Public Health Relevance of Graves' Orbitopathy

and Division of Clinical Immunology and Rheumatology (S.M.), Working Group for Health Economics and Clinical Epidemiology, Hannover Medical School, 30625 Hannover, Germany.
The Journal of Clinical Endocrinology and Metabolism (Impact Factor: 6.31). 11/2012; 98(1). DOI: 10.1210/jc.2012-3119
Source: PubMed

ABSTRACT Context:Disfiguring proptosis and functional impairment in patients with Graves' orbitopathy (GO) may lead to impaired earning capacity and to considerable indirect/direct costs.Objective:The aim of the study was to investigate the public health relevance of GO.Design and Setting:This cross-sectional study was performed between 2005 and 2009 at a multidisciplinary university orbital center.Patients:A total of 310 unselected patients with GO of various degrees of severity and activity participated in the study.Interventions:We conducted an observational study.Main Outcome Measures:We measured work disability and sick leave as well as the resulting indirect/direct costs of GO-specific therapies.Results:Of 215 employed patients, 47 (21.9%) were temporarily work disabled, and 12 (5.6%) were permanently work disabled. Five (2.3%) had lost their jobs, and nine (4.2%) had retired early. The mean duration of sick leave was 22.3 d/yr. Compared with the German average of 11.6 d/yr, 32 (15%) patients had taken longer sick leaves. The duration of sick leave correlated with the disease severity (P = 0.015), and work disability correlated with diplopia (P < 0.001). Multivariable analysis identified diplopia as the principal predictor for work disability (odds ratio, 1.7; P < 0.001). The average costs due to sick leave and work disability ranged between 3,301€ (4,153$) and 6,683€ (8,407$) per patient per year. Direct costs were 388 ± 56€ (488 ± 70$) per patient per year and per year were higher in sight-threatening GO (1,185 ± 2,569€; 1,491 ± 3,232$) than in moderate-to-severe (373 ± 896€; 469 ± 1,127$; P = 0.013) or in mild GO (332 ± 857€; 418 ± 1,078$; P = 0.016). Total indirect costs ranged between 3,318€ (4,174$) (friction cost method) and 6,738€ (8,476$) (human capital approach). Work impairment as well as direct and indirect costs of GO significantly correlated with the scores of the internationally standardized and specific GO quality-of-life questionnaire.Conclusions:Productivity loss and a prolonged therapy for GO incur great indirect and direct costs.

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    ABSTRACT: Background: Preliminary studies have shown that Rituximab (RTX) is effective in the treatment of active Graves' orbitopathy (GO). Methods: We conducted a double blind, randomized, trial (EUDRACT 2007-003910-33) to compare RTX to intravenous methylprednisolone (ivMP) in patients with active moderate-severe GO. Thirty-two patients were randomized to receive either ivMP (7.5 g) or RTX (2000 mg or 500 mg). Primary endpoint was the decrease of the CAS of 2 points or to <3 at week 24. Changes of proptosis, lid fissure, diplopia and eye muscle motility, quality of life score were secondary end points. The number of therapeutic responses, disease reactivationand surgical procedures required during follow-up and the patients' quality of life, were also assessed. Findings: The CAS decreased with both treatments, but more after RTX at 16, 20 and 24 weeks (P<0.04, P<0.02, P<0.006, respectively), whether 1000 mg RTX twice or 500 mg RTX once was employed (P=NS). At 24 weeks 100% of RTX patients improved compared to 69% after ivMP (P<0.001). Disease reactivation was never observed in RTX patients, but in five after ivMP. Patients treated with RTX scored better motility at 52 weeks in both the right (P=0.014) and the left eye (P= 0.026). Overall rehabilitative surgical procedures carried out during follow-up (at 76 weeks) were 12 in 16 ivMP patients and 5 in 15 RTX patients (P=0.049). Interpretation: The results of this trial confirm preliminary reports on a better therapeutic outcome of RTX in active moderate-severe GO, when compared to ivMP, even after a lower RTX dose. The better eye motility outcome, visual functioning of the quality of life assessment and the reduced number of surgical procedures in patients after RTX seem to suggest a disease modifying effectof the drug.
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    ABSTRACT: Purpose We aimed to identify the best approach to work ability assessment in patients with thyroid disease by evaluating the factor structure, measurement equivalence, known-groups validity, and predictive validity of a broad set of work ability items. Methods Based on the literature and interviews with thyroid patients, 24 work ability items were selected from previous questionnaires, revised, or developed anew. Items were tested among 632 patients with thyroid disease (non-toxic goiter, toxic nodular goiter, Graves’ disease (with or without orbitopathy), autoimmune hypothyroidism, and other thyroid diseases), 391 of which had participated in a study 5 years previously. Responses to select items were compared to general population data. We used confirmatory factor analyses for categorical data, logistic regression analyses and tests of differential item function, and head-to-head comparisons of relative validity in distinguishing known groups. Results Although all work ability items loaded on a common factor, the optimal factor solution included five factors: role physical, role emotional, thyroid-specific limitations, work limitations (without disease attribution), and work performance. The scale on thyroid-specific limitations showed the most power in distinguishing clinical groups and time since diagnosis. A global single item proved useful for comparisons with the general population, and a thyroid-specific item predicted labor market exclusion within the next 5 years (OR 5.0, 95 % CI 2.7–9.1). Conclusions Items on work limitations with attribution to thyroid disease were most effective in detecting impact on work ability and showed good predictive validity. Generic work ability items remain useful for general population comparisons.
    Quality of Life Research 12/2014; DOI:10.1007/s11136-014-0896-0 · 2.86 Impact Factor
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