Rheumatology
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The aim of this study was to identify subgroups in terms of adaptation to FM and to test differences in FM severity between these subgroups. ⋯ Heterogeneity of FM was shown by five clinically meaningful profiles of modifiable factors that were associated with FM severity. It is of clinical interest to examine whether these profiles are associated with FM prognosis and the effectiveness of interventions, which would enhance the development of customized interventions based on adaptation profiles in FM.
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Randomized Controlled Trial Multicenter Study
Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA.
The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. ⋯ In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals.
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Review Comparative Study
Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons.
Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice. ⋯ Key challenges for the integration of biosimilars into everyday practice include questions about interchangeability, switching and automatic substitution. Several switching studies have shown that biosimilars can be used in place of reference products while maintaining efficacy and safety. Additional ongoing studies and registries may help to optimize the process of switching, and different funding models are examining the optimal mechanisms to ensure effective uptake of these new treatments.
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Multicenter Study Observational Study
Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.
To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). ⋯ It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib.