O0107 a Phase Ii, Multicenter, Open‐label Study of the Safety, Tolerability, and Effectiveness of Natalizumab in Adolescents With Moderately to Severely Active Crohn’s Disease.
Year: 2004
Type: conference-abstract
Abstract: Introduction: AntegrenTM (natalizumab), a humanized IgG4 monoclonal antibody, inhibits interactions between alpha4 integrin adhesion molecules expressed on the surface of leukocytes and their counter-receptors on vascular endothelial cells. This may prevent the recruitment and migration of alpha4 integrin-expressing leukocytes into inflamed gut mucosal tissue. This study evaluated the safety, tolerability, and efficacy of natalizumab in adolescent patients with moderately to severely active Crohn’s disease (CD). Methods: 38 adolescent patients, 11–17 years of age (mean of 14.4 years), with active CD (Pediatric Crohn’s Disease Activity Index [PCDAI] >30) received natalizumab (3 mg/kg) by intravenous infusion at 0, 4, and 8 weeks. The primary objective was to determine the safety and tolerability of natalizumab in this patient population as assessed by adverse events, laboratory parameters and vital signs. Efficacy was assessed by PCDAI every two weeks, through Week 12. Results: A total of 27 males (71%) and 11 females (29%) were enrolled. The mean disease duration from diagnosis was 34.6 months. A total of 29% of patients were on steroids, 39% were on immunomodulators and 18% were on 5ASA compounds at study entry. The most common adverse events considered related to natalizumab were headache (13%) and pyrexia (11%). There were eight serious adverse events, none of which were considered related to study drug. No opportunistic infections or lymphomas were reported in this study. A total of 63% of subjects achieved a clinical response (a ≥ 15 point decrease from baseline PCDAI) and 34% were in clinical remission (PCDAI ≤ 10) at some time point during the 12-week treatment phase. Response and remission rates at each time point are shown below (Table 1). Conclusion: Natalizumab appears to be well tolerated in adolescent patients with active CD. The safety profile of natalizumab in adolescents was similar to that observed in adult CD patients in a Phase III randomized, double-blind, placebo-controlled study (ENACT-1). Additionally, treatment with natalizumab in this study appeared to be associated with clinical benefit. Long-term safety and tolerability is currently being evaluated in an open-label extension study.
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W4390567565