Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.
Certolizumab pegol (Cimzia) is a pegylated humanized antibody fragment also directed
against TNF alpha, acting similarly to infliximab and adalimumab. Although
unlike other monoclonal antibodies (infliximab, adalimumab), certolizumab pegol
is missing a certain portion of the molecule and, therefore, does not induce in
vitro complement activation which can be toxic to normal cells. Theoretically
this may result in better tolerability of certolizumab pegol in patients as
compared with other TNF antibodies6.
This medication was approved in 2008 by the U.S. Food and Drug Administration for
the treatment of moderate to severe Crohn's disease in patients who do not
respond sufficiently or adequately to standard medical therapy. Certolizumab
pegol 400 mg subcutaneously has been effective in inducing and maintaining
clinical remissions for over 3.5 years without the need for increasing doses
(based on the PRECiSE2 and PRECiSE3 studies)6.
The standard dose of certolizumab pegol is 400 mg subcutaneously at week 0,
week 2, and then week 4 to induce remission. Maintenance dosing is 400 mg
subcutaneously every 4 weeks in patients who demonstrate a clinical response.
The side effects of certolizumab (Cimzia)
Certolizumab is generally well-tolerated. The incidence of adverse events in
the literature was similar between placebo and treatment groups.
Nasopharyngitis, injection site pain or other injection site reaction, and
infections were more common in the treatment groups.
Patients might also experience upper respiratory tract infections,
urinary
tract infections, or a rash. The most common adverse reactions leading to the
discontinuation of the drug were abdominal pain, diarrhea, and intestinal
obstruction (rarely).
Since certolizumab pegol is similar to the other biologic agents, it is
reasonable to assume that it might increase the risk for serious infections
including tuberculosis. However, in ongoing clinical studies (including over
5000 certolizumab-treated patients), the overall rate of TB is approximately
0.61 per 100 patient-years, the majority of cases occurring in countries with
high endemic rates of TB. No cases have been reported in the US or Canada. Rare
cases of opportunistic infections have been reported.
There have also been some cases of worsening heart failure, the majority of
which have been mild or moderate. The reason for this effect on the heart is
unclear. As a precaution, individuals with heart disease should inform their
physician of this condition before receiving infliximab, adalimumab, or
certolizumab.
Hypersensitivity reactions have been reported including
angioedema,
allergic dermatitis, dizziness, shortness of breath,
hot flushes, hypotension (low
blood pressure),
malaise, fainting (syncope). Patients experiencing symptoms of severe allergic reactions
should seek emergency care immediately.
Crohn's Disease - Symptoms at Onset of DiseaseQuestion: The symptoms of crohn's disease can vary greatly from patient to patient. What were your symptoms at the onset of your disease?
Abdominal pain is pain in the belly and can be acute or chronic. Causes include inflammation, distention of an organ, and loss of the blood supply to an organ. Abdominal pain can reflect a major problem with one of the organs in the abdomen such as the appendix, gallbladder, large and small intestine, pancreas, liver, colon, duodenum, and spleen.
Diarrhea is a change is the frequency and looseness of bowel movements. Cramping, abdominal pain, and the sensation of rectal urgency are all symptoms of diarrhea. Absorbents and anti-motility medications are used to treat diarrhea.
Gallstones are stones that form when substances in the bile harden. Gallstones (formed in the gallbladder) can be as small as a grain of sand or as large as a golf ball. There can be just one large stone, hundreds of tiny stones, or any combination. The majority of gallstones do not cause symptoms.
Pink eye, also called conjunctivitis, is redness or irritation of the conjunctivae, the membranes on the inner part of the eyelids and the membranes covering the whites of the eyes. These membranes react to a wide range of bacteria, viruses, allergy-provoking agents, irritants, and toxic agents.
Anemia is the condition of having less than the normal number of red blood cells or less than the normal quantity of hemoglobin in the blood. The oxygen-carrying capacity of the blood is, therefore, decreased.
Colon cancer is a malignancy that arises from the inner lining of the colon. Most, if not all, of these cancers develop from colonic polyps. Removal of these precancerous polyps can prevent colon cancer.
Anal itching is the irritation of the skin at the exit of the rectum, known as the anus, accompanied by the desire to scratch. Causes include everything from irritating foods we eat, to certain disease and infections. Treatment options include local anesthetics, vasoconstrictors, protectants, astringents, antiseptics, keratolytics, analgesics, and corticosteroids. If condition persists, a doctor examination may be needed to identify an underlying cause.
Clostridium difficile (C. difficile) is a bacterium, and is one of the most common causes of infection of the colon. C. difficile spores are found frequently in hospitals, nursing homes, extended care facilities, and nurseries for newborn infants. They can be found on bedpans, furniture, toilet seats, linens, telephones, stethoscopes, fingernails, rings, floors, infants' rooms, and diaper pails. They even can be carried by pets. Antibiotic-associated (C. difficile) colitis is an infection of the colon caused by C. difficile that occurs primarily among individuals who have been using antibiotics. Treatment for C. difficile colitis hydration, replenishment of electrolyte deficiencies, discontinuing the antibiotic that caused the colitis, and using antibiotics to eradicate the C. difficile bacterium.
Ulcerative colitis is a chronic inflammation of the colon. Symptoms include abdominal pain, diarrhea, and rectal bleeding. Ulcerative colitis is closely related to Crohn's disease, and together they are referred to as inflammatory bowel disease. Treatment depends upon the type of ulcerative colitis diagnosed.
Small intestinal bacterial overgrowth (SIBO) refers to a condition in which abnormally large numbers of bacteria (at least 100,000 bacteria per ml of fluid) are present in the small intestine and the types of bacteria in the small intestine resemble more the bacteria of the colon than the small intestine. There are many conditions associated with small intestinal bacterial overgrowth, to include: diabetes, scleroderma, Crohn's disease, and others. There is a striking similarity between the symptoms of irritable bowel syndrome and SIBO. It has been theorized that SIBO may be responsible for the symptoms of at least some patients with irritable bowel syndrome. Symptoms of SIBO include: excess gas, abdominal bloating, diarrhea, and abdominal pain.
Ankylosing spondylitis is a type of arthritis that causes chronic inflammation of the spine. The tendency to develop ankylosing spondylitis is genetically inherited.
Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves antiinflammatory medications and exercise.
Inflammation of the inner lining of the colon is referred to as colitis. Symptoms of the inflammation of the colon lining include diarrhea, pain, and blood in the stool. There are several causes of colitis including infection, ischemia of the colon, inflammatory bowel disease (Crohn's disease, Ulcerative colitis, or microscopic colitis). Treatment depends on the cause of the colitis.
Canker sore is a small ulcer crater in the lining of the mouth. Canker sores are one of the most
common problems that occur in the mouth. Canker sores typically last for
10-14 days and they heal without leaving a scar.
The inflammatory bowel diseases (IBD) are Crohn's disease (CD) and ulcerative colitis (UC). The intestinal complications of Crohn's disease and ulcerative colitis differ because of the characteristically dissimilar behaviors of the intestinal inflammation in these two diseases.
Gastritis is an inflammation of the stomach lining. Causes of gastritis include drinking too much alcohol, medications such as NSAIDs, ibuprofen, aspirin, H. pylori infection, severe infections, burns, anemia, and autoimmune disorders. Gastritis is diagnosed with endoscopy, blood tests, or stool tests. Treatment depends upon the cause of gastritis.
Erythema nodosum is a skin inflammation that results in reddish, painful, tender lumps most commonly located in the front of the legs below the knees. Erythema nodosum can resolve on its own in 3 to 6 weeks, leaving a bruised area. Treatments include anti-inflammatory medications and cortisone by mouth or injection.
Corticosteroid drugs such as prednisone and prednisolone are commonly used to treat asthma, allergic reactions, RA, and IBD. Steroids such as these do have serious drawbacks such as steroid withdrawal symptoms such as: fatigue, weakness, decreased appetite, weight loss, nausea, vomiting, abdominal pain, and diarrhea. Speak with your healthcare provider prior to tapering off steroid medications.
Chronic pain is pain (an unpleasant sense of discomfort) that persists or progresses over a long period of time. In contrast to acute pain that arises suddenly in response to a specific injury and is usually treatable, chronic pain persists over time and is often resistant to medical treatments.
Bronchiectasis is a condition in which the bronchial tubes of the lung become damaged. Inflammation from infection or other causes destroys the smooth muscles of the bronchial tubes. Bronchiectasis is a form of COPD (which includes emphysema and chronic bronchitis). There are three primary types of bronchiectasis: 1) cylindrical bronchiectasis; 2) saccular bronchiectasis; and 3) cystic bronchiectasis. Bronchiectasis may also be acquired or congenital. The most common symptoms of bronchiectasis are recurrent cough and sputum production. There is no cure for bronchiectasis. Treatment is often geared toward controlling the symptoms of bronchiectasis.
Primary sclerosing cholangitis (PSC) is a chronic, progressive disease of the bile ducts that channel bile from the liver into the intestines. There is an association between primary sclerosing cholangitis and ulcerative colitis and Crohn's disease. Symptoms of primary sclerosing cholangitis include abnormal liver blood tests, itching, fatigue, and jaundice. Primary sclerosing cholangitis is treated with medications and in some cases, liver transplant.
Digestion is the complex process of turning food you eat into the energy you need to survive. The digestive process also involves creating waste to be eliminated, and is made of a series of muscles that coordinate the movement of food.
Vitamin D deficiency has been linked with rickets, cancer, cardiovascular disease, severe asthma in children and cognitive impairment in older adults. Causes include not ingesting enough of the vitamin over time, having limited exposure to sunlight, having dark skin, and obesity. Symptoms include bone pain and muscle weakness. Treatment for vitamin D deficiency involves obtaining more vitamin D through supplements, diet, or exposure to sunlight.
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