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

PALACE 1-3: ACR20 RESPONSE

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

OTEZLA SIGNIFICANTLY IMPROVED ACR20 RESPONSE AT WEEK 16 1

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

Bar chart from a PALACE 1 study that represents the percent improvement of ACR20 response at week 16

Otezla also significantly improved ACR20 response vs placebo at week 16 in PALACE 2 and 3; nonresponder imputation; intent-to-treat analysis 1,2

  • PALACE 2: 32% vs 19%, Otezla 30 mg BID (n=162) vs placebo (n=159), respectively (P<0.05) 1
  • PALACE 3: 41% vs 18%, Otezla 30 mg BID (n=167) vs placebo (n=169), respectively (P<0.0001) 1,2

*FAS consists of all patients who were randomized as specified in the protocol.

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SUSTAINED RESULTS WITH DATA IN ACR20 RESPONSE THROUGH 5 YEARS 2

PALACE 1-3: ACR20 responders

Line chart from a pooled PALACE 1-3 study that represents the ACR20 response 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. n/N, number of responders/number of patients who had sufficient data for a definitive determination of response status at the timepoint, which includes patients who discontinued early between the preceding timepoint and the specific timepoint.

  • Placebo-controlled efficacy data were collected and analyzed through week 24. Placebo nonresponders at week 16 were re-randomized to either Otezla treatment arm. At week 24, all remaining patients were re-randomized to either Otezla treatment arm. Patients treated with Otezla remained on their initial treatment 1
  • 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 2,§

 §The OLE period was from weeks 52 to 260.

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5-Year Safety Data Video

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PALACE 4: ACR20 RESPONSE

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

OTEZLA SIGNIFICANTLY IMPROVED ACR20 RESPONSE IN DMARD-NAÏVE PATIENTS AT WEEK 16 3,4

PALACE 4: ACR20 responders at week 16 (primary endpoint)

Bar chart from a PALACE 4 study that represents percent improvement in ACR response at week 16
Thumbnail image for video about the PALACE 4 clinical trial data in Psoriatic Arthritis DMARD-naïve patients

PALACE 4 Data Video

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SUSTAINED RESULTS IN ACR20 RESPONSE THROUGH 5 YEARS FOR DMARD-NAÏVE PATIENTS 3,4

PALACE 4: ACR20 responders

Line chart from a PALACE 4 study that represents ACR20 response 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 reactions, lack of efficacy, and other (withdrawal by patient, loss of follow-up, protocol violation, noncompliance, and other). §§n/N, number of responders/number of subjects who had sufficient data for a definitive determination of response status at the timepoint, which includes subjects who discontinued early between the preceding timepoint and the specific timepoint.

  • Placebo-controlled efficacy data were collected and analyzed through week 24. Placebo nonresponders at week 16 were re-randomized to either Otezla arm. At week 24, all remaining patients receiving placebo were re-randomized to either Otezla treatment arm. Patients treated with Otezla remained on their initial treatment. Patients entering a long-term extension phase could be treated through 5 years 4
  • 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 3,4,***

***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

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ACTIVE: ACR20 RESPONSE

ACTIVE: Evaluated in biologic-naïve patients with active psoriatic arthritis (N=219) who had a documented diagnosis of psoriatic arthritis of ≥3 months’ duration along with ≥3 swollen and ≥3 tender joints 5

ACR20 RESPONSE THROUGH WEEK 52 IN BIOLOGIC-NAÏVE PATIENTS 5

ACTIVE: The primary endpoint of ACR20 response at week 16 was significantly greater
with Otezla 30 mg BID (38.2%, n=110) vs placebo (20.2%, n=109); P=0.0040
[Nonresponder imputation; FAS] 5

Line chart from an Otezla study that represents ACR20 response 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.

Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn. 3

 

ACR, American College of Rheumatology; BID, twice daily; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; DMARDs, disease-modifying antirheumatic drugs; FAS, full analysis set; 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
  • 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. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 3. Data on file, Amgen Inc. 4. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 5. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698.