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001-es BibID:BIBFORM036076
035-os BibID:PMID:19637334
Első szerző:Reinisch, Walter
Cím:Fontolizumab in moderate to severe Crohn's disease: a phase 2, randomized, double-blind, placebo-controlled, multiple-dose study / Walter Reinisch, Williem de Villiers, László Bene, László Simon, István Rácz, Seymour Katz, István Altorjay, Brian Feagan, Dennis Riff, Charles N. Bernstein, Daniel Hommes, Paul Rutgeerts, Antoine Cortot, Michael Gaspari, May Cheng, Tillman Pearce, Bruce E. Sands
Dátum:2010
ISSN:1078-0998
Megjegyzések:BACKGROUND: The safety and efficacy of fontolizumab, a humanized anti-interferon gamma antibody, was investigated in patients with Crohn's disease (CD). Elevated gut mucosal levels of interferon gamma, a key cytokine involved in the inflammatory process of CD, are associated with disease symptoms. METHODS: A total of 201 patients with Crohn's Disease Activity Index (CDAI) scores between 250 and 450 were randomized to receive an initial intravenous dose of 1.0 or 4.0 mg/kg fontolizumab or placebo, followed by up to 3 subcutaneous doses of 0.1 or 1.0 mg/kg fontolizumab or placebo every 4 weeks. Clinical response at day 29, the primary efficacy endpoint, was defined as a decrease in the CDAI of at least 100 points from baseline levels. RESULTS: Of 201 patients, 135 (67%) completed the study. Day 29 response rates were similar in all treatment groups (31%-38%). At subsequent timepoints a significantly greater proportion of patients in the 1.0 mg/kg intravenous / 1.0 mg/kg subcutaneous fontolizumab group had clinical response and significantly greater improvement in the CDAI score compared with patients who received placebo. All fontolizumab groups had significant improvement in C-reactive protein levels. The overall frequency of adverse events was similar in all groups (58%-75%); most events were related to exacerbation of CD. There was a low frequency (5.2%) of neutralizing antibodies to fontolizumab. CONCLUSIONS: Although a strong clinical response to fontolizumab was not observed, significant decreases in C-reactive protein levels suggest a biological effect. Fontolizumab was well tolerated, and further studies to assess its efficacy are warranted.
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Megjelenés:Inflammatory Bowel Diseases 16 : 2 (2010), p. 233-42. -
További szerzők:Villiers, Williem de Bene László (Budapest) Simon László (orvos Szekszárd) Rácz István (orvos Győr) Katz, Seymour Altorjay István (1954-) (belgyógyász, gasztroenterológus, onkológus) Feagan, Brian Riff, Dennis Bernstein, Charles N. Hommes, Daniel Rutgeerts, Paul Cortot, Antoine Gaspari, Michael Cheng, May Pearce, Tillman Sands, Bruce E.
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