A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid:a protocol for the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial

Chalmers, J R, Wojnarowska, F, Kirtschig, G, Nunn, A J, Bratton, D J, Mason, J, Foster, K A, Whitham, D and Williams, H C and BLISTER Study Group (2015) A randomized controlled trial to compare the safety and effectiveness of doxycycline (200 mg daily) with oral prednisolone (0.5 mg kg(-1) daily) for initial treatment of bullous pemphigoid:a protocol for the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Trial. British Journal of Dermatology, 173 (1). pp. 227-234. ISSN 0007-0963

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Abstract

BACKGROUND: Bullous pemphigoid (BP) is the most common autoimmune blistering disease in older people, and is associated with significant morbidity and mortality. Oral corticosteroids are usually effective but the side-effects are thought to contribute to the high morbidity and mortality rate. Treatment with oral tetracyclines may be effective but high-quality, randomized controlled trials (RCTs) are needed to confirm this. OBJECTIVES: To compare the effectiveness and safety of two strategies for treating BP. METHODS: This is a two-arm, parallel group, 52-week RCT comparing doxycycline with prednisolone for initial treatment of BP. Dose is fixed for the initial 6 weeks of treatment (doxycycline 200 mg daily; prednisolone 0.5 mg kg(-1) daily), after which it can be adjusted according to need. A total of 256 patients with BP will be recruited in the U.K. and Germany. RESULTS: The primary outcomes are: (i) effectiveness (assessor-blinded blister count at 6 weeks) and (ii) safety [proportion of patients experiencing ≥ grade 3 adverse events (i.e. severe, life: threatening or fatal) related to trial medication during the year of follow-up]. Primary effectiveness analysis will be an assessment of whether doxycycline can be considered noninferior to prednisolone after 6 weeks of treatment. Primary safety analysis is a superiority analysis at 12 months. Secondary outcomes include longer-term assessment of effectiveness, relapse rates, the proportion of patients experiencing any grade of adverse events related to treatment, quality of life and cost-effectiveness. CONCLUSIONS: The trial will provide good evidence for whether the strategy of starting BP treatment with doxycycline is a useful alternative to prednisolone.

Item Type:	Article
Additional Information:	© 2015 British Association of Dermatologists.
Uncontrolled Keywords:	dermatologic agents,doxycycline,drug administration schedule,humans,bullous pemphigoid,prednisolone,recurrence,treatment outcome,comparative study,multicenter study,randomized controlled trial
Faculty \ School:	Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User:	Pure Connector
Date Deposited:	11 Feb 2017 02:17
Last Modified:	03 Nov 2022 15:42
URI:	https://ueaeprints.uea.ac.uk/id/eprint/62438
DOI:	10.1111/bjd.13729

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