Objective. To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein, in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren's syndrome (SS). Methods. Thirty patients with primary SS were randomized to receive treatment with RSLV-132 or placebo intravenously once per week for 2 weeks, and then every 2 weeks for 12 weeks. Eight patients received placebo and 20 patients received RSLV-132 at a dose of 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Profile of Fatigue (ProF), and the Digit Symbol Substitution Test (DSST). Results. Patients randomized to receive RSLV-132 experienced clinically meaningful improvements in the ESSPRI score (P = 0.27), FACIT-F score (P = 0.05), ProF score (P = 0.07), and DSST (P = 0.02) from baseline to day 99, whereas patients who received placebo showed no changes in any of these clinical efficacy measures. This improvement was significantly correlated with increased expression of selected interferon-inducible genes (Pearson's correlations, each P < 0.05). Conclusion. Administration of RSLV-132 improved severe fatigue, as determined by 4 independent patientreported measures of fatigue, in patients with primary SS. Clinicaltrials.gov identifier: NCT03247686.
Summary
Background
The motivations for patients presenting to melanoma screening clinics (MSCs) with concerning skin lesions are poorly understood. Social media (SoMe) refers to online platforms designed to facilitate sharing of information with billions of users worldwide. There is evidence of patients posting skin lesion ‘selfies’ on SoMe, influencing internet searches. Interventions through SoMe may have positive impacts on health seeking behaviour.
Aim
To identify the influence of SoMe on patients presenting to an MSC service, and to establish whether patients have been exposed to SoMe posts on skin cancer, from medical authorities or the public.
Method
For this pilot study, qualitative data were collected from patient questionnaires over 7 consecutive weeks at MSCs in Newcastle upon Tyne hospitals. Questions involved demographics, factors influencing attendance, use of SoMe and exposure to content on skin lesions on SoMe.
Results
Questionnaires were collected from 249 patients across a range of ages. Self‐examination of lesions was the most common driver. One person in the study population described SoMe as having motivated their attendance, while 30 patients recalled seeing posts from health authorities regarding skin cancer. Qualitative data indicated that patients could be influenced by targeted public health campaigns on SoMe.
Conclusions
This study suggests that SoMe is not currently a major conscious driver to attend an MSC, even among SoMe‐familiar populations. However, the fact that SoMe is ubiquitous in society, in conjunction with our qualitative data, may suggest that current strategies for SoMe melanoma information delivery are not of requisite quality to break through to target populations.
Twenty percent of patients with Sjögren’s syndrome experience associated neurological disease. Transverse myelitis (TM) frequently forms part of a neuromyelitis optica spectrum disorder associated with the presence of anti-aquaporin 4 (AQP4) antibodies. We report the first described case of a patient who developed TM and the presence of a newly recognized antibody, anti-myelin oligodendrocyte protein (MOG), who went on to develop Sjögren’s syndrome. AQP4 and MOG antibodies should be tested to guide prognostically the chances of further relapse as well as the type and duration of immunotherapy in patients with coexisting Sjögren’s syndrome and TM.
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