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Q&A: Drs Cline and Pichardo on the Potential Use of Methotrexate for ELPV

Q&A: Drs Cline and Pichardo on the Potential Use of Methotrexate for ELPV

Fri, 01/31/2020 - 18:33

Erosive lichen planus of the vulva (ELPV) can be a difficult-to-treat disease, with approximately 25% of patients not responding to first-line therapy. A recent research letter, published in JAMA Dermatology, found a proportion of patients with recalcitrant disease benefited from methotrexate.

According to the study results, 70% of patients experienced improvements in ELPV (19 out of 27). These findings were based on medical records of women with ELPV who attended the vulvar clinic at the Wake Forest Baptist Department of Dermatology from January 2009 through January 2019.

The mean dose of methotrexate was 12.5 mg and the mean duration of treatment was 15.6 months. All patients also received concomitant topical treatments, predominately clobetasol (78%), and 15 were instructed to apply tacrolimus with gauze for vulvar lesions. Other concomitant systemic medications included gabapentin, short-course prednisone, and mycophenolate mofetil.

Among the 19 patients who reported improvements with methotrexate, 14 (52%) experienced these improvements after 1 month.

At the time of analysis, 8 patients (30%) were still on methotrexate and 19 had stopped treatment. Reasons for discontinuing treatment included adverse effects (n=8 [30%]), remission (n=5 [19%]), loss to follow-up (n=4 [15%]), and switching to mycophenolate mofetil (n=2 [7%]). Among the 8 patients who stopped methotrexate therapy due to adverse effects, 6 (22%) maintained clinical improvement, while 2 (7%) did not.

The most common adverse effects included fatigue and gastrointestinal distress, with 11 patients (41%) reporting at least 1 adverse effect while receiving methotrexate. In addition, 3 patients (11%) developed malignant neoplasms.

Dr Cline

Abigail Cline, MD, department of dermatology, Wake Forest School of Medicine (left).

Corresponding author Abigail Cline, MD, and principal investigator Rita Pichardo, MD, discussed these findings further with The Dermatologist.  Dr Cline is with the Center for Dermatology Research in the department of dermatology at Wake Forest School of Medicine, and Dr Pichardo is an associate professor of dermatology at Wake Forest School of Medicine.

Dr Pichardo

Rita Pichardo, MD, associate professor of dermatology, Wake Forest school of Medicine (right).

The Dermatologist: Why did you and your team decide to do this study? Were you surprised by the findings or expecting to find recalcitrant erosive lichen planus respond to methotrexate?

Dr Cline: Our team decided to do this study because Wake Forest Department of Dermatology has a specialized vulvar disease clinic that diagnoses and treats patients with vulvar dermatoses. I was interested in this patient population because of the significant morbidity associated with vulvar dermatoses. These are older female patients who suffer for years in silence and are reluctant to talk about their conditions because of fear or embarrassment. Also, they often don’t know that without treatment, these conditions can result in chronic pain of the vulva, loss of normal vulvar architecture, or even vulvar carcinoma.

Treatment is often frustrating because these conditions may be recalcitrant to standard therapies, such as topical corticosteroids. Luckily, the Wake Forest Department of Dermatology has experts that are comfortable treating these patients with systemic immunosuppressants, such as methotrexate.

I talked to Dr Pichardo about her experience using methotrexate in these patients. She told me about the promising results of using methotrexate for recalcitrant ELPV. As I did the retrospective chart review, I found the data to be very promising.

The Dermatologist: How will these findings impact clinical practice? Does this offer some hope for patients with recalcitrant disease?

Dr Cline: I hope these findings will impact clinical practice and offer patients a potential treatment option. Currently there are no good evidence-based recommendations for systemic treatment of ELPV. Therapeutic options need to be broadened, with the development of specific measures for diagnosis and management guidelines. I believe this small study should support further research into using methotrexate for this disease. While more research needs to be done, I think this is a promising starting point.

The Dermatologist: What other studies are needed to support the use of methotrexate for recalcitrant erosive lichen planus? What other research is needed to improve therapeutic options for women with this disease?

Dr Cline: To investigate the efficacy of using methotrexate for recalcitrant ELPV, randomized and placebo-controlled trials are necessary. However, ELPV is a relatively rare disease with a limited number of patients. To perform such a study, the participation of multiple centers would be necessary.

In addition, greater education and discussion about this disease will lead to better treatment options. We should educate medical professionals, such as gynecologists and dermatologists, to recognize this disease and ask patients about it. Patients may be suffering in silence and not mention their symptoms to their medical providers. For example, one of the patients in this study had symptoms 20 years before she was finally diagnosed. Through greater outreach, we can find more patients. With more patients, we can improve the therapeutic options for this disease. 

The Dermatologist: What recommendations do you have for providers treating patients with recalcitrant ELPV?

Dr Pichardo: ELPV is a condition that affects patients’ quality of life. Providers should understand the discomfort, burning sensation, and pain that these patients experience. I recommend they take the time and discuss with patients the recalcitrant nature of this condition and the potential risks for scarring and squamous cell carcinoma, especially if patients have a delay in treatment or lack of follow-up and maintenance.

The Dermatologist: Any other thoughts or comments you would like to add about this study or treating patients with this disease?

Dr Pichardo: It is important to perform a general skin examination in patients with lichen planus. This disease may affect the scalp, oral mucosa, genital area, and skin. Many patients with genital lichen planus also have oral lichen planus. Both areas are difficult to treat but, with oral and systemic medications, control can be achieved.

Patients with erosive lichen planus should be seen often by a dermatologist until the condition is controlled. After that time, a treatment maintenance is highly recommended. I suggest to my patients to be evaluated by the dermatologist and gynecologist every year, 6 months apart. The idea is to recognize early progression of the disease and avoid complications, such as distortion of the genital architecture and squamous cell carcinoma of the vulva.

Reference

Cline A, Cuellar-Barboza A, Jorizzo JL, Pichardo RO. Methotrexate for the treatment of recalcitrant erosive lichen planus of the vulva [published online January 02, 2020]. JAMA Dermatol. doi:10.1001/jamadermatol.2019.4062

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