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Oral Ulcers in Behçet's Disease

Safety

Safety data from Otezla® (apremilast) clinical trials

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  • Adverse Reactions Through Week 12
  • Laboratory Parameters

RELIEF: Adverse reactions through week 121,3

Adverse reactions reported in ≥5% of patients on Otezla 30 mg twice daily and with
at least 1% greater frequency than patients on placebo up to week 121,3,a

 
Placebo
(N = 103)
n (%)
Otezla 30 mg BID
(N = 104)
n (%)
Adverse reaction
Diarrheaa21 (20.4)43 (41.3)
Nauseaa11 (10.7)20 (19.2)
Headache11 (10.7)15 (14.4)
Upper respiratory tract infection5 (4.9)12 (11.5)
Abdominal pain upper2 (1.9)9 (8.7)
Vomitinga2 (1.9)9 (8.7)
Back pain6 (5.8)8 (7.7)
Viral upper respiratory tract infection5 (4.9)7 (6.7)
Arthralgia3 (2.9)6 (5.8)

aThere were no serious adverse reactions of diarrhea, nausea, or vomiting.

  • The most commonly reported adverse reactions (≥10%) for Otezla include diarrhea, nausea, headache, and upper respiratory tract infection
  • Discontinuation of treatment due to adverse reactions during the placebo-controlled period of the study was 2.9% for patients taking Otezla and 4.9% for placebo

The majority of patients reporting diarrhea, nausea, and vomiting did so within the first week, and the events tended to resolve over time3

  • Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. Monitor patients who are more susceptible to complications of diarrhea or vomiting1

The Full Prescribing Information for Otezla has no requirement for routine laboratory monitoring1

RELIEF: Selected marked abnormalities in laboratory parameters
(placebo-controlled period, safety population)2

 
Placebo(N = 103)
n/ma (%)
Otezla 30 mg BID (N = 104)
n/ma (%)
Chemistry
ALT >3x ULN1/98 (1.0)1/103 (1.0)
Hematology
Lymphocytes <0.8 x 109/L1/98 (1.0)0/102 (0.0)
Neutrophils <1.0 x 109/L0/98 (0.0)1/102 (1.0)
Platelets >600 x 109/L0/98 (0.0)1/102 (1.0)
a

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.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

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