SPRAY ON THE UNEXPECTED

SERNIVO features a novel betamethasone formulation that allows for a balance of high penetration/permeation and low systemic absorption.1,a

THE SERNIVO mechanism of balance

SERNIVO is formulated for balance, providing high penetration in the epidermis and dermis, with low systemic absorption.1

Penetration of
betamethasone after 24 hours 1

SERNIVO utilizes long-chain oleyl alcohol2,3 and is formulated to deliver the active ingredient to the epidermal layers affected most by plaque psoriasis, even at 24 hours following application.1,3

aOf several prototype formulations tested in vitro, SERNIVO provided the best balance of high penetration/permeation and low absorption.1

A closer look:
Limited steroid absorption

Betamethasones into receptor fluid in vitro

Of 6 different formulations tested (F-10_A - F-10), SERNIVO (the F-10 test formulation) demonstrated an optimal balance of penetration, permeation, and absorption—
high penetration/permeation with minimal receptor fluid levels.1

EXPECT POWERFUL RESULTS

In 2 clinical studies of 538 patients with mild-to-moderate plaque psoriasis, a significant
proportion of patients using SERNIVO Spray achieved treatment success versus vehicle at4,a:

  • Day 15 (20.3% vs 5%; p<0.001)
  • Day 29 (38.7% vs 12.6%; p<0.001)

Pooled treatment success analysis as defined by
IGA= 0 or 1 and ≥2-grade reduction from baseline4

*Primary endpoint; **Secondary endpoint
p value calculated using Cochran-Mantel-Haenszel test
IGA = Investigator's Global Assessment

Expect Rapid Results

DAY 4

Within the first 4 days of treatment**

  • 13.2% of patients achieved a ≥50% reduction in Total Sign Score (TSS50) at Day 4 (vs 6.6% for vehicle; p=0.020; predefined secondary endpoint)4,5,a
    • Improvements were reported in scaling, erythema, and plaque elevation (patients reporting Day 4 scores of 0 or 1 included 42.5% for scaling, 27.4% for erythema, and approximately 30% for plaque elevation)3,b
  • Patient-reported itching decreased by approximately 50%4,c
DAY 8

At day 8**

  • 34.3% of patients achieved a ≥50% reduction in TSS50 at Day 8 (vs 22% for vehicle; p=0.004)4,5,a
  • 11% of patients using SERNIVO had achieved treatment success (compared with 4% for vehicle; p=0.010)4,a
DAY 15

By day 15*

  • Approximately half of patients achieved a ≥50% reduction in TSS50 scores (vs 29% for vehicle; p<0.001)4,5,a
  • 2 of 3 patients reported that their redness had disappeared or had almost disappeared6
  • After 2 weeks of use, patients reported improved quality of life and high treatment satisfaction with SERNIVO in both low (3%-10%) and high (>10%) body surface area (BSA) groups, compared with Dermatology Life Quality Index (DLQI) scores at baseline8,d
DAY 29

After 29 days of treatment**

  • Nearly 75% of all plaques on elbows and knees were clear or almost clear of redness and scaling6
  • Approximately 60% of patients achieved a TSS score of ≤1 (vs approximately 30% for vehicle)4

Patients in clinical studies were adults (18 years and older) and had
plaque psoriasis on 10% to 20% of their body surface area (BSA).4

*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.4,5
bBased on results from a phase 3, randomized, vehicle-controlled, double-blind, parallel-group study of subjects with moderate psoriasis. Subjects were randomized to either SERNIVO (n=174), diprolene lotion (n=90), or vehicle (n=87).3
cItching 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.7
dBased on results from an open-label, multicenter study of adults with moderate plaque psoriasis (N=45) taking SERNIVO.8

With proven tolerability

SERNIVO demonstrated an excellent safety profile in clinical studies.2

Adverse reactions occurring in ≥1% of patients treated with SERNIVO Spray for up to 4 weeks2

During 28 days of treatment with SERNIVO, few patients experienced adverse events2

  • The most common adverse reactions occurring in ≥1% of patients treated with SERNIVO Spray for up to 4 weeks were pruritus (6.0%), burning and/or stinging (4.5%), pain (2.3%), and atrophy (1.1%)2
SERNIVO is approved for up to 4 weeks of use2

Experience elegance redefined

SERNIVO Spray features a patented oil-in-water emulsion,2 with a lotion-like elegance.

The SERNIVO formulation surrounds oil droplets with emulsifiers, allowing the drug to be suspended in the vehicle without separation.
In skin hydration and elasticity studies, SERNIVO demonstrated emollient-like properties and significantly improved skin elasticity at 1 hour (p<0.01).9
SERNIVO Spray can be used on hard-to-treat elbows and knees,4,a
as well as widespread plaques and hairy areas.b

aIn clinical studies, more than one-third of all target lesions were on elbows or knees.6
bAvoid use on the face, scalp, axilla, groin or other intertriginous areas.

Unexpected versatility

A versatile betamethasone formulation that can easily be applied.

  • Patients in clinical studies had 10% to 20% of their body surface area affected4
  • The SERNIVO formulation is nongreasy10 and may provide a patient-friendly treatment experience
  • The spray-dispensing mechanism allows patients to easily apply SERNIVO on hard-to-reach areas
EASE OF USE: SERNIVO is effective for hard-to-reach plaques on the back, in addition to hard-to-treat elbows and knees,4 and hairy areas.a,b

aAll clinical trial subjects were adults (18 years and older) and had a BSA of 10% to 20%.4
bIn clinical studies, more than one-third of all target lesions were on elbows or knees.6