Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial.

INTRODUCTION: For patients with rheumatoid arthritis (RA) whose treatment with a tumour necrosis factor inhibitor (TNFi) is failing, several biological treatment options are available. Often, another TNFi or a biological with another mode of action is prescribed. The objective of this study was to compare the effectiveness and cost-effectiveness of three biologic treatments with different modes of action in patients with RA whose TNFi therapy is failing. METHODS: We conducted a pragmatic, 1-year randomised trial in a multicentre setting. Patients with active RA despite previous TNFi treatment were randomised to receive abatacept, rituximab or a different TNFi. The primary outcome (Disease Activity Score in 28 joints) and the secondary outcomes (Health Assessment Questionnaire Disability Index and 36-item Short Form Health Survey scores) were analysed using linear mixed models. Cost-effectiveness was analysed on the basis of incremental net monetary benefit, which was based on quality-adjusted life-years (calculated using EQ-5D scores), and all medication expenditures consumed in 1 year. All analyses were also corrected for possible confounders. RESULTS: Of 144 randomised patients, 5 were excluded and 139 started taking abatacept (43 patients), rituximab (46 patients) or a different TNFi (50 patients). There were no significant differences between the three groups with respect to multiple measures of RA outcomes. However, our analysis revealed that rituximab therapy is significantly more cost-effective than both abatacept and TNFi over a willingness-to-pay range of 0 to 80,000 euros. CONCLUSIONS: All three treatment options were similarly effective; however, when costs were factored into the treatment decision, rituximab was the best option available to patients whose first TNFi treatment failed. However, generalization of these costs to other countries should be undertaken carefully. TRIAL REGISTRATION: Netherlands Trial Register number NTR1605. Registered 24 December 2008.

Cortisol during the day in patients with systemic lupus erythematosus or primary Sjogren's syndrome.

OBJECTIVE: To compare the level and change of cortisol during the day of patients with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS) with low and high erythrocyte sedimentation rate (ESR). METHODS: Saliva was collected in the real-life environment of 21 women with SLE, 16 women with pSS, and 30 age-matched healthy women at 9 fixed timepoints during 2 consecutive days. Repeated measures ANOVA was performed to examine whether cortisol levels during the day were different for the patients with low ESR (≤ 20 mm/h) versus those with high ESR (> 20 mm/h). RESULTS: The groups with low and high ESR showed the characteristic change of cortisol during the day (time-of-day effect, F = 124.9, p < 0.001). The cortisol awakening level was lower for patients with high ESR than for patients with low ESR (group*time effect, F = 3.1, p = 0.02). CONCLUSION: The cortisol awakening level differs for patients with low and high ESR, which indicates the usefulness of further studies of hypothalamic-pituitary-adrenal axis dynamics in patients with SLE and pSS.

Psychological and somatic predictors of perceived and measured ocular dryness of patients with primary Sjögren's syndrome.

OBJECTIVE: To test if age, disease activity, pain, fatigue, and depression are associated with subjective and objective ocular dryness of patients with primary Sjögren's syndrome (pSS). METHODS: Sixty female patients with pSS and 60 age matched healthy controls filled out visual analog scale (VAS) scores of ocular dryness and pain, and questionnaires regarding fatigue (Multidimensional Fatigue Inventory) and depression (Zung). Lacrimal tear production was measured by Schirmer I test. As surrogate indicators of disease activity the erythrocyte sedimentation rate, hemoglobin concentration, and total serum immunoglobulin G were determined. RESULTS: Perceived ocular sicca symptoms were not related to Schirmer I test scores. The rate of tear production was related to age (r = -0.47, p < 0.001), disease activity (r = -0.27, p < 0.05), and pain (r = 0.42, p < 0.001). Age and pain together explained 42% of the variance of the Schirmer I test results. CONCLUSION: Not unexpectedly, age and disease activity were associated with ocular dryness, but contrary to expectation, pain was associated with more instead of less tear production. We did not find evidence that pain, fatigue, or depression are associated with reduced tear production or perceived ocular dryness.