This month's news from across the specialty
What's hot
February 1, 2020
In this monthly column, members of Dermatology World's Editorial Advisory Workgroup identify exciting news from across the specialty.
Apremilast, an oral inhibitor of phosphodiesterase 4, was approved in 2014 for the treatment of psoriasis and psoriatic arthritis. Earlier this year, the drug gained a third approved indication for the treatment of adult patients with oral ulcers associated with Behҫet’s Disease (BD). A recent paper in the New England Journal of Medicine (2019; 381:1918-28) reported the efficacy of the drug in a phase 3 placebo-controlled trial of 207 BD patients who had used ≥1 non-biologic medication(s) for oral ulcers. The primary endpoint, change in area under the curve (AUC) at 12 weeks, showed a significant decrease in oral ulcers in patients treated with apremilast (AUC 129.5) compared to placebo (AUC 222.1, P<0.001). Similar to psoriasis, common side effects in BD patients treated with apremilast included diarrhea, nausea, and headache.
BD is rare, occurring in approximately 7:100,000. Recurrent aphthous stomatitis, by contrast, is more common, and apremilast may also be an option for this condition. In the same issue of the New England Journal of Medicine (2019; 381:1975-7), Kolios and colleagues reported complete resolution of recurrent aphthous stomatitis in four out of five patients after two to six weeks of apremilast 30mg BID. All patients had previously failed treatment with topical glucocorticoids and oral colchicine. Patients remained nearly clear at last follow-up (range 2-24 months), suggesting apremilast is a new potential option for patients with refractory oral aphthous ulcers.
Many dermatologists start methotrexate with a test dose, followed by liver function tests and a complete blood count before the second dose. Is a test dose really necessary?
A review of electronic medical records over a five-year period from dermatology and rheumatology identified 812 patients who were started on methotrexate (J Am Acad Dermatol. 2019; 80(4): 1160-2).
Of these, 174 met the inclusion criteria. Patients were included if use of a test dose, the initial dosage, dose changes, date and reason of discontinuation, and baseline and follow-up lab values for a four-month period after starting methotrexate were documented.
Most dermatology patients received a test dose, and most rheumatology patients did not. The initial methotrexate dose was lower in the test dose group. Patients receiving a test dose had significantly more blood draws than those without a test dose during the first four months of therapy. Initial doses were lower in dermatology patients (mean 5.9 mg) than in rheumatology patients (mean 8.4 mg, P = 0.001).
There were no deaths or hospitalizations due to methotrexate toxicity. Lab tests performed one week after a test dose showed no new 3 or 4 abnormalities. There was discontinuation of methotrexate in one patient with mild (grade 1) alanine aminotransferase elevation of unknown etiology. There were no discontinuations due to hematologic toxicity. Most discontinuations were due to nausea. The incidence of methotrexate discontinuation and of grade 2 lab abnormalities during the first four months of treatment were similar in both the test dose and non-test dose groups.
The authors concluded that the test dose for methotrexate can be omitted in patients with normal renal function. A starting dose of methotrexate at 15-17.5 mg/week is associated with a low risk for serious adverse events.
What are your patients posting on Instagram and Twitter after Mohs surgery? What insights do these posts hold regarding the patient’s mindset postoperatively? Encouragingly, the most common theme is informing others about skin cancer, according to a recent article (Archives of Dermatological Research. 2019. 311: 731-4). Investigators conducted a search of public Instagram posts and tweets on Twitter with either #mohssurgery or @mohssurgery. About 91% of posts on Instagram and 75% of tweets were posted after the surgery was completed, and the majority, 93% and 65% respectively, were posted by women. The most common theme was spreading awareness of skin cancer and promoting sun protection. Other themes that demonstrate patients' postoperative thought processes were concern of appearance while recovering, satisfaction of the healing process, and how Mohs affected daily living. Also, several posts focused on thankfulness for beating cancer and reflecting on how the experience made the patient stronger. Social media platforms can educate as well as be a support network. Patients are using these platforms primarily to inform followers about skin cancer, but these platforms also allow patients to have support and encouragement throughout the healing process. They are a window into information about how the patient is reacting in the immediate postoperative period which may be different than the information that is assessed via formal feedback surveys.
What do I tell my patients about cannabis or cannabis-derived products, including cannabidiol (CBD)?
CBD seems to be available everywhere now, including in drugs, food, cosmetics, dietary supplements, and animal health products. Patients have shared with their dermatologists that they are using CBD orally and topically. But are these products safe to use?
Aside from one prescription drug approved to treat epilepsy, these products have not been approved by the FDA and many questions remain regarding CBD’s safety, including reports of products containing contaminants such as pesticides and heavy metals. Consumers need to be aware of the potential risks associated with using CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and mood changes. In addition, animal studies have shown CBD can be detrimental to the male reproductive system. Finally, vulnerable populations such as pregnant women should be especially careful as initial research shows it can affect fetal brain development and result in premature birth and low birth weight. Finally, further research needs to be done on how much CBD is absorbed from CBD-infused skin creams.
The FDA recognizes there is significant public interest in CBD products, but wants the public to know there is very limited data about CBD’s safety. The agency is working on answering questions about the science, safety, and quality of products containing CBD through ongoing efforts, including feedback from FDA hearings and information/data gathering through a public docket. In the fall of 2019, the FDA provided a revised Consumer Update focused on “What You Need to Know (and What We’re Working to Find Out) about Products Containing Cannabis or Cannabis-derived Compounds, including CBD” along with a series of tweets from FDA’s Principal Deputy Commissioner Dr. Amy Abernathy.
Bottom line: Please tell your patients that the myriad CBD products on the market have not been evaluated by the FDA or determined to be safe, further research is necessary, and there may be harmful side effects. The AAD has plans to host an educational session on cannabis at the AAD Innovation Academy in Seattle.
