Axial Spondyloarthritis (SpA): Biologic Guideline

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A guideline is intended to assist healthcare professionals in the choice of disease-specific treatments.

Clinical judgement should be exercised on the applicability of any guideline, influenced by individual patient characteristics. Clinicians should be mindful of the potential for harmful polypharmacy and increased susceptibility to adverse drug reactions in patients with multiple morbidities or frailty.

If, after discussion with the patient or carer, there are good reasons for not following a guideline, it is good practice to record these and communicate them to others involved in the care of the patient.

Eligibility

The British Society for Rheumatology (BSR) has established eligibility criteria for the use of biologic medicines in SpA. This is the standard used in GGC and is outlined in figure 1 below:

Fig.1 Treatment algorithm for biologic therapy in axSpA

BMO: bone marrow oedema; VAS: visual analogue scale

From: BSR and BHPR guideline for the treatment of axial spondyloarthritis (including ankylosing spondylitis) with biologics. Rheumatology (Oxford). 2016;56(2):313-316. doi:10.1093/rheumatology/kew223 
Rheumatology (Oxford) | © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: [email protected]

Choice of Therapy

Two mechanisms of action are available as outline in table 1.

 

TNF blockade

IL-17A Blockade
Most cost-effective agent Amgevita - Adalimumab* Secukinumab
Alternatives Etanercept*  
  Infliximab IV*  
  Golimumab  
  Certolizumab  
  Infliximab s/c*  

*Biosimilar agents are licensed for these originator products.

Both TNF Blockade & IL-17A Blockade are appropriate initiation therapy

Where no clinical requirement for a specific TNF blocker exists, the most cost-effective subcutaneous agent (originator or biosimilar) should be used. Currently adalimumab is the most cost effective TNFi and should be used in preference to other biologic agents unless specific clinical considerations require a specific TNFi or medicine with a different mechanism of action.

Confidential drug costs are emailed to all biologic prescribers on a 6 monthly basis from GGC public health pharmacy.

BSR: Assessing Response

  1. Initial efficacy response should be assessed following 3–6 months of therapy and responders should then be reassessed every 6 months
  2. Response is defined as a reduction in the BASDAI and spinal pain VAS of ⩾2 U from baseline
  3. If, because of cognitive or communication difficulties, the BASDAI cannot be used to monitor disease activity, the decision to initiate and continue therapy should be
    based on the treating clinician’s assessment of disease activity

BSR: Withdrawal of Therapy

  1. In the absence of an initial clinical response by 6 months, or failure to maintain response at two consecutive assessments, withdrawal should be considered
  2. There is no evidence to support the withdrawal (of anti-TNF therapy) in treatment responders

Off-label dosing and drug monitoring

  1. A decision to prescribe a biologic drug for an approved condition but using doses that are ‘off label’ e.g. tapering, is a decision for the rheumatologist and patient.
  2. Increasing the interval of dosing or dose reduction at same frequency could be considered when:
    1. patients have maintained remission/LDA for a sustained period
    2. Infection concerns have developed
    3. Tolerability/patient request
  3. Use of biologic drug level monitoring (for infliximab and adalimumab) could be considered when adjusting dose, or where secondary failure has occurred to inform choice of subsequent therapy. Advice can be found at: https://www.nhsggc.org.uk/about-us/professional-support-sites/laboratory-medicine/laboratory-disciplines/biochemistry/biological-therapy-monitoring/
  4. All bDMARDS and tsDMARDS are not included in near patient testing arrangements. Responsibility for any blood monitoring remains with the prescriber.

Last reviewed: 30 November 2020

Next review: 30 November 2022

Author(s): Martin Perry

Version: 3

Author Email(s): [email protected]

Approved By: Medicines Utilisation Subcommittee of ADTC

Document Id: 653