Evaluation of quality of life outcomes and safety of Cyclosporine therapy in patients with moderate to severe plaque psoriasis. A prospective, single arm study

Title Evaluation of quality of life outcomes and safety of Cyclosporine therapy in patients with moderate to severe plaque psoriasis A prospective single arm study

Introduction Psoriasis is a chronic immune mediated inflammatory skin disease affecting 2 to 3 percent of the global population with Indian prevalence up to 2.8. It is associated with systemic comorbidities such as psoriatic arthritis metabolic syndrome cardiovascular disease and depression causing significant impairment in health related quality of life QoL. Cyclosporine a calcineurin inhibitor is a potent systemic therapy with rapid onset of action widely used in moderate to severe psoriasis. However its long term use is limited by nephrotoxicity hypertension hepatotoxicity and other adverse events. There is limited real world data from Indian tertiary care centers particularly in low resource settings on the impact of cyclosporine on QoL and safety.

Objectives Primary Objective To evaluate the impact of cyclosporine on QoL using DLQI from baseline to Week 12.

Secondary Objectives To assess safety by monitoring laboratory parameters blood pressure and adverse events. To evaluate QoL using EQ 5D 5L at baseline and Week 12.

Endpoints Primary Endpoint Change in DLQI and EQ 5D 5L scores from baseline to Week 12. Secondary Endpoints Safety assessment using lab tests CBC RFT LFT blood pressure and adverse drug reactions graded by Hartwig and Siegel scale.

Methodology This is a prospective single arm open label study conducted at the Dermatology OPD of a tertiary care teaching hospital. Adults aged 18 to 65 years with moderate to severe plaque psoriasis requiring cyclosporine will be included. Exclusions include non plaque variants prior cyclosporine use and contraindications. Participants will receive cyclosporine 3 to 5 mg per kg per day in divided doses. Follow up includes telephonic visits at Weeks 4 and 8 and in person assessment at Week 12 with clinical laboratory and QoL evaluations.

Statistics Sample size 58 patients calculated to detect a mean DLQI difference of 4 with standard deviation of 10 with 80 percent power and alpha 0.05 accounting for 10 percent dropout. Descriptive statistics will summarize demographics. Paired t test will assess changes in DLQI and EQ 5D 5L. Chi square test will analyze adverse drug reaction frequencies. Significance will be set at p less than 0.05.