Indications -- Psoriasis/Chronic Inflammation Message Board

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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation

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To: Miljenko Zuanic who wrote (408)	5/16/2003 4:04:22 AM
From: Icebrg	Read Replies (1) of 631

>>Something strange is going on???>> Indeed. Crohn's seems to be very a difficult beast to tame (We already knew that). Elan's phase II trial with Crohn's disease also had a somewhat fuzzy response picture. The group given two infusions of 6 mg of natalizumab per kilogram did not have a significantly higher rate of clinical remission (defined by a score of less than 150 on the Crohn’s Disease Activity Index) than the placebo group at week 6 (the prospectively defined primary end point in the efficacy analysis). However, both groups that received two infusions of natalizumab had higher remission rates than the placebo group at multiple time points. Natalizumab also produced a significant improvement in response rates (defined by a reduction of at least 70 points in the score on the Crohn’s Disease Activity Index). The highest remission rate was 44 percent and the highest response rate was 71 percent (at week 6 in the group given two infusions of 3 mg per kilogram). Overall, the two infusions of 6 mg of natalizumab per kilogram and of 3 mg per kilogram had similar effects. The quality of life improved in all natalizumab groups; C-reactive protein levels improved in groups receiving two infusions of natalizumab. The rates of adverse events were similar in all four groups. What is the opinion? Are the doses used in these two trials comparable? I.e does 2 mg per kg of Antegren correspond to 2 mg per kg of MLN02 in "strenght"? As they are both mAbs aiming for the same integrin (but not the same epitope) my guess would be that they are similar. If that is the case it appears that Elan's use of higher doses (3 and 6 mg vs. 0,5 and 2 mg) could account for some of the differences in the results seen. Let's hope that the forthcoming Antegren phase III results will be somewhat more conclusive. Erik

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