Mean BASDAI Research Articles

THU0270 European ankylosing spondylitis (AS) infliximab cohort (EASIC) long-term extension: Efficacy and safety of infliximab over a time period of more than 7 years in patients with AS

BackgroundThe knowledge on the long term efficacy and safety of anti-TNF therapy in patients with AS is rather limited.Methods71/81 patients (87.7%) who completed the 2 year (y) EASIC trial (after...

AB0552 Analysis of patients lost to follow-up in an outpatient rheumatology clinic

BackgroundAnkylosing Spondylitis (AS) patients in routine clinical practice are usually seen at regular intervals (every few weeks to months) depending on their disease activity and type of therapy. However, many...

AB0539 Psychological status evaluation in spondylarthritis tunisian patients and relationship with diseases features

BackgroundThe prevalence of psychological disorders is greater in patients with rheumatologic conditions than among the general population.ObjectivesWe aim in this study to determine the frequency of depression and anxiety disorders...

SAT0535 Diagnosis, Disease Burden and Disease Manifestations of the Sapho Syndrome in Germany: Results from a Nationwide Patient Survey

BackgroundThe term SAPHO syndrome describes a rare, probably underdiagnosed and heterogeneous disease entity. Characteristic disease features include skin, bone and joint manifestations and a predisposition for involvement of the anterior...

THU0272 Efficacy of oral prednisolone in active ankylosing spondylitis – results of a double blind placebo controlled trial

BackgroundTo date no clinical trials are available showing efficacy of moderatly dosed prednisolone for the therapy of active ankylosing spondylitis (AS).ObjectivesTo evaluate the efficacy and safety of moderately dosed prednisolone...

AB0902 Different clinical expression of patients with ankylosing spondyloarthritis by sex according the time of evolution. Regisponser data

BackgroundIt’s a potentially serious illness that can cause significant functional disability and ultimately axial fusion.Historically it has been considered a disease that mainly affects men,but recent studies have shown that...

AB0569 Association between periodontal condition with disease duration and activity in colombian patients with spondyloarthritis

BackgroundIt has been suggested that rheumatic diseases may have additional underlying factors in common with chronic periodontitis. Spondyloarthritis (SpA) is associated with other inflammatory diseases such as psoriasis and uveitis;...

OP0096 Tobacco smoking is associated with increased disease activity in HLA-B27 positive axial spondyloarthritis patients, but does not alter the course of disease activity

BackgroundSmoking is associated with increased disease activity in patients with ankylosing spondylitis (AS) and early axial spondyloarthritis (SpA) in cross-sectional studies, however causation has not been established.ObjectivesTo investigate the impact...

THU0276 A randomized, open-label study to explore whether partial remission can be maintained with naproxen or no treatment in patients with early, active axial spondyloarthritis: Preliminary results of INFAST part II

BackgroundIn patients with axial spondyloarthritis (SpA) who have achieved partial remission, it is unclear whether continuous treatment with NSAIDs is superior to stopping treatment.ObjectivesTo investigate whether continued treatment with naproxen...

Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study

To evaluate the longer-term efficacy of etanercept in patients with severe and advanced active AS. Seventy-seven patients who completed the randomized, double-blind, placebo-controlled 12-week SPINE study enrolled in a 12-week open-label extension and received s.c. etanercept 50 mg once weekly. The etanercept/etanercept group received a total of 24 weeks treatment with etanercept (n = 38); the placebo/etanercept group received placebo during the double-blind study then 12 weeks' etanercept treatment during the open-label extension (n = 39). At the end of the open-label extension, BASDAI scores in the etanercept/etanercept group had further decreased beyond reductions observed during the double-blind study [mean (s.d.) change from baseline -37.6 (22.4) at end of extension vs -27.4 (23.8) at end of double-blind study]. Mean (s.d.) BASDAI scores also improved in the placebo/etanercept group once switched to etanercept [-28.6 (24.3) vs -15.0 (20.0)]. Similar trends were observed in BASFI and BASMI scores. In the placebo/etanercept group, total back pain decreased to similar levels achieved in the etanercept group in the double-blind study. Pain levels continued to decrease with longer-term etanercept therapy in the etanercept/etanercept group. Despite the improvements in symptoms and inflammatory markers observed shortly after initiation of once-weekly etanercept, there was no notable plateauing effect on patient-reported outcomes. Indeed, signs and symptoms of severe and advanced active AS continued to improve after up to 24 weeks, treatment with etanercept.

Clinical diversity of ankylosing spondylitis in the real practice of a rheumatologist in Russia (Part 1)

Система комплексной поддержки и сопровождения научного журнала Elpub позволяет запустить двуязычный сайт журнала со встроенной системой электронной редакции в соответствии с лучшими издательскими практиками, а так же предусматривает техническую и методическую поддержку со стороны специалистов НЭИКОН.

Persistent clinical efficacy and safety of infliximab in ankylosing spondylitis after 8 years--early clinical response predicts long-term outcome

To report for the first time on the efficacy and safety of anti-TNF therapy after 8 years of follow-up in patients with active AS, and analyse possible short-term predictors for long-term clinical outcomes. In this open-label extension of a randomized controlled trial, proportions of the initially included 69 patients with active AS were treated with infliximab 5 mg/kg i.v./6 weeks for 8 years. The last report was published after 5 years. All analyses were based on completers. Overall, 33 (48%) patients completed 8 years. Their mean (s.d.) BASDAI [2.6 (1.9)], BASFI [3.3 (2.6)] and BASMI [2.7 (2.4)] remained low at Year 8. At the end of Year 8, most patients were either in partial remission (n = 8, 24%) or had low disease activity (BASDAI < 3; n = 21, 64%). No new serious adverse events occurred within the past 3 years. Adverse events were the most frequent reason for dropout (56%). There were no differences between completers and dropouts at baseline, but the latter had higher BASFI values at dropout. No baseline parameter was associated with good long-term response to infliximab, but lower BASDAI levels after 12 weeks were predictive of a higher probability of partial remission [odds ratio (OR) 2.9, 95% CI 1.3, 6.3, P = 0.007], low disease activity (OR 1.7, 95% CI 1.2, 2.3, P = 0.005) or remaining on treatment (OR 0.79, 95% CI 0.61, 1.01, P = 0.06) after 8 years. Almost half of the initially treated patients remained on anti-TNF therapy for 8 years, and almost 90% were in partial remission or had low disease activity. Short-term response (low BASDAI at 3 months) is predictive of outcome after 8 years. Infliximab therapy was safe over 8 years.

Spondyloarthritis in women: differences in disease onset, clinical presentation, and Bath Ankylosing Spondylitis Disease Activity and Functional indices (BASDAI and BASFI) between men and women with spondyloarthritides

The aim of this study is to assess the gender differences in spondyloarthritides (SpAs) in terms of disease onset, clinical presentation, and the Bath Ankylosing Spondylitis Disease Activity and Functional indices (BASDAI and BASFI). We analysed data from a predominantly female cohort. Five hundred and 16 patients (male:female = 172:344) with SpA who were assessed at our clinic were asked to complete a questionnaire addressing data related to their disease onset (first symptom at presentation, age at which the first symptom presented, age of diagnosis, and delay in diagnosis), clinical presentation (main problem the disease caused them, night pain/sleep disturbance, well-being over the past week, and well-being over the previous 6months), disease activity indices (erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and BASDAI), and functional index (BASFI). Compared with men, women had greater age at presentation, longer disease duration, more delayed diagnoses and greater age at diagnosis. Back pain was the main presenting symptom equally distributed for both genders. Women had more neck, knee and hip pain as presenting symptoms, while men experienced more feet pain. Back pain is also the main problem that the disease is causing to both sexes. More women had lower back pain, fatigue, neck pain, and pain with pressure as the main problems caused by the disease, while men had more joint pains. Women had significantly greater night pain and sleep disturbance than men. Furthermore, they experienced a worse well-being over past week and over past 6months in addition to a higher mean ESR (P < 0.005), CRP (NS), BASDAI (P < 0.005) and BASFI (P < 0.05) scores. With regard to the items of the BASDAI index, it displays that women experienced significantly more fatigue (BASDAI 1; P < 0.001), total back pain (BASDAI 2; P < 0.05), and longer duration of morning stiffness (BASDAI 6; P = 0.09). With regard to the items of the BASFI index, women showed greater difficulty in reaching high shelves (BASFI 3; P < 0.001), getting up from the floor when lying on their back (BASFI 5; P < 0.001), and looking over their shoulders (BASFI 8; P < 0.05). SpAs present and progress differently in men and women. Women have more neck, knee, and hip pain at presentation and their main problems arise from the neck, back (lower and upper), fatigue and enthesitis during the course of the disease, whilst in men, feet pain was reported more often as presenting symptom than in women, with joint pain being the main problem caused by the disease.

Outcome and safety of TNFα antagonist therapy in 475 consecutive outpatients (with rheumatoid arthritis or spondyloarthropathies) treated by a single physician according to their eligibility for clinical trials

ObjectiveTo investigate the effectiveness and safety of TNFα antagonists in patients with rheumatoid arthritis (RA) or spondyloarthropathies (SpA) treated by a single physician, according to the presence of the inclusion and non-inclusion criteria used to select patients for pivotal clinical trials. MethodsEffectiveness was evaluated based on four categories defined by the DAS28-ESR and BASDAI values, from a very good response (mean DAS-28-ESR less than 3.2 and mean BASDAI less than 2.0) to failure (DAS28-ESR unchanged or greater than 5.1 and BASDAI unchanged). Serious adverse events were defined as events that required permanent TNFα antagonist discontinuation or that led to sequelae, hospital admission, or death. ResultsThe study included 475 patients, 230 with RA, 226 with SpA, 10 with juvenile-onset arthritis, and nine with unclassifiable arthritis. Mean number of TNFα antagonists used per patient was 1.3 and mean duration of TNFα antagonist treatment was 28±23 months. Overall, 41% of patients met the inclusion and non-inclusion criteria used in pivotal trials; the proportion was 43% in the RA group and 40% in the SpA group. These patients had a 3-fold higher rate of very good responses (54 versus 19%) and a 5-fold lower rate of failures (5 versus 25%) compared to the other patients. Of the 15 (3%) patients who died, none met pivotal trial criteria. The group that met pivotal trial criteria had a significantly lower rate of serious adverse events (11 versus 16%; Chi2, p=0.0001), although age was similar in the two groups (53±16 years versus 57±14 years). ConclusionPatients meeting the selection criteria used in pivotal trials had a higher response rate and significantly fewer serious adverse events.

Assessing Back Pain: Does the Oswestry Disability Questionnaire Accurately Measure Function in Ankylosing Spondylitis?

To determine whether the Oswestry Disability Questionnaire (ODQ) can be used to assess the degree of pain or disability in patients with ankylosing spondylitis (AS). The ODQ was administered to a cohort of patients with AS. The resulting pain scores were correlated to the conventional measures in AS, the Bath AS Disease Activity Index and Functional Index (BASDAI and BASFI), as well as the Total and Nocturnal Back Pain scores, and the patient global assessment score. A total of 49 patients with AS were assessed (38 men, 11 women), mean age 40 years (range 17-68). The mean ODQ score was 40/100 (range 0-92), the mean BASDAI 3.7/10 (range 0-9.5), the mean BASFI 3.3/10 (range 0-9.7), the mean total back pain score 3.7/10 (range 0-10), and the mean patient global assessment score 3.6/10 (range 0-10). Correlation between the ODQ and the traditional AS outcome measures was very good, with a correlation coefficient of r = 0.73 (BASFI) and r = 0.70 (BASDAI). Correlations between the ODQ and the total back pain score (r = 0.70) and the patient self-reported global assessment (r = 0.61) were good. The strong correlations between the ODQ and BASFI and BASDAI indicate that it identifies both activity and function domains in AS. This is the first demonstration of a role for this outcome measure in the assessment of patients with AS.

O14 Immune response to outer membrane protein of S. typhimurium in patients with JIA-ERA

Results: Mean age of patients was 34.9 + 8.3 years and mean duration of disease was 8.1 + 5.8 years. Mean BASDAI and BASFI scores were 3.5 + 1.5 and 3.7 + 1.7 respectively. The mean BMD and T score in spine (L1–L4) were 0.915 + 0.160 and −1.643 + 1.375 respectively. The mean BMD and T score in neck femur were 0.8449 + 0.120 and −1.2418 + 1.142 respectively. The mean BMD and T score in femur trochanter were 0.6842 + 0.1171 and −1.1295 + 0.978 respectively. Osteoporosis was seen in 29 (36%) and osteopenia was present in 40 (50%) patients. One of the patients had wedge compression fracture (T12–L1) with associated cauda equine syndrome. Factors associated with osteoporosis were longer disease duration, higher CRP, BASFI and BASDAI. Conclusion: Osteoporosis is a significant problem in AS and needs to be dealt with at an early stage to prevent related problems.

Two distinct patterns of ankylosing spondylitis in Moroccan patients

Ankylosing spondylitis (AS) is characterised by a geographic differences in terms of prevalence and clinical expression of the disease. The aim of our study was to describe the actual features of AS in Morocco and we wanted to examine a large population of patients for evidence of phenotypic clustering that could suggest the presence of distinct clinical entities. We investigated 117 patients with a diagnosis of primary AS according to the modified New York criteria. All patients were evaluated according to a standardised data collection form, including demographic variables and disease history with clinical and radiological features. To analyse our data and try to individualise clinical subsets, we applied a two-step cluster analysis using log-likelihood distance measures. Patient's mean age at onset was 25.51 +/- 10.8 year. The mean BASDAI and BASFI score was 33.5 +/- 20.3 and 38.9 +/- 27.5, respectively. Radiographic damage was present in 99.1% of the subjects and radiographic hip involvement in 47.3%. Only 52.6% of patients had been treated with disease modifying antirheumatic drugs. Cluster analysis detected two distinct populations within the data set. Statistically significant differences were found between the two groups particularly concerning activity of the disease, age at onset and the hygienic conditions. Our study revealed that the Moroccan AS was active and severe and suggested that the age at onset and the precarious hygienic level has the greatest capacity to predict activity and severity of the disease.

Serum and synovial fluid levels of p40 IL12/23 in spondyloarthropathy patients

IL-23 is the main inductor in Th17 polarization of naive T cells, inducing IL-17 production. IL-17 has been demonstrated to be elevated in ankylosing spondylitis (AS). The p40 subunit is common to IL-12 and IL-23. We assessed serum and synovial levels of p40 IL12/23 in spondyloarthropathy (SpA) patients and the evolution under anti-TNF. SpA patients fulfilling ESSG criteria were included. Healthy volunteers served as controls. P40 IL12/23 was assessed using Human Quantikine ELISA (R&D Systems), and at the same time, BASDAI, ESR, CRP, IL-17, MMP-3. Patients treated with anti-TNF were evaluated again after 10 weeks of treatment. Statistical analysis used Mann Whitney and correlation tests. Twenty-seven SpA outpatients (20 men), mean age 40.3 years, mean disease duration 10.5 years, HLA B27 positive n = 21, peripheral arthritis n = 8, mean BASDAI 45.7, mean CRP 30.7 mg/l, and 24 controls (12 men), mean age 50.4 years, were included. There is no statistical difference in serum levels of p40IL12/23 between patients (mean 77.8 pg/ml) and controls (103 pg/ml) and between patients with axial and peripheral involvement. Levels were higher in HLA B-27 negative patients (p = 0.02). No statistical correlation was found between p40 IL12/40 serum levels and each of BASDAI, ESR, CRP, serum levels of IL 17, MMP 3. Fourteen AS patients were treated with TNF blockers. Whereas significant reduction in BASDAI, ESR, and CRP were obvious after treatment, there was no significant change in serum level of p40 IL12/23. Mean levels of synovial p40 IL12/23 were higher in SpA patients (n = 6; mean 536 pg/ml) compared to osteoarthritis patients (n = 3; 133 pg/ml) and compared with paired serum SpA levels. These results suggest that serum levels of p40 IL-12/23 may not be considered as a biologic tool of disease activity assessment in SpA patients.

Serum levels of MMP-3 and cathepsin K in patients with ankylosing spondylitis: Effect of TNFα antagonist therapy

Objective To measure serum levels of MMP-3 and cathepsin K in patients with ankylosing spondylitis (AS) and in controls and to look for changes in these variables during TNFα antagonist therapy. Methods We prospectively studied a group of patients who met New York criteria for AS and a group of healthy volunteers. We recorded age, disease duration, main features of the disease, BASDAI, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). Serum MMP-3 and cathepsin K were assayed in duplicate using ELISA kits (Quantikine MMP-3, R&D Systems; and Cathepsin K, Biomedica). We also assayed IL-17 (Quantikine IL-17, R&D Systems) and BMP-7 (human BMP-7 DuoSet, R&D Systems). In patients treated with TNFα antagonists, the assays were repeated 10 weeks after treatment initiation. The Mann–Whitney test was used for between-group comparisons and the Wilcoxon test for evaluations of changes under treatment. Correlation testing was performed. P-values less than 0.05 were considered significant. Results We studied 23 outpatients with AS and 21 controls, with mean age of 39.9 years and 41.2 years, respectively (NS). Disease duration was 10.1 years (1.3); most patients had axial disease ( n = 21) and carried HLA-B27 ( n = 19). At baseline, the mean BASDAI was 44.1 mm (4.1) and the mean CRP level was 22.3 mg/L (4.7). Serum MMP-3 levels were significantly higher in the patients than in the controls (4.71 vs. 2.79 ng/ml, P = 0.04); levels were also higher for cathepsin K (6.4 vs. 3.6 pg/ml) and IL-17 (60.4 vs. 32 pg/ml), but the differences were not statistically significant. No difference was noted for BMP-7. The only positive correlation was between the ESR and the CRP level ( P = 0.0002). Thirteen patients were evaluated 10 weeks into TNFα antagonist therapy (adalimumab, n = 7; etanercept, n = 4; or infliximab, n = 2). Serum MMP-3 decreased significantly ( P = 0.04); significant decreases were also noted for the ESR, CRP, and BASDAI. Conclusion MMP-3 is significantly increased in patients with active AS but fails to correlate significantly with conventional variables used to assess disease activity. TNFα antagonist therapy induces a significant decrease in MMP-3 levels, together with decreases in conventional variables (ESR, CRP, and BASDAI). MMP-3 may be a biomarker for disease activity in AS but supplies no additional information to the clinician.

The Burden of Ankylosing Spondylitis in Spain

Objective To investigate the burden of ankylosing spondylitis (AS) in Spain, as baseline for economic evaluation of the use of biological agents. Methods A cross-sectional retrospective observational study was performed in 601 patients with AS in Spain, using a methodology developed in studies in the United Kingdom and Canada. Patients were mailed a questionnaire asking about their health-care consumption, out-of-pocket expenses, work capacity, need for informal care during the past 3 months, as well as quality of life. Patient's current functional status and disease activity level was assessed using the Bath functional and disease activity indexes (BASFI and BASDAI). Results The mean age (median) was 47.8 (12.4) years, and the mean disease duration was 18.8 years. Eighty percent of patients were male, and slightly more than half of patients below 65 years of age were working. The mean (median) BASDAI and BASFI scores were 4.3 (2.5) and 3.8 (2.9), respectively, and all levels of disease severity were represented. The mean (median) total annual cost per patient is estimated at €20,328 (€7920). Direct health care represented 22.8%, investments (adaptations of house and devices) and informal care 43.5%, and productivity losses 33.7%. Costs increased significantly with worsening disease, in particular diminishing physical function, covering a range between €5000 and €75,000 per patient and year. The mean (median) utility was 0.59 (0.30). Utility showed a significant inverse relation with BASFI and BASDAI, covering a range from 0.80 for patients with BASFI/BASDAI below 3 to 0.25 for patients with BASFI/BASDAI greater than 7. Conclusions As in studies in other countries, all types of costs accelerate steeply with worsening disease while utility decreases significantly, indicating the need to prevent disease progression.