Re-treatment With TRU-015 Results in Sustained Improvement in Patients With RA: Presented at ACR/ARHP
By Liz Meszaros
PHILADELPHIA -- October 19, 2009 -- Repeat administration of experimental drug TRU-015 is well tolerated and results in sustained improvement in disease activity in patients with rheumatoid arthritis (RA), according to data presented at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
Pharmacodynamic and pharmacokinetic profiles after a second re-treatment phase were comparable to initial treatment.
These data, presented here on October 18, are from the second re-treatment phase of a phase 2b, double-blind, placebo-controlled, randomised, clinical trial of 276 subjects with active RA. For the initial randomised, double-blind phase of the trial, patients received a single infusion of placebo, or 200, 400, 800, or 1,600 mg of TRU-015. In the initial study, improvement in disease activity was seen at 24 weeks in the groups receiving the 800- and 1,600-mg doses.
For the first open-label re-treatment phase, patients received 800 mg of TRU-015 at 24-week intervals, and further improvement was seen.
For the second re-treatment phase, 226 subjects -- 94% of the 240 subjects from the first re-treatment phase -- were included. Re-treatment infusions were generally well tolerated, and no patients experienced any serious adverse events on the day of the infusion. Serious adverse events were seen in 3% of the subjects during the second re-treatment period, and this incidence was similar to the one seen in the initial double-blind phase of the study (800-mg group 4%; placebo 2%) and the first re-treatment phase (4%).
Patients were treated with TRU-015 800 mg in the initial treatment, and, in the first and second re-treatment phases, had comparable pharmacodynamic and pharmacokinetic parameters after each treatment.
Twenty-four weeks after the second re-treatment, this group achieved ACR20, ACR50, and ACR70 response rates of 72%, 39%, and 21%, respectively. These rates were similar to the responses seen after the first re-treatment phase (70%, 40%, and 23%). Reductions of the Disease Activity Score using 28 joint counts, the Health Assessment Questionnaire, and C-reactive protein test that were observed at the end of the double-blind treatment and first re-treatment periods were maintained or improved during the second re-treatment phase.
“We saw increases in response rates after each re-treatment, with no increase in adverse events,” said coinvestigator Patricia Leith, PharmD, Trubion Pharmaceuticals, Seattle, Washington. “Perhaps even more encouraging is that our patients want to remain on the protocol, and come back for retreatment,” she added.
Funding for this study was provided by Trubion Pharmaceuticals and Wyeth Research.
[Presentation title: Sustained Safety and Efficacy of TRU-015 With Continued Retreatment of Rheumatoid Arthritis Subjects Following a Phase 2B Study. Abstract 403]
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