Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis,[31] targeting both IL-12 and IL-23.
[34] 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.
[29] 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);[30] active psoriatic arthritis in adults;[30] moderately to severely active Crohn's disease in adults;[30] and moderately to severely active ulcerative colitis in adults.
In November 2008, the Committee for Medicinal Products for Human Use 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.
[30] Ustekinumab is approved in Canada, the European Union, and the United States to treat moderate to severe plaque psoriasis.
[44] In December 2008, Health Canada 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.
[45][46] The FDA approved ustekinumab in September 2009, for the treatment of adults with moderate to severe plaque psoriasis.
[48] Since September 2017, ustekinumab is available on the AU Pharmaceutical Benefits Scheme for the treatment of severe Crohn's disease in adults.
[49] In 2019, the European Commission authorized the use of ustekinumab for adults with moderately to severely active ulcerative colitis.
[36][30] In October 2019, the FDA approved the use of ustekinumab for adults with moderately to severely active ulcerative colitis.
[57][58] 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.
[2][52] 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.
[19][20] 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.
[15][16] 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.
[5][66][52] 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.
[9] 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.