- Adrenal Glands
Located on the top of each kidney and are responsible for releasing different classes of hormones. Hormones released from the kidney control many important functions in the body, including managing blood sugar levels, regulating inflammation, regulating the balance of salt and water, controlling the “fight or flight” response to stress, maintaining pregnancy, and initiating and controlling sexual maturation during childhood and puberty. The adrenal glands are also an important source of sex steroids, such as estrogen and testosterone.1
- Adverse Event
A harmful and negative outcome that happens when a patient has been provided with medical care.1
A medicine that reduces or relieves headaches, sore muscles, arthritis, or other aches and pains.3
Occurs when your blood does not carry enough oxygen to the rest of the rest of your body. The most common cause of anemia is not having enough iron. Your body needs iron to make hemoglobin. Hemoglobin is an iron-rich protein that gives the red color to blood. It carries oxygen from the lungs to the rest of the body.3
- Anifrolumab (Saphnelo™)
A treatment for systemic lupus erythematosus which works by inhibiting a key protein in the immune system called the IFNAR receptor. This protein acts like a transmitter, amplifying signals from tiny messengers called type I interferons. This activates many parts of the immune system and can trigger major inflammation. For more information, visit What You Need to Know About Saphnelo.
- Anti-Malarial Drugs
Drugs used for the treatment of malaria which are also widely used in the management of lupus symptoms.
- Anti-TNF a
A class of drugs that block the action of tumor necrosis factor (TNF); used in cases of rheumatoid arthritis because TNF instigates inflammation of the joints.
Reducing or counteracting inflammation; can also refer to a drug that reduces inflammation.2
A protein made by the body’s immune system that circulates in the blood, recognizes foreign substances like bacteria and viruses, and defends the body against them.1
- Anticardiolipin Antibodies (ACA)
- Antinuclear antibody
An antibody that binds to the nuclei of the body’s own cells. Nearly all SLE patients have this antibody. However, it can be found in healthy people and in most people with autoimmune disease.
- Antiphospholipid syndrome
An autoimmune disorder caused when antibodies—immune system cells that fight off bacteria and viruses—mistakenly attack healthy body tissues and organs.1(See autoimmune disease)
- Approved Drugs
In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.
Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more.
Literally means joint inflammation. Although joint inflammation is a symptom or sign rather than a specific diagnosis, the term arthritis is often used to refer to any disorder that affects the joints. Joints are places where two bones meet, such as your elbow or knee.1
A disease in which plaque builds up inside your arteries. Plaque is a sticky substance made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, plaque hardens and narrows your arteries. That limits the flow of oxygen-rich blood to your body.3
A misdirected immune response that occurs when the immune system goes awry and remains in a state of hyperactivity even after the infections or stimulus for the response has been resolved.
- Autoimmune Disease(s)
A type of disease in which the immune system malfunctions and mistakenly attacks healthy cells, tissues, and organs. These attacks can affect any part of the body, weakening bodily function and even become life-threatening.1
- B Cells
A type of white blood cell that is part of the immune system. They produce antibodies, which are used to attack invading bacteria, viruses, and toxins.1
- Belimumab (benlysta)
Benlysta is a human monoclonal antibody that was approved for the treatment of lupus by the U.S. Food and Drug Administration (FDA) on March 9, 2011 and for lupus nephritis on December 17, 2020. Benlysta was also approved by the FDA to treat lupus in children and teens (5 to 17) in 2019 and for treatment of lupus nephritis in the age group in 2022. 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. For more information, visit What You Need to Know About Benlysta.
Biologics are a newer category of therapy in which therapy is directed toward neutralizing proteins in the body that are causing inflammation. Some are administered via intravenous (IV) infusions and others are injections you give yourself.4 Examples of biologics used for lupus treatment include Benlysta (belimumab), Rituxan (rituximab), and Saphnelo (anifrolumab).
- Biological Pathway
A series of actions among molecules in a cell that leads to a certain product or a change in the cell. It can trigger the assembly of new molecules, such as a fat or protein, turn genes on and off, or spur a cell to move.1
- Biological disease-modifying anti-rheumatic drugs (bDMARDs)
A class of drugs indicated for the treatment of inflammatory arthritides and connective tissue diseases. bDMARDs are immunosuppressive and immunomodulatory agents, examples of which include infliximab, adalimumab, etanercept, rituximab, abatacept, rituximab, tocilizumab, tofacitinib, among others.1
Short for biological marker; an objective measure that captures what is happening in a cell or an organism at a given moment.1
Without knowledge of certain facts that could serve for guidance or cause bias (see Bias).1
- Blood Chemistry Test
A group of tests that measures different chemicals in the blood. The tests can give doctors information about your muscles (including the heart), bones, and organs, such as the kidneys and liver.
- CAR-T cell therapy
Chimeric antigen receptor T cell therapy (CAR-T cell therapy) introduces a receptor gene to a person’s T cells, a type of immune cell. This gene provides instructions for making a protein, called the chimeric antigen receptor (CAR), that attaches to specific antigens or markers on other cells in the body. In lupus, the specific genetically engineered T cell can attack B cell markers that then leads to B cell depletion.3 (See T cells; see B Cells; see gene)
Coronavirus disease 2019 (COVID-19) is an illness caused by a virus. This virus is a new coronavirus that has spread throughout the world. It is thought to spread mainly through close contact from person to person.3
A strong but flexible material found in some parts of the body (such as the nose, the outer ear, and some joints).2
- Cellular metabolism
The sum of all chemical changes that take place in a cell through which energy and basic components are provided for essential processes, including the synthesis of new molecules and the breakdown and removal of others.1
- Central nervous system
The part of the nervous system which in vertebrates consists of the brain and spinal cord, to which sensory impulses are transmitted and from which motor impulses pass out, and which coordinates the activity of the entire nervous system.2
Inflammation of the cerebrum (the enlarged front and upper part of the brain that is the center of thinking).2
Thread-like structures located inside animal and plant cells, made of protein and a single molecule of deoxyribonucleic acid (DNA).1
- Chronic Fatigue Syndrome
A serious, long-term illness that affects many body systems. Another name for it is myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). CFS can often make you unable to do your usual activities. Sometimes you may not even be able to get out of bed.3
- Chronic Pain
Pain that may last for weeks, months, or even years. The original cause may have been an injury or infection. There may be an ongoing cause of pain, such as arthritis or cancer. In some cases, there is no clear cause.3
Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.
- Clinical Trial
A scientifically controlled study of the safety and effectiveness of a therapeutic agent (such as a drug or vaccine) using consenting human subject.2
- Clinical Trial Sponsor
A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. Also called trial sponsor.1
Of, relating to, being, or involving conscious intellectual activity (as thinking, reasoning, or remembering).2
In epidemiology, a group of individuals with some characteristics in common and followed over a period of time.1
Two or more disorders or illnesses occurring in the same person. They can occur at the same time or one after the other. Comorbidity also implies interactions between the illnesses that can worsen the course of both.1
Proteins in normal blood that, in combination with antibodies, causes the destruction of certain antigens (such as bacteria and other foreign invaders) (See Antibody).2
- Complementary and Alternative Therapy
Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc.
- Complete Blood Count (CBC) Test
Common blood test often performed as part of a routine checkup. The CBC can help detect blood diseases and disorders, such as anemia, infections, clotting problems, blood cancers, and immune system disorders.1
- Congenital Heart Block
A rare condition that affects the heart's electrical system, which controls and coordinates its pumping function. This can interfere with the heart's normal rate and rhythm and may significantly limit the ability of the heart to pump blood to the rest of the body.1
- Connective Tissue
Tissue that binds structures together, form a framework and support for organs and the body as a whole, store fat, transport substances, protect against disease, and help repair tissue damage. They occur throughout the body.1
An experiment in which the subjects are treated as in a parallel experiment except for omission of the procedure or agent under test and which is used as a standard of comparison in judging experimental effects.2
- Control Group
The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
- Controlled Trial
A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all.1
- Coronary Artery Disease (CAD)
The most common type of heart disease. It is the leading cause of death in the United States in both men and women. CAD happens when the arteries that supply blood to heart muscle become hardened and narrowed. This is due to the buildup of cholesterol and other material, called plaque, on their inner walls.3
A medication derived from the natural hormone cortisone, produced by the cortex of the adrenal glands, that reduces inflammation and swelling. Corticosteroids are not the same as "anabolic steroids" (performance enhancing drugs being used and abused in sports) and are used to treat a variety of health problems.3
Damage refers to organ damage due to disease activity. It is principally assessed using the Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI), which measures irreversible damage that has occurred after the diagnosis of lupus and predicts future mortality.1
A serious medical illness and disorder of the brain. Feelings persist and interfere with everyday life, more than just a feeling of being sad or "blue" for a few days.3
One of a group of muscle diseases known as the inflammatory myopathies, which are characterized by chronic muscle inflammation accompanied by muscle weakness. (See myopathies)1
- Diagnostic Biomarker
Detects or confirms the presence of a disease or condition of interest, or identifies an individual with a subtype of the disease.1
- Double-blind Study
A study in which neither the participating individuals nor the study staff knows which medicine is being used, so they can describe what happens without bias.1
- Drug-Induced Lupus (DIL)
Lupus triggered by certain types of blood pressure medications, anti-seizure medications and antibiotics. People who have drug-induced lupus usually get better when they stop taking the medication. Rarely, symptoms may persist even after the drug is stopped.4
- Early Phase 1 (formerly listed as Phase 0)
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals.1
(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it.
- End-stage-renal disease
A medical condition in which a person's kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life.5
The branch of medical science that investigates all the factors that determine the presence or absence of diseases and disorders.1
- Exclusion Criteria
Exclusion criteria features of the potential study participants who meet the inclusion criteria but present with additional characteristics that could interfere with the success of the study or increase their risk for an unfavorable outcome. Common exclusion criteria include characteristics of eligible individuals that make them highly likely to be lost to follow-up, miss scheduled appointments to collect data, provide inaccurate data, have comorbidities that could bias the results of the study, or increase their risk for adverse events (most relevant in studies testing interventions).1
The basic physical unit of inheritance; passed from parents to offspring and contain the information needed to specify traits.1
- Gene Expression
The process by which the information encoded in a gene is used to direct the assembly of a protein molecule.1
- Genetic Disorder
A disease caused in whole or in part by a change (mutation) in the DNA sequence away from the normal sequence.1
The study of genes and the way that certain traits or conditions are passed down from one generation to another.1
- Health Disparity/disparities
A health difference that adversely affects socially disadvantaged populations in the areas of incidence and/or prevalence of disease as well as premature or excessive mortality.1
- Heart Attack
Happens when the flow of oxygen-rich blood to a section of heart muscle suddenly becomes blocked and the heart can’t get oxygen.1
- IgG (Immunoglobulin G)
A class of immunoglobulins (antibodies) circulating in the blood that facilitate the destruction of microorganisms foreign to the body (See antibodies).2
- IgM (Immunoglobulin M)
A class of immunoglobulins (antibodies) that includes the primary antibodies released into the blood early in the immune response and that are highly efficient in binding complement. (See antibodies) (See complement)2
- Immune Complex
Molecular complexes formed in the blood by combination of an antigen and an antibody that tend to accumulate in bodily tissue and are associated with various diseases or disorders (See antigen) (See antibodies).2
- Immune Response
A bodily response that occurs when lymphocytes (immune-system cells) identify the antigen-like molecule as foreign and create antibodies and lymphocytes capable of rendering it harmless (See antigen) (See antibodies).2
Causing or characterized by immunosuppression (the suppression of the immune system as by drugs or disease).2
The rate of occurrence of new cases of a disease in a population group over a period of time.1
A bodily response to injury or disease in which heat, redness, and swelling are present2
- Innate Immunity
Immunity possessed by a group (as a species or race) that is present in an individual at birth (See immunity/immune system).2
Any of a group of heat-stable soluble basic antiviral glycoprotein cytokines of low molecular weight that are produced by cells exposed usually to the action of a virus, sometimes to the action of another intracellular parasite (such as a bacterium), or experimentally to the action of some chemicals (See cytokines).2
- Interleukin-2 (IL-2)
One of a group of related proteins made by white blood cells (leukocytes) and other cells in the body. It increases the growth and activity of B cells and T cells (lymphocytes) in the body and affects the development of the immune system.1 (See B cells; see T cells).
Types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.
- Investigational Drug
A drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and effectiveness first by clinical investigators and then by practicing physicians using patients who have given informed consent to participate (See clinical trial).2
- Investigational Group
The group in a clinical research study that receives the drug, vaccine, or other intervention being tested. Interventions may also include medical procedures (such as radiation therapy and surgery), medical devices, behavior changes (such as diet and exercise), education programs, and counseling. Also called experimental group and intervention group (See intervention).1
Almost any abnormality involving any tissue or organ due to any disease or any injury. There are many types of lesions and many ways to classify lesions (e.g., a benign lesion is non-cancerous whereas a malignant lesion is cancerous).
A decrease in the number of circulating white blood cells (leukocytes) in the blood. As the principal function of white cells is to combat infection, a decrease in the number of these cells can place patients at increased risk for infection.
- Lymph Nodes
Any one of many rounded masses of tissue in the body through which lymph passes to be filtered and cleaned. Lymph is a pale fluid that contains white blood cells and that passes through channels in the body and helps to keep bodily tissues healthy.2
Cell of the immune system that functions in the destruction of foreign antigens (such as bacteria and viruses).2
- Malar Rash
An erythematous (red), flat facial rash that affects the skin in the malar area (over the cheekbones) and extends over the bridge of the nose.1
- Metabolic syndrome
A group of risk factors that raise risk for heart disease and other health problems (See heart disease).1
The chemical processes by which a plant or an animal uses food, water, etc., to grow and heal and to make energy.2
A community of microorganisms (such as bacteria, fungi, and viruses) that inhabit a particular environment and especially the collection of microorganisms living in or on the human body.2
- Mixed connective tissue disease
Systemic lupus erythematosus, scleroderma, and polymyositis. (See autoimmune disorders) (See systemic lupus erythematosus) (See scleroderma).1
- Monoclonal Antibodies
Antibodies that derived from the clone of a single B cell and that is produced in large quantities of identical cells that act against the same antigen (as a cancer cell) (See antibody) (See antigen) (See B cells)2
- Natural History Study
Study of the natural development of something (such as an organism or a disease) over a period of time.
- Neonatal lupus
Neonatal lupus is not true lupus. It is a rare condition associated with anti-SSA/Ro and/or anti-SSB/La antibodies from the mother that affect the fetus. At birth, the baby may have a skin rash, liver problems, or low blood cell counts, but these symptoms typically disappear completely after six months with no lasting effects. For more information, visit What is Neonatal Lupus?
An inflammation of the kidney. See also: What is lupus nephritis?
- Nervous system
The system of nerves in your body that sends messages for controlling movement and feeling between the brain and the other parts of the body.1
One who specializes in the branch of medicine concerned especially with the structure, function, and diseases of the nervous system.2
A branch of medicine concerned especially with the structure, function, and diseases of the nervous system.2
Cells regarded as the first line of defense in the innate arm of the immune system. (See immune system)1
- New Drug Application (NDA)
An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
A nonsteroidal anti-inflammatory drug (such as aspirin and ibuprofen). 2 (See anti-inflammatory)
- Observational Study
A type of study in which individuals are observed or certain outcomes are measured. 1
Of, relating to, or being a drug used to treat a condition for which it has not been officially approved by the FDA to specifically treat the condition. 2
A branch of medicine concerned with the prevention, diagnosis, treatment and study of cancer. 2
- Open Label
The researcher and the participant in a research study know the treatment the participant is receiving. 2
- Open Studies/Open-Label Study
being or relating to a clinical trial in which the treatment given to each subject is not concealed from either the researchers or the subject.2 (See clinical trial)
A physician who specializes in ophthalmology, a branch of medicine that deals with the diagnosis and treatment of disorders of the eye.2
Osteoarthritis is the most common form of arthritis. It causes pain, swelling, and reduced motion in your joints. It can occur in any joint, but usually it affects your hands, knees, hips or spine.3 (See arthritis)
The development of a disease. The origin of a disease and the chain of events leading to that disease.
The study of the essential nature of diseases and especially of the structural and functional changes produced by them.2
A branch of medicine dealing with the development, care, and diseases of infants, children, and adolescents.2
- Peer Review
A process of subjecting an author’s scholarly work, research or ideas to the scrutiny of others who are experts in the same field.1
- Phase I Trials
A research study in which an experimental drug or treatment is tested in a small group of people (20-80) for the first time. The purpose is to evaluate its safety and identify side effects. 1
- Phase II Trials
A research study in which the experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety. 1
- Phase III Trials
A research study in which the experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments. 1
- Phase IV Trials
A research study conducted after a drug is licensed and approved by the FDA; researchers track its safety, seeking more information about its risks, benefits, and optimal use. 1
An immunological response to light, usually sunlight. Photosensitive individuals typically break out in a rash when exposed to sunlight; how much exposure it takes to cause a reaction varies from person to person.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.
- Placebo Controlled Study
A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
- Placebo Effect
A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.
- Plaquenil (Hydroxychloroquine)
A common brand name for hydroxychloroquine. Hydroxychloroquine belongs to the family of medicines called “antimalarials” (AMs), which are also classified as disease-modifying anti-rheumatic drugs, or DMARDs. These drugs were initially used to prevent and to treat malaria but are no longer used for those purposes; more effective drugs have since been developed. In 1956, the U.S. Food and Drug Administration approved hydroxychloroquine for symptoms of lupus and rheumatoid arthritis, particularly skin inflammation, hair loss, mouth sores, fatigue, and joint pain. For more information on hydroxychloroquine, visit: Hydroxychloroquine (Plaquenil): Benefits, Side Effects, and Dosing .
A small, round, thin blood cell that helps blood to stop flowing from a cut by becoming thick and sticky2
- Population study
A study of a group of individuals taken from the general population who share a common characteristic, such as age, sex, or health condition. This group may be studied for different reasons, such as their response to a drug or risk of getting a disease.1
An elevation in blood pressure in a pregnant woman of 140/90, with protein in the urine, or swelling (edema) of the feet, hands, and/or face.
Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out.
The number of people in a population group who have a disease or condition in a specific period of time.1
- Primary endpoint
An objective tool used to measure how beneficial a medical intervention is to a patient’s feeling, function, and survival.1 (See interventions)
- Principal Investigator (PI)
A doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.1
A broad term used to describe protein in the urine. Persistent proteinuria is a marker of kidney damage.1
A carefully designed plan to safeguard the research participants’ health and answer specific research questions.1
- Randomized Controlled Trial
A clinical trial in which the subjects are randomly distributed into groups which are either subjected to the experimental procedure (as use of a drug) or which serve as controls2 (See clinical trial)
- Raynaud’s Phenomenon
A condition that affects your blood vessels. If you have Raynaud’s phenomenon, you have periods of time called “attacks” when your body does not send enough blood to the hands and feet. During an attack, your fingers and toes may feel very cold or numb and change color (usually to white or blue). 1
A disease that causes stiffness and pain in the muscles and swelling and pain in the joints.2
- Rheumatoid Arthritis
A form of arthritis that causes pain, swelling, stiffness and loss of function in your joints. 3 (See arthritis)
One who specializes in rheumatology2 (See rheumatology)
An autoimmune disorder that may involve changes in the skin, blood vessels, muscles, and internal organs.1 (See autoimmune disease)
An abnormal state in which you become unconscious and your body moves in an uncontrolled and violent way2
- Side effect
An often harmful and unwanted effect of a drug or chemical that occurs along with the desired effect2
- Single-blind Study
A study in which one party, either the investigator or participant, does not know which medicine is being used, so they can describe what happens without bias; also called single-masked study.1
- Sjogren’s Syndrome
An autoimmune disorder in which immune cells attack and destroy the glands that produce tears and saliva (See autoimmune disease)1
- Standard of Care
The degree of care or competence that one is expected to exercise in a particular circumstance or role.2
- Statistical Significance
The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.1
- Systemic Lupus Erythematosus (SLE)
A chronic, inflammatory, variable autoimmune disease of connective tissue that occurs chiefly in women and is typically characterized by fever, skin rash, fatigue, and joint pain and often by disorders of the blood, kidneys, heart, lungs, and brain2 (See autoimmune disease)
- T Cells
A type of white blood cell that is part of the immune system. T cells destroy the body’s own cells that have themselves been taken over by viruses or become cancerous.1
An immunosuppressive drug whose main use is after organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection.1
The formation of a blood clot inside a blood vessel that obstructs the natural flow of blood through the circulatory system.1
The capacity of the body to endure or become less responsive to a substance (as a drug) or a physiological insult especially with repeated use or exposure2
An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.
- Treatment Trials
Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.1
- Voclosporin (Lupkynis™)
Lupkynis is a drug developed to treat lupus nephritis, a lupus-related kidney disease caused by inflammation. It is taken as a pill in combination with standard of care therapies and works by suppressing the immune system. The FDA approved voclosporin for the treatment of lupus nephritis in the U.S. on January 22, 2021. For more information, visit: Lupkynis™ (voclosporin): What you need to know
2 Merriam-Webster Dictionary
3 Medline Plus
4 Mayo Clinic