Ustekinumab

Ustekinumab
Mass / length primary structure	145.6 kDa
Identifier
External IDs	CAS number : 815610-63-0;
Drug information
ATC code	L04 AC05
Drug class	Monoclonal antibodies

Ustekinumab (trade name Stelara ^® ; manufacturer Janssen-Cilag ) is a drug that is used in the treatment of psoriasis . Ustekinumab is a human monoclonal antibody against the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23) and has been approved since January 2009.

pharmacology

Application areas (indications)

Ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults and adolescents from 12 years of age in whom other therapies have not responded, are contraindicated or have not been tolerated.

It has also been found to be effective in psoriatic arthritis , which affects around a fifth of psoriasis patients. Ustekinumab is also approved for their treatment if the disease has not responded adequately to other drugs, so-called disease-modifying anti-inflammatory drugs.

Ustekinumab is also approved for use in adult patients with moderate to severe Crohn's disease and moderate to severe ulcerative colitis who have not responded well enough to other treatments or are unable to use them.

Contraindications (contraindications)

Ustekinumab is contraindicated in cases of known hypersensitivity to the active substance and active clinically relevant infections.

pregnancy and breast feeding period

There are insufficient data on the safety of ustekinumab in pregnancy. Although animal studies have shown no evidence of teratogenicity , contraceptive measures are recommended for up to 15 weeks after the use of ustekinumab.

It is not known whether ustekinumab is excreted in human milk.

Interactions

Possible interactions with other medicinal products have not been or insufficiently investigated. Similarly, the safety of ustekinumab in combination with other immunosuppressive agents, including PUVA therapy, has not been evaluated. According to information from the manufacturer, live vaccines should not be given in a temporal context with ustekinumab.

Adverse drug effects

The most common side effects with ustekinumab include infections, especially of the upper respiratory tract (> 10%). Frequently (1–10%) depression, dizziness, headache, diarrhea, itching, back and muscle pain and fatigue also occur. In addition, reactions at the injection site can be observed. There is also evidence of possible cardiovascular risks.

Individual evidence

↑ Summary of the EPAR from Stelara , European Medicines Agency, accessed on February 8, 2019
↑ ^a ^b ^c ^d ^e ^f Specialist information Stelara 45mg solution for injection. Janssen-Cilag. July 2015.
↑ ^a ^b Iain B McInnes, Arthur Kavanaugh, Alice B Gottlieb, Lluís Puig, Proton Rahman, Christopher Ritchlin, Carrie Brodmerkel, Shu Li, Yuhua Wang, Alan M Mendelsohn, Mittie K Doyle: Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. In: The Lancet. 2013, S., doi : 10.1016 / S0140-6736 (13) 60594-2 .
^ European Medicines Agency - EPAR summary for the public

[1] Summary of the EPAR from Stelara , European Medicines Agency, accessed on February 8, 2019

[Fachinfo-2] ↑ ^a ^b ^c ^d ^e ^f Specialist information Stelara 45mg solution for injection. Janssen-Cilag. July 2015.

[DOI10.1016/S0140-6736(13)60594-2-3] Iain B McInnes, Arthur Kavanaugh, Alice B Gottlieb, Lluís Puig, Proton Rahman, Christopher Ritchlin, Carrie Brodmerkel, Shu Li, Yuhua Wang, Alan M Mendelsohn, Mittie K Doyle: Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. In: The Lancet. 2013, S., doi : 10.1016 / S0140-6736 (13) 60594-2 .

[4] European Medicines Agency - EPAR summary for the public