Saturday, January 7, 2012

Lupus

Systemic Lupus Erythematosus in Women: An Overview
Background information
    The National Public Health Association at the S.L.E. Lupus Foundation reported Systemic Lupus Erythematosus in 2000 as,
…nearly 8 percent of Caucasians were to be in fair or poor health compared to nearly 13percent of Latinos, nearly 14 percent of African Americans, and more than 17 percent of Native Americans. In addition to ethnicity (race, cultural values, beliefs, and practices), some potential reasons for racial health disparities include communication barriers, lack of access to care, lower income levels, and lack of insurance (What is lupus ?, n. d.).
    Lupus does not have a cause, or a cure. Five decades have past finally; a new treatment is in the last stage of FDA approval (appendix 4). Lupus is difficult to diagnose. Many symptoms overlap creating many differential diagnoses to rule out before diagnosing one with Lupus. Lupus is insidious, and subtle. The Lupus Research Institute Organization lists the criteria of 11 symptoms for Lupus (Appendix 1). Other types Lupus are a Discoid Lupus, and a drug-induced Lupus.
Systemic Lupus Erythematosus in Women: An Overview
    Systemic Lupus Erythematosus (SLE, Lupus) is an autoimmune female dominated illness. Researchers at Brigham and Women’s Hospital, in Boston, Massachusetts created a registry for women from all ethnic backgrounds to tract epidemiology (BWH Researchers seek better understanding of lupus, improved patient care, 2008).  The federal government does not invest enough money in researching Lupus or autoimmune disorders. Researchers are tracking the illness. Finding a cure is not as beneficial financial as treating the symptoms. By tracking the epidemiology and establishing cultural competency will allow those inflicted to work with the physicians and facilities. 

    Systemic Lupus Erythematosus is an autoimmune phospholipids disease (About Lupus, Lupus Diagnosis). Treatment of Lupus is managing the symptoms of the disease. According to the Lupus Research Institute, more than 1.5 million Americans have Lupus (About Lupus, Lupus Diagnosis). Phospholipids cause swelling in patients with the disease. Swelling is a reaction from the immune system and a break down on the illness described below.  SLE is not communicable.             
    Factors that make women vulnerable to Lupus 90 % of Lupus patients are women according to the Statistics Reveal Risk factors for Lupus (About Lupus, Lupus Diagnosis). Average age of onset varies from 15-44. Lupus is the leading causes of other illnesses, kidney disease, stroke, premature cardiovascular disease in women who are in childbearing years, according to SLE Lupus Foundation, The transmission rate genetically is low (n. d.).
Gender and Racial disparities with Lupus
    African American women risk is three times higher than Caucasian women are suffer worse, and diagnosed later (About Lupus, Lupus Diagnosis). The risk assessment for the Asian American and Latinos rates two times higher.  Latino American, Asian AmericanAfrican American Native American women have varying levels of disease and complications due to secondary illness according to Lupus in Minorities: Nature versus Nurture (LUMINA). This study confirms Latino females have higher mortality rates and secondary diseases with the kidneys with a quick progression to deathLatino females suffer with cardiovascular problems. “Genetic and ethnic factors appear to be more important certain organ manifestations at disease that there are probably other genetic factors affecting the presentation (About Lupus, Lupus Diagnosis). African American females have a connection with the following: cerebral hemorrhage, Cerebral Vascular Accident, and seizures.
Environmental factors that make the Lupus vulnerable
        Brigham and Women’s Hospital have a registry of SLE patients since 1992. The design was to identify, “genetic and environmental risk factors for lupus and improve outcomes for patients” (BWH Researchers seek better understanding of lupus, improved patient care, 2008).  Karen Costenbader describes SLE as “heterogeneous disease and may in fact prove to be a complex combination of diseases (BWH Researchers seek better understanding of lupus, improved patient care, 2008). Costenbader, and Elizabeth Karlson, have narrowed research to modifiable risk factors…smoking, reproductive hormones, environmental toxins such as air pollution, ultraviolet light (BWH Researchers seek better understanding of lupus, improved patient care, 2008).  
    The Roxbury Lupus Project examined occupational exposure to silica and solvents as a risk factor for lupus (BWH Researchers seek better understanding of lupus, improved patient care, 2008). Other occupational studies relating to Lupus are mining, agricultural exposure to silica urban areas, silica dust exposure in construction, and demolition work, silica exposure with tobacco manufacturing, and dental amalgams (BWH Researchers seek better understanding of lupus, improved patient care, 2008) . Patricia A. Fraser found, “increased risk of SLE associated with exposure to urban silica dust, and further that longer exposure to silica is associated with greater risk” (BWH Researchers seek better understanding of lupus, improved patient care, 2008).  Proximity to hazardous waste sites are also under analysis. 
    Reproductive hormone assessment as a factor for women is prevalent when 90% of SLE patients are women. Costenbader and Karlson found the following links with elevated risk factors, early onset of menses, menopause, and use of hormones  for pregnancy prevention, or replacement therapy (BWH Researchers seek better understanding of lupus, improved patient care, 2008).
    The Cardiovascular component to the registry has shown thus far that women between 35-40 have atherosclerosis and have,” greater than 50 times the risk of having a myocardial infarction as compared with age-matched controls” (BWH Researchers seek better understanding of lupus, improved patient care, 2008).  A retrospective review identified that patient lifestyle on average was sedentary; perhaps from painful symptoms (BWH Researchers seek better understanding of lupus, improved patient care, 2008).
Alternative methods and the effects
    The Merck Manuel states” treatment depends on which body system is affected, whether or not it is severe or mild, or the level of activity of inflammation” (Beers, 2008). Merck lists the following treatment:  if the condition is mild, non-steroidal anti-inflammatory drugs, for dermatological, sunscreen will protect the skin along with steroidal ointment to control the inflammation, active Lupus requires steroids to control inflammation (Beers, 2008). When steroids are ineffective, immunosuppressive agents become, the treatment of choice when kidney, nervous, and vascular systems are effected (About Lupus, Lupus Diagnosis). After controlling the symptomsdecreasing the steroid down when improvement shows. For severe uncontrollable Lupus, a bone marrow transplant becomes an option (Lahita, 2004).
Alternative and homeopathic treatments for Lupus and the effects
    Many individuals use meditation as a method to reduce pain, combat depression, and stress. Acupuncture is another option to decrease symptoms by strategically placing needles to relieve symptoms. Massage and hypnotherapy reduce symptoms as well. Prayer and spirituality is a component of belief systems that is beneficial to relieve symptoms.
    Deydroepiandrosterone (DHEA) is a natural substance in the body. The Lupus patient has lower levels of DHEA.   “is an intermediate to androstenediol and androstenedione, which has the potential to become estrogen or testosterone” (Patavion, 2001). DHEA regulates the immune system. Studies have cited that patients were able to reduce the amount of steroids needed, and had less flares (Patavion, 2001)
    Fatty acids are from fish oils also known as omega-3 fatty acids “inhibit the autoimmune activity of the b and t lymphocytes and the abnormal interleukin expression” (Patavion, 2001). Fatty acids are good for reducing cholesterol, which is usually high in Lupus patients. These acids also suppress macrophage activity, production of cycloaxygenase that contribute to renal damage, and delays lymphoproliferation (Patavion, 2001).
    Flax seed oil is 70% omega-3 reduces, “antibodies, anticardiolipn and anti-DNA properties” (Patavion, 2001). In SLE patients, these antibodies become elevated, and the result is that flax seed oil reduces the antibodies. Flax seed oil decreases creatinine levels, and platelet inhibition, which delays proteinuria, with kidney disease patients.
    Vitamins are low in SLE patients. Low vitamin D levels makes susceptibility to osteoporosis, and heart disease is higher than average. Taking Vitamin D inhibits lymphocyte activation and cytokine release (Patavion, 2001). 15 minutes of sunlight a day improves Vitamin D levels.
    Antioxidants are low with SLE patients. Lipid peroxidase is high with Lupus (Patavion, 2001). To combat this alpha-tocopherol and beta-carotene is best. These antioxidants, “decrease in anti-double stranded DNA titers and a decrease in lymphoproliferation (Patavion, 2001)”
    Dietary changes can naturally combat some problems found with SLE patients For instance eating foods high in vitamins, and minerals. However, Patavion discusses the need to avoid alfalfa seeds because of its molecular similarities to Lupus, and  in mice, mimic SLE (2001). The study showed removing alfalfa seeds and the mice improved but when later when reintroduced the flare happened again (Patavion, 2001). Other foods that have similar properties to avoid raw are, legumes, soybeans, clover, and onions. Cooking destroys the effects.   
Cultural Competency of Women with Lupus
              Asians, Native Americans, and Latinos all have the same basic healthcare treatments that consist of the balance, Asians have yin and yang, Native Americans call it “Universe, and Latinos call it a balance of hot and cold elements. These ethnicities believe in herbal and traditional remedies. Traditionally these ethnicities believe in family decisions regarding healthcare. The root tipterygium wilfordi Hook F (twHF) is a vine like plant that inhibits IL-2, interferon-1 and PGE. Asians use this as an herbal remedy. This herb reduces the need to prednisone by 50%.  Asians believe strongly in massage, acupressure, acupuncture, moxibustion, and derma-abrasion. Between expenses, and oriented to the present time, which negatively influences healthcare with African Americans. African Americans do not traditionally donate organs or blood unless the need is familial. African Americans do believe in the use of herbal remedies.
Effects with beliefs and values have on treatment options
    Asian Americans believe in yin and yang, which is the concept of maintaining balance between forces.  Asians like other cultures. Native Americans believe that remedies will work when seeing it work. Native Americans focus of healing. Treatment is healing the ailment and body, by ridding it of “evil” Latinos believe in ridding the body of the evil spirit and that illness is a sign of wrongdoing by the parents, and families, alive or dead.  African Americans have distrusted Caucasians possibly stemming from slavery that going to a ‘white’ institution a hard decision to make (Galanti, n. d.). These reasons are factors in why African Americans will wait to seek healthcare out later than other cultures.
Conclusion
Autoimmune diseases treatment is the same medications, at the same stages of illness, and severity. Research on Lupus and other autoimmune diseases are not a high priority funding wise. Researchers are busy tracking the epidemiology looking for clues about the disease. Working with an ethnic minority has to allow room for non-traditional medicine, or alternative medicines. Alternative medicine is part of the culture. Harmony can work when both the healthcare worker and the patient cooperate how to incorporate both methods together.
 References
About Lupus, Lupus Diagnosis. (n.d.). Retrieved September 19, 2009, from Lupus Research Institute: http://www.lupusresearchinstitute.org/lupus/lupus_diagnosis
Beers, M. H. (Ed.). (2008). Systemic lupus erythematosus. (M. R. Laboratories, Producer, & Merck & Co, Inc. Whitehouse Station, New Jersey) Retrieved September 7, 2009, from Merck Source The Merck Manuals Online Medical Library Home Edition For Patients and Caregivers: http://www.merck.com/mmhe/sec09/ch126/ch126b.html
BWH researchers seek better understanding of lupus, improved patient care. (2008, 2 10). Retrieved September 21, 2009, from Brigham and Women's Hospital, a teaching affiliate of Harvard: Rheumatology Update: http://www.brighamandwomens.org/rheumatology/Medical/RheumUpdate/lupus.aspx
Galanti, G.A. (n. d.). Cultural Profiles, African Americans. Retrieved September 22, 2009, from Cultural Diversity: http://www.ggalanti.com/cultural_profiles/african_american.html
Lahita, R. P. (2004). Lupus Q&A: everything you need to know about Lupus. Retrieved September 14, 2009, from books.google.com: http://books.google.com/books?id=nptpD7S8BXkC&pg=PA47&lpg=PA47&dq=who+is+vunerable+to+lupus&source=bl&ots=fBTu_TRJzv&sig=QfgksVRygKsczVZCxP-NuSvlhgI&hl=en&ei=NZ6uSoePMILGlAeahP3ZBg&sa=X&oi=book_result&ct=result&resnum=7#v=onepage&q=&f=false
Patavion, T. B. (2001, June 6). Natural medicine and nutritional therapy as an alternative treatment in systemic lupus erythematosus. Retrieved September 20, 2009, from Alternative Medicine Review. 6 (5(:460-471): http://www.chiro.org/nutrition/ABSTRACTS/Natural_Medicine_and_Lupus.shtml
What is lupus? (n. d.). Retrieved September 19, 2009, from S.L.E. Lupus Foundation: http://www.lupusny.org/lupus.php

 Appendix 1
Criteria for diagnosis of SLE from About Lupus, Lupus Diagnosis:
1. Malar rash: butterfly-shaped rash across cheeks and nose.
2. Discoid (skin) rash: raised red patches.
3. Photosensitivity: is a skin rash that results from a reaction to sunlight.
4. Mouth or nose ulcers: usually painless
5. Arthritis: (which is not erosive in two or more joints) along with tenderness, swelling, or effusion. With nonerosive arthritis, the bones around joints are undamaged.
6. Cardiopulmonary involvement: inflammation of the lining around the heart (peridcarditits) and/or lungs (pleuritis
8. Neurologic disorder: seizures and/or psychosis
9. Hematologic disorder, hemolytic anemia low white blood cell count, or low platelet count.
10. Immunologic disorder; the antibodies to double stranded DNA, antibodies to Sm or antibodies to cardiolipin.
11. Antinuclear antibodies a positive test in the absence of drugs known to induce it. A positive antinuclear antibody (ANA) test does not automatically mean you have lupus. Your immune system is your body's natural defense against disease. A positive ANA blood test shows that your immune system is making an antibody (protein) that reacts with components of your body's cells. This is autoimmunity and may or may not be harmful to your body. Therefore, while a positive ANA may be associated with an autoimmune illness like lupus, it does not mean you have the disease. Approximately 20% of the normal population will have a positive ANA test; positive tests are in other conditions, such as thyroid disease, certain liver conditions, and other autoimmune diseases (n. d.).
Appendix 2
Some Triggers for flares – from Lupus Q&A: Everything you need to know by Robert G. Lahita, and Robert H. Phillips, copy write 2004 Avery, Penguin group USA New York, New York.                                                                                                                                                                                                          
Sunlight, ultraviolet light, stress, surgical procedures, pregnancy, abortion, Changes with the pregnancy, sulfa-based medications, birth control pills, and radiation therapy”(2004)
Appendix 3
Types of Lupus - from Lupus Q&A: Everything you need to know by Robert G. Lahita, and Robert H. Phillips, copy write 2004 Avery, Penguin group USA New York, New York:                                                                                                            
Discoid Lupus is predominately a skin disease is termed cutaneous lupus Erythematosus. The skin inflammation is limited to the face and scalp. The inflammation can be self-limiting, continuous, and reoccur. This type of Lupus is not systemic.
Drug-induced Lupus occurs with certain medications that when discontinued so does the lupus.
Systemic Lupus Is an Antiphospholipid disease, which is autoimmune. The definition of autoimmune is when the body does not recognize what the phagocytes are attacking and attacks the normal body tissue as a foreign agent. See below for details.
Appendix 3
Systemic Erythematosus Lupus and the Immune Response from Lupus Q&A: Everything you need to know by Robert G. Lahita, and Robert H. Phillips, copy write 2004 Avery, Penguin group USA New York, New York:                                                                                                             
Lupus is an inflammatory disease because inflammation is a reaction of tissues to infection, injury, or invasion. Lupus has swelling, redness, pain, heat, and reduced function. The main components of the immune system are b-lymphocytes (b cells), t lymphocytes (t cells), and phagocytes. Each has a specific purpose.
T cells are from the thymus. There are several kinds of, and they fight off the antigen. Suppressor cells suppress the immune function. T cells are also cytotoxic T cells that recognize, attack, and destroy. They are important to help find subsets of lymphocytes. T cells have markers. T cells have specific monoclonal antibodies, which are not present with Lupus patients. T cells recognize foreign invaders and responds by killing them or presenting them to b cells to create and antibody. 
B cells (found in the bursa part of the chicken gut), are lymphocytes responsible for many parts of the immune process, but most important is the role of maturation into plasma cells and production of antibodies. These lymphocytes produce in the lymphoid tissue. Antigens are any substances produced inside the body or coming from outside the body that the immune system recognizes as being foreign-like germs, bacteria, viruses, or fungi. It is a trigger for the immune response to eliminate unwanted foreign invaders.
Phagocytes destroy certain particles and debris. The phagocyte, called macrophage digests and destroys particles and debris. Macrophages also send signals to lymphocytes by producing cytokines that cause the joint pain and swelling when a lupus patient goes into a flare
Appendix 4
LUPUS NEWS
FIRST-EVER LUPUS DRUG TRIAL SUCCESSFULLY COMPLETED


Lupus Foundation of America, North Texas Chapter                           August 2009

Dear Lupus Supporter,

This is a historic day for all people living with lupus.  It has been 40 years since man landed on the moon, but July 20, 2009 will be remembered as the day when a breakthrough in lupus may have occurred. 
 
Human Genome Sciences (HGS) and GlaxoSmithKline announced that their drug, BENLYSTA™, which was developed specifically to treat lupus, was successful in reaching the primary endpoint and most of the secondary endpoints in the first of two pivotal Phase III trials. The 52-week study was innovative in its design. Carefully selected patient participants coupled with a new patient responder index were key factors in the successful result. The drug was generally well tolerated.  
 
The trial is the largest double-blinded, randomized Phase III trial ever completed in lupus. The FDA has required the company to complete two such trials and the data from the second trial will be announced in November. Should this trial confirm the results of the 52-week study, HGS and its partner, GlaxoSmithKline, will submit an application to the FDA for approval to market BENLYSTA.

Following are FAQ's for your review:

Frequently Asked Questions
BENLYSTA ™
(Formerly Lymphostat-B)
 
1.      What is BENLYSTA?
BENLYSTA is a human monoclonal antibody that is being investigated as a potential new treatment for lupus. A monoclonal antibody is a type of protein made in the laboratory that is developed to find and attach to only one type of substance in the body. 
 
2.      How does BENLYSTA work? 
BENLYSTA is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator, or BLyS® (pronounced bliss), a naturally occurring protein which was discovered by scientists at Human Genome Sciences (HGS). Elevated levels of BLyS prolong the survival of B cells which can contribute to the production of autoantibodies - antibodies that target the body's own tissues.  Previous studies have shown that BENLYSTA can reduce autoantibody levels and help control autoimmune disease activity.

3.      Who developed BENLYSTA?
BENLYSTA is being co-developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK). 
 
4.      What clinical research has been conducted on BENLYSTA? 
HGS released Phase II clinical trial results for BENLYSTA in June 2006. The results demonstrated that it significantly reduced disease activity versus a placebo in patients with clinically active lupus, and appeared generally safe and well-tolerated.
In July 2009, HGS announced positive top-line results from the Phase III clinical trial, BLISS-52, which will continue to be analyzed. Results from the Phase III BLISS-76 clinical trial are expected to be released in November 2009. The design of the two trials is similar, but the duration of therapy in the two trials is different, 52 weeks for BLISS-52, and 76 weeks for BLISS-76.The BLISS-52 study was conducted primarily in Asia, South America, and Eastern Europe, and BLISS-76 is being conducted mostly in North America and Europe. 
 
5.      What are the results of the BLISS-52, Phase III BENLYSTA study? 
The study demonstrated thatlupus patients who were treated with BENLYSTA had improvement in overall disease activity without clinically significant flare-ups in one or more isolated organs when compared to patients who received the placebo (inactive agent). The patients receiving BENLYSTA also were able to reduce their intake of steroid medications. The study is the largest ever to be completed for lupus and the first Phase III (late stage) trial of a new biologic immune therapy for lupus to succeed in meeting its primary endpoint and most of its secondary endpoints.
 
6.      If BENLYSTA is approved by the FDA, what does it mean for people with lupus?  
While clinical trials are still ongoing, assuming success, BENLYSTA could represent a breakthrough in the treatment of lupus. If approved, BENLYSTA could be the first drug approved to treat lupus in more than 50 years AND would bethe first drug developed specifically for lupus since the disease was discovered more than a century ago!
 
7.      What makes BENLYSTA different from other lupus treatments? 
BENLYSTA could be the FIRST FDA-approvedmedication specifically designed for the treatment of lupus. Current medications are borrowed from other diseases and conditions and some are used off-label, which means they were never approved by the FDA for lupus. These drugs include high doses of steroids, antimalarial medications, immunosupressive drugs, and organ-rejection drugs - many which have serious and devastating side effects.  
 
8.      When will the drug be available for patients?
More information on this issue will be available after the results of BLISS-76, a longer-term Phase III clinical study, are released this fall.  The results from the BLISS-52 study and the BLISS-72 study will be submitted to the U.S. Food and Drug Administration (FDA) for review. The review process can take anywhere from six months to several years to complete.  ONLY after receiving FDA approval will the drug be available to patients. 
 
9.      What side effects have been found with BENLYSTA?
In earlier Phase II studies, BENLYSTA has shown no increase in overall or serious side effects or infections. More information will be available on this issue as the data continues to be analyzed along with the results for the BLISS-76 clinical study which are expected to be released in November.  
 
10.  Are there other treatments being researched for lupus?
There are several promising treatments in the near-term pipeline. More companies are involved in lupus research and there are more potential new therapies being investigated than ever before.
 
11.  Why has it taken so long to find a treatment for lupus?
Lupus is a complex disease. It can affect multiple organ systems and symptoms can range in severity from one day to the next.  And it can affect each person differently with varying responses to treatment. The complexity presents challenges in evaluating potential new therapies. With each research study, regardless of the outcome, there are new discoveries that help pave the way for new therapies.
  
More information will be available about this drug as it enters the FDA approval 


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