Volume 119, Issue 6, Pages 1473-1482 (December 2000) Recombinant human interleukin 10 in the treatment of patients with mild to moderately active Crohn's disease  Richard N. Fedorak, *, Alfred Gangl, ‡, Charles O. Elson, §, Paul Rutgeerts, ∥, Stefan Schreiber, ¶, Gary Wild, #, Stephen B. Hanauer, **, Ann Kilian, ‡‡, Marielle Cohard, ‡‡, Alexandre LeBeaut, ‡‡, Brian Feagan, §§  Gastroenterology  Volume 119, Issue 6, Pages 1473-1482 (December 2000) DOI: 10.1053/gast.2000.20229 Copyright © 2000 American Gastroenterological Association Terms and Conditions

Fig. 1 Mean hemoglobin concentration for 5 rhuIL-10 doses and placebo during the treatment and follow-up phases. Hemoglobin values decreased in a dose-dependent manner within 3 days of beginning rhuIL-10 and plateaued by 21 days. Hemoglobin values recovered to baseline levels within several weeks of stopping treatment. Gastroenterology 2000 119, 1473-1482DOI: (10.1053/gast.2000.20229) Copyright © 2000 American Gastroenterological Association Terms and Conditions

Fig. 2 Mean platelet count for 5 rhuIL-10 doses and placebo during the treatment and follow-up phases. Platelet counts decreased in a dose-dependent manner within 3 days of beginning rhuIL-10 treatment and plateaued by 8 days. Platelet counts recovered to baseline levels within 2 weeks of stopping treatment. Gastroenterology 2000 119, 1473-1482DOI: (10.1053/gast.2000.20229) Copyright © 2000 American Gastroenterological Association Terms and Conditions

Fig. 3 Percentage of patients achieving (A) clinical and endoscopic (complete) remission or (B) clinical remission at day 29 in patients treated for 28 days with subcutaneous rhuIL-10 or placebo, using intent-to-treat data set. (A) Clinical and endoscopic (complete) remission is defined as a CDAI at day 29 of <150 and a decrease from baseline CDAI of >100, plus physician global assessment of improvement or resolution in endoscopic appearance. (B) Clinical remission is defined similarly relative to changes in CDAI, but does not include assessment of endoscopic appearance. The most effective dose of rhuIL-10 is 5 μg/kg; doses above this were less effective. Gastroenterology 2000 119, 1473-1482DOI: (10.1053/gast.2000.20229) Copyright © 2000 American Gastroenterological Association Terms and Conditions

Fig. 4 Serum concentration vs. time for 4 doses of rhuIL-10. The pharmacokinetic profile revealed a dose-dependent absorption and systemic exposure to rhuIL-10. Mean values for Cmax, Tmax, and AUC increased in a dose-related but not dose-proportional fashion. Gastroenterology 2000 119, 1473-1482DOI: (10.1053/gast.2000.20229) Copyright © 2000 American Gastroenterological Association Terms and Conditions

Fig. 5 Mean CDAI for 4 doses of rhuIL-10 and placebo during the treatment phase and first 2 weeks of the follow-up phase, before therapy for recurrence of Crohn's disease, using the intent-to-treat data set. During the first 2 weeks of follow-up, patients who had received 5 and 10 μg/kg rhuIL-10 during the treatment phase continued to show a decrease in CDAI; in contrast, patients who had received 1 and 20 μg/kg rhuIL-10 or placebo during the treatment phase showed increases in their CDAI. Gastroenterology 2000 119, 1473-1482DOI: (10.1053/gast.2000.20229) Copyright © 2000 American Gastroenterological Association Terms and Conditions