Rapid onset of action of calcipotriol/betamethasone dipropionate cutaneous foam in psoriasis, even in patients with more severe disease

J Eur Acad Dermatol Venereol. 2019 Jun;33(6):1116-1123. doi: 10.1111/jdv.15398. Epub 2019 Mar 27.

Abstract

Background: The effectiveness of topical therapies in psoriasis is dependent on, amongst other factors, patient adherence. Together with treatment effectiveness and reduction of symptoms, speed of onset and health-related quality of life (HRQoL) are important influencers of adherence.

Methods: This pooled analysis of three Phase II/III trials evaluated the efficacy of topical fixed-dose combination calcipotriol 50 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) vs. foam vehicle at early timepoints in mild-to-severe psoriasis using clinically meaningful modified Psoriasis Area and Severity Index (mPASI) and Dermatology Life Quality Index (DLQI) targets.

Results: A greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved absolute mPASI targets 0 (15.1% vs. 1.0%), ≤1 (41.4% vs. 5.2%), ≤3 (78.5% vs. 29.2%) and ≤5 (90.2% vs. 62.5%) at week 4 (P < 0.001; all targets). Significant differences between Cal/BD-foam- vs. foam-vehicle-treated patients were observed as early as week 1 in those achieving mPASI ≤1 (6.8% vs. 1.5%; P < 0.01), ≤3 (40.4% vs. 22.8%; P < 0.001) and ≤5 (69.7% vs. 50.8%; P < 0.001). In patients with more severe psoriasis (baseline mPASI >10), a greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved mPASI ≤1 (20.2% vs. 5.9%; P < 0.05), ≤3 (49.2% vs. 8.8%; P < 0.001) and ≤5 (63.7% vs. 26.5%; P < 0.001) at week 4. In patients with severely impaired HRQoL (baseline DLQI >10), a greater proportion of Cal/BD-foam- vs. foam-vehicle-treated patients achieved target DLQI ≤1 or 0 (week 4: DLQI ≤1, 25.0% vs. 4%; P = 0.001; DLQI 0, 17.4% vs. 2.0%; P = 0.006).

Conclusion: We report rapid onset of action and greater efficacy with Cal/BD foam vs. foam vehicle, even in patients with more severe psoriasis, manageable with topical treatments. This may support physician management of patient expectations and improve patient adherence, translating into overall topical treatment effectiveness.

MeSH terms

  • Administration, Cutaneous
  • Betamethasone / administration & dosage
  • Betamethasone / analogs & derivatives*
  • Betamethasone / therapeutic use
  • Calcitriol / administration & dosage
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Patient Compliance
  • Psoriasis / drug therapy*
  • Randomized Controlled Trials as Topic
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • calcipotriene
  • betamethasone-17,21-dipropionate
  • Betamethasone
  • Calcitriol

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