Alhalabi Marouf M, Abbas Ahmad J
Gastroenterology Department of Damascus Hospital, Damascus, Syria.
Damascus Hospital, Damascus, Syria.
Ann Med Surg (Lond). 2022 Mar 2;75:103456. doi: 10.1016/j.amsu.2022.103456. eCollection 2022 Mar.
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.
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, 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.
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.
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.
溃疡性结肠炎是一种免疫介导性疾病，在儿科治疗中面临挑战，因为它通常病情严重且范围广泛。当前的儿科溃疡性结肠炎指南对于低体重儿童使用戈利木单抗的用法和剂量给出的推荐力度较弱。我们报告了一例使用未获批准、未推荐剂量的皮下注射戈利木单抗治疗低体重慢性活动性溃疡性结肠炎患儿的病例。
一名10岁叙利亚女孩，未使用过抗TNF药物，患有慢性活动性溃疡性结肠炎，体重25kg，身高142cm，体表面积（BSA）为0.993平方米，既往用药包括口服泼尼松和美沙拉嗪，未接受过手术。我们在第0周和第2周分别使用200mg、100mg戈利木单抗进行诱导治疗，然后每四周使用50mg，持续约两年。
关于儿科使用皮下注射戈利木单抗的推荐力度较弱，因为其依据的是一项开放标签的药代动力学队列研究。戈利木单抗有100mg/1ml、50mg/0.5ml规格的SmartJect剂型，以及45mg/0.45ml规格的VarioJect剂型，后者可提供10mg至45mg的戈利木单抗，增量为5mg/0.05ml。戈利木单抗VarioJect剂型供应短缺，在包括叙利亚在内的多个地区无法获得。推荐的戈利木单抗维持剂量总是需要两支注射器，这增加了额外负担。
本病例表明，对于体重<45kg的儿童，在第0周和第2周分别使用200mg、100mg戈利木单抗进行诱导治疗，然后每四周使用50mg是有效且安全的，在两年的治疗期间未出现副作用或不良事件。
