Terapia cu anticorpi monoclonali anti-TNF-alfa în maladiile inflamatorii intestinale la copii

Abstract

Summary Introduction: Inflammatory bowel diseases are chronic, relapsing inflammatory disorders increasingly diagnosed in children. The number of children diagnosed with inflammatory bowel disease is continuously increasing worldwide as well as in the Republic of Moldova. In pediatric patients with ulcerative colitis and moderate-to-severe Crohn’s disease, the pharmacokinetic profile of golimumab has been shown to be comparable between children and adults, suggesting similar clinical benefits and safety. Anti-TNF-alpha monoclonal antibodies represent a major advance in pediatric inflammatory bowel disease (IBD). Objective: To evaluate long-term efficacy and safety of golimumab in pediatric IBD. Materials and Methods: The study enrolled 45 pediatric patients with inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, diagnosed in accordance with the ESPGHAN criteria. All patients were treated with golimumab and were prospectively monitored over a 98-week follow-up period to evaluate long-term efficacy and safety outcomes. Results: We evaluated the efficacy and safety of Golimumab in pediatric patients with inflammatory bowel disease. Group I (n=12), previously treated with corticosteroids or azathioprine, transitioned to Golimumab monotherapy. Group II (n=29) received Golimumab as primary therapy. Initial clinical improvement was observed at 6–12 weeks, with complete remission achieved at 48 weeks and maintained long-term with regular dosing. In Group III (n=4, Crohn’s disease), monotherapy was insufficient; combination therapy (Golimumab + corticosteroids/azathioprine) was initiated at 12 weeks, and three patients achieved remission by 74 weeks. No major adverse events were reported. These results support Golimumab as an effective and safe treatment, both as monotherapy and in combination, for pediatric patients with inflammatory bowel disease Conclusion: Real-world evidence indicates that Golimumab is effective in pediatric patients, particularly those with severe disease (PUCAI >65), who may require adjunctive corticosteroid therapy. Clinical studies demonstrate that Golimumab can both induce and maintain clinical and endoscopic remission in children with moderate to severe disease refractory to conventional therapies, such as corticosteroids or azathioprine.