On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).
Oral Ulcers in Behçet's Disease
(N = 103)
Otezla 30 mg BID
(N = 104)
|Diarrheaa||21 (20.4)||43 (41.3)|
|Nauseaa||11 (10.7)||20 (19.2)|
|Headache||11 (10.7)||15 (14.4)|
|Upper respiratory tract infection||5 (4.9)||12 (11.5)|
|Abdominal pain upper||2 (1.9)||9 (8.7)|
|Vomitinga||2 (1.9)||9 (8.7)|
|Back pain||6 (5.8)||8 (7.7)|
|Viral upper respiratory tract infection||5 (4.9)||7 (6.7)|
|Arthralgia||3 (2.9)||6 (5.8)|
aThere were no serious adverse reactions of diarrhea, nausea, or vomiting.
Placebo(N = 103)
Otezla 30 mg BID (N = 104)
|ALT >3x ULN||1/98 (1.0)||1/103 (1.0)|
|Lymphocytes <0.8 x 109/L||1/98 (1.0)||0/102 (0.0)|
|Neutrophils <1.0 x 109/L||0/98 (0.0)||1/102 (1.0)|
|Platelets >600 x 109/L||0/98 (0.0)||1/102 (1.0)|
n/m, number of patients with at least 1 occurrence of the abnormality/number of patients with a baseline value and at least 1 postbaseline value for criteria requiring baseline or number of patients with at least 1 postbaseline value for criteria not requiring baseline. Data collected later than 28 days after the last dose of Otezla® (apremilast) were excluded. Patient incidence was 100 times n divided by m. Laboratory test results with no abnormalities were excluded from the table.
ALT, alanine aminotransferase; ULN, upper limit of normal.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of Apremilast for oral ulcers in Behçet’s Syndrome. N Engl J Med. 2019; 381:1918-1928.
Otezla® (apremitast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Warnings and Precautions
Use in Specific Populations