10.1.3 Drugs that suppress the rheumatic disease process

Drugs used not listed here:

Penicillamine
  • Tablets 125mg, 250mg (£88.75 = 250mg 12 hourly)

Indications

  • Severe rheumatoid arthritis

Notes

  1. Refer to individual shared care guidelines for use in Rheumatology conditions
Hydroxychloroquine
  • Tablets 200mg (£3.40 = 200mg 12 hourly)

Indications

  • Treatment of adults with rheumatic disease, in particular systemic lupus erythematosus and rheumatoid arthritis

Notes

  1. Refer to individual shared care guidelines for use in Rheumatology conditions
  2. The Royal College of Ophthalmologists has issued updated guidance for monitoring for hydroxychloroquine retinopathy. The new guidance requires a consultant-led service. The CCG is working towards commissioning a service in Devon and will issue an updated shared care guideline when the service is in place
Leflunomide
  • Tablets 10mg, 20mg (£4.31 = 20mg daily)

Indications

  • Active rheumatoid arthritis
  • Active psoriatic arthritis

Notes

  1. Refer to individual shared care guidelines for use in Rheumatology conditions
Apremilast
  • Tablets 10mg, 20mg, 30mg

Notes

  1. For use in line with NICE TA419 Apremilast recommended for treating moderate to severe plaque psoriasis (November 2016)
  2. For use in line with NICE TA433 Apremilast for treating active psoriatic arthritis
Baricitinib
  • Tablets 2mg, 4mg

Notes

  1. NICE TA466: Baricitinib (Olumiant) is recommended as an option for treating active rheumatoid arthritis in adults (August 2017):
    1. with methotrexate, in those whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only when the criteria of the NICE TA are met
    2. with methotrexate, in those whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only when the criteria of the NICE TA are met
    3. as monotherapy for those who cannot take methotrexate because it is contraindicated or because of intolerance, only when the criteria of the NICE TA are met
    4. continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained
  2. NICE TA681: Baricitinib (Olumiant) is recommended as an option for treating moderate to severe atopic dermatitis in adults (March 2021), only if:
    1. the disease has not responded to at least 1 systemic immunosuppressant, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are not suitable, and
    2. the company provides it according to the commercial arrangement
    3. assess response from 8 weeks and stop baricitinib if there has not been an adequate response at 16 weeks, as defined in the NICE TA
  3. MHRA Drug Safety Update (March 2020): Baricitinib (Olumiant): risk of venous thromboembolism
    1. Use caution if considering baricitinib in patients with additional risk factors for deep vein thrombosis and pulmonary embolism, such as prior medical history of venous thromboembolism, surgery, immobilisation, older age, and obesity
    2. Discontinue baricitinib treatment permanently if clinical features of venous thromboembolism occur
    3. Advise patients undergoing treatment with baricitinib to seek urgent medical attention if they experience a painful swollen leg, chest pain, or shortness of breath
  4. MHRA Drug Safety Update (August 2020): Baricitinib (Olumiant): increased risk of diverticulitis, particularly in patients with risk factors
    1. cases of diverticulitis and gastrointestinal perforation have been reported in patients taking baricitinib
    2. use caution in patients with pre-existing diverticular disease and inpatients on long term concomitant medications associated with an increased risk of diverticulitis such as non-steroidal anti-inflammatory drugs (NSAIDs),corticosteroids, and opioids
    3. advise patients on baricitinib to seek immediate medical care if they experience severe abdominal pain especially accompanied with fever, nausea and vomiting or other symptoms of diverticulitis
    4. ensure prompt evaluation of any patients on baricitinib who present with new-onset abdominal signs and symptoms to identify early diverticulitis or gastrointestinal perforation
Filgotinib
  • Tablets 100mg, 200mg

Notes

  1. NICE TA676: Filgotinib for treating moderate to severe rheumatoid arthritis (February 2021):
    1. Filgotinib (Jyseleca), with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs), only if:
      • disease is moderate or severe (a disease activity score [DAS28] of 3.2 or more) and
      • the company provides filgotinib according to the commercial arrangement
    2. Filgotinib (Jyseleca), with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if:
      • disease is severe (a DAS28 of more than 5.1) and
      • they cannot have rituximab and
      • the company provides filgotinib according to the commercial arrangement
    3. Filgotinib (Jyseleca), with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if:
      • disease is severe (a DAS28 of more than 5.1) and
      • the company provides filgotinib according to the commercial arrangement
    4. Filgotinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria in note 1a, 1b or 1c are met
    5. If more than 1 treatment is suitable, start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose)
    6. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. If this initial response is not maintained at 6 months, stop treatment
    7. When using the DAS28, healthcare professionals should take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any adjustments they consider appropriate
Tofacitinib
  • Tablets 5mg, 10mg

Notes

  1. NICE TA480: Tofacitnib for moderate to severe rheumatoid arthritis (October 2017):
    1. Tofacitnib (Xeljanz), with methotrexate, is recommended 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 anti-rheumatic drugs (DMARDs), only when the criteria of the NICE TA are met
    2. Tofacitinib (Xeljanz), with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot have, other DMARDs, including at least 1 biological DMARD, only when the criteria of the NICE TA are met
    3. Tofacitinib can be used as monotherapy for adults who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria in of the NICE TA are met.
  2. NICE TA543: Tofacitnib (Xeljanz), with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults, only when the criteria of the NICE TA are met (October 2018)
  3. NICE TA547: Tofacitinib (Xeljanz) is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment (November 2018)
  4. MHRA Drug Safety Update (March 2020): Tofacitinib (Xeljanz): new measures to minimise risk of venous thromboembolism and of serious and fatal infections.
    1. Tofacitinib is associated with a dose-dependent increased risk of serious venous thromboembolism
    2. Use caution in any patients with known risk factors for venous thromboembolism in addition to the underlying disease
    3. In patients with ulcerative colitis who have known risk factors for venous thromboembolism in addition to the underlying disease, use of 10mg twice daily tofacitinib for maintenance treatment is not recommended unless no suitable alternative treatment is available
    4. Do not exceed the recommended dose of 5mg twice daily for rheumatoid arthritis or 5mg twice daily for psoriatic arthritis in any patients
    5. Inform patients of the signs and symptoms of venous thromboembolism before they start tofacitinib and advise them to seek prompt medical help if they develop signs such as a painful swollen leg, chest pain, or shortness of breath
    6. Discontinue tofacitinib treatment permanently if signs of venous thromboembolism occur
    7. Patients older than 65 years of age are at an increased risk of serious infections and should be treated with tofacitinib only if there is no alternative treatment
Upadacitinib
  • Modified release tablets 15mg

Notes

  1. NICE TA665: Upadacitinib for treating severe rheumatoid arthritis (December 2020):
    1. Upadacitinib (Rinvoq), with methotrexate, is recommended 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), only if:
      • disease is severe (a disease activity score [DAS28] of more than 5.1) and
      • the company provides upadacitinib according to the commercial arrangement
    2. Upadacitinib (Rinvoq), with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if:
      • disease is severe (a DAS28 of more than 5.1) and
      • they cannot have rituximab and
      • the company provides upadacitinib according to the commercial arrangement
    3. Upadacitinib (Rinvoq), with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if:
      • disease is severe (a DAS28 of more than 5.1) and
      • the company provides upadacitinib according to the commercial arrangement
    4. Upadacitinib can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria of NICE TA665 are met
    5. For all patients treated in line with NICE TA655 above, continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, stop treatment if at least a moderate EULAR response is not maintained
    6. When using the DAS28, healthcare professionals should take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any adjustments they consider appropriate

Cytokine modulators

NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept are recommended for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (January 2016)

NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (February 2016)

Abatacept
  • 250mg vial, powder for reconstitution
  • Injection 125mg pre-filled syringe

Notes

  1. NICE TA195: Adalimumab, etanercept, infliximab, rituximab, and abatacept are recommended for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (August 2010)
  2. NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab are recommended as possible treatments for people with polyarticular juvenile idiopathic arthritis (NHS England Commissioned) (December 2015)
Adalimumab
  • Injection 40mg

Notes

  1. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
  2. NICE TA195: Adalimumab, etanercept, infliximab, rituximab, and abatacept are recommended for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (August 2010)
  3. NICE TA199: Psoriatic arthritis - etanercept, infliximab and adalimumab (August 2010)
  4. NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab are recommended as possible treatments for people with polyarticular juvenile idiopathic arthritis. Adalimumab and etanercept are recommended as possible treatments for people with enthesitis-related juvenile idiopathic arthritis (NHS England Commissioned) (December 2015)
  5. NICE TA392: Adalimumab recommended for treating moderate to severe hidradenitis suppurativa (June 2016) (NHS England commissioned)
  6. NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people (July 2017)
  7. NICE TA460: Adalimumab and dexamethasone for treating non-infectious uveitis (July 2017)
Anakinra
  • Solution for injection pre-filled syringes 100mg in 0.67ml

Notes

  1. NICE TA685: Anakinra (Kineret) is recommended as an option for treating Still's disease with moderate to high disease activity, or continued disease activity after non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids (March 2021). It is only recommended for:
    1. adult-onset Still's disease that has responded inadequately to 2 or more conventional disease‑modifying antirheumatic drugs (DMARDs)
    2. systemic juvenile idiopathic arthritis in people 8 months and older with a body weight of 10 kg or more that has not responded to at least 1 conventional DMARD
Belimumab
  • Powder for solution for infusion 120mg vial, 400mg vial

Notes

  1. NICE TA397: Belimumab (Benlysta) is recommended as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in adults only, only when the criteria of the NICE TA are met (June 2016)
  2. MHRA Drug Safety Update (April 2019): Belimumab (Benlysta): increased risk of serious psychiatric events seen in clinical trials
Certolizumab pegol
  • Prefilled syringe 200mg

Notes

  1. The commissioning of certolizumab is accepted in Devon as an alternative first line biological treatment option to NICE recommended tumour necrosis factor inhibitors for patients with ankylosing spondylitis who have had an inadequate response to NSAIDs. The patient's clinical condition and response to treatment should meet the criteria outlined in NICE TA383 (see Commissioning Policy for more details)
  2. NICE TA415: Certolizumab pegol (Cimzia), in combination with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other disease-modifying antirheumatic drugs (DMARDs) including at least 1 tumour necrosis factor‑alpha (TNF‑alpha) inhibitor, only when the criteria of the NICE TA are met (October 2016)
  3. NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs (May 2017):
    1. Certolizumab pegol (Cimzia) alone, or in combination with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults, only when the criteria of the NICE TA are met
  4. NICE TA574: Certolizumab pegol (Cimzia) is recommended as an option for treating plaque psoriasis in adults, only when the criteria of the NICE TA are met (April 2019)
Etanercept
  • Paediatric injection 10mg vial with solvent
  • 25mg, 50mg vial with solvent
  • 25mg, 50mg prefilled syringe

Notes

  1. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
  2. Once commenced on therapy, etanercept should be brand prescribed to ensure continuity of supply for patients.
  3. NICE TA35: Arthritis (juvenile idiopathic), etanercept (March 2002)
  4. NICE TA195: Adalimumab, etanercept, infliximab, rituximab, and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (August 2010)
  5. NICE TA199: Psoriatic arthritis - etanercept, infliximab and adalimumab (August 2010)
  6. NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab are recommended as possible treatments for people with polyarticular juvenile idiopathic arthritis. Etanercept is recommended as a possible treatment for people with psoriatic juvenile idiopathic arthritis (NHS England Commissioned) (December 2015)
  7. NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people (July 2017)
Golimumab
  • Injection 50mg prefilled pen or prefilled syringe

Notes

  1. NICE TA220: Psoriatic arthritis – golimumab (April 2011)
  2. NICE TA225: Rheumatoid arthritis (after the failure of previous anti-rheumatic drugs) – golimumab (partially updated by TA375) (June 2011)
  3. NICE TA233: Ankylosing spondylitis – golimumab (August 2011)
  4. NICE TA497: Golimumab is recommended for treating severe non-radiographic axial spondyloarthritis (January 2018)
Infliximab
  • 100mg powder for reconstitution for intravenous infusion

Notes

  1. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
  2. Once commenced on therapy, infliximab should be brand prescribed to ensure continuity of supply for patients.
  3. NICE TA195: Adalimumab, etanercept, infliximab, rituximab, and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (August 2010)
  4. NICE TA199: Psoriatic arthritis - etanercept, infliximab and adalimumab (August 2010)
  5. NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262)
Sarilumab
  • Solution for injection 150mg/1.14ml, 200mg/1.14ml

Notes

  1. From 01 February 2021, an interim clinical commissioning policy has been put in place to define routine access to sarilumab for the treatment of COVID-19 across the UK.
    1. Sarilumab is recommended as a treatment option for adults (aged 18 years and over) hospitalised with COVID-19 in accordance with the criteria set out in the interim policy (17 February 2021) (see policy for more details).
    2. Sarilumab is to be delivered as a once-only intravenous infusion. Sarilumab is available as a prefilled syringe (see policy for details).
    3. Information on co-administration with corticosteroids and remdesivir is included in the policy.
    4. Pre-authorised use of sarilumab for individual patients with COVID-19 is required using Bluteq (CEM/CMO/2021/006 alert)
    5. Supplies of sarilumab are not expected until February 2021. Contact the hospital pharmacy department before prescribing to determine availability.
    6. Use of sarilumab by intravenous infusion for the treatment of COVID-19 is off-label. The Royal Devon and Exeter NHS Foundation Trust has given approval for the use of sarilumab by intravenous infusion for Covid-19. Seek advice from the pharmacy department at Northern Devon Healthcare NHS Trust on whether approval has been given for use in Covid-19 before prescribing sarilumab for this indication.
  2. NICE TA485: Sarilumab for moderate to severe rheumatoid arthritis (November 2017)
Tocilizumab
  • Solution for injection pre-filled syringes 180mg in 1ml
  • Concentrate for solution for infusion 20mg in 1ml

Notes

  1. From 01 February 2021, an interim clinical commissioning policy has been put in place to define routine access to tocilizumab for the treatment of COVID-19 across the UK.
    1. Tocilizumab is recommended as a treatment option for adults (aged 18 years and over) hospitalised with COVID-19 in accordance with the criteria set out in the interim policy (17 February 2021) (see policy for details).
    2. Tocilizumab is to be delivered as a once-only intravenous infusion (see policy for details).
    3. Information on co-administration with corticosteroids and remdesivir is included in the policy.
    4. Pre-authorised use of tocilizumab for individual patients with COVID-19 is required using Bluteq (CEM/CMO/2021/006 alert).
    5. Use of tocilizumab by intravenous infusion for the treatment of COVID-19 is off-label. Northern Devon Healthcare NHS Trust and the Royal Devon and Exeter NHS Foundation NHS Trust have given approval for the use of tocilizumab by intravenous infusion for COVID-19.
  2. The commissioning of tocilizumab subcutaneous injection is accepted in Devon as an alternative treatment option to tocilizumab intravenous infusion for the treatment of rheumatoid arthritis where use is in line with NICE guidance for tocilizumab (NICE TA247 and NICE TA375) (see Commissioning Policy for more details)
  3. NICE TA238: Tocilizumab (RoActemra) is recommended for the treatment of systemic juvenile idiopathic arthritis in children and young people aged 2 years and older whose disease has responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids and methotrexate (December 2011)
  4. NICE TA247: Tocilizumab (RoActemra) in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults, only when the criteria of the NICE TA are met (February 2012)
  5. NICE TA373: Abatacept (Orencia), adalimumab (Humira), etanercept (Enbrel) and tocilizumab (RoActemra) are recommended as options for treating polyarticular juvenile idiopathic arthritis (JIA), including polyarticular‑onset, polyarticular‑course and extended oligoarticular JIA (December 2015)
  6. NICE TA375: Adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade, Remsima, Inflectra), certolizumab pegol (Cimzia), golimumab (Simponi), tocilizumab (RoActemra) and abatacept (Orencia), all in combination with methotrexate, are recommended as options for treating rheumatoid arthritis, only when the criteria of the NICE TA are met (January 2016)
  7. 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 when the criteria of the NICE TA are met (April 2018)
  8. MHRA Drug Safety Update (July 2019): rare risk of serious liver injury including cases requiring transplantation
    1. rare but serious cases of drug-induced liver injury, including acute liver failure and hepatitis, have been reported in patients treated with tocilizumab; some cases required liver transplantation
    2. advise patients to seek medical help immediately if they experience signs and symptoms of liver injury, such as tiredness, abdominal pain, and jaundice
    3. monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at initiation, every 4–8 weeks during the first 6 months of treatment, and every 12 weeks thereafter in patients with rheumatological indications
    4. exercise caution when considering treatment initiation in patients with ALT or AST higher than 1.5-times the upper limit of normal (ULN); initiation of treatment is not recommended in patients with ALT or AST higher than 5-times the ULN
    5. if liver enzyme abnormalities are identified, consult the dose modifications recommended, which have not changed
Ustekinumab
  • Solution for injection pre-filled syringes and vials 45mg in 0.5ml
  • Concentrate for solution for infusion vials 130mg in 26ml

Notes

  1. NICE TA180: Ustekinumab (Stelara) is recommended as a treatment option for adults with plaque psoriasis, only when the criteria of the NICE TA are met (September 2009)
  2. NICE TA340: Ustekinumab (Stelara) is recommended as an option, alone or in combination with methotrexate, for treating active psoriatic arthritis in adults, only when the criteria of the NICE TA are met (June 2015)
  3. NICE TA455: Adalimumab (Humira), etanercept (Enbrel) and ustekinumab (Stelara) for treating plaque psoriasis in children and young people (July 2017): Ustekinumab (Stelara) is recommended as an option for treating plaque psoriasis in children and young people aged 12 years or older, only if the disease:
    1. is severe, as defined by a total PASI of 10 or more
    2. has not responded to standard systemic therapy, such as ciclosporin, methotrexate or phototherapy, or these options are contraindicated or not tolerated
  4. NICE TA456: Ustekinumab (Stelara) is recommended, within its marketing authorisation, as an option for treating moderately to severely active Crohn's disease, that is, for adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF‑alpha inhibitor or have medical contraindications to such therapies (July 2017)
  5. NICE TA633: Ustekinumab (Stelara) is recommended as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only when the criteria of the NICE TA are met (June 2020)

 

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