The first biological therapeutics in rheumatology are approaching patent expiration, encouraging development of 'follow-on' versions, known as 'biosimilars'. Biological agents range from simple replacement hormones to complex monoclonal antibodies and soluble receptors: large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate. Post-translational modifications, such as glycosylation, may occur from changes in cell lines and/or manufacturing processes, resulting in products that are highly similar, but not identical, to approved 'reference' agents, hence, the term 'biosimilar', rather than 'bioidentical'. Even minor modifications in manufacturing processes, which iteratively occur with reference products due to improvements in efficiency, scale up to meet commercial demands or changes in manufacturing sites, may alter biological function and/or immunogenicity, potentially changing their safety and efficacy profile. As biosimilars are now in randomised controlled trials for treatment of rheumatic diseases, rheumatologists face decisions regarding equipoise and will need to consider their clinical use versus reference products. A clear understanding of the inherent differences between reference antibodies and biosimilars, their clinical implications and the processes governing regulation, approval and clinical use of biosimilars, is paramount. A panel of international experts in the field of rheumatology recently convened to evaluate and discuss these issues.

ObjectivesTo compare the presentation of seropositive and seronegative early rheumatoid arthritis (RA) in disease-modifying antirheumatic drug (DMARD)-naïve patients classified according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria.MethodsAll patients had symptom duration from first swollen joint <2 years and were DMARD naïve with an indication for DMARD treatment. Patients were stratified as seropositive (positive rheumatoid factor (RF)+ and/or anticitrullinated peptide antibody (ACPA)+) or seronegative (RF− and ACPA−), and disease characteristics were compared between groups.ResultsA total of 234 patients were included, and 36 (15.4%) were seronegative. Ultrasonography (US) scores for joints (median 55 vs 25, p<0.001) and tendons (median 3 vs 0, p<0.001), number of swollen joints (median 17 vs 8, p<0.001), disease activity score (DAS; mean 3.9 vs 3.4, p=0.03) and physician global assessment (mean 49.1 vs 38.9, p=0.006) were significantly higher in seronegative patients compared with seropositive. Total van der Heijde-modified Sharp score, Richie Articular Index and patient-reported outcome measures were similar between groups.ConclusionsSeronegative patients had higher levels of inflammation, assessed both clinically and by US, than seropositive patients. These differences may reflect the high number of involved joints required for seronegative patients to fulfil the 2010 ACR/EULAR classification criteria for RA.Trial registration numberNCT01205854; Pre-results.

Although HPs regarded sexuality as a relevant topic in rheumatic health care, they seldom raised the topic in consultations. Those with further education in sexuality addressed sexual issues more frequently and felt more comfortable. Correspondingly, the majority of respondents requested more education. Such training should be part of the basic HPs' education, as well as part of postgraduate courses.

Bilateral assessments of ECU, TB, and FDL tendons were as sensitive to change as the sum scores of all tendons, and scoring of this reduced number of tendons is suggested to be included in US scorings for follow-up of RA patients.

Considering the key position of patients' global assessment in clinical practice and research, we wanted to examine the relationships between patients' global assessment and biological, functional, and mental variables, and to explore the relative contribution of these variables on patients' assessment of arthritis impact. Patients with RA of < or = 4 yrs duration were examined at baseline (n = 238) and after 12 and 24 months (n = 216). Study variables were tender joints, ESR, CRP, hand X-ray abnormalities and self-reported global arthritis impact, pain, disability, and symptoms of depression. 2-yr mean scores were computed for all variables. Strong correlations were found between patients' global assessment and pain (r = .73), depression (r = .68), disability (r = .64), and tender joints (r = .51), while ESR, CRP, and X-ray abnormalities correlated weakly with the global assessment. Using a multivariate approach, however, the relative effects of disability and tender joints were no longer statistically significant, whereas pain and depression still had significant impact on patients' global assessments.