Treating a blistering skin condition called pemphigoid with antibiotics is a safer long-term solution than steroids. The results of the BLISTER study were published in the Lancet this week.
Pemphigoid is an intensely itchy autoimmune skin condition that occurs mostly in over 70s. 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 for pemphigoid but are also 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.
253 patients from the UK and Germany were randomised to treatments of either:
- 200mg/day oral doxycycline, or
- 0.5mg/kg/day oral prednisolone
for six weeks. The treatments were then either continued if the BP was under control, or treatment switched or the dose of prednisolone adjusted as per normal clinical practice.
The trial looked at two main outcomes: effectiveness and safety, so that they could measure the trade-off between the two treatments. The effectiveness was defined by short-term control at 6 weeks, and safety was judged a year after randomisation.
74% of patients who started on the doxycycline antibiotic had three or less blisters at six weeks, compared to 91% of those on prednisolone. However, 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 shows a significantly safer outcome at one year when starting people with pemphigoid on doxycycline rather than prednisolone.
Whilst guidelines have mentioned using tetracycline antibiotics as a possible treatment for pemphigoid, there has been a lack of high quality evidence to inform this recommendation. The BLISTER study has helped to fill this evidence gap. It used a large sample size and a flexible trial design which allowed for adjustment, switching and additional treatments as would happen in normal clinical practice.
This press release presents independent research funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (06/403/51). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR Health Technology Assessment Programme, the NIHR, NHS or the Department of Health.
This study was supported by the UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. We would like to acknowledge the support of the UK NIHR Clinical Research Network, particularly in providing research nurse support at the many centres around the UK.