Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis.
ABSTRACT Etanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).
Forty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.
The mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann-Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.
This small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.
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ABSTRACT: To assess the labour market position of patients with ankylosing spondylitis (AS) in relation to disease duration and to identify potential factors in relation to withdrawal from the labour force. A cross sectional mail survey was conducted among 658 patients with AS. Participation in the labour force was defined as having a paid job. The independent effect of duration of disease was examined by an indirect method of standardisation. A broad variety of risk factors were examined separately and in a combined analysis, including sociodemographic factors, disease related variables, coping styles, and work related factors. Attributable and preventable fractions were calculated from the combined analyses to assess the relative importance of the contributing factors. Probability of participation in the labour force was similarly reduced in patients with AS with different durations of disease. Pacing to cope with limitations was the most relevant factor in increasing the risk of withdrawal from the labour force, accounting for 73% of withdrawals. Coping with limitations by often seeking creative solutions, high disease activity, increased age, and insufficient support from colleagues or management were also positively associated with withdrawal from the labour force. Technical or ergonomic adjustments of the workplace, working in large companies, and coping with dependency style through frequent acceptance were negatively associated. Of these factors, technical or ergonomic adjustment was the most relevant in terms of reducing the risk. Sociodemographic factors, disease related factors, coping styles, and work related factors contribute simultaneously to withdrawal from the labour force.Annals of the Rheumatic Diseases 09/2002; 61(8):693-9. · 9.11 Impact Factor
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ABSTRACT: Although disease-specific health status measures are available for ankylosing spondylitis (AS), no instrument exists for assessing quality of life (QoL) in the condition. To produce an AS-specific QoL measure that would be relevant and acceptable to respondents, valid, and reliable. The ASQoL employs the needs-based model of QoL and was developed in parallel in the UK and the Netherlands (NL). Content was derived from interviews with patients in each country. Face and content validity were assessed through patient field test interviews (UK and NL). A postal survey in the UK produced a more efficient version of the ASQoL, which was tested for scaling properties, reliability, internal consistency, and validity in a further postal survey in each country. A 41 item questionnaire was derived from interview transcripts. Field testing interviews confirmed acceptability. Rasch analysis of data from the first survey (n=121) produced a 26 item questionnaire. Rasch analysis of data from the second survey (UK: n=164; NL: n=154) showed some item misfit, but showed that items formed a hierarchical order and were stable over time. Problematic items were removed giving an 18 item scale. Both language versions had excellent internal consistency (alpha=0.89-0.91), test-retest reliability (r(s)=0.92 UK and r(s)=0.91 NL), and validity. The ASQoL provides a valuable tool for assessing the impact of interventions for AS and for evaluating models of service delivery. It is well accepted by patients, taking about four minutes to complete, and has excellent scaling and psychometric properties.Annals of the Rheumatic Diseases 02/2003; 62(1):20-6. · 9.11 Impact Factor
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ABSTRACT: Using prospectively collected registry data to investigate sick leave (sickness benefit and sickness compensation) over a 7-yr period in patients with AS in comparison with population-based controls matched for age, sex and residential area. We investigated 122 (21 women and 101 men) outpatients with AS in South Sweden, born 1942 or later, from rheumatology specialist care for their sick leave during a 7-yr period. Mean (S.D.) age was 43 (11) yrs and mean (S.D.) disease duration was 20 (11) yrs. Two controls per case, matched for age, sex and residential area were selected from the Swedish National Population Register. Data concerning sick leave for cases and controls, based on the subjects' unique 10-digit personal identification number, were retrieved from the national register of the Swedish Social Insurance Agency. More AS patients than controls were registered for sickness benefit (52 vs 36%, P < 0.01) and sickness compensation (42 vs 11%, P < 0.001). Cases had an increased risk for sick leave compared with controls with a relative risk of 1.8; 95% CI 1.5, 2.1; and cases had more days with sick leave than controls (median number of more days per year 30; 95% CI 2, 72). Using the Swedish Social Insurance Agency's registers for sick leave, we found that patients with AS in rheumatology specialist care in South Sweden have an increased level of sick leave compared with controls. These population-based registers have a great potential for studies of the effects of different interventions on sick leave.Rheumatology (Oxford, England) 01/2009; 48(3):289-92. · 4.24 Impact Factor