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.
