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4 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 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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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

*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.

In the early treatment of PsA

FOREMOST: OLIGOARTICULAR PsA

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. The Active Treatment Extension phase continued up to 48 weeks 1,2

Hypothetical patient

Do you have newly diagnosed patients like Fred with few joints involved?

Fred

Presentation:

  • Struggles with joint tenderness despite treatment with an NSAID
  • Total joint count: 2 SJC, 3 TJC
  • HAQ-DI: 1.0 2
  • Physical function loss as a result of swollen/tender joints

Treatment History:

  • Naproxen (NSAID): Dose increased to 500 mg BID

Patient Considerations:

  • 34 years old, construction manager
  • Seeking treatment that fits within his lifestyle

Hypothetical patient

Paula_2_no-bg 1

FOREMOST: A global trial uniquely focused on early oligoarticular PsA patients like Fred, with a distinct primary endpoint to precisely measure low disease activity 2,3

Study design: Phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Patients with oligoarticular PsA (>1 but ≤4 tender and >1 but ≤4 swollen joint count) and early disease (signs and symptoms of PsA ≤5 years’ duration) were randomized 2:1 to receive either Otezla 30 mg BID (n=203) or placebo (n=105) for 24 weeks, stratified based on concomitant medication use, with an early escape at week 16. The Active Treatment Extension phase continued up to 48 weeks. 2

MDA-JOINTS: A DISTINCT PRIMARY ENDPOINT TO PRECISELY MEASURE LOW DISEASE ACTIVITY IN PsA

In the FOREMOST trial, MDA-Joints were defined as the proportion of subjects who achieved a clinical state of minimal disease activity. 4

To achieve MDA-Joints, patients needed to have: 4

IN THE FOREMOST TRIAL, OLIGOARTICULAR PsA WAS DEFINED AS 2-4 SWOLLEN JOINTS AND 2-4 TENDER JOINTS WITH A TOTAL ACTIVE JOINT COUNT RANGE OF 2-8. 5

87% of participants had a total joint count of 2-4. 13% of participants had a total joint count of 5-8. 4,5

One active joint could be swollen, tender, or both.

1 in 3 patients on Otezla achieved MDA-joints response in sentinel joints by week 16 2

FOREMOST: Patients achieving MDA-Joints response in sentinel joints at week 16

Sentinel joints pertain to joints affected at baseline.

FOREMOST POST-HOC ANALYSIS: PATIENTS ON PLACEBO SHOWED INCREASED JOINT COUNT PROGRESSION UNTIL CROSSING OVER TO OTEZLA

FOREMOST post-hoc analysis: Joint count increased from 4 or less to 5 or more for a higher proportion of patients treated with placebo vs Otezla 2,7

§Patients with ≤4 active joints at baseline. Based on all joints. One active joint could be swollen, tender, or both. **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 48 weeks. ††Patients discontinued treatment during the placebo-controlled phase due to adverse events, withdrawal by patient, and lack of efficacy. Patients discontinued treatment during the apremilast-extension phase due to lack of efficacy, adverse event, and withdrawal by patient. 4

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

 

BID, twice daily; BSA, body surface area; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire—Disability Index; LEI, Leeds Enthesitis Index;
MDA-Joints, minimal disease activity-joints; MI, multiple imputation; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis; SJC, swollen
joint count; TJC, tender joint count; VAS, visual analog scale.

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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

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

Please click here for the full Prescribing Information.

References: 1. Gossec L, Gladman D, Coates L, et al. Presented at: 32nd Annual Meeting of the European Academy of Dermatology and Venereology (EADV); October 11-14, 2023; Berlin, Germany. 2. Gossec L, Coates LC, Gladman DD, et al. Ann Rheum Dis. 2024;83(11):1480-1488. 3. Coates LC, Helliwell PS. J
Rheumatol.
2016;43(2):371-375. 4. Data on file, Amgen; 2023. 5. Mease P, Gladman D, Coates LC, et al. Presented at: ACR/ARHP Annual Meeting; November
10-15, 2023; San Diego, CA [1]. 6. Mease P, Gladman D, Coates LC, et al. Presented at: ACR/ARHP Annual Meeting; November 10-15, 2023; San Diego, CA [2].
7. Gossec L, Coates L, Gladman D, et al. Presented at: Annual European Congress of Rheumatology (EULAR 2024); June 12-15, 2024; Vienna, Austria.