Warning

ADALIMUMAB (ADA)

Administration: Subcutaneous injection

Dose: 40mg subcutaneously once fortnightly

Time to response: 2 weeks to 3 months

Indications:

  • Rheumatoid Arthritis.
  • Psoriatic Arthritis.
  • Ankylosing Spondylitis.
  • Non-Radiographic Spondyloarthropathies.
  • Juvenile Idiopathic Arthritis.

Contraindications:

  • Pregnancy & breast feeding.
  • Active infection.
  • Active/untreated latent TB.
  • Septic arthritis in last 12 months.
  • Clear history of demyelinating disease.
  • Malignancy excluding basal cell carcinoma and that diagnosed and treated more than 10yrs previously.

Cautions:

  • Previous HBV or HCV.
  • Pulmonary fibrosis.
  • NYHA class III/IV heart failure.
  • Patients who have received previous PUVA or UVB therapy should be discussed with dermatology.

Monitoring:

  • FBC, U&E, LFT every 3-6 months

Vaccinations:

  • Avoid live attenuated vaccines.
  • Offer annual influenza vaccination.
  • In those who are biologic naïve pneumococcal vaccination and Sars-Cov-2 vaccination should ideally be performed at least 2 weeks before commencing biologic treatment.
  • Assuming no contraindications before starting treatment:
    • Patients >50 should undergo vaccination against HZV.
    • Those who are varicella zoster negative should be offered varicella vaccination.

In the event of:

  • Injection site reaction – usually settles without further intervention.
  • Sore throat/fever/bruising/pallor – stop ADALIMUMAB and check FBC.
  • Serious infection – stop ADALIMUMAB and restart once infection resolved.
  • Surgery – stop 1 week prior to surgery and resume after wound healing.
  • SLE syndrome – stop ADALIMUMAB and contact rheumatology.
  • Increasing dyspnoea – stop ADALIMUMAB and arrange CXR.

Stop ADALIMUMAB if:

  • WBC < 3.5 x109/L
  • ALT/AST > two times normal
  • Neutrophils < 2.0 x 109/l
  • Platelets < 150 x 109/l

CERTOLIZUMAB

Administration: Subcutaneous injection

Dose: 400mg at weeks 0,2 & 4 and 200mg once fortnightly as a maintenance dose

Time to response: 2 weeks to 3 months

Indications:

  • Rheumatoid Arthritis.
  • Psoriatic Arthritis.
  • Ankylosing Spondylitis.
  • Non-Radiographic Spondyloarthropathies.

Contraindications:

  • Active infection.
  • Active/untreated latent TB.
  • Septic arthritis in last 12 months.
  • Clear history of demyelinating disease.
  • Malignancy excluding basal cell carcinoma and that diagnosed and treated more than 10yrs previously.

Cautions:

  • Previous HBV or HCV.
  • Pulmonary fibrosis.
  • NYHA class III/IV heart failure.
  • Patients who have received previous PUVA or UVB therapy should be discussed with dermatology.

Monitoring:

  • FBC, U&E, LFT every 3-6 months

Vaccinations:

  • Avoid live attenuated vaccines.
  • Offer annual influenza vaccination.
  • In those who are biologic naïve pneumococcal vaccination and Sars- Cov-2 vaccination should ideally be performed at least 2 weeks before commencing biologic treatment.
  • Assuming no contraindications before starting treatment:
    • Patients >50 should undergo vaccination against HZV.
    • Those who are varicella zoster negative should be offered varicella vaccination.

In the event of:

  • Injection site reaction – usually settles without further intervention.
  • Sore throat/fever/bruising pallor – stop CERTOLIZUMAB and check FBC.
  • Serious infection – stop CERTOLIZUMAB and restart once infection resolved.
  • Surgery – stop 1 week prior to surgery and resume after wound healing.
  • SLE syndrome – stop CERTOLIZUMAB and contact rheumatology.
  • Increasing dyspnoea – stop CERTOLIZUMAB and arrange CXR.
  • Pregnancy – the drug can be continued throughout pregnancy.

Stop CERTOLIZUMAB if:

  • WBC < 3.5 x109/L
  • ALT/AST > two times normal
  • Neutrophils < 2.0 x 109/l
  • Platelets < 150 x 109/l

ETANERCEPT (ETAN)

Administration: Subcutaneous injection

Dose: 50mg once weekly

Time to response: 2 weeks to 3 months

Indications:

  • Rheumatoid Arthritis.
  • Psoriatic Arthritis.
  • Ankylosing Spondylitis.
  • Non-Radiographic Spondyloarthropathies.
  • Juvenile Idiopathic Arthritis.

Contraindications:

  • Active infection.
  • Active/untreated latent TB.
  • Septic arthritis in last 12 months.
  • Clear history of demyelinating disease.
  • Malignancy excluding basal cell carcinoma and that diagnosed and treated more than 10yrs previously.

Cautions:

  • Previous HBV or HCV.
  • Pulmonary fibrosis.
  • NYHA class III/IV heart failure.
  • Patients who have received previous PUVA or UVB therapy should be discussed with dermatology.

Monitoring:

  • FBC, U&E, LFTs every 3-6 months

Vaccinations:

  • Avoid live attenuated vaccines.
  • Offer annual influenza vaccination.
  • In those who are biologic naïve pneumococcal vaccination and Sars-Cov-2 vaccination should ideally be performed at least 2 weeks before commencing biologic treatment.
  • Assuming no contraindications before starting treatment:
    • Patients >50 should undergo vaccination against HZV.
    • Those who are varicella zoster negative should be offered varicella vaccination.

In the event of:

  • Injection site reaction – usually settles without further intervention.
  • Sore throat/fever/bruising/pallor – stop drug and check FBC.
  • Serious infection – stop ETANERCEPT and restart once infection resolved.
  • Surgery – stop 1 week prior to surgery and resume after wound healing.
  • SLE syndrome – stop drug and contact rheumatology.
  • Increasing dyspnoea – stop drug and arrange CXR.
  • Pregnancy – can be used during first 6 months.
  • Breastfeeding – there is no evidence that it is harmful.

Stop ETANERCEPT if:

  • WBC < 3.5 x109/L
  • ALT/AST > two times normal
  • Neutrophils < 2.0 x 109/l
  • Platelets <150 x 109

GOLIMUMAB

Administration: Subcutaneous injection

Dose: 50mg subcutaneously once monthly

Time to response: 2 weeks to 3 months

Indications:

  • Rheumatoid Arthritis.
  • Psoriatic Arthritis.
  • Ankylosing Spondylitis.
  • Non-Radiographic Spondyloarthropathies.

Contraindications:

  • Active infection.
  • Active/untreated latent TB.
  • Septic arthritis in last 12 months.
  • Clear history of demyelinating disease.
  • Malignancy excluding basal cell carcinoma and that diagnosed and treated more than 10yrs previously.

Monitoring:

  • FBC, U&E, LFTs every 3-6 months

Vaccinations:

  • Avoid live attenuated vaccines.
  • Offer annual influenza vaccination.
  • In those who are biologic naïve pneumococcal vaccination and Sars-Cov-2 vaccination should ideally be performed at least 2 weeks before commencing biologic treatment.
  • Assuming no contraindications before starting treatment:
    • Patients >50 should undergo vaccination against HZV.
    • Those who are varicella zoster negative should be offered varicella vaccination.

In the event of:

  • Injection site reaction – usually settles without further intervention.
  • Sore throat/fever/bruising/pallor – stop GOLIMUMAB and check FBC.
  • Serious infection – stop drug and restart once infection resolved.
  • Surgery – stop 1 week prior to surgery and resume after wound healing.
  • SLE syndrome – stop drug and contact rheumatology.
  • Increasing dyspnoea – stop drug and arrange CXR.
  • Pregnancy – can be taken during first 3 months.
  • Breastfeeding – can be used with caution.

Stop GOLIMUMAB if:

  • WBC < 3.5 x109/L
  • ALT/AST > two times normal
  • Neutrophils < 2.0 x 109/l
  • Platelets <150 x 109/l

INFLIXIMAB (INF)

Administration: Intravenous infusion

Dose:

  • Usually 3mg/kg given at weeks 0,2 & 6 and then once every 8 weeks.
  • In selected cases 5mg/kg may be given.

Time to response: 2 weeks to 3 months

Indications:

  • Rheumatoid Arthritis.
  • Psoriatic Arthritis.
  • Ankylosing Spondylitis.
  • Non-Radiographic Spondyloarthropathies.

Contraindications:

  • Active infection.
  • Active/untreated latent TB.
  • Septic arthritis in last 12 months.
  • NYHA class III/IV heart failure.
  • Clear history of demyelinating disease.
  • Malignancy excluding basal cell carcinoma and that diagnosed and treated more than 10yrs previously.

Cautions:

  • Previous HBV or HCV.
  • Pulmonary fibrosis.

Monitoring: Will be performed on the medical day bed unit prior to infusion.

Vaccinations:

  • Avoid live attenuated vaccines.
  • Offer annual influenza vaccination.
  • In those who are biologic naïve pneumococcal vaccination and Sars-Cov-2 vaccination should ideally be performed at least 2 weeks before commencing biologic treatment.
  • Assuming no contraindications before starting treatment:
    • Patients >50 should undergo vaccination against HZV.
    • Those who are varicella zoster negative should be offered varicella vaccination.

In the event of:

  • Infusion reaction – affects 10% of patients usually consisting of nausea, headache or rash. This will be managed on the day unit.
  • Sore throat/fever/bruising/pallor – check FBC.
  • Serious infection – stop INFLIXIMAB and restart once infection resolved.
  • Surgery – stop 4 weeks prior to surgery and resume after wound healing.
  • SLE syndrome – contact rheumatology.
  • Increasing dyspnoea – arrange CXR.
  • Pregnancy – may be used during first 4 months of pregnancy.
  • Breastfeeding – may be used with caution.

Stop INFLIXIMAB if:

  • WBC < 3.5 x109/L
  • ALT/AST > two times normal
  • Neutrophils < 2.0 x 109/l
  • Platelets <150 x 109/l

Editorial Information

Last reviewed: 16/11/2021

Next review date: 16/11/2024

Author(s): Dr Karen Donaldson (lead author), Dr Elizabeth Murphy, Professor Robin Munro, Dr Sanjiv Nandwani, Dr Saira Batool, Dr Georgiana Young, (other contributors to documents included in guideline).

Version: V1

Approved By: Dr Karen Donaldson Rheumatology Clinical Lead; Rheumatology Consultants

Reviewer name(s): Karen Donaldson.