Improvements in Plaque Psoriasis Associated with Calcipotriol/Betamethasone Aerosol Foam Treatment: A Post Hoc Analysis of Non-interventional Studies and Clinical Experience

Article

作者: Jablonski Bernasconi, Marie Y ; Halioua, Bruno ; Lazaridou, Elizabeth ; Krogager Eeg, Martin ; Pesiridis, Georgios ; Campanati, Anna ; Ratzinger, Gudrun ; Gerdes, Sascha

INTRODUCTION:

Plaque psoriasis is a chronic relapsing inflammatory skin disease that is associated with extensive disease burden that often requires long-term therapy. Treatment of psoriasis with 4 weeks of the aerosol foam formulation of calcipotriol/betamethasone dipropionate (Cal/BD; Enstilar®, LEO Pharma) has been demonstrated to be effective, well tolerated, and associated with high patient satisfaction. Cal/BD foam is approved as a first-line treatment in multiple countries, where several non-interventional studies (NIS) have corroborated the beneficial efficacy and safety profiles determined in the randomized clinical trials. Heterogenicity in these NIS, however, prevents the use of a data pooling strategy for comparisons of effectiveness outcomes across different patient populations.

METHODS:

Therefore, here, we report on a post hoc analysis of effectiveness data consolidated from six prospective NIS to discern any differences in improvement in signs and symptoms of psoriasis attributable to Cal/BD foam treatment across the countries. In addition, we provide real-world experience of clinicians with Cal/BD foam treatment, factoring in changes in usage since these NIS were performed in their local markets.

RESULTS:

This post hoc analysis of Cal/BD foam NIS brings together data outside of randomized clinical trials from six countries to provide real-world evidence in 1388 patients showing that 4 weeks of Cal/BD foam is an effective and safe treatment option with quick onset of action for patients with psoriasis.

CONCLUSION:

These results show that regardless of NIS location, Cal/BD foam remains a well-tolerated, efficacious option for patient care that could be used as a first-line topical therapy for mild-to-severe psoriasis.

2010-02-01·Journal of pharmaceutical and biomedical analysis3区 · 医学

Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds

3区 · 医学

Article

作者: Minshan Shou ; Qiang Fu ; Robert Markovich ; Dwight Chien ; Abu M. Rustum

Betamethasone (9alpha-fluoro-16beta-methylprednisolone) is one of the members of the corticosteriod family of active pharmaceutical ingredient (API), which is widely used as an anti-inflammatory agent and also as a starting material to manufacture various esters of betamethasone. A stability-indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated which can separate and accurately quantitate low levels of 26 betamethasone related compounds. The stability-indicating capability of the method was demonstrated through adequate separation of all potential betamethasone related compounds from betamethasone and also from each other that are present in aged and stress degraded betamethasone stability samples. Chromatographic separation of betamethasone and its related compounds was achieved by using a gradient elution at a flow rate of 1.0mL/min on a ACE 3 C18 column (150mmx4.6mm, 3microm particle size, 100A pore size) at 40 degrees C. Mobile phase A of the gradient was 0.1% methanesulfonic acid in aqueous solution and mobile phase B was a mixture of tert-butanol and 1,4-dioxane (7:93, v/v). UV detection at 254nm was employed to monitor the analytes. For betamethasone 21-aldehyde, the QL and DL were 0.02% and 0.01% respectively. For betamethasone and the rest of the betamethasone related compounds, the QL and DL were 0.05% and 0.02%. The precision of betamethasone assay is 0.6% and the accuracy of betamethasone assay ranged from 98.1% to 99.9%.

2009-11-01·European journal of dermatology : EJD

Henna tattoo and Sweet’s syndrome: a possible relation

Letter

作者: Selores, Manuela ; Lobo, Inês ; Rosmaninho, Aristóteles ; Amorim, Isabel ; Machado, Susana

Auteur(s) : Aristoteles Rosmaninho, Susana Machado, Isabel Amorim, Ines Lobo, Manuela Selores Department of Dermatology, Centro hospitalar do Porto-HSA, Rua D. Manuel II s/n°, 4099-001 Porto, Portugal A 23-year-old Caucasian woman had a henna tattoo applied to her left hand while on holiday in Morocco. Three days later she developed edema, erythema and moderate pruritus over the tattooed area. A diagnosis of allergic contact dermatitis (CD) was made and betamethasone acceponate [...]

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