Plaque psoriasis (specialist use only)
▶BY SUBCUTANEOUS INJECTION
▶Adult (body-weight up to 100 kg): Initially 45 mg, then
45 mg after 4 weeks, then 45 mg every 12 weeks,
consider discontinuation if no response within
28 weeks
▶Adult (body-weight 100 kg and above): Initially 90 mg,
then 90 mg after 4 weeks, then 90 mg every 12 weeks,
consider discontinuation if no response within
28 weeks
Psoriatic arthritis (specialist use only)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Initially 45 mg, then 45 mg after 4 weeks, then
45 mg every 12 weeks, consider discontinuation if no
response within 28 weeks, higher doses of 90 mg may
be used in patients with body-weight over 100 kg
Crohn’s disease (specialist use only) | Ulcerative colitis
(specialist use only)
▶INITIALLY BY INTRAVENOUS INFUSION
▶Adult (body-weight up to 56 kg): 260 mg, then (by
subcutaneous injection) 90 mg after 8 weeks, then (by
subcutaneous injection) 90 mg every 12 weeks, if
response is inadequate 8 weeks after first subcutaneous
dose, or response is lost, dosing frequency may be
increased—consult product literature; consider
discontinuation if no response within 16 weeks of
initial dose or increase in dosing frequency
▶Adult (body-weight 56–85 kg): 390 mg, then (by
subcutaneous injection) 90 mg after 8 weeks, then (by
subcutaneous injection) 90 mg every 12 weeks, if
response is inadequate 8 weeks after first subcutaneous
dose, or response is lost, dosing frequency may be
increased—consult product literature; consider
discontinuation if no response within 16 weeks of
initial dose or increase in dosing frequency
▶Adult (body-weight 86 kg and above): 520 mg, then (by
subcutaneous injection) 90 mg after 8 weeks, then (by
subcutaneous injection) 90 mg every 12 weeks, if
response is inadequate 8 weeks after first subcutaneous
dose, or response is lost, dosing frequency may be
increased—consult product literature; consider
discontinuation if no response within 16 weeks of
initial dose or increase in dosing frequency
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Active infection
PDF page 1186
Development of malignancy. elderly. history of
malignancy. predisposition to infection. start appropriate
treatment if widespread erythema and skin exfoliation
develop, and stop ustekinumab treatment if exfoliative
dermatitis suspected
CAUTIONS, FURTHER INFORMATION
▶Tuberculosis Active tuberculosis should be treated with
standard treatment for at least 2 months before starting
ustekinumab. Patients who have previously received
adequate treatment for tuberculosis can start ustekinumab
but should be monitored every 3 months for possible
recurrence. In patients without active tuberculosis but
who were previously not treated adequately,
chemoprophylaxis should ideally be completed before
starting ustekinumab. In patients at high risk of
tuberculosis who cannot be assessed by tuberculin skin
test, chemoprophylaxis can be given concurrently with
ustekinumab.
PDF page 1186
Tuberculosis Patients should be evaluated for tuberculosis
before treatment.
PDF page 1187
NICE decisions
▶Ustekinumab for the treatment of adults with moderate to
severe psoriasis (updated March 2017) NICE TA180
Ustekinumab is recommended as a treatment option for
adults with plaque psoriasis only if:
. the disease is severe, defined by a total Psoriasis Area
Severity Index (PASI) score of 10 or more and a
Dermatology Life Quality Index (DLQI) score of 10 or
more, and
. the psoriasis has not responded to standard systemic
therapies (e.g. ciclosporin, methotrexate and psoralen
and long-wave ultraviolet radiation), or patients are
intolerant to or have a contra-indication to these
treatments.
Ustekinumab treatment should be stopped 16 weeks after
starting treatment if the psoriasis has not shown a 75%
reduction in the PASI score from when treatment started,
or a 50% reduction in the PASI score and a 5-point
reduction in the DLQI score from when treatment started.
www.nice.org.uk/guidance/ta180
▶Ustekinumab for treating active psoriatic arthritis (updated
March 2017) NICE TA340
Ustekinumab is recommended as an option, alone or in
combination with methotrexate, for treating active
psoriatic arthritis in adults only when:
. treatment with tumour necrosis factor (TNF) alpha
inhibitors is contra-indicated but would otherwise be
considered, or
. the patient has had treatment with 1 or more TNF-alpha
inhibitors.
Ustekinumab should be stopped at 24 weeks, if the
psoriatic arthritis has not shown adequate response using
the Psoriatic Arthritis Response Criteria (PsARC).
Patients currently receiving ustekinumab who do not
meet the above criteria and whose treatment was started
within the NHS before this guidance was published, should
have the option to continue treatment until they and their
clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta340
▶Ustekinumab for moderately to severely active Crohn’s
disease after previous treatment (July 2017) NICE TA456
Ustekinumab is recommended as an option for treating
moderately to severely active Crohn’s disease in adults
who have had an inadequate response with, lost response
to, or were intolerant to either conventional therapy or a
TNF-alpha inhibitor or have medical contra-indications to
such therapies.
Ustekinumab should be given until treatment failure
(including the need for surgery) or until 12 months after
Musculoskeletal system
the start of treatment, whichever is shorter.
www.nice.org.uk/guidance/ta456
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (March
2014) that ustekinumab (Stelara ®) is accepted for
restricted use within NHS Scotland either alone or in
combination with methotrexate, for the treatment of
active psoriatic arthritis in adults who have responded
inadequately to previous therapy with a non-biological
disease-modifying anti-rheumatic drug, and failed on, or
are unsuitable for, treatment with a TNF inhibitor.
The Scottish Medicines Consortium has advised (July
2017) that ustekinumab (Stelara ®) is accepted for use
within NHS Scotland for the treatment of adults with
moderately to severely active Crohn’s disease who have
had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a tumour
necrosis factor-alpha antagonist or have medical contra-
indications to such therapies. This advice is contingent
upon the continuing availability of the patient access
scheme in NHS Scotland or a list price that is equivalent or
lower.
SMC No. SMC2250
The Scottish Medicines Consortium has advised (April
2020) that ustekinumab (Stelara ®) is accepted for use
within NHS Scotland for the treatment of adults with
moderately to severely active ulcerative colitis who have
had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a biologic or
have medical contra-indications to such therapies. This
advice is contingent upon the continuing availability of
the patient access scheme in NHS Scotland or a list price
that is equivalent or lower.
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