Ulcerative colitis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult (body-weight up to 80 kg): Initially 200 mg, then
100 mg after 2 weeks; maintenance 50 mg every
4 weeks, alternatively maintenance 100 mg every
4 weeks, if inadequate response, review treatment if no
response after 4 doses
▶Adult (body-weight 80 kg and above): Initially 200 mg,
then 100 mg after 2 weeks; maintenance 100 mg every
4 weeks, review treatment if no response after 4 doses
Rheumatoid arthritis (initiated by a specialist) | Psoriatic
arthritis (initiated by a specialist) | Ankylosing
spondylitis (initiated by a specialist) | Non-radiographic
axial spondyloarthritis (initiated by a specialist)
▶BY SUBCUTANEOUS INJECTION
▶Adult (body-weight up to 100 kg): 50 mg once a month,
on the same date each month, review treatment if no
response after 3–4 doses
▶Adult (body-weight 100 kg and above): Initially 50 mg
once a month for 3–4 doses, on the same date each
month, dose may be increased if inadequate response,
increased to 100 mg once a month, review treatment if
inadequate response to this higher dose after
3–4 doses
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Active infection (do not initiate until active
infections are controlled; discontinue if new serious
infection develops until infection controlled).
demyelinating disorders (risk of exacerbation). hepatitis B
virus—monitor for active infection. history or
development of malignancy. mild heart failure
(discontinue if symptoms develop or worsen).
predisposition to infection. risk factors for dysplasia or
carcinoma of the colon—screen for dysplasia regularly
CAUTIONS, FURTHER INFORMATION
▶Tuberculosis Active tuberculosis should be treated with
standard treatment for at least 2 months before starting
golimumab. Patients who have previously received
adequate treatment for tuberculosis can start golimumab
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 golimumab. In patients at high risk of tuberculosis
who cannot be assessed by tuberculin skin test,
chemoprophylaxis can be given concurrently with
Musculoskeletal system
golimumab. Patients who have tested negative for latent
tuberculosis, and those who are receiving or who have
completed treatment for latent tuberculosis, should be
monitored closely for symptoms of active infection.
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NICE decisions
▶Golimumab for the treatment of psoriatic arthritis (April
2011) NICE TA220
Golimumab is an option for the treatment of active and
progressive psoriatic arthritis in adults only if:
. golimumab is used as described in the NICE guidance
(August 2010) for other tumour necrosis factor (TNF)
inhibitors, and
. the manufacturer provides the 100 mg dose of
Musculoskeletal system
golimumab at the same price as the 50 mg dose.
www.nice.org.uk/guidance/ta220
▶Adalimumab, etanercept, infliximab, certolizumab pegol,
golimumab, tocilizumab and abatacept for rheumatoid
arthritis not previously treated with DMARDs or after
conventional DMARDs only have failed (January 2016)
NICE TA375
Golimumab, in combination with methotrexate, is
recommended as an option for treating rheumatoid
arthritis, only if all the following criteria are met:
. disease is severe, that is, a disease activity score (DAS28)
greater than 5.1,
. disease has not responded to intensive therapy with a
combination of conventional disease-modifying
antirheumatic drugs (DMARDs),
. the manufacturer provides golimumab as agreed in the
patient access schemes.
Continue treatment only if there is a moderate response
measured using European League Against Rheumatism
(EULAR) criteria at 6 months after starting therapy. After
initial response within 6 months, withdraw treatment if a
moderate EULAR response is not maintained.
Patients currently receiving treatment with golimumab
whose disease does not meet the above criteria should
have the option to continue their treatment until they and
their NHS clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta375
▶Golimumab for the treatment of rheumatoid arthritis after
the failure of previous disease-modifying antirheumatic drugs
(June 2011) NICE TA225
Golimumab, in combination with methotrexate, is an
option for the treatment of rheumatoid arthritis in
patients who have had an inadequate response to
DMARDs, including a TNF inhibitor, if golimumab is used
as described in the NICE technology appraisal guidance
195 (August 2010) for other TNF inhibitors, and the
manufacturer provides the 100 mg dose of golimumab at
the same price as the 50 mg dose.
www.nice.org.uk/guidance/ta225
▶TNF-alpha inhibitors for ankylosing spondylitis and non-
radiographic axial spondyloarthritis (February 2016)
NICE TA383
Adalimumab, certolizumab pegol, etanercept, golimumab
and infliximab are recommended as options for treating
severe active ankylosing spondylitis in patients whose
disease has responded inadequately to, or who are
intolerant of, non-steroidal anti-inflammatory drugs
(NSAIDs).
The response to treatment should be assessed 12 weeks
after the start of treatment. Treatment should only be
continued if there is clear evidence of response.
Treatment with another tumour necrosis factor (TNF) -
alpha inhibitor is recommended in those who cannot
tolerate, or whose disease has not responded to, treatment
with the first TNF-alpha inhibitor, or in those whose
disease has stopped responding after an initial response.
www.nice.org.uk/guidance/ta383
▶Golimumab for treating non-radiographic axial
spondyloarthritis (January 2018) NICE TA497
Golimumab is recommended, within its marketing
authorisation, as an option for treating severe non-
radiographic axial spondyloarthritis in adults whose
disease has responded inadequately to, or who cannot
tolerate, non-steroidal anti-inflammatory drugs.
If patients and their clinicians consider golimumab to be
one of a range of suitable treatments, including
adalimumab, etanercept and certolizumab pegol, the least
expensive (taking into account administration costs and
patient access schemes) should be chosen.
Assess the response to golimumab 12 weeks after the
start of treatment. Continue treatment only if there is
clear evidence of response, defined as:
. a reduction in the Bath Ankylosing Spondylitis Disease
Activity Index (BASDAI) score to 50% of the pre-
treatment value or by 2 or more units, and
. a reduction in the spinal pain visual analogue scale
(VAS) score by 2 cm or more.
www.nice.org.uk/guidance/ta497
▶Infliximab, adalimumab and golimumab for treating
moderately-to-severely active ulcerative colitis after the
failure of conventional therapy (February 2015) NICE TA329
Golimumab is an option for treating moderately-to-
severely active ulcerative colitis in adults whose disease
has responded inadequately to conventional therapy
including corticosteroids and mercaptopurine or
azathioprine, or in adults who are intolerant to or have
contra-indications for conventional therapies.
Golimumab is recommended only if the manufacturer
provides the 100 mg dose of golimumab at the same cost as
the 50 mg dose, as agreed in the patient access scheme.
The choice of treatment should be made on an
individual basis and if more than one treatment is suitable,
the least expensive should be chosen.
Golimumab should be given as a planned course of
treatment until treatment fails (including the need for
surgery) or until 12 months after starting treatment,
whichever is shorter. Treatment should be continued only
if there is clear evidence of a response. Patients who
continue treatment should be reassessed at least every
12 months to determine whether ongoing treatment is still
clinically appropriate.
www.nice.org.uk/guidance/ta329
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2012)
that golimumab (Simponi ®) is accepted for restricted use
within NHS Scotland at a dose of 50 mg, alone or in
combination with methotrexate, for the treatment of
active and progressive psoriatic arthritis in adults whose
disease has not responded to adequate trials of at least two
standard DMARDs, administered either individually or in
combination.
The Scottish Medicines Consortium has advised (February
2016) that golimumab (Simponi ®) is accepted for use
within NHS Scotland for the treatment of adults with
severe, active non-radiographic axial spondyloarthritis
with objective signs of inflammation as indicated by
elevated C-reactive protein (CRP) and/or magnetic
resonance imaging (MRI) evidence, who have had an
inadequate response to, or are intolerant to non-steroidal
anti-inflammatory drugs (NSAIDs). 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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