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Moderate to Severe Plaque Psoriasis
Placebo(n = 506) n (%)
|
Otezla 30 mg BID (n = 920) n (%)
|
|
---|---|---|
Adverse reaction | ||
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 painb | 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) |
The safety of Otezla was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials (including the ESTEEM studies).
Two subjects treated with Otezla experienced serious adverse reaction of abdominal pain.
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.
Placebo(n = 102) n (%)
|
Otezla 30 mg BID (n = 200) n (%)
|
|
---|---|---|
Adverse reaction | ||
Diarrhea | 11 (11) | 61 (31) |
Nausea | 6 (6) | 43 (22) |
Headache | 5 (5) | 24 (12) |
Vomiting | 2 (2) | 11 (6) |
Otezla was evaluated in a Phase 3, multicenter, randomized, placebo-controlled study in adults with moderate to severe plaque psoriasis of the scalp. A total of 302 patients were randomized to receive Otezla 30 mg BID or placebo.
Placebo(n = 84) n (%)
|
Otezla 30 mg BID (n = 83) n (%)
|
|
---|---|---|
Adverse reaction | ||
Headache | 3 (3.6) | 11 (13.3) |
Nausea | 1 (1.2) | 9 (10.8) |
Diarrhea | 3 (3.6) | 9 (10.8) |
Upper respiratory tract infection | 2 (2.4) | 6 (7.2) |
Tension headache | 4 (4.8) | 5 (6.0) |
Nasopharyngitis | 8 (9.5) | 4 (4.8) |
Placebo/Otezla 30 mg BID (N=84) n (%)
|
Otezla 30 mg BID/
Otezla 30 mg BID (N=163) n (%) |
|
---|---|---|
Adverse reactions | ||
Nausea | 8 (9.5) | 6 (3.7) |
Nasopharyngitis | 0 | 5 (3.1) |
Urinary tract infection | 2 (2.4) | 5 (3.1) |
Diarrhea | 14 (16.7) | 4 (2.5) |
Back pain | 0 | 4 (2.5) |
Includes all patients who received Otezla during the time interval relative to the start of Otezla administration.
BID, twice daily.
Otezla Exposure Period2,a | ||||
---|---|---|---|---|
Weeks 0 to ≤52 Otezla 30 mg BID (n = 1184) n (%)
|
Weeks >52 to ≤104 Otezla 30 mg BID (n = 653) n (%)
|
Weeks >104 to ≤156 Otezla 30 mg BID (n = 402) n (%)
|
Weeks >156 to ≤208 Otezla 30 mg BID (n = 291) n (%)
|
|
Adverse reaction | ||||
Diarrhea | 205 (17.3) | 15 (2.3) | 7 (1.7) | 7 (2.4) |
Nausea | 186 (15.7) | 5 (0.8) | 6 (1.5) | 3 (1.0) |
Upper respiratory tract infection | 184 (15.5) | 58 (8.9) | 28 (7.0) | 28 (9.6) |
Nasopharyngitis | 167 (14.1) | 43 (6.6) | 24 (6.0) | 15 (5.2) |
Tension headache | 106 (9.0) | 8 (1.2) | 5 (1.2) | 3 (1.0) |
Headache | 75 (6.3) | 6 (0.9) | 7 (1.7) | 2 (0.7) |
Includes all patients in the ESTEEM trials who received Otezla during the time interval relative to the start of Otezla administration.
BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis.
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 (systemic) | 0.0 | 0.0 |
Reactivation of tuberculosis (TB)c | 0.0 | 0.0 |
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.
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).
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.
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.
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 <75 x 109/L | 0.0 | 0.0 |
Did not have to be drawn when patient was fasting. ALT, alanine aminotransferase; AST, aspartate aminotransferase; 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]. Thousand Oaks, CA: Amgen Inc. 2. Van Voorhees AS, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. J Am Acad Dermatol. 2020. doi:10.1016/j.jaad.2020.01.072 3. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 4. Data on file, Amgen Inc.
Reference: 1. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 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. 5. Reich K, Gooderham M, Bewley A, et al. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. Journal of the American Academy of Dermatology (2020), doi:10.1016/j.jaad.2020.01.072.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 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. 5. Reich K, Gooderham M, Bewley A, et al. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. Journal of the American Academy of Dermatology (2020), doi:10.1016/j.jaad.2020.01.072.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 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. 5. Reich K, Gooderham M, Bewley A, et al. J Eur Acad Dermatol Venereol. 2018;32(3):397-402. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. Journal of the American Academy of Dermatology (2020), doi:10.1016/j.jaad.2020.01.072.
Otezla® (apremilast) is indicated for the treatment of adult 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.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.
Otezla® (apremilast) is indicated for the treatment of adult 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.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.