Rheumatology would like to introduce its latest offering to break the mould from being more than just an academic journal to providing news from around the globe. We welcome news items by rheumatologists or scientists around the world. They should be written in plain English for an international audience in no more than 100 words citing the original news source. The tone should be objective and factual. All contributions will be edited to fit a consistent style and format. Generic names must be used, no tradenames. The new articles will be published online with an interactive map to depict the representative region of the news.
Topics can include:
- Drug updates from EMA and FDA
- New or revised guidelines along with its clinical relevance and impact
- Professional and regulatory environment of rheumatologists
FDA approves lesinurad to treat high blood uric acid levels associated with gout December 22, 2015 The U.S. Food and Drug Administration approved lesinurad, a selective uric acid re-absorption inhibitor, to treat hyperuricemia associated with gout when used in combination with a xanthine oxidase inhibitor. Lesinurad (200mg and 400mg once daily) showed significant therapeutic effects in the CLEAR1 and CLEAR2 trials in combination with allopurinol in symptomatic gout patients not achieving target (< 6.0 mg/dl) serum acid uric levels under their current allopurinol dose. In the CRYSTAL trial, lesinurad was tested in combination with febuxostat in tophaceous gout patients, leading to a statistically significant higher proportion of patients reaching the serum uric acid level target < 5.0 mg/dl) at 6 months, at least for the 400mg lesinurad dose. Although the drug is well tolerated, a higher incidence of renal-related adverse patients in association with a xanthine oxidase inhibitor. The FDA has required a post-marketing study to further evaluate the renal and cardiovascular safety of the drug. Source: www.fda.gov Contributed by: Bernard Lauwerys, MD, PhD, Department of Rheumatology, Cliniques Universitaires Saint-Luc & Université Catholique de Louvain, Brussels, Belgium
FDA approves secukinumab for use in patients with psoriatic arthritis and ankylosing spondylitis January, 2016 After EMA in October 2015, FDA approved in January 2016 Novartis’ submission for the use of secukinumab, an anti-IL17A antibody, in adult patients with psoriatic arthritis and ankylosing spondylitis. Monthly subcutaneous 150 mg of secukinumab injections (after an intravenous loading dose of 10 mg/kg at week 0, 2 and 4 in MEASURE1, and a subcutaneous loading dose of 150 mg at week 1, 2, 3 and 4 in MEASURE2) resulted in significantly higher ASAS20 responses at 4 months (61%) compared to placebo (28%) in two ankylosing spondylitis trials published in the December 2015 issue of the New England Journal of Medicine. In psoriatic arthritis patients, higher rates of ACR20 responses were obtained at week 24 in patients receiving monthly subcutaneous 150 mg secukinumab injections (after a IV 10 mg/kg loading dose at week 0, 2 and 4 in FUTURE1, or a subcutaneous 150 mg loading dose at week 1, 2, 3 and 4 in FUTURE2) compared to placebo. The treatment was overall well tolerated; a slightly higher rate of infections (including candida infections) was reported in the secukinumab group. Source: www.novartis.com Contributed by Bernard R. Lauwerys, Department of Rheumatology, Cliniques Universitaires Saint-Luc & Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Brussels, Belgium
Molecular signatures and disease activity in pediatric systemic lupus erythematosus patients April 21, 2016 In a paper published in Cell, R. Banchereau recapitulated several years of gene expression analyses performed in the Dallas paediatric SLE cohort. About 924 longitudinal samples obtained from158 lupus patients were included in an exhaustive panel of analyses, to find correlations between patterns of gene expression in whole blood samples and disease activity. Of the numerous molecular pathways scrutinized (because they were overexpressed in SLE samples), a plasmablast signature was found to be most reliably associated with disease activity in the whole group of samples (more than the interferon signature, a well-known hallmark of the disease). A major limitation of the study was the definition of disease activity, based on SLEDAI score ranges (0-2; 3-7; >7). As expected, the SLEDAI >7 category was strongly enriched in lupus nephritis patients, raising the question whether the plasmablast signature is associated with disease severity rather than activity. One of the most striking observations is the molecular heterogeneity of the disease, as evidenced by the identification of seven clusters of patients, in whom distinct molecular pathways drive disease activity: interferon signature and myeloid lineage in one group of patients vs. plasmablast signature in another group, plasmablast and lymphoid lineage in a third group, etc. These observations need to be replicated in independent cohorts of patients. If verifiable, they will pave the way to a new molecular taxonomy of the disease, in which disease-associated pathways (i.e. definite targets of therapy), rather than clinical signs of heterogeneous pathogenic significance, will guide therapeutic decisions. Source: Banchereau R, et al. Personalized immunomonitoring uncovers molecular networks that stratify lupus patients. Cell; 165: 551-565. Contributed by Bernard R. Lauwerys, Department of Rheumatology, Cliniques Universitaires Saint-Luc & Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain, Brussels, Belgium
Low-dose IV cyclophosphamide equally efficacious compared to oral mycophenolate in Indian patients with lupus nephritis
February 2, 2016
In an advance online publication of Kidney International, Rathi et al. report the results of a prospectice non-inferiority controlled randomized trial comparing IV low-dose cyclophosphamide (Euro-Lupus protocol) to oral mycophenolate as induction regimens in 100 patients with lupus nephritis (class III, IV, III+V, IV+V and V). Both treatment arms delivered similar results at 6 months (also in a sub-analysis excluding the class V patients). Renal response, decrease in urinary Protein/Creatinine ratio (uPCR) <3 in subjects with a baseline ratio, along with stabilization of improvement of serum creatinine, was obtained in 74% of the patients in both groups. Complete renal remission (return to normal serum creatinine, proteinuria < 0.5g/day and inactive urine sediment) was obtained in 50% of the patients in each group. While the Euro-Lupus regimen was initally tested in a (mainly Caucasian) European population of patients, this study brings additional evidence that the less toxic low-dose IV cyclophosphomide approach is also efficacious in non-Caucasian patients.
Source: Rathi et al. Comparison of low-dose intravenous cyclophosphamide with oral mycophenolate mofetil in the treatment of lupus nephritis, Kidney International advance online publication, 21 October 2015; doi: 10.1038/ki.2015.318 & Houssiau FA. Moving East: the Euro-Lupus Nephritis regimen in Asia, Kidney International advance online publication, doi: 10.1016/j.kint.2015.11.003
Contributed by: Bernard Lauwerys, MD, PhD, Department of Rheumatology, Cliniques Universitaires Saint-Luc & Université catholique de Louvain, Brussels, Belgium
PARE installs a new Chair-Elect: improving communication will be a priority June 2016 At the end of the EULAR 2016 congress in London, the Standing Committee of People with Arthritis/Rheumatism in Europe (PARE), the patient pillar in EULAR, welcomed its new Chair-Elect. Current chair Dieter Wiek (Germany) introduced newcomer Nele Caeyers (Belgium) into her new tasks and responsibilities. Nele has been active in PARE as a volunteer since 2005 and has served on the board since 2014. “Working with PARE has been truly inspiring in many different ways”, Nele says. “Not only did I learn a lot on a personal basis, but I was also able to take home best practices to enhance the work of ReumaNet, our platform in Flanders, Belgium. By accepting the position of Chair-Elect, I want to give something back and use my skills for the benefit of others. PARE has a well-oiled team. It will be four challenging, but remarkable years.” Improving communication internally and between the different stakeholders will be high on Nele’s to do list. “In these times of internet, social media and emailing ‘à volonté’ we still sometimes fail to get the right message across. Optimizing communication will lead to saving time and resources. And in the end a better quality of life for all people with RMD’s.” Contributed by: Nele Caeyers, the new Chair-Elect of PARE
BSR publishes its second report for the national clinical audit for rheumatoid and early inflammatory arthritis in England and Wales September 2016 The BSR published the 2nd report for the national clinical audit for rheumatoid and early inflammatory arthritis in England and Wales on 25 July. The key findings, which were featured by the BBC, include: • A postcode lottery exists, meaning that depending on where a patient lives, they are far more or less likely to access treatment at an early stage • Only 20% of patients who see a GP with suspected rheumatoid and early inflammatory arthritis are referred to specialist services within 3 days • The national findings disguised considerable variation in practice and patient care at a local level • 68% of patients were treated with DMARDs disease modifying drugs within 6 weeks of referral, up from 53% in year 1 • Data from the audit is being used to facilitate discussions with commissioners and deliver better patient care. Source: http://www.rheumatology.org.uk/resources/audits/annual_report/second_annual_report.aspx Contributed by: The British Society for Rheumatology
New Guidelines for the treatment of axial spondyloarthritis with biologics August 2016
These guidelines provide evidence-based guidance for UK clinicians prescribing biologic drugs for adult patients across the spectrum of axSpA. This includes the criteria for starting treatment, the choice of drug and assessing response to treatment, along with recommendations in other areas such as switching, as part of the guidelines’ treatment algorithm. The guidelines are accredited by NICE, which underpins the fact that they have been developed through a critically-evaluated, high quality process. Peripheral spondyloarthritis and juvenile SpA are outside the scope of these guidelines, which are addressed in the BSR 2012 guidelines for the management of PsA.
Read the new guidelines here.
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