔDAS28-4(CRP) (data not shown) from W24 to W48 favoured tofacitinib + MTX vs tofacitinib + PBO.Conclusion:This post hoc analysis of data from pts randomised and treated in ORAL Shift demonstrated that, regardless of the disease activity state criterion met at W24, generally a majority of pts receiving tofacitinib maintained achievement of the corresponding disease activity criterion at W48, with or without continued MTX. Differences between treatment groups in LS mean ΔDAS28-4(ESR) from W24 to W48, as defined by achievement of LDA or remission with a variety of disease activity measures, were less than a change of 1.2, which is considered to be the threshold for a minimal clinically important improvement.2References:[1]Cohen et al. Lancet Rheumatol 2019; 1: E23-34.[2]Ward et al. Ann Rheum Dis 2015; 74: 1691-1696.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Gemma Turner, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:Roy Fleischmann Speakers bureau: Pfizer Inc, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celltrion, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis, UCB, Grant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celltrion, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Samumed, Sanofi-Aventis, UCB, VORSO, Boulos Haraoui Speakers bureau: Amgen, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Eli Lilly, Merck, Pfizer Inc, UCB, Grant/research support from: AbbVie, Maya H Buch Speakers bureau: AbbVie, Consultant of: AbbVie, Eli Lilly, Gilead, MSD, Pfizer Inc, Roche, Sanofi, Grant/research support from: Pfizer Inc, Roche, UCB, David Gold Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Gosford Sawyerr Consultant of: Pfizer Inc, Employee of: Syneos Health Inc, Harry Shi Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Annette Diehl Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Kristen Lee Shareholder of: Pfizer Inc, Employee of: Pfizer Inc.

Association between comorbidities and disease activity in axial spondyloarthritis: results from the BSRBR-AS

Objective Whether comorbidities influence disease activity assessment in axial SpA (axSpA) is unclear. Comorbidities inflate DAS28 in rheumatoid arthritis through the patient global score. We examined whether axSpA disease activity measures are differentially affected, and whether comorbidities inflate the AS disease activity score (ASDAS) through the patient global component. Methods We used baseline data from the British Society for Rheumatology Biologics Register for AS, including 14 physician diagnosed comorbidities. Linear models were used to compare disease activity (BASDAI, spinal pain, ASDAS) and ESR/CRP according to comorbidity count, adjusted for age, gender, BMI, smoking, socioeconomic status, and education. The same models were used to examine whether the patient global score was associated with comorbidities, additionally adjusting for other ASDAS components. Results The number of participants eligible for analysis was 2043 (67% male, mean age 49 years); 44% had at least one comorbidity. Each additional comorbidity was associated with higher BASDAI by 0.40 units (95% CI: 0.27, 0.52) and spinal pain by 0.53 (95% CI: 0.37, 0.68). Effect size for ASDAS (0.09 units; 95% CI: 0.03, 0.15) was not clinically significant. ESR and CRP were not associated with comorbidity count. Depression, heart failure and peptic ulcer were consistently associated with higher disease activity measures, but not CRP/ESR. Patient global was associated with comorbidity count, but not independently of other ASDAS components (P = 0.75). Conclusion Comorbidities were associated with higher patient reported disease activity in axSpA. Clinicians should be mindful of the potential impact of comorbidities on patient reported outcome measures and consider additionally collecting ASDAS when comorbidities are present.

Serum Levels of Beta-2 Microglobulin in Rheumatoid Arthritis Patients and its Relationship with Disease Activity: Can it be used as a Disease Activity Marker?

Background Beta-2 microglobulin (β2M) is mainly released from activated lymphocytes. Increased serum β2M levels have been shown in autoimmune diseases. The aim of this study was to analyse the serum levels of β2M in rheumatoid arthritis (RA) patients and to evaluate its relationship with disease activity measures. Material and Methods This cross-sectional study included 137 RA patients, 102 ankylosing spondylitis patients (AS) and 50 healthy controls (HC). To assess the disease activity of RA patients, the 28-joint Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR), the 28-joint Disease Activity Score-C-Reactive Protein (DAS28-CRP), the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) were used. A p value of <0.05 was considered statistically significant. Results Serum β2M levels were significantly higher in RA patients (2.95±1.19 mg/L) compared with HC (2.21±0.54 mg/L) and AS patients (2.200.58 mg/L) (p<0.001). There was a statistically significant correlation between β2M levels and DAS28-ESR (rs=0.359, p<0.001), DAS28-CRP (rs=0.293, p=0.001), SDAI (rs=0.332, p<0.001) and CDAI (rs=0.291, p=0.001). Serum β2M levels were higher in the RA group with DAS28-ESR ≥3.2 (3.30±1.42 mg/L) than in the DAS28-ESR <3.2 group (2.67±0.87 mg/L) (p=0.002). Conclusion Our study revealed that serum β2M levels were higher in RA patients than in healthy controls, and, in contrast to other studies, we found positive correlations between β2M levels and RA disease activity measures.

Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): data from the Peruvian Almenara Lupus Cohort

ObjectiveThe Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) clinician-reported outcome (ClinRO) and the LFA-REAL patient-reported outcome (PRO) were developed in order to capture manifestations of SLE from the perspective of both the clinician and the patient. The aim of this study is to compare the LFA-REAL ClinRO and PRO with other lupus disease activity measures.MethodsA cross-sectional analysis of patients from a single-centre cohort was performed using Spearman’s correlation. Disease activity measures included were LFA-REAL ClinRO (range 0–1400), LFA-REAL PRO (range 0–1200), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), clinical SLEDAI-2K and Physician Global Assessment (PGA, range 0–100).ResultsTwo hundred and twenty-seven patients with SLE were studied. The mean age was 46.3 (SD: 13.8); 212 (93.4%) were female. The mean (SD) LFA-REAL ClinRO was 25.4 (34.7), LFA-REAL PRO was 241.1 (187.6), PGA was 11.9 (15.4), SLEDAI-2K was 2.3 (3.3) and clinical SLEDAI-2K was 1.6 (2.9). The LFA-REAL ClinRO correlated with PGA (r=0.758, p<0.001), SLEDAI-2K (r=0.608, p<0.001) and clinical SLEDAI-2K (r=0.697, p<0.001); the LFA-REAL PRO correlated modestly with PGA (r=0.160, p=0.016), SLEDAI-2K (r=0.121, p=0.069), clinical SLEDAI-2K (r=0.143, p=0.031) and LFA-REAL ClinRO (r=0.161, p=0.015).ConclusionsThe LFA-REAL ClinRO and the LFA-REAL PRO had good and weak correlations, respectively, with several physician-based disease activity measures in a cross-sectional study, suggesting their potential usefulness in establishing disease severity. Longitudinal studies will be required to determine their value in monitoring patients with SLE.