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

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.

Fixed‐dose combination calcipotriol/betamethasone dipropionate foam provides a rapid onset of action, effective itch relief and improves patient quality of life

“…13 A rapid onset of action is therefore a meaningful outcome to patients and may even increase their adherence to topical treatments. 22,23 Recent analyses have evaluated the efficacy of Cal/BD foam at early time points and provided evidence for its rapid onset of action.…”

“…21 This is significant, as unrealistic expectations of the speed of onset of action have been shown to lead to poor adherence and treatment outcomes. 22,23 It is therefore plausible that adherence to a topical treatment, which is typically low, is likely to improve if patients are able to experience an early onset of action, with sustained improvement over time. 23 Fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous aerosol foam (Cal/BD foam; Enstilar â [LEO Pharma, Ballerup, Denmark]) is a topical treatment which has previously demonstrated clinical efficacy and safety in the treatment of psoriasis (discussed in Tada Y, et al and Stein Gold L, et al of this supplement).…”

“…22,23 It is therefore plausible that adherence to a topical treatment, which is typically low, is likely to improve if patients are able to experience an early onset of action, with sustained improvement over time. 23 Fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous aerosol foam (Cal/BD foam; Enstilar â [LEO Pharma, Ballerup, Denmark]) is a topical treatment which has previously demonstrated clinical efficacy and safety in the treatment of psoriasis (discussed in Tada Y, et al and Stein Gold L, et al of this supplement). [24][25][26][27][28] Accordingly, this article will highlight previously published and important findings on the impact of Cal/BD foam on itch relief, quality of sleep, onset of action and HRQoL.…”

Plaque-Type Psoriasis Treated with Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam: A Prospective Study on Clinical and Dermoscopic Predictor Factors in Response Achievement and Retention

“…Whereas it has been demonstrated that the efficacy of such a treatment is independent of the patient’s body mass index and disease extent/severity [ 1 , 2 ], there is a lack of data regarding possible local (lesional) factors influencing therapeutic outcomes. In this regard, we recently showed that the therapeutic response of psoriatic patients to narrowband ultraviolet B (NB-UVB) phototherapy may be significantly influenced by the clinical features of each lesion, with plaques localized on the legs and/or showing more scaling/infiltration being associated to treatment resistance [ 6 ].…”

Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5–15% and PGA ≥ 3: Post-Hoc Analysis From Three Randomized Controlled Trials

“…In the pooled analysis reported here, treatment success by PGA was achieved by 72 patients (28.8%) as early as week 2, compared with only 2 (2.4%) patients in the foam vehicle group. Furthermore, an analysis of speed of action of Cal/BD foam, performed on the overall population of these three trials, demonstrated a rapid onset of action with Cal/BD and a greater efficacy versus foam vehicle, even in patients with moderate-to-severe psoriasis [ 21 ]. These observations are consistent with increased skin penetration and local bioavailability associated with application of the stable, supersaturated Cal/BD foam [ 6 ].…”