Moderate to severe active rheumatoid arthritis when
response to disease-modifying antirheumatic drugs
(including methotrexate) has been inadequate (as
monotherapy or in combination with methotrexate) |
Severe, active and progressive rheumatoid arthritis in
patients not previously treated with methotrexate or
other disease-modifying antirheumatic drugs (in
combination with methotrexate) | Active psoriatic
arthritis when response to disease-modifying
antirheumatic drugs has been inadequate (as
monotherapy or in combination with methotrexate)
▶BY SUBCUTANEOUS INJECTION
▶Adult: Loading dose 400 mg every 2 weeks for 3 doses,
then maintenance 200 mg every 2 weeks, once clinical
response is confirmed, an alternative maintenance
dosing of 400 mg every 4 weeks can be considered,
review treatment if no response within 12 weeks
Treatment of severe active ankylosing spondylitis in
patients who have had an inadequate response to, or are
intolerant of NSAIDs | Treatment of severe active axial
spondyloarthritis, without radiographic evidence of
ankylosing spondylitis but with objective signs of
inflammation, in patients who have had an inadequate
response to, or are intolerant of NSAIDs
▶BY SUBCUTANEOUS INJECTION
▶Adult: Loading dose 400 mg every 2 weeks for 3 doses,
then maintenance 200 mg every 2 weeks, alternatively
maintenance 400 mg every 4 weeks, review treatment if
no response within 12 weeks
Moderate to severe plaque psoriasis
▶BY SUBCUTANEOUS INJECTION
▶Adult: Loading dose 400 mg every 2 weeks for 3 doses,
then maintenance 200 mg every 2 weeks, an alternative
maintenance dosing of 400 mg every 2 weeks can be
considered in patients with insufficient response,
review treatment if no response within 16 weeks
PDF page 1195
NICE decisions
▶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
Certolizumab pegol, in combination with methotrexate, is
recommended as an option for treating rheumatoid
arthritis, only if the following criteria are met:
. disease is severe, that is, a disease activity score (DAS28)
Musculoskeletal system
greater than 5.1,
. disease has not responded to intensive therapy with a
combination of conventional disease-modifying
antirheumatic drugs (DMARDs),
. the manufacturers provide certolizumab pegol as agreed
in the patient access schemes.
Certolizumab pegol can be used as monotherapy in
patients who cannot take methotrexate because it is
contra-indicated or because of intolerance, when the
criteria above are met.
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 certolizumab pegol within
the NHS whose disease does not meet the above criteria
should have the option to continue their treatment until
they and their clinician consider it appropriate to stop.
www.nice.org.uk/ta375
▶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 adult patients
whose disease has responded inadequately to, or who are
intolerant of, non-steroidal anti-inflammatory drugs.
Adalimumab, certolizumab pegol and etanercept are
also recommended as options for treating severe non-
radiographic axial spondyloarthritis 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/ta383
▶Certolizumab pegol for treating rheumatoid arthritis after
inadequate response to a TNF-alpha inhibitor (October 2016)
NICE TA415
Certolizumab pegol, in combination with methotrexate, or
as monotherapy, is recommended as an option for treating
active rheumatoid arthritis in adults who have had an
inadequate response to, or who cannot tolerate, other
disease-modifying antirheumatic drugs (DMARDs)
including at least 1 tumour necrosis factor-alpha (TNF-
alpha) inhibitor, only if the following criteria are met:
. disease activity is severe and
. rituximab is contra-indicated or not tolerated, or if
monotherapy, rituximab cannot be given because
methotrexate is contra-indicated or not tolerated and
. the manufacturers provide certolizumab pegol as agreed
in the patient access scheme.
Continue treatment only if there is at least 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 at least a moderate EULAR response is not
maintained.
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their clinician consider it
appropriate to stop.
www.nice.org.uk/ta415
▶Certolizumab pegol and secukinumab for treating active
psoriatic arthritis after inadequate response to DMARDs (May
2017) NICE TA445
Certolizumab pegol alone, or in combination with
methotrexate, is recommended as an option for treating
active psoriatic arthritis in adults only if:
. it is used as described in the NICE technology appraisal
guidance on etanercept, infliximab and adalimumab for
the treatment of psoriatic arthritis (TA199
recommendations 1.1 and 1.2), or
. the person has had a tumour necrosis factor (TNF)-alpha
inhibitor but their disease has stopped responding after
the first 12 weeks.
Certolizumab pegol is only recommended if the
manufacturer provides it as agreed in the patient access
scheme.
Assess the response to treatment after 12 weeks.
Treatment should only be continued if there is clear
evidence of response, defined as an improvement in at
least 2 of the 4 Psoriatic Arthritis Response Criteria
(PsARC), 1 of which must be joint tenderness or swelling
score, with no worsening in any of the 4 criteria. People
whose disease has a Psoriasis Area and Severity Index
(PASI) 75 response but whose PsARC response does not
justify continuing treatment should be assessed by a
dermatologist.
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their clinician consider it
appropriate to stop.
www.nice.org.uk/guidance/ta445
▶Certolizumab pegol for treating moderate to severe plaque
psoriasis (April 2019) NICE TA574
Certolizumab pegol (Cimzia ®) is recommended as an
option for treating plaque psoriasis in adults, only if:
. the disease is severe, as defined by a total Psoriasis Area
and Severity Index (PASI) of 10 or more and a
Dermatology Life Quality Index (DLQI) of more than 10,
and
. the disease has not responded to other systemic
treatments, including ciclosporin, methotrexate and
phototherapy, or these options are contra-indicated or
not tolerated, and
. the lowest maintenance dosage of certolizumab pegol is
used after the loading dosage, and
. the manufacturer provides the drug according to the
commercial arrangement.
Stop certolizumab pegol at 16 weeks if the psoriasis has
not responded adequately. An adequate response is
defined as:
. a 75% reduction in the PASI score (PASI 75) from when
treatment started, or
. a 50% reduction in the PASI score (PASI 50) and a 5-
point reduction in DLQI from when treatment started.
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
it appropriate to stop.
www.nice.org.uk/guidance/ta574
Scottish Medicines Consortium (SMC) decisions
SMC No. SMC2132
The Scottish Medicines Consortium has advised (April 2019)
that certolizumab pegol (Cimzia ®) is accepted for
restricted use within NHS Scotland for the treatment of
moderate to severe plaque psoriasis in adults who have
failed to respond to standard systemic therapies (including
ciclosporin, methotrexate and phototherapy), are
intolerant to, or have a contra-indication to these
treatments. 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.
PDF pages 1196, 1197
