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 describe the frequency and predictors of nonserious infections (NSI) and compare incidence across biologic agents within the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR‐RA). Methods The BSRBR‐RA is a prospective observational cohort study. An NSI was defined as an infection that did not require hospitalization or intravenous therapy. Infections were captured from clinician questionnaires and patient diaries. Individuals were considered “at risk” from the date of initiation of biologic treatment for up to 3 years. Drug exposure was defined by agent: tumor necrosis factor inhibitor (TNFi), interleukin‐6 (IL‐6) inhibitor, B cell depletion (rituximab), or conventional synthetic disease‐modifying antirheumatic drugs (csDMARDs) alone. A multiple‐failure Cox model was used with multivariable adjustment. Missing data were addressed using multiple imputation. Results There were 17,304 NSI in 8,145 patients, with an event rate of 27.0 per person per year (95% confidence interval [95% CI] 26.6–27.4). Increasing age, female sex, comorbidity burden, glucocorticoid therapy, higher Disease Activity Score in 28 joints, and higher Health Assessment Questionnaire disability index were associated with an increased risk of NSI. There was a significant reduction in NSI risk with csDMARDs compared to biologic treatments. Compared to TNFi, IL‐6 inhibition and rituximab were associated with a higher NSI risk (adjusted hazard ratio 1.45 [95% CI 1.29–1.63] and adjusted hazard ratio 1.28 [95% CI 1.14–1.45], respectively), while the csDMARD cohort had a lower risk (adjusted hazard ratio 0.64 [95% CI 0.59–0.70]). Within the TNFi class, adalimumab was associated with a higher NSI risk than etanercept (adjusted hazard ratio 1.11 [95% CI 1.05–1.17]). Conclusion NSI occur frequently in RA, and predictors mirror those reported with serious infections. All biologics are associated with a greater risk of NSI, with differences observed between agents. While unmeasured confounding must be considered, the magnitude of effect is large, and a relationship between NSI and targeted immunomodulatory therapy likely exists.

PurposeThe purpose of this paper is to evaluate an annual rheumatology regional audit programme that has been running since 2000 in the West Midlands with no additional funding. Specifically it seeks to identify the strengths of, and difficulties with, regional audit and establish if, and how, regional audit differs from local audit.Design/methodology/approachA qualitative approach was adopted and theoretical sampling used to select seven individuals with a range of experiences of the audit process. Semi‐structured interviews were conducted, recorded and transcribed, and analysed using thematic analysis.FindingsThe programme was thought to be valuable with unforeseen educational benefits for trainees and in fostering positive relations across the region. Regional audit appears to overcome some of the problems with local audit by utilising resources effectively and having sound leadership. Barriers to regional audit included problems with communication between the organising panel and data collecting units, fostering ownership and ensuring closure of the “audit loop”.Research limitations/implicationsThe findings are limited by the small sample and the single region nature of the study. The findings have informed a questionnaire to measure agreement to the perceptions identified and survey change of practice occurring as a result of previous regional audits.Practical implicationsThe findings will inform future planning and hopefully ensure sustainability of this large unfunded programme; the findings will also be of use to other regions and specialties looking to adopt regional audit.Originality/valueRegional audit offers a useful and feasible adjunct to national audit and this paper describes an evaluation of an innovative scheme.

-Strengthening clinical audit is crucial for improving the quality of healthcare provision. The West Midlands Rheumatology Service and Training Committee coordinates an innovative programme of regional audits and the experience of rheumatology healthcare professionals involved was surveyed. This was a questionnairebased study in which respondents rated statements relating to regional audit on Likert scales. Out of 105 staff, 70 replied. There was consensus that results of regional audit have been robust, valid and reliable; regional audits benefit patients and units; provide educational opportunities for specialist registrars (SpRs); and are more efficient than local audit by allowing comparison between units. Opinion was divided about how well informed respondents were and how effective they are at closing the audit loop. Many units reported changes in practice. Regional audit is widely perceived to be a valuable clinical governance tool supporting significant changes to clinical practice, and an excellent training opportunity for SpRs. Recommendations for a successful regional audit scheme are described in this article.

Foundation doctors have a limited ability to self assess. Nevertheless, this needs to be developed through constructive feedback and appraisal.