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4 INDICATIONSOtezla® (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 pediatric patients 6 years of age and older and weighing at least 20 kg 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.
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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 FORMOST ACTIVE
Psoriatic Arthritis
Overview ACR20 Response Oligoarticular PsA Joint Tenderness and Swelling Dactylitis Enthesitis Fatigue Pain Physical Function cDAPSA
Psoriatic Arthritis
Overview Adverse Reactions Through Week 16 Adverse Reactions Through 5 Years FOREMOST Safety ACTIVE Safety Adverse Events of Special Interest Laboratory Parameters
Plaque Psoriasis
Why Systemic Therapy? About Plaque Psoriasis Patient Stories
Plaque Psoriasis
Overview ADVANCE ESTEEM SPROUT STYLE DISCREET LIBERATE
Plaque Psoriasis
Overview Mild to Moderate
Plaque Psoriasis PASI-75 Response Mean PASI Response Pediatric Response Scalp Response Nail Response Itch Response Genital Response Patient Photo Library Real-World Data
Plaque Psoriasis
Overview Adverse Reactions Through Week 16 Pediatric: Adverse Reactions 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 Co-Pay and Patient Support Coverage
Plaque Psoriasis Psoriatic Arthritis Oral Ulcers in Behçet's Disease
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: 1 million+ patients treated globally since 2014 1-3,* PsO SAFETY PsA SAFETY

A small pill with a big history: 1 million+ patients treated globally since 2014 1-3,*

PsO SAFETY PsA SAFETY REFERENCES & FOOTNOTE
REFERENCES REFERENCES & FOOTNOTE

*Estimates of patients treated reflect global data since launch (Apr 2014-Mar 2023; US=59% 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.

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Otezla can treat joint tenderness and swelling in psoriatic arthritis from the start 1,2

PALACE 1-3: JOINT TENDERNESS AND SWELLING

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 3

MEAN REDUCTION IN JOINT TENDERNESS AND SWELLING THROUGH 5 YEARS 2,4

PALACE 1-3: Mean percentage reduction in tender and swollen joints

Line chart from a pooled PALACE 1-3 study that represents the mean percent reduction in tender and swollen joints

*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. †Data are presented “as observed” with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 260 weeks. ‡The n at each timepoint represents patients with a baseline value and a post-baseline value at the timepoint and includes patients who discontinued early between the preceding timepoint and the specific timepoint.

  • Consider open-label extension (OLE) phase study limitations when interpreting results. The OLE was not blinded, not controlled, and included 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 4,§

§The OLE period was from weeks 52 to 260.

Thumbnail image of a video about Otezla in clinical studies for the treatment of oral ulcers in Behçet's Disease

5-Year Safety Data Video

WATCH VIDEO

PALACE 4: JOINT TENDERNESS AND SWELLING

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 2,5

MEAN REDUCTION IN JOINT TENDERNESS AND SWELLING THROUGH 5 YEARS
FOR DMARD-NAÏVE PATIENTS 2

PALACE 4: Mean percentage reduction in tender and swollen joints

Line chart from a PALACE 4 study that represents the mean percent reduction in tender and swollen joints through 5 years

**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. ††Data are presented “as observed” with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 260 weeks. ‡‡Patients discontinued treatment during the study due to adverse events, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, noncompliance, and other). §§The n at each timepoint represents patients with a baseline value and a post-baseline value at the timepoint and includes subjects who discontinued early between the preceding timepoint and the specific timepoint.

  • Consider open-label extension (OLE) phase study limitations when interpreting results. The OLE was not blinded, not controlled, and included 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 2,5,***

***The OLE period was from weeks 52 to 260.

Thumbnail image for video about the PALACE 4 clinical trial data in Psoriatic Arthritis DMARD-naïve patients

PALACE 4 Data Video

WATCH VIDEO

FOREMOST:POST-HOC ANALYSIS IN PROGRESSION OF NUMBER OF ACTIVE JOINTS

FOREMOST: Evaluated in patients with oligoarticular PsA (>1 but ≤4 tender and swollen joints involved) and early disease (signs and symptoms of PsA ≤5 years’ duration). Patients were randomized 2:1 to receive either Otezla 30 mg BID (n=203) or placebo (n=105) for 24 weeks and stratified based on concomitant medication use, with an early escape at week 16. 6,7

Progression of number of active joint count

†††Patients with ≤4 active joints at baseline. Based on all joints. One active joint could be swollen, tender, or both.

Post-hoc analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

IN THE FOREMOST TRIAL, 87% OF PATIENTS HAD A TOTAL JOINT COUNT OF 2-4, AND 13% HAD A TOTAL JOINT COUNT OF 5-8 6,8

ACTIVE: JOINT TENDERNESS AND SWELLING

ACTIVE: Evaluated in biologic-naïve patients with active PsA (N=219) who had a documented diagnosis of PsA of ≥3 months’ duration along with ≥3 swollen and ≥3 tender joints 9

JOINT TENDERNESS REDUCTION THROUGH WEEK 52 IN BIOLOGIC-NAÏVE PATIENTS 9

ACTIVE: Mean percentage reduction in tender joints

Line chart from an ACTIVE study that represents the mean percent reduction in tender joints through week 52

‡‡‡Data are presented “as observed” with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 52 weeks. §§§The n at each timepoint represents patients with a baseline value and a post-baseline value at the timepoint and includes subjects who discontinued early between the preceding timepoint and the specific timepoint. ****Includes all patients exposed to Otezla from baseline who completed treatment through week 52. ††††At week 16, patients receiving placebo were eligible to be switched to Otezla; at week 24, all remaining patients receiving placebo were switched to Otezla. Only patients who received ≥1 dose of Otezla were included.

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. 2

SWOLLEN JOINT REDUCTION THROUGH WEEK 52 IN BIOLOGIC-NAÏVE PATIENTS 9

ACTIVE: Mean percentage reduction in swollen joints

Line chart from an ACTIVE study that represents the mean percent reduction in swollen joints through week 52

‡‡‡‡Data are presented “as observed” with no imputation for missing values in order to describe outcomes among those patients who continued to receive treatment over 52 weeks. §§§§The n at each timepoint represents patients with a baseline value and a post-baseline value at the timepoint and includes subjects who discontinued early between the preceding timepoint and the specific timepoint. *****Includes all patients exposed to Otezla from baseline who completed treatment through week 52. †††††At week 16, patients receiving placebo were eligible to be switched to Otezla; at week 24, all remaining patients receiving placebo were switched to Otezla. Only patients who received ≥1 dose of Otezla were included.

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. 2

 

BID, twice daily; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis; SJC, swollen joint count; TJC, tender joint count.

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IMPORTANT SAFETY INFORMATION 

Contraindications

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

Warnings and Precautions

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® (apremilast) 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 adult 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 adult 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 adult patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Body weight loss of 5%-10% occurred in 12% (19/163) of pediatric patients with moderate to severe plaque psoriasis treated with Otezla compared to 2.5% (2/80) with placebo. Body weight loss of ≥ 10% occurred in 1% (1/163) of pediatric patients treated with Otezla twice daily compared to 0% (0/80) of patients with placebo. Closely monitor growth (height and weight) in Otezla-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted
    • 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 adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile 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® is indicated for the treatment of:

  • Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
  • Adult patients with active psoriatic arthritis
  • Adult patients with oral ulcers associated with Behçet’s Disease

References: 1. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. J Rheumatol. 2015;42(3):479-488. 2. Data on file, Amgen Inc. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 4. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 5. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 6. Mease P, Gladman D, Coates LC, et al. 16-week results from FOREMOST, a placebo-controlled study involving oligoarticular psoriatic arthritis treated with apremilast. Presented at: ACR/ARHP Annual Meeting; November 10-15, 2023; San Diego, CA. 7. Gossec L, Gladman D, Coates L, et al. Early oligoarticular psoriatic arthritis responds to treatment with apremilast: week 16 results from FOREMOST—a phase 4 randomized controlled trial. Presented at: 32nd Annual Meeting of the European Academy of Dermatology and Venereology (EADV); October 11-14, 2023; Berlin, Germany. 8. Mease P, Gladman D, Coates LC, et al. 16-week results from FOREMOST, a placebo-controlled study involving oligoarticular psoriatic arthritis treated with apremilast. Abstract 1691. ACR 2023, November 13, 2023. 9. Nash P, Ohson K, Walsh J, et al; ACTIVE Investigators. Ann Rheum Dis. 2018;77(5):690-698.