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The bullous pemphigoid steroids and tetracyclines study
Can antibiotics be used to treat a skin disease called bullous pemphigoid?
What was this study about?

Pemphigoid is an intensely itchy autoimmune skin condition; it is associated with increased mortality and other neurological diseases such as dementia and motor neurone disease. Oral steroids have been used for over 50 years to treat pemphigoid but they are associated with significant side effects, particularly for the elderly. There is also uncertainty around the optimal dose to use. Strong steroid creams can also be used to treat the condition, but these are not always practical. The BLISTER trial looked at whether using doxycycline antibiotics were a safer long-term solution for pemphigoid, even if they were slightly less effective in the short-term than oral prednisolone.

Who was included?

253 patients from the UK and Germany were randomised a strategy of starting treatment with either 200mg/day oral doxycycline, or 0.5mg/kg/day oral prednisolone.

What difference did this study make?

The trial looked at two main outcomes: short term control at 6 weeks and safety in the 12 months following randomisation. We expected those starting on steroids to have a better outcome at 6 weeks; the results showed that 74% of patients who started on the doxycycline antibiotic had three or less blisters at six weeks, compared to 91% of those on prednisolone; the confidence interval for this difference was within limits set out before the start of the study for a successful outcome. Those with an unfavourable outcome on doxycycline at 6 weeks were able to switch to steroids.

 

The long-term safety outcome showed that 18.2% patients on doxycycline experienced a treatment-related severe or life threatening adverse effect compared to 36.3% patients on prednisolone. This represented a significantly safer outcome at one year when starting people with pemphigoid on doxycycline rather than prednisolone.

Contact details

When did it take place?

Recruitment to BLISTER ended on 30 September 2013, and the trial results were published in March 2017.

Where did it take place?

There are sites in the UK and in Germany.

Who funded the study?

Further information


Type of study:
Randomised trial
Status:
Closed
Study start date:
02 March 2009

Related Publications

Mason, J.M., Chalmers, J.R., Godec, T., Nunn, A.J., Kirtschig, G., Wojnarowska, F., Childs, M., Whitham, D., Schmidt, E., Harman, K., Walton, S., Chapman, A., Williams, H.C., on behalf of the UK Dermatology Clinical Trials Network BLISTER Study Grou.

Doxycycline compared with prednisolone therapy for patients with bullous pemphigoid: cost-effectiveness analysis of the BLISTER trial. British Journal of Dermatology. 2018; 178:415-423

Chalmers, J.R., Wojnarowska, F., Kirtschig, G., Mason, J., Childs, M., Whitham, D., Harman, K., Chapman, A., Walton, S., Schmidt, E., Godec, T.R., Nunn, A.J., Williams, H.

A randomised controlled trial to compare the safety, effectiveness and cost-effectiveness of doxycycline (200 mg/day) with that of oral prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid: the Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) trial. Health Technology Assessment. 2017; 21:1-90

Chalmers, J.R., Wojnarowska, F., Kirtschig, G., Nunn, A.J., Bratton, D.J., Mason, J., Foster, K.A., Whitham, D., Williams, H.C., on behalf of the BLISTER study grou.

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. 2015; 173:227-34

Marina, N., Bielack, S., Whelan, J., Smeland, S., Krailo, M, Sydes, M.R., Butterfass-Bahloul, T., Calaminus, G., Bernstein, .

International collaboration is feasible in trials for rare conditions: The EURAMOS Experience. Cancer Treatment and Research. 2010; 152:339-353

Marina, N., Bielack, S., Sydes, M.R., Bernstein, M., Butterfass-Bahloul, Smeland, S., Holliday, A., Whelan, .

International collaboration is feasible in trials for rare conditions: the EURAMOS experience. Journal of Clinical Oncology. 2007; 25:726S, 20501-726S, 20501