Ustekinumab, sold under the brand name Stelara among others, is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

medication used for the treatment of

Crohn's disease Crohn's disease is a type of inflammatory bowel disease (IBD) that may affect any segment of the gastrointestinal tract. Symptoms often include abdominal pain, diarrhea, fever, abdominal distension, and weight loss. Complications outside of the ...

ulcerative colitis Ulcerative colitis (UC) is one of the two types of inflammatory bowel disease (IBD), with the other type being Crohn's disease. It is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary sympto ...

plaque psoriasis Psoriasis is a long-lasting, noncontagious autoimmune disease characterized by patches of abnormal skin. These areas are red, pink, or purple, dry, itchy, and scaly. Psoriasis varies in severity from small localized patches to complete b ...

and

psoriatic arthritis Psoriatic arthritis (PsA) is a long-term inflammatory arthritis that may occur in some people affected by the autoimmune disease psoriasis. The classic features of psoriatic arthritis include dactylitis (sausage-like swelling of the fingers ...

, targeting both IL-12 and IL-23. It is administered either by

intravenous infusion Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutr ...

subcutaneous injection Subcutaneous administration is the insertion of medications beneath the skin either by injection or infusion. A subcutaneous injection is administered as a bolus (medicine), bolus into the subcutis, the layer of skin directly below the dermis and ...

. The antibody targets a subunit of human

interleukin 12 Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, helper T cells and human B-lymphoblast, lymphoblastoid cells (NC-37) in response to antigenic stimulation. IL-12 belongs to the ...

and

interleukin 23 Interleukin 23 (IL-23) is a heterodimeric cytokine composed of an IL-12B (IL-12p40) subunit (which is shared with IL-12) and an IL-23A (IL-23p19) subunit. IL-23 is part of the IL-12 family of cytokines. The functional receptor for IL-23 (t ...

, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease. Ustekinumab was developed by Centocor Ortho Biotech. Ustekinumab is approved to treat Crohn's disease in the United States, Israel, Australia, and the European Union; and ulcerative colitis in the United States, and in the European Union to people who have not responded to more traditional treatments. It was found not effective for

multiple sclerosis Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit ...

Medical uses

Ustekinumab is used to treat

psoriasis Psoriasis is a long-lasting, noncontagious autoimmune disease characterized by patches of abnormal skin. These areas are red, pink, or purple, dry, itchy, and scaly. Psoriasis varies in severity from small localized patches to complete b ...

. This includes

when it affects the skin. It is indicated for the treatment of adult and adolescent patients (12 years and older) with moderate to severe

(Ps) who are candidates for

phototherapy Light therapy, also called phototherapy or bright light therapy is the exposure to direct sunlight or artificial light at controlled wavelengths in order to treat a variety of medical disorders, including seasonal affective disorder (SAD), circ ...

or systemic therapy, and adults with active psoriatic arthritis (PsA) alone or in combination with

methotrexate Methotrexate, formerly known as amethopterin, is a chemotherapy agent and immunosuppressive drug, immune-system suppressant. It is used to treat cancer, autoimmune diseases, and ectopic pregnancy, ectopic pregnancies. Types of cancers it is u ...

. It is also used to treat moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. In the European Union, ustekinumab is authorized for the treatment of moderate to severe plaque psoriasis in people above the age of six years whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A); active psoriatic arthritis in adults; moderately to severely active Crohn's disease in adults; and moderately to severely active ulcerative colitis in adults.

Adverse effects

The most common side effects include

upper respiratory tract infection An upper respiratory tract infection (URTI) is an illness caused by an acute infection, which involves the upper respiratory tract, including the nose, sinuses, pharynx, larynx or trachea. This commonly includes nasal obstruction, sore throat ...

headache A headache, also known as cephalalgia, is the symptom of pain in the face, head, or neck. It can occur as a migraine, tension-type headache, or cluster headache. There is an increased risk of Depression (mood), depression in those with severe ...

fatigue Fatigue is a state of tiredness (which is not sleepiness), exhaustion or loss of energy. It is a signs and symptoms, symptom of any of various diseases; it is not a disease in itself. Fatigue (in the medical sense) is sometimes associated wit ...

nausea Nausea is a diffuse sensation of unease and discomfort, sometimes perceived as an urge to vomit. It can be a debilitating symptom if prolonged and has been described as placing discomfort on the chest, abdomen, or back of the throat. Over 30 d ...

vomiting Vomiting (also known as emesis, puking and throwing up) is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose. Vomiting can be the result of ailments like food poisoning, gastroenteritis, pre ...

, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus,

urinary tract infection A urinary tract infection (UTI) is an infection that affects a part of the urinary tract. Lower urinary tract infections may involve the bladder (cystitis) or urethra (urethritis) while upper urinary tract infections affect the kidney (pyel ...

, sinusitis, abdominal pain, fever, and diarrhea. Clinical trials have shown that subcutaneous ustekinumab was generally well tolerated. Most treatment-emergent adverse events were of mild severity.

Pregnancy

It is unknown if the medication is safe during pregnancy or breastfeeding.

Mechanism of action

Ustekinumab is designed to interfere with the triggering of the body's

inflammatory response Inflammation (from ) is part of the biological response of body tissues to harmful stimuli, such as pathogens, damaged cells, or irritants. The five cardinal signs are heat, pain, redness, swelling, and loss of function (Latin ''calor'', '' ...

through the suppression of certain

cytokines Cytokines () are a broad and loose category of small proteins (~5–25 kDa) important in cell signaling. Cytokines are produced by a broad range of cells, including immune cells like macrophages, B cell, B lymphocytes, T cell, T lymphocytes ...

. Specifically, it blocks

interleukin Interleukins (ILs) are a group of cytokines (secreted proteins and signal molecules) that are expressed and secreted by white blood cells (leukocytes) as well as some other body cells. The human genome encodes more than 50 interleukins and related ...

IL-12 and IL-23 which help activate certain

T-cells T cells (also known as T lymphocytes) are an important part of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell receptor (TCR) on their cell ...

. It binds to the

p-40 The Curtiss P-40 Warhawk is an American single-engined, single-seat, all-metal fighter-bomber that first flew in 1938. The P-40 design was a modification of the previous Curtiss P-36 Hawk which reduced development time and enabled a rapid entr ...

subunit of both IL-12 and IL-23 so that they subsequently cannot bind to their receptors.

History

In December 2007, a

biologic license application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inters ...

with the US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) was filed by Centocor; and Janssen-Cilag International (collaborator) submitted a marketing authorization application to the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

(EMA). In November 2008, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the EMA adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to other systemic therapies.

Society and culture

Legal status

Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe

. In September 2013, the US

(FDA) approved the use of ustekinumab for the treatment of

. In December 2008,

Health Canada Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ...

approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis. The FDA approved ustekinumab in September 2016, to treat Crohn's disease. Since September 2017, ustekinumab has been available on the AU Pharmaceutical Benefits Scheme to treat severe Crohn's disease in adults. In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis. In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.

Biosimilars

In October 2023, ustekinumab-auub (Wezlana) was approved for medical use in the United States. In November 2023, the

(CHMP) of the

(EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Uzpruvo, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis and Crohn's disease in adults. The applicant for this medicinal product is STADA Arzneimittel AG. Uzpruvo is a biosimilar medicinal product. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Uzpruvo was authorized for medical use in the European Union in January 2024. In November 2023, Jamteki was approved for medical use in Canada. In December 2023, Wezlana and Wezlana I.V. were approved for medical use in Canada. In February 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults. The applicant for this medicinal product is Samsung Bioepis NL B.V. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Pyzchiva is a biosimilar medicinal product. Pyzchiva was authorized for medical use in the European Union in April 2024. Ustekinumab-aekn (Selarsdi) was approved for medical use in the United States in April 2024. In April 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Wezenla, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, and Crohn's disease in adults. The applicant for this medicinal product is Amgen Technology (Ireland) UC. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Wezenla was authorized for medical use in the European Union in June 2024. Ustekinumab-ttwe (Pyzchiva) was approved for medical use in the United States in June 2024. In June 2024, the CHMP recommended granting a marketing authorization for Steqeyma, a biosimilar medicine for the treatment of adults with moderately-to severely-active Crohn's disease, plaque psoriasis, pediatric plaque psoriasis and psoriatic arthritis. The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Steqeyma was authorized for medical use in the European Union in August 2024. In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eksunbi, intended for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease in adults. The applicant for this medicinal product is Samsung Bioepis NL B.V. Eksunbi is a biosimilar medicinal product. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Eksunbi is a biosimilar medicinal product. Eksunbi was authorized for medical use in the European Union in September 2024. In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Otulfi, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease. The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH. Otulfi is a biosimilar medicinal product. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Otulfi was authorized for medical use in the European Union in September 2024. In July 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Fymskina, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn's disease. The applicant for this medicinal product is Formycon AG. Fymskina is a biosimilar medicinal product. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Fymskina was authorized for medical use in the European Union in September 2024. In July 2024, Steqeyma and Steqeyma IV were approved for medical use in Canada. In August 2024, Pyzchiva and Pyzchiva I.V. were approved for medical use in Canada. Steqeyma was approved for medical use in Australia in September 2024. In September 2024, ustekinumab-aauz (Otulfi) was approved for medical use in the United States.fda.gov
/ref>fda.gov
/ref> Ustekinumab-srlf (Imuldosa) was approved for medical use in the United States in October 2024. In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Absimky, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease, or ulcerative colitis. The applicant for this medicinal product is Accord Healthcare S.L.U. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Absimky is a biosimilar medicinal product. Absimky was authorized for medical use in the European Union in December 2024. In October 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Imuldosa, intended for the treatment of people with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease. The applicant for this medicinal product is Accord Healthcare S.L.U. Imuldosa is a biosimilar medicinal product. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Imuldosa was authorized for medical use in the European Union in December 2024. Ustekinumab-kfce (Yesintek) was approved for medical use in the United States in December 2024. In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yesintek, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease. The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited. Yesintek is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in January 2009. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Ustekinumab-stba (Steqeyma) was approved for medical use in the United States in December 2024. In March 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Qoyvolma, intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis, Crohn's disease or ulcerative colitis. The applicant for this medicinal product is Celltrion Healthcare Hungary Kft. Qoyvolma is a biosimilar medicinal product. It is highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in January 2009. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Ustekinumab-hmny, (Starjemza) was approved for medical use in the United States in May 2025.

References

{{Authority control Immunosuppressants Drugs developed by Johnson & Johnson Janssen Biotech Monoclonal antibodies Disease-modifying antirheumatic drugs