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

Identifying active Psoriatic Arthritis (PsA) patients by disease activity 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 161

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; full analysis set)*

*Patients were given Otezla 30 mg twice daily. 65% of patients received concomitant therapy with at least one 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 161,2
cdapsa-week16-week52-responses

cDAPSA focuses primarily on joint manifestations and can be used in a treat-to-target approach4

The cDAPSA, which was derived from DAPSA, includes all DAPSA components,
but excludes CRP to obtain a fully clinical score4,5

cdapsa-dapsa-components
  • 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 outcome6
  • DAPSA consists of 5 components: tender joint count, swollen joint count, Patient Assessment of Pain (PAP), Patient Global Assessment of Disease Activity (PtGA), and C-reactive protein (CRP)7

cDAPSA was retrospectively evaluated in a subset of patients with psoriatic arthritis
taking Otezla from the PALACE 1-3 clinical trials4,‡

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).4

ENDPOINT

Probability of achieving cDAPSA treatment targets at week 52

cDAPSA DISEASE ACTIVITY CATEGORIES

REM <4
LDA >4 to <13
MDA > 13 to <27
HDA >27
  • Treatment targets are remission (≤4) or low disease activity (>4 to ≤13)4

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 524

Percentage of patients achieving cDAPSA treatment targets with Otezla by week 52 4,§

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 164,††,‡‡
Icon of 47 percent number inside a sketched, orange and white circle

††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).

Otezla patients achieving treatment targets at week 52 had lower disease activity (cDAPSA) scores at baseline4

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

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, 20204,§§§

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

BID, twice daily; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; DMARDs, disease-modifying antirheumatic drugs; HDA, high disease activity; LDA, low disease activity; MDA, moderate disease activity; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; REM, remission; 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

  • 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. Data on file, Amgen Inc. 3. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 4. Mease PJ, Gladman DD, Ogdie A, et al. Arthritis Res Care (Hoboken). 2020;72(6):814-821. 5. Ogdie A, Coates LC, Gladman DD. Rheumatology (Oxford). 2020;59(suppl 1):i37-i46. 6. Singh JA, Guyatt G, Ogdie A, et al. Arthritis Rheum. 2019;71(1):5-32. 7. Schoels MM, Aletaha D, Alasti F, Smolen JS. Ann Rheum Dis. 2016;75(5):811-818.