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  1. APRIL 2019 11 April 2019 by Professor Graham R V Hughes MD FRCP Easter comes late this year. Frenetic Brexit politics – the Westminster establishment fighting to overturn the ‘popular vote’. So sad. Last week I gave a lecture at an ‘immuno-therapy’ meeting in Madrid. Three hundred attendees, including representatives of the Spanish patients’ APS Society. The atmosphere was fantastic. So many doctors (and patients’) wanting to learn more about our syndrome. Talking about ‘learning more’, we now have a date for our own Patients’ Meeting – Friday, 13th September 2019. (For details of the programme and admission, please visit our website: www.ghic.world). This year we are opening up the meeting to include topics on Sjogren’s and lupus, as well as antiphospholipid syndrome. I will also send this blog, as well as details or our annual Patients’ Meeting, to our colleagues in Spain. Patient of the Month “I still feel tired all the time”. Mrs J.S. aged 55, was referred by her G.P. complaining of a variety of symptoms, including aches and pains, headaches, constipation, pins and needles and mental sluggishness. Above all else, she felt constantly fatigued. Despite this very full set of symptoms, the diagnosis remained uncertain. The pins and needles in both hands were put down to carpal tunnel syndrome. But there was little else to find. In view of the frequent headaches, Mrs J.S. was referred to a neurologist who arranged for further tests, including a brain MRI (which showed two small ‘dot’ lesions – reported as probably not significant. To her credit, the neurologist considered lupus and arranged lupus blood tests among the more routine ones. The tests came back showing a normal blood count. However, the ESR (the guide to inflammation) came back ‘borderline positive’ at 35 (normal under 20). The tests for lupus were essentially negative (anti-DNA negative, ANA ‘weak’ (1 in 80). What is the diagnosis (1)? The penny dropped. Could this be thyroid? Bilateral carpal tunnel syndrome is certainly seen in ‘low thyroid’, and significantly Mrs J.S. had a sister with ‘Hashimotos thyroiditis’ – and underactive thyroid with auto-immune features. As with all her other tests the thyroid blood tests were ‘borderline’. Nevertheless, the fatigue, the constipation, the aches and pains, could all be down to ‘low thyroid’. Following a *‘kerbside consult’, with her endocrinology colleague, she instituted thyroxine treatment. Within 2 months the pins and needles were gone and the mental sluggishness, as well as the constipation, were improving. BUT – the aches and pains and the fatigue remained – as bad as ever. What is the diagnosis (2)? It turned out that Mrs J.S. had suffered a series of miscarriages in her early 20’s and she and her husband remained childless. Could the problems – especially the frequent headaches – be due to Hughes Syndrome? Sure enough the antiphospholipid antibody (aPL) tests were strongly positive – not even ‘borderline’. She was started on clopidogrel (‘Plavix’) – an anti-clotting drug similar to aspirin (Mrs J.S. had previously tried aspirin but found it caused indigestion. Result? An almost immediate lessening of the headaches. And, if anything, a further improvement in her memory problems. BUT: no improvement in the fatigue or the aches and pains. What is the diagnosis (3)? Mrs J.S. was referred to a lupus clinic. Again, the results were similar (‘borderline’ ANA and negative anti-DNA). The lupus clinic doctor had seen this before – possible ‘Sjogren’s syndrome’. And, sure enough, the Shirmer’s test – a simple ‘blotting paper’ eye test was completely dry – a useful and very inexpensive screening test for the dry eyes of Sjogren’s Syndrome. Low dose hydroxychloroquine (Plaquenil) (one a day) was started. Three months later at follow-up clinic, ‘fatigue gone. Aches gone. Back to normal life”. What is this patient teaching us? I often talk of ‘The Big Three’ diseases – Lupus, Sjogren’s and Hughes Syndrome, which can overlap clinically However, the world of auto-immune diseases in which I practice includes another ‘big three’, which frequently go together : Hughes Syndrome, Sjogren’s Syndrome and low thyroid (often, specifically, Hashimoto’s thyroiditis) – three ‘named’ syndromes. Clearly, to miss one or even two of the triad would be an ‘under-treatment’. The three conditions can have similar features. And fortunately, potentially very successful treatment – thyroid, aspirin (or Plavix) and hydroxychloroquine. I call the combination of aspirin and hydroxychloroquine (derived from quinine) my ‘two trees’ – treatment –willow and cinchona. Perhaps the biggest lesson from this patient is that there may be more than one diagnosis causing the problems. PROFESSOR GRAHAM R V HUGHES MD FRCP Head of The London Lupus Centre London Bridge Hospital http://www.ghic.world/blog/april-2019
  2. U.K. Study Rejects Rituximab for Sjogren’s News | March 20, 2017 | Sjögren's Syndrome By Amy Reyes A British study finds that rituximab is "neither clinically or cost-effective" in a study of patients with primary Sjogren’s syndrome who were being treated for fatigue and oral dryness. These findings differ from the newly issued treatment guidelines for Sjogren's syndrome in the U.S. in which the Sjogren’s Syndrome Foundation recommends the use of rituximab for patients with oral dryness. However, for fatigue, the foundation strongly recommended exercise. The guidelines were based on a review of published studies, case reports and input from both physicians and patients. In the new study, which was accepted for publication on March 7 in the journal Arthritis & Rheumatology, researchers led by Simon J. Bowman, Ph.D., of University Hospitals Birmingham NHS Foundation Trust in the United Kingdom, conducted a randomized, double-blind, placebo-controlled trial (referred to as the TRACTISS trial ) of 133 patients from 25 clinics with primary Sjogren’s syndrome. This trial enrolled Sjogren’s patients who suffered from symptomatic fatigue and oral dryness. They received two doses of 1,000 mg rituximab, but at the 48-week assessment, patients did not report having a response to treatment that was considered significant (30% reduction from baseline of Oral Dryness or Fatigue VAS) as compared to those in the placebo group. “These and other patient-reported outcomes of Ocular and Overall Dryness, Joint Pain and Global Assessment of disease activity were not significantly improved by rituximab at any time-point,” the researchers wrote. “We also did not observe a significant benefit in terms of lachrymal flow, or in any of the composite patient-reported outcomes, or disease activity indices, except for a one-off significant difference between groups in the ESSDAI score at week 36.” Composite disease activity scores, and patient-reported outcome measures confirmed no benefit for rituximab. There was no improvement in any domain of the SF-36 for rituximab over placebo, or in the SF-36 component scores. There was also no improvement in the PROFAD-SSI domains at any time-point for rituximab compared to placebo. There were slightly more adverse events reported in total for rituximab, but no difference in serious adverse events (ten in each group). "Although there did not appear to be any excess risk due to rituximab, the results of the TRACTISS trial do not support the general use of rituximab in treating PSS, particularly in patients with recent disease onset and / or low disease activity," the authors wrote. "Rituximab may still have a role in treating PSS patients with high levels of systemic disease activity who have failed to improve following conventional immunosuppressive therapy." TRACTISS is the fourth, double-blind, placebo-controlled, randomized trial of rituximab. The first study, a pilot in 17 patients, reported a greater reduction in fatigue among patients randomized to rituximab, but it wasn’t sustained. The TEARS study analyzed 120 patients randomized to either rituximab or placebo. A significant response was detected at six weeks, particularly in fatigue, but it wasn’t sustained at 24 weeks. “Although there did not appear to be any excess risk due to rituximab, the results of the TRACTISS trial do not support the general use of rituximab in treating primary Sjogren’s syndrome, particularly in patients with recent disease onset and/or low disease activity,” the researchers wrote. “Rituximab may still have a role in treating these patients with high levels of systemic disease activity who have failed to improve following conventional immunosuppressive therapy.” DISCLOSURES The study was funded by Arthritis Research UK. Hoffman La Roche provided rituximab free of charge to the study. Hoffman La Roche was permitted to review results prior to submission, but final decision on content and publication remained with the authors. REFERENCES Simon J Bowman PhD, Colin C Everett, John L O’Dwyer, et al. "Randomized Controlled Trial of Rituximab and cost effectiveness analysis in treating fatigue and oral dryness in primary Sjogren’s Syndrome," Accepted Article for publication March 7, 2017. Arthritis & Rheumatology. DOI 10.1002/art.40093 http://www.rheumatologynetwork.com/sjogrens-syndrome/uk-study-rejects-rituximab-sjogren’s?GUID=&rememberme=1&ts=21032017
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