Bath Ankylosing Spondylitis Disease Activity Index Research Articles

Biologic disease-modifying anti-rheumatic drugs and patient-reported outcomes in axial SpA: a systematic review and a call for action.

This paper is to assess the efficacy of different biologic DMARDs (bDMARDs) on several patient-reported outcomes (PROs) in randomized controlled trials (RCT) in axial spondyloarthritis (axSpA). A systematic literature review (SLR) was performed. MEDLINE (May 1, 2018) was used with the filters "published in the last 10 years" and "humans." The PICO criteria used were Patients: adults with radiographic axSpA (r-axSpA) or non-radiographic axSpA (nr-axSpA); Intervention: any bDMARD; Compararator: placebo (PBO)/any different drug; Outcome: the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL), the EuroQol-5D (EQ-5D), the Short Form 36 Health Survey physical component summary (SF36-PCS), the Short Form 36 Health Survey mental component summary (SF36-MCS), and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). After screening 84 initial references and manually selecting other 9, 24 publications, assessing TNF inhibitors (TNFi) or IL17A inhibitors (IL17Ai) were selected. Four RCTs quantified the minimal clinical important difference (MCID) between treatment arms. Most of the RCTs compared the mean difference of PROs between different timepoints. Overall, the treatment arm was superior to the comparator. PROs were often underreported or highly heterogeneously presented. MCID was seldom mentioned. There is a need to raise the standard of care on SpA by aiming at remission and PRO associated improvements. In order to achieve this goal, the target must be clearly defined, reported, and tested.

AB0720 SOLUBLE TRANSFERRIN RECEPTOR IN DIAGNOSIS OF IRON DEFICIENCY ANEMIA IN PATIENTS WITH SPONDYLOARTHRITIS

Background:Anemia is a frequent hematological disorder in patients with rheumatic diseases. The main pathogenetic variants of anemia are anemia of chronic disease (ACD), iron deficiency anemia (IDA), and anemia of chronic disease with iron deficiency (ACD/IDA). The presence of systemic inflammation hinders to diagnose absolute iron deficiency, because standard tests of iron status are affected by it. Soluble transferrin receptors (sTfR) measurement and the calculation of the sTfR/ log ferritin index (sTfR index) are recommended, but data about diagnostically significant levels of these indicators in patients with spondyloarthritis (SpA) is currently limited.Objectives:To assess the diagnostic significance of sTfR and the sTfR index for detecting absolute iron deficiency in patients with SpA and anemia.Methods:Complete blood count, standart iron metabolism parameters, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were evaluated in 68 patients with SpA. Serum concentration of sTfR was measured with enzyme-linked immunosorbent assay (ELISA) using sTfR ELISA kit («Monobind Inc.», USA). The sTfR index was calculated by the formula sTfR/log10ferritin. Anemia was defined using the World Health Organization criteria. Depending on the serum ferritin concentration, transferrin saturation, and CRP level, ACD, IDA, or combined anemia (ACD/IDA) were diagnosed. Disease activity was determined by the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score based on CRP) scales. Receiver operating characteristic (ROC) analysis was performed with MedCalc.Results:Anemia was found in 48 of 68 (70,6%) SpA patients. 16 (33,3%) patients had ACD and 32 (66,7%) had ACD/IDA. Hemoglobin level in ACD was 118 [112; 123] g/L, in ACD/IDA – 110 [106; 120] g/L, in non-anemic patients – 133 [129; 145] g/L (p<0.001 for all groups). CRP and ESR values were higher in ACD compared to ACD/IDA patients (31.5 [20.3; 46.4] mg/L and 27.0 [16.0; 35.5] mm/h versus 9.8 [5.6; 16.9] mg/L and 15.5 [12.0; 22.5] mm/h, respectively [p=0.00 and p=0.038]). No statistically significant difference was found between all groups in BASDAI and ASDAS-CRP scores.ACD/IDA patients had significant increases in serum sTfR levels (1.7 [1.4; 2.2] mg/L) compared to ACD (1.5 [1.1; 1.7] mg/L, p=0,04) and to non-anemic patients (1,3 [1,1; 1,6] mg/L, p=0,003). The sTfR index was significantly higher in ACD/IDA (0.93 [0.82; 1.24]) compared to patients with ACD (0.64 [0.48; 0.75], p<0.001) and without anemia (0.67 [0.56; 0.81], p<0.001).The areas under the curves (AUCs) for distinguishing between ACD/IDA and ACD were 0.85 for sTfR index (p<0,001), 0.72 for sTfR (p<0,001). The sTfR index (cutoff >0.83) and sTfR (cutoff >1.39 mg/L) had sensitivities of 75% and 53%, and specificities of 83% and 81%, respectively.Conclusion:According to obtained data, serum concentration of sTfR >1.39 mg/L and the sTfR index >0.83 point to the presence of iron deficiency component in the structure of anemic syndrome in patients with SpA.

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

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

THU0378 DO COMORBIDITIES DECREASE THE FIRST TNF-INHIBITOR RETENTION AND TREATMENT RESPONSE IN AXIAL SPONDYLOARTHRITIS PATIENTS? DATA FROM TURKBIO

Background:The frequency of comorbidities has increased in spondyloarthritis patients compared to the general population. The effect of comorbidities on tumour necrosis factor alpha inhibitor (TNFi) drug retention and treatment response has not been well evaluated.Objectives:The purpose of this study to assess the impact of comorbidities on the first TNFi drug survival and treatment response in patients with axial spondyloarthritis (axSpA) registered in theTURKBIOdatabase.Methods:In this study, the frequency of comorbidities, disease activity scores at baseline and month 6 and drug retention were recorded in AxSpA patients iniating first TNFi treatment between 2011 and 2019. Kaplan Meier plot and log rank tests were used for drug survival analysis. Cox regression analysis with HR was performed to evaluate the correlation between comorbidities and drug survival.Results:There were 2428 patients with AxSpA (39.3% female) who used their first TNFi during the study period. Among them, a total of 770 (31%) had at least one comorbid disease. Hypertension was the most common comorbidity (9.7%), followed by the affective disorders (8%) and chronic lung disease (5.8%). The baseline characteristics of patients are shown in Table 1.The presence of any comorbidity did not impact the first TNFi retention (Figure 1). When comorbidities were analysed seperately, we found that only history of cerebrovascular event was negatively associated with drug retention rate (HR: 6.9, p:0.008). There was no statistically significant difference in Bath AS Disease Activity Index 50% (BASDAI50) response between patients with and without comorbidity at 6 months. Less axSpA patients with comorbidity achieved a ASDAS score ≤ 2.1 compared to patients without comorbidity at 6 months.Table 1.Baseline Characteristics of PatientsRadiographic Spondyloarthritis, n (%)2318 (95.5)Female, n(%)954 (39.3)Age, year42.2±11.8Age at diagnosis, years32.5± 11.3Age at initial TNFi, years39.4 ± 11.1Symptom duration, years9.7± 7.5Time to initial TNFi, years7±6.8HLA-B27- positivity, n (%)1144 (47.1)Smokers, n (%)1068 (44)Baseline BASDAI35.5±22.2Baseline ASDAS-CRP2.8±1.1Baseline CRP (mg/L)15.7±24.4VAS global patient46.6±28.7-Quantitative variables are presented as mean ± SD, and qualitative variables are presented as frequency and percentage-ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein VAS, visual analogue scaleConclusion:The results of this study demonstrated that the presence of previous cerebrovascular event decreased the first TNFi survival in patients with axSpA. It also suggested that comorbidities might decrease TNFi treatment response.Disclosure of Interests:None declared

Non-Steroidal Anti-Inflammatory Drug Etoricoxib Facilitates the Application of Individualized Exercise Programs in Patients with Ankylosing Spondylitis.

Background and objectives: The main objective of this study is to highlight the efficiency of different therapeutic means in patients with ankylosing spondylitis, resulting in the improvement of their quality of life. Materials and Methods: We conducted a randomized, longitudinal, controlled trial on 92 patients with ankylosing spondylitis over a period of 6 years. Disease activity was assessed using the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score. The assessment of functional disabilities was performed using BASFI (Bath Ankylosing Spondylitis Functional Index). We assessed the quality of life using the HAQ questionnaire (Health Assessment Questionnaire). Based on the HAQ, we calculated the minimum number of patients to be treated for 52 weeks to prevent a decrease in the quality of life for at least one of them (the number needed to treat (NNT)). Results: For the combination therapy group, the result we obtained was 2, lower than the other therapies compared (the medication group and the group with physical exercise). We point out a correlation between the improvement of the functional status (BASFI) and the increase of the quality of life (HAQ), estimated as moderately high (0.8). The superiority of the effects of the combined treatment, in which we combined a nonsteroidal anti-inflammatory drug (etoricoxib) to the exercise program, is reflected by the model of the significant improvements (p < 0.05) obtained for the functional status and quality of life scores (BASFI and HAQ). Conclusions: The nonsteroidal anti-inflammatory drugs, in our case, etoricoxib, facilitate the application of individualized exercise programs in patients with ankylosing spondylitis.

Lower concentration of vitamin D is associated with lower DAS28 and VAS-pain scores in patients with inflammatory rheumatic diseases treated with infliximab: a pilot study.

Vitamin D is beneficial in patients with immune-mediated rheumatic diseases as it has been shown that it lowers the incidence risk and the level of inflammation. To examine the association between clinical outcomes and initial 25-hydroxyvitamin D [25(OH)D] concentrations in patients with the immune-mediated rheumatic diseases treated with infliximab for 9months. This study was performed in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) treated with infliximab for at least 38weeks. Disease activity was assessed using Disease Activity Score (DAS28) for RA and PsA and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS, while the global assessment was performed using the Visual Analogue Scale (VAS). Patients were divided into 2 groups according to 25(OH)D concentration which was classified as deficient or non-deficient (below and above 50nmol/L, respectively). Concentrations of infliximab (IFX) and C-reactive protein (CRP) were measured according to the manufacturer's instructions.This study was performed in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) treated with infliximab for at least 38weeks. Disease activity was assessed using Disease Activity Score (DAS28) for RA and PsA and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS, while the global assessment was performed using the Visual Analogue Scale (VAS). Patients were divided into 2 groups according to 25(OH)D concentration which was classified as deficient or non-deficient (below and above 50nmol/L, respectively). Concentrations of infliximab (IFX) and C-reactive protein (CRP) were measured according to the manufacturer's instructions. The study included 23 patients (14 with RA, 6 with AS and 3 with PsA), median age 54years, 15 females. Vitamin D deficient and non-deficient groups had median initial concentrations of 38 and 61nmol/L, respectively. DAS28 and pain on VAS calculated at the 2nd and 38th week showed a statistically significant decrease only in RA and PsA patients with vitamin D deficiency (P = 0.02 and 0.06, respectively). Lower initial concentration of 25(OH)D in patients treated with infliximab was associated with better improvement of clinical measures (DAS28 and VAS) of disease after 9months of therapy.

5-year efficacy and safety of secukinumab in patients with ankylosing spondylitis: end-of-study results from the phase 3 MEASURE 2 trial.

Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin 17A, has shown significant and sustained improvement in the signs and symptoms of ankylosing spondylitis over 3 years in the MEASURE 2 study. We report the 5-year (end-of-study) results of subcutaneous secukinumab 150 mg in the MEASURE 2 study. MEASURE 2 was a phase 3, double-blind, randomised, placebo-controlled, study done in 13 countries and 53 centres. Patients with ankylosing spondylitis who were 18 years of age or older and fulfilled the modified New York criteria were randomly assigned to receive secukinumab (150 mg or 75 mg) or placebo subcutaneously at baseline and weeks 1, 2, and 3, and then every 4 weeks from week 4. At week 16, patients initially given placebo were randomly assigned again (placebo switchers) to receive secukinumab 150 mg or 75 mg. Efficacy results are reported for patients initially randomised to secukinumab 150 mg and those who switched from placebo to secukinumab 150 mg at week 16. An optional dose escalation from secukinumab 75 mg to 150 mg was initiated beginning week 140. We assessed efficacy endpoints at week 260 (5 years), including Assessment of Spondyloarthritis International Society (ASAS) 20 and ASAS 40, inactive disease according to ankylosing spondylitis disease activity score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI50, Bath Ankylosing Spondylitis Metrology Index, Bath Ankylosing Spondylitis Functional Index, Short Form-36 Physical Component Summary, and ASAS partial remission. Analyses were stratified by anti-tumour necrosis factor (TNF) status (anti-TNF-naive and anti-TNF inadequate response). The safety analysis included all patients who received one dose or more of secukinumab. We report data as observed without accounting for missing data. The MEASURE 2 study was registered with ClinicalTrials.gov, NCT01649375. 219 patients were randomly assigned during the trial and 150 (68%) completed 5 years of treatment, including 82 (77%) of 106 patients in the secukinumab 150 mg group and 68 (65%) of 105 in the secukinumab 75 mg group. Efficacy analysis in the secukinumab 150 mg group included 53 patients who completed the study and one additional patient who was assessed in the treatment period weeks 212-260, but did not complete the study. 134 (61%) of 219 patients were anti-TNF-naive and 85 (39%) were anti-TNF inadequate responders. ASAS responses at 5 years with secukinumab 150 mg were 36 (67%) of 54 patients (ASA20) and 27 (50%) patients (ASAS40). Sustained improvement was observed across other efficacy endpoints with secukinumab 150 mg at 5 years. At 5 years, the proportion of patients achieving efficacy endpoints of BASDAI 50 response was 53% (44/83); ASAS 5/6 response was 51% (42/83); ASDAS-CRP inactive disease was 21% (17/81); and ASAS partial remission was 25% (21/83). Exposure-adjusted incidence rates with any secukinumab dose for selected adverse events were 1·0 per 100 patient-years (95% CI 0·4-1·9) for Candida infections, 0·5 (0·1-1·2) for Crohn's disease, 0·4 (0·1-1·1) for ulcerative colitis, 0·6 (0·2-1·4) for major adverse cardiovascular events, 0·5 (0·1-1·2) for uveitis, and 0·6 (0·2-1·4) for malignant or unspecified tumours. Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in patients with ankylosing spondylitis after 5 years of treatment. The safety profile of secukinumab remained consistent with previous reports. Novartis Pharma.

Non-steroidal anti-inflammatory drugs in patients with stable ankylosing spondylitis receiving tumor necrosis factor inhibitor: continued vs withdrawn.

To investigate the effect of non-steroidal anti-inflammatory drugs (NSAIDs) on disease activity in patients with stable ankylosing spondylitis (AS) receiving tumor necrosis factor inhibitor (TNFi). In this retrospective observational study, a total of 189 patients with stable AS receiving TNFi were included. Patients were classified into NSAID withdrawn group (n = 48) and NSAID continued group (n = 141), according to the use of NSAIDs. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were measured every 3months, and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was measured every 6months as parameters to evaluate disease activity. ESR, CRP, and BASDAI at each time point, and time-averaged values of each parameter during the observation period of 1year were compared between the two groups. Repeated-measure ANOVA was performed to compare changes in disease activity parameters during the observation period between the two groups. The level of ESR, CRP, and BASDAI at baseline and during the observation period did not differ between the two groups. The time-averaged values of ESR (p = 0.096), CRP (p = 0.136), and BASDAI (p = 0.421), and changes of ESR (p = 0.101), CRP (p = 0.714), and BASDAI (p = 0.613) during the observation period were not significantly different between the two groups. The continued use of NSAIDs in patients with stable AS receiving TNFi had no additional benefit in controlling the disease activity, as compared to patients who withdrew NSAIDs. Considering the risk of toxicity of long-term NSAID use, withdrawal of NSAIDs in stable AS patients receiving TNFi may be preferable. Key points • There is a lack of supportive evidence whether to continue or withdraw non-steroidal anti-inflammatory drugs (NSAIDs) in patients with stable ankylosing spondylitis (AS) receiving tumor necrosis factor inhibitor (TNFi). • Compared with patients who withdrew NSAIDs, continuing NSAIDs in patients with stable AS receiving TNFi had no additional benefit in controlling disease activity. • The results of the present study provide evidence that supports withdrawal of NSAIDs in patients with stable AS receiving TNFi.

Predictive value of semi-quantitative index from F-18-fluoride PET/CT for treatment response in patients with ankylosing spondylitis

PurposeWe aimed to investigate whether the lesion-to-background ratio (LBR) of the whole spinal column in ankylosing spondylitis (AS) patients based on baseline F-18-fluoride positron emission tomography/computed tomography (PET/CT) is associated with treatment response. MethodsTwenty-eight male patients with a wide range of disease activity were included in this study. Abnormal bone metabolic lesions on baseline F-18-fluoride PET/CT were visually assessed in three areas: anterior discovertebral units (DVUs) and posterior joints (cervical, thoracic, and lumbar facet joints, costovertebral joints, and costotransverse joints) of vertebrae and sacroiliac joints of the sacrum. The highest maximum standardized uptake value (SUVmax) of lesions within each area was measured. The LBR as a semi-quantitative index was defined as SUVmax of the lesion divided by mean SUV of the L5 vertebral body. Clinical disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and treatment response was evaluated based on follow-up BASDAI score. ResultsThe median follow-up period was 4.5 years (range, 0.9–5.5). The BASDAI score significantly decreased from median 6.6 (range, 1.0–9.5) at baseline to 2.0 (range, 0.6–8.1) at follow-up (P < 0.001), and the median change in BASDAI score was -3.4 (range, -8.2–4.4). The LBR of posterior joints in the spinal column had a significant positive correlation with follow-up BASDAI score (r = 0.394, P = 0.042). ConclusionIn patients with AS, the LBR of posterior joints of the spinal column on baseline PET/CT could be considered one of the potential surrogate markers for predicting treatment response.

Comparative analysis of the diagnostic values of T2 mapping and diffusion-weighted imaging for sacroiliitis in ankylosing spondylitis.

To investigate the diagnostic values of T2 mapping and diffusion-weighted imaging (DWI) for active sacroiliitis in ankylosing spondylitis (AS) and to evaluate the correlations of T2 and ADC values with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Spondyloarthritis Research Consortium of Canada (SPARCC) scores. A total of 77 AS patients with sacroiliitis and 45 healthy controls were enrolled. All patients were scanned by standard magnetic resonance imaging longitudinal relaxation time (T1)-weighted imaging (T1WI), fat-saturated T2-weighted imaging (FS-T2WI)] and DWI, and T2 mapping of the sacroiliac joints. According to whether subchondral bone marrow edema was present in the FS-T2WI sequence, the 77 patients were divided into an active group (41 cases) and an inactive group (36 cases). The T2 and apparent diffusion coefficient (ADC) values of the subchondral bone marrow were measured in the active group, the inactive group, and the healthy control group. The average T2 and ADC values were compared among the three groups. Receiver operating characteristic (ROC) curves were used to analyze the diagnostic efficacy of T2 and ADC values for sacroiliitis. The correlations of T2 and ADC values with the BASDAI score and the SPARCC score were analyzed. The T2 and ADC values in the active group were higher than those in the inactive group, while that in the inactive group were significantly higher than those in the healthy control group (p < 0.0001). The T2 and ADC values of the AS patients were positively correlated with BASDAI scores, and the correlation coefficients (r) were 0.786 (p < 0.0001) and 0.842 (p < 0.0001), respectively. The areas under the ROC curves (AUCs) of T2 and ADC values between the active and inactive groups, the active group and the healthy control group, and the inactive group and the healthy control group were 0.889 (95% CI, 0.80-0.95) and 0.917 (95% CI, 0.83-0.97), 0.982 (95% CI, 0.93-1.00) and 0.984 (95% CI, 0.93-1.00), and 0.628 (95% CI, 0.51-0.73) and 0.871 (95% CI, 0.78-0.94), respectively. The T2 and ADC values of the AS patients in the active group were positively correlated with SPARCC scores, and the correlation coefficients (r) were 0.757 (p < 0.0001) and 0.764 (p < 0.0001), respectively. T2 and ADC values can be used to quantitatively assess the activity of AS, and the efficacy of the ADC value in the diagnosis of AS was higher than that of the T2 value.

Serum calprotectin: a promising biomarker in rheumatoid arthritis and axial spondyloarthritis

BackgroundCalprotectin (S100A8/S100A9 protein) is known as a damage-associated molecular pattern (DAMP) protein and reflects mainly neutrophil activation. Serum calprotectin levels might be a good alternative to acute-phase protein as a biomarker in inflammatory rheumatic diseases. The aim of this study is to investigate the association of serum calprotectin with disease activity and severity in rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and psoriatic arthritis (PsA).MethodsSerum calprotectin was measured in patients with RA, axSpA, and PsA from the prospective Swiss Clinical Quality Management (SCQM) registry. Asymptomatic first-degree relatives of RA patients were used as healthy controls (HC). Outcomes included swollen joint count (SJC), Disease Activity Score (DAS), Health Assessment questionnaire (HAQ), joint radiographs, and ultrasound power Doppler (USPD) score for RA; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Ankylosing Spondylitis Disease Activity Score (ASDAS) and coxitis for axSpA; and SJC and Disease Activity Index for PSoriatic Arthritis (DAPSA) for PsA. Comparison of outcomes by calprotectin quartile levels was performed using Kruskal-Wallis tests for continuous outcomes or trend tests for categorical outcomes.ResultsA total of 1729 subjects [RA = 969, axSpA = 451, PsA = 237, and HC = 72] were included. Median levels of serum calprotectin were higher in each disease group compared to HC (p < 0.01). In RA patients, all clinical outcomes were statistically different between quartiles of serum calprotectin, indicating an association between calprotectin levels and higher disease activity (SJC, DAS, and USPD scores) and severity (joint radiographs and HAQ). In axSpA, an association between calprotectin levels and ASDAS score (p < 0.01) and prevalence of coxitis (p = 0.02) was observed. For PsA patients, SJC and DAPSA did not differ across calprotectin quartiles.ConclusionsThis large study supports the association of serum calprotectin levels with disease activity in both RA and axSpA, but not in PsA.

Association of body mass index on disease activity in axial spondyloarthritis: systematic review and meta-analysis

ObjectivesIn axial spondyloarthritis (axSpA), higher body mass index (BMI) is associated with worse outcomes including response to biologics. Further clarity is needed on whether BMI is associated with disease activity...

Outcomes of Total Hip Arthroplasty in Patients with Ankylosing Spondylitis at Hasan Sadikin General Hospital Bandung

Peripheral joints involvement in Ankylosing spondylitis (AS) has been reported in 73% of these cases, with the hip being the most commonly affected diarthrodial joint. The reported prevalence of hip involvement in AS varies from 19 to 36%. Total Hip Arthroplasty (THA) is often required to manage pain and restore function and mobility. The aim of this study was to retrospectively analyze outcomes related to performing THA on patients with AS.Methods:We evaluated the oncologic, functional outcome and complications of a patient 27 years old with Ewing sarcoma Data of 19 AS patients who underwent 29 THAs between 2014 and 2018 were retrospectively analyzed. Clinical and imaging data were collected preoperatively, postoperatively, and during the follow-up period for surgical outcomes.Results:There were 14 males and 5 females with 29 affected hips (53% bilateral, 47% unilateral). The average patient at surgery was 31.7 years old (range, 17-47 years). After surgeries, overall inclinations and anteversions of acetabular cups were 44.9°±0.3° (range, 30°–50°) and 18.42°±0.30° (range, 0°–25°) respectively. Mean Visual Analogue Scale (VAS) score decreased from 7.4±0.14 (range, 4–10) preoperatively to 3.21±0.09 (range, 0–4) at final follow-up. Mean Harris Hip Score (HHS) improved from 24.36±2.6 (range, 15–45) to 92±1.66 (range, 80–95) at final follow-up. Postoperative Range of Motion (ROM) was improved from 10.26°±2.61° (range, 0°–50°) preoperatively to 84.26°±0.76° (range, 70°–100°) at final follow-up. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, which shows the activity of disease, was 7.6±0.17, and it decreased to 3.5±0.15 at last follow-up. There were post-operative complications in 8 hips (27.6%). Superficial wound infection was documented in 3 hips (10.3%), sciatic nerve injury in 1 hip (3.4%), implant loosening in 2 hip (6.9%), and heterotopic ossification was documented in 2 hips (6.9%) at final follow-up.Conclusion:Surgical outcomes of THA for AS patients with hip involvement are satisfactory.

Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement

This study aimed to assess the efficacy of needle-knife (NK) combined with etanercept (NKCE) in attenuating pain, inflammation, disease activity, and improving hip joint function in ankylosing spondylitis (AS) patients with hip joint involvement.Totally, 90 patients with active AS involving unilateral hip joint were enrolled and randomly assigned in 1:1:1 ratio to receive NKCE, NK or conventional drugs (control). The ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint were assessed at baseline (W0), after 1-week treatment (W1) and after 24-week treatment (W24).ESR and CRP were decreased in NKCE group compared with NK and control groups, while was not attenuated in NK group compared with control group. Regrading pain and disease activity, NKCE group presented a reduction in hip pain VAS score and BASDAI compared with NK and control groups, and NK group showed a decrease in hip pain VAS score and BASDAI compared with control group. Besides, BASFI was lowered in NKCE and NK groups compared with control group, but similar between NKCE and NK groups. mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.NKCE decreases hip pain, inflammation, disease activity and improves hip joint function in AS patients with hip joint involvement.

Real-world evidence of TNF inhibition in axial spondyloarthritis: can we generalise the results from clinical trials?

Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour...

Association between C-reactive protein gene variant and treatment efficacy of etanercept in ankylosing spondylitis patients receiving hip arthroplasty.

BackgroundC‐reactive protein (CRP) level is one of the most widely used parameters to assess ankylosing spondylitis (AS), since CRP is associated with poor radiographic progression of AS patients. Recent studies have investigated the association between CRP gene variants and AS risk, but with conflicting findings.Material and MethodsWe enrolled 232 AS cases and 314 controls in this case‐control study. Next, we assessed the association of CRP gene rs3091244 polymorphism with the efficacy of etanercept for AS. Genotyping was done using a custom‐by‐design 48‐Plex SNP scanTM Kit.ResultsCRP gene rs3091244 polymorphism was associated with an increased risk of AS in this Chinese population. Clinical indicators of AS patients including morning stiffness time, Bath AS function index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Visual Analogue Scale (VAS), erythrocyte sedimentation rate (ESR), and CRP were significantly decreased after 12 weeks of etanercept treatment. Furthermore, AA genotype carriers showed higher values of VAS, BASDAI, BASFI, and CRP before etanercept treatment. AA genotype or A allele of rs3091244 polymorphism was associated with Ankylosing Spondylitis Assessment Study group response criteria 20 scores (ASAS20) and Assessment in SpondyloArthritis international Society 40 response (ASAS40) improvement. In addition, AA genotype carriers showed significantly higher CRP levels compared with genotype GG carriers (16.3 vs 8.8 mg/L).ConclusionCRP gene rs3091244 polymorphism is associated with an increased risk of AS. Additionally, rs3091244 polymorphism could serve as a biomarker for good response to etanercept treatment in AS.

Investigation of the effectiveness of aerobic exercise training in individuals with ankylosing spondylitis: Randomized controlled study

Objective To investigate the effect of the addition of aerobic training to spinal mobility exercises on disease-specific outcomes and functional exercise capacity, aerobic capacity and respiratory muscle strength of ankylosing spondylitis (AS) patients. Methods The study included 31 volunteers (mean age: 44.90 ± 11.52 years) diagnosed with AS. The demographic characteristics and disease-related data of all subjects were recorded, then, the Bath AS Disease Activity Index (BASDAI), Bath AS Metrology Index (BASMI) and Bath AS Disease Function Index (BASFI), the 6-minute walk test, the Bruce Treadmill Test and spirometry were used, respectively. The intervention group attended a 12-week program of aerobic exercise sessions, plus supervised spinal mobility exercises, 3 days a week. The control group performed the supervised spinal mobility exercises only, 3 times a week, for 12 weeks. Results There was a significant improvement in BASDAI (p = .002), BASMI (p = .021), 6 DYT (p = .036), VO2 max (p = .000), MIP (p = .005) and MEP (p = .022) results in the intervention group after 12 weeks of training. In the comparisons of the pre-treatment and post-treatment differences, BASDAI (p = .032) decreased and VO2 (p = .001) max increased, showing significant improvements in the intervention group and these values were maintained. Conclusion It is striking that improvements in all parameters except BASFI were achieved in the aerobic training group. These results demonstrate that an aerobic exercise program should be included in an individual exercise prescription for the management of AS.

The Impact of Comorbidity on Patient-Reported Outcomes in Psoriatic Arthritis: A Systematic Literature Review.

IntroductionA systematic literature review was conducted with the aim to analyse the impact of comorbidity on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA).MethodsA sensitive search strategy of the Medline, Embase and the Cochrane Library (up to March 2019) was applied to retrieve studies for inclusion in this systematic literature review. s of the ACR and EULAR scientific meetings were also searched. The selection criteria were: (1) patients with PsA (population) with a comorbidity (intervention) and (2) report of any impact of the comorbidity on PROs. Systematic literature reviews, randomized controlled trials and observational were included in this systematic literature review. Two of the authors selected the articles and collected the data.ResultsEighteen articles were included in this systematic literature review, with most being cross-sectional studies that included more than 9000 patients with PsA. Some studies analysed the impact of an individual comorbidity, such as fibromyalgia (FM), and in others the analysis was according to the number of comorbidities. The most frequently analysed PROs were function, quality of life and fatigue. Analysis of the studies included in the review showed that patients with a higher number of comorbidities and/or more severe comorbidities reported worse impacts of their disease on function, patient’s global assessment (PGA), pain, fatigue, work disability and quality of life. Specifically, FM had a negative impact on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), function, quality of sleep and quality of life; anxiety and depression had a negative impact on function and fatigue; metabolic syndrome had a negative impact on BASDAI, function, PGA and quality of life; obesity had a negative impact on function and pain; smoking (current and ex-smokers) had a negative impact on pain, function, fatigue, quality of life and overall health; alcohol intake had a negative impact on pain, function, fatigue, quality of life and overall health.ConclusionsThe prevalence and impact of medical comorbidity on PROs are very high in patients with PsA.Electronic Supplementary MaterialThe online version of this article (10.1007/s40744-020-00202-x) contains supplementary material, which is available to authorized users.

EP39 Assessing the differences in times to general practitioner presentation and diagnosis, and outcomes, for axial spondyloarthritis patients in different ethnic groups

Abstract Background There is a documented delay to diagnosis of axial spondyloarthritis. The Luton &amp; Dunstable University Hospital Rheumatology department looks after an ethnically diverse population of patients with the condition. This study aimed to compare time from symptom onset to general practitioner (GP) presentation, time from symptom onset to diagnosis, and response to treatment between different ethnic groups. Methods 124 patients with axial spondyloarthritis, according to the Luton &amp; Dunstable University Hospital Infoflex database, were identified. 24 patients were excluded due to a peripheral spondyloarthritis diagnosis. A retrospective case note review of 100 case records was undertaken. Data were analysed using Microsoft Excel. Results The mean age was 44 years. 64 (64%) patients were male and 36 (36%) were female. Ethnicity breakdown showed 58 White British patients; 12 Pakistani; 7 White Other; 6 Bangladeshi; 5 White Irish; 5 Asian; 4 Indian and 3 Black Caribbean. There were 70 Caucasian (White British, Irish or Other) and 30 non-Caucasian patients. Based on available data for 57 patients, the median time of symptom onset to GP presentation was 48 months. Based on available data for 49 patients, the median time of symptom onset to diagnosis was 53 months. The mean time of symptom onset to GP presentation was 93 months in Caucasians vs. 66 months in non-Caucasians. The mean time of symptom onset to diagnosis was 91 months in Caucasians vs. 70 months in non-Caucasians. 12 patients presented within one year of symptom onset. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) data were available for 7/12 patients who presented within one year of symptom onset and 25/45 patients who presented after one year. Following NSAIDs or biologics, there was a larger decrease in the first measured BASDAI for those who presented within one year of symptom onset (Mean BASDAI decrease: 2.77 vs. 2.06). BASDAI data were available for 43/70 Caucasian patients and 18/30 non-Caucasian patients, regardless of time of presentation. The mean decrease in first measured BASDAI was smaller in Caucasian patients vs. non-Caucasian patients (Mean BASDAI decrease: 2.49 vs. 2.66). BASDAI data were available for 5/7 Caucasian and 2/5 non-Caucasian patients presenting within one year of symptom onset. The mean BASDAI decrease was 5.65 in non-Caucasian patients vs. 1.62 in Caucasian patients. BASDAI data were available for 15/26 Caucasian and 10/19 non-Caucasian patients presenting after one year of symptom onset. Mean BASDAI decrease was 2.26 in non-Caucasian vs. 1.93 in Caucasian patients. Conclusion There is a shorter mean time of symptom onset to GP presentation and diagnosis in non-Caucasians compared to Caucasians. There is a higher response to treatment in patients who present within one year of symptom onset, supporting the hypothesis that early diagnosis leads to better outcomes. Disclosures: A. Owusu-Agyei: None. A. Verdiyeva: None. M. Chan: None.

EP12 Bilateral lipoma arborescens as a presenting feature of ankylosing spondylitis

Abstract Background Lipoma arborescens (LA) is a rare, slow growing lesion defined as a villous lipomatous proliferation of the synovial membrane with replacement of the synovial tissue by mature fatty cells. It usually involves the knee and can be associated with degenerative joint disease, trauma, diabetes mellitus and very occasionally with inflammatory arthritis. Diagnosis is made using MRI which shows a synovial mass that is isointense relative to fat and joint effusion. Histologically there is diffuse replacement of the subsynovial layer with mature adipocytes and infiltration of mononuclear cells. Treatment is with synovectomy and treating any underlying condition. Methods We present the first case bilateral knee LA as a presenting feature of ankylosing spondylitis. Results A 29-year-old Caucasian male presented to a knee orthopaedic surgeon with a two-year history of atraumatic bilateral knee swelling. He had a ten-year history of intermittent knee pain and stiffness which was unresponsive to non-steroidal anti-inflammatory drugs (NSAIDs) and physiotherapy. Examination revealed large bilateral knee effusions with restriction of movement. Plain radiographs of his knee joints showed minor osteophytic lipping laterally on his right knee. He had an MRI of both his knees which showed bilateral joint effusions and bilateral LA. He was referred to the rheumatology team for consideration of underlying inflammatory arthritis. Further questioning revealed no history of uveitis, dactylitis, psoriasis, inflammatory bowel disease but lower back pain which was long standing. Blood tests showed rheumatoid factor, anti-CCP, anti-DsDNA, ENA were negative with ANA positive in a homogenous pattern. C-reactive protein (CRP) was only slightly raised at 5.6mg/L. Knee aspirate showed mixed inflammatory cells. Radiographs of his spine showed no syndesmophytes but sacroiliac joints showed established bilateral sacroiliitis. A diagnosis of ankylosing spondylitis with secondary LA was made. He was commenced on sulfasalazine to treat his peripheral inflammatory arthritis along with continuation of NSAID. He remained symptomatic with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 8 and Spinal pain VAS of 9. As he fulfilled NICE guidelines for biologic use in AS, he was commenced on adalimumab 40 mg fortnightly injections and had a good response to treatment with improvement in BASDAI, pain VAS, knee swelling and normalisation of CRP. Conclusion There have been reports of LA in association with inflammatory joint disease. This is the first case of bilateral LA as a presenting feature of ankylosing spondylitis. It has been demonstrated that LA plays a role in joint inflammation and damage through tumour necrosis factor alpha (TNFα) and matrix metalloproteinase 3 (MMP3). MMP3 is known to cause joint erosion in inflammatory joint conditions such as rheumatoid arthritis and ankylosing spondylitis. It is therefore proposed that while managing LA, looking for underlying inflammatory arthritis may provide the answer. Disclosures S. Khalid None. M. Cox None. M. Kazmi None.