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Adverse Reactions through Week 16 in Plaque Psoriasis | Otezla® (apremilast) Healthcare Professional Site
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3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with 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. Read less

Read less
Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
Oral Ulcers in Behçet’s Disease
About Behçet's Disease Oral Ulcers in BD
Oral Ulcers in Behçet’s Disease
Clinical Response of Oral Ulcers Oral Ulcers: Pain Results Oral Ulcers: Complete Response Oral Ulcers: Maintenance of Response Oral Ulcers: Daily Average
Oral Ulcers in Behçet’s Disease
Study Design
Oral Ulcers in Behçet’s Disease
RELIEF Safety Laboratory Parameters
Psoriatic Arthritis
About Psoriatic Arthritis
Psoriatic Arthritis
Overview PALACE 1-3 PALACE 4 ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years ACTIVE Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis
Plaque Psoriasis
Overview ADVANCE ESTEEM STYLE DISCREET LIBERATE
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library
Plaque Psoriasis
Overview Adverse Reactions Through Week 16 Adverse Reactions Weeks 16 to 32 Adverse Reactions Through 5 Years Adverse Events of Special Interest Laboratory Parameters
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Mechanism of Disease (MOD) Otezla MOA
Dosing

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA SEE THE DATA

First and only oral therapy approved for mild, moderate, and severe plaque psoriasis, and active PsA

SEE THE DATA REFERENCES

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1 START TODAY WITHOUT DELAY

No lab monitoring. No TB or baseline blood panel tests. No planning around live vaccines 1

 START TODAY WITHOUT DELAY REFERENCES

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,* PLAQUE PSORIASIS SAFETY PsA SAFETY

A small pill with a big history: 840,000+ patients treated globally since 2014 1.3,*

PLAQUE PSORIASIS SAFETY PsA SAFETY REFERENCES & FOOTNOTE
REFERENCES REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=58% of data). Calculations based on observed drug utilization parameters and number of units distributed. Utilization patterns change over time to best represent current markets.

FDA, U.S. Food and Drug Administration; PsA, psoriatic arthritis; TB, tuberculosis.

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Otezla® (apremilast) FDA approval letter. March 21, 2014.

JUMP TO:

Otezla has an established safety profile across all severities of plaque psoriasis 1,2

ADVANCE: WEEK 16 SAFETY

Adverse reactions through week 16 in patients with mild to moderate plaque psoriasis 1

AN ESTABLISHED SAFETY PROFILE IN MILD TO MODERATE PATIENTS THROUGH WEEK 16 1

ADVANCE: Treatment-emergent adverse events (TEAEs) at week 16 1

Chart 1 of Otezla safety in plaque psoriasis at Week 16
  • The most commonly reported TEAEs that occurred in ≥5% of patients in either treatment group were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection 1

ADVERSE EVENTS IN MILD TO MODERATE PLAQUE PSORIASIS PATIENTS WERE CONSISTENT WITH THE ESTABLISHED OTEZLA SAFETY PROFILE IN MODERATE TO SEVERE PLAQUE PSORIASIS PATIENTS. THESE EVENTS TENDED TO RESOLVE OVER TIME WITH CONTINUED DOSING 1-5

ESTEEM: WEEK 16 SAFETY

Adverse reactions through week 16 in patients with moderate to severe plaque psoriasis 2

AN ESTABLISHED SAFETY PROFILE IN MODERATE TO SEVERE PATIENTS THROUGH WEEK 16 2

ESTEEM: Adverse reactions reported in ≥1% of subjects on Otezla
and with greater frequency than in subjects on placebo through week 16 2,*

Chart 2 of Otezla safety in plaque psoriasis at Week 16

*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 a serious adverse reaction of abdominal pain.

  • Discontinuation of treatment due to any adverse reaction was 6.1% for patients taking Otezla and 4.1% for placebo 2
  • The most common adverse reactions leading to discontinuation for patients taking Otezla were nausea (1.6%), diarrhea (1.0%), headache (0.8%) 2

THE MAJORITY OF PATIENTS REPORTING
NAUSEA AND DIARRHEA DID SO WITHIN
THE FIRST 2 WEEKS; THE EVENTS
TENDED TO RESOLVE OVER TIME WITH CONTINUED DOSING 3,4

  • 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 vomiting 2

STYLE: WEEK 16 SAFETY

Adverse reactions through week 16 in moderate to severe scalp psoriasis 6

AN ESTABLISHED SAFETY PROFILE IN SCALP PSORIASIS THROUGH WEEK 16 6

STYLE: Most common adverse reactions reported in ≥5% of patients on Otezla
and with greater frequency than in patients on placebo through week 16 6,‡

Chart 3 of Otezla safety in plaque psoriasis at Week 16

‡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.

  • Discontinuation rates due to gastrointestinal adverse reactions in patients who received Otezla 30 mg BID vs placebo, respectively 2,6:
    • Diarrhea: 3% vs 0%
    • Nausea: 1.5% vs 1%
    • Vomiting: 1.5% vs 0%
Video about the STYLE clinical trial study design and primary enbpoint of Otezla® (apremilast)

STYLE Data Video

WATCH VIDEO

DISCONTINUATION OF TREATMENT DUE TO ANY ADVERSE EVENT DURING THE 16-WEEK PLACEBO-CONTROLLED PERIOD WAS 6% FOR PATIENTS TAKING OTEZLA AND 3% FOR PLACEBO 2

DISCREET: WEEK 16 SAFETY

Adverse reactions through week 16 in patients with moderate to severe plaque psoriasis and moderate to severe plaque psoriasis of the genital area 5,7

AN ESTABLISHED SAFETY PROFILE THROUGH WEEK 16 5

DISCREET: Most common TEAEs through week 16 5,§

discreet-week-16-safety
discreet-week-16-safety-mobile

§Each subject is counted once for each applicable specific TEAE. Subject incidence is 100 times the number (n) of subjects reporting the event divided by N.

**Patient years=39.8. ††Patient years=41.2.

  • The most commonly reported adverse events that occurred in ≥5% of patients in either treatment group were diarrhea, headache, nausea, and nasopharyngitis 5

THE SAFETY AND TOLERABILITY PROFILE IN THE DISCREET CLINICAL TRIAL WAS CONSISTENT WITH THE OTEZLA SAFETY PROFILE ESTABLISHED IN ADULT SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS 2

LIBERATE: WEEK 16 SAFETY

Adverse reactions through week 16 in patients with moderate to severe plaque psoriasis 8

AN ESTABLISHED SAFETY PROFILE IN MODERATE TO SEVERE PATIENTS THROUGH WEEK 16 8

LIBERATE: Most common adverse reactions reported in ≥5% of patients
in any treatment group through week 16 8

Chart 4 of Otezla safety in plaque psoriasis at Week 16
  • Discontinuation of treatment due to adverse reactions was 3.6% for Otezla and 2.4% for placebo 8
 

BID, twice daily.

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IMPORTANT SAFETY INFORMATION 

Contraindications

Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation 

Warnings and Precautions

Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

  • Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider
    discontinuation of Otezla
    • Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of
      patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
  • Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
  • Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

Please click here for the full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients with 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.

References: 1. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 3. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 4. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 5. Data on file, Amgen Inc. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 7. Merola F, Parish L, Guenther L, et al. Abstract presented at: the 31st Annual Meeting of the European Academy of Dermatology and Venereology (EADV); September 7-10, 2022. 8. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.