Novel Calcipotriene, Betamethasone Dipropionate Cream Linked With Improved Outcomes and QOL in Psoriasis

A novel formulation of calcipotriene (CAL), betamethasone dipropionate (BDP) cream was found to be more effective, provide superior quality of life, and safe in patients with psoriasis, compared with standard CAL/BDP topical suspension/gel.

Calcipotriene (CAL), betamethasone dipropionate (BDP) cream with PAD technology (Wynzora) may lead to improved outcomes and greater quality of life in patients with psoriasis, according to study findings published recently in Journal of the American Geriatrics Society.

As the first-line treatment of mild-to-moderate plaque psoriasis, fixed dose combination of CAL and BDP has demonstrated efficacy and safety for more than 2 decades. However, researchers note that several limitations regarding the combination therapy’s long-term stability in aqueous environments have restricted the treatment to non-aqueous oil- or paraffin-based formulations (eg, ointment, topical suspension [TS]/gel, foam), which cause a greasy or sticky feeling that contributes to non-adherence among patients.

“Patients prefer a topical formulation that dries quickly, without the sticky or greasy properties that affects skin/hair/clothing,” added researchers.

Recently, CAL/BDP cream leveraging PAD technology (Wynzora), formulations with relatively high robustness against coalescence that maintains their physical-chemical stability, was shown to meet its primary efficacy and safety endpoints in a phase 3 trial of patients with plaque psoriasis from Europe.

Seeking to increase the precision of estimates of the efficacy and safety profile of CAL/BDP PAD-cream, researchers pooled these findings with another phase 3 trial investigating the combination therapy in the United States with similar inclusion criteria.

“Both studies were randomized, multi-center, parallel-group, investigator blinded studies comparing CAL/BDP PAD-cream to the active comparator (CAL/BDP TS) and vehicle cream (CAL/BDP PAD-cream without active ingredients).”

Overall, 1188 patients with plaque psoriasis who completed the trials were randomized to receive CAL/BDP PAD-cream (n = 526), CAL/BDP TS (n = 513), or vehicle cream (n = 149) once daily for 8 weeks across both studies. Primary objectives regarding efficacy, safety, and QOL were assessed at baseline, week 1, week 4, week 6, and week 8.

Efficacy measures included physician’s global assessment (PGA), modified psoriasis area and severity index (mPASI), dermatology life quality index (DLQI), and psoriasis treatment convenience scale.

After 8 weeks of treatment, efficacy and safety measures for CAL/BDP PAD-cream formulation demonstrated superiority in all endpoints compared with CAL/BDP TS and vehicle cream:

  • Significantly higher percentage of patients achieved PGA treatment success with CAL/BDP PAD-cream (43.2%) than CAL/BDP TS (31.9%) and vehicle cream (5.2%) (P < .0001)
  • Mean percent reduction in mPASI for CAL/BDP PAD-cream (64.6%) was statistically greater than for CAL/BDP TS (56.4%) and vehicle cream (20.0%) (P < .0001)
  • DLQI score of 0 or 1, indicating that psoriasis disease had no effect on patient’s life, was obtained by 43.8% in the CAL/BDP PAD-cream group vs 34.2% in the CAL/BDP TS group (P = .0005)

No adverse drug reaction with a frequency of greater than 1% was associated with the CAL/BDP PAD-cream.

“Based on this unique combination of high efficacy combined with favorable safety and excellent treatment preference in a single product, CAL/BDP PAD-cream can be considered a first-line topical therapy of psoriasis,” concluded researchers.

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