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Biotech / Medical : IMNR - Immune Response
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To: Tom Genna who wrote (1173)11/23/1998 10:45:00 PM
From: Tom Genna  Read Replies (1) of 1510
 
On Sept 11 1998 the FDA approved ARAVA for the treatment of RA. Compare the clinical results of Arava with the phase II results of Immune Response's IR501. There is virtually no difference.

KANSAS CITY, MO -- Sept. 11, 1998 -- The United States Food and Drug Administration has approved Hoechst Marion Roussel's Arava(TM)
(leflunomide) for the treatment of active rheumatoid arthritis (RA) in adults.

Arava was statistically significantly superior to placebo and the effect was consistent with the active control drug, methotrexate (41 percent response rate for Arava versus 19 percent for placebo versus 35 percent for methotrexate) in reducing the signs and symptoms of RA as measured by ACR success rate defined as completing 12 months of treatment and ACR response at endpoint.

Patients treated with Arava began showing improvements as early as one month after treatment initiation and sustained improvement throughout the course of treatment. In fact, a greater percentage of Arava-treated patients were ACR responders overall compared to patients receiving placebo (52 percent for Arava versus 26 percent for placebo versus 46 percent for methotrexate).
Additionally, separate results from this same study show that Arava is effective in slowing the progression of RA. Arava is also the first and only drug to be indicated to retard structural joint damage caused by RA.

Now read IR's report:

The results of the trial indicated that the treatment was safe, with none of the patients discontinuing the trial due to treatment-related adverse events. Patients in both treatment groups showed improvement in disease condition. Most importantly, the 90 microgram dose group showed a statistically significant improvement when compared to control patients, as measured in accordance with the American College of Rheumatology criteria for improvement (ACR 20 criteria). After the final injection, 50% of the treated patients improved compared with 19% of the control group. The differences between treated and control patients were statistically significant. The 300 microgram dose group demonstrated favorable trends with 37% of the patients showing improvement after the final injection, compared to a 19% improvement in the control group. The ACR 20 criteria require an improvement
in tender and swollen joint counts of at least 20% from baseline, along with improvement in 3 of 5 other disease-related criteria. Patients who showed improvement after treatment also had evidence of reduction in the circulating level of the inflammatory cytokine tumor necrosis factor alpha (TNF-a).

IR
drug vs placebo

50-19
37-19

ARAVA
41-19
52-26
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