A study of dose reduction of biologic drugs in axial spondyloarthritis
Research type
Research Study
Full title
An observational study of dose reduction of biologic drugs in axial spondyloarthritis (axSpA) in “real life” clinical practice; to determine whether formal dose reduction regimes should be advocated in order to optimise treatment.
IRAS ID
220621
Contact name
Liz Van Rossen
Contact email
Sponsor organisation
East Kent Hospitals University NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Many patients with severe axSpA receive treatment with TNF inhibitor therapy drugs. These are generally highly effective but have risks of toxicity and are expensive. Many patients in the UK and elsewhere choose to reduce the dose. In rheumatoid arthritis this appears to be effective and safe (Van Herwaarden, wet al, 2014).
If dose reduced regimes are effective for some patients without significant drawbacks, they may allow cost savings and potentially greater safety.In patients with axSpA the dose may be reduced either by increasing the interval between injections (Adalimumab, Etanercept, Certolizumab, and Golimumab) or infusions (infliximab) or reducing the dose (Infliximab and Etanercept) (Zavada et al, 2016; Navarro-Compan et et, 2016, Holroyd, 2016)
We wish to understand whether the use of reduced dose regimes would be a worthwhile development of our services of patients with axSpA.
Where patients attending our clinics with well controlled disease have chosen to reduce the dose, we wish to document the dose reduction regime, the duration of dose reduction and the measures of disease activity, function, quality of life and metreology as well as some blood markers, CRP, ESR (if tested). We would collect baseline data i.e. age, gender, disease duration, HLA-B27 status (if tested).
Working collaboratively with clinicians across England, we will identify patients who have reduced their dose, either on their own volition or through medical advice, and ask their consent for all the above information to be recorded on a spreadsheet.
We can observe and document the main dose reduction regimes used, the effect (disease measures) on patients, the duration of successful dose reduction, any adverse associations, and potential cost savings. We also aim to identify patient characteristics associated with successful dose reduction.
If patients can manage successful dose reduction, we can advocate a prospective dose reduction study.
REC name
Wales REC 6
REC reference
17/WA/0296
Date of REC Opinion
11 Oct 2017
REC opinion
Further Information Favourable Opinion