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Tocilizumab and Giant Cell Arteritis

In 2018, the National Institute for Health and Care Excellence (NICE) approved Tocilizumab (TCZ) for the treatment of Giant Cell Arteritis in certain circumstances*. PMRGCAuk were instrumental in supporting this introduction and we will watch closely throughout the one year licensing period to understand the impact for those with GCA.

A recent paper published in the Journal of Rheumatology outlines the criteria under which patients might receive TCZ and the needs for the future.

Giant Cell Arteritis: new concepts, treatments and the unmet need that remains

Our summary:

The article, by a prestigious panel of rheumatologists from England’s leading hospitals and universities, summarises recent exciting advances in the assessment and treatment of Giant Cell Arteritis.  The cue for the article is the recent approval by NICE, the National Institute for Health care excellence, of tocilizumab  (TCZ) – and therefore its approval for use in the NHS.  Approval of new, and particularly costly, medicines by NICE is a complex process, and PMRGCAuk can rightly claim some of the credit for the approval, having vigorously represented the patients’ view at the NICE panel’s consultation.

TCZ is one of the newly introduced ‘biologics’ – specifically it is an antibody interfering with the action of a damaging molecule   -  ‘IL-6’  -  that the body produces in excess in Giant Cell Arteritis.  IL-6 is key to setting up inflammation in the wall of blood vessels.  Notably,  Prof Bhaskar Dasgupta, PMRCAuk’s president, was involved in implicating IL6 for the first time as a major factor in causing inflammation in the condition, and  is the lead author of this article. 

Significantly, NICE has put quite severe restrictions on the circumstances in which  TCZ can be used – most importantly limiting its use to patients  who are refractory – meaning they have not responded to conventional treatment with glucocorticoids (‘steroids’), or who relapsed after taking  them.  Also currently TCZ  can only be prescribed for a year’s duration.  These restrictions prompted the  national effort written up in this article,  which points out the need for defining  precisely what is meant by those terms of  relapsing and refractory disease.  Working to exact definitions, as well as keeping regional and national databases of TCZ usage, will  provide essential  information when in a few years time NICE looks again  at the use of TCZ – and then hopefully may extend the circumstances under which it can be used.

The effectiveness of TCZ in the large clinical trial which showed its effect  in Giant Cell Arteritis was indeed  very encouraging  – though unfortunately not everyone benefitted.  Overall over half the patients treated with TCZ (about 54%) remained in remission  as their steroid treatment was tapered,  whilst only 16% of patients without TCZ remained in remission.   So work remains to be done to conquer the disease.

The wide-ranging article also deals with the most up-to- date techniques for diagnosing GCA, and the design of hospital services to maximise rapid diagnosis.  Confirmation of the diagnosis may now involve either an ultrasound examination, capable of picking up the characteristic thickening of the walls of arteries, or the longer established technique of temporal artery biopsy that many of our members will recall.  The ultrasound scan when available can replace the need for a biopsy, and importantly can also be repeated at intervals to provide  for example firm evidence of relapse after steroid withdrawal.   Further information – including how extensively the arteries of the body are inflamed, can be provided by more complicated (though entirely painless) scans such as Magnetic Resonance Imaging or specialised CT scans (PET-CT).   Fast diagnosis, by the design of Fast-Track pathways for patients to reach the right specialist, with a minimum of delay before treatment is started,  remains  the key to preventing complications.

 

 

* NB Your doctor may decide that TCZ is not suitable for you for specific clinical reasons, unrelated to NICE guidance.

 

 

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