Uptake and effectiveness of the seasonal trivalent influenza vaccine in autoimmune inflammatory rheumatic disease patients receiving corticosteroids and disease modifying anti-rheumatic drugs

Study type
Protocol
Date of Approval
Study reference ID
16_288
Lay Summary

Patients with inflammatory arthritis (e.g. rheumatoid arthritis) on immune suppressing medicines are at increased risk of flu and its complications. Several small studies suggest that they have a weaker immune response and may derive less protection from standard-dose seasonal flu vaccines. The purpose of this study is to examine whether standard-dose seasonal flu vaccine reduces their risk of developing seasonal flu and its complications. We will also examine whether administration of flu vaccine causes a flare of arthritis, whether the proportion of arthritis patients receiving the seasonal flu vaccine has increased over the last 10 years, and if some regions of the UK perform poorly in vaccinating this at-risk population. For this study we will identify arthritis patients on immune suppressing treatments and find out if they have received the flu vaccine yearly between 2006 and 2016. They will be divided into two groups depending on whether they received the flu vaccine. The rates of flu, chest infection, hospital admission for chest problems, and death in the flu season will be compared between the groups. The proportion of patients receiving the seasonal flu vaccine in each year and in different parts of UK will be calculated.

Technical Summary

Objectives: (1) To examine whether vaccination with seasonal trivalent influenza vaccine (STIV) reduces the
incidence of influenza like illness and lowers respiratory tract infection, exacerbation of chronic obstructive airway
disease, pneumonia, hospitalization and mortality in auto-immune rheumatic disease (AIRD) patients on corticosteroids or disease modifying anti-rheumatic drugs (DMARDs); (2) To investigate temporal trends and geographic variation in uptake of STIV in this patient group; and (3) To investigate if STIV causes flare of AIRD.
Design: Primary care based cohort study using data from the CPRD.
Study period: 01/09/2006-31/08/2016.
Methodology: Unadjusted GP consultation and hospital admission rate ratios for each outcome and mortality rate ratio will be calculated. This will be adjusted for the propensity of being vaccinated. Adjusted illness and mortality hazard ratios and their 95% confidence intervals will be calculated, and used to compute vaccine effectiveness. Rates of vaccination will be calculated for each year and region and will be stratified by age and AIRD type. The risk of primary care consultation for joint pain, fatigue, fever, vasculitis in the 15 day period before and 90 day period after STIV administration will be compared to that in the rest of the influenza year using self-controlled case series methodology.

Health Outcomes to be Measured

Primary care consultations for lower respiratory tract infection requiring antibiotics, influenza, influenza-like illness, or exacerbation of chronic obstructive airway disease (COPD); - Hospitalisation due to influenza, influenza-like illness, pneumonia, or exacerbation of chronic obstructive airway disease; - Death due to pneumonia or influenza; - Number of GP consultations for joint pain, fatigue, fever, vasculitis in the pre-defined periods before and after STIV. Data on these will be extracted from primary care records using Read codes. Hospital Episode Statistics (HES) and ONS data will be used to identify the reasons for hospital admission, and the causes of death respectively. Primary end-points: primary care consultation for lower respiratory tract infection requiring antibiotics Secondary end-points: - Primary care consultation for influenza-like illness - Primary care consultation for exacerbation of COPD - Hospitalization for influenza-like illness or pneumonia - Death due to influenza-like illness, pneumonia, exacerbation of COPD - Temporal trend in the uptake of STIV in AIRD patients on DMARDs and/or immunosuppressive agents - Geographic variation in the uptake of STIV - Primary care consultation for AIRD flare after STIV administration.

Collaborators

Abhishek Abhishek - Chief Investigator - University of Nottingham
Abhishek Abhishek - Corresponding Applicant - University of Nottingham
Christian Mallen - Collaborator - Keele University
Georgina Nakafero - Collaborator - University of Nottingham
Jonathan Van-Tam - Collaborator - University of Nottingham
Matthew Grainge - Collaborator - University of Nottingham
Michael Doherty - Collaborator - University of Nottingham
Puja Myles - Collaborator - CPRD
Weiya Zhang - Collaborator - University of Nottingham

Linkages

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