×
There are updates to the co-pay card. If your patient is having issues using their co-pay card, click here for more information.
Otezla RELIEF Study Design for Oral Ulcers Associated With Behcet's Disease | Otezla® (apremilast) Healthcare Professional Site
Close window icon

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
Resources Overview Downloadable Resources Patient Profiles Billing and Coding Video Hub FAQs
Start Today Formulary Access Co-Pay and Patient Support
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.

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.

Accordion icon

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. 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.