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Psoriatic Arthritis
Placebo
|
Otezla 30 mg BID
|
|||
---|---|---|---|---|
Day 1 to Day 5 (N=495)n (%) | Day 6 to Day 112 (N=490)n (%) | Day 1 to Day 5(N=497)n (%) | Day 6 to Day 112(N=493)n (%) | |
Adverse reaction | ||||
Diarrheab | 6 (1.2) | 8 (1.6) | 46 (9.3) | 38 (7.7) |
Nauseab | 7 (1.4) | 15 (3.1) | 37 (7.4) | 44 (8.9) |
Headacheb | 9 (1.8) | 11 (2.2) | 24 (4.8) | 29 (5.9) |
Upper respiratory tract infectionc | 3 (0.6) | 9 (1.8) | 3 (0.6) | 19 (3.9) |
Vomitingb | 2 (0.4) | 2 (0.4) | 4 (0.8) | 16 (3.2) |
Nasopharyngitisc | 1 (0.2) | 8 (1.6) | 1 (0.2) | 13 (2.6) |
Upper abdominal painc | 0 (0.0) | 1 (0.2) | 3 (0.6) | 10 (2.0) |
aAfter initial 5-day titration. bOf the reported gastrointestinal adverse reactions, 1 patient experienced a serious adverse reaction of nausea and vomiting in Otezla 30 mg twice daily; 1 patient treated with Otezla 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 patient treated with Otezla 30 mg twice daily experienced a serious adverse reaction of headache. cOf the reported adverse drug reactions, none were serious.
BID, twice daily; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.
Includes all patients who received Otezla during the time interval relative to the start of Otezla administration.
PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy.
Placebothrough week 16
(145.0 patient-years) |
Otezla 30 mg twice dailythrough week 16
(142.6 patient-years) |
Otezla 30 mg twice dailythrough year 5
(2196.7 patient-years) |
|
---|---|---|---|
Major adverse cardiac eventsb | |||
Events | 0.7 | 0.0 | 0.3 |
Malignancies | |||
Hematologic | 0.0 | 0.0 | 0.1 |
Skin (excluding melanoma) | 2.1 | 0.0 | 0.3 |
Solid | 0.7 | 0.7 | 0.5 |
Infections | |||
Non-opportunistic serious | 1.4 | 0.7 | 1.1 |
Opportunistic (systemic) | 0.0 | 0.0 | 0.1 |
New cases of tuberculosis (TB)c | 0.0 | 0.0 | 0.0 |
Reactivation of TB | 0.0 | 0.0 | 0.0 |
Exposure-adjusted incidence rate/100 patient-years is 100 times the number (n) of patients reporting the event divided by patient-years (up to the first event start date for patients reporting the event). bMajor adverse cardiac events (MACE) were defined as TEAEs of acute or fatal myocardial infarction, stroke or fatal stroke, or sudden cardiac death. cPatients with a history of active or incompletely treated TB were excluded from the trials. The trials included 32 patients with a medical history of TB (including latent TB and pulmonary TB), or a positive tuberculin test.
PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TEAEs, treatment-emergent adverse events.
Laboratory abnormalities reported in the placebo-controlled period and long-term exposure period in patients on Otezla 30 mg twice daily2 |
Placebo-controlleda
|
Exposure periodb
|
||||||
Weeks 0 to ≤24 | Weeks 0 to ≤24 | Weeks 0 to ≤52 | Weeks >52 to ≤104 | Weeks >104 to ≤156 | Weeks >156 to ≤208 | Weeks >208 to ≤260 | |
Laboratory parameter | Placebo (N = 495) %, (n/N) |
Otezla 30 mg BID (N = 497) %, (n/N) |
Otezla 30 mg BID (N = 721) %, (n/N) |
Otezla 30 mg BID (N = 520) %, (n/N) |
Otezla 30 mg BID (N = 443) %, (n/N) |
Otezla 30 mg BID (N = 401) %, (n/N) |
Otezla 30 mg BID (N = 364) %, (n/N) |
Chemistry | |||||||
ALT >3x ULN | 0.2 (1/492) | 1.4 (7/492) | 1.3 (9/713) | 0.4 (2/518) | 0.5 (2/442) | 0.2 (1/401) | 0.3 (1/363) |
AST >3x ULN | 0.4 (2/491) | 0.4 (2/492) | 0.6 (4/713) | 0.2 (1/518) | 0.7 (3/442) | 0.5 (2/401) | 0.3 (1/363) |
Bilirubin >1.8x ULN | 0.0 | 0.4 (2/492) | 0.3 (2/713) | 0.4 (2/518) | 0.5 (2/442) | 0.7 (3/401) | 1.1 (4/363) |
Creatinine >1.7x ULN | 0.2 (1/492) | 0.2 (1/492) | 0.1 (1/713) | 0.0 | 0.0 | 0.2 (1/401) | 0.3 (1/363) |
Cholesterol >7.8 mmol/Lc | 2.0 (10/492) | 3.5 (17/492) | 3.8 (27/713) | 2.3 (12/518) | 2.9 (13/442) | 2.5 (10/401) | 2.8 (10/363) |
Urate, male >590 μmol/L; female >480 μmol/Ld | 2.8 (14/492) | 3.5 (17/492) | 3.8 (27/713) | 3.7 (19/518) | 4.3 (19/442) | 6.0 (24/401) | 3.9 (14/363) |
Hematology | |||||||
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL | 0.2 (1/489) | 0.4 (2/489) | 0.7 (5/713) | 0.8 (4/517) | 1.1 (5/442) | 1.2 (5/401) | 1.4 (5/362) |
Leukocytes <1.5 x 109/L | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Lymphocytes <0.8 x 109/L | 3.5 (17/488) | 3.3 (16/489) | 3.9 (28/713) | 2.9 (15/517) | 3.2 (14/442) | 2.5 (10/401) | 4.4 (16/362) |
Neutrophils <1.0 x 109/L | 0.4 (2/488) | 0.2 (1/489) | 0.3 (2/713) | 0.6 (3/517) | 0.5 (2/442) | 0.5 (2/401) | 1.1 (4/362) |
Platelets <75 x 109/L | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 (1/441) | 0.0 | 0.6 (2/362) |
Placebo-controlled period includes all data through week 16 for patients initially assigned to placebo who escaped, and all data through week 24 for all other patients.
Otezla-exposure period includes all Otezla-exposure data, regardless of when the Otezla exposure started (week 0, 16, or 24).
Did not have to be drawn when the patient was fasting.
Urate, male >9.9 mg/dL; female >8.1 mg/dL.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; ULN, upper limit of normal.
Number of Patients (%) | ||||
---|---|---|---|---|
Placebo
(N=176)
|
Otezla 30 mg BID
(N=175)
|
|||
Adverse reactions | ||||
Any TEAE | 71 (40.3) | 86 (49.1) | ||
Diarrhea | 3 (1.7) | 20 (11.4) | ||
Nausea | 4 (2.3) | 25 (14.3) | ||
Headache | 4 (2.3) | 14 (8.0) |
aBefore early escape.
BID, twice daily; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; TEAE, treatment-emergent adverse event.
The majority of diarrhea and nausea adverse reactions were generally reported within
the first 2 weeks of treatment and tended to resolve within 4 weeks with continued dosing3
aIncludes all patients who received Otezla during the time interval relative to the start of Otezla administration.
DMARD, disease-modifying antirheumatic drug.
During the Otezla exposure period, discontinuation due to adverse reactions
occurred at 5.2% for years 0 to ≤1, 3.5% for years >1 to ≤2, 3.1% for years >2 to ≤3,
0.0% for years >3 to ≤4, and 1.5% for years >4 to ≤5
Placebo
through week 16 (51.3 patient-years) |
Otezla 30 mg BID
through week 16 (50.7 patient-years) |
Otezla 30 mg BID
through year 5 (792.5 patient-years) |
|
Major adverse cardiac eventsb | |||
Events | 0 | 0 | 0 |
Malignancies | |||
Hematologic | 0 | 0 | 0 |
Skin (excluding melanoma) | 2.0 | 0 | 0.5 |
Solid tumors | 0 | 0 | 0.3 |
Infections | |||
Non-opportunistic serious | 2.0 | 2.0 | 0.6 |
Opportunistic (systemic) | 0 | 0 | 0 |
New cases of TBc | 0 | 0 | 0 |
Reactivation of TB | 0 | 0 | 0 |
aExposure-adjusted incidence rate/100 patient-years is 100 times the number (n) of patients reporting the event divided by the patient-years (up to the first event start date for patients reporting the event). bMajor adverse cardiac events were defined as TEAEs of acute or fatal myocardial infarction, stroke or fatal stroke, or sudden cardiac death. cPatients with a history of active or incompletely treated TB were excluded from the trials. No patients in the placebo or Otezla 30 mg BID treatment groups were identified as having potential risks for TB. No cases of reactivation or de novo TB were reported.3
TB, tuberculosis.
Otezla exposure perioda
|
|||||
Years 0 to ≤1 |
Years >1 to ≤2 |
Years >2 to ≤3 |
Years >3 to ≤4 |
Years >4 to ≤5 |
|
Laboratory parameter | Otezla 30 mg BID (N=252)% (n/N) | Otezla 30 mg BID (N=201)% (n/N) | Otezla 30 mg BID (N=163)% (n/N) | Otezla 30 mg BID (N=138)% (n/N) | Otezla 30 mg BID (N=130)% (n/N) |
Chemistry | |||||
ALT >3 x ULN | 1.2 (3/246) | 1.0 (2/200) | 1.9 (3/161) | 1.5 (2/137) | 0 |
AST >3 x ULN | 1.2 (3/246) | 2.0 (4/200) | 1.2 (2/161) | 1.5 (2/137) | 0 |
Bilirubin >1.8 x ULN | 0 | 0 | 1.2 (2/161) | 0 | 0 |
Cholesterol >7.8 mmol/Lb,c | 3.3 (8/246) | 4.5 (9/200) | 4.3 (7/161) | 3.6 (5/137) | 2.3 (3/130) |
Creatinine >1.7 x ULN | 0.4 (1/246) | 1.0 (2/200) | 1.9 (3/161) | 1.5 (2/137) | 1.5 (2/130) |
Urate, male >590 µmol/L; female >480 µmol/L |
3.7 (9/246) | 4.5 (9/200) | 2.5 (4/161) | 5.1 (7/137) | 1.5 (2/130) |
Hematology | |||||
Hemoglobin, male <10.5 g/dL; female <8.5 g/dL |
0.8 (2/245) | 1.0 (2/199) | 0.6 (1/160) | 2.2 (3/136) | 2.3 (3/129) |
Leukocytes <1.5 x 109/L | 0 | 0 | 0 | 0 | 0 |
Lymphocytes <0.8 x 109/L | 1.6 (4/244) | 0.5 (1/199) | 3.1 (5/160) | 0.7 (1/136) | 1.6 (2/129) |
Neutrophils <1.0 x 109/L | 0.8 (2/244) | 0 | 0 | 0 | 0.8 (1/129) |
Platelets <75 x 109/L | 0 | 0 | 0 | 0 | 0 |
aOtezla exposure period includes all Otezla exposure data, regardless of when the Otezla exposure started. bEquivalent to 302 mg/dL. cDid not have to be drawn when the patient was fasting.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.
Placebo-controlled phase
(weeks 0-24)a
|
Cumulative Otezla exposureb
|
|||
---|---|---|---|---|
Placebo (N=109) |
Otezla 30 mg BID (N=109) |
Otezla 30 mg BID (N=206) |
||
Adverse reactions | ||||
Diarrheac | 11.0%c | 14.7%c | 16.0% | |
Nausea | 1.8% | 8.3% | 7.8% | |
Nasopharyngitis | 6.4% | 8.3% | 7.8% | |
Headache | 3.7% | 7.3% | 5.8% | |
Hypertension | 6.4% | 6.4% | 6.3% | |
Upper respiratory tract infection | 10.1% | 4.6% | 6.8% |
aIncludes data through week 16 for placebo patients who escaped, and data through week 24 for all other patients. bIncludes all available Otezla exposure data (including data beyond 52 weeks): patients with multiple reports are only counted once. cProtocol-defined characterization of diarrhea of two or more watery or liquid stools/day: placebo (8.3%) and Otezla 30 mg BID (11%).
ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; BID, twice daily.
Discontinuations due to any adverse reactions occured at 8.3%
during the Otezla exposure period (N=206)1
Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.
Reference: 1. Data on file, Amgen Inc.
Reference: 1. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Data on file, Amgen Inc.
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.
References: 1. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698. 2. Data on file, Amgen Inc.
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.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.
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.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.