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.
The aim of this study was to ascertain whether fibromyalgia patients with positive ANA develop other features of connective tissue disease over 2-4 years' follow-up. Patients attending our clinic with a diagnosis of fibromyalgia were identified. All ANA-positive patients (n = 12) were recruited and matched for age and sex with 12 ANA-negative FMS patients. As further control groups, patients with a diagnosis of osteoarthritis (OA) were included. A screening questionnaire for possible features of connective tissue disease was sent to all participants. Patients who had three or more positive criteria were invited for further assessment. The ANA-positive rate was 12/137 (8.8%) in FMS and 20/225 (8.9%) in OA patients. All ANA positivity was at a low titre. Fourteen out of 20 (70%) FMS patients and 17/30 (56.7%) OA patients had three or more criteria (P = 0.34). No significant differences in the number of the positive criteria were found between those who were ANA positive or negative in both groups. On full assessment we found one patient who fulfilled the criteria for SLE from the ANA-positive FMS group and one in the ANA-negative group who fulfilled the criteria for primary Sjögren's syndrome. Of the patients with OA, one who was ANA positive was diagnosed as having rheumatoid arthritis. The results from our study show that ANA (at least in low titre) is not a good predictor of the future development of connective tissue.
BackgroundThe diagnostic delay in axial spondyloarthritis is reported to be improving after campaigns by ASAS and the rheumatology community to educate primary care physicians to refer patients for early assessment1. MRI scanning has also been in widespread use since 2000. We conducted a local study to assess if diagnostic delay was improving in our well-defined cohort of ankylosing spondylitis (AS) patients who are reviewed in our physiotherapy-led service, and to compare this with national trends.ObjectivesWe set out to determine the time to diagnosis of AS in our cohort and to assess if this has changed over time. Our aim is to reduce diagnostic delay by educating local primary care clinicians about inflammatory back pain (IBP) and the importance of early recognition and referral.MethodsPatients were identified from the physiotherapy database of 53 patients currently reviewed under the AS service at a district hospital in the North West of England. We assessed mean and median delay to diagnosis, gender, family history of AS, those diagnosed pre- and post-2000, patient age and date of first presentation to primary care with IBP, and date of first rheumatology review. Only those fulfilling diagnostic criteria for AS were included in the dataset.Results44 males and 9 females with age range 28–83 years.Mean delay to diagnosis was 8.94 years. Median delay to diagnosis: 8 years.1962–1999 (10 patients) Mean 6.7 years. Median 7 years2000–2004 (13 patients) Mean 9.5 years. Median 7 years2005–2009 (15 patients) Mean 9.8 years. Median 8 years2010–2015 (16 patients) Mean 9.1 years. Median 7 yearsRange of diagnostic delay was 0 to 40 years. 15% were diagnosed in <2 years. 42% diagnosed in <5 years. 58% diagnosed in <10 years. The pre-2000 mean delay to diagnosis was 6.7 years, Post-2000 mean delay was 9.45. However, 81% of our AS patients were diagnosed post-2000.42% of patients were on biologic therapy, the remainder were on NSAIDs. No significant difference was seen between the sexes. 19% of patients had a clear family history of AS, and no difference was seen in delay to diagnosis compared to those without family history.ConclusionsOur findings closely reflect those of national data obtained in recent studies2. Diagnostic delay has not improved in the time frame of this local study, although AS diagnoses have proportionally increased, likely due to increased use of MRI. Why is the delay not improving? Back pain remains a common presenting complaint in primary care, with lack of recognition of associated extra-articular features. In conclusion, there remains a need for education on when to suspect axial spondyloarthritis and refer to secondary care.To follow up this study we are holding a series of AS targeted educational meetings with primary care colleagues, a local AS patient support group and regional special interest group. We will assess this intervention and subsequent referrals with the aim of improving confidence in suspected AS cases.ReferencesSrensen J, Hetland ML; all departments of rheumatology in Denmark. Di...
The results of this pilot study demonstrate the potential diagnostic utility of FS and TOS assessments in SSc patients and further work is now needed to validate these techniques prospectively in a larger group of SSc patients across the spectrum of the disease, and also patients with other types of vasculopathy and conditions that can cause skin fibrosis.
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