Biologics for ulcerative colitis Types side effects cost and more
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Biologics are medications that companies make from living cells. They attack certain cells and proteins in the immune system responsible for inflammatory diseases. Ulcerative colitis (UC) is a condition that affects the digestive tract. A person with UC has an overactive immune system that causes inflammation in the intestines. Biologic medications can be an effective alternative to help control the symptoms of UC, which can worsen sporadically in periods known as “flare-ups” or “flares.” Scientists and drug manufacturers make these medications from specially engineered living cells or antibodies. After growing the cells in a laboratory, scientists extract special proteins and use these to make each drug. These proteins then operate by targeting a particular receptor found on immune cells. Doctors use different biologics to treat a variety of conditions, including cancer and several autoimmune disorders. The following is a summary of the potential advantages and disadvantages of using biologics to treat UC: Prosdirectly attack cells and proteins responsible for UC inflammationalternative for 20–40% of people who do not respond to typical treatments such as 5-aminosalicylates or corticosteroidsmay reduce surgery risk Conscan be expensivea person may need to inject them, which can be challenging or uncomfortable may stop working over timeraise the risk of infection This article describes the types of biologics that may help treat UC. We also look into their side effects and costs. What they are and how they treat UC In a person with UC, the immune system is overactive and mistakenly attacks cells in the body. Biologics are medications that attack specific cells and proteins in the immune system that cause inflammatory disease processes. For this reason, doctors also refer to treatment with biologics as targeted therapy. Usually, a doctor would prescribe biologics to treat adults who have moderate-to-severe UC. There are different types of biologics that may fit a person best on the basis of their symptoms. These include:anti-tumor necrosis factor (TNF) agentsintegrin receptor antagonistsinterleukin inhibitorsJanus kinase (JAK) inhibitors Anti-TNF agents Anti-TNF agents can help treat UC in adults by reducing symptoms and helping to heal inflamed tissues. These drugs target the protein tumor necrosis factor-alpha, which promotes inflammation and may be responsible for the development of UC. People with UC usually see improvements in their symptoms within 8 weeks of starting treatment with an anti-TNF agent. Some people experience more immediate results. Types of anti-TNF agents Different types of anti-TNF agents may help treat UC. These include:Generic nameBrand nameDosageadalimumabHumiraFour injections, 160 milligrams (mg) each.2 weeks later: Two injections, 80 mg each.From then on: One injection, 40 mg every 2 weeks.adalimumab-attoAmjevitaFour injections, 160 mg each.2 weeks later: Two injections, 80 mg each.From then on: One injection, 40 mg every 2 weeks.adalimumab-adbmCyltezoFour injections, 160 mg each.2 weeks later: Two injections, 80 mg each.From then on: One injection, 40 mg every 2 weeks.golimumabSimponiTwo starter doses. From then on: Every 4 weeks.infliximabRemicadeIntravenous infusion. First three doses at 0, 2, and 6 weeks.From then on: Every 8 weeks.infliximab-abdaRenflexisIntravenous infusion. First three doses at 0, 2, and 6 weeks.From then on: Every 8 weeks.infliximab-dyybInflectraIntravenous infusion. First three doses at 0, 2, and 6 weeks.From then on: Every 8 weeks.infliximab-qbtxIXIFIIntravenous infusion. First three doses at 0, 2, and 6 weeks.From then on: Every 8 weeks. Adalimumab A doctor may prescribe adalimumab (Humira) if a person did not respond well to other immune suppressors, such as corticosteroids, azathioprine (Imuran), or 6-mercaptopurine (Purinethol). In a clinical study, more than 17% of participants with UC who took adalimumab experienced remission after 52 weeks of the treatment. A person can self-administer the injections at home after receiving instructions from a healthcare professional. Golimumab A doctor may prescribe golimumab (Simponi) for people who need continuous steroid treatment or for people who have not found other UC medications effective. In a clinical trial, after 6 weeks, more people from the group that took golimumab than those from the group who did not experience:a response to the treatmenta remission of UC symptomsimprovements in the appearance of the intestines on endoscopy imaging If the body responds to this treatment, a person can keep taking it to maintain remission. Another trial showed that participants had maintained remission after the 30th and 54th weeks of treatment. A person can self-administer these injections at home after receiving instructions from a healthcare professional. Infliximab A doctor may prescribe infliximab (Remicade) if a person with UC did not benefit from other treatments. Infliximab is the only anti-TNF agent that a doctor can prescribe to children with UC, starting from the age of 6 years. In clinical studies, adult and pediatric participants experienced remission and healing of the intestinal wall with this treatment. Integrin receptor antagonists A doctor may prescribe the integrin receptor antagonist vedolizumab (Entyvio) for adults with moderate to severe UC. This drug can be suitable for people with an intolerance to anti-TNF agents or people who did not find these drugs to be effective. It may also benefit people with a dependence on corticosteroids. Vedolizumab may start to have noticeable benefits after 6 weeks. In clinical studies, more people in the treatment group achieved remission after 52 weeks than those in the control group. In the treatment group, the researchers also found improvements in the appearance of the intestines. Dosage The typical dose per infusion is 300 mg. A person will have their next infusions at 2 and 6 weeks. From then on, they will get a transfusion every 8 weeks. Interleukin inhibitor Ustekinumab (Stelara) is an antibody that blocks two proteins and signaling molecules that doctors call interleukin-12 and interleukin-23. Both play an important role in the inflammatory and immune responses and contribute to chronic inflammation that is associated with UC. Ustekinumab is suitable for adults with the condition. It may lead to remission after 8 weeks, and in clinical studies, researchers found that this treatment led to improvements in the appearance of the intestines. Dosage For the first dose, a person has 6 mg for each kilogram that they weigh. The doctor will decide on the best approach after that. Janus kinase inhibitors In 2019, tofacitinib (Xeljanz) was the first biologic medication to gain Federal Drug Administration (FDA) approval to treat UC. It targets JAK proteins and blocks their activity. A second JAK inhibitor, upadacitinib (Rinvoq), gained approval for treating UC in March 2022. JAK proteins send signals that promote the activity of the immune system. Blocking these proteins stops or slows certain immune functions. Doctors may prescribe tofacitinib to people with moderate to severe UC that has not responded well to other treatments. People with an intolerance to anti-TNF agents may benefit from this approach. In one study, 60% of participants who took tofacitinib had improvements in their UC symptoms after 8 weeks. They also experienced less bleeding from their rectums after 2 weeks. In 7% of participants in the treatment group, researchers observed improvements in the appearance of the intestines, compared with 3% of the placebo group. Dosage This drug is available as a pill. A doctor may prescribe 10 mg twice a day for 8 weeks. If the treatment appears to be effective, they may lower the dosage to 5 mg twice a day going forward. Biologics side effects Like all drugs, biologics can cause side effects. People have to inject many of these medications, and at the site of the injection, a person may experience:rednessitchinessbruisingpainswelling Other side effects of biologics include:headachefeverchillshivesrashes Side effects of tofacitinib may differ from those of injectable biologics. A person may experience:diarrheaheadachehigh or low blood pressure Allergic reactions can also occur, and they may cause symptoms such as hives and difficulty breathing. In rare cases, a person may experience anaphylaxis.If a side effect is bothersome or may indicate an allergic reaction, a person should contact a doctor. If any side effect is concerning or severe, they should dial 911 or otherwise contact emergency services. Anaphylaxis is a severe allergic reaction that can be life threatening. The symptoms develop suddenly and include:hivesswelling of the face or mouthwheezingfast, shallow breathinga fast heart rateclammy skinanxiety or confusiondizzinessvomitingblue or white lipsfainting or loss of consciousness If someone has these symptoms:Check whether they are carrying an epinephrine pen. If they are, follow the instructions on the side of the pen to use it.Dial 911 or the number of the nearest emergency department.Lay the person down from a standing position. If they have vomited, turn them onto their side.Stay with them until the emergency services arrive. Some people may need more than one epinephrine injection. If the symptoms do not improve in 5–15 minutes, or they come back, use a second pen if the person has one. Safety Before prescribing a biologic, a healthcare professional should describe the risks in detail. Some include:Arthritis: Anti-TNF agents can help treat some causes of joint pain, but they can also cause new joint pain in some cases.Liver problems: In rare cases, biologics have links with liver problems. Anyone who notices yellowing of the eyes or skin while taking these medications should receive medical attention straight away.Lupus-like reactions: These reactions to anti-TNF treatment are rare. A person should stop the treatment and contact a doctor if a rash, joint pain, fever, or muscle aches develop.Cancer: While the risk is low, researchers have found some associations between anti-TNF agents and lymphoma. Because biologics affect the immune system, a person taking this type of medication may have an increased risk of infections, some of which can be severe. For this reason, it is important for a person to take the necessary vaccinations, including those for:influenzapneumoniahepatitis A person should contact a healthcare professional immediately if a new cough, a fever, or any other flu symptoms develop. Interactions with other medications Interactions between biologics and other medications can be significant, and each type of biologic drug can present different risks. A doctor should be aware of all the over-the-counter or prescription medications, and all the supplements, herbal medications, and vitamins that a person takes before they prescribe a biologic. Anyone using a biologic for UC should speak with a doctor before receiving a vaccine. For people who use certain biologic medications, including golimumab, infliximab, and adalimumab, having a live vaccine can be dangerous, and doctors recommend avoiding it. Cost Biologics can be expensive. According to research from 2018, this type of treatment costs $10,000–30,000 per year on average, and the more expensive types can cost more than $500,000 annually. Although many medical insurance plans may cover biologics, depending on a person’s deductible, the cost can still be high. A doctor may instead recommend a type of drug they call a “biosimilar.” There is very little clinical difference between these drugs and biologics. Biosimilars are less expensive but just as safe and effective. The FDA approved the use of biosimilars in an effort to reduce costs. However, the FDA does not regulate whether insurance companies cover the costs of these drugs. Summary table The following table provides an overview of biologics available to treat UC. The abbreviation “IV” stands for “intravenous.”DrugBrand nameType FormSelf-administered?adalimumabHumiraAnti-TNFInjectionYesadalimumab-attoAmjevitaAnti-TNFInjectionYesadalimumab-adbmCyltezoAnti-TNFInjectionYesgolimumabSimponiAnti-TNFInjectionYesinfliximabRemicadeAnti-TNFIV infusionNoinfliximab-abdaRenflexisAnti-TNFIV infusionNoinfliximab-dyybInflectraAnti-TNFIV infusionNoinfliximab-qbtxIXIFIAnti-TNFIV infusionNovedolizumabEntyvioIntegrin receptor antagonistIV infusionNoustekinumabStelaraInterleukin inhibitorIV infusionNotofacitinibXeljanzJAK inhibitorPillYesupadacitinibRinvoqJAK inhibitorPillYes Summary A range of biologic drugs can reduce UC symptoms in adults and help achieve remission. For children with moderate to severe UC, a doctor may prescribe infliximab. Biologics are effective because they target the specific factors in the immune system that cause UC. However, these drugs can cause side effects. It is important to discuss the risks and potential benefits of each option thoroughly with the doctor. Frequently asked questions Below, we answer some questions that people often ask about biologics for ulcerative colitis. How long do you take biologics for ulcerative colitis A person can feel better within 6–8 weeks of taking biologics, although some drugs can take more time to be effective. When considering whether to stop, a person should consult with their doctor on the basis of criteria such as the current symptom level, any medication side effects, existing comorbidities, and more. Which biologic is safest for ulcerative colitis In a 2020 study, researchers found that taking vedolizumab comes with the lowest risk of infection, followed by ustekinumab. Do biologics make you gain weight Some biologic medications that doctors use to treat UC can cause weight gain, but research does not indicate that the gain is necessarily severe. 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