Certolizumab pegol (Cimzia®) is currently the only PEGylated anti-TNFα biologic approved for the treatment of rheumatoid arthritis and Crohn disease. The product, developed by UCB, is a humanized ...antigen-binding fragment (Fab′) of a monoclonal antibody that has been conjugated to polyethylene glycol. Certolizumab pegol was approved as a treatment for rheumatoid arthritis in the EU, US and Canada in 2009, and as a treatment for Crohn disease in Switzerland in 2007 and the US in 2008. Certolizumab pegol is entering into an increasingly competitive marketplace, especially in rheumatoid arthritis, but clinical data demonstrate benefits across a range of clinical, radiographic and patient reported outcomes.
Background:
Involvement of the axial skeleton (sacroiliac joints and spine) is a relatively frequent manifestation associated with psoriatic skin disease, mostly along with involvement of peripheral ...musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are referred to as psoriatic arthritis (PsA). Data suggest that up to 30% of patients with psoriasis have PsA. Depending on the definition used, the prevalence of axial involvement varies from 25% to 70% of patients with PsA. However, there are currently no widely accepted criteria for axial involvement in PsA.Objective: The overarching aim of the Axial Involvement in Psoriatic Arthritis (AXIS) study is to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.
Design:
Prospective, multicenter, multinational, cross-sectional study.
Methods and analyses:
In this multicenter, multinational, cross-sectional study, eligible patients adult patients diagnosed with PsA and fulfilling Classification Criteria for Psoriatic Arthritis (CASPAR) with musculoskeletal symptom duration of ⩽10 years not treated with biological or targeted synthetic disease-modifying anti-rheumatic drugs will be recruited prospectively. They will undergo study-related clinical and imaging examinations. Imaging will include radiography and magnetic resonance imaging examinations of sacroiliac joints and spine. Local investigators will evaluate for the presence of axial involvement based on clinical and imaging information which will represent the primary outcome of the study. In addition, imaging will undergo evaluation by central review. Finally, the central clinical committee will determine the presence of axial involvement based on all available information.
Ethics:
The study will be performed according to the ethical principles of the Declaration of Helsinki and International Council for Harmonisation Good Clinical Practice guidelines. The study protocol will be approved by the individual Independent Ethics Committee / Institutional Review Board of participating centers. Written informed consent will be obtained from all included patients.Registration: ClinicalTrials.gov ID: NCT04434885.
Since 2003, patients have become increasingly involved in research endeavours related to psoriatic arthritis (PsA), progressing into a patient research partner (PRP) role. This paper reviews the ...general considerations related to PRP involvement in research endeavours and more specifically, the evolution of PRP contributions related to PsA research. The addition of the perspective from individuals with lived experience of PsA can bring unique insights to the research process, and increase the likelihood that the results of research are meaningful and relevant to PsA patients. There are also potential issues to address when incorporating PRPs, such as the need for additional time and effort to identify, train, and collaborate with PRPs as members of a research team. Overall, while there are challenges to overcome, and the opportunities to include PRPs are sometimes overlooked, efforts to include PRPs in PsA research should offer significant benefits to patients, researchers, and trials.
BackgroundGuidelines suggest treatment in rheumatoid arthritis (RA) to target remission, in close consultation with the patient. Our recent qualitative study of the patients' perspective on remission ...in RA identified 26 domains. The current study aimed to identify a short list of the most important aspects to inform future research.MethodsPatients with RA from the Netherlands, the UK, Austria, Denmark, France and the USA completed a survey that contained all domains identified in our qualitative study. They rated domains for importance (‘not important’, ‘important’ or ‘essential’ to characterise a period of remission) and if important or essential, whether this domain needs to be ‘less’, ‘almost gone’ or ‘gone’ to reflect remission. Respondents were also asked to determine their personal top 3 most important/essential domains. Frequency of specific domains in the top 3 was calculated, and domains were sorted on the percentage of patients that evaluated a particular domain as ‘essential’.ResultsOf 274 respondents, 75% were female, mean (SD) age 57(13) years, disease duration 12(9) years. The top 3 were as follows: pain (67%), fatigue (33%) and independence (19%); domains most frequently rated as ‘essential’ were as follows: pain (60%), being mobile (52%), physical function (51%), being independent (47%) and fatigue (41%). Pain needed to be less (13%), almost gone (42%) or gone (45%) to reflect remission. Similar patterns were seen for fatigue, independence, mobility and physical functioning.ConclusionPatients identified pain, fatigue and independence as the most important domains of RA disease activity that need to be improved to reflect remission.
The perspective from individuals with psoriatic arthritis (PsA) can be beneficial to PsA research, increasing the likelihood that the results are meaningful and relevant to PsA patients. While there ...has been an advancement of patient research partner (PRP) involvement in PsA research over time, the effort is still in its infancy. Measures to ensure PRP engagement (PRPE) occurs and its impact evaluated need to be implemented routinely to increase PRPE in PsA research.
This article examines the current landscape of biosimilar development in rheumatology. As misperceptions about biosimilars exist regarding their comparability to the reference products for clinical ...use, we review the development paradigm with the goal of improving rheumatologists' understanding of the rigor with which biosimilars are developed. With an emphasis on European Union and US markets, it gives an overview of some of the challenges and issues related to biosimilar development that need to be considered by rheumatologists in this increasingly growing therapeutic space.
The relationship between crystal quality and the properties of indium phosphide nanowires grown on silicon (111) has been studied by transmission electron microscopy, photoluminescence spectroscopy, ...and photoelectrochemistry. Wires with no defects and with {111} twin boundaries parallel and perpendicular to the growth direction were obtained by metalorganic vapor-phase epitaxy using liquid indium catalyst. Room temperature photoluminescence from the defect-free nanowires is ∼7 times more intense than that from the wires with twin boundaries. An open-circuit photovoltage of 100 mV is observed for photoelectrochemical cells made with the defect-free nanowires, whereas no photovoltage is recorded for those with twins.
Vertical indium phosphide nanowires have been grown epitaxially on silicon (111) by metalorganic vapor-phase epitaxy. Liquid indium droplets were formed in situ and used to catalyze deposition. For ...growth at 350 °C, about 70% of the wires were vertical, while the remaining ones were distributed in the 3 other directions. The vertical fraction, growth rate, and tapering of the wires increased with temperature and V/III ratio. At 370 °C and V/III equal to 200, 100% of the wires were vertical with a density of ∼1.0 × 109 cm−2 and average dimensions of 3.9 μm in length, 45 nm in base width, and 15 nm in tip width. X-ray diffraction and transmission electron microscopy revealed that the wires were single-crystal zinc blende, although they contained a high density of rotational twins perpendicular to the growth direction. The room temperature photoluminescence spectrum exhibited one peak centered at 912 ± 10 nm with a FWHM of ∼60 nm.
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