OTEZLA HAS A PROVEN SAFETY AND TOLERABILITY PROFILE1
The incidence of most adverse reactions did not increase with longer-term use1
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
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.
- 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.
- 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.
- Data on file, Celgene Corporation.