The OTEZLA® international website
This site is intended for healthcare professionals outside the U.S.
The OTEZLA® international website
This site is intended for healthcare professionals outside the U.S.
|
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) |
The long-term safety profile of OTEZLA was generally
similar to that observed in clinical trials1,2
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.
On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).
Effective November 21, 2019, refer to the Amgen's Terms of Use relating to the access of Amgen websites, applications and digital services and Privacy Statement concerning the collection and use of your personal information.
For information collected by Celgene prior to November 21, 2019, refer to Celgene's Terms of Use and Privacy Policy.