Long-term oral prednisolone exposure in primary care for bullous pemphigoid: population-based study

Abstract

Background: Oral prednisolone is the mainstay treatment for bullous pemphigoid, an auto-immune blistering skin disorder affecting older people. Moderate to high dose treatment is often initiated in secondary care, but then continued in primary care. Aim: To describe long-term oral prednisolone prescribing in UK primary care for adults with bullous pemphigoid 1998-2017. Design and setting: A prospective cohort study using routinely collected data from the Clinical Practice Research Datalink, a primary care database containing the healthcare records for over 17 million people in the UK. Method: Oral prednisolone exposure was characterised in terms of the proportion of individuals with incident bullous pemphigoid prescribed oral prednisolone following their diagnosis and the duration and dose of prednisolone. Results: 2,312 (69.6%) of 3,322 people with bullous pemphigoid were prescribed oral prednisolone in primary care. The median duration of exposure was 10.6 months (IQR 3.4 to 24.0). Of prednisolone users, 71.5% were continuously exposed for >3 months, 39.8% for >1 year, 14.7% for >3 years, 5.0% for >5 years, and 1.7% for >10 years. The median cumulative dose was 2,974mg (IQR 1,059 to 6,456). Maximum daily doses were ≥10mg/day in 74.4% of users, ≥20mg/day in 40.7%, ≥30mg/day in 18.2%, ≥40mg/day in 6.6%, ≥50mg/day in 3.8%, and ≥60mg/day in 1.9%. Conclusions: A high proportion of people with incident bullous pemphigoid are treated with oral prednisolone in UK primary care. Primary and secondary care should address steroid-sparing alternatives and, where switching is not possible, ensure prophylactic treatments and proactive monitoring of potential side-effects are in place.

Study Design of a Phase 2/3 Randomized Controlled Trial of Dupilumab in Adults with Bullous Pemphigoid: LIBERTY-BP ADEPT

“…Even low doses of OCS may result in OCS-related adverse events such as osteoporosis, heart failure, diabetes and infections [ 64 ], highlighting the importance of minimizing OCS treatment duration. In clinical practice, the duration of continuous treatment with OCS is often much longer; a recent prospective cohort study of 2,312 patients with BP in the UK found that a substantial proportion of patients (39.7%) were continuously treated with OCS for over a year, with 14.7% of patients treated with OCS for > 3 years, 5.0% for > 5 years and 1.7% for > 10 years [ 65 ].…”

“…The aim of the LIBERTY BP-ADEPT study (i.e., to assess whether and to what extent treatment with dupilumab can sustain disease remission once OCSs are tapered off by week 16 or earlier) is reflected in the choice of the primary and key secondary endpoints: the proportion of patients with sustained remission at week 36 (at least 20 weeks after OCS are tapered off at week 16 or sooner) and the cumulative dose of OCS from baseline to week 36. The primary endpoint in this study is quite stringent, particularly given the short timeline to achieve this endpoint relative to treatment durations commonly used in clinical practice, which are often substantially longer than 16 weeks [ 65 ].…”