Table of ContentsView AllTable of ContentsBiologics in Ulcerative Colitis TreatmentAnti-TNF AgentsIntegrin Receptor AntagonistsInterleukin InhibitorsJanus Kinase InhibitorsSide EffectsInteractionsCan Biologics Be Combined With Other Therapies?Cost
Table of ContentsView All
View All
Table of Contents
Biologics in Ulcerative Colitis Treatment
Anti-TNF Agents
Integrin Receptor Antagonists
Interleukin Inhibitors
Janus Kinase Inhibitors
Side Effects
Interactions
Can Biologics Be Combined With Other Therapies?
Cost
There are four types of biologics identified in the treatment of ulcerative colitis: anti-tumor necrosis factor (TNF) agents, integrin receptor antagonists, interleukin inhibitors, and Janus kinase (JAK) inhibitors.
Biologics are treatments that target specific parts of the immune system to decrease inflammation or the body’s immune response. They are made from living organisms or components of living organisms.
Getty Images / FilippoBacci
Biologicsare large-molecule medications created in a lab from various living components such as proteins, tissues, and antibodies.
Biologics target specific parts of your body to either help your immune system work better or attack harmful cells. They are a common form of treatment used in ulcerative colitis.
Inulcerative colitis, your immune system mistakenly attacks healthy cells in the lining of the colon and rectum. As a result, you have an overproduction of proteins that cause inflammation, leading to ulcers, bloody diarrhea, or stomach pain.
Fortunately, biologics can target these inflammatory proteins and help prevent the symptoms and complications of ulcerative colitis.
Pros vs. Cons of Biologic Treatment in Ulcerative Colitis
ProsDirectly attacks inflammatory proteins that cause ulcerative colitisAlternative medication that can be used in people who do not respond to steroids or salicylatesReduces the need for surgery
Directly attacks inflammatory proteins that cause ulcerative colitis
Alternative medication that can be used in people who do not respond to steroids or salicylates
Reduces the need for surgery
Risk for infusion site reaction
Requires regular monitoring such as blood tests, side effects, and signs of disease progression
How Are Biologics Made?
Biologics can be created from living organisms, such as human or animal cells. For example, one type of biologic is classified as amonoclonal antibody (mAb). The first step in producing an mAb is injecting a specific antigen or foreign substance into a subject.
The subject can be isolated human cells, a mouse, or a combination of both. Once injected, the subject will develop antibodies and immune cells against this foreign substance.
Tumor necrosis factor-alpha(TNF-alpha) is an inflammatory protein that causes the inflammation responsible for ulcerative colitis. Anti-TNF alpha agents are monoclonal antibodies that attach to TNF-alpha, preventing the protein from stimulating the immune system to cause inflammation.
Anti-TNF alpha agents can take between one to eight weeks to start working, so you should expect to feel better within a few weeks of starting treatment.
Infliximab
If you have never been on a biologic before, infliximab is the first one you might try for ulcerative colitis.
Infliximab has been the standard therapy in treating ulcerative colitis due to a study called ACT-1 and ACT-2.
According to the results, infliximab controlled ulcerative colitis symptoms much better than a placebo (non-therapeutic substance). In ACT-1 and ACT-2, 60-70% of infliximab users achieved clinical response compared with 29% and 37% of placebo users, respectively.
The results of this trial prompted the FDA to approve infliximab as a treatment for moderate to severe ulcerative colitis.
Adalimumab
Adalimumab (brand nameHumira) is an anti-TNF alpha agent that can be used for moderate-to-severe ulcerative colitis.
While infliximab is the biologic of choice, Humira is an option if you do not want to go into a clinic to get IV infusions. With Humira, you have the flexibility to administer your medication at home via an injection into the fatty tissue.
Two main clinical trials determined the efficacy of adalimumab. The first trial concluded that 18.5% of only participants had seen the benefits of adalimumab after eight weeks of treatment compared with 9.2% in the placebo group.
However, another trial was conducted, ULTRA-2. The ULTRA-2 study found that adalimumab provided a clinical response in 50.4% of participants compared with 34.6% on placebo at week eight.
Golimumab
Golimumab, or Simponi, is an anti-TNF alpha agent for moderate-to-severe ulcerative colitis.
Similar to Humira, Simponi is administered via an injection in the fatty tissue. Simponi can be used after you tried Remicade and did not receive enough relief from the medication.
Entyvio, also known as vedolizumab, is a different type of biologic that blocks integrin adhesion molecules.
Integrin adhesion molecules are proteins that help inflammatory cells bind to gut tissues. Integrin receptor antagonists attack the integrin protein, preventing inflammatory cells from interacting with tissues in the gut. As a result, there is a decrease in inflammation in the colon and rectum.
Entyvio may be used if you did not respond to an anti-TNF alpha agent or if the medication stopped working.
Vedolizumab and infliximab are considered superior to other biologics based on a study called GEMINI-1. The study concluded that 47% of people had clinical benefits after six weeks of vedolizumab therapy.
Entyvio is given as an IV infusion at a clinic every eight weeks.
Stelara, also known as ustekinumab, is a monoclonal antibody that targets specific proteins called interleukin-12 (IL-12) and interleukin-23 (IL-23).
Interleukinsare signal molecules of the immune system that regulate immune responses, inflammation, and blood cell production.
In ulcerative colitis, the main interleukins that cause inflammation are IL-12 and IL-23. Interleukin inhibitors weaken the signal for the immune system to cause inflammation. It is recommended to consider Stelara after you have tried and failed to respond to an anti-TNF alpha agent or other biologic agents.
According to Stelara’s clinical trials, users saw improvement in their ulcerative colitis after eight weeks of treatment. Participants in the studies had previously tried a biologic (such as an anti-TNF agent or vedolizumab) and other standard therapy, such as corticosteroids.
Xeljanz is used after you have tried and failed to respond to anti-TNF alpha agents or other biologics.
While Xeljanz is an option in treating ulcerative colitis, it may not be the safest choice. You should always talk to your healthcare provider about the risks and benefits of taking any biologic.
Based on Xeljanz clinical trials, about 60% of users could see improvements in their ulcerative colitis symptoms after eight weeks of therapy.
Depending on which biologic you take, you may experience different side effects. These can range from mild to more severe and can vary from person to person.
The most common side effects for each biologic are listed below.
Before starting biologics, it is important to talk to your healthcare provider about any medications that you have taken in the past or are currently taking to avoid any interactions. Since biologics weaken the immune system, it is recommended to be up to date with all your vaccinations to avoid the risk of getting sick.
Live vaccinesare the only vaccines you should avoid while on a biologic. If you plan on getting a live vaccine, it is recommended to get it six weeks before starting the biologic.
You should not combine any biologic agents together. Combining biologics does not make the medications work better. In fact, using multiple biologics together can increase the risk of life-threatening infections, cancer, and damage to the liver.
Other medications, calledimmunosuppressants, can be used to help manage ulcerative colitis.
There is clinical uncertainty about combining biologics and immunosuppressants. Emerging studies indicate that the combination of infliximab and azathioprine had better healing rates in ulcerative colitis than using infliximab alone.
However, a limitation of combining biologics and immunosuppressants is the risk of easily getting sick since your immune system is weakened. In addition, limited studies indicate optimal medication management when using both types of medications.
How Much Do Biologics Cost?
While biologics are effective medications, they can be expensive. Based on a 2016 study comparing the cost of different biologics, these medications can range from $928 to $2,700 per dose.
Fortunately, many medical insurances may cover a portion of the cost of biologic therapy. However, what your insurance will cover is not always guaranteed, and costs may still be high.
Due to the high costs of biologics, your healthcare provider may consider trying abiosimilarinstead. Biosimilars are nearly identical to biologics and are close to being a “generic” version of the initial product. They are made up of the same biologic components and work the same. The main benefit of biosimilars is that they are less expensive than biologics.
Summary
Each type of biologic has its own unique characteristics, such as form of administration, how it works, and side effects.
Although generally considered safe, it’s important to be aware of potential side effects and risks. For example, you shouldn’t combine biologics with other biologics or live vaccines.
Talk with your healthcare provider about medications, over-the-counter products, and supplements you are currently taking or vaccines you plan to get.
The author would like to recognize and thank Alexya Rosas for contributing to this article.
23 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.National Institutes of Health. DailyMed.Label: XELJANZ- tofacitinib tablet, film coated.Awan H, Fatima U, Eaw R, Knox N, Alrubaiy L.The efficacy of currently licensed biologics for treatment of ulcerative colitis: a literature review.Cureus. 2023;15(4):e37609. doi:10.7759/cureus.37609Food and Drug Administration.What are “biologics” questions and answers.American Cancer Society.Monoclonal antibodies and their side effects.Liu JK.The history of monoclonal antibody development - progress, remaining challenges and future innovations.Ann Med Surg (Lond). 2014;3(4):113-116. doi:10.1016/j.amsu.2014.09.001Peyrin-Biroulet L, Sandborn WJ, Panaccione R, et al.Tumour necrosis factor inhibitors in inflammatory bowel disease: the story continues.Therap Adv Gastroenterol. 2021;14:17562848211059954. doi:10.1177/17562848211059954Vasudevan A, Gibson PR, van Langenberg DR.Time to clinical response and remission for therapeutics in inflammatory bowel diseases: what should the clinician expect, what should patients be told?World J Gastroenterol. 2017;23(35):6385-6402. doi:10.3748/wjg.v23.i35.6385National Institutes of Health. DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.National Institutes of Health. DailyMed.Label: Humira- adalimumab kit.Food and Drug Administration.Simponi label.Rutgeerts P, Sandborn WJ, Feagan BG, et al.Infliximab for induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2005;353(23):2462-2476. doi:10.1056/NEJMoa050516Hindryckx P, Baert F, Hart A, et al.Clinical trials in ulcerative colitis: a historical perspective.J Crohns Colitis. 2015;9(7):580-588. doi:10.1093/ecco-jcc/jjv074Reinisch W, Sandborn WJ, Hommes DW, et al.Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.Gut. 2011;60(6):780-787. doi:10.1136/gut.2010.221127Sandborn WJ, van Assche G, Reinisch W, et al.Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2012;142(2):257-265.e653. doi:10.1053/j.gastro.2011.10.032Sandborn WJ, Feagan BG, Marano C, et al.Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2014;146(1):96-109.e1. doi:10.1053/j.gastro.2013.06.010National Institutes of Health. DailyMed.Label: Entyvio- vedolizumab injection, solution.Allamneni C, Venkata K, Yun H, et al.Comparative effectiveness of vedolizumab vs. infliximab induction therapy in ulcerative colitis: experience of a real-world cohort at a tertiary inflammatory bowel disease center.Gastroenterology Res. 2018;11(1):41-45. doi:10.14740/gr934wFeagan BG, Rutgeerts P, Sands BE, et al.Vedolizumab as induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2013;369(8):699-710. doi:10.1056/NEJMoa1215734National Institutes of Health. DailyMed.Label: Stelara- ustekinumab injection solution.Reich J, Wasan S, Farraye FA.Vaccinating patients with inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2016;12(9):540-546.Solitano V, Ma C, Hanžel J, et al.Advanced combination treatment with biologic agents and novel small molecule drugs for inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2023;19(5):251-263.Gu T, Shah N, Deshpande G, Tang DH, Eisenberg DF.Comparing biologic cost per treated patient across indications among adult US managed care patients: a retrospective cohort study.Drugs Real World Outcomes. 2016;3(4):369-381. doi:10.1007/s40801-016-0093-2Food and Drug Administration.Biosimilars basics for patients.
23 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.National Institutes of Health. DailyMed.Label: XELJANZ- tofacitinib tablet, film coated.Awan H, Fatima U, Eaw R, Knox N, Alrubaiy L.The efficacy of currently licensed biologics for treatment of ulcerative colitis: a literature review.Cureus. 2023;15(4):e37609. doi:10.7759/cureus.37609Food and Drug Administration.What are “biologics” questions and answers.American Cancer Society.Monoclonal antibodies and their side effects.Liu JK.The history of monoclonal antibody development - progress, remaining challenges and future innovations.Ann Med Surg (Lond). 2014;3(4):113-116. doi:10.1016/j.amsu.2014.09.001Peyrin-Biroulet L, Sandborn WJ, Panaccione R, et al.Tumour necrosis factor inhibitors in inflammatory bowel disease: the story continues.Therap Adv Gastroenterol. 2021;14:17562848211059954. doi:10.1177/17562848211059954Vasudevan A, Gibson PR, van Langenberg DR.Time to clinical response and remission for therapeutics in inflammatory bowel diseases: what should the clinician expect, what should patients be told?World J Gastroenterol. 2017;23(35):6385-6402. doi:10.3748/wjg.v23.i35.6385National Institutes of Health. DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.National Institutes of Health. DailyMed.Label: Humira- adalimumab kit.Food and Drug Administration.Simponi label.Rutgeerts P, Sandborn WJ, Feagan BG, et al.Infliximab for induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2005;353(23):2462-2476. doi:10.1056/NEJMoa050516Hindryckx P, Baert F, Hart A, et al.Clinical trials in ulcerative colitis: a historical perspective.J Crohns Colitis. 2015;9(7):580-588. doi:10.1093/ecco-jcc/jjv074Reinisch W, Sandborn WJ, Hommes DW, et al.Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.Gut. 2011;60(6):780-787. doi:10.1136/gut.2010.221127Sandborn WJ, van Assche G, Reinisch W, et al.Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2012;142(2):257-265.e653. doi:10.1053/j.gastro.2011.10.032Sandborn WJ, Feagan BG, Marano C, et al.Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2014;146(1):96-109.e1. doi:10.1053/j.gastro.2013.06.010National Institutes of Health. DailyMed.Label: Entyvio- vedolizumab injection, solution.Allamneni C, Venkata K, Yun H, et al.Comparative effectiveness of vedolizumab vs. infliximab induction therapy in ulcerative colitis: experience of a real-world cohort at a tertiary inflammatory bowel disease center.Gastroenterology Res. 2018;11(1):41-45. doi:10.14740/gr934wFeagan BG, Rutgeerts P, Sands BE, et al.Vedolizumab as induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2013;369(8):699-710. doi:10.1056/NEJMoa1215734National Institutes of Health. DailyMed.Label: Stelara- ustekinumab injection solution.Reich J, Wasan S, Farraye FA.Vaccinating patients with inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2016;12(9):540-546.Solitano V, Ma C, Hanžel J, et al.Advanced combination treatment with biologic agents and novel small molecule drugs for inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2023;19(5):251-263.Gu T, Shah N, Deshpande G, Tang DH, Eisenberg DF.Comparing biologic cost per treated patient across indications among adult US managed care patients: a retrospective cohort study.Drugs Real World Outcomes. 2016;3(4):369-381. doi:10.1007/s40801-016-0093-2Food and Drug Administration.Biosimilars basics for patients.
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
National Institutes of Health. DailyMed.Label: XELJANZ- tofacitinib tablet, film coated.Awan H, Fatima U, Eaw R, Knox N, Alrubaiy L.The efficacy of currently licensed biologics for treatment of ulcerative colitis: a literature review.Cureus. 2023;15(4):e37609. doi:10.7759/cureus.37609Food and Drug Administration.What are “biologics” questions and answers.American Cancer Society.Monoclonal antibodies and their side effects.Liu JK.The history of monoclonal antibody development - progress, remaining challenges and future innovations.Ann Med Surg (Lond). 2014;3(4):113-116. doi:10.1016/j.amsu.2014.09.001Peyrin-Biroulet L, Sandborn WJ, Panaccione R, et al.Tumour necrosis factor inhibitors in inflammatory bowel disease: the story continues.Therap Adv Gastroenterol. 2021;14:17562848211059954. doi:10.1177/17562848211059954Vasudevan A, Gibson PR, van Langenberg DR.Time to clinical response and remission for therapeutics in inflammatory bowel diseases: what should the clinician expect, what should patients be told?World J Gastroenterol. 2017;23(35):6385-6402. doi:10.3748/wjg.v23.i35.6385National Institutes of Health. DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.National Institutes of Health. DailyMed.Label: Humira- adalimumab kit.Food and Drug Administration.Simponi label.Rutgeerts P, Sandborn WJ, Feagan BG, et al.Infliximab for induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2005;353(23):2462-2476. doi:10.1056/NEJMoa050516Hindryckx P, Baert F, Hart A, et al.Clinical trials in ulcerative colitis: a historical perspective.J Crohns Colitis. 2015;9(7):580-588. doi:10.1093/ecco-jcc/jjv074Reinisch W, Sandborn WJ, Hommes DW, et al.Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.Gut. 2011;60(6):780-787. doi:10.1136/gut.2010.221127Sandborn WJ, van Assche G, Reinisch W, et al.Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2012;142(2):257-265.e653. doi:10.1053/j.gastro.2011.10.032Sandborn WJ, Feagan BG, Marano C, et al.Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2014;146(1):96-109.e1. doi:10.1053/j.gastro.2013.06.010National Institutes of Health. DailyMed.Label: Entyvio- vedolizumab injection, solution.Allamneni C, Venkata K, Yun H, et al.Comparative effectiveness of vedolizumab vs. infliximab induction therapy in ulcerative colitis: experience of a real-world cohort at a tertiary inflammatory bowel disease center.Gastroenterology Res. 2018;11(1):41-45. doi:10.14740/gr934wFeagan BG, Rutgeerts P, Sands BE, et al.Vedolizumab as induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2013;369(8):699-710. doi:10.1056/NEJMoa1215734National Institutes of Health. DailyMed.Label: Stelara- ustekinumab injection solution.Reich J, Wasan S, Farraye FA.Vaccinating patients with inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2016;12(9):540-546.Solitano V, Ma C, Hanžel J, et al.Advanced combination treatment with biologic agents and novel small molecule drugs for inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2023;19(5):251-263.Gu T, Shah N, Deshpande G, Tang DH, Eisenberg DF.Comparing biologic cost per treated patient across indications among adult US managed care patients: a retrospective cohort study.Drugs Real World Outcomes. 2016;3(4):369-381. doi:10.1007/s40801-016-0093-2Food and Drug Administration.Biosimilars basics for patients.
National Institutes of Health. DailyMed.Label: XELJANZ- tofacitinib tablet, film coated.
Awan H, Fatima U, Eaw R, Knox N, Alrubaiy L.The efficacy of currently licensed biologics for treatment of ulcerative colitis: a literature review.Cureus. 2023;15(4):e37609. doi:10.7759/cureus.37609
Food and Drug Administration.What are “biologics” questions and answers.
American Cancer Society.Monoclonal antibodies and their side effects.
Liu JK.The history of monoclonal antibody development - progress, remaining challenges and future innovations.Ann Med Surg (Lond). 2014;3(4):113-116. doi:10.1016/j.amsu.2014.09.001
Peyrin-Biroulet L, Sandborn WJ, Panaccione R, et al.Tumour necrosis factor inhibitors in inflammatory bowel disease: the story continues.Therap Adv Gastroenterol. 2021;14:17562848211059954. doi:10.1177/17562848211059954
Vasudevan A, Gibson PR, van Langenberg DR.Time to clinical response and remission for therapeutics in inflammatory bowel diseases: what should the clinician expect, what should patients be told?World J Gastroenterol. 2017;23(35):6385-6402. doi:10.3748/wjg.v23.i35.6385
National Institutes of Health. DailyMed.Label: Remicade- infliximab injection, powder, lyophilized, for solution.
National Institutes of Health. DailyMed.Label: Humira- adalimumab kit.
Food and Drug Administration.Simponi label.
Rutgeerts P, Sandborn WJ, Feagan BG, et al.Infliximab for induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2005;353(23):2462-2476. doi:10.1056/NEJMoa050516
Hindryckx P, Baert F, Hart A, et al.Clinical trials in ulcerative colitis: a historical perspective.J Crohns Colitis. 2015;9(7):580-588. doi:10.1093/ecco-jcc/jjv074
Reinisch W, Sandborn WJ, Hommes DW, et al.Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.Gut. 2011;60(6):780-787. doi:10.1136/gut.2010.221127
Sandborn WJ, van Assche G, Reinisch W, et al.Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2012;142(2):257-265.e653. doi:10.1053/j.gastro.2011.10.032
Sandborn WJ, Feagan BG, Marano C, et al.Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2014;146(1):96-109.e1. doi:10.1053/j.gastro.2013.06.010
National Institutes of Health. DailyMed.Label: Entyvio- vedolizumab injection, solution.
Allamneni C, Venkata K, Yun H, et al.Comparative effectiveness of vedolizumab vs. infliximab induction therapy in ulcerative colitis: experience of a real-world cohort at a tertiary inflammatory bowel disease center.Gastroenterology Res. 2018;11(1):41-45. doi:10.14740/gr934w
Feagan BG, Rutgeerts P, Sands BE, et al.Vedolizumab as induction and maintenance therapy for ulcerative colitis.N Engl J Med. 2013;369(8):699-710. doi:10.1056/NEJMoa1215734
National Institutes of Health. DailyMed.Label: Stelara- ustekinumab injection solution.
Reich J, Wasan S, Farraye FA.Vaccinating patients with inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2016;12(9):540-546.
Solitano V, Ma C, Hanžel J, et al.Advanced combination treatment with biologic agents and novel small molecule drugs for inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2023;19(5):251-263.
Gu T, Shah N, Deshpande G, Tang DH, Eisenberg DF.Comparing biologic cost per treated patient across indications among adult US managed care patients: a retrospective cohort study.Drugs Real World Outcomes. 2016;3(4):369-381. doi:10.1007/s40801-016-0093-2
Food and Drug Administration.Biosimilars basics for patients.
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