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» Medical
Papers MITAX and MYODAM Indices “For the past six years a group of rheumatologists and neurologists have been trying hard to establish better ways of assessing patients with inflammatory muscle disease. It is now generally agreed that, especially in a clinical trial, it is important to have three types of assessment. The first should define disease activity meaning ongoing inflammation invariably requiring steroids or other drugs which suppress the immune system. For the second we need to distinguish damage, or permanent change, for which it would be inappropriate to treat with steroids or immunosuppressive drugs. Thirdly, we need an assessment tool which captures the patients' own view of their disease – often radically different from that of their physicians! Several years ago the Myositis Support Group very generously supported a research fellow, Dr Shabina Sultan, based at the Middlesex Hospital to help develop and test a new activity and a new damage index for patients with Myositis. The activity index is known as MITAX (Myositis Intention to Treat Activity Index) and the damage index is known as MYODAM. The philosophy behind the MITAX index was based upon a similar index that was devised over twenty years ago for patients with lupus and is known as the BILAG index. It is, in brief, dependent upon the principle of 'the physicians intention to treat'. In practice a group of physicians got together to see if they agreed on how they thought they would treat the different aspects of Myositis. The effects of Myositis were considered in six different organs or systems and within each of these, those clinical features which the doctors felt they would treat with large doses of steroids and/or immunosuppressive drugs constitute a grade A; those with ongoing inflammation though less active than the grade A will be given a grade B; those with mild ongoing inflammation will get a grade C. Those patients in whom the organ or system was once active but is no longer active will get a D whereas those organs or systems which have never been involved will get a grade E. Dr Sultan's main task has been to show that the proposed index of activity is both valid and reliable. In order to demonstrate validity she has examined several hundred sets of notes from patients with Myositis to determine whether or not patients who clearly fell into the A-E categories were actually treated in the way that the physician predicted they would. In order to demonstrate the reliability she has visited eight Myositis clinics and has assessed over 100 patients immediately after the 'home' rheumatologist has done so. She has carried out similar assessments with the damage index as well. Although we continue to make minor adjustments in the indices it is very encouraging that the international trial of rituximab that has been organised from the University of Pittsburgh by Dr Chester Oddis will be using the MITAX and MYODAM indices as part of their patient assessments. This is largely because the provisional results of Dr Sultan's work have shown a high degree of correlation in virtually all aspects of the proposed indices. We have just received further good news that
the Myositis Support Group has agreed to support the development
of a computerised version of the index for which I am again extremely
grateful to them. This really should herald a new dawn in clinical
trials work for patients with inflammatory muscle disease.” 
MITAX and MYODAM Indices “It has been a very busy year, which in fact started in August 2003. There have been two parts to the research. The first was to assess the inter-rater reliability of two tools to assess disease activity and damage in patients with myositis. In essence I was checking if two different doctors would get similar results when using these questionnaire based assessments on the same patient. I have now assessed a total of 120 patients in seven centres with the local physician; University College London, Pittsburgh, Sweden, Prague, Manchester, St Georges (London) and Queens Square (London). The initial results are promising although some aspects of the tools may require modification before further use. The other aspect of the research has been to assess the effect of B lymphocyte depletion therapy using rituximab in myositis. I have now treated 5 patients resistant to conventional therapies. One patient now appears to be in remission and the treatment has failed in the second patient who has required re-treatment. It is too early to assess the effect in the other patients. The research has been generously funded by the Myositis Support Group (UK).” << Top
Professor David Isenberg writing in Newsletter 55, December 2003 Myositis Activity Assessment Programme – up and running “Fortunately myositis does not kill many
of its victims but it is responsible for affecting their life styles
quite considerably. With the encouragement of new types of drugs
to treat patients with myositis it has become extremely important
to develop accurate ways of determining if and to what degree these
drugs (and for that matter the old standard ones!) are actually
helping the patient. In making this kind of assessment we have to
distinguish disease activity from damage. Activity implies ongoing
inflammation and for this some form of drug is needed to stop this
process in its tracks. In contrast damage refers to permanent change
which no drug will be able to effect. The obvious example of inflammation
in a patient with myositis is the inflammation that occurs within
the muscles themselves. A good example of damage is the unsightly
deposition of calcium (calcinosis) that occurs in a number of patients
for which no treatment (apart from surgical removal) is available.
It is now a realistic goal that by December 2004 reliable and validated indices for assessing the degree of disease activity and damage in patients with myositis will have been devised and shown to be reliable and valid tools. Although some later modification will probably be required. This will truly be a major leap forward in our attempts to improve the lot of those with serious inflammatory muscle disease.” << Top
Report written for Newsletter 53, December 2003 based on the talk given by Professor David Isenberg at the Myositis Support Group Annual Meeting International Myositis Outcome Assessment Collaborative Study Group Professor David Isenberg is the academic director of Rheumatology at University College London. He has had many years of myositis experience and is currently co-ordinating international plans to reassess the ways which myositis is assessed and managed. The group of world-wide specialists is known as the International Myositis Outcome Assessment Collaborative Study Group (IMOACSG). Professor Isenberg’s presentation was an explanation of the IMOACSG and why it now is essential to get together on an international level to ensure in particular that rheumatologists and neurologists are using the same methods of assessment for their patients so trials of new therapies can be meaningfully compared. Dermatomyositis, polymyositis, inclusion body myositis and juvenile dermatomyositis are grouped together as myositis and constitute a group of diseases known as inflammatory myopathies. As more is discovered about these diseases they are more easily distinguished clinically, pathologically and in their response to treatment. One question often asked by specialists themselves is, ‘Why does one patient with polymyositis responded very well to treatment and another also suffering from polymyositis not at all?’ Initially, unresponsive polymyositis sufferers found their diagnosis being changed to other conditions such as inclusion body myositis or a muscular dystrophy. Indeed this is often the correct answer in many cases and a re-diagnosis requires reassessment of the muscle biopsy by an expert. However, there is growing evidence to suggest that within a classification there are subtypes. Another important question a doctor will ask themselves when examining a patient is, ‘What is disease activity and what is disease damage?’ This is a very important question to answer and the most difficult to get right. By ‘activity’ it is implied that there is an active process of inflammation going on whereas ‘damage’ implies permanent change which will not be amenable to immunosuppressive drugs. When a disease is active is must have medical intervention. However, this may be accompanied by side effects of the drugs. It is a balance, enough drug(s) must be given to control activity but not render the patient ill with too many side effects. Disease damage can be limited by early effective control of disease activity. One of the areas in development by the IMOACSG are guidelines to clarify ‘what is activity’ and ‘what is damage’. In principle the ideas of disease activity and disease damage are simple however for these guidelines to work they must when applied by the specialist to assess the patient give the same result. There must be a uniform consensus within defined limits if these guidelines are to be of any beneficial use. With our knowledge of the diseases expanding, new treatments emerging, and an international drive for reassessment of our current tools, now is the time to take steps to introduce internationally accepted guidelines. This will attempt to insure correct diagnosis, protocols for treatment (depending on the diagnosis and possibly disease subtype) and uniform assessment and management of the disease. << Top
Professor David Isenberg writing in Newsletter 52, July 2002 International Myositis Outcome Assessment Collaborative Study Group "For the second successive year a group of rheumatologists and neurologists have met in London to conduct a ‘real patient’ assessment exercise which was supported by the Myositis Support Group. As many of you will know, in the past three years a major international effort has been going on to try and agree optimal methods of assessing disease activity (meaning clinical features which can be improved) and damage items (clinical features which have become permanent). This exercise is extremely important as there are several new drugs on the horizon that are likely to be used in the treatment of myositis even though in the main they were introduced for the treatment of other conditions. For example, recently some patients with myositis have been given antibodies to TNF alpha, a form of treatment introduced for patients with rheumatoid arthritis. To be sure that these drugs are effective and to determine any risks from side effects it seems extremely important to those of us participating in this exercise that we agree which types of assessment should be used as soon as possible. The initial meeting of this group headed by myself, Professor David Scott (from the UK) and Drs Fred Miller and Lisa Ryder (from the USA) took place in Glasgow in June 1999. Since then there have been several meetings and a vast amount of Internet communication. We believe that we are now coming very close to agreement and in order to try out the ‘new and improved’ versions of the indices we tried last year, seven physicians were invited to the Centre for Rheumatology, the Middlesex Hospital, University College London (3 coming from the United States, 1 from Sweden, 1 from Czechoslovakia and 2 from the UK) to assess the same adult patients during the course of a long but fascinating day. In addition, Clarissa Pilkington simultaneously organized a similar exercise on children with myositis. The patients stood up to what must have seemed incessant questioning and examination very well and we were extremely grateful to them. Also on hand were two statisticians who will be helping us to analyse the results. An initial assessment of the data produced shows a much greater improvement in our levels of agreement about disease activity and damage assessment and a preliminary abstract describing our findings has been submitted to the American College of Rheumatology for presentation at this year’s ACR meeting. I am now in the process, together with many colleagues, of writing up the full results from this year’s meeting together with what I hope will be a fairly definitive statement about the recommended activity and damage assessment ‘tools’. Various other related exercises are ongoing and I am very confident that within the next two years we will have readily available and widely used methods of assessing patients with myositis that are internationally agreed and properly validated." << Top Professor David Isenberg writing in Newsletter 51, March 2002 International Myositis Outcome Assessment Collaborative Study Group "Following an inaugural meeting of rheumatologists interested in how patients with myositis are assessed clinically at the European League Against Arthritis meeting in Glasgow in July 2000 a major leap forward has taken place. Over 70 rheumatologists and neurologists in the UK, continental Europe and North America have participated. Innumerable e-mail exchanges and several meetings including a meeting in London last March, kindly supported by the Myositis Support Group in which seven patients with myositis were assessed by seven rheumatologists/neurologists to try out some of the new tools. These tools are aimed to distinguish disease activity (active disease that may respond to immunosuppressive or other drugs) from damage (permanent change where immunosuppressive and other treatments are unlikely to be very effective). Following a further two-day meeting in San Francisco in November, shortly before the American College of Rheumatology meeting, it was agreed that there is a great need for a further patient-based exercise to try out these new activity and damage tools. To this end my colleagues and I have been invited to ask seven myositis patients to come to the Middlesex Hospital during a weekend in May where again they will be assessed by seven different rheumatologists or neurologists. It is only by achieving an internationally agreed set of activity and damage measures that we will really be able to measure the impact of new drugs as they are introduced for the treatment of myositis. It is truly an exciting time for those of us interested in trying to improve the lot of patients with inflammatory muscle disease. I think there is now a realistic prospect that within the next three years reliable, validated indices will be internationally accepted and used in all future trials." << Back to newsletters page |
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