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Safety

  • Adverse Reactions
    through Week 16
  • Adverse Reactions
    through Week 156
  • Additional
    Safety
  • Laboratory
    Parameters

The most common adverse reactions with Otezla® (apremilast) through week 161

Adverse reactions reported in ≥2% of patients on Otezla 30 mg twice daily and ≥1% than that observed in patients on placebo for up to day 112 (week 16)1

Placebo Otezla 30 mg twice daily
Adverse Reaction Day 1 to Day 5 (N = 495)
n (%)
Day 6 to Day 112 (N = 490)
n (%)
Day 1 to Day 5 (N = 497)
n (%)
Day 6 to Day 112 (N = 493)
n (%)
Diarrheaa 6 (1.2) 8 (1.6) 46 (9.3) 38 (7.7)
Nauseaa 7 (1.4) 15 (3.1) 37 (7.4) 44 (8.9)
Headachea 9 (1.8) 11 (2.2) 24 (4.8) 29 (5.9)
Upper respiratory tract infectionb 3 (0.6) 9 (1.8) 3 (0.6) 19 (3.9)
Vomitinga 2 (0.4) 2 (0.4) 4 (0.8) 16 (3.2)
Nasopharyngitisb 1 (0.2) 8 (1.6) 1 (0.2) 13 (2.6)
Abdominal pain upperb 0 (0.0) 1 (0.2) 3 (0.6) 10 (2.0)
a

Of the reported gastrointestinal adverse reactions, 1 patient experienced a serious adverse reaction of nausea and vomiting in Otezla 30 mg twice daily; 1 patient treated with Otezla 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 patient treated with Otezla 30 mg twice daily experienced a serious adverse reaction of headache.

b

Of the reported adverse drug reactions, none were serious.

  • The majority of patients reporting the most common adverse reactions did so within the first 2 weeks, and the events tended to resolve over time with continued dosing1

Discontinuation rates due to adverse reactions in the 3 trials1

  • Most common adverse reactions leading to discontinuation: nausea (1.8%), diarrhea (1.8%), and headache (1.2%)
  • Otezla® (apremilast) arm 4.6%; placebo arm 1.2%

The most common adverse reactions through week 1562

Adverse reactions in ≥5% of patients on Otezla 30 mg twice daily, any treatment group2

Otezla 30 mg twice daily
Weeks 0 to ≤52
(N = 721)
n (%)
Weeks >52 to ≤104
(N = 520)
n (%)
Weeks >104 to ≤156
(N = 443)
n (%)
Diarrhea 112 (15.5) 20 (3.8) 11 (2.5)
Nausea 108 (15.0) 11 (2.1) 10 (2.3)
Upper respiratory tract infection 60 (8.3) 27 (5.2) 23 (5.2)
Headache 75 (10.4) 17 (3.3) 12 (2.7)
Nasopharyngitis 41 (5.7) 31 (6.0) 19 (4.3)

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

  • Discontinuation due to AEs occurred at 1.6% during weeks >104 to ≤156, 2.4% during weeks >52 to ≤104, and 7.5% during weeks 0 to ≤52

Adverse reactions with Otezla® (apremilast)2

Adverse reactions of special interest2

Exposure-adjusted incidence rate/
100 patient-yearsa
Placebo
(168.2 patient-years)
Otezla 30 mg twice daily
(769.0 patient-years)
Major adverse cardiac events
Events 0.0 0.1
Malignancies
Hematologic 0.0 0.0
Skin (excluding melanoma) 1.2 0.5
Solid (including melanoma) 0.6 0.1
Infections
Non-opportunistic serious 0.6 0.5
Opportunistic (systemic) 0.6 0.0
New cases of tuberculosis (TB)b 0.0 0.0
Reactivation of TB 0.0 0.0
a

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).

b

Patients with a history of active or incompletely treated TB were excluded from the trials. The trials included 32 patients with a history of fully treated TB, a positive PPD or QuantiFERON®, or a history of receiving preventive medication for TB.

The adverse reactions of special interest were generally similar through 156 weeks

Laboratory abnormalities reported in the placebo-controlled period and long-term exposure period in patients on Otezla 30 mg twice daily2


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

Selected marked abnormalities in laboratory parameters2

Laboratory parameter Placebo-controlleda Exposure Periodb
Weeks 0 to ≤24 Weeks 0 to ≤24 Weeks 0 to ≤52 Weeks >52 to ≤104 Weeks >104 to ≤156
Placebo
(N = 495)
%, (n/N)
Otezla 30 mg
twice daily
(N = 497)
%, (n/N)
Otezla 30 mg
twice daily
(N = 721)
%, (n/N)
Otezla 30 mg
twice daily
(N = 520)
%, (n,N)
Otezla 30 mg
twice daily
(N = 443)
%, (n/N)
Chemistry
AST >3x ULN 0.2(1/492) 1.4(7/492) 1.3(9/713) 0.4(2/518) 0.5(2/442)
AST >3x ULN 0.4(2/491) 0.4(2/492) 0.6(4/713) 0.2(1/518) 0.7(3/442)
Bilirubin >1.8x ULN 0.0 0.4(2/492) 0.3(2/713) 0.4(2/518) 0.5(2/442)
Creatinine >1.7x ULN 0.2(1/492) 0.2(1/492) 0.1(1/713) 0.0 0.0
Cholesterol >7.8 mmol/Lc 2.0(10/492) 3.5(17/492) 3.8(27/713) 2.3(12/518) 2.9(13/442)
Urate, male >590 μmol/L;
female >480 μmol/Ld
2.8(14/492) 3.5(17/492) 3.8(27/713) 3.7(19/518) 4.3(19/442)
Hematology
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL 0.2(1/489) 0.4(2/489) 0.7(5/713) 0.8(4/517) 1.1(5/442)
Leukocytes <1.5 x 109/L 0.0 0.0 0.0 0.0 0.0
Lymphocytes <0.8 x 109/L 3.5(17/488) 3.3(16/489) 3.9(28/713) 2.9(15/517) 3.2(14/442)
Neutrophils <1.0 x 109/L 0.4(2/488) 0.2(1/489) 0.3(2/713) 0.6(3/517) 0.5(2/442)
Platelets <75 x 109/L 0.0 0.0 0.0 0.0 0.2(1/441)
a

Placebo-controlled period includes all data through week 16 for patients initially assigned to placebo who escaped, and all data through week 24 for all other patients.

b

Otezla-exposure period includes all Otezla-exposure data, regardless of when the Otezla exposure started (week 0, 16, or 24).

c

Did not have to be drawn when the patient was fasting.

d

Urate, male >9.9 mg/dL; female >8.1 mg/dL.

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

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