Post Marketing Surveillance Study to Assess Safety and Efficacy of Cyclosporine Micro-Emulsion (Neoral®) Treatment in Psoriasis Patients

  • Ümmühan Kiremitçi
  • Ferihan Uslu

J Turk Acad Dermatol 2011;5(3):0-0


To assess efficacy and safety of Cyclosporine micro-emulsion (Neoral®) in psoriasis treatment.

Material and Methods:

A total of 102 patients (mean age: 42.1 ± 11.2; 51.0% were males) who were considered appropriate for Cyclosporine micro-emulsion (Neoral®) treatment by study investigators were enrolled in this multicentre post marketing surveillance study (COLO400CTR05) at 2 different centers in Turkey between September 2005 – June 2009. Data were collected at a total of 17 visits in 12 months for each patient. Efficacy was evaluated in terms of PASI and DLQI scores, while alteration in blood pressure and serum creatinine levels together with adverse events were recorded to evaluate safety during follow up.


Of 102 patients 87.3% completed the 3rd month visit. Psoriasis vulgaris was the leading diagnosis (90.2%) and the average duration of psoriasis was 15.2±8.6 years. When compared to values obtained in the last visit, a significant but steady decline was observed in PASI as well as DLQI scores at each consecutive visit performed during the course of the study (p<0.05 for PASI scores and p<0.001 for DLQI scores). Relapse was identified in 8.8% of patients. Adverse events were reported to be mild in 60.0% of patients while the relation of adverse events to the study medication was considered to be suspicious in 86.0% of cases.


In conclusion, offering steady state and graduated resolution of extent and severity of disease and positive impact on quality of life, cyclosporine therapy in micro-emulsion form seems to be associated with low relapse rate as well as high patient compliance in severe psoriasis treatment for up to 12 months of follow up performed in accordance with therapeutic guidelines.

Keywords: Psoriasis,cyclosporine micro-emulsion,safety,efficacy,PASI,DLQI