"The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are "...
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Psoriatic Arthritis Clinical Trials
OTEZLA was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled trials [Studies PsA-1, PsA-2, and PsA-3] of similar design in adult patients with active psoriatic arthritis [see Clinical Studies]. Across the 3 studies, there were 1493 patients randomized equally to placebo, OTEZLA 20 mg twice daily or OTEZLA 30 mg twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. Placebo patients whose tender and swollen joint counts had not improved by at least 20% were rerandomized 1:1 in a blinded fashion to either OTEZLA 20 mg twice daily or 30 mg twice daily at week 16 while OTEZLA patients remained on their initial treatment. Patients ranged in age from 18 to 83 years, with an overall median age of 51 years.
The majority of the most common adverse reactions presented in Table 2 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of patients with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for patients taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated patients.
Table 2: Adverse Reactions Reported in ≥ 2% of
Patients on OTEZLA 30 mg Twice Daily and ≥ 1% Than That Observed in
Patients on Placebo for up to Day 112 (Week 16)
|Preferred Term||Placebo||OTEZLA 30 mg BID|
|Day 1 to 5
|Day 6 to Day 112
|Day 1 to 5
|Day 6 to Day 112
|Diarrheaa||6 (1.2)||8 (1.6)||46 (9.3)||38 (7.7)|
|Nauseaa||7 (1.4)||15 (3.1)||37 (7.4)||44 (8.9)|
|Headachea||9 (1.8)||11 (2.2)||24 (4.8)||29 (5.9)|
|Upper respiratory tract infectionb||3 (0.6)||9 (1.8)||3 (0.6)||19 (3.9)|
|Vomitinga||2 (0.4)||2 (0.4)||4 (0.8)||16 (3.2)|
|Nasopharyngitisb||1 (0.2)||8 (1.6)||1 (0.2)||13 (2.6)|
|Abdominal pain upperb||0 (0.0)||1 (0.2)||3 (0.6)||10 (2.0)|
|a Of the reported gastrointestinal adverse
reactions, 1 subject experienced a serious adverse reaction of nausea and
vomiting in OTEZLA 30 mg twice daily; 1 subject 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
b Of the reported adverse drug reactions none were serious.
c n (%) indicates number of patients and percent.
Other adverse reactions reported in patients on OTEZLA in clinical studies including extension studies:
Immune system disorders: Hypersensitivity
Investigations: Weight decrease
Gastrointestinal Disorders: Frequent bowel movement, gastroesophageal reflux disease, dyspepsia
Metabolism and Nutrition Disorders: Decreased appetite*
Nervous System Disorders: Migraine
Respiratory, Thoracic, and Mediastinal Disorders: Cough
Skin and Subcutaneous Tissue Disorders: Rash
*1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction.
Psoriasis Clinical Trials
The safety of OTEZLA® was assessed in 1426 subjects in 3 randomized, double-blind, placebo-controlled trials in adult subjects with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Subjects were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days [see DOSAGE AND ADMINISTRATION]. Subjects ranged in age from 18 to 83 years, with an overall median age of 46 years.
Diarrhea, nausea, and upper respiratory tract infection were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking OTEZLA were nausea (1.6%), diarrhea (1.0%), and headache (0.8%). The proportion of subjects with psoriasis who discontinued treatment due to any adverse reaction was 6.1% for subjects treated with OTEZLA 30 mg twice daily and 4.1% for placebo-treated subjects.
Table 3: Adverse Reactions Reported in ≥ 1% of
Subjects on OTEZLA and With Greater Frequency Than in Subjects on Placebo; up
to Day 112 (Week 16)
|OTEZLA 30 mg BID
|Preferred Term||n (%)||n (%)|
|Diarrhea||32 (6)||160 (17)|
|Nausea||35 (7)||155 (17)|
|Upper respiratory tract infection||31 (6)||84 (9)|
|Tension headache||21 (4)||75 (8)|
|Headache||19 (4)||55 (6)|
|Abdominal pain*||11 (2)||39 (4)|
|Vomiting||8 (2)||35 (4)|
|Fatigue||9 (2)||29 (3)|
|Dyspepsia||6 (1)||29 (3)|
|Decreased appetite||5 (1)||26 (3)|
|Insomnia||4 (1)||21 (2)|
|Back pain||4 (1)||20 (2)|
|Migraine||5 (1)||19 (2)|
|Frequent bowel movements||1 (0)||17 (2)|
|Depression||2 (0)||12 (1)|
|Bronchitis||2 (0)||12 (1)|
|Tooth abscess||0 (0)||10 (1)|
|Folliculitis||0 (0)||9 (1)|
|Sinus headache||0 (0)||9 (1)|
|*Two subjects treated with OTEZLA experienced serious adverse reaction of abdominal pain.|
Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA.
Read the Otezla (apremilast tablets) Side Effects Center for a complete guide to possible side effects
Strong CYP450 Inducers
Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers (such as rifampin) and may result in loss of efficacy [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/1/2016
Additional Otezla Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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