Ocular morbidity associated with Giant Cell Arteritis and Polymyalgia Rheumatica: a controlled cohort study using the UK Clinical Practice Research Datalink

Study type
Protocol
Date of Approval
Study reference ID
16_259
Lay Summary

Visual loss is one of the most serious potential consequences of a diagnosis of polymyalgia rheumatic (PMR) and giant cell arteritis (GCA). While glucocorticoids ('steroids') are commonly used to reduce the risk to the eyes, this treatment itself carries a risk of cataract and glaucoma. To date little is known about who is at most risk of eye complications in these diseases and how drugs might best be used. In this study, we will aim to establish whether the use of commonly prescribed medications are associated with a reduced risk for eye disease in patients with GCA and or PMR. We will compare the rates of development of eye disease in GCA and or PMR patients with exposure to these drugs to those without exposure. We will examine the background rate of eye disease in subjects with and without exposure in an age matched healthy population who have no evidence of GCA and or PMR. In addition the risk benefit of glucocorticoid (GC) treatment strategies will be investigated to rationalise approaches to treatment.

Technical Summary

The objective is to document the rate of ocular morbidity attributable to a diagnosis of polymyalgia rheumatica (PMR) and or giant cell arteritis (GCA) in a longitudinal community setting, including blindness, anterior ischaemic optic neuropathy (AION), optic atrophy, cataract, and glaucoma. It is anticipated that around 10% patients with PMR will develop GCA during follow up (analysis of the data will allow us to clarify this figure).

These will be analysed as a separate groups: PMR alone, GCA alone and those with PMR who develop GCA (termed PMR/GCA).

This will follow two stages:
Stage 1 (analysis of cases and controls):
a) We will examine the absolute rate of ocular morbidity in cases and controls
b) Using survival methodology risk factors that influence the rate of ocular morbidity relative to the comparison cohorts will be explored.
c) Examine the influence of aspirin, statins, beta blockers and ACE inhibitors on ocular morbidity both prior to and after the diagnosis date, treating these exposures as time dependent covariates.
Stage 2 will be confined to those in the disease cohort. In this analysis we will examine the relationship between the use of different glucocorticoid (GC) regimens and ocular morbidity using survival analysis.

Health Outcomes to be Measured

Blindness AION Optic atrophy Cataract surgery Glaucoma Death

Collaborators

Alexander MacGregor - Chief Investigator - University of East Anglia
Max Yates - Corresponding Applicant - University of East Anglia
Allan Clark - Collaborator - University of East Anglia
Richard A Watts - Collaborator - Ipswich Hospital NHS Trust

Linkages

HES Admitted Patient Care;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Townsend Score;Practice Level Index of Multiple Deprivation