Tofacitinib in Pediatric Psoriasis: An Open-Label Trial to Study Its Safety and Efficacy in Children

Abstract

Introduction: Psoriasis is a chronic, multifactorial, inflammatory disorder, with an estimated prevalence of 0.71% in children. The commonly used therapeutic agents target the underlying inflammation. Tofacitinib has demonstrated efficacy in adult psoriasis. Aim: To study the efficacy, safety, and tolerability of tofacitinib in pediatric patients with moderate to severe chronic plaque psoriasis. Methods: The study included children aged between 8 and 17 years, with moderate to severe psoriasis, given tofacitinib 5 mg orally twice daily for at least 36 weeks. The clinical response was estimated using the Psoriasis Area and Severity Index (PASI) score, Physician’s Global Assessment (PGA), and the Children’s Dermatology Life Quality Index (CDLQI). The incidence and severity of adverse events (AEs) were meticulously recorded in each case. Results: A total of 47 patients, with a median age of 12.3 years, completed the study. At week 12, 55.32% achieved PASI 75, and 70.21% at week 36. PGA of clear or almost clear responses at week 12 were 59.57 and 65.96%, ­respectfully, at week 36. Relatively few and mostly minor ­adverse effects were noted. No severe AEs were reported. ­Conclusion: The treatment with tofacitinib was safe and well tolerated, and led to significant improvement of their disease and quality of life as reflected in CDLQI scores. However, the results need to be validated in larger multicenter trials.