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Fatigue Data for Otezla in the Treatment for Psoriatic Arthritis in Adult Patients — Efficacy | 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

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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: 920,000+ patients treated globally since 2014 1.2,* PsO SAFETY PsA SAFETY

A small pill with a big history: 920,000+ patients treated globally since 2014 1.2,*

PsO SAFETY PsA SAFETY REFERENCES & FOOTNOTE

Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=57% 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.

It’s time to focus on fatigue in psoriatic arthritis from the start

PALACE 1-3: FATIGUE

PALACE 1-3: Evaluated in adult patients with active psoriatic arthritis (N=1493) who had a documented diagnosis of psoriatic arthritis of
≥6 months’ duration along with ≥3 swollen and ≥3 tender joints despite prior or current DMARD treatment 1

MEAN CHANGE IN FATIGUE SCORE THROUGH 5 YEARS 2

PALACE 1-3: Mean Change in FACIT-F

Bar chart from a PALACE 1-3 study that represents the mean percent change in FACIT-Fatigue score through 5 years

*Prespecified pooled analysis; weeks 16, 24, and 52 were prespecified secondary endpoints. Includes all patients exposed to Otezla, including during the placebo-controlled period, regardless of when patients started taking Otezla (baseline, week 16, or week 24) through week 260. FACIT-F is a 13-item, self-administered questionnaire that assesses fatigue and its physical impact on daily activities and function. The total FACIT-F score ranges from 0 to 52, with lower scores denoting higher levels of fatigue.

  • Consider open-label extension (OLE) phase study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias. Overall, from weeks 52 to 260, a total of 156 patients (30%) discontinued during the study, of which 33 patients (6.3%) discontinued due to adverse events. 3,§

§The OLE period was from weeks 52 to 260.

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5-Year Safety Data Video

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PALACE 4: FATIGUE

PALACE 4: Evaluated in DMARD-naïve patients with active PsA (N=527) who had a documented diagnosis of PsA of ≥3 months’ duration along with ≥3 swollen and ≥3 tender joints 4

MEAN CHANGE IN FATIGUE SCORE OVER 5 YEARS FOR DMARD-NAÏVE PATIENTS

PALACE 4: Change in FACIT-F

Bar chart from PALACE 4 study that represents the mean percent change in FACIT-Fatigue score through 5 years
Mean MASES at baseline: Otezla 30 mg BID, 3.7; placebo, 3.6 2

**Prespecified pooled analysis; weeks 16, 24, and 52 were prespecified secondary endpoints. Mean score at baseline was 30.82 for Otezla 30 mg BID and 31.76 for placebo. ††Includes all patients exposed to Otezla, including during the placebo-controlled period, regardless of when patients started taking Otezla (baseline, week 16, or week 24) through week 260. ‡‡FACIT-F is a 13-item, self-administered questionnaire that assesses fatigue and its physical impact on daily activities and function. The total FACIT-F score ranges from 0–52, with lower scores denoting higher levels of fatigue.

  • Consider open-label extension (OLE) phase study limitations when interpreting results. The OLE is not blinded, not controlled, and includes inherent self-selection bias. Overall, from weeks 52 to 260, a total of 80 patients (31.5%) discontinued during the study, of which 16 patients (6.3%) discontinued due to adverse events 2,4,§§

§§The OLE period was from weeks 52–260.

 

AEs, adverse events; BID, twice daily; DMARDs, disease-modifying antirheumatic drugs; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; OLE, open-label extension; PsA, psoriatic arthritis.

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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. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 4. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263