The research and clinical team at the Montreal General Hospital Lupus Clinic are involved in the following projects:
Updated October 2011
Some Completed Projects:
1. “A Phase 3, Randomized, Controlled Study to Evaluate Belimumab (LymphoStat-B™ ) in Subjects with SLE.” GREAT NEWS - THIS DRUG HAS BEEN APPROVED IN CANADA and THE U.S.A. The MGH lupus clinic was instrumental in bringing this first new treatment for lupus in over 50 years to patients.
We are collaborating in an international clinical trial assessing one of the new biological agents that may eventually be used to treat lupus.
In the last Lupus Clinic newsletter, they reported on the results of a trial comparing Belimumab combined with usual care to usual care alone. This trial involved almost 900 patients from Asia, South America, and Eastern Europe. After 52 weeks, a greater proportion of patients receiving Belimumab improved when compared to patients receiving usual care alone. 57.6% of patients receiving Belimumab 10 mg/kg improved versus 51.7% receiving Belimumab 1 mg/kg versus 43.6% receiving placebo. Belimumab is the first in a new class of drugs that inhibits the activity of the B lymphocytes, cells responsible for producing autoantibodies. Autoantibodies are responsible for causing many of the signs and symptoms of SLE. The trial was sponsored by the pharmaceutical companies, Human Genome Sciences and GlaxoSmithKline.
At the International Lupus Meeting held in Vancouver in June 2010, Dr. Rich Furie of New York presented the results of a similar study conducted in the United States and Canada involving 819 patients. Several patients from our centre participated in this study. After 52 weeks, as in the Asian/South American study, a greater proportion of patients receiving Belimumab improved when compared to patients receiving usual care alone; 43.2% of patients receiving Belimumab 10 mg/kg improved versus 40.6% receiving Belimumab 1 mg/kg versus 33.6% receiving usual care. After 76 weeks, patients receiving Belimumab continued to do better than those receiving usual care, but the improvement was a little less than at 52 weeks. A higher percentage of patients receiving Belimumab reduced their prednisone. Belimumab was generally well tolerated with comparable proportions of patients experiencing side effects in the treated and untreated groups.
The pharmaceutical company is seeking approval from both the Food and Drug Administration in the United States and Health Canada to make this drug available to patients with SLE. The company hopes to receive approval sometime in 2011.
2) "Medication Use in Systemic Lupus (SLE)"
3) “1000 Faces of Lupus.”
A Canadian-wide study that assembled a large group of patients with lupus to identify ethnic differences in manifestations and disease outcome. It also identified socioeconomic, cultural, and environmental factors that may influence the course and outcome of lupus in different ethnic groups.
4) “Health Improvement and Prevention Program (HIPP)”
A CaNIOS multicentre study to determine the effect of implementing a program that was developed to reduce the risk of cardiovascular disease and osteoporosis and to improve the quality of life in persons with SLE.
Recruitment is now complete with 288 participants enrolled in this study. Baseline results, presented this year at the Canadian Rheumatology Association scientific meeting in Quebec City, showed that female subjects with SLE have many risk factors for both cardiovascular disease and osteoporosis. These risks should be identified early and properly managed. We are in the last year of this study. Final analysis to determine the effect of HIPP will begin in early January 2011.
5) “The Role of Thrombophilic Factors in Patients with Systemic Lupus Erythematosus (ThromboFIL).”
This study aimed to determine the risk of thrombosis (clotting) in patients with lupus and demonstrate that the risk for thrombosis is greater in persons who have antiphospholipid antibodies.
6) “Antiphospholipid Antibody Syndrome (APLS).”
This research will improve understanding of why patients with antiphospholipid antibodies have an increased risk of developing blood clots.
7) “GENES: Genetic and Environmental Factors in SLE.”
8) “Neurological Involvement in Lupus.” Dr. Appenzeller, a rheumatology fellow, under the mentorship of Dr. Clarke, will be collaborating with neuroscientists at the Montreal Neurological Institute to determine if patients with lupus are experiencing any neurological problems.
We are collaborating in a national study that examines the role of genetic and environmental factors in SLE.
If you would like any information on these projects, or would like to participate in a project listed below, contact Michele Tobaly at michele.tobaly@muhc.mgill.ca.
WHAT'S UP NOW:
1) “Lymphoma Risk in SLE.”
Drs. Clarke and Bernatsky are continuing their research on the risk of cancer in patients with lupus. In this project, they are assessing why patients with lupus have a slightly increased risk of developing lymphoma. They will evaluate the influence of the medications used in treating lupus and the activity of lupus itself on the risk of lymphoma.
2) “Long-term Outcome of Lupus Pregnancies.”
Dr. Vinet, a rheumatology fellow, under the mentorship of Drs. Clarke and Pineau, will be collaborating with lupus investigators in the US and the UK to evaluate the health and well-being of children of mothers with lupus.
3) “SLE Annual Assessment: Predicting Disease Outcomes in Patients with Lupus.”
The goal of this research is to identify markers from the patient’s medical history, physical examination, blood tests, or imaging studies that will allow us to predict the progression of the disease.
4) “The Systemic Lupus International Collaborating Clinics (SLICC) Registry for Atherosclerosis in Systemic Lupus Erythematosus.”
This study involves newly diagnosed patients with lupus from 30 lupus centres worldwide. It is establishing an international registry of patients to study heart disease in lupus.
5) “The Systemic Lupus International Collaborating Clinics (SLICC) Study of Involvement of the Nervous System in SLE.”
This study also involves newly diagnosed lupus patients and will help provide more information about involvement of the nervous system (brain, spinal cord, and peripheral nerves) in SLE.
6) "The Association between Anti-Ro and QTc prolongation"
7) "Humor in SLE: a pilot study"
A new study (directed by Dr. Pineau) looking at the potential impact humor therapy may have on individuals with Lupus is presently under way at our centre (for more information, contact Jennifer Lee at 514-934-4830). Fortunately, there is no need to wait for FDA approval to start adding a bit of laughter in your daily life!
8) "Development and Evaluation of an Adapted Yoga Program as Adjunct Therapy for Persons with Systemic Lupus (SLE): a pilot study".
A new study (directed by Carolyn Neville, Dr. Bernatsky and Wendy Singer) looking to evaluate a yoga program as adjunct therapy for persons living with lupus. The first of its kind for lupus!
9) “LUNNET – Lupus Nephritis – New Emerging Team.”
This study will provide more information about kidney involvement in patients with lupus. It will examine new ways of making an earlier diagnosis of kidney disease.
10) "Study of the Association between Lupus Cutaneous Manifestations and Systemic Lupus Erythematosus Disease Activity"
11) “The Canadian Validation of LupusPRO (Patient Reported Outcome) Questionnaire for Systemic Erythematosus Lupus”.
The LupusPro questionnaire is a tool already being used to measure the quality of life of patients with SLE within the United States. The questionnaire is easily completed by patient and may become the standard for measurement of quality of life in clinical studies of lupus. We are collaborating with other centers in the United States and the Philippines to assess the use of this questionnaire in other cultures, languages and countries. You will be asked to take part in this new study at your next annual visit.
