3 INDICATIONS

3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more

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

PALACE 1-3: Joint Tenderness
and Swelling

PALACE 1-3: Evaluated in DMARD-naïve 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 joints1

Mean reduction in joint tenderness and swelling through 5 years2

PALACE 1-3: Mean percent reduction in tender and swollen joints
Prespecified analysis; data as observed2,*,†

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 events2,§

§ The OLE period was from weeks 52 to 260.

PALACE 4: Joint Tenderness and Swelling

PALACE 4: Evaluated in adult 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 despite prior or current DMARD treatment3,4

Mean reduction in joint tenderness and swelling through 5 years for DMARD-naïve patients3

PALACE 4: Mean percent reduction in tender and swollen joints
Prespecified analysis; data as observed3,**,††,‡‡

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 events3,4,***

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

ACTIVE: Joint Tenderness and Swelling

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 joints5

Joint tenderness reduction through week 52 in biologic-naïve patients5

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.

  • Statistical significance was not reached for the first secondary endpoint. Hierarchical testing was therefore stopped, making the remaining secondary endpoint statistically nonsignificant. No conclusions of statistical or clinical significance can be drawn5

Joint swelling reduction through week 52 in biologic-naïve patients5

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.

  • Statistical significance was not reached for the first secondary endpoint. Hierarchical testing was therefore stopped, making the remaining secondary endpoint statistically nonsignificant. No conclusions of statistical or clinical significance can be drawn5

ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; BID, twice daily; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; DMARD, disease-modifying antirheumatic drug; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; 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

  • 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
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 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
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients 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

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult patients 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.

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.