Proactive therapy with spray foam for psoriasis vulgaris persistently effective

Proactive management with the foam spray fixed combination of calcipotriol and betamethasone dipropionate resulted in fewer relapses and improved long-term symptom control compared with a reactive treatment strategy with a comparable safety profile. This is the conclusion of the PSO-LONG randomized, vehicle-controlled trial.

The objective of the phase III study was to investigate the long-term efficacy and safety of twice-weekly proactive therapy with the fixed combination of calcipotriol 0.005% and betamethasone dipropionate 0.064% as a spray foam compared with reactive therapy for psoriasis vulgaris (Fig. 1) [1]. Overall, more days in remission and fewer relapses were achieved under the proactive treatment regimen with the fixed combination.

Study design

In an initial 4-week open-label phase, calcipotriol (Cal)/betamethasone dipropionate (BD) spray foam (Enstilar®) was used 1× daily in all patients [2]. 545 patients who achieved a Physician’s Global Assessment (PGA) score of 0 (appearance-free) or 1 (near-appearance-free) were eligible to participate in the subsequent 52-week maintenance phase and were randomized 1:1 to the Proactive Management (Cal/BD spray foam, n=272) or Reactive Management (vehicle spray foam, n=273) study arms, each 2x/week or as an as-needed therapy 1×/day for 4 weeks if relapse occurred.

Effectiveness endpoints

The primary endpoint was time to first relapse. 251 patients (46.1%) completed the 52-week maintenance phase. Proactive use of Cal/BD spray foam significantly reduced the risk of first relapse by 43% compared with reactive therapy (HR 0.57; 95% CI, 47-69%; p<0.001). The median time to first relapse was 56 days under the proactive regimen and 30 days under reactive therapy. For 50% of patients, the time to first relapse had doubled compared with reactive therapy. Furthermore, proactive use had a positive impact on remission duration. Over the one-year period*, patients in the proactive study arm were in remission an average of 41 days longer than the reactively treated control group (p<0.001) with 37.5 additional treatment days per year. The relapse rate decreased by 46% with proactive treatment with Cal/BD spray foam (95% CI: 37-54%; p<0.001).

* Recurrences per exposure year

Safety data

The safety and tolerability profile of proactive Cal/BD spray foam treatment was favorable throughout the study period. The incidence of adverse events was comparable in both study arms, as were rebound phenomena (6 and 7 rebounds, respectively). The discontinuation rate due to adverse events was also similar under proactive and reactive therapy (0.7% and 0.4%, respectively). The results of this new study are promising and indicate that proactive management with Enstilar® spray foam leads to improved long-term control of plaque psoriasis compared to the conventional reactive treatment strategy.

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