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.
-Secondary care rheumatology services for patients with inflammatory arthritis (IA) in the West Midlands were audited using Arthritis and Musculoskeletal Alliance (ARMA) standards of care. Questionnaires were analysed from 1,715 patients in 11 rheumatology departments. ARMA standards recommend full multidisciplinary team assessment; referral rates to nurse specialists (52.3%), physiotherapists (48.7%) and occupational therapists (36.5%) were, however, lower than expected. Attendance at existing hospital-led education groups was rare (8.9%), awareness of existing helplines was moderate (59.2%) but the proportion of patients reporting satisfaction with advice about their disease was high (80.5%). Significant variations were found between departments. For patients with IA <2 years (n=236), 84.5% were seen by a rheumatologist within the ARMA standard of 12 weeks of referral; diagnosis of a type of IA was made at the first rheumatology appointment in 66.4%; 82.8% of rheumatoid arthritis patients had commenced disease-modifying drugs, although time to commencement varied across departments. This study raises issues regarding provision of rheumatology services, prioritisation of patient referral and patient education.KEY WORDS: inflammatory arthritis, referral, regional audit, standards of care IntroductionInflammatory arthritis (IA) is an umbrella term for a number of diseases, principally rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Inflammatory arthritis has a huge impact on patients' lives and imposes a heavy financial burden on both the NHS and national productivity. 1,2 There has historically been great variation in provision of services for people with IA in the UK. 3 With major advances in therapy, however, there is a pressing need to evaluate, optimise and integrate services for these individuals. 4 The Arthritis and Musculoskeletal Alliance (ARMA) published standards of care for people with IA in 2004 3 and these have been supported by the RA guidelines from the British Society for Rheumatology. 5,6 Moreover, a Musculoskeletal Services Framework has now been published by the Department of Health, 7 which re-enforces the same principles of fast access to an array of services.The ARMA standards were developed by an expert working group including people with IA, representatives of user organisations, service providers and clinicians. Following a review of needs of people with IA, evidence-based standards were determined to meet those needs with appropriate provision of musculoskeletal services. 3 The standards include ensuring patients with IA are seen by a rheumatology specialist within 12 weeks of referral, with a developmental standard of six weeks (Standard 4). This is crucial since early, intensive treatment with disease-modifying anti-rheumatic drugs (DMARDs) improves outcome for some types of IA, especially RA. [8][9][10] Access to and full assessment by members of a rheumatology Accessibility and quality of secondary care rheumatology services for people with inflam...
In a pragmatic setting, anti-TNF therapy led to reduced need for steroid injections and other DMARDs, as well as reductions in use of several hospital resources. Wider replication of these findings will be important for planning delivery.
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