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Home » Topics A–Z » 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 the 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.
In July 2019, apremilast was also approved by the FDA for treatment of oral ulcers associated with Behçet disease.
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.
ESTEEM - 1 | ESTEEM 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) |
Table 2 Adverse reactions reported in >1% of subjects on apremilast and with greater frequency than in subjects on placebo; up to day 112 (Week 16)
Adverse reaction | Placebo (N= 506) no. (%) | Apremilast (N= 920) no. (%) |
---|---|---|
Diarrhoea | 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) |
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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