These patients achieved PGA scores equating to “clear” or “almost clear” at week 82
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See the results between baseline and week 8
See the results between baseline and week 8
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Baseline
Week 1
Week 4
Week 6
Week 8
Baseline
Week 1
Week 4
Week 6
Week 8
Baseline
Week 1
Week 4
Week 6
Week 8
Baseline
Week 1
Week 4
Week 6
Week 8
Baseline
Week 1
Week 4
Week 6
Week 8
Baseline
Week 1
Week 4
Week 6
Week 8
PGA: Physician Global Assessment.
Consistent improvement continued through week 82,†
Study design
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle– and active comparator–controlled clinical trial in adult patients with mild-to-moderate plaque psoriasis. In the trial, 794 patients were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or Cal/BDP TS, 0.005%/0.064%. The majority of patients in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of patients had disease of mild severity. Disease severity was determined by a 5-grade PGA scale.5
The primary efficacy endpoint was the proportion of patients with treatment success at week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the PGA score and a PGA score equating to “clear” or “almost clear.” Other evaluated outcomes included a reduction in itch as defined by at least a 4-point improvement in the 11-point NRS from baseline to week 4.5
BDP: betamethasone dipropionate; Cal: calcipotriene; NRS: Peak Pruritus Numerical Rating Scale; TS: topical suspension.
Study design
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle– and active comparator–controlled clinical trial in adult patients with mild-to-moderate plaque psoriasis. In the trial, 794 patients were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or Cal/BDP TS, 0.005%/0.064%. The majority of patients in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of patients had disease of mild severity. Disease severity was determined by a 5-grade PGA scale.5
The primary efficacy endpoint was the proportion of patients with treatment success at week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the PGA score and a PGA score equating to “clear” or “almost clear.” Other evaluated outcomes included a reduction in itch as defined by at least a 4-point improvement in the 11-point NRS from baseline to week 4.5
BDP: betamethasone dipropionate; Cal: calcipotriene; NRS: Peak Pruritus Numerical Rating Scale; TS: topical suspension.
Continual reductions in itching through week 82,†,§
Study design
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle– and active comparator–controlled clinical trial in adult patients with mild-to-moderate plaque psoriasis. In the trial, 794 patients were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or Cal/BDP TS, 0.005%/0.064%. The majority of patients in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of patients had disease of mild severity. Disease severity was determined by a 5-grade PGA scale.5
The primary efficacy endpoint was the proportion of patients with treatment success at week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the PGA score and a PGA score equating to “clear” or “almost clear.” Other evaluated outcomes included a reduction in itch as defined by at least a 4-point improvement in the 11-point NRS from baseline to week 4.5
*Wynzora cream (36.0%) demonstrated a ≥1-grade improvement in significantly more patients than vehicle (12.6%) at week 1 (P<0.0001).1
†Wynzora cream (37.4%) was noninferior to calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% (22.8%) for the primary endpoint of treatment success at week 8.5
‡When used as directed.
§NRS itch is an 11-point scale that quantifies itch intensity; a 4-point improvement is defined with respect to baseline. Patients with observed baseline NRS ≥4.3
Study design
The safety and efficacy of Wynzora cream were evaluated in a randomized, multicenter, noninferiority, vehicle– and active comparator–controlled clinical trial in adult patients with mild-to-moderate plaque psoriasis. In the trial, 794 patients were randomized to 1 of 3 treatment groups: Wynzora cream, vehicle cream, or Cal/BDP TS, 0.005%/0.064%. The majority of patients in the trial (81.7%) had disease of moderate severity at baseline, while 18.3% of patients had disease of mild severity. Disease severity was determined by a 5-grade PGA scale.5
The primary efficacy endpoint was the proportion of patients with treatment success at week 8. Treatment success was defined as at least a 2-grade improvement from baseline in the PGA score and a PGA score equating to “clear” or “almost clear.” Other evaluated outcomes included a reduction in itch as defined by at least a 4-point improvement in the 11-point NRS from baseline to week 4.5
*Wynzora cream (36.0%) demonstrated a ≥1-grade improvement in significantly more patients than vehicle (12.6%) at week 1 (P<0.0001).1
†Wynzora cream (37.4%) was noninferior to calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% (22.8%) for the primary endpoint of treatment success at week 8.5
‡When used as directed.
§NRS itch is an 11-point scale that quantifies itch intensity; a 4-point improvement is defined with respect to baseline. Patients with observed baseline NRS ≥4.3
Relieving itch with Wynzora—or simply reducing its severity—is a vital component in improving patients’ quality of life7
INDICATION: Wynzora® (calcipotriene and betamethasone dipropionate) Cream, 0.005%/0.064% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. ADVERSE EVENTS: In the pivotal trial, the most common adverse reactions (≥1%) were: upper respiratory infection (7%), headache (2%), and application site infection (1%). WARNINGS AND PRECAUTIONS: For topical use only. Patients should not use more than 100g of Wynzora® Cream per week. Do not use near or in the mouth, eyes or intravaginally. Avoid using Wynzora® Cream on the face, groin or armpits, or if they have atrophy at the treatment site. Discontinue use once plaque psoriasis is under control or at 8 weeks. Do not use Wynzora® Cream with occlusive dressings. Hypercalcemia and hypercalciuria have been observed with topical use of calcipotriene. Wynzora® Cream can cause reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency during and after withdrawal of treatment. Wynzora® Cream may cause vision problems, including increasing the risk of cataracts and glaucoma. It is not known if Wynzora® Cream may harm your unborn baby. Breastfeeding women should not apply Wynzora® Cream directly to the nipple or areola; it is not known whether topically administered calcipotriene and betamethasone dipropionate is absorbed in human milk.
Please see Full Prescribing Information for Wynzora.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
References: 1. Pinter A, Iversen L, Praestegaard M, Stein Gold L. Fixed dose calcipotriene (CAL) and betamethasone dipropionate (BDP) cream significantly improves plaque psoriasis at week one in a pooled analysis of phase 3 data. Poster presented at: European Academy of Dermatology and Venereology Congress; September 7-10, 2022; Milan, Italy. 2. Stein Gold L, Green LJ, Dhawan S, Vestbjerg B, Praestegaard M, Selmer J. A phase 3, randomized trial demonstrating the improved efficacy and patient acceptability of fixed dose calcipotriene and betamethasone dipropionate cream. J Drugs Dermatol. 2021;20(4):420-425. doi:10.36849/JDD.2021.5653 3. Data on File. MC2 Therapeutics. 4. Pinter A, Praestegaard M, Selmer J, Reich A. Calcipotriene and betamethasone dipropionate cream demonstrates high treatment success in patients with scalp psoriasis. SKIN J Cutan Med. 2022;6(2):s9. doi:10.25251/skin.6.supp.9 5. Wynzora® Cream. Package insert. MC2 Therapeutics; 2020. 6. Han G, Feldman SR, Bhatia N, Praestegaard M. Calcipotriene (CAL) and betamethasone dipropionate (BDP) cream (CAL 0.005%/BDP 0.064% W/W) improved plaque psoriasis at week one in a phase 3 trial. SKIN J Cutan Med. 2022;6(4):s42. doi:10.25251/skin.6.supp.42 7. Feldman SR. Disease burden and treatment adherence in psoriasis patients. Cutis. 2013;92(5):258-263.
