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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

Read less

Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE THE DATA

IDENTIFYING ACTIVE PsA PATIENTS WHO ARE MOST LIKELY TO ACHIEVE TREATMENT TARGETS

A closer look at PALACE 1-3 results from the cDAPSA post-hoc analysis

OTEZLA SIGNIFICANTLY IMPROVED ACR20 RESPONSE AT WEEK 16 1

PALACE 1: ACR20 responders at week 16 (primary endpoint) 1,2

  • 38% ACR20 response with Otezla 30 mg BID (n=168) vs 19% with placebo (n=168) with or without DMARDs; P=0.0001 (nonresponder imputation; FAS) *

*Patients were given Otezla 30 mg BID. 65% of patients received concomitant therapy with at least 1 DMARD, including 55% methotrexate.

  • Otezla also demonstrated a statistically similar improvement in ACR20 response in PALACE 2 (Otezla [n=162] 32% vs placebo [n=159] 19%; P=0.006) and PALACE 3 (Otezla [n=167] 41% vs placebo [n=169] 18%; P<0.0001) at week 16 1,2

At week 16, the respective percentages of patients with ACR50 and ACR70
responses were as follows 2,†:

Table of CDAPSA responses in Otezla patients at Week 16

At week 52, the respective percentages of patients with ACR50 and ACR70
responses were as follows
 2,†:

Table of CDAPSA responses in Otezla patients at Week 52

 Did not reach statistical significance.

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

cDAPSA FOCUSES PRIMARILY ON JOINT MANIFESTATIONS AND CAN BE USED IN A
TREAT-TO-TARGET APPROACH 3

The cDAPSA, which was derived from DAPSA, includes all DAPSA components,
but excludes CRP to obtain a fully clinical score 3,4

Chart of CDAPSA DAPSA components in Otezla
  • The American College of Rheumatology (ACR) guidelines recommend a “treat-to-target” treatment approach, which entails regularly assessing an outcome (eg, REM or LDA) and adjusting therapies as needed to reach that outcome 5
  • DAPSA consists of 5 components: tender joint count (TJC), swollen joint count (SJC), Patient Assessment of Pain (PAP), Patient Global Assessment of Disease Activity (PtGA), and C-reactive protein (CRP) 6

A TREAT-TO-TARGET APPROACH USING cDAPSA

Watch Dr. Leventhal explain how cDAPSA can be used to measure disease activity

VIDEO TRANSCRIPT

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Dr. Leventhal: Hi, I’m Dr. Lawrence J. Leventhal, Rheumatologist at Holy Redeemer Hospital and Medical Center, and today I would like to discuss a treat-to-target approach for your patients with psoriatic arthritis, using the Clinical Disease Activity Index for Psoriatic Arthritis, or cDAPSA. Current guidelines, such as the American College of Rheumatology and National Psoriasis Foundation guidelines, recommend a treat-to-target approach when managing patients with psoriatic arthritis. 1 A treat-to-target approach entails regularly assessing an outcome and adjusting therapies, as needed, to reach a target disease activity level. 2 Multiple tools can be used to assess outcomes, such as minimal disease activity, or MDA, and the Disease Activity Index for Psoriatic Arthritis, or DAPSA. 1 Today, I would like to elaborate on cDAPSA, which is a tool that measures disease activity based on 4 components that primarily focus on joint manifestations. 3 The cDAPSA total score is a combination of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity. 3 The score can range from 0 to 154 and includes 4 categories. A score of 0 to 4 represents remission, 5-13 represents low disease activity, 14-27 represents moderate disease activity, and 28-154 represents high disease activity. 3,4 I hope this short presentation helped you better understand a treat-to-target approach using the cDAPSA tool in managing patients with psoriatic arthritis. Thank you!

References: 1. Singh, et al. Arthritis Rheumatol. 2019;71:5-32. 2. Ogdie, et al. Rheumatology (Oxford). 2020;59:i37-i46. 3. Schoels, et al. Ann Rheum Dis. 2016;75:811-818. 4. Mease, et al. Arthritis Care Res (Hoboken). 2020;72:814-821.

cDAPSA was retrospectively evaluated in a subset of patients with psoriatic arthritis
taking Otezla from the PALACE 1-3 clinical trials 3,‡

The post-hoc analysis included patients from the PALACE 1, 2, and 3 clinical trials receiving Otezla 30 mg BID who had undergone randomization at baseline and had cDAPSA components available to calculate responses (n=494). 3

Table of probability of achieving CDAPSA treatment targets with Otezla
  • Treatment targets are remission (≤4) or low disease activity (>4 to ≤13) 3

Clinical remission does not mean drug-free remission or complete absence of disease.

 cDAPSA was calculated as a composite score based on swollen joint count, tender joint count, PAP, and PtGA with possible scores ranging from 0 to 154.

OTEZLA PATIENTS WHO ACHIEVED TREATMENT TARGETS BY WEEK 52 3

Percentage of patients achieving cDAPSA treatment targets with Otezla by week 52

Bar chart of the percentage of Otezla patients achieving cDAPSA treatment targets by week 52

 § Clinical remission does not mean drug-free remission or complete absence of disease. **Includes patients who had undergone randomization and who had available cDAPSA components at baseline (n=494).

This longitudinal assessment retrospectively analyzed pooled patients within each cDAPSA disease activity category at week 52 to determine mean cDAPSA score at baseline.

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

  • 37% of moderate patients activity on Otezla achieved treatment targets by week 16 2,††,‡‡
Icon of 47 percent number inside a sketched, orange and white circle

of Otezla patients with moderate disease activity at baseline achieved treatment targets by week 52 3

 ††Clinical remission does not mean drug-free remission or complete absence of disease. ‡‡Includes patients who had undergone randomization and who had available cDAPSA components at baseline (n=494).

RESULTS OF cDAPSA POST-HOC ANALYSIS FROM PALACE 1-3

Watch Dr. Sulich discuss the main results of the cDAPSA post-hoc analysis from PALACE 1-3

VIDEO TRANSCRIPT

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Otezla Is the Only Oral Therapy with Scalp Data in Its Label 2

Dr. Sulich: Hello! I’m Dr. Andrew Sulich. Let’s review the PALACE 1-3 results and cDAPSA post-hoc analysis in adult patients with active psoriatic arthritis, which identified patients who are most likely to achieve treatment targets. 1-4 Otezla® , apremilast, is an oral, nonbiologic PDE4 inhibitor indicated for the treatment of adult patients with active psoriatic arthritis. 5 It is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation. 1493 total patients were involved in PALACE 1-3 trials. During the placebo-controlled phase, patients were randomized to receive Otezla 20 mg or 30 mg twice daily or placebo. The primary endpoint was the percentage of patients achieving an American College of Rheumatology criteria for an at least 20% improvement, or ACR20 response, at week 16. 5,6 Significantly more patients receiving Otezla achieved ACR20 response compared with the placebo at week 16 in PALACE 1. Similar results were seen in PALACE 2 and 3. 5 At week 16, the ACR50 and ACR70 responses did not reach significance in the PALACE 1-3 trials. 5 Pooled PALACE 1-3 ACR20, ACR50, and ACR70 responses in patients at week 52 were 55%, 26%, and 12%, respectively. 6 This is exploratory and has not been adjusted for multiple comparisons. Otezla has an established safety profile. In the PALACE 1-3 trials, the most common adverse reactions in at least 5% of patients receiving Otezla through week 16 were: diarrhea, nausea, and headache. 5 Treatment was discontinued due to any adverse reactions in 4.6% of Otezla treated patients and 1.2% of placebo treated patients. 5 Postmarketing reports of severe diarrhea, nausea, and vomiting have been associated with the use of Otezla. In some cases patients were hospitalized. Monitor patients who are more susceptible to complications of diarrhea or vomiting. 5 The most common adverse reactions that occurred at week 52 in at least 5% of patients were consistent with those observed through week 52. 6 Let’s dive into the cDAPSA post-hoc analysis data from the PALACE 1-3 trials. cDAPSA was retrospectively evaluated in 494 patients receiving Otezla 30 mg twice daily who had undergone randomization who had cDAPSA components available at baseline. 4 Outcome measures included the probability of achieving cDAPSA treatment targets, defined as achieving either remission or low disease activity, LDA, at week 52. 4 Let’s first look at the cDAPSA longitudinal assessment of disease activity through week 52. This assessment retrospectively analyzed pooled patients within each cDAPSA disease activity category at week 52 to determine the mean cDAPSA scores at baseline. 4 We can see that those who achieved treatment targets at week 52 had lower cDAPSA scores at baseline versus patients who did not. 4 Now, let’s discuss the percentage of patients who achieved cDAPSA treatment targets at week 52 according to their disease activity at baseline. Almost half of the patients with moderate disease activity at baseline achieved treatment targets of remission or LDA by week 52… 4 and approximately 37% achieved treatment targets at week 16. 4 We are now approaching the end of this video. Before I summarize the key take-home messages, let’s listen to the important safety information for Otezla.

VO: 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 or 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. Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% reported depression or depressed mood compared to 0.8% treated with placebo. Suicidal ideation and behavior was observed in 0.2% of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% of patients exposed to Otezla, compared to none in placebo-treated patients. Two patients who received placebo committed suicide compared to none on Otezla. Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla. Body weight loss of 5 to 10% was reported in 10% of patients taking Otezla and in 3.3% 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 (for example, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended. Adverse Reactions. The most common adverse reactions (5% or more) are diarrhea, nausea, and headache. Use in Specific Populations. Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Please see the Full Prescribing Information for Otezla provided on OtezlaPro.com.

Dr. Sulich: As noted previously, this post hoc analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. In conclusion, this short video highlighted Otezla data from the PALACE 1-3 trials and a cDAPSA post-hoc analysis that identified which patients were likely to achieve treatment targets based on disease activity at baseline. 4 Thank you for listening!

References: 1. Kavanaugh, et al. Ann Rheum Dis 2014;73:1020-1026. 2. Cutolo, et al. J Rheumatol. 2016;43:9. 3. Edwards, et al. Ann Rheum Dis. 2016;75:1065-1073. 4. Mease, et al. Arthritis Care Res (Hoboken). 2020;72:814-821. 5. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 6. Kavanaugh, et al. Arthritis Res Ther. 2019;21:118.

OTEZLA PATIENTS ACHIEVING TREATMENT TARGETS AT WEEK 52 HAD LOWER DISEASE ACTIVITY (cDAPSA) SCORES AT BASELINE 3

Longitudinal assessment of disease activity through week 52 by cDAPSA category

Line graph of a longitudinal assessment of disease activity through week 52 by cDAPSA category

§§Post-hoc analyses were performed using multiple imputation for discontinuations and missing values. ***Includes patients randomized to receive Otezla 30 mg BID at baseline and who had available cDAPSA components at week 52 (n=375). †††The probability of achieving cDAPSA categories at week 52 was evaluated on the basis of baseline and week 16, with cDAPSA activity categories defined as follows: REM score <4, LDA score >4 to ≤13, MDA score >13 to ≤27, and HDA score >27. ‡‡‡Clinical remission does not mean drug-free remission or complete absence of disease.

This longitudinal assessment retrospectively analyzed pooled patients within each cDAPSA disease activity category at week 52 to determine mean cDAPSA scores at baseline.

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

“PATIENTS WHO ACHIEVED TREATMENT TARGETS AT WEEK 52 HAD LOWER MEAN cDAPSA SCORES AT BASELINE COMPARED WITH PATIENTS WHO DID NOT.”

— MEASE ET AL, 2020 3,§§§

 §§§cDAPSA was calculated as a composite score based on SJC, TJC, PAP, and PtGA with possible scores ranging from 0 to 154.

ACR, American College of Rheumatology; BID, twice daily; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; DMARDs, disease-modifying antirheumatic drugs; FAS, full analysis set; HDA, high disease activity; LDA, low disease activity; MDA, moderate disease activity; PsA, psoriatic arthritis; REM, remission; SJC, swollen joint count; TJC, tender joint count.

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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
  • 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. Mease PJ, Gladman DD, Ogdie A, et al. Arthritis Res Care (Hoboken). 2020;72(6):814-821. 4. Ogdie A, Coates LC, Gladman DD. Rheumatology (Oxford). 2020;59(suppl 1):i37-i46. 5. Singh JA, Guyatt G, Ogdie A, et al. Arthritis Rheum. 2019;71(1):5-32. 6. Schoels MM, Aletaha D, Alasti F, Smolen JS. Ann Rheum Dis. 2016;75(5):811-818.