Due to the absence of a uniformly effective treatment for severe lupus, autologous hematopoietic stem cell transplantation (HSCT) has been proposed as a potential therapy. Hematopoietic stem cells are immature blood cells that can develop into all of the different blood and immune cells the body uses. Researchers believe that resetting the immune system may stop or slow down the progression of lupus. Read More
Scientists in Great Britain have studied how the anti-rejection drug azathioprine might increase the risk of skin cancer among transplant patients. The in vitro (test tube) study showed that azathioprine, which also is used to treat lupus, accumulates in a patient's DNA and makes cells more sensitive to ultraviolet (UV) light. When patients are exposed to low doses of UV light, the drug alters the DNA, triggering mutations in cells.
Themodest increase in risk of cancer among transplant patients taking azathioprine along with other immune suppressing drugs is widely known. However, an epidemiological study of cancers and lupus has not discovered a parallel increase in cancer among lupus patients taking azathioprine. Since lupus patients are advised to wear sun block and avoid sun exposure anyway, there is no reason to discontinue use of the drug if the risk/benefit ratio warrants its use. Lupus patients should advise their doctor if they notice any unusual skin lesions as part of their regular disease-monitoring activities. Read the news report on this study.
A Randomized Trial Annals of Internal Medicine 142(12) part 1: 953-962 (June 21, 2005) Jill P. Buyon, MD, Michelle A. Petri, MD, MPH, Mimi Y. Kim, sCd, et.al.
Clinicians sometimes avoid hormone therapy (HT) in women with lupus because they think estrogens activate the disease. In this multicenter, double-blind trial, 351 menopausal lupus patients were randomly assigned to HT or placebo for 12 months. Severe flares were infrequent in both groups and were not significantly increased in women taking HT. Women taking HT had more mild to moderate flares than those taking placebo (1.14 flares v. 0.86 flares/person/year). Four women taking HT and one woman taking placebo had thromboembolic (blood clotting) events. The researchers note that these findings are not generalizable to women with high levels of anticardiolipin antibodies, lupus anticoagulant, or previous incidences of thrombosis.
The researchers conclude that adding a short course of hormone therapy is associated with a small risk for increasing the natural flare rate of lupus. Most of these flares are mild to moderate. The benefits of HT can be balanced against the flare risk because HT does not significantly increase the risk for severe flare compared to placebo. This is important information for many women who have been avoiding hormone therapy to ameliorate the unpleasant side effects of menopause for fear of exacerbating their lupus.
American Journal of Obstetrics and Gynecology 192:6, 1897-1904 (June 2005) Eliza F. Chakravarty, MD, Iris Colon, MD, Elizabeth S. Langren, BA, et. al.
This study of pregnancies in lupus patients over a 10-year period looked at 63 pregnancies in 48 women. Twelve pregnancies were complicated by preeclampsia (also known as toxemia, involving high blood pressure, weight gain, and protein in the urine after the 20th week of pregnancy). Rates of deaths of babies near the end of pregnancy or at the time of birth due to this condition are high. First-time pregnancies, African American background and a history of high blood pressure or kidney disease all increase the risk of preeclampsia, which makes this condition of special concern for women who have lupus.
Currently, the only way to treat preeclampsia is to deliver the baby. However, complications can occur because of prematurity of an infant at time of delivery. The researchers in this study concluded that low platelet counts, high blood pressure, and the need for prednisone all may be predictive factors for problems occurring in pregnancies of women with lupus.
Other factors found to be associated with premature delivery in lupus pregnancies included prednisone use at the time a woman gets pregnant, use of blood pressure medications, and a severe flare during pregnancy. Physicians managing lupus pregnancies, which are always considered high-risk, will want to monitor these factors in their patients.
SLE Neurology 2005; 64:2102-2107 (June 2005) Jamal Mikdashi, MD, MPH, Allan Krumholz, MD and Barry Handwerger, MD
This study followed 195 lupus patients for nine months and kept track of incidences and manifestations of neuropsychiatric SLE (NP-SLE) and seizures. Isolated seizures were found to be common (28 patients), while recurrent seizures, or epilepsy, although less frequent, did occur (12 of the 28). Predictors of seizures included disease activity (in particular, psychosis), moderate-to-high levels of anticardiolipin and anti-Sm antibodies, and damage accrual. Predictors of epilepsy were higher disease activity at baseline (when the study began), concurrent NP-SLE manifestations, prior strokes, and male gender.
The researchers conclusion is that the risk of seizure and epilepsy in lupus is increased in those individuals with higher disease activity at baseline, prior neuropsychiatric lupus disease, and positive tests for both anticardiolipin and anti-Sm antibodies. The ability to better predict seizures in individuals with NP-SLE may be useful in determining caregiving needs and the ability to perform activities of daily living, which are determinants of disability status.
Unlike other studies that have examined seizure risk factors after the fact, the goal of this study was to look for factors at the time of SLE diagnosis. These factors may help in understanding the pathogenesis of provoked seizures in SLE. It is believed that seizure occurrence is primarily related to increased disease activity, and that epilepsy may often be related to prior damage such as stroke. This information is vital for physicians in determining how best to treat lupus patients at higher risk for neurological manifestations like seizures.
2005 44(7):902-906 (July 2005) D. A. Isenberg, A. Rahman, E. Allen, et. al.
The British Isles Lupus Assessment Group (BILAG) disease activity index is a way to measure flares and improvements in patients by measuring improvement or worsening of lupus disease in various organs. The BILAG is widely used in current clinical trials, where measuring disease activity is one way to understand the drug's efficacy. One of the obstacles in the process of FDA drug approval has been the difficulty in clearly demonstrating response to therapy in clinical trials. The complexity of lupus and the potential for multiple organ involvement have been major factors.
This study was designed to evaluate a recently revised version of the BILAG that includes organs not covered in the original instrument (e.g. GI tract, liver, and eyes). The new version of BILAG was reliably able to distinguish patients with flares in different organ systems and showed a high level of agreement among physicians using the BILAG. The only exception was in patients with musculoskeletal involvement.
BILAG 2004 is likely to be valuable in clinical trials assessing new therapies for the treatment of SLE, as it provides a more comprehensive system-based disease activity measure than has been available previously.
Further validation studies are under way. Read the complete abstract
Press Release, October 18, 2005
Riquent (abetimus sodium), being developed by La Jolla Pharmaceutical (LJP) Company for lupus kidney disease, has been given "approvable" status by the U.S. Food and Drug Administration (FDA), pending the successful completion of a Phase 3 clinical benefit trial that was initiated in August 2004 under a Special Protocol Assessment (SPA). Although trial enrollment was delayed in March 2005 to conserve cash the trial is ongoing; to date there are 37 sites in the U.S. with 27 patients enrolled. The total number of patients in the study is expected to be 500-600 (approximately 300 patients were in the previous Phase 3 study).
Human Genome Sciences, Inc. has announced the results of its Phase II clinical study of LymphoStat-B (belimumab), an investigational lupus treatment. The findings suggest that LymphoStat-B may be effective after 52 weeks of treatment among a subgroup representing 75 percent of the patients in the study. Eighty-two percent of the study participants also were receiving prednisone therapy. Study data showed a trend toward greater reduction in the use of prednisone among all active patients in the study.
MedImmune, Inc. of Gaithersburg, MD and Medarex, Inc. of Princeton, NJ have filed an Investigational New Drug application (IND) with the U.S. Food & Drug Administration for MEDI-545, a fully human monoclonal antibody (MAb) targeting interferon-alpha. Levels of interferon-alpha are elevated in many patients with active lupus and other autoimmune disorders.
Studies using a lupus disease animal model have shown that MEDI-545 binds to interferon-alpha and neutralizes its activity. Company officials estimate it could take five to 10 years before the drug might be made available for clinical use. Read the complete October 13, 2005 press release.
Although some vaccines can make autoimmune diseases worse, use of the influenza vaccine (flu shot) appears to be safe in people with systemic lupus erythematosus (SLE). Go to the LFA website for additional information.
The global pharmaceutical industry has launched a new website that gives details of clinical trials on new medicines in an effort to allay patient fears over drug safety. For additional information, read the article on the LFA website.
The National Center for Complementary and Alternative Medicine (NCCAM) has launched a new, free Online Continuing Education Series in complementary and alternative medicine (CAM). Read more on the LFA website.
The LFA successfully advocated to have language which heightens federal efforts on lupus included in the report accompanying the 2006 Senate Labor, Health and Human Services, Education and Related Agencies (Labor HHS) Subcommittee appropriations bill. Read more on the LFA website.
The LFA has launched a new national lupus awareness campaign entitled "Theres More to Lupus Than You Know." You may view the campaign materials, including our new TV public service announcement.