Body Psoriasis


Body psoriasis

SORILUX Foam delivers effective, steroid-free treatment for plaque psoriasis of the body

SORILUX Foam was evaluated as monotherapy for mild-to-moderate plaque psoriasis of the body in 2 multicenter, randomized, double-blind, vehicle-controlled, Phase III studies including 659 patients aged 12 to 89 years (10 patients were <18 years of age).1

Study design1

  • At baseline, patients were required to have plaque psoriasis with an Investigator’s Static Global Assessment (ISGA) score of 2 (mild) or 3 (moderate) on a 5-point scale for erythema, thickness, and scaliness
    • At baseline, 71% of patients had moderate psoriasis and 29% of patients had mild psoriasis
  • Patients were instructed to self-administer SORILUX Foam or vehicle foam as monotherapy twice daily, morning and evening, for 8 weeks

Treatment success was defined as an ISGA score of clear (0) or almost clear (1) AND at least a 2-grade improvement in the ISGA score from baseline to week 8.2

  • Patients with mild psoriasis (ISGA score 2) at baseline needed to be graded as clear (ISGA score 0) at week 8 to achieve treatment success

Think you know calcipotriene? Look again.

SORILUX Foam—photos of actual patients who achieved treatment success in clinical trials

Patient 1—Leg


Image showing psoriasis on calf of an actual patient at baseline. Sorilux calcipotriene foam, clinical studies.

Image showing cleared up psoriasis on calf of an actual patient at week 8. Sorilux calcipotriene foam, clinical studies

Patient 2—Elbow


Image showing psoriasis on an elbow (underside) of an actual patient at baseline. Sorilux calcipotriene foam, clinical studies

Image showing cleared up psoriasis on an elbow (underside) of an actual patient at week 8. Sorilux calcipotriene foam, clinical studies

Actual patients from clinical trials, who are representative of patients who achieved treatment success. Individual results may vary.

FDA approval of SORILUX Foam was based on the totality of clinical evidence, including 2 Phase III studies


Chart showing percentage of patients who achieved treatment success at week 8 of a clinical study 1 of Sorilux foam for body psoriasis

*P=0.058

Patients graded as mild at baseline showed a greater response to vehicle foam than SORILUX Foam (3/34 and 2/73, respectively).

Because the overall treatment success rate in Study 1 did not achieve statistical significance, P values are not included for patients with mild or moderate psoriasis.


Chart showing percentage of patients who achieved treatment success at week 8 of a clinical study 2 of Sorilux foam for body psoriasis

*P=0.016

P=0.859

P=0.015

The proportion of patients who achieved treatment success with SORILUX Foam in Study 2 was statistically significant for all patients and for patients with moderate psoriasis of the body when compared with vehicle foam.

Rate of adverse reactions was similar between patients using SORILUX Foam and patients using vehicle foam

APPLICATION SITE REACTIONS FROM 2 PIVOTAL STUDIES FOR PLAQUE PSORIASIS OF THE BODY1

THE MOST FREQUENT ADVERSE REACTIONS REPORTED BY >1% OF PATIENTS IN CLINICAL STUDIES SORILUX FOAM
(N=437)
VEHICLE FOAM
(N=222)
Application site erythema 2% 1%
Application site irritation 2% 1%
Application site pruritus 2% 3%

References: 1. Feldman SR, Matheson R, Bruce S, et al; U0267-301 & 302 Study Investigators. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012;13(4):261-271. 2. SORILUX Foam [package insert]. Greenville, NC: Mayne Pharma; 2016.

Indication

SORILUX Foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older.

For more information, please see full Prescribing Information and Patient Information Leaflet

Important Safety Information

  • SORILUX Foam should not be used by patients with known hypercalcemia
  • The propellant in SORILUX Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application
  • Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored
  • Physicians may wish to limit or avoid use of phototherapy in patients who use SORILUX Foam
  • Safety and effectiveness of SORILUX Foam in pediatric patients less than 18 years of age have not been established
  • Instruct the patient to avoid excessive exposure of the treated areas to either natural or artificial sunlight, including tanning booths and sun lamps
  • SORILUX Foam is not for oral, ophthalmic, or intravaginal use
  • Adverse reactions reported in ≥1% of subjects treated with SORILUX Foam and at a higher incidence than subjects treated with vehicle were application site erythema (2%) and application site pain (3%). The incidence of these adverse reactions was similar between the body and scalp

Medical Information & Adverse Drug Events Reporting

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.