FDA approved to treat:
Plaque psoriasis (moderate to
Patient must be 18 years or
older and a candidate for phototherapy or systemic (works
throughout the body) therapy
Psoriasis is the first disease
for which the U.S. Food and Drug Administration (FDA) has
What’s involved in taking
Patients receive injections
from a health-care provider. After the initial injection, the
patient returns 4 weeks later for the next injection. The
patient then returns once every 12 weeks for an injection.
A health-care provider gives
the injections to ensure that each patient is carefully
monitored at regular intervals.
The patient’s weight
determines the dosage. For patients weighing 220 pounds or less,
the recommended dose is 45 milligrams. The recommended dose for
patients who weigh more than 220 pounds is 90 milligrams.
Before ustekinumab is
prescribed, the patient has screenings tests for the hepatitis B
virus and latent (not causing symptoms) tuberculosis (TB).
How does ustekinumab work?
Psoriasis occurs when the body produces skin cells too quickly.
Ustekinumab blocks 2 proteins in the skin, IL-12 and IL-23, which
are believed to lead to an overproduction of skin cells and the
inflammation of psoriasis. This is the first medication approved for
treatment of psoriasis that works this way.
Effectiveness: More than
2,200 patients with moderate to severe psoriasis were enrolled in
the clinical trials for ustekinumab. The results from these clinical
trials show that ustekinumab may more effectively clear the skin
than the other biologics currently approved for the treatment of
psoriasis. Here is what the studies show:
In the first phase of clinical
trials, 77% of the patients who received ustekinumab had a
significant reduction in the severity of their psoriasis between
weeks 4 and 24. The researchers observed that 77% of the
patients given ustekinumab had a 75% reduction in their PASI
scores. PASI stands for Psoriasis Area and Severity Index. It
allows researchers to assign numbers to determine the severity
of a person’s psoriasis.
Favorable results also were
seen during Phase 3 of the clinical trials. It is during this
phase that the long-term safety and efficacy of a medication are
assessed. The data from Phase 3 show that more than half (67%)
of the patients who received ustekinumab had a 75% reduction of
their psoriasis. In this same study, 3% of the patients who
received the placebo (inactive ingredient) had a 75% reduction.
It is important to know that
not every patient sees clearer skin with ustekinumab. In some
cases, the psoriasis does not respond at all or responds
partially. The people in the Phase 3 clinical trial who
responded partially had a tendency to weigh more, have more
severe psoriasis, have had a skin disease for a longer time, not
get relief from other biologic medications, and have psoriatic
The clinical trials show that
when the patient stops receiving ustekinumab, the psoriasis
gradually returns. To continue seeing results, a patient may
need to take ustekinumab indefinitely.
Safety and side effects:
Continued regular dosing brings up concerns about safety and side
effects. It was such concerns that delayed the FDA’s approval of
ustekinumab for several months. This medication was approved because
more than 2,200 patients were enrolled in the clinical trials and
the trials showed that ustekinumab is generally well tolerated. The
trials did not show any major safety issues in the patients who have
received ustekinumab for as long as 18 months.
Side effects seen during the clinical trials were generally mild.
The most commonly reported mild side effects were upper respiratory
problems such as cough and congestion, headache, joint pain, and
mild skin reactions at the injection site. Lab tests showed a
reduced number of white blood cells in the patients given
ustekinumab. This was expected as ustekinumab suppresses the immune
The primary concerns for any medication that suppresses the immune
system are an increased risk for a serious infection and an
increased risk for developing cancer.
During the clinical trials, 2 patients were hospitalized for a
serious infection. One developed cellulitis (a serious infection
deep within the skin), and one developed herpes zoster (shingles). It is important to remember
that more than 2,200 patients were enrolled in these clinical
Two patients enrolled in a clinical trial were diagnosed with skin
cancer. One patient who did not receive ustekinumab was diagnosed
with squamous cell carcinoma (a common type of skin cancer). One
patient receiving ustekinumab was diagnosed with basal cell
carcinoma (the most common type of skin cancer).
To learn about the long-term safety and possible side effects,
studies continue to monitor patients receiving ustekinumab.
O'Neill JL, Kalb RE. “Ustekinumab in the therapy of chronic plaque
psoriasis.” Biologics 2009; 3: 159-68.
Patel RV, Clark LN, Lebwohl M et al. “Treatments for
psoriasis and the risk of malignancy.” Journal of the American
Academy of Dermatology June 2009; 60: 1001-17.
U.S. Food and Drug Administration, Center for Drug Evaluation and
Research. “FDA Advisory Committee Unanimously Recommends Approval of
Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis.”
June 17, 2008.
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developed by the American Academy of Dermatology