copaydosingefficacyresourcesafety

THIS SITE IS INTENDED FOR US AUDIENCES ONLY

Safety

Otezla® (apremilast) has a proven safety profile1,2
  • Adverse Reactions Through Week 16Button to view the adverse reactions through week 16 reported in the PALACE 1-3 clinical trials
  • Adverse Reactions Through Week 156Button to view the adverse reactions reported in the ESTEEM clinical trials through week 156
  • Additional SafetyButton to view additional safety information from the ESTEEM clinical trials
  • Laboratory ParametersButton to view a table of selected abnormalities in laboratory parameters reported in the ESTEEM clinical trials

ADVERSE REACTIONS THROUGH WEEK 161

Adverse reactions reported in ≥1% of patients on Otezla and with greater frequency than in subjects on placebo; up to day 112 (week 16)1,a

 
Placebo(n = 506) n (%)
Otezla 30 mg BID (n = 920) n (%)
Adverse Reaction
Diarrhea32 (6)160 (17)
Nausea35 (7)155 (17)
Upper respiratory tract infection31 (6)84 (9)
Tension headache21 (4)75 (8)
Headache19 (4)55 (6)
Abdominal painb11 (2)39 (4)
Vomiting8 (2)35 (4)
Fatigue9 (2)29 (3)
Dyspepsia6 (1)29 (3)
Decreased appetite5 (1)26 (3)
Insomnia4 (1)21 (2)
Back pain4 (1)20 (2)
Migraine5 (1)19 (2)
Frequent bowel movements1 (0)17 (2)
Depression2 (0)12 (1)
Bronchitis2 (0)12 (1)
Tooth abcess0 (0)10 (1)
Folliculitis0 (0)9 (1)
Sinus headache0 (0)9 (1)

aThe safety of Otezla was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials (including the ESTEEM studies). bTwo subjects treated with Otezla experienced serious adverse reaction of abdominal pain.

The majority of patients reporting nausea and diarrhea did so within the first 2 weeks; the events tended to resolve over time with continued dosing2

  • 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
  • Discontinuation of treatment due to any adverse reaction was 6.1% for patients taking Otezla and 4.1% for placebo1
  • The most common adverse reactions leading to discontinuation for patients taking Otezla were nausea (1.6%), diarrhea (1.0%), headache (0.8%)1

LIBERATE

  • The most common adverse reactions in ≥5% of patients were nausea, diarrhea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. Discontinuation of treatment due to adverse reactions was 3.6% for Otezla and 2.4% for placebo3

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; LIBERATE, Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis.

ESTEEM®: ADVERSE REACTIONS THROUGH WEEK 1564

Adverse reactions reported in >5% of patients on Otezla and with greater frequency than in subjects on placebo; up to week 1564

 Otezla Exposure Period4,a
Weeks 0 to ≤52 Otezla 30 mg BID (n = 1184) n (%)
Weeks >52 to ≤104 Otezla 30 mg BID (n = 654) n (%)
Weeks >104 to ≤156 Otezla 30 mg BID (n = 401) n (%)
Adverse Reaction
Diarrhea205 (17.3)15 (2.3)7 (1.7)
Nausea186 (15.7)5 (0.8)6 (1.5)
Upper respiratory tract infection184 (15.5)58 (8.9)27 (6.7)
Nasopharyngitis167 (14.1)43 (6.6)24 (6.0)
Tension headache106 (9.0)8 (1.2)5 (1.2)
Headache75 (6.3)6 (0.9)7 (1.7)
a

Includes all patients in the ESTEEM trials who received Otezla during the time interval relative to the start of Otezla administration.

  • Discontinuation due to adverse reactions occurred at 7.9% during weeks 0 to ≤52, 3.1% during weeks >52 to ≤104, and 3.5% during weeks >104 to ≤1564

The long-term safety profile through 3 years, including serious adverse reactions, was consistent with that observed through 16 weeks1,4

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis.

ESTEEM®: ADVERSE REACTIONS OF SPECIAL INTEREST2

Adverse reactions of special interest2,a

Exposure-adjusted incidence rate/100 patient-yearsb

 
Placebo (n = 418)
Otezla 30 mg BID(n = 1184)
Major adverse cardiac events
Events0.90.5
Malignancies
Hematologic0.00.0
Skin (excluding melanoma)0.91.1
Skin (including melanoma)0.90.4
Infections
Non-opportunistic serious1.71.0
Opportunistic (systemic)0.00.0
Reactivation of tuberculosis (TB)c0.00.0

aThe placebo group includes data from weeks 0 to 16. For the Otezla group, all data for subjects exposed to Otezla are included regardless of when the Otezla exposure started. bExposure-adjusted incidence rate/100 patient-years is 100 times the number (n) of patients reporting the event divided by patient-years (up to the first event start date for patients reporting the event). cPatients with a history of active or incompletely treated TB were excluded from the trials. There was no requirement for latent TB screening. The trials included 9 patients with a history of either latent TB, pulmonary TB, disseminated TB, or a positive tuberculin test or QuantiFERON®-TB Gold.

In the pooled safety data for the phase 3 studies, 2 patients reported positive QuantiFERON®-TB Gold test results; both were in ESTEEM 1. Both patient cases were sent for adjudication. One was adjudicated as latent TB; it is unknown whether the patient had latent TB prior to study enrollment. Both patients were treated prophylactically with TB therapy.

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis.

ESTEEM®: Laboratory parameters2

Selected marked abnormalities in laboratory parameters (weeks 0 to 16, pooled placebo-controlled safety population)2

 
Placebo(n = 418) (%)
Otezla 30 mg BID(n = 832) (%)
Chemistry
ALT >3x ULN0.20.1
AST >3x ULN0.70.2
Bilirubin >1.8x ULN0.20.2
Creatinine >1.7x ULN0.00.1
Cholesterol >7.8 mmol/La2.10.8
Urate, name >590 μmol/L; female >480 μmol/L5.03.4
Hemoglobin A1c >9%0.50.5
Hematology
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL0.70.2
Lymphocytes <0.8 x 109/L3.01.1
Neutrophils <1.0 X 109/L0.00.0
Platelets <75 x 109/L0.20.0
a

Did not have to be drawn when patient was fasting.

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; ULN, upper limit of normal.

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

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Data on file, Celgene Corporation. 3. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 4. Crowley J, Thaçi D, Joly P, et al. J Am Acad Dermatol. 2017;77(2):310-317.

Indications & Important Safety Information

Please click here for Full Prescribing Information.

You are leaving the Otezla® (apremilast) website

Do you wish to leave this site?

Are You a
Healthcare Professional?

Getting Otezla Gets Even Easier

8 out of 10commercially insured lives in the US have preferred access with no biologic step required for Otezla® (apremilast)1

Click here for a complete list of plans
Reference: 1. Data on file, Celgene Corporation.
01/18 USII-APR180063