The following information comes from DailyMed, an FDA label information provider.

The following serious adverse reactions of Otezla (apremilast) are discussed in greater detail in other sections:

• Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
• Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache
• Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Adverse Reactions

The following adverse reactions are described elsewhere in the labeling:

• Diarrhea, Nausea, and Vomiting
• Depression
• Weight Decrease
• Drug Interactions

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. 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. Placebo patients whose tender and swollen joint counts had not improved by at least 20% were re-randomized 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.

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. 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.

Severe worsening of psoriasis (rebound) occurred in 0.3% (4/1184) subjects following discontinuation of treatment with OTEZLA.

Behçet’s Disease Clinical Trials

OTEZLA was evaluated in Phase 3, multicenter, randomized, placebo-controlled study (BCT-002) in adult patients with Behçet’s Disease (BD) with active oral ulcers. A total of 207 patients were randomized to receive OTEZLA 30 mg twice daily or placebo twice daily. Titration was used over the first 5 days. After Week 12, all patients received treatment with OTEZLA 30 mg twice daily. Patients ranged in age from 19 to 72, with a mean age of 40 years.

Diarrhea, nausea, headache, and upper respiratory tract infection were the most commonly reported adverse reactions. The proportion of patients with BD who discontinued treatment due to any adverse reaction during the placebo-controlled period of the study, was 2.9% for patients treated with OTEZLA 30 mg twice daily and 4.9% for placebo-treated patients.

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