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The OTEZLA® international website

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OTEZLA HAS A PROVEN SAFETY AND TOLERABILITY PROFILE1

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

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 (%)
Diarrhea112 (15.5)20 (3.8)12 (2.7)4 (1.0)
Nausea108 (15.0)11 (2.1)10 (2.3)3 (0.7)
Upper respiratory tract infection60 (8.3)27 (5.2)24 (5.4)21 (5.2)
Headache75 (10.4)17 (3.3)12 (2.7)7 (1.7)
Nasopharyngitis41 (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

OTEZLA HAS A PROVEN LONG-TERM SAFETY PROFILE2

Rates of serious adverse reactions of interest were comparable between OTEZLA and placebo3

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. 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.
  2. 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.
  3. Data on file, Celgene Corporation.
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