Cytokine modulators (Formulary)

ADALIMUMAB

Important: Therapy notes

Amgevita brand first-line
Humira second-line.

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

See NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people.
See NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed.
See NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe (Amgevita) 20mg/0·4mL, 40mg/0·8mL (hospital use only)

Dosage:

Refer to Department of Rheumatology GP information leaflet for adalimumab.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe (Humira) 40mg/0·4mL (hospital use only)

Dosage:

Refer to Department of Rheumatology GP information leaflet for adalimumab.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled pen (Amgevita) 40mg/0·8mL (hospital use only)

Dosage:

Refer to Department of Rheumatology GP information leaflet for adalimumab.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled pen (Humira) 40mg/0·4mL (hospital use only)

Dosage:

Refer to Department of Rheumatology GP information leaflet for adalimumab.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

BARICITINIB

Important: Therapy notes

MHRA advice: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality (April 2023) (www.gov.uk).
MHRA advice: Baricitinib (Olumiant) - risk of venous thromboembolism (March 2020) (www.gov.uk).
MHRA advice: Baricitinib (Olumiant): increased risk of diverticulitis, particularly in patients with risk factors (August 2020) (www.gov.uk).

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Tablets (Olumiant^®) 2mg, 4mg

Dosage:

As per SMC 1265/17: treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate.
SMC restriction: In patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs. In patients with severe disease inadequately controlled by a TNF antagonist, it may be used in patients ineligible to receive rituximab.

Refer to Department of Rheumatology GP information leaflet for baricitinib.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

BIMEKIZUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe and pre-filled pen (Restricted: hospital use only)

Dosage:

Indication:

SMC2605: Alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
SMC restriction: use in patients with active psoriatic arthritis who have not responded adequately to two conventional DMARDs, given either alone or in combination.

Place in therapy:

For those with psoriatic arthritis for whom anti-TNF is not appropriate. Secukinumab 150mg weekly, if poor response escalate to 300mg or alternatively switch to bimekizumab.

Notes:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

CERTOLIZUMAB PEGOL

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe 200mg/mL (s)

Dosage:

See NICE:

TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people.
TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed.
TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

ETANERCEPT

Important: Therapy notes

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

See NICE:

TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people.
TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed.
TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Important: Formulation and dosage details

Formulation:

Solution for injection (Enbrel^®) 25mg vial (s)

Dosage:

Prescribe etanercept by brand name.
Refer to Department of Rheumatology GP information leaflet for etanercept.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Pre-filled syringe (Enbrel^®, Benepali^®) 25mg, 50mg (s)

Dosage:

Prescribe etanercept by brand name.
Refer to Department of Rheumatology GP information leaflet for etanercept.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Pre-filled pen (Enbrel^®) 25mg, (Enbrel^®, Benepali^®) 50mg (s)

Dosage:

Prescribe etanercept by brand name.
Refer to Department of Rheumatology GP information leaflet for etanercept.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

FILGOTINIB

Important: Therapy notes

MHRA advice: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality (April 2023) (www.gov.uk).

Risk minimisation materials

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Film-coated tablets 100mg, 200mg (under specialist direction only)

Dosage:

As per SMC 2365: filgotinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX).
SMC restriction: in patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs and in patients with severe disease inadequately controlled by a TNF antagonist in whom rituximab is not appropriate.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

GUSELKUMAB

Important: Therapy notes

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled pen (Tremfya®) 100mg

Dosage:

100mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks.
For patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered.
Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment.

As per SMC 2360: alone or in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
SMC restriction: (i) patients whose disease has not responded adequately or who have been
intolerant to two previous conventional disease-modifying antirheumatic drug (DMARD) therapies but have not received biologic DMARD therapy (biologic-naïve population); (ii) patients whose disease has not responded adequately to conventional DMARDs and one or more tumour necrosis factor (TNF) inhibitors (biologic-experienced population); and (iii) patients in whom TNF inhibitors are contraindicated or not tolerated.

Important: Formulation and dosage details

Formulation:

Solution for injection in pre-filled syringe (Tremfya®) 100mg

Dosage:

100mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks.
For patients at high risk for joint damage according to clinical judgement, a dose of 100 mg every 4 weeks may be considered.
Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment.

As per SMC 2360: alone or in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
SMC restriction: (i) patients whose disease has not responded adequately or who have been
intolerant to two previous conventional disease-modifying antirheumatic drug (DMARD) therapies but have not received biologic DMARD therapy (biologic-naïve population); (ii) patients whose disease has not responded adequately to conventional DMARDs and one or more tumour necrosis factor (TNF) inhibitors (biologic-experienced population); and (iii) patients in whom TNF inhibitors are contraindicated or not tolerated.

Notes:

Guselkumab is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriatic arthritis.
See Summary of Product Characteristics (SPC) for more details.

INFLIXIMAB

Important: Therapy notes

Prescribe infliximab by brand name.

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion (Inflectra®, Remsima®, Zessly®) 100mg (s)

Dosage:

See NICE:

TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed.
TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis.

RITUXIMAB

Important: Therapy notes

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Concentrate for solution for infusion (Truxima^®) 100mg/10mL, 500mg/50mL (s)

Dosage:

Prescribe rituximab by brand name.
Refer to Department of Rheumatology GP Information Leaflet for rituximab.

SARILUMAB

Important: Therapy notes

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe 150mg, 200mg (specialist use only)

Dosage:

Refer to Department of Rheumatology GP information leaflet for sarilumab (Kevzara^®).
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled pen 150mg, 200mg (s)

Dosage:

Refer to Department of Rheumatology GP information leaflet for sarilumab (Kevzara^®).
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

SECUKINUMAB

Important: Therapy notes

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe 150mg (Hospital use only)

Dosage:

As per SMC 1167/16: alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
SMC restriction: Use in patients whose disease has not responded to adequate trials of at least two standard DMARDs either individually or in combination.

and SMC 1159/16: Treatment of active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy.

See also NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people.

Place in therapy for psoriatic arthritis:

For those with psoriatic arthritis for whom anti-TNF is not appropriate. Secukinumab 150mg weekly, if poor response escalate to 300mg or alternatively switch to bimekizumab.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

TOCILIZUMAB

Important: Therapy notes

MHRA advice: Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation (July 2019) (www.gov.uk).

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

See NICE TA375 - Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed.

Important: Formulation and dosage details

Formulation:

Concentrate for solution for intravenous infusion 80mg/4mL, 200mg/10mL, 400mg/20mL (s)

Dosage:

Refer to Department of Rheumatology GP information leaflet for subcutaneous tocilizumab.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe 162mg/0·9mL (s)

Dosage:

Refer to Department of Rheumatology GP information leaflet for subcutaneous tocilizumab.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

TOFACITINIB

Important: Therapy notes

MHRA advice: Tofacitinib (Xeljanz): new measures to minimise risk of major adverse cardiovascular events and malignancies (October 2021) (www.gov.uk).
MHRA advice: Tofacitinib (Xeljanz) - new measures to minimise risk of venous thromboembolism and of serious and fatal infections (March 2020) (www.gov.uk).
MHRA advice: Tofacitinib (Xeljanz) - restriction of 10mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing (May 2019) (www.gov.uk).

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Tablets 5mg (s)

Dosage:

As per SMC 1298/18: In combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Tofacitinib can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
SMC restriction: In patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs. In patients with severe disease inadequately controlled by a tumour necrosis factor (TNF) antagonist, it may be used in patients ineligible to receive rituximab.

Refer to Department of Rheumatology GP information leaflet for tofacitinib (Xeljanz^®).

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Important: Formulation and dosage details

Formulation:

Modified release tablets 11mg (hospital use only)

Dosage:

Once daily alternative.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot

UPADACITINIB

Important: Therapy notes

For NHS Highland Rheumatology Department GP and Patient information click here (NHSH intranet access required)

Important: Formulation and dosage details

Formulation:

Tablet 15mg prolonged release (specialist initiation only)

Dosage:

As per SMC 2361: for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Upadacitinib may be used as monotherapy or in combination with methotrexate.
SMC restriction: for use in patients with psoriatic arthritis whose disease has not responded adequately to at least two conventional DMARDs (cDMARDs), given either alone or in combination.

and 2315: for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.
SMC restriction: in patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs and in patients with severe disease inadequately controlled by a TNF antagonist in whom rituximab is not appropriate.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot