Key clinical-trial evidence for crisaborole

Author: Anoma Ranaweera, Medical Writer, Auckland, New Zealand. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, March 2017.

In December 2016, the US Food and Drug Administration (FDA) approved 2% crisaborole topical ointment (EUCRISA, Anacor Pharmaceuticals, California, USA) to treat mild to moderate atopic dermatitis in patients 2 years of age and older.

The approval of crisaborole was based on results of two large, identical, multicenter, randomised, double-blind, parallel-group, vehicle-controlled (non-medicated ointment) trials (Trials 1 and 2) that treated 1522 patients aged  2–79 years with mild to moderate atopic dermatitis.

Crisaborole is the first and only non-steroidal topical monotherapy for atopic dermatitis that inhibits the phosphodiesterase-4 (PDE-4) enzyme in the skin.

Overactive PDE-4 has been shown to contribute to the signs and symptoms of atopic dermatitis.

Major trials supporting clinical efficacy of crisaborole

See below to view Table 1 and Table 2:

View Table 1

Trial 1

Trial 2

Eucrisa

(n = 503)

Vehicle

(n = 256)

Eucrisa

(n = 513)

Vehicle

(n = 250)

Success in IGSA×

32.8%

25.4%

31.4%

18%

View Table 2

Event [No. Patients (%)]

Crisaborole (n = 1012)

Vehicle (n = 499)

Treatment-related AE∗

Application site pain

45 (4.4)

6 (1.2)  [P=0.0001]

Treatment-emergent AE

Gastrointestinal disorders

27 (2.7)

12 (2.4)

Application site pruritus

5 (0.5)

6 (1.2)

Pyrexia

19 (1.9)

7 (1.4)

Nasopharyngitis

18 (1.8)

6 (1.2)

Staphylococcal skin infection

1 (0.1)

5 (1.0) [P= 0.017]

Upper respiratory tract infection

30 (3.0)

15 (3.0)

Headache

11 (1.1)

1 (0.2)

Cough

12 (1.2)

8 (1.6)

Skin and subcutaneous tissue disorders

37 (3.7)

21 (4.2)

Dermatitis atopic

7 (0.7)

8 (1.6)

Next steps with crisaborole 

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