Search

Abstract Objectives To analyse clinical outcomes of a non-medical switch from originator adalimumab (ADA) to its ABP501 biosimilar (ABP) over 6 months in patients with inflammatory rheumatic musculoskeletal diseases (RMD) in relation to comorbidity as a risk factor for therapy discontinuation. Methods RMD patients switching from originator ADA to ABP were identified from a large routine database from October 2018 onwards. Documented clinical data at the time of non-medical switching (baseline), and at 3 and 6 months were collected. Comorbidities were represented by the Charlson Comorbidity Index (CCI) at baseline and patients were categorized based on CCI > 0. Differences in the ABP retention rate over 6 months between patients with CCI = 0 and patients with CCI > 0 were analysed using Bayesian exponential regression. Results A total of 111 patients with axial spondyloarthritis (n = 68), rheumatoid arthritis (n = 23) and psoriatic arthritis (n = 15), were identified, 74.8% of whom had continued treatment with ABP after 6 months, while a smaller proportion had either switched to another ADA biosimilar (10.8%), switched back to originator ADA (7.2%), switched to a different biologic (3.6%), or dropped out (3.6%). At baseline, a CCI > 0 was found in 38% of patients. Cardiovascular comorbidities (40%) were most prevalent followed by diseases of the skin (33%), the gastrointestinal tract (20%) and the eye (20%). ABP treatment was continued after 6 months in 74% of patients with CCI = 0 and in 76% with CCI > 0. Bayesian analysis showed only a small difference (months) in the APB continuation rate between groups (estimate 0.0012, 95% credible interval (CrI) -0.0337 to 0.0361). Adjusting for age, sex, and disease subtype revealed somewhat shorter retention rates for patients with CCI > 0, but the distribution of the difference included 0 (estimate -0.0689, 95% CrI -0.2246 to 0.0234). Conclusion In a non-medical switch scenario of RMD patients, there was no evidence for a considerable difference in ABP retention rates over 6 months between comorbidity groups.

Abstract Objective Define the prevalence and location of inflammatory and structural lesions on magnetic resonance imaging (MRI) in patients with rheumatoid arthritis (RA) and radiographic axial spondyloarthritis (r-axSpA) with neck pain as leading clinical symptom. Methods Patients with diagnosis of RA and r-axSpA were consecutively included if they had chronic (> 3 months) neck pain. Clinical assessment, neck pain questionnaires and MRIs of the cervical spine (CS) were performed. Results 107 patients (59 RA and 48 r-axSpA) were included. While there was no difference in the Northwick-Park-Neck-Pain-questionnaire, patients with RA reported higher neck pain compared to r-axSpA on a numeric rating scale (5.0 ± 3.6 vs. 3.0 ± 3.1; p = 0.003). Inflammatory lesions occurred predominantly in the craniocervical area in RA and in the lower CS segments in r-axSpA. Bone marrow edema (BME) was more frequent in axSpA (BME-score axSpA/RA: 0.35vs0.17; p

Abstract Background In spondyloarthritides (SpA) and fibromyalgia (FM), patients suffer from generalized pain. The impact of FM on PRO validated in SpA has not been systematically studied. Objective Study the performance of PROs developed for SpA in patients with primary (p) FM without chronic inflammatory-rheumatic disease vs. SpA without and with concomitant (c) FM. Methods Patients with pFM, axSpA or PsA and indication for treatment adaptation were prospectively included. Standardized PROs were assessed: BASDAI, ASDAS-CRP, DAPSA, patient´s global assessment, BASFI, LEI, MASES, SPARCC Enthesitis Score and FIQ. Results 300 patients were included (100/diagnosis). More males were found in axSpA vs. PsA and pFM group (67, 33 and 2/100, respectively), while 12 axSpA (axSpA+) and 16 PsA (PsA+) patients had cFM. pFM patients showed significantly higher scores in all assessments vs. axSpA or PsA, with exception of ASDAS-CRP (3.3 ± 0.6 in FM vs. 3.1 ± 1.0 in axSpA) and duration of low lumbar morning stiffness. Similar results were also found in the subanalysis of female patients only. In addition, patients with axSpA + or PsA + showed no differences to patients with pFM, while significantly higher scores were found for FM, axSpA + and PsA + for almost all FIQ items compared to axSpA- or PsA-. Conclusions PROs originally developed for axSpA or PsA need to be interpreted differently in the presence or absence of cFM. ASDAS-CRP and duration of lumbar morning stiffness were not affected by cFM. FM-specific questionnaires also showed high scores in patients with SpA with cFM but not in those without.

Abstract Background In patients with tender and swollen finger joints, the differential diagnosis between rheumatoid arthritis (RA) and osteoarthritis (OA) of the hands can be initially difficult. This prospective study (the TryCort study) was performed to study the diagnostic value of prednisolone in differentiating between RA and hand OA. We present the results of this potentially diagnostic test in patients with possible RA in daily clinical practice by demonstrating the results of a pilot and a validation part of this ‘prednisolone test’ (pred-test). Methods We investigated the response to a 3-day course of 20 mg of prednisolone in patients with suspicion of RA. All patients received 1 g of paracetamol per day for 5 days for pain relief. On days 3–5, a morning dose of 20 mg of prednisolone was added. Hand pain was quantified on a 0–10 Numerical Rating Scale, and the subjective percentage of improvement (0–100%) was recorded. Thresholds for response to prednisolone were investigated in a pilot phase with differentiation in response between patients with RA and patients with OA of the hands, both with pain in the hands ≥4. In a validation phase, the best differentiating cut-off of the pilot phase was applied to discriminate responders from non-responders in consecutive patients with hand pain ≥4 referred because of suspected RA. Final diagnoses were made by the expert upon re-examination at week 12. Primary outcomes were the sensitivity and specificity of a positive test in relation to the diagnosis. Results A percentage of 40% subjective improvement of pain in the hands on day 3 discriminated best between RA and OA in the pilot phase. Among 95 patients with complete data in the validation phase, RA was diagnosed in about 50%. Patients with RA had more swollen joints, higher C-reactive protein levels and slightly higher Health Assessment Questionnaire scores. The pred-test was positive in 42.1% of all patients (40 of 95). The median percentage of improvement on day 5 was higher in RA than in non-RA: 50% (IQR 30–60%) vs. 20% (IQR 10–30%) (p