Rheumatoid arthritis [severe, active and progressive, not
previously treated with methotrexate] | Rheumatoid
arthritis [moderate-to-severe, in combination with
methotrexate or alone if methotrexate inappropriate,
when response to at least one disease-modifying
antirheumatic drug or tumour necrosis factor inhibitor
has been inadequate, or in those who are intolerant of
these drugs]
▶BY INTRAVENOUS INFUSION
▶Adult: 8 mg/kg every 4 weeks (max. per dose 800 mg),
for dose adjustments in patients with liver enzyme
abnormalities, or low absolute neutrophil or platelet
count—consult product literature
▶BY SUBCUTANEOUS INJECTION
▶Adult: 162 mg once weekly, administer to abdomen,
thigh or upper arm, for dose adjustments in patients
with liver enzyme abnormalities, or low absolute
neutrophil or platelet count—consult product
literature
Giant cell arteritis [in combination with a tapering course
of glucocorticoid or alone following discontinuation of
glucocorticoid]
▶BY SUBCUTANEOUS INJECTION
▶Adult: 162 mg once weekly, administer to abdomen,
thigh or upper arm, for dose adjustments in patients
with liver enzyme abnormalities, or low absolute
neutrophil or platelet count—consult product
literature, not to be used alone for acute relapses;
review need for treatment beyond 52 weeks
PDF page 1184
Do not initiate if absolute
neutrophil count less than 2 6 109/litre. severe active
infection
PDF page 1185
History of diverticulitis. history of intestinal
ulceration. history of recurrent or chronic infection
(interrupt treatment if serious infection occurs). low
absolute neutrophil count. low platelet count.
predisposition to infection (interrupt treatment if serious
infection occurs)
CAUTIONS, FURTHER INFORMATION
▶Tuberculosis Patients with latent tuberculosis should be
treated with standard therapy before starting tocilizumab.
PDF page 1185
Tuberculosis Patients should be evaluated for tuberculosis
before treatment.
PDF page 1185
Manufacturer advises to record the brand name and batch
number after each administration.
l HANDLING AND STORAGE Manufacturer advises protect
from light and store in a refrigerator (2–8 °C)—consult
product literature for further information regarding
storage conditions outside refrigerator and after
preparation of the infusion.
PDF page 1185
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
Tocilizumab (RoActemra ®), 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), and
. the manufacturers provide tocilizumab as agreed in the
patient access schemes.
Tocilizumab 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 tocilizumab 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
▶Tocilizumab for the treatment of rheumatoid arthritis
(February 2012) NICE TA247
Tocilizumab (RoActemra ®), in combination with
methotrexate, is recommended as an option for the
treatment of rheumatoid arthritis in adults if:
. the disease has responded inadequately to DMARDs and
a TNF inhibitor and the patient cannot receive rituximab
because of contra-indications or intolerance, and
tocilizumab is used as described for TNF inhibitor
treatments (specifically the recommendations on
disease activity) in the NICE guidance Adalimumab,
etanercept, infliximab, rituximab and abatacept for the
Musculoskeletal system
treatment of rheumatoid arthritis after the failure of a
TNF inhibitor (August 2010), or
. the disease has responded inadequately to one or more
TNF inhibitor treatments and to rituximab
. and the manufacturer provides tocilizumab with the
discount agreed as part of the patient access scheme.
Patients currently receiving tocilizumab for the treatment
of rheumatoid arthritis who do not meet these criteria
should have the option to continue treatment until they
and their clinicians consider it appropriate to stop.
www.nice.org.uk/guidance/ta247
▶Tocilizumab for treating giant cell arteritis (April 2018)
NICE TA518
Tocilizumab (RoActemra ®), when used with a tapering
course of glucocorticoids (and when used alone after
glucocorticoids), is recommended as an option for treating
giant cell arteritis in adults, only if:
. they have relapsing or refractory disease,
. they have not already had tocilizumab,
. tocilizumab is stopped after 1 year of uninterrupted
treatment at most, and
. the manufacturer provides it with the discount agreed in
the patient access scheme.
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/ta518
Scottish Medicines Consortium (SMC) decisions
SMC No. SMC2014
The Scottish Medicines Consortium has advised (September
2018) that tocilizumab (RoActemra ®) is accepted for
restricted use within NHS Scotland for the treatment of
giant cell arteritis in adults, subject to a 12-month clinical
stopping rule. 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 1185, 1186
