Regular, outcomes-based treatment effective in vulvar lichen sclerosus

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Counsel patients on cancer risk

We congratulate the authors on an article that has profound implications for patients with vulvar lichen sclerosus and their physicians worldwide. Until now, suppression of the disease has concerned physicians and has often been inadequate. The reduction in cancer among patients with VLS who were treated with [topical corticosteroids] is no longer speculative. This focus of concern can effectively communicate the message that long-term use of a TCS likely prevents the progression of VLS and the development of squamous cell carcinoma.

In the study, cohort treatment was tailored to the severity of disease, using the presence or absence and degree of hyperkeratosis as the principal marker of severity. The most severe cases with extensive hyperkeratosis were treated twice daily with a superpotent TCS and less severe cases with a reduced-potency TCS for the initial treatment period.

This use is in contrast to the recommendations of guidelines. Starting with a superpotent corticosteroid has been advocated for all patients either as an initial 3-month once-daily regimen or a tapered regimen for 3 months. Signs at presentation vary considerably, with some women displaying severe widespread genital pallor, hyperkeratosis, fissures, and erosions, whereas others show subtle pallor; there are yet others who are asymptomatic. Hyperkeratosis alone may not be a sufficient marker of active disease, because ecchymoses and erosions may also be important. Tailoring treatment to the severity of the disease makes sense, because in other inflammatory diseases, such as atopic eczema, dermatologists routinely tailor the potency of the corticosteroid used to the severity of the disease.

This article is an important contribution to our knowledge, providing the first evidence in women of the association between malignant neoplasms and poor compliance with treatment. This information will allow us to better inform our patients and encourage those who find it difficult to comply for various reasons.

Dr. Susan M. Cooper is with the department of dermatology, Oxford University Hospitals Trust, Oxford, England. Dr. Nina Madnani is with the department of dermatology, P.D. Hinduja National Hospital and Medical Research Center, Mumbai. Dr. Lynnette Margesson is with the Geisel School of Medicine, Dartmouth College, Hanover, N.H. They disclosed no conflicts of interest. These comments were excerpted from their accompanying editorial (JAMA Dermatol. 2015 June 12 [doi:10.1001/jamadermatol.2015.0644]).


AT WCD 2015


VANCOUVER, B.C. – Women with vulvar lichen sclerosus (VLS) who consistently used topical corticosteroids that had been titrated to normalize skin color and texture had significantly better outcomes than patients who sometimes skipped treatment, a prospective single-center cohort study found.

Most notably, none of the treatment-compliant patients developed vulvar carcinoma during an average of almost 5 years of follow-up, compared with 4.7% of the partially compliant group (P < .001), reported Dr. Jason Lee, a dermatologist with the University of Sydney, Australia.

“We are proposing a paradigm shift to change the way we manage this condition,” Dr. Lee said at the World Congress of Dermatology. “Clinicians should aim for individual regular treatment of patients with vulvar lichen sclerosus. The treatment is safe, and the course of the disease can be altered by treatment.”

The report appeared simultaneously in JAMA Dermatology (2015 June 12 [doi:10.1001/jamadermatol.2015.0643]).

Vulvar lichen sclerosus is an uncommon disease that causes vulvar itching, pain, and sexual dysfunction, and can significantly alter the vulvar architecture. Before clinicians began treating VLS with superpotent topical corticosteroids, about 5% of cases were thought to progress to vulvar intraepithelial neoplasia or invasive squamous cell carcinoma.

Furthermore, even fairly mild cases can become cancerous, Dr. Lee noted. “Until now, it was thought that cancer was inevitable in some women with VLS,” he added. “Short-term control is easy, but long-term management lacks data, and research has not addressed whether treatment can prevent scarring or cancer.”

To assess the impact of individualized topical corticosteroid therapy with regular follow-up, Dr. Lee and his associates studied 507 women with biopsy-proven VLS during 2008-2014. Patients averaged 55 years of age at presentation and had an average symptom history of 5 years.

The investigators graded cases as mild, moderate, severe, or very severe depending on degree of hyperkeratosis, and titrated treatment with the goal of normalizing skin color and texture. They classified patients as treatment-compliant if they said they followed treatment directions most or all of the time, and as partially compliant if they said they followed directions some, little, or none of the time. They saw patients at least once a year for follow-up.

Most patients initially needed superpotent or ultrapotent topical corticosteroids to control their disease and then switched to moderate or mild strength formulations to maintain results, Dr. Lee and his associates reported.

About 30% of patients were only partially compliant with treatment. These patients were significantly less likely to achieve symptom resolution (58% vs. 93%) and resolution of dyspareunia (66% vs. 94%), and were more likely to develop adhesions and scars during follow-up (40% vs. 3%), compared with fully compliant patients (P < .001 for all), the researchers said. Rates of steroid dermatitis and reversible steroid-induced cutaneous atrophy were similar between the fully and partially compliant groups (2.2% vs. 4%, and 1.1% vs. 2%, respectively).

Based on the findings, clinicians would need to treat 21 cases of VLS to prevent 1 case of vulvar cancer and 2.7 cases to prevent scarring, said Dr. Lee.

“This is the first study adequately powered to demonstrate that cancer and scarring can be prevented by regular treatment according to clinical outcome, not symptoms,” he added.

But Dr. Lee acknowledged that selection bias could have affected the results. “We did find that patients who were not complying with treatment were more likely to have severe disease at the start of the study,” he said. “They probably were at increased risk of cancer to start with.”

The dermatology department of Royal North Shore Hospital partially funded the work. The investigators reported having no relevant conflicts of interest.

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