Patient-reported itching decreased by
approximately 50% at day 42,b
*Primary endpoint; **Secondary endpoint.
aPooled data based on results from 2 randomized, controlled studies of adults with moderate plaque psoriasis with similar methodology. Subjects were randomized to either SERNIVO (n=356), diprolene lotion (n=90), or vehicle (n=182).
Treatment success was defined as an Investigator’s Global Assessment (IGA) of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline.2,3
bItching was assessed proactively using Fisher’s exact test, with subjects asked if they were experiencing itching (yes/no) at each visit (days 4, 8, 15, and 29) or had experienced itching since their last visit (post-hoc analysis).4
cOf several prototype formulations tested in vitro, SERNIVO provided the best balance of high penetration/permeation and low absorption.5
dAvoid use on the face, scalp, axilla, groin, or other intertriginous areas.
SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia or unmasking of latent diabetes mellitus, and glucosuria. These events are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings. Avoid use on the face, scalp, axilla, groin or other intertriginous areas. Use of SERNIVO Spray is not recommended in pediatric patients as they are more susceptible to systemic toxicity. Allergic contact dermatitis may occur. The most common adverse reactions (≥1%) were application site pruritus, burning and/or stinging, pain, and atrophy. Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. These are not all the possible side effects of SERNIVO Spray.
Please refer to Full Prescribing Information.
SERNIVO Spray is indicated for the treatment of mild-to-moderate plaque psoriasis in patients 18 years of age or older.
To report ADVERSE EVENTS, call 1-800-399-2561 or AE@encorederm.com, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.