By Rebecca H. Allen, MD, MPH
Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI
Dr. Allen reports she is a Nexplanon trainer for Merck, a Liletta trainer for Actavis, and on the advisory board for Bayer, Actavis, and Vermillion.
Synopsis: In this prospective cohort study, women with vulvar lichen sclerosus who were compliant with preventive topical corticosteroids were significantly less likely to develop vulvar intraepithelial neoplasia and squamous cell carcinoma than women who were partially compliant with therapy.
Source: Lee A, et al. Long-term management of adult vulvar lichen sclerosus: A prospective cohort study of 507 women. JAMA Dermatol Published online June 12, 2015.
This is an Australian prospective cohort study of 507 adult women with biopsy-proven vulvar lichen sclerosus from January 2008 to September 2014 in a single practice. The cohort was divided into two groups based on self-report of compliance: compliant (followed treatment instructions most or all of the time) and partially compliant (followed treatment instructions some or a little of the time or not at all). All women had to have at least 2 years of follow-up, and follow-up occurred every 3 to 6 months for the first 2 years, then annually thereafter. Data recorded included age, ethnicity, menopausal status, symptoms, clinical features, severity of disease, and adverse effects. Initial treatment regimens were determined based on severity of hyperkeratosis:
- Very mild: 1% hydrocortisone ointment
- Mild: 0.1% methylprednisolone aceponate ointment
- Moderate: 0.05% betamethasone dipropionate ointment
- Severe: 0.05% betamethasone dipropionate ointment
- Very severe: 0.05% clobetasol propionate ointment
Once the vulvar skin had returned to normal color and texture and symptoms were alleviated, long-term preventive management was initiated with a gradual reduction in topical corticosteroid potency. However, women were instructed to use the ointment at least three times a week for maintenance, whether or not they were having symptoms.
The mean age of the cohort was 55.4 years (range 18-86 years) with a mean duration of symptoms of 5 years (range 0.1-40 years). The vast majority of the sample was white (94%) and almost 70% were postmenopausal. The mean duration of follow-up was 4.7 years (range 2-6.8 years). Nearly all women were symptomatic (97%) and three-quarters of those who were sexually active had dyspareunia. Most patients had mild-to-moderate disease; however, 30% had severe disease. Approximately two-thirds of the cohort (70%) reported that they were compliant with treatment and 30% were partially compliant. In total, 86% of compliant patients achieved complete resolution of symptoms and skin changes for the long-term compared to 73% of the partially compliant patients. There were no cases of squamous cell carcinoma (SCC) or vulvar intraepithelial neoplasia (VIN) in the compliant group and seven cases in the partially compliant group (3 SCC and 4 VIN, P < 0.001). There was no difference between the two groups in corticosteroid dermatitis (2.2% vs 4%, P = 0.37) or atrophy (1.1% vs 2%, P = 0.43).
COMMENTARY
Vulvar lichen sclerosus is a skin condition that causes itching, irritation, and dyspareunia.1 Characteristically it involves loss of normal vulvar architecture, which can include fusion of the clitoral hood, labia minora fused to the labia majora leading to complete resorption of minora, and posterior midline fusion, which narrows the vaginal opening. Accepted initial treatment for vulvar lichen sclerosus includes topical superpotent steroid ointment, such as 0.05% clobetasol propionate.1 If left untreated, it is estimated that 5% of vulvar lichen sclerosus cases will progress to squamous cell carcinoma.2 The ideal long-term management of vulvar lichen sclerosus is unclear. Some experts advocate lifelong preventive therapy while other experts believe that only severe cases need to be regularly followed. Some practitioners advocate treating only when symptoms are bothersome. In addition, there is concern over the possible risk of adverse effects of chronic topical corticosteroids such as corticosteroid dermatitis and skin atrophy.3 This prospective cohort study set out to determine the answer to that question.
This is one of the largest studies of vulvar lichen sclerosus in the literature, with an average follow-up of 4.7 years. Since the ideal study design, a randomized controlled trial, was not able to be performed, the authors divided their cohort into those who were compliant with therapy and those who were partially compliant. The partially compliant group contained women who applied treatment only when symptomatic, forgot to use their treatment, used the treatment less often than recommended, or refused any topical corticosteroid more potent than 1% hydrocortisone for fear of side effects. The authors were able to show significantly higher levels of symptom resolution, reduced progression of adhesions or scarring, and improvement in dyspareunia for the compliant group compared to the partially compliant group. Importantly, no cases of VIN or squamous cell carcinoma developed in the compliant group, and side effects of long-term corticosteroid treatment were uncommon. The weakness of this study is the reliance on self-report of the woman as to whether or not she had been compliant. Without prospective data collection, such as diaries, this kind of reporting can be subject to many biases.
Nevertheless, this study adds important information to the treatment of vulvar lichen sclerosus. Women who are compliant with therapy can achieve both remission of symptoms and prevent progression of scarring and the development of SCC and VIN. This should motivate women to adhere to preventive therapy. Although no randomized controlled trials provide evidence of the most effective steroid regimen, a reasonable approach is to begin with once-daily application of ultrapotent topical steroids for 4 weeks, tapering to alternate days for 4 weeks, followed by 4 weeks of twice-weekly application.1 This protocol will need to be individualized to the patient, as some women will need longer initial treatment periods to control symptoms before reaching maintenance. Once patients reach the maintenance phase of treatment (2-3 times weekly), they should be reminded to return to be seen at least annually and as needed if persistent lesions appear for biopsy evaluation to rule out VIN and SCC.3 This study adds valuable information to providers about patient counseling regarding the prognosis of vulvar lichen sclerosus.
References
- ACOG Practice Bulletin Number 93. Diagnosis and management of vulvar skin disorders. May 2008 (Reaffirmed 2013).
- Neill SM, et al. British Association of Dermatologists’ guidelines for the management of lichen sclerosus 2010. Br J Dermatol 2010;163:672-682.
- Cooper SM, et al. Reduced risk of squamous cell carcinoma with adequate treatment of vulvar lichen sclerosus. JAMA Dermatol 2015; June 12. doi: 10.1001/jamadermatol.2015.0644 [Epub ahead of print].
In this prospective cohort study, women with vulvar lichen sclerosus who were compliant with preventive topical corticosteroids were significantly less likely to develop vulvar intraepithelial neoplasia and squamous cell carcinoma than women who were partially compliant with therapy.
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