Clinical, Quality of Life, Patient Adherence, and Safety Outcomes of Short-Course (12 Weeks) Treatment with Cyclosporine in Patients with Severe Psoriasis (the Practice Study)

Abstract

Background: Apart from clinical outcomes, the "real-world" outcomes of intermittent short-course cyclosporine treatment remain poorly documented.

Objective: To evaluate various outcomes of short-course cyclosporine treatment for severe psoriasis; and to describe dermatologists' use of the Rule of Tens.

Methods: A 12-week pharmacoepidemiological study; 112 evaluable patients recruited by 43 dermatologists.

Results: The mean initial cyclosporine dose was 2.88±0.74 mg/kg/day. At 12 weeks, 64.3% of patients were continued beyond the study period at mean dose of 2.51±0.91 mg/kg/day. Percent body surface affected, Psoriasis Area Severity Index score, and patient and physician rating of psoriasis severity decreased significantly, while quality of life (QoL) improved significantly. Median patient satisfaction at 12 weeks was 85 (0~100 scale). Patient-reported non-adherence was 43.9% and 56.1%, respectively at both the time points (p=0.18). In modeling on logarithmized outcomes variables, living along was consistently the single most important (negative) determinant of therapeutic and patient outcomes. Safety and tolerance parameters were similar to the ones reported in the literature. Only 7.3% of physicians correctly identified the measures included in the Rule of Tens and the Rule's criterion for inferring severe psoriasis.

Conclusion: With adequate monitoring and patient adherence, cyclosporine treatment reduces the severity of severe psoriasis, improves QoL, and is appropriately tolerated; leading to high patient satisfaction. Social support is a key determinant of therapeutic and patient outcomes and patients living along may require clinical attention. The relevance of the Rule of Tens was not evident.

Keywords: Cyclosporine; Pharmacoepidemiology; Psoriasis; Treatment outcome.