Key clinical-trial evidence for apremilast

Author:Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2015.

Apremilast (Otezla®; Cellgene, New Jersey, USA) is an oral small molecule inhibitor of the enzyme phosphodiesterase 4, which plays an important role in chronic inflammation associated with psoriasis.

On September 23, 2014 the US Food and Drug Administration (FDA) approved apremilast for treatment of patients with moderate-to-severe plaque psoriasis mostly on the basis of results from 2 multicentre clinical trials — ESTEEM 1 and ESTEEM 2.

ESTEEM trials

The proportion of subjects who achieved PASI-75 responses, and sPGA (static physician global assessment score — physician's impression of the disease at a single point) of clear (0) or almost clear (1), are presented in Table 1.

Table 1: Clinical Response at Week 16 in Studies ESTEEM-1 and ESTEEM-2
ESTEEM - 1ESTEEM 2
  Placebo Apremilast Placebo Apremilast
No. randomised 282 562 137 274
PASI 75%; no. (%) 15 (5.3) 186 (33.1) 8 (5.8) 79 (28.8)
sPGA no. (%) 11 (3.9) 122 (21.7) 6 (4.4) 56 (20.4)

Adverse reactions

Table 2 Adverse reactions reported in >1% of subjects on apremilst and with greater frequency than in subjects on placebo; up to day 112 (Week 16)

Adverse reactionPlacebo (N= 506) no. (%)Apremilast (N= 920) no. (%)
Diarrhea 32 (6) 160 (17)
Nausea 35 (7) 155 (17)
Upper respiratory tract infection 31 (6) 84 (9)
Tension headache 21 (4) 75 (8)
Headache 19 (4) 55 (6)
Abdominal pain 11 (2) 39 (4)
Vomiting 8 (2) 35 (4)
Fatigue 9 (2) 29 (3)
Dyspepsia 6 (1) 29 (3)
Decrease appetite 5 (1) 26 (3)
Insomnia 4 (1) 21 (2)
Back pain 4 (1) 20 (2)
Migraine 5 (1) 19 (2)
Frequent bowel movements 1 (0) 17 (2)
Depression 2 (0) 12 (1)
Bronchitis 2 (0) 12 (1)
Tooth abscess 0 (0) 10 (1)
Folliculitis 0 (0) 9 (1)
Sinus headache 0 (0) 9 (1)

Future directions

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