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ABSTRACT: The Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire is a disease- specific instrument developed to measure quality of life (QoL) in patients with psoriatic arthritis (PsA). The aim of this study was to translate the measure into Dutch and to determine its psychometric properties.
Translation of the original English PsAQoL into Dutch was performed by bilingual and lay panel. Ten field-test interviews with PsA patients were performed to assess face and content validity. In total, 211 PsA patients were included in a test-retest postal survey to investigate the reliability and construct validity of the Dutch adaptation of the PsAQoL. The PsAQoL, Health Assessment Questionnaire (HAQ) and Skindex-17 were administered on two different occasions approximately two weeks apart.
The Dutch version of the PsAQoL was found to be relevant, understandable and easy to complete in only a few minutes. It correlated as expected with the HAQ (Spearman's ρ = 0.72) and the 2 subscales of the Skindex-17 (ρ = 0.40 for the psychosocial and ρ = 0.46 for the symptom scale). Furthermore, the measure had good internal consistency (Cronbach's α = 0.92) and test-retest reliability (ρ = 0.89). The PsAQoL was able to define groups of patients based on self-reported general health status, self-reported severity of PsA and flare of arthritis. Duration of PsA did not influence PsAQoL scores.
The Dutch version of the PsAQoL is a valid and reliable questionnaire suitable for use in clinical or research settings to asses PsA-specific QoL.
PLoS ONE 01/2013; 8(2):e55912. · 4.09 Impact Factor
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ABSTRACT: The aim of this study was to investigate the effect of three years of tumor necrosis factor-alpha (TNF-α) blocking therapy on bone turnover as well as to analyze the predictive value of early changes in bone turnover markers (BTM) for treatment discontinuation in patients with ankylosing spondylitis (AS).
This is a prospective cohort study of 111 consecutive AS outpatients who started TNF-α blocking therapy. Clinical assessments and BTM were assessed at baseline, three and six months, as well as at one, two, and three years. Z-scores of BTM were calculated to correct for age and gender. Bone mineral density (BMD) was assessed yearly.
After three years, 72 patients (65%) were still using their first TNF-α blocking agent. In these patients, TNF-α blocking therapy resulted in significantly increased bone-specific alkaline phosphatase, a marker of bone formation; decreased serum collagen-telopeptide (sCTX), a marker of bone resorption; and increased lumbar spine and hip BMD compared to baseline. Baseline to three months decrease in sCTX Z-score (HR: 0.394, 95% CI: 0.263 to 0.591), AS disease activity score (ASDAS; HR: 0.488, 95% CI: 0.317 to 0.752), and physician's global disease activity (HR: 0.739, 95% CI: 0.600 to 0.909) were independent inversely related predictors of time to treatment discontinuation because of inefficacy or intolerance. Early decrease in sCTX Z-score correlated significantly with good long-term response regarding disease activity, physical function and quality of life.
Three years of TNF-α blocking therapy results in a bone turnover balance that favors bone formation, especially mineralization, in combination with continuous improvement of lumbar spine BMD. Early change in sCTX can serve as an objective measure in the evaluation of TNF-α blocking therapy in AS, in addition to the currently used more subjective measures.
Arthritis research & therapy 04/2012; 14(2):R98. · 4.27 Impact Factor
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ABSTRACT: Identifying the characteristics of patients with ankylosing spondylitis (AS) before start of treatment which are able to predict a beneficial response to tumor necrosis factor-alpha (TNF-α) blocking therapy is relevant, especially in view of the high costs and potential side-effects of these agents. This review provides an overview of clinical trials and observational studies investigating baseline predictors of response after 3-6 months of TNF-α blocking therapy and baseline predictors of long-term anti-TNF-α treatment continuation in AS.
In multiple studies, increased acute phase reactants, higher disease activity, higher functional status, younger age, and HLA-B27 positivity were identified as independent baseline predictors of achieving clinical response to TNF-α blocking therapy. Increased acute phase reactants, presence of peripheral arthritis, and male sex were repeatedly identified as independent baseline predictors of anti-TNF-α treatment continuation.
Several studies using multivariate analyses identified comparable baseline predictors of response and/or continuation of TNF-α blocking therapy. The single predictors identified have, at best, moderate capacity to predict treatment response in the individual patient. The development of a prediction model may lead to a more robust instrument to support physicians in decision making on TNF-α blocking therapy in AS in daily clinical practice.
Current opinion in rheumatology 03/2012; 24(3):290-8. · 4.60 Impact Factor
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ABSTRACT: Identifying ankylosing spondylitis (AS) patients who are likely to benefit from tumor necrosis factor-alpha (TNF-α) blocking therapy is important, especially in view of the costs and potential side effects of these agents. Recently, the AS Disease Activity Score (ASDAS) has been developed to assess both subjective and objective aspects of AS disease activity. However, data about the predictive value of the ASDAS with respect to clinical response to TNF-α blocking therapy are lacking. The aim of the present study was to identify baseline predictors of response and discontinuation of TNF-α blocking therapy in AS patients in daily clinical practice.
AS outpatients who started TNF-α blocking therapy were included in the Groningen Leeuwarden Ankylosing Spondylitis (GLAS) study, an ongoing prospective longitudinal observational cohort study with follow-up visits according to a fixed protocol. For the present analysis, patients were excluded if they had previously received anti-TNF-α treatment. Predictor analyses of response and treatment discontinuation were performed using logistic and Cox regression models, respectively.
Between November 2004 and April 2010, 220 patients started treatment with infliximab (n = 32), etanercept (n = 137), or adalimumab (n = 51). At three and six months, 68% and 63% of patients were Assessments in Ankylosing Spondylitis (ASAS)20 responders, 49% and 46% ASAS40 responders, and 49% and 50% Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 responders, respectively. Baseline predictors of response were younger age, male gender, higher ASDAS score, higher erythrocyte sedimentation rate (ESR) level, higher C-reactive protein (CRP) level, presence of peripheral arthritis, higher patient's global assessment of disease activity, and lower modified Schober test. In August 2010, 64% of patients were still using their TNF-α blocking agent with a median follow-up of 33.1 months (range 2.4 to 68.2). Baseline predictors of discontinuation of TNF-α blocking therapy were female gender, absence of peripheral arthritis, higher BASDAI, lower ESR level, and lower CRP level.
Besides younger age and male gender, objective variables such as higher inflammatory markers or ASDAS score were identified as independent baseline predictors of response and/or continuation of TNF-α blocking therapy. In contrast, higher baseline BASDAI score was independently associated with treatment discontinuation. Based on these results, it seems clinically relevant to include more objective variables in the evaluation of anti-TNF-α treatment.
Arthritis research & therapy 06/2011; 13(3):R94. · 4.27 Impact Factor
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Suzanne Arends,
Eveline van der Veer,
Henk Groen,
Pieternella M Houtman,
Tim L T A Jansen,
Martha K Leijsma,
Johan Bijzet,
Pieter C Limburg,
Cees G M Kallenberg, Anneke Spoorenberg,
Elisabeth Brouwer
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ABSTRACT: To investigate whether level of serum matrix metalloproteinase-3 (MMP-3) can serve as a biomarker for monitoring and predicting response to etanercept treatment in patients with ankylosing spondylitis (AS) in daily clinical practice.
Ninety-two consecutive AS outpatients with active disease who started etanercept treatment were included in this longitudinal observational study. Clinical data were collected prospectively at baseline and after 3 and 12 months of treatment. At the same timepoints, serum MMP-3 levels were measured retrospectively by ELISA.
Since baseline serum MMP-3 levels were significantly higher in male compared to female patients with AS, data analysis was split for gender. Changes in serum MMP-3 levels after etanercept treatment correlated positively with changes in clinical assessments of disease activity and physical function in both male and female patients. Receiver operating characteristic analysis in male patients showed that baseline serum MMP-3 levels had poor accuracy (AUC < 0.7) to discriminate between Assessments in Ankylosing Spondylitis 20 (ASAS20) or ASAS40 responders and nonresponders after 3 or 12 months of treatment. The accuracy of change in serum MMP-3 levels from baseline to 3 months in predicting response after 3 or 12 months of treatment was poor for ASAS40 (AUC < 0.7) or moderate for ASAS20 (AUC = 0.752 and 0.744, respectively), and was not superior to the accuracy of change in the currently used objective biomarkers, erythrocyte sedimentation rate and C-reactive protein.
Although significant changes in serum MMP-3 levels were found after etanercept treatment, data analysis indicates that serum MMP-3 levels are not very useful for monitoring and predicting response to etanercept treatment in patients with AS in daily clinical practice.
The Journal of Rheumatology 06/2011; 38(8):1644-50. · 3.69 Impact Factor
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ABSTRACT: To investigate if the tragus-to-wall distance (TWD) is more reliable compared to the occiput-to-wall distance (OWD) as a measurement for thoracic spine extension in patients with ankylosing spondylitis (AS).
Data from the OASIS cohort, an international longitudinal observational study on outcome in AS, were used. Measurements of OWD and TWD were performed at baseline and at 6, 12, 18, and 24 months. Paired data of Tx and Tx+6 months were used to perform test-retest measurements (intraclass correlations, limits of agreement, and interperiod correlation matrix). Bland and Altman plots were constructed to investigate the agreement between both observations, assuming that there was no true change between 0 and 6 months. To investigate whether a change in disease activity would have influenced the results, limits of agreement were calculated in a subgroup of patients with a stable Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; defined as a maximum BASDAI change of +/- 1) between T0 and T6 and compared with the results of the whole group. Limits of agreement were also calculated for kyphosed patients only.
The test-retest intraclass correlations were between 0.94 and 0.96 for OWD and between 0.93 and 0.95 for TWD. The direct measurement-remeasurement correlation calculated by extrapolation of the interperiod correlation regression line was 0.92 for OWD and 0.90 for TWD. OWD and TWD showed comparable reliability on the entire value of scores. The lower 95% limit of agreement was between -3.4 cm and -2.5 cm for OWD and between -3.4 cm and -3.1 cm for TWD. The upper limit of agreement was between 3.1 cm and 4.2 cm for OWD and between 2.9 cm and 3.9 cm for TWD. In all patients as well as in kyphosed patients only, limits of agreement were comparable between OWD and TWD. The patterns of the scatterplots according to Bland and Altman were similar for OWD and TWD. Measurement error was more pronounced in kyphosed patients compared to patients with a normal thoracic extension. However, over the entire range of kyphosis, measurement error was similar.
OWD and TWD are equally reliable in assessing thoracic spine extension. Although the TWD is in general easier to perform in AS patients compared to OWD, we recommend the OWD measurement over TWD: in OWD measurement a value of zero easily distinguishes patients with normal thoracic spine extension from kyphosed patients.
The Journal of Rheumatology 10/2004; 31(9):1779-84. · 3.69 Impact Factor
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ABSTRACT: To select the most appropriate radiologic scoring method for the evaluation of radiographic progression in ankylosing spondylitis (AS) in clinical trials.
The validity of the currently available methods, the Bath Ankylosing Spondylitis Radiology Index (BASRI), the Stoke Ankylosing Spondylitis Spine Score (SASSS), and the modified SASSS (M-SASSS), was tested according to the aspects of the Outcome Measures in Rheumatology Clinical Trials filter: truth, discrimination (reliability and sensitivity to change), and feasibility, using radiographs of 133 patients at 4 different time points (baseline, 1 year, 2 years, and 4 years). One observer scored these sets in chronological order. To assess interobserver reliability, a second observer scored radiographs of 20 patients at the 4 different time points.
After 4 years, 9% and 8% of patients showed changes >0 in the sacroiliac (SI) joints and hips, respectively. Independent of the method chosen, approximately 40% of patients showed changes in both the lumbar and cervical spine. Therefore, it was concluded that, for the assessment of progression, SI joints and hips are of minor importance. The intraclass correlation coefficient (ICC) varied from 0.87 to 0.98 and ICCs for intraobserver scores varied from 0.96 to 0.99. Concerning progression scores, only the ICC for the M-SASSS measured after 2 years remained acceptable (0.82). The intraobserver scores for progression after 2 years of followup were an ICC of 0.93 for the BASRI, an ICC of 0.79 for the SASSS, and an ICC of 0.95 for the M-SASSS. Concerning sensitivity to change, it was found that the M-SASSS classified the highest percentage of patients with a change >0.
The M-SASSS is the most appropriate method by which to score the radiographic progression in AS patients in clinical trials.
Arthritis & Rheumatism 08/2004; 50(8):2622-32. · 7.87 Impact Factor
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ABSTRACT: Objective
To select the most appropriate radiologic scoring method for the evaluation of radiographic progression in ankylosing spondylitis (AS) in clinical trials.Methods
The validity of the currently available methods, the Bath Ankylosing Spondylitis Radiology Index (BASRI), the Stoke Ankylosing Spondylitis Spine Score (SASSS), and the modified SASSS (M-SASSS), was tested according to the aspects of the Outcome Measures in Rheumatology Clinical Trials filter: truth, discrimination (reliability and sensitivity to change), and feasibility, using radiographs of 133 patients at 4 different time points (baseline, 1 year, 2 years, and 4 years). One observer scored these sets in chronological order. To assess interobserver reliability, a second observer scored radiographs of 20 patients at the 4 different time points.ResultsAfter 4 years, 9% and 8% of patients showed changes >0 in the sacroiliac (SI) joints and hips, respectively. Independent of the method chosen, ∼40% of patients showed changes in both the lumbar and cervical spine. Therefore, it was concluded that, for the assessment of progression, SI joints and hips are of minor importance. The intraclass correlation coefficient (ICC) varied from 0.87 to 0.98 and ICCs for intraobserver scores varied from 0.96 to 0.99. Concerning progression scores, only the ICC for the M-SASSS measured after 2 years remained acceptable (0.82). The intraobserver scores for progression after 2 years of followup were an ICC of 0.93 for the BASRI, an ICC of 0.79 for the SASSS, and an ICC of 0.95 for the M-SASSS. Concerning sensitivity to change, it was found that the M-SASSS classified the highest percentage of patients with a change >0.Conclusion
The M-SASSS is the most appropriate method by which to score the radiographic progression in AS patients in clinical trials.
Arthritis & Rheumatism 07/2004; 50(8):2622 - 2632. · 7.87 Impact Factor
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ABSTRACT: To assess the differences in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) between patients with and without peripheral arthritis/enthesitis. To investigate whether scores on the BASDAI change by omitting the 2 questions on peripheral disease.
Disease activity was assessed on a 10-cm visual analog scale and by BASDAI. Alternative BASDAIs were constructed by omitting the peripheral joints question and/or the enthesitis question. Correlations between the alternative BASDAIs and other measures of disease activity were calculated. Generalized estimating equations (GEE) were used to assess whether having peripheral arthritis influenced BASDAI and alternative BASDAI scores, and to assess whether peripheral arthritis influenced the score of the individual questions of the BASDAI.
At baseline, the BASDAI was calculated in 214 patients. In patients with peripheral arthritis (n = 56), the mean (SD) BASDAI score was 4.4 (2.3) as compared with 3.1 (1.9) (P < 0.0001) in the patients without peripheral arthritis (n = 158). The relationship between arthritis and the BASDAI score appeared to be truly longitudinal (GEE regression coefficient beta = 0.64; 95% confidence interval 0.28-1.00). Peripheral arthritis was significantly longitudinally associated with all separate item scores of the BASDAI. Omitting the peripheral joints and/or enthesitis question from the BASDAI questionnaire only partially explained the difference in BASDAI score between the 2 groups.
Disease activity measured by the BASDAI is higher in patients with concomitant peripheral disease compared with patients with disease restricted to the axial skeleton. The increased BASDAI score in patients with peripheral arthritis is partially explained by increased overall disease activity as well as by a disproportionate contribution of the peripheral joints question to the overall score.
Arthritis & Rheumatism 04/2004; 51(2):154-9. · 7.87 Impact Factor
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ABSTRACT: To compare reliability and change over time of radiological scoring methods in ankylosing spondylitis (AS).
Two trained observers scored 217 sets of radiographs from baseline and from one and 2 years' followup. Sacroiliac (SI) joints were grade 0-4 by the New York method and Stoke Ankylosing Spondylitis Spine Score (SASSS). Hips and cervical and lumbar spine were graded 0-4 by Bath Ankylosing Spondylitis Radiology Index (BASRI). BASRI spinal scores and New York SI are combined into BASRI-spine (score 2-12) and with the addition of BASRI-hips into BASRI-total (2-16). Cervical and lumbar spine were also scored in detail (SASSS, 0-36 each) and were combined into SASSS-total or "modified" SASSS (both range 0-72). To assess change a smallest detectable difference (SDD) was estimated for data on a quasi-interval scale.
The SI scoring methods showed intra and interobserver kappa between 0.36 and 0.70. The BASRI-hip reached kappa between 0.59 and 0.84. Combined SASSS scores were most reliable, with intra and interobserver intraclass correlation coefficients (ICC) between 0.90 and 0.96. The ICC of the combined BASRI scores were also very good, ranging from 0.85 to 0.95. For SI New York, SI SASSS, and BASRI-hip, 0.3-1.2% of patients deteriorated 1 grade; 7.5% deteriorated 1 grade (6.3% of maximum score) in BASRI-spine and BASRI-total, and observers agreed in up to 48% of the cases that no change occurred. The SDD was lowest (7.5; 10% of maximum score) for "modified" SASSS. Only 0.8% of patients deteriorated more than the SDD and observers agreed in up to 92% of the cases that no change occurred.
Radiological scoring methods for AS are moderately to excellently reliable. Under the selected scoring conditions (concealed time order, average of 2 observers, SDD based on interobserver data, unselected patient population) there was too little change over 2 years to be detected reliably by the scoring methods.
The Journal of Rheumatology 02/2004; 31(1):125-32. · 3.69 Impact Factor
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ABSTRACT: To evaluate the smallest detectable difference (SDD) of symptomatic outcome or process variables in ankylosing spondylitis (AS) patients from various countries.
Thirty consecutive AS patients with axial involvement were recruited from 1 center in each of 4 countries (Spain, Morocco, France, The Netherlands), for a total of 120 patients. Fourteen variables were studied in 6 domains: pain (3 variables), stiffness (1 variable), function (2 variables), spinal mobility (3 variables), patient global assessment (4 variables), and the domain of enthesiopathy (1 variable). All patients were evaluated twice within a 1-week period during which no clinical or therapeutic change occurred. Intracenter reliability was evaluated using the intraclass correlation coefficient (ICC). The SDD was determined using the Bland-Altman method.
Of the 14 variables evaluated in the 120 patients (82% males, 42 +/- 12 years old, with a mean disease duration of 17 +/- 13 years), only the SDD for the variable occiput-to-wall distance showed statistically significant difference among centers. For the entire group, the SDD, expressed as percentage of the range of the variable, varied from 10% (Mander enthesis index) to 39% (spinal pain at night last week). The intraobserver reliability was good (ICC > 0.80) except for the variables morning stiffness and modified Schober test (ICCs of 0.76 and 0.60, respectively).
This study suggests that the evaluation of AS patients is homogenous and reliable in different centers of different European and North African countries. Evaluation of the SDD of the symptomatic outcome or process variables is a starting point to determine the minimum clinically important difference, permitting the presentation of results of clinical studies on an individual basis.
Arthritis & Rheumatism 01/2003; 47(6):582-7. · 7.87 Impact Factor
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ABSTRACT: To investigate whether the single-item fatigue question of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Multidimensional Fatigue Inventory (MFI) are appropriate instruments to measure fatigue in ankylosing spondylitis (AS); to identify factors that influence fatigue in AS; and to assess how fatigue in all its aspects is associated with quality of life in AS.
A total of 812 patients with AS were included. Patients completed questionnaires on disease activity (BASDAI), functional ability (Bath Ankylosing Spondylitis Functional Index [BASFI]), global well-being (Bath Ankylosing Spondylitis Global Score [BAS-G]), overall perceived health (EuroQoL visual analog scale), and quality of life (Ankylosing Spondylitis Quality of Life questionnaire, and Short Form 36 [SF-36]). Patients were dichotomized into a F+ group (fatigue = major symptom) if the BASDAI fatigue score was > 5.0 and a F- group (fatigue = minor symptom) if the fatigue score was < 5.0. Reproducibility was assessed with intraclass correlation coefficients, and responsiveness was calculated according to 3 different methods. Logistic regression analysis was used to determine which factors were associated with fatigue. Multiple regression analysis was used to investigate whether fatigue contributes in explaining quality of life.
Fifty-three percent of the patients were assigned to the F+ group. They scored significantly worse compared with the F- group with respect to each dimension of the MFI and to all other questionnaires studied (all P < 0.001). The BASDAI fatigue question, as well as each separate dimension of the MFI, showed moderate to good reproducibility (0.57-0.75) and responsiveness (0.23-0.96). Fatigue was, in the opinion of the patients, highly associated with pain (70% of patients) and stiffness (54% of patients). Logistic regression analysis showed that scores on BASDAI, BASFI, BAS-G, and mental health status (SF-36) were independently associated with fatigue (R(2) = 0.52). Multiple regression analysis showed that scores on the BASDAI fatigue question were significantly associated with quality of life. With the 5 MFI dimensions as explanatory variables, different aspects of fatigue were associated with different domains of quality of life.
Fatigue as a major symptom of AS can effectively be measured with either a single-item question on the intensity of fatigue or with the MFI. The MFI, however, provides more insight into specific dimensions of fatigue. Fatigue appears to be associated with the level of disease activity, functional ability, global well-being, and mental health status. In addition, fatigue negatively influences different aspects of quality of life.
Arthritis & Rheumatism 02/2002; 47(1):8-16. · 7.87 Impact Factor
