The OTEZLA® international website

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OTEZLA HAS A PROVEN 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)
Placebo OTEZLA
(30 mg BID)
OTEZLA
(30 mg BID)
Adverse Reactions
Diarrhea 28 (6.7) 148 (17.8) 221 (18.7)
Nausea 28 (6.7) 148 (17.8) 221 (18.7)
Upper respiratory
tract infection
27 (6.5) 70 (8.4) 227 (19.2)
Nasopharyngitis 29 (6.9) 61 (7.3) 196 (16.6)
Tension headache 14 (3.3) 61 (7.3) 115 (9.7)
Headache 14 (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.

There were no increases in frequency or severity of adverse reactions with long-term exposure to OTEZLA® up to 5 years. Please see full Important Safety Information.
For the majority of patients reporting diarrhea and nausea, these symptoms were mild to moderate in severity, occurred during the first 2 weeks of treatment, and generally resolved in the first month with continued treatment. Please see full Important Safety Information.
Adverse reactions leading to discontinuation (including nausea and diarrhea) did not increase with long-term exposure to OTEZLA® (11.1% over 182 weeks). Please see full Important Safety Information.

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.
  3. OTEZLA Summary of Product Characteristics. Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands; 2020.
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OTEZLA is approved in 54 countries*
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On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).

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