BLISTER

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.

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.

The trial results were published in the Lancet: Doxycycline versus prednisolone as an initial treatment strategy for bullous pemphigoid: a pragmatic, non-inferiority, randomised controlled trial

Type of study

Randomised trial

Contact details

blister@nottingham.ac.uk

Who funded the study?

The National Institute for Health Research Health Technology Assessment Programme - part of the NHS.

When did it take place?

Recruitment to BLISTER ended on 30 September 2013.

Where did it take place?

There are sites in the UK and in Germany.

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.