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The OTEZLA® international website

This site is intended for healthcare professionals outside the U.S.

OTEZLA HAS A FAVORABLE SAFETY AND TOLERABILITY PROFILE

Adverse reactions reported in ≥5% of patients1,2
 
Placebo-controlled period
Cumulative exposure
Weeks 0 to 16
(n = 418)
Weeks 0 to 16
(n = 832)
Weeks 0 to 156a
(n = 1,184)
PlaceboOTEZLA
(30 mg BID)
OTEZLA
(30 mg BID)
Adverse Reactions
Diarrhea28 (6.7)148 (17.8)221 (18.7)
Nausea28 (6.7)148 (17.8)221 (18.7)
Upper respiratory
tract infection
27 (6.5)70 (8.4)227 (19.2)
Nasopharyngitis29 (6.9)61 (7.3)196 (16.6)
Tension headache14 (3.3)61 (7.3)115 (9.7)
Headache14 (3.3)48 (5.8)86 (7.3)

aPooled data from ESTEEM 1 and ESTEEM 2. Includes all patients who received OTEZLA regardless of when OTEZLA exposure started. OTEZLA exposure is based on each patient’s total exposure to OTEZLA, defined as the time interval between the date of the first dose and the date of the last dose, inclusive.

Discontinuation of treatment due to any adverse reaction was 5.4%
for patients taking OTEZLA vs 3.8% for placebo at week 161

BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis.

References:

  1. Reich K, Papp K, Gordon K, et al. Long-term Safety and Tolerability of Apremilast in Patients With Psoriasis: Pooled Safety Analysis of Two Phase 3, Randomized, Controlled Trials (ESTEEM 1 and 2). Presented at the Summer Academy Meeting of the American Academy of Dermatology (AAD) 2015; 19-23 August 2015; New York, NY.
  2. Crowley J, Thaçi D, Joly P, et al. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017;77(2):310-317.
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OTEZLA International Websites
OTEZLA is approved in 51 Countries
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