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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.

PALACE 4

OTEZLA COULD BE A GREAT PLACE TO START FOR PATIENTS WITH MODERATE DISEASE ACTIVITY

Hypothetical patient

Would you prescribe Otezla for newly diagnosed patients like Paula with many joints involved?

Paula

Presentation:

  • Struggles with some daily activities
  • Total joint count: 4 SJC, 8 TJC
  • Enthesitis
  • cDAPSA score: 21

Treatment History:

  • DMARD-naïve
  • NSAID dose recently increased

Patient Considerations:

  • 51 years old, kindergarten teacher's aid
  • BMI: 30

Hypothetical patient

Paula_2_no-bg

PALACE 1-3 studied DMARD-experienced patients

PALACE 1-3 Study design: Multicenter, randomized, double-blind, placebo-controlled Phase 3 trials. Adult patients with active PsA were randomized 1:1:1 to receive either Otezla 30 mg BID, Otezla 20 mg BID, or a placebo for 24 weeks 1

PALACE 1-3 Primary endpoint: In PALACE 1, Otezla significantly improved ACR20 response vs placebo: 38%, Otezla (n=168) vs 19% placebo (n=168), with or without DMARDs, at week 16; P=0.0001 (nonresponder imputation; FAS). Consistent results were seen with PALACE 2 and 3 1,2

PALACE 4 studied DMARD-naïve patients, like Paula

PALACE 4 Study design: Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 DMARD-naïve adult patients with active psoriatic arthritis 3,4

Primary endpoint:

A DIFFERENCE IN DMARD-NAÏVE PATIENTS:

Nearly 2x the ACR20 response rate at 16 weeks with Otezla 30 mg BID (31%, n=176) vs placebo (16%, n=176, P=0.001) 4,*

*Primary endpoint; nonresponder imputation; FAS.

cDAPSA IS A COMPOSITE SCORE THAT MEASURES DISEASE ACTIVITY IN PsA 5,6

cDAPSA assesses four domains and adds them together for a composite score. The cDAPSA,
which was derived from DAPSA, includes all DAPSA components except CRP to obtain a fully
clinical score 5,6

cDAPSA Disease Activity Score 5,6,†

The cDAPSA composite score places patients into one of four disease activity levels 5

cDAPSA Disease Activity Levels

How do you measure disease activity in your PsA patients?

cDAPSA is calculated as a composite score based on SJC, TJC, PAP, and PtGA with possible scores ranging from 0-154. Clinical remission does not mean drug‑ free remission or complete absence of disease.

PALACE 4: POST HOC ANALYSIS

AMONG MODERATE DISEASE ACTIVITY PATIENTS ASSESSED AT WEEK 16, 44% ACHIEVED LOW DISEASE ACTIVITY OR REMISSION 2

cDAPSA was retrospectively evaluated in a subset of patients with PsA taking Otezla from the PALACE 1-3 and PALACE 4 clinical trials. 5,7,§,**

  • Endpoint: Probability of achieving cDAPSA treatment targets at week 52 5,6

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

PALACE 1-3: DMARD-experienced patients (post-hoc analysis; MI) 5,††

  • Patients with HDA at baseline (n=367): 4% had REM ‡‡ at week 52, 21% had LDA, 39% had ModDA, and 36% had HDA
  • 47% with ModDA at baseline achieved treatment targets §§ (n=121): 11% had REM ‡‡ at week 52, 36% had LDA, 39% had ModDA, and 14% had HDA
  • 37% achieved treatment targets by week 16

  • Patients with LDA at baseline (n=6): 19% had REM ‡‡ at week 52, 52% had LDA, 27% had ModDA, and 2% had HDA

§cDAPSA is calculated as a composite score based on SJC, TJC, PAP, and PtGA with possible scores ranging from 0-154. **The post-hoc analyses included patients from the PALACE 1-3 and 4 clinical trials receiving Otezla 30 mg BID who had undergone randomization at baseline and had cDAPSA components available to calculate responses (PALACE 1-3, n=494; PALACE 4, n=175). ††Includes randomized patients who received Otezla 30 mg BID at baseline and had available cDAPSA components at baseline (PALACE 1-3, n=494; PALACE 4, n=175). ‡‡Clinical remission does not mean drug-free remission or complete absence of disease. §§REM or LDA.

OTEZLA PATIENTS WHO ACHIEVED LOW DISEASE ACTIVITY OR REMISSION HAD LITTLE TO NO ARTICULAR OR OTHER PsA MANIFESTATIONS AT 52 WEEKS 7,9

What could achieving low disease activity or remission mean for your patients?

In PALACE 1-3

  • In patients who achieved low disease activity at 52 weeks (mean baseline; mean results at week 52; n=106): Swollen joint count (8.76; 1.11; n=106); tender joint count (14.82; 2.47; n=106); dactylitis count *** (2.84; 0.47; n=43); enthesitis count (MASES) *** (3.28; 1.16; n=67); PASI score *** (8.23; 3.97; n=51) 5
  • In patients who achieved remission at 52 weeks (mean baseline; mean results at week 52; n=25): Swollen joint count (9.08; 0.12; n=25); tender joint count (12.16; 0.40; n=25); dactylitis count *** (2.33; 0.00; n=9); enthesitis count (MASES) *** (1.86; 0.43; n=7); PASI score *** (9.52; 2.66; n=14) 5

***Not included in the cDAPSA treatment target calculation.

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

ACR, American College of Rheumatology; BID, twice daily; BMI, body mass index; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; FAS, full analysis set; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MI, multiple imputation; NSAID, nonsteroidal anti-inflammatory drug; PAP, Patient Assessment of Pain; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PtGA, Patient Global Assessment of Disease Activity; 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. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen; 2019. 
3. Data on file, Amgen; 2018. 4. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 5. Mease PJ, Gladman DD, Ogdie A, et al. Arthritis Care Res (Hoboken). 2020;72(6):814-821. 6. Schoels MM, Aletaha D, Alasti F, et al. Ann Rheum Dis. 2016;75(5):811-818. 7. Mease PJ, Kavanaugh A, Ogdie A, et al. J Rheumatol. 2022;49(7):694-699. 8. Mease PJ, Kavanaugh A, Ogdie A, et al. Presented at: ACR Convergence 2020; November 5-9, 2020. 9. Mease PJ, Kavanaugh A, Ogdie A, et al. J Rheumatol. 2022;49(7):694-699 [epub].