The OTEZLA® international website

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OTEZLA HAS A PROVEN SAFETY AND TOLERABILITY PROFILE1,2

The incidence of most adverse reactions did not increase with longer-term use1,2

OTEZLA 30 mg BID exposure period
 
Weeks 0 to ≤52
(n = 721)
Weeks > 52 to ≤104
(n = 520)
Weeks > 104 to ≤156
(n = 443)
Weeks > 156 to ≤208
(n = 401)
Adverse reactions in ≥5% of
patients, any treatment group, n (%)
Diarrhea 112 (15.5) 20 (3.8) 12 (2.7) 4 (1.0)
Nausea 108 (15.0) 11 (2.1) 10 (2.3) 3 (0.7)
Upper respiratory tract infection 60 (8.3) 27 (5.2) 24 (5.4) 21 (5.2)
Headache 75 (10.4) 17 (3.3) 12 (2.7) 7 (1.7)
Nasopharyngitis 41 (5.7) 31 (6.0) 20 (4.5) 26 (6.5)
  • Nausea and diarrhea were generally mild to moderate in severity, occurred during the first 2 weeks of treatment, and generally resolved in the first month with continued treatment
  • Most adverse reactions were mild to moderate in severity across all 4 years of OTEZLA treatment

The long-term safety profile of OTEZLA was generally
similar to that observed in clinical trials1,2

OTEZLA HAS A PROVEN LONG-TERM SAFETY PROFILE3

Rates of serious adverse reactions of interest were comparable between OTEZLA and placebo4

 

aExposure-adjusted incidence rate/100 patient-years is 100 times the number (n) of patients reporting the event divided by patient-years (up to the first event start date for patients reporting the event).

bPatients with a history of active or incompletely treated TB were excluded from the trials. The trials included 32 patients with a history of fully treated TB, a positive PPD or QuantiFERON®, or a history of receiving preventive medication for TB.

cData includes assessments from the placebo-controlled phase (weeks 0 to 24, placebo only) and the OTEZLA-exposure periods (weeks 0 to ≥24 and weeks 0 to ≥52). The OTEZLA exposure period includes all OTEZLA data, irrespective of when OTEZLA was started through study termination/withdrawal, or the data cutoff date. The exposure time for a subject with a specific event was the treatment duration up to the start date (inclusive) of the first occurrence of the specific event.

BID, twice daily; PPD, purified protein derivative.

References:

  1. OTEZLA Summary of Product Characteristics. Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, The Netherlands; 2020.
  2. Mease PJ, Gladman DD, Gomez-Reino JJ, et al. Consistent safety profile with up to 4 years of apremilast treatment: analysis of data from 1,493 subjects with psoriatic arthritis in 3 large, phase III, long-term studies. Presented at: the 2017 ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, CA.
  3. Mease PJ, Gladman DD, Gomez-Reino JJ, et al. Long-term (156-Week) Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Arthritis: Pooled Safety Analysis of Three Phase lll, Randomized, Controlled Trials. Presented at: the Annual European Congress of Rheumatology EULAR 2016: 8-11 June 2016; London, UK.
  4. Data on file, Amgen Inc.
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