North East and North Cumbria
ICS Formulary
 
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10 Musculoskeletal and joint diseases
10-01-03 Cytokine modulators

Abatacept Orencia®
Formulary
  • Abatacept 250mg injection is approved for:
    • Juvenile idiopathic arthritis in patients aged six years and above (licensed) and under six years. It should only be prescribed with informed consent.
    • People aged 6 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose diease has responded inadequately to other DMARDs, including at least one tumour necrosis factor (TNF) inhibitor in accordance with NICE.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
    • Treatment of severe treatment-resistant morphoea in line with NHS England Clinical Commissioning Policy
    • Treating modertae rheumatoid arthritis after conventional DMARDs have failed in line with NICE
    • Treating idiopathic inflammatory myopathies in adults and children aged 2 and over in line with NHS England Commissioning Policy
  • Abatacept 125mg SC injection (prefilled syringe) is approved for moderate to severe rheumatoid arthritis in accordance with NICE.
Link  Clinical Commissioning Policy (210505P) Statement: Abatacept for treatment of severe treatment-resistant morphoea (localised scleroderma)
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Adalimumab
Formulary
  • Adalimumab is approved for:
    • The treatment of adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE 
    • Rheumatoid arthritis after the failure of a TNF inhibitor in accordance with NICE.
    • Treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • As a second-line anti-TNF therapy in children with juvenile idiopathic arthritis and uveitis.
    • Children and adults aged 2 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose disease has responded inadequately to 1 or more DMARD in accordance with NICE.
    • Treating moderate rheumatoid arhritis after conventional DMARDs have failed in line with NICE

 

Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
Link  NICE TA199: Psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Anakinra Kineret®
Formulary
  • Approved for:
    • Juvenile Idiopathic Arthritis (JIA) in line with NICE and NHS England Clinical Commissioning Policy: E03/P/d
    • Periodic Fevers and Autoinflammatory conditions in line with NHS England Clinical Commissioning Policy: 170062P
    • Adult‑onset Still’s disease and systemic juvenile idiopathic arthritis in people 8 months and older in line with NICE
    • Cryopyrin Associated Periodic Syndrome in line with NHSE Service Specification
    • The treatment of severe gout in patients who have not responded to other treatment and for patients with pseudogout who have failed to respond to conventional treatment or unable to tolerate conventional treatment.
    • Chronic Infantile Neurocutaneous Arthritis (CINCA) and Muckle-Wells Syndrome (unlicensedunlicensed indications).
    • Islet cell transplantation as part of a protocol including alemtuzumab and etanercept to improve outcomes (i.e. insulin dependance)
    • Haemophagocytic Lymphohistiocytosis (HLH) for adults and children in all ages

 

Link  NICE TA685: Anakinra for treating Still’s disease

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Apremilast Otezla®
Formulary
  • Approved for the treatment of psoriatic arthritis in line with NICE
Link  MHRA Drug Safety Update (Jan 2017): Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
Link  NICE TA433: Apremilast for treating active psoriatic arthritis

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Belimumab Benlysta®
Formulary

  • Approved for treating active autoantibody-positive systemic lupus erythematosus in line with NICE

Link  MHRA Drug Safety Update (April 2019): Belimumab (Benlysta▼): increased risk of serious psychiatric events seen in clinical trials
Link  NICE TA752: Belimumab for treating active autoantibody-positive systemic lupus erythematosus

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Bimekizumab  Bimzelx®
Formulary
  • 160mg/1ml solution for injection - pre-filled pen and syringes
  • Approved for the treatment of active psoriatic arthritis in line with NICE
  • Approved fofr the treatment of axial spondyloartritis in line with NICE



Link  NICE TA916: Bimekizumab for treating active psoriatic arthritis
Link  NICE TA918: Bimekizumab for treating axial spondyloarthritis

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Certolizumab Pegol Cimzia®
Formulary
  • Approved for:
    • Adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
    • Rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor in accordance with NICE.
    • Severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Psoriatic arthritis in accordance with NICE.

Link  NICE TA 415 - Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis

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Etanercept
Formulary

Prescribe by brand name.

  • Approved formulations include 10mg (Enbrel®) 25mg injection (Enbrel®, Benepali® & Erelzi®), 50mg injection (Enbrel®, Benepali® & Erelzi®). 
  • Approved for:
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in line with NICE.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • Treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • The treatment of juvenile idiopathic arthritis (JIA) in people 2 years or older whose disease has responded inadequately to, or who are intolerant of methotrexate in line with NICE.
    • Treatment of Juvenile Scleroderma (Its use will be subject to informed consent and specialists using etanercept in this indication should collect data on patient outcomes. If after a six month trial, treatment were found to be beneficial, it would be continued for two years. If unsuccessful after six months, treatment should be discontinued).
    • People aged 2 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose diease has responded inadequately to, or who are intolerant of methotrexate in line with NICE.
    • Treating moderate rheumatoid arthritis after conventional DMARDs have failed in line with NICE


Link  NICE TA35: Adult psoriasis
Link  NICE TA195: Rheumatoid arthritis after the failure of a TNF inhibitor
Link  NICE TA199: Psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for JIA
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Golimumab Simponi®
Formulary
  • Approved for:
    • Rheumatoid arthritis in accordance with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • The treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
    • The treatment of non-radiographic axial spondyloarthritis in accordance with NICE

 

Link  NICE TA220: psoriatic arthritis
Link  NICE TA497: Golimumab for treating non-radiographic axial spondyloarthritis
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis

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Guselkumab  Tremfya
Formulary
  • 100 mg/1 mL as a pre-filled syringe
  • Approved (alone or with methotrexate) for treating active psoriatic arthritis after inadequate response to DMARDs in line with NICE

Overview | Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs | Guidance | NICE

Link  NICE TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs

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Infliximab Remsima®, Inflectra®, Remicade®
Formulary
  • Approved for:
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs have failed in accordance with NICE.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Psoriatic arthritis in accordance with NICE.
    • JIA in patients who have not responded to etanercept.
    • Juvenile dermatomyositis and paediatric onset Behcet’s disease where there has been intolerance or lack of response to 1st and 2nd line therapies.
    • The treatment of severe active ankylosing spondylitis in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs in accordance with NICE.
    • Treating moderate rheumatoid arthritis after conventional DMARDs have failed in line with NICE
    • Refractory sarcoidosis (excluding neurosarcoidosis) in adults in line with NHSE Specialised Commissioing Policy 


  • Prescribe by brand name; Remsima®, Inflectra®, Remicade®. 

 

Link  NHSE Specialised Commissioning Policy: Infliximab for refractory sarcoidosis (excluding neurosarcoidosis) (adults)
Link  NICE TA195: Rheumatoid arthritis (after failure of a TNF inhibitor)
Link  NICE TA199: Psoriatic arthritis
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
Link  NICE TA715: Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed

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Ixekizumab Taltz®
Formulary
  • 80mg/ml pre-filled syringe or pen
  • Approved for the treatment of axial spondyloarthritis in line with NICE
  • Approved for the treatment of active psoriatic arthritis after inadequate response to DMARDS

Link  NICE TA537: Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA718: Ixekizumab for treating axial spondyloarthritis

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Rituximab
Formulary
  • Approved for:
    • Adults with severe systemic lupus erythematosus who have failed conventional therapies.
    • Rheumatoid arthritis after the failure of a TNF inhibitor in line with NICE.
    • Combination with methotrexate as first-line biological therapy in cases where there is an absolute contraindication to tumour necrosis factor inhibitors (NETAG approval).
    • Combination with other (non-methotrexate) disease modifying antirheumatic drugs and as monotherapy in cases in which conventional treatment with tumour necrosis factor inhibitors or methotrexate is deemed unsafe (NETAG approval).
    • For immunoglobulin G4-related disease (IgG4-RD) in accordance with NHS England Commissioning Criteria
    • Myositis in accordance with NHS England Commissioning Criteria
    • Juvenile Idiopathic Arthritis (JIA) in accordance with NHS England Commissioning Criteria

 

Link  NHS England Commissioning Policies (Specialised Rheumatology)
Link  NICE TA195: Rheumatoid arthritis - after failure of a TNF inhibitor
Link  NTAG - Treatment Appraisal Decision Summary - Rituximab Biosimilars
Link  MHRA Drug Safety Update (Dec 2013): Rituximab: screen for hepatitis B virus before treatment.
Link  MHRA Drug Safety Update (Dec 2014): Rituximab: progressive multifocal leukoencephalopathy in a patient

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Sarilumab  Kevzara®
Formulary

  • 150mg/1.14mL & 200mg/1.14mL injection

  • Approved as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs) in line with NICE

Link  NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis

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Secukinumab Cosentyx®
Formulary
  • Approved for active ankylosing spondylitis in line with NICE.
  • Approved for psoriatic arthritis in line with NICE.
  • Approved for the treatment of non-radiographic axial spondyloarthritis in line with NICE
Link  NICE TA407: Secukinumab for active ankylosing spondylitis after treatment with non-steroidal anti-inflammatory drugs or TNF-alpha inhibitors
Link  NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA719: Secukinumab for treating non-radiographic axial spondyloarthritis

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Tocilizumab RoActemra®
Formulary
  • IV preparations approved for:
    • Systemic JIA in children and young people aged 2 years and older in line with NICE.
    • People aged 2 years and older to treat polyarticular juvenile idiopathic arthritis (JIA) whose diease has responded inadequately to previous therapy with methotrexate in line with NICE.
    • An alternative treatment to anakinra for patients with systemic onset JIA who have already received treatment with etanercept and adalimumab (NETAG approval). Not recommended for polyarticular JIA.
    • Rheumatoid arthritis in accordance with NICE.
    • Treatment in adults with severe rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed in accordance with NICE.
  • 162mg SC injection is approved for:
    • Rheumatoid arthritis in accordance with NICE.
    • 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.
  • Monitoring: monitoring of tocilizumab in adult patients can be undertaken by GPs under a shared care arrangement Amber

 

Link  MHRA Drug Safety Update (July 2019): Tocilizumab (RoActemra): rare risk of serious liver injury including cases requiring transplantation
Link  NICE TA247: Tocilizumab for the treatment of rheumatoid arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA518: Tocilizumab for treating giant cell arteritis
Link  North of Tyne, Gateshead and North Cumbria - Tocilizumab monitoring Shared Care Guideline 2023

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Upadacitinib Rinvoq®
Formulary
  • Approved for the treatment of severe active rheumatoid arthritis in adults in line with NICE.
  • Approved for the treatment of moderate rheumatoid arthritis in line with NICE.
  • Approved for the treatment of active psoriatic arthritis after inadeqaute response to DMARDs in line with NICE.



Link  MHRA Drug Safety Update (April 2023): Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
Link  NICE TA665: Upadacitinib for treating severe rheumatoid arthritis
Link  NICE TA744: Upadacitinib for treating moderate rheumatoid arthritis
Link  NICE TA768: Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
Link  NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis
Link  NICE TA829: Upadacitinib for treating active ankylosing spondylitis
Link  NICE TA861: Upadacitinib for treating active non-radiographic axial spondyloarthritis

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Ustekinumab Stelara®
Formulary
  • Approved for psoriatic arthritis in accordance with NICE.
Link  MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis
Link  NICE TA340: Ustekinumab for treating active psoriatic arthritis (Updated March 2017)

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