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2009 Post-ACR Report
November 02, 2009
The future treatment paradigm for rheumatoid arthritis was altered by a regulatory event which occurred at the same time as with the ACR meeting. Rituxan received a complete response letter for the treatment of rheumatoid arthritis patients who no longer respond to disease modifying anti-rheumatic drug (DMARD) therapy due to the risk of Progressive Multifocal Leukoencaphalopathy (PML). This complete response letter will prevent Rituxan from moving forward in the treatment scheme towards the front-line patient population. While this was a disappointing development for Rituxan, other compounds continued to show promise at increasing treatment options for rheumatoid arthritis patients. Top-line data from subcutaneously dosed Orencia showed the safety of this new formulation. Updated data from CP-690550 continued to confirm this compound as the front-runner in the race to be the first to market orally dosed immunomodulatory agent.
One of the most highly anticipated presentations at this year’s meeting was Benlysta for the treatment of systemic lupus erythematosus (SLE). SLE is a notoriously difficult to treat disease and no agent has been approved for this indication in over 50 years. Data from the first pivotal phase III study showed that the drug is effective at controlling the disease in patients with serologically positive SLE (those with autoantibodies). These results were subsequently confirmed by data from the second pivotal study which became available after the meeting. These results are exciting given the number of failed trials including some highly notable agents such as Rituxan.
On the whole there was little groundbreaking data at this year’s ACR meeting, but several drugs presented their first significant disease response data. These included two compounds from Eli Lilly, LY2439821 and LY2127399 for rheumatoid arthritis and Orencia for psoriatic arthritis. LY2439821 has a novel mechanism of action, targeting the cytokine interleukin-17 (IL-17). While the data from these compounds were all from early stage trials, all showed statistically significant responses to treatment.
Attached we provide our thoughts on these and other noteworthy presented data sets. We have also provided a comprehensive list of all the 61 actual data events entered into BioMedTracker from the meeting.
For full report, please download the PDF version at the top of this page.
For our disclosures, please read the BioMedTracker Research Standards.