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3 Negative ANCA: Very little or no fluorescence is present. Atypical p-anca: This is seen in most cases of ulcerative colitis, as well as some patients with Crohn s disease and RA. Anti-Double-Stranded DNA The anti-double-stranded DNA (anti-dsdna) test is a blood test used to diagnose and monitor SLE. The test is commonly performed through an ELISA assay. It is typically ordered following a positive ANA test in people who have clinical signs of SLE. A high level of anti-dsdna is strongly associated with SLE, and it is often significantly increased during or just prior to an SLE flare-up. Only xx% to xx% of individuals with SLE have anti-dsdna. Low to moderate levels of the autoantibody may be seen with other autoimmune disorders, including Sjögren s syndromes and mixed connective tissue disease (MCTD). Extractable Nuclear Antigen Antibodies Panel Extractable nuclear antigen antibodies (ENA) are a subset of ANA. Because certain autoimmune disorders are characteristically associated with the presence of one or more extractable nuclear antigen antibodies, this association can be used to help diagnose an autoimmune disorder and to distinguish between disorders. The ENA panel is typically a group of x or x autoantibody tests. A 4-panel ENA includes anti-ribonucleoprotein, Smith antibody, and anti- Sjögren s symptom A and B. A 6-test ENA panel will also include scleroderma antibodies, anti-topoisomerase (SCL-70), and antihistidyl transfer RNA syntheses antibodies (Anti-Jo1). Rheumatoid Factor Rheumatoid factor (RF) testing is completed through a blood test to help diagnose RA and Sjögren s syndrome. The RF test is valuable in confirming RA or Sjögren s syndrome, but it can be positive in persistent bacterial, viral, and parasitic infections, as well as certain cancers. It can also be detected in lung, liver, and kidney disease. Nearly xx% of those with RA and between xx% and xx% of individuals with Sjögren s syndrome will have positive RF tests. According to labtestsonline.org, the frequency of false positive RF results occurring in individuals who do not have RA or Sjögren s syndrome increases with age. Copyright BCC Research, Wellesley, MA USA, 89

4 The following table projects the global market for medications to treat Crohn s disease through TABLE 17 GLOBAL MARKET FOR MEDICATIONS TO TREAT CROHN S DISEASE, THROUGH 2016 ($ MILLIONS) CAGR% Source: BCC Research PSORIASIS DEFINITION Psoriasis is a chronic skin disorder characterized by epidermal hyperproliferation and dermal inflammation that varies in severity from minor, localized patches to complete body coverage. Psoriasis affects between x% and x% of the global population, making it one of the most prevalent autoimmune diseases worldwide. It can be associated with other inflammatory conditions, such as psoriatic arthritis, IBD, and coronary artery disease. There are five types of psoriasis: plaque, guttate, inverse, pustular, and erythrodermic. The most common form is plaque psoriasis, which appears on the first layer of skin. According to the National Psoriasis Foundation, xx% of patients with psoriasis have mild disease, xx% have moderate disease, and x% have severe disease. The foundation also estimates that the direct and indirect costs of psoriasis in the U.S. are more than $xx billion, with the indirect cost of missed workdays accounting for xx % of the cost. SYMPTOMS AND DIAGNOSIS In plaque psoriasis, silvery-white skin appears at the affected site. Plaques frequently occur on the skin of the elbows and knees, but the disease can affect any area, including the scalp, the palms of the hands, the soles of the feet, and the genitals. Psoriasis can also cause inflammation of the joints, which is known as psoriatic arthritis. Copyright BCC Research, Wellesley, MA USA, 38

5 like receptors), whereas others such as complement molecules exist in soluble form. The innate immune system holds an established number of options for fighting invaders. Although innate receptors can counteract some invaders, they can also active the adaptive immune system. ADAPTIVE IMMUNE SYSTEM The adaptive immune system comes into play if the initial barriers or the innate immune system cannot handle the foreign invasion. The adaptive system is composed of unique cells and molecules generated as either bone marrow lymphocytes (B cell) or thymus lymphocytes (T cell). T cells and B cells are the only cells capable of producing somatically generated receptors. Each lymphocyte randomly generates a unique receptor, and when they are combined, they create a set of receptors individualized to the particular self or nonself environment. The receptors are also able to remember substances (i.e., immunologic memory) and mount a more vigorous attack with subsequent invasions. According to Lange s Basic and Clinical Pharmacology, the adaptive immune system has a number of distinguishing characteristics that contribute to the elimination of pathogens. These include the ability to: Respond to a variety of antigens in specific ways Discriminate between foreign and self antigens Respond to previously identified antigens in learned ways by initiating vigorous memory responses GENETICS AND AUTOIMMUNE DISEASES A number of genes collectively increase a patient s vulnerability or susceptibility to autoimmune disease. An individual does not usually inherit a specific gene that causes a specific defect in immune response, but instead inherits several genes that interplay with the environment and other exposures to increase vulnerability or susceptibility to autoimmune disease. A key to developing effective treatments for autoimmune diseases is acquiring an understanding of the genes involved in autoimmune activity. This complex system is designed to protect the body from the invasion of foreign cells. In a normally regulated body system, most of body s defenses are unleashed on invading cells, leaving the body s normal cells untouched. In individuals with uncontrolled autoimmune systems, the body s defenses are unable to differentiate between the self and nonself cells, which can lead to erroneous attacks on the body s normal cells. Copyright BCC Research, Wellesley, MA USA 8