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Past Trials

Louise Coote Lupus Unit

Louise Coote Lupus Unit has a dedicated drugs trials team consisting of Professor D’Cruz DP, Dr Shirish R Sangle, and research nurse Lee Chung. Louise Nel will be joining the team as a research co-coordinator. Their team has an outstanding record of best recruitment in the UK in these trials including Benlysta (belimumab) and abatacept.

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The British Isles Lupus Assessment Group (BILAG)

This is a UK based group of lupus experts led by Prof David Isenberg that has been studying how disease activity can be accurately measured in clinical practice and also in clinical trials. This has been a long process of evolution, constantly refining the measures we use to quantify disease activity. The BILAG group is also a very  cohesive group of lupus clinicians that has collaborated on many other studies.

References
Isenberg DA, Allen E, Farewell V, D'Cruz D, Alarcón GS, Aranow C, Bruce IN, Dooley MA, Fortin PR, Ginzler EM, Gladman DD, Hanly JG, Inanc M, Kalunian K, Khamashta M, Merrill JT, Nived O, Petri M, Ramsey-Goldman R, Sturfelt G, Urowitz M, Wallace DJ, Gordon C, Rahman A. An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. Ann Rheum Dis. 2011;70:54-9.
 
Yee CS, Cresswell L, Farewell V, Rahman A, Teh LS, Griffiths B, Bruce IN, Ahmad Y, Prabu A, Akil M, McHugh N, D'Cruz D, Khamashta MA, Isenberg DA, Gordon C. Numerical scoring for the BILAG-2004 index. Rheumatology (Oxford). 2010;49:1665-9.

McElhone K, Castelino M, Abbott J, Bruce IN, Ahmad Y, Shelmerdine J, Peers K, Isenberg D, Ferenkeh-Koroma A, Griffiths B, Akil M, Maddison P, Gordon C, Teh LS. The LupusQoL and associations with demographics and clinical measurements in patients with systemic lupus erythematosus. J Rheumatol. 2010;37:2273-9.

The Systemic Lupus Erythematosus International Collaborating Clinics (SLICC)

The Louise Coote Lupus Clinic has been part of this international study group for many years.This group has led the way in setting up large scale international collaborative studies that have been very influential in understanding the clinical features of lupus. For example, one important study showed that life expectancy has significantly improved for lupus patients over the last 40 years or so.

Reference
Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcón G, Senécal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006;54:2550-7.

Diet

One interesting trial was aimed at trying to help patients with lupus on steroids to lose weight. The study showed that this was possible and that reducing carbohydrate intake might be a useful way to avoid the weight gain associated with steroid use. However, what was surprising was that losing weight, by whatever means, led a significant improvement in fatigue – a severe and debilitating aspect of lupus that profoundly affects quality of life.

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The Eurolupus project and Lupus Nephritis

The Louise Coote Lupus Unit is part of the Eurolupus consortium which has been engaged in large scale long term studies of lupus across Europe. These studies have enrolled 1000 lupus patients and followed them for long periods of time to learn more about the natural history of lupus and its various clinical features. We have also been involved in two large European studies in kidney disease that have demonstrated that it is possible to use lower and safer doses of the powerful drug cyclophosphamide without compromising effectiveness at preventing kidney failure.

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Rituximab

Rituximab has been used in the in the treatment of severe lupus for many years. It works by depleting the antibody producing B cells in lupus patients. However, two large studies failed to show that it was better than a placebo drug in patients with severe lupus. It is unlikely ever to get a license for use in lupus but it remains widely used by many lupus clinics around the world.

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Belimumab (Benlysta)

Belimumab is an antibody treatment that reduces the number of the antibody producing B cells in the immune system which produce the characteristic lupus antibodies. The Lupus Clinical trials unit entered 10 patients into this international study – the largest number recruited in the UK. In all, over 1,600 patients were recruited from over 200 hospitals around the world. Patients were allocated to receive a dummy drug (placeo) or two different doses of belimumab (Benlysta). All patients also received their usual lupus treatments. The results showed that patients who received belimumab responded better than patients who were on the placebo and the drug was relatively safe and well tolerated.

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