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Is Wynzora cream used to treat plaque psoriasis?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on April 17, 2023.

Official answer

by Drugs.com

Yes, Wynzora is approved to treat plaque psoriasis in adults 18 years and older. Wynzora is a cream that contains calcipotriene, a vitamin D analog, and betamethasone dipropionate, a topical corticosteroid. It is applied to the skin once daily for up to 8 weeks, but if your skin clears sooner, treatment may be discontinued.

Plaque psoriasis is a chronic skin condition often found on the elbows, knees, scalp and lower back. It is characterized by raised, red lesions with a silvery white scale that may itch, burn or bleed. The exact cause of psoriasis is not known and there is no cure, but symptoms can usually be well-managed with treatment.

Wynzora is manufactured by MC2 Therapeutics. It was first approved in July 2020.

How well does Wynzora work for psoriasis?

Studies have shown that after 8 weeks of treatment, over one-third of patients will have a 2-grade improvement in their skin symptoms that their doctor will describe as “clear or almost clear” and itching will also dramatically improve. Some people saw improvement in their skin symptoms, “flare-ups” and itching as early as the first week of treatment.

Studies

In Phase 3 studies, Wynzora was compared to a vehicle (cream that contains no active medicine) in 794 subjects with mild-to-moderate psoriasis. Over 80% of patients had moderate psoriasis symptoms at the start of the study.

Investigators primarily sought to determine which group had the best treatment success after 8 weeks of treatment. Treatment success was defined as a Physician’s Global Assessment (PGA) score of at least a 2-grade improvement from baseline and equating to skin of “clear” or “almost clear. A reduction in itch, a secondary endpoint, was also evaluated at week four.

Skin improvements

After 8 weeks of treatment, 37.4% of patients using Wynzora showed a result of “clear or almost clear” skin (and a 2-grade improvement in skin symptoms) compared to 3.7% for the vehicle control group.

When looking at improvements after one week, the group receiving Wynzora demonstrated a ≥1-grade improvement in significantly more patients (36%) than the vehicle group (12.6%). In addition, over 83% of patients had at least a 1-grade improvement from baseline (the start of the study) at week 8.

Itching

Wynzora works quickly to help alleviate the common symptom of itching patients in psoriasis. Studies have shown that relief of itching can positively impact a patient’s quality of life.

After the first week of treatment, over twice as many people receiving Wynzora had improvements in itching compared to the vehicle group and it continued to improve over 8 weeks.

  • The symptom of itching (pruritus) was evaluated as a secondary outcome in studies. A reduction in itch was defined as at least a 4-point improvement in the 11-point peak pruritus numeric rating scale (NRS) from baseline to Week 4.
  • In patients who had at least a score of 4 for itching (peak pruritus NRS) at the beginning of treatment, almost 3 times as many patients receiving Wynzora had a reduction of itch (60.3%) vs. the vehicle group (21.4%) after 4 weeks of treatment.
  • There was also a significantly greater improvement in itching at week 1 in the group receiving Wynzora (44%) compared to the inactive vehicle group (20.4%). At week 1, 2 out of every 5 patients using Wynzora had a significantly greater improvement in the symptom of itching.

Related Questions

Wynzora vs. Taclonex

In a phase 3 comparative study at week 8, treatment with Wynzora cream was shown to be as effective as treatment with Taclonex (treatment not worse or non-inferior) for the primary endpoint of treatment success (37.4% vs. 22.8%, respectively).

Treatment success was defined as at least a 2-grade improvement from baseline in the Physician’s Global Assessment (PGA) score and an PGA score equating to “clear” or “almost clear”.

Taclonex (calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064%) is a topical liquid used to treat plaque psoriasis that also contains calcipotriene and betamethasone dipropionate. Taclonex Topical Suspension (liquid) is approved to treat plaque psoriasis of the scalp and body in people 12 years and older.

Taclonex topical suspension and Wynzora topical cream are the same strength products and both are applied once daily.

Related: How do I apply Wynzora cream?

Can Wynzora be used on the scalp?

Yes, Wynzora has been shown to be an effective treatment for psoriasis of the scalp with results starting at week 1 and improvement continuing over 8 weeks.

For patients with scalp psoriasis, 29.5% of people had an improvement in symptoms (a ≥1-grade improvement in physician-determined score) compared to 0.2% using the vehicle, a statistically significant improvement.

Improvements had also been demonstrated when to treat areas on the elbows and knees.

What are the typical side effects?

Wynzora is well-tolerated by most patients. Less than 1% of patients experienced application-site irritation from the cream.

The most common side effects for Wynzora compared to the vehicle only (the cream without medicine), respectively, includes:

  • upper respiratory infection (7% vs. 5%)
  • headache (2% vs. 0%)
  • application site irritation (1% vs. 0%)

Other more serious side effects and warnings are:

  • changes in calcium levels in the blood or urine (seen with use of calcipotriene)
  • changes in the endocrine system due to HPA axis suppression with use of a corticosteroid
  • eye changes: an increase in the risk of cataracts and glaucoma

Adrenal suppression was seen in 6 out of 26 subjects (23%) after 4 weeks of treatment and in 3 out of 25 subjects (12%) after 8 weeks of treatment with Wynzora.

Learn more: Wynzora side effects in greater detail

This is not all the information you need to know about Wynzora (calcipotriene and betamethasone dipropionate) cream for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References
  • Wynzora (calcipotriene and betamethasone dipropionate) prescribing information. MC2 Therapeutics, Ltd. Guildford, United Kingdom. Accessed Apr 17, 2023 at https://www.wynzora.com/wp-content/uploads/2022/01/Wynzora_USPI_12.0_clean-12.24.2021.pdf
  • Pinter A, Praestegaard M, Selmer J, et al. 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
  • 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.
  • Stein Gold L, Green LJ, Dhawan S, et al. 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.
  • Wynzora.com. Accessed Apr 17, 2023 at https://www.wynzora.com/efficacy/ and https://www.wynzora.com/efficacy/#itchdata

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