Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy.

OBJECTIVES: To compare the effects of rituximab versus placebo on salivary gland ultrasound (SGUS) in primary Sjögren's syndrome (PSS) in a multicentre, multiobserver phase III trial substudy. METHODS: Subjects consenting to SGUS were randomised to rituximab or placebo given at weeks 0, 2, 24 and 26, and scanned at baseline and weeks 16 and 48. Sonographers completed a 0-11 total ultrasound score (TUS) comprising domains of echogenicity, homogeneity, glandular definition, glands involved and hypoechoic foci size. Baseline-adjusted TUS values were analysed over time, modelling change from baseline at each time point. For each TUS domain, we fitted a repeated-measures logistic regression model to model the odds of a response in the rituximab arm (≥1-point improvement) as a function of the baseline score, age category, disease duration and time point. RESULTS: 52 patients (n=26 rituximab and n=26 placebo) from nine centres completed baseline and one or more follow-up visits. Estimated between-group differences (rituximab-placebo) in baseline-adjusted TUS were -1.2 (95% CI -2.1 to -0.3; P=0.0099) and -1.2 (95% CI -2.0 to -0.5; P=0.0023) at weeks 16 and 48. Glandular definition improved in the rituximab arm with an OR of 6.8 (95% CI 1.1 to 43.0; P=0.043) at week 16 and 10.3 (95% CI 1.0 to 105.9; P=0.050) at week 48. CONCLUSIONS: We demonstrated statistically significant improvement in TUS after rituximab compared with placebo. This encourages further research into both B cell depletion therapies in PSS and SGUS as an imaging biomarker. TRIAL REGISTRATION NUMBER: 65360827, 2010-021430-64; Results.

The TRACTISS protocol: a randomised double blind placebo controlled clinical trial of anti-B-cell therapy in patients with primary Sjögren's Syndrome.

BACKGROUND: Primary Sjögren's Syndrome (PSS) mainly affects women (9:1 female:male ratio) and is one of the commonest autoimmune diseases with a prevalence of 0.1 - 0.6% of adult women. For patients with PSS there is currently no effective therapy that can alter the progression of the disease. The aim of the TRACTISS study is to establish whether in patients with PSS, treatment with rituximab improves clinical outcomes. METHODS/DESIGN: TRACTISS is a UK multi-centre, double-blind, randomised, controlled, parallel group trial of 110 patients with PSS. Patients will be randomised on a 1:1 basis to receive two courses of either rituximab or placebo infusion in addition to standard therapy, and will be followed up for up to 48 weeks. The primary objective is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness. Secondary outcomes include ocular dryness, salivary flow rates, lacrimal flow, patient quality of life, measures of disease damage and disease activity, serological and peripheral blood biomarkers, and glandular histology and composition. DISCUSSION: The TRACTISS trial will provide direct evidence as to whether rituximab in patients with PSS leads to an improvement in patient symptoms and a reduction in disease damage and activity. TRIAL REGISTRATION: UKCRN Portfolio ID: 9809 ISRCTN65360827.

Lonizing radiation regulations and the dental practitioner: 3. Quality assurance in dental radiography.

UNLABELLED: This is the last in a series of three articles on X-ray dose reduction and covers aspects of quality assurance. The first outlined radiation physics and protection and the second the legislation relating to radiation safety. CLINICAL RELEVANCE: Quality assurance is an essential part of dental radiography and is required to produce images of a consistently high standard, necessary for accurate diagnosis.

Ionizing radiation regulations and the dental practitioner: 1. The nature of ionizing radiation and its use in dentistry.

UNLABELLED: Legislation governing the use of ionizing radiation in the workplace and in medical treatment first became law in 1985 and 1988, being superseded by the Ionizing Radiations Regulations 1999 (IRR99) and the Ionizing Radiation (Medical Exposure) Regulations 2000, (IR(ME)R 2000), respectively. This legislation ensures a safe environment in which to work and receive treatment and requires that those involved in the radiographic process must be appropriately trained for the type of radiographic practice they perform. A list of the topics required is detailed in Schedule 2 of IR(ME)R 2000 and is paraphrased in Table 1, with the extent and amount of knowledge required depending on the type of radiographic practice undertaken. CLINICAL RELEVANCE: Virtually all dental practitioners undertake radiography as part of their clinical practice. Legislation requires that users of radiation, including dentists and members of the dental team, understand the basic principles of radiation physics, hazards and protection, and are able to undertake dental radiography safely with the production of high quality, diagnostic images.

Ionizing radiation regulations and the dental practitioner: 2. Regulations for the use of X-rays in dentistry.

The first article in this series covered radiation hazards and protection. To minimize the potential harmful effects of X-rays, legislation has been introduced by a number of countries including the European Union.

A case report of open craniofacial sutures, a novel feature of systemic sclerosis?

Scleroderma is an uncommon connective-tissue disease, its key feature being excessive collagen deposition resulting in fibrosis of the skin and internal organs. There are different types that can vary in severity from localized scleroderma to systemic sclerosis. Various clinical and radiographic findings can be attributed to the disease, which arise owing to the progressive nature of microvascular changes and collagen deposition. These include limited mouth opening, xerostomia, periodontal disease and cardiac and pulmonary disease. Whilst bone resorption has been reported, as far as we are aware, the literature has not described a case with failure of bony suture closure. Hence, we would like to describe what is probably a unique case of a patient with a 5-year history of systemic sclerosis, who was referred for management of increased mobility of her upper central incisors. Radiographic imaging (conventional and three-dimensional) confirmed increased bone resorption, partly owing to periodontal disease, but also owing to an open premaxillary suture. Similarly, other craniofacial sutures were diagnosed as being open, and, to our knowledge, this represents a yet undescribed finding in a patient suffering from scleroderma.

Case report: oral manifestations and radiographic features of osteosarcoma.

Although osteosarcoma of the jaws is a rare tumour, early diagnosis is a prognostic determinant. Patients with osteosarcoma of the jaws are likely to present to the general dental practitioner initially, however, as the condition is uncommon, many dentists may be unfamiliar with its early radiographic features.

Salivary gland ultrasound abnormalities in primary Sjögren's syndrome: consensual US-SG core items definition and reliability.

OBJECTIVES: Ultrasonography (US) is sensitive for detecting echostructural abnormalities of the major salivary glands (SGs) in primary Sjögren's syndrome (pSS). Our objectives were to define selected US-SG echostructural abnormalities in pSS, set up a preliminary atlas of these definitions and evaluate the consensual definitions reliability in both static and acquisition US-SG images. METHODS: International experts in SG US in pSS participated in consensus meetings to select and define echostructural abnormalities in pSS. The US reliability of detecting these abnormalities was assessed using a two-step method. First 12 experts used a web-based standardised form to evaluate 60 static US-SG images. Intra observer and interobserver reliabilities were expressed in κ values. Second, five experts, who participated all throughout the study, evaluated US-SG acquisition interobserver reliability in pSS patients. RESULTS: Parotid glands (PGs) and submandibular glands (SMGs) intra observer US reliability on static images was substantial (κ > 0.60) for the two main reliable items (echogenicity and homogeneity) and for the advised pSS diagnosis. PG inter observer reliability was substantial for homogeneity. SMGs interobserver reliability was moderate for homogeneity (κ = 0.46) and fair for echogenicity (κ = 0.38). On acquisition images, PGs interobserver reliability was substantial (κ = 0.62) for echogenicity and moderate (κ = 0.52) for homogeneity. The advised pSS diagnosis reliability was substantial (κ = 0.66). SMGs interobserver reliability was fair (0.20< κ ≤ 0.40) for echogenicity and homogeneity and either slight or poor for all other US core items. CONCLUSION: This work identified two most reliable US-SG items (echogenicity and homogeneity) to be used by US-SG trained experts. US-PG interobserver reliability result for echogenicity is in line with diagnosis of pSS.