By Gary M. White, MD

Note: This is a summary only. Please consult the latest information when prescribing.

Ustekinumab (trade name STELARA®) is a human monoclonal antibody that binds to IL-12 and IL-23. It is very effective against psoriasis.



Warnings and Precautions

Pregnancy Category B

Predisposition to Infection

Use of ustekinumab predisposes the patient to infection, e.g., tuberculosis, herpes zoster, pneumonia, sinusitis. Get PPD before starting and annually. Make sure there is no chronic/active infection before starting.


Skin Cancer

Can Ustekinumab Be Used If Methotrexate fails?

Ustekinumab has its same high efficacy for patients who fail MTX. Immediate transitioning from methotrexate to ustekinumab can be recommended and a washout period is not needed. Overlapping ustekinumab and methotrexate treatment for up to 1 month has been shown not to increase side effects. Of note, ustekinumab is FDA-approved for active psoriatic arthritis, alone or in combination with methotrexate.

Does Ustekinumab Precipitate Psoriatic Arthritis?

Ustekinumab is FDA-approved for active psoriatic arthritis. However, it has recently been reported to flare psoriatic arthritis [Jama Derm Dec 2013;149;1410 and BJD 2015;173;272]. Patients may either have preexisting joint disease flare or the ustekinumab can unmask or precipitate new onset arthritis. In the four patients reported [Jama Derm Dec 2013;149;1410], the psoriasis greatly improved at the same time. Stopping the ustekinumab can clear or greatly improve the psoriatic arthritis.

8 Week Interval?

From the Canadian Product Monograph
"For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks."

Dosing interval adjustment: In PHOENIX 1, Week 28 and Week 40 partial responders and Week 40 nonresponders were adjusted from every-12-weeks to every-8-weeks dosing. Approximately 40%-50% of Week 28 partial responders to every-12-weeks dosing achieved PASI 75 response after adjustment to every-8-weeks dosing and this proportion of PASI 75 responders was maintained through Week 52. A similar proportion of patients who were PASI 75 responders at Week 28 and subsequently became partial responders or nonresponders at Week 40 achieved PASI 75 response following a dosing interval adjustment to every 8 weeks.

In PHOENIX 2, among patients initially randomized to 90 mg dosing who were partial responders at Week 28, dosing adjustment to every 8 weeks resulted in consistently superior efficacy as compared with continued every-12-weeks dosing: Partial responders randomized to 90 mg every 8 weeks achieved PASI 75 response at more visits between Weeks 40 and 52 than partial responders randomized to continue 90 mg every 12 weeks (p = 0.014), and a higher proportion of subjects achieved a PASI 75 response at Week 52 (68.8% with every-8-weeks dosing versus 33.3% with every-12-weeks dosing; p = 0.004). Among patients initially randomized to 45 mg dosing who were partial responders at Week 28, response rates were not higher among patients in whom dosing was adjusted to every 8 weeks compared with patients who continued every-12-weeks dosing.

Reversible Posterior Leukoencephalopathy Syndrome

A 65-year-old woman on ustekinumab therapy for psoriasis developed acute onset of confusion, headache, nausea, vomiting, and seizures. She had received 12 doses of STELARA® over approximately two years. After a full workup, a diagnosis of RPLS was made. The ustekinumab was stopped. She made a full recovery [Arch Dermatol. 2011 Oct;147(10):1197-202].

Major Adverse Cardiac Events

Are major adverse cardiac events (MACE) more frequent in patients treated with anti-IL 12/23 drugs (ustekinumab and briakinumab) treated patients? There is a number "imbalance" toward that in the first 12-24 weeks, but not to the point of p < 0.05. PSOLAR data which goes out longer shows much less MACE observed than expected. Studies are ongoing.

Adolescents 12-17 Years of Age

Adolescents 12-17 years of age with psoriasis did well on standard doses of ustekinumab with no unexpected adverse events through 1 year [JAAD 2015;73;594].

Genetic Polymorphism and Response to Treatment

Patients with psoriasis who are HLA-C*06-positive respond better to ustekinumab that those who are negative [JAAD 2016;74;374].

Vasculitis associated with ustekinumab

As of 2016, 19 patients have been described with vasculitis potentially triggered by ustekinumab. 12/19 were female. The age was typically between 51 and 64 years of age. Most patients were prescribed ustekinumab for psoriasis [J of Drugs in Dermatol 2016;15;358].


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