16 September 2020
Updated 15 April 2021
What's new?
NICE states that patients with relapsing or refractory GCA can receive tocilizumab for up to one year, providing they have not previously received this therapy. However, there are potential risks to patients from stopping tocilizumab during the pandemic, related to a reduced ability to regularly assess for relapse and risks of restarting high dose steroid if this occurs.
This concern led to a proposal from the GIRFT rheumatology workstream, the MRC TARGET Partnership and the Specialised Rheumatology CRG Chair, who led discussions with NHS England to mitigate these risks. As a result, tocilizumab treatment in England can now be extended until 30 June 2021 for the subgroup of GCA patients considered to be at a high risk of relapse.
Extensions can now be sought for patients who received their tocilizumab treatment for large vessel vasculitis, critical ischaemia, or if they had a flare during months 6-12 of treatment, which has subsequently come under control. Approval for a treatment extension has to be ratified at the (virtual) regional MDT meeting and a new Blueteq form has to be completed. Please provide as much outcome data as possible on this form.
In partnership with NHS England, the MRC TARGET Partnership seek to capture a minimum dataset through the new Blueteq form, detailing response to tocilizumab over the first 12 months of treatment. The aim is to capture evidence to show if tocilizumab is steroid-sparing in routine clinical practice, and to capture data on the frequency of major relapses defined by the requirement for significant escalations in glucocorticoid dose over the first 12 months of treatment.
What is the UK GCA Consortium Tocilizumab Registry?
It's a national registry that aims to understand the epidemiology and pathogenesis of GCA and long-term disease outcomes. Supported by a Medical Research Council (MRC) award, a National GCA Partnership called TARGET (Treatment According to Response in Giant cEll arTeritis) has been established.
What is its role?
The UK GCA Consortium and MRC TARGET Partnership have worked closely with NHS England and NHS Improvement prior to, and during, the COVID-19 pandemic to establish a national GCA registry designed to capture a minimal dataset on the effectiveness of tocilizumab in controlling refractory or relapsing GCA. It aims to capture significant real-life UK clinical outcome data in time for NICE’s scheduled review of the current tocilizumab guidelines in 2021.
The UK GCA Tocilizumab Registry will follow patient outcomes during or within 6 months of stopping tocilizumab. The registry will provide real world data to assess the impact of applying the current guidelines and may highlight areas of need requiring a review of the current technology appraisal.
Who should be recruited?
The UK GCA Consortium aspires to formally recruit the majority of patients with GCA who have been treated with tocilizumab in the UK in order to ensure that maximal real-world data are available, through data linkage, to guide future treatment strategies. We encourage all NHS sites in England, Wales, Northern Ireland and Scotland who prescribe tocilizumab for GCA to participate.
In light of the COVID-19 pandemic, the UK GCA Tocilizumab Registry has been redesigned to reduce the burden on sites by capturing a smaller dataset. Patients can be recruited retrospectively and by telephone or video consultation in order to avoid unnecessary face to face consultations. Vasculitis UK has generously supported the formation of a Biobank focusing on risk of relapse following cessation of therapy. Importantly, sample collection can be undertaken remotely alongside routine monitoring blood tests.
Why is it important?
NICE may review the technology appraisal evaluating tocilizumab for GCA three years after the initial publication. Therefore, it is important that as many patients as possible are included in the Registry to maximise the data collected in this short time. Having real-world data available, through data linkage, will allow a wider health economic assessment of the impact of the current guidelines, expanding on the initial assessment by NICE. This is important because current funding arrangements do not permit clinicians to start prescribing tocilizumab again if relapse occurs.
How can I find out more?
The success of the Registry depends on all sites enrolling their patients who have currently or previously received tocilizumab for GCA and supporting a national biobank. The setup process is quick and there is no minimum recruitment target or requirement for samples to be processed at the local site.
Further details are available from MRCTarget@leeds.ac.uk or by calling 0113 343 7764. Establishment of the Registry was supported by Roche Products Ltd., and is currently funded by the Medical Research Council. VasculitisUK is generously funding an associated Biobank.