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Topical crisaborole ointment for atopic dermatitis: Hoping for a painless introduction


DII small banner By Warren R. Heymann, MD
Aug. 13, 2016


Any dermatologist who treats atopic dermatitis (AD) must be eagerly awaiting the introduction of 2% Crisaborole ointment. This is equally true for patients (and their parents!) who are steroid-phobic and uncomfortable with the black box warning for calcineurin inhibitors (despite our reassurances).

I have used apremilast (Otezla) off-label for a few patients with moderately severe AD with reasonable success in a couple of them. Acting as a phosphodiesterase inhibitor (PDE), it has been approved for psoriasis and has been reported to be effective in AD, in a study of 16 patients 10 of whom received a dose of 30 mg twice a day, there was a significant decrease in the Eczema Area and Severity Index (EASI) and Dermatology Life Quality Index (DLQI) (1). For most patients, the main side effects of diarrhea, mood changes (depression) and weight loss (most adults don’t complain about that!) are generally tolerated. I am hopeful that Otezla will be approved for AD, but in the meanwhile, the impending introduction of a topical PDE inhibitor will be most welcome.
 
Zane et al have reported their experience with 2% ointment in an evaluation of 34 patients, 31 of whom completed the study. Crisaborole is a boron-based PDE4 inhibitor. The inhibition of PDE4 blocks the conversion of cAMP to 5’AMP, thereby facilitating the interaction of cAMP and protein kinase A, which prevents activation of pro-inflammatory cytokines. Study patients were aged 2 to 17 years old, with >25% body surface area (BSA) involvement. The ointment was applied twice a day; absorption was rapid, with a safe steady state level reached by day 8. Improvement of symptoms (notably pruritus) was reached by day 5. Additionally, the mean percentage of skin involvement was reduced by 75%. Twenty-three of 34 patients (68%) experienced adverse reactions, none serious. Twelve (35%) had application site pain (causing a 2 year-old patient to leave the study) and 2 (6%) had application site paresthesias. The authors concluded that 2% Crisaborole ointment appears to be safe and effective in children and adolescents with AD involving at least 25% BSA (2).

I hope they’re right. I have learned that from a patient’s (and parent’s) perspective, first impressions count with a new drug. If there are problems from the outset, there may never be a second chance. If more than a third of patients complain of pain, stinging, or burning at the site of application, this must be discussed before that ointment ever hits the epidermis. Perhaps it would be best to approach its introduction using it in combination with topical steroids first (analogous to how stinging and burning with topical tacrolimus is diminished) before using it as monotherapy. I have introduced several “wonder drugs” over the years to my patients – I usually wonder why they don’t work as well as billed and why my patients seem to have more adverse reactions than reported. I’m not looking for miracles — I’d be delighted if 2% Crisaborole ointment is a well-tolerated reasonably effective agent for AD. We’ll find out soon.

1. Samara A, et al. A pilot study of an oral phosphodiesterase inhibitor (apremilast) for atopic dermatitis in adults. Arch Dermatol 2012; 148; 890-7.
2. Zane LT, et al. Crisaborole topical ointment, 2% in patients ages 12 to 7 years with atopic dermatitis: A phase 1b, open-label, maximal-use systemic exposure study. Pediatr Dermatol 2016; 33: 380-7.

*I formerly served on the advisory board of Anacor Pharmaceuticals, LLC.

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