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Safety

  • Adverse Reactions
  • Additional Safety
  • Laboratory Parameters

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

Placebo (n = 506)
n (%)
Otezla 30 mg BID
(n = 920) n (%)
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 paina 11 (2) 39 (4)
Vomiting 8 (2) 35 (4)
Fatigue 9 (2) 29 (3)
Dyspepsia 6 (1) 29 (3)
Decreased 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 abcess 0 (0) 10 (1)
Folliculitis 0 (0) 9 (1)
Sinus headache 0 (0) 9 (1)
a

Two subjects treated with Otezla experienced serious adverse reaction of abdominal pain.

The long-term safety profile of Otezla through 3 years was generally similar to that observed with Otezla through 16 weeks2

  • 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

Discontinuation rates due to adverse reactions1

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

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

Serious adverse events of interest2,a

Exposure-adjusted incidence rate/100 patient-yearsb
Placebo (n = 418)
Otezla 30 mg BID (n = 1184)
Major adverse cardiac events
Events 0.9 0.5
Malignancies
Hematologic 0.0 0.0
Skin (excluding melanoma) 0.9 1.1
Skin (including melanoma) 0.9 0.4
Infections
Non-opportunistic serious 1.7 1.0
Opportunistic 0.0 0.0
Reactivation of tuberculosis (TB)c 0.0 0.0
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.
a

The 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.

b

Exposure-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).

c

Patients 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.

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

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

Laboratory parameter
Placebo (n = 418) %
Otezla 30 mg BID (n = 832) %
Chemistry
ALT >3x ULN 0.2 0.1
AST >3x ULN 0.7 0.2
Bilirubin >1.8x ULN 0.2 0.2
Creatinine >1.7x ULN 0.0 0.1
Cholesterol >7.8 mmol/La 2.1 0.8
Urate, male >590 µmol/L; female >480 µmol/L 5.0 3.4
Hemoglobin A1c >9% 0.5 0.5
Hematology
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL 0.7 0.2
Lymphocytes <0.8 x 109/L 3.0 1.1
Neutrophils <1.0 x 109/L 0.0 0.0
Platelets >600 x 109/L 0.2 0.0
a

Did not have to be drawn when patient was fasting.

ULN, upper limit of normal.

References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation; 2015. 2. Data on file, Celgene Corporation.

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Indications & Important Safety Information

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