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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

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Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE THE DATA

RELIEF STUDY DESIGN

Study Design 1

Horizontal bar chart of a RELIEF study design a double-blind, placebo-controlled treatment of 12 weeks, active treatment of 52 weeks, and post-treatment observational follow-up of 4 weeks on Otezla

Baseline demographics and disease characteristics were balanced between study arms, with a mean duration of BD diagnosis of 6.8 years; mean oral ulcer count of 4.2 (Otezla) and 3.9 (placebo). 1,2

Study design:

  • RELIEF: Multicenter, randomized, double-blind, placebo-controlled Phase 3 study 1,2
  • 207 adult patients with BD with active oral ulcers 1
  • Randomized 1:1 to either Otezla 30 mg BID (n=104) or placebo (n=103) for 12 weeks 1,2
  • Doses were titrated for the first 5 days 2
  • After week 12, all patients received Otezla 30 mg BID for the 52-week active treatment phase 3

Criteria and endpoints

Measures of oral ulcers 2:

  • Change from baseline in the pain of oral ulcers as measured by VAS at week 12
  • Proportion of patients achieving oral ulcer complete response (oral ulcer–free) at week 12
  • Proportion of patients achieving oral ulcer complete response (oral ulcer–free) by week 6 and who remained oral ulcer–free for at least 6 additional weeks during the 12-week placebo-controlled treatment phase
  • Daily average number of oral ulcers during the 12-week placebo-controlled treatment phase

Selected inclusion criteria 2,3:

  • Met the ISG criteria for BD
  • >2 oral ulcers at screening and at least 2 oral ulcers at randomization, and without currently active major organ involvement
  • Oral ulcers that occurred >3 times in the previous 12 months prior to randomization
  • Candidates for systemic therapy
  • Prior treatment with at least 1 non-biologic BD therapy, such as immunosuppressants, colchicine, oral or topical corticosteroids, or NSAIDs. Previous exposure to biologic therapies was permitted for manifestations other than oral ulcers 1-3
  • Patients with mild BD-related ocular lesions not requiring systemic immunosuppressive therapy were allowed 1-3

Selected exclusion criteria:

  • BD-related active major organ involvement 2
  • Topical corticosteroids, colchicine, immunosuppressants, and biologics were not allowed during the placebo-controlled period 1

Patient demographics

Disease characteristics:

  • Mean duration: 6.8 years 2
  • All patients had a history of recurrent oral ulcers that were currently active 3
    • Baseline oral ulcer counts (Otezla: 4.2; placebo: 3.9) 2
  • Patients also had a history of 2:
    • Skin lesions (99%)
    • Genital ulcers (90%)
    • Musculoskeletal manifestations (73%)
    • Ocular manifestations (17%)
    • Neurologic manifestations (10%)
    • Gastrointestinal manifestations (9%)
    • Vascular involvement (1%)

Mean age 2,3:

  • 40 years (19 to 72 years)
Thumbnail image of a video about Otezla in clinical studies for the treatment of oral ulcers in Behçet's Disease

Otezla in Behçet’s
Disease Video

WATCH VIDEO
 

BD, Behçet’s Disease; BID, twice daily; ISG, International Study Group; NSAIDs, nonsteroidal anti-inflammatory drugs; VAS, visual analog scale.

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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
  • 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. Hatemi G, Mahr A, Ishigatsubo Y, et al. N Engl J Med. 2019;381(20):1918-1928. 2. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 3. Data on file, Amgen, Inc.