ObjectiveTo investigate whether antidrug antibodies and/or drug non‐trough levels predict the long‐term treatment response in a large cohort of patients with rheumatoid arthritis (RA) treated with adalimumab or etanercept and to identify factors influencing antidrug antibody and drug levels to optimize future treatment decisions.MethodsA total of 331 patients from an observational prospective cohort were selected (160 patients treated with adalimumab and 171 treated with etanercept). Antidrug antibody levels were measured by radioimmunoassay, and drug levels were measured by enzyme‐linked immunosorbent assay in 835 serial serum samples obtained 3, 6, and 12 months after initiation of therapy. The association between antidrug antibodies and drug non‐trough levels and the treatment response (change in the Disease Activity Score in 28 joints) was evaluated.ResultsAmong patients who completed 12 months of followup, antidrug antibodies were detected in 24.8% of those receiving adalimumab (31 of 125) and in none of those receiving etanercept. At 3 months, antidrug antibody formation and low adalimumab levels were significant predictors of no response according to the European League Against Rheumatism (EULAR) criteria at 12 months (area under the receiver operating characteristic curve 0.71 [95% confidence interval (95% CI) 0.57, 0.85]). Antidrug antibody–positive patients received lower median dosages of methotrexate compared with antidrug antibody–negative patients (15 mg/week versus 20 mg/week; P = 0.01) and had a longer disease duration (14.0 versus 7.7 years; P = 0.03). The adalimumab level was the best predictor of change in the DAS28 at 12 months, after adjustment for confounders (regression coefficient 0.060 [95% CI 0.015, 0.10], P = 0.009). Etanercept levels were associated with the EULAR response at 12 months (regression coefficient 0.088 [95% CI 0.019, 0.16], P = 0.012); however, this difference was not significant after adjustment. A body mass index of ≥30 kg/m2 and poor adherence were associated with lower drug levels.ConclusionPharmacologic testing in anti–tumor necrosis factor–treated patients is clinically useful even in the absence of trough levels. At 3 months, antidrug antibodies and low adalimumab levels are significant predictors of no response according to the EULAR criteria at 12 months.
Objective To identify cases of Sjogren's syndrome among women with chronic dyspareunia who did not Design Prospective recruitment over 12 months.Setting Tertiary referral service for the assessment of vulva1 disease.Participants Women with chronic dyspareunia who had musculoskeletal symptoms, Raynaud's phenomenon or symptoms of ocular or oral dryness. MethodsThe women underwent a Schirmer tear test and a comprehensive auto-antibody screen including latex fixation test for rheumatoid factor, antinuclear, anti-Ro, anti-La and anti-salivary duct antibodies. A labial salivary gland biopsy and vaginal biopsy were taken for routine histological analysis.Main outcome measures Cases of definite and probable Sjogren's syndrome were identified using the European criteria.Results Eleven women were assessed for features of Sjogren's syndrome. Four had definite primary Sjogren's syndrome, two had probable primary Sjogren's syndrome and one had probable secondary Sjogren's syndrome. Among these seven women the median duration of vaginal symptoms was seven years (range 0-25-20), of ocular symptoms was one year (range 0.25-2) and of oral symptoms was 1.5 years (range 0-6). In all but one woman dyspareunia presented before ocular or oral symptoms, often by many years.Conclusions Although well-recognised as a feature of established Sj ogren's syndrome, this study emphasises that chronic dyspareunia can be a presenting feature in these women, antedating the emergence of ocular or oral symptoms by many years. Symptoms of ocular or oral dryness, Raynaud's phenomenon or musculoskeletal symptoms should be sought in women with chronic dyspareunia to identify those who merit further investigation.already have a diagnosed rheumatological disorder.
The occurrence of pelvic insufficiency fractures in patients with rheumatoid arthritis has not previously been well emphasized. These fractures are difficult to detect clinically and appropriate radiological investigation is necessary for diagnosis. We describe five patients with a spectrum of radiological features and discuss the approach to diagnosis and treatment of these lesions.
An algorithm (Stoke index) has been designed to give a global measure of disease activity in rheumatoid arthritis. This algorithm has been created as an easy to use flow diagram based on two objective laboratory measures (C-reactive protein and erythrocyte sedimentation rate), one subjective and two semi-objective clinical measures (morning stiffness, synovitis score and Ritchie articular index). Results of six clinical markers and seven laboratory markers of disease activity on a cohort of 371 rheumatoid patients have been used to evaluate the algorithm and compare it with a previously described index of disease activity (Mallya-Mace index). Principal component analysis validates its ability to measure disease activity. Sensitivity is described by the distribution of patients between the two index scores. Change in index score by patients over a 6-month period indicates reversibility. The Stoke index demonstrates greater sensitivity and reversibility than the Mallya-Mace index. These findings indicate that the algorithm described provides a useful index of global disease activity for use in the assessment of rheumatoid arthritis.
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