Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions
Sascha Gerdes, Marion Krakor, Tobias Anger, Hans Joachim Hutt, Andreas Körber, Sascha Gerdes, Marion Krakor, Tobias Anger, Hans Joachim Hutt, Andreas Körber
Abstract
Background/aims: To assess the efficacy and tolerability of the new aerosol foam of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in psoriasis vulgaris under daily practice conditions.
Methods: 410 adult psoriasis patients (56% male) from 87 German sites were enrolled in a 4-week, open-label, prospective, non-controlled, observational, non-interventional study.
Results: At baseline, patients presented with a psoriasis severity of mild (41.81%), moderate (49.63%), and severe (8.31%) assessed by an investigator global assessment (IGA). After 4 weeks of treatment, 49% of the patients achieved an IGA of clear/almost clear. The mean affected body surface area was reduced from 12.91 to 7.55%, the PASI from 10.4 to 5.2 (p < 0.0001). 43% of the patients with severe IGA achieved treatment success (IGA = 0/1 and ≥2-step improvement). 93% of the patients did not show any adverse events.
Conclusion: The new Cal/BD foam showed a convincing efficacy and tolerability profile in daily practice, particularly in patients with severer disease manifestations.
Keywords: Fixed combination; Quality of life; Real-world evidence; Topical therapy.
© 2018 S. Karger AG, Basel.
Source: PubMed