11 Mar Doxycycline vs Steroids For Blistering Disease Bullous Pemphigoid
MedicalResearch.com Interview with:
Dr. Williams
Hywel C. Williams DSc, FMedSci, NIHR Senior Investigator
Director of the NIHR Health Technology Assessment Programme
Professor of Dermato-Epidemiology and
Co-Director of the Centre of Evidence-Based Dermatology,
University of Nottingham
Queen’s Medical Centre
Nottingham University Hospitals NHS Trust,
Nottingham, UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Pemphigoid is a potentially serious skin condition characterised by the appearance of large tense blisters appearing on the skin. These blisters are itchy and eventually burst, leaving raw areas of skin that can become infected. Pemphigoid is much commoner in the elderly, and is on the increase. It is due to the body’s own immune system attaching certain structures in the skin ie an auto-immune disease. The main treatment for pemphigoid is oral steroids (prednisolone). Prednisolone is usually quite good at clearing the blisters, but when given for long periods as is needed for people with pemphigoid, they cause serious side effects such as diabetes, infection, raised blood pressure and fractures, so safer oral treatments are needed for this disease. Tetracycline antibiotics are one such possible treatment – they have been used by some for pemphigoid for many years, but our Cochrane review did not find any good evidence to show that it works.
So we applied to the UK National Institute of Health Research Health Technology Programme to do a definitive evaluation of treating pemphigoid with one of the tetracyclines called doxycycline. We tested the strategy of staring patients with pemphigoid with doxycycline versus standard treatment with oral prednisolone. If those starting on doxycycline did not achieve good enough control, they could switch to prednisolone as would happen in clinical practice. Our main outcomes were blister control at 6 weeks, and severe, life threatening and fatal treatment related adverse events at 52 weeks. The study was designed as a non-inferiority study – by that we mean that we never expected doxycycline to be as good as prednisolone for blister control, so we agreed to put up with a degree of lower effectiveness provided that there were clear long term safety gains.
MedicalResearch.com: What are the main findings?
Response: The study showed that those starting off on doxycycline, 74% had good blister control at 6 weeks compared with 91% on prednisolone. At 52 weeks, related severe, life-threatening or fatal events for those who started on doxycycline were half the rate of those who started on prednisolone (18% compared with 36% respectively). So even though starting off on doxycycline was not as good as prednisolone in terms of blister control, putting up with the reduced short-term effectiveness seemed worthwhile give the significant long term safety gains.
MedicalResearch.com: What should readers take away from your report?
Response: Steroid creams applied in large quantities to the skin are probably the safest way of treating pemphigoid, but applying such creams daily to large parts of the body for several months may not be a practical option for many, so oral treatments are needed.
Our study for the first time provides useful estimates on the trade-off between lower effectiveness and better long term safety that will allow patients and doctors to make more informed decisions about whether to try starting off on doxycycline rather than oral prednisolone. Oral prednisolone or steroid creams can still be used later if the doxycycline alone is not enough.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Given that doxycycline is clearly not as effective as oral prednisolone in pemphigoid, perhaps future studies might consider using topical or oral steroids to induce a remission in pemphigoid and then to introduce doxycycline or other drugs like methotrexate to maintain that remission. Such an idea will need to be tested in a full scale pragmatic randomised controlled trial.
MedicalResearch.com: Is there anything else you would like to add?
Response: I am now the new Director of the NIHR HTA that funded this study, although I had nothing to do with the funding decision as we have strict conflict of interest policies.
“This publication 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, National Health Service, or the Department of Health”
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Last Updated on March 11, 2017 by Marie Benz MD FAAD