Subcutaneous golimumab to treat a biological naïve chronically active ulcerative colitis child. A case report

INTRODUCTION: Ulcerative colitis is an immune-mediated disease that carries challenges in pediatrics since it's frequently severe and extensive. Current pediatric ulcerative colitis guidelines offer a weak recommendation regarding the usage and the dosage of golimumab in low-weight children. We present a case of an off-label, unrecommended dose of subcutaneous golimumab to treat low-weight chronic active ulcerative colitis child. CASE PRESENTATION: A 10-year-old Syrian girl, anti-TNF naïve, chronically active ulcerative colitis was weighs 25 kg, standing 142 cm tall, body surface area (BSA) of 0.993 m(2), past medications included oral prednisone and mesalamine, no prior surgery. We used golimumab 200 mg, 100 mg at weeks 0, 2 as induction, then 50 mg every four weeks for about two years. CLINICAL DISCUSSION: The recommendation regarding the use of subcutaneous golimumab in pediatrics is weak since is based on an open-label pharmacokinetics cohort. It is available in 100 mg/1 ml, 50 mg/0.5 ml as a smart SmartJect, or in 45 mg/0.45 ml in VarioJect which provides golimumab from 10 mg to 45 mg in increments of 5 mg/0.05 ml. Golimumab Varioject is in short supply, and unavailable in several regions including Syria. The recommended golimumab maintenance dose always requires two injectors, which adds another burden. CONCLUSION: This case demonstrated that golimumab 200 mg, 100 mg at week 0, 2 as an induction then 50 mg every four weeks was efficacious and safe in<45 kg children, there were no side effects or adverse events during two years therapy period.