Patients in the MOR103 1.0 mg/kg and 1.5 mg/kg had significant decreases of DAS28 at Week 4, with a mean difference of 1.12 and 0.61, respectively, while patients in the placebo group had a slight increase (0.17) in DAS28. The percentage of patients who achieved EULAR response was significantly greater in the MOR103 1.0 mg/kg (68.2%) and 1.5 mg/kg (69.5%) groups compared to placebo (7.4%) (P=0.0002 and P=0.0001, respectively).
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Explore This IssueJanuary 2013
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Overall, the results of the study showed a favorable safety of MOR103 at all dose levels and promising clinical activity with 1.0 mg/kg as the dose that demonstrates the efficacy potential of MOR103.
“Provided that MOR103 will confirm the promising initial study results in further clinical development, it has the potential to become a valuable means in the therapeutic armentarium of future RA treatment,” said Dr. Burkhardt.
Pooled Analysis of Short- and Long-Term Efficacy of Tofacitinib
Gerd R. Burmester, MD, of the department of rheumatology and clinical immunology at Charité-University Medicine Berlin, reported on short- and long-term efficacy of tofacitinib in patients with RA who fail to achieve adequate response to prior treatment with TNF inhibitors. Using data from multiple randomized clinical trials that pooled 614 patients to access short-term efficacy at three months, the study found that patients treated with tofacitinib at 5 or 10 mg twice daily achieved significant reductions in the signs and symptoms of RA (as measured by ACR20/50/70 response and DAS28-defined remission) and improvement in physical function (as measured by the Health Assessment Questionnaire-Disability Index [HAQ-DI]) and other patient-reported outcomes, such as pain and fatigue, compared with placebo.
This efficacy was maintained over 24 months as shown by the sustained improvement in signs and symptoms of RA (measured by ACR20/50/70 and DAS) as well as physical function (HAQ-DI), pain, and fatigue in 510 patients pooled from the long-term extension studies. For the short-term analysis, the efficacy of tofacitinib was demonstrated regardless of inadequate response to one or two prior TNF inhibitors.
According to Dr. Burmester, these results show consistent improvement in signs and symptoms of RA and physical function with tofacitinib in patients who are difficult to treat (i.e., those with an inadequate response to previous treatment with TNF inhibitors). Based on these large patient numbers, including long-term observations, he said that tofacitinib may also be a therapeutic option in those patients who have failed biologics.
Mary Beth Nierengarten is a freelance medical journalist based in St. Paul, Minn.