Recommended Topic Related To:

Otezla

"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 "...

Otezla

SIDE EFFECTS

Clinical Trials Experience In Psoriatic Arthritis

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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.

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 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 two 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
(N=495)
n (%)c
Day 6 to Day 112
(N=490)
n (%)
Day 1 to 5
(N=497)
n (%)
Day 6 to Day 112
(N=493)
n (%)
Diarrhea a 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 headache.
b Of the reported adverse drug reactions none were serious.
cn (%) 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.

Read the Otezla (apremilast tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Strong CYP 450 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].

Last reviewed on RxList: 3/31/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

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.


Women's Health

Find out what women really need.