Crohn’s disease is a hereditary autoimmune condition that in most cases can be managed with medication, and occasionally surgery. You and your doctor will develop a treatment plan that includes medications which are appropriate for your particular symptoms. There are many options available, including antibiotics, steroids, immunomudolators, anti-inflammatory drugs, and biological agents.
The choice will be made based on the amount of your gastrointestinal tract that is affected, the severity of your symptoms, and your medical history. This article focuses on the use of Cimizia, also commonly called Cimza or Certoluzimab pegol. You’ll learn what it is, how it works, the pros and cons of using it, and the research on its effectiveness.
What is Cimzia? (skip to next section for non-technical explanation)
Cimzia is a very powerful medication, and is associated with serious infections and malignancy. It is a member of the family of drugs called TNF blockers, whose function is specified for human necrosis factor TNFa. It is a biological compound, called a Fab’ fragment. It includes both a light and a heavy chain of amino acids; the light chain consists of 214 amino acids, and the heavy chain includes 229. Cimzia is created using E. coli bacteria and PEG2MAL40K.
Unlike some drugs for the treatment of Crohn’s disease, Cimzia is designed for injection. It comes in two forms, the first is a lypholized powder that is recombined with sterile water for injection. Cimzia’s other form is a single-use pre-loaded syringe. Each 1mL dose, from the powder or the preloaded syringes, contains 200 mg of Certoluzimab pegol. The pH of this solution is approximately 4.7. Cimzia includes no preservatives. The powder is white, and the prepared solution ranges in color from clear to pale yellow.
How it Works Against Crohn's Disease
It is important to note that Cimzia is not designed for use by patients with mild Crohn’s disease. This medication is generally prescribed when other therapies fail, and is for use in moderate to severe Crohn’s disease in adults only. Children should not be given Cimzia.
Crohn’s disease results in the production of too much of the protein known as tumor necrosis factor-alpha (TNFa) by the immune system. The result is inflammation, pain, and damage to the gastrointestinal tract. Cimzia works by blocking the production of TNF. As a PEGylated medication, it stays in the body for a longer period of time. Cimzia is the only PEGylated biologic agent used in the treatment of Crohn’s disease.
Administration & Side Effects
Cimzia is designed for subcutaneous injection in 1mL syringes. The normal dose for an otherwise healthy adult with Crohn’s disease is 400mg, as two separate injections, every four weeks. Injections should not be given in areas where the skin is red, bruised, tender, or hard. Injections should also be given in different sites each time. Most often, doctors recommend that Cimzia be injected into the thigh or abdomen.
Cimzia doesn’t work for everyone. As a result, patients are given three initial doses of 400mg, each spaced two weeks apart. If a clinical response is noted, maintenance dosage of Cimzia is administered on a monthly basis. Dosage may vary based on the severity of an individual’s condition, however.
Side effects for Cimzia can be severe. Fatal systemic infections have occurred in some patients as a result of the drug’s immune-suppressing function. This biologic medication is known to lead to malignancy in susceptible individuals, too. Frequent blood tests may be required while you are on Cimzia, to measure immune response. Heart failure was reported in some cases, as well.
Allergic reactions leading to hives, difficulty breathing, swelling of the face, throat, lips, or tongue have been reported. Severe side effects include serious infections that cause fever, diarrhea, vomiting, sore throat, and flu-like symptoms, shortness of breath with swelling of the hands and feet, chest pain, ongoing cough, coughing up blood or mucus, rapid or slow heart rate, burning during urination, confusion, neck stiffness, seizures, a severe skin rash that causes blistering and redness, dizziness, numbness, muscle weakness, joint pain with swelling or fever, unusual thoughts or behaviors, patchy skin color, red spots, or a butterfly-shaped rash on the face that worsens in sunlight.
Minor side effects for Cimzia include stuffy nose, sinus pain, stomach pain, mild diarrhea, constipation, and pain or irritation at the injection site.
Pros & Cons – According to Patients
Patients who have been prescribed Cimzia often report that the medication doesn’t last the full three to four weeks that the doses are designed for. Another common complaint that many cite is frequent illness when taking this medication, due to its immune-suppressing action. The second shot seems to be more painful for many patients, as well. Depending on insurance plans, Cimzia can be too expensive for some patients.
On a positive note, users who were previously prescribed Remicade tend to find Cimzia more pleasant and effective. One patient reported 5 of 8 fistulas closing within a month of beginning the medication. Even patients with excellent results often report severe and uncomfortable side effects, however.
Research & Studies on Cimzia
In research studies regarding the efficacy of Cimzia, individuals who showed a clinical response to the medication showed significant reduction in symptoms within 6 to 26 weeks. By the 26 week mark, nearly half of these patients were in remission. Upper respiratory infections, rash, and urinary infections were the most commonly reported side effects in pre-market trials of Cimzia.
Roughly 8% of patients stopped taking this medication due to side effects during research trials, compared to 7% of individuals taking a placebo. Clinical trials of this medication included approximately 94% caucasians, and 55% of participants were female. As a result, the side effects and efficacy for individuals of other racial backgrounds may not be well understood, particularly for males.
Post-market studies have revealed possible connections between Cimzia and systemic vasculitis, severe skin reactions, and sarcoidosis.
Due to the potential for drug interactions, Cimzia is not recommended for combination with Anakinra, Abatacept, Rituximab, or Natalizumab. Live vaccines should be avoided while you are on Cimzia. Laboratory tests, particularly those related to blood coagulation, may demonstrate incorrect results if you are taking Cimzia. Make sure that all of your doctors are aware that you are on this medication.
If you suffer from Crohn's disease, you should consider asking your physician about Cimzia. It is an effective medication for the treatment of Crohn's symptoms for many patients. Although results will not always be the same, you could find relief from many of your symptoms even after just one Cimzia treatment. Be sure to pay attention to side effects, and report any that are serious to your physician to ensure your safety while taking this medication.
Do you have any experiences with Cimzia you'd like to tell us about? Feel free to send it along and we'll post it here on the site to help others learn more about its effectiveness for Crohns.