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Psoriatic Arthritis

Study Design

Otezla® (apremilast) was evaluated in one of the largest global clinical development programs ever conducted in psoriatic arthritis1,2
 
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PALACE 1-3 clinical trial program

Program1:

  • Multicenter, randomized, double-blind, placebo-controlled phase 3 trials of similar design
  • 1493 adult patients with active psoriatic arthritis

Study design:

  • Randomized 1:1:1 to either Otezla 30 mg twice daily, Otezla 20 mg twice daily, or placebo1
  • Doses were titrated during the first 5 days1
  • Placebo controlled to week 241
  • Blinded Otezla treatment to 52 weeks, with an open-label, long-term extension to 5 years2

Primary endpoint1:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria1:

  • Had a documented diagnosis of psoriatic arthritis of ≥6 months’ duration
  • Had ≥3 swollen and ≥3 tender joints, despite prior or current treatment with DMARDs
  • PALACE 3: 1 qualifying psoriatic skin lesion of ≥2 cm in diameter

Selected exclusion criteria:

  • Failed >3 agents for psoriatic arthritis (small molecules or biologics) or >1 TNF-α inhibitor1
  • Active TB or a history of incompletely treated TB; however, screening for latent TB was not required2
  • Hepatitis B or hepatitis C positive at screening2
  • History of HIV2

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; HIV, human immunodeficiency virus; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TB, tuberculosis; TNF, tumor necrosis factor.

Baseline disease characteristics and treatment history

Disease characteristics1:

  • Median duration: 5 years
  • Mean tender joint count: 23.0
  • Mean swollen joint count: 13.0

Psoriatic arthritis types1:

  • Symmetric polyarthritis (62%)
  • Asymmetric oligoarthritis (27%)
  • DIP joint arthritis (6%)
  • Arthritis mutilans (3%)
  • Predominant spondylitis (2%)

Treatment history1:

  • Small-molecule DMARDs only (76%)
  • Biologic DMARDs (22%)

Concomitant therapy1:

  • ≥1 DMARD (65%) including MTX (55%)
  • Low-dose oral corticosteroids (14%)
  • NSAIDs (71%)

DIP, distal interphalangeal joint; MTX, methotrexate; NSAIDs, nonsteroidal anti-inflammatory drugs.

Next: PALACE 4 Clinical Trial Program

PALACE 4 clinical trial program

Program:

  • Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel group study2,3
  • 527 DMARD-naïve adult patients with active psoriatic arthritis3

Study design:

  • Randomized 1:1:1 to either Otezla 30 mg twice daily, Otezla 20 mg twice daily, or placebo3
  • Doses were titrated during the first week of treatment3
  • Placebo controlled to week 243
    • Patients on placebo whose swollen and tender joint scores had not improved by ≥20% at week 16 were re-randomized 1:1 to the Otezla arms. At week 24, all remaining placebo patients were also re-randomized to the Otezla arms3
  • Open-label long-term extension phase continued up to 5 years3
  • The study design of PALACE 4 was consistent with PALACE 1-32-6

Primary endpoint3:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria3:

  • Had a documented diagnosis of psoriatic arthritis of ≥3 months’ duration
  • Had ≥3 swollen and ≥3 tender joints

Selected exclusion criteria:

  • Previous treatment with csDMARDs or biologics3
  • Active TB or a history of incompletely treated TB; however, screening for latent TB was not required3
  • Hepatitis B or hepatitis C positive at screening2
  • History of HIV2

ACR, American College of Rheumatology; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; DMARD, disease-modifying antirheumatic drug; HIV, human immunodeficiency virus; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TB, tuberculosis.

Baseline disease characteristics and concomitant therapy

Disease characteristics:

  • Median duration: 1.1 years2
  • Mean tender joint count: 20.13
  • Mean swollen joint count: 11.23

Concomitant therapy3*:

  • Stable dose oral corticosteroids (7.2%)
  • Stable dose of NSAIDs (73%)
*

Stable doses of oral corticosteroids (prednisone ≤10 mg/day or equivalent for ≥1 month) and NSAIDs (≥2 weeks) before study entry.

NSAIDs, nonsteroidal anti-inflammatory drugs.

Next: ACTIVE Clinical Trial Program

ACTIVE® clinical trial program

Program2,7:

  • Phase IIIb multicenter, randomized, double-blind, placebo-controlled, parallel group study
  • 219 adult patients with active psoriatic arthritis

Study design2,7:

  • Randomized 1:1 to either Otezla 30 mg twice daily, or placebo
  • Doses were titrated over the first week of treatment
  • Placebo controlled to week 24
  • At week 24, all remaining placebo patients were switched to Otezla with dose titration through week 52; open-label treatment phase up to week 104

Primary endpoint2,7:

  • Percentage of patients achieving ACR20 response at week 16

Selected inclusion criteria2,7:

  • Had a documented diagnosis of active psoriatic arthritis of ≥3 months’ duration
  • Had ≥3 swollen and ≥3 tender joints
  • Biologic treatment-naïve
  • May be exposed to 1 DMARD
    • Must discontinue DMARD ≥1 day prior to baseline visit
    • No requirement for DMARD washout, except for cyclosporine (4-week washout) and leflunomide (12-week washout)

Selected exclusion criteria:

  • Active TB or history of incompletely treated TB2,7
  • Hepatitis B or C positive at screening2
  • History of HIV2

ACR, American College of Rheumatology; ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients With Psoriatic Arthritis; DMARD, disease-modifying antirheumatic drug; HIV, human immunodeficiency virus; TB, tuberculosis.

Baseline disease characteristics and treatment history

Disease characteristics:

  • Median duration: 1.8 years2
  • Mean tender joint count: 17.82,7
  • Mean swollen joint count: 9.52,7

Treatment history2,7:

  • Previous DMARD use: 69.4%
  • Prior MTX use: 58%
MTX, methotrexate.

 

Next: Efficacy

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc. 3. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 4. Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. J Rheumatol. 2015;42(3):479-488. 5. Cutolo M, Myerson GE, Fleischmann RM, et al. J Rheumatol. 2016;43(9):1724-1734. 6. Edwards CJ, Blanco JC, Crowley J, et al. Ann Rheum Dis. 2016;75(6):1065-1073. 7. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

Otezla® (apremitast) is indicated for the treatment of 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.

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% (1/1 308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1 308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezia 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% (3/1 441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1 441) 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
    • Behcet’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% (1 9/382) 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 ¡n 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rilampin, a strong CYP4SO enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP45O enzyme inducers (e.g., rifampin. phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, ptacebo%): 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 (east 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 (2M, 0.2)
  • Behçet’s Disease: Adverse reactions reported in 5% of patients taking Otezta, 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://mothertoaby.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 breastleeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastled 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/mm); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

Otezla® (apremitast) is indicated for the treatment of 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.

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% (1/1 308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1 308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezia 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% (3/1 441) oF patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1 441) 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
    • Behcet’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% (1 9/382) 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 ¡n 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rilampin, a strong CYP4SO enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP45O enzyme inducers (e.g., rifampin. phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, ptacebo%): 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 (east 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 (2M, 0.2)
  • Behçet’s Disease: Adverse reactions reported in 5% of patients taking Otezta, 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 letal 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 breastleeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastled 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/mm); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.