- Safety Profile
IN MODERATE TO SEVERE PLAQUE PSORIASIS
TREMFYA® SAFETY PROFILE (ECLIPSE)1
ECLIPSE: SUMMARY OF SAFETY FINDINGS THROUGH WEEK 56
|ADVERSE EVENT RATES THROUGH WEEK 56|
|SAFETY ANALYSIS SET, n||534||511|
|AVERAGE DURATION OF FOLLOW-UP (WEEKS)||54.90||53.67|
|≥1 ADVERSE EVENT, n (%)||416 (77.9%)||417 (81.6%)|
|≥1 SERIOUS ADVERSE EVENT, n (%)||33 (6.2%)||37 (7.2%)|
|SELECT ADVERSE EVENTS*|
|INFECTIONS, n (%)||313 (58.6%)||331 (64.8%)|
|SERIOUS INFECTIONS, n (%)||6 (1.1%)||5 (1.0%)|
|INFLAMMATORY BOWEL DISEASE, n (%)†||0||3 (0.6%)|
|SERIOUS HYPERSENSITIVITY REACTIONS, n (%)‡||0||1 (0.2%)§|
No safety comparisons can be made between TREMFYA® and Cosentyx® based upon this presentation.
*Selected adverse events represent events included in Warnings and Precautions section of this current Prescribing Information for each product.
†Inflammatory bowel disease includes Crohn’s disease, colitis, or inflammatory bowel disease. Of these 3 treatment-emergent adverse events, there was 1 serious adverse event of Crohn’s disease.
‡Anaphylactic reactions include adverse events of anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock, and Type 1 hypersensitivity. Serum sickness-like reactions include adverse events of serum sickness and serum sickness-like reaction.
§Anaphylactoid reaction to wasp bite.
Reference: 1. Data on file. Janssen Biotech, Inc.