Efficacy and safety of pioglitazone add-on to methotrexate therapy in plaque psoriasis patient – A randomised control open label study

Abstract

Background: Psoriasis is a chronic inflammatory disease that impairs physical health and quality of life. Conventional therapies often yield variable responses, highlighting the need for adjunctive options. Aims and Objectives: The aim of the study was to evaluate the efficacy and safety of pioglitazone as an addon to standard treatment in moderate to severe psoriasis. Materials and Methods: An openlabel, randomized, interventional study was conducted in the dermatology outpatient department of a tertiary care hospital. Ninety patients were equally allocated into three groups: Standard therapy alone, standard therapy plus pioglitazone 7.5 mg/day, or plus 15 mg/day. Patients were followed for 12 weeks. Results: Baseline characteristics and psoriasis area and severity index (PASI) scores were comparable across groups. No significant differences were observed at baseline (P=0.643) or week 4 (P=0.762). Significant PASI reduction emerged at week 8 (P=0.008) and week 12 (P<0.001), with the higherdose group showing superior improvement (P<0.001). PASI ≥50 was achieved in 57.7%, 64.0%, and 81.5% of patients, while PASI ≥75 was attained only in the higherdose group (18.5%). Mean PASI improvement was 50.0%, 47.2%, and 66.8% in Groups A, B, and C, respectively. Dermatology life quality index scores improved in all groups, with the greatest reduction in the higherdose group (10.56±5.02), followed by 8.00±3.32 and 6.81±2.48 (P=0.015 at week 12). Adverse events were mild, mainly gastrointestinal, with no serious events. Conclusion: Pioglitazone addon therapy improved disease severity and quality of life, with greater benefit at higher doses and good tolerability, supporting its potential as an adjunct option.