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EULAR: Ofatumumab (HuMax-CD20) for RA Seems Effective in Phase I
Published on Rheumatology Network
(http://www.rheumatologynetwork.com)
EULAR: Ofatumumab (HuMax-CD20) for RA Seems Effective in
Phase II Trial
June 18, 2007 | Rheumatoid Arthritis [1]
BARCELONA, Spain -- Ofatumumab (HuMax-CD20), an investigational fully human antibody, appears
to be safe and effective for rheumatoid arthritis, researchers said here.
BARCELONA, Spain, June 18 -- Ofatumumab (HuMax-CD20), an investigational fully human antibody,
appears to be safe and effective for rheumatoid arthritis, researchers said here.
In a phase II trial, patients getting any of three doses of the drug had a significantly better chance of
having a 20% reduction in RA symptoms after 24 weeks, according to Mikkel stergaard, M.D., Ph.D.,
of Copenhagen University Hospital in Denmark.
"The drug works as expected," Dr. stergaard said during the of the European League Against
Rheumatism (EULAR) meeting here, Officials of GlaxoSmithKline and Genmab A/S of Denmark, which
are developing the drug, said they plan phase III trials.
The drug -- which targets the CD20 protein on the surface of B-cells -- is also being studied for
rituximab (Rituxan)-resistant follicular non-Hodgkin's lymphoma.
The investigational agent targets the same molecule that rituxan does, but rituximab is a chimeric
monoclonal antibody, while ofatumumab is a fully human antibody, which might suggest fewer side
effects.
But Dr. stergaard said it's not possible to say how the new drug stacks up against rituximab on the
basis of the current randomized, placebo-controlled trial involving 225 patients with active RA.
Volunteers in the trial were randomized to placebo or 300, 700, or 1,000 mg of ofatumumab, infused
on the first and 14th day of the study. There was no further treatment with the drug.
Patients were allowed to continue concomitant methotrexate and low-dose corticosteroids.
At 24 weeks (halfway through the study), the researchers found:
15% of placebo controls had a 20% reduction in symptoms (the so-called ACR20).
In contrast, 41% of those getting 300 mg, 49% of those getting 700 mg, and 46% of those
getting 1,000 mg of ofatumumab reported the same level of improvement.
The differences from placebo were statistically significant at P=0.002), P
Results were similar (and also significant) for the ACR50 response - 5% for placebo and 19%,
26%, and 26% for 300, 700, and 1,000 mg respectively.
Most of the adverse events see were mild and related to the infusion, he said.
Of the initial 53 patients, two had a serious infusion-related reaction and one had
infusion-related bronchospasm. A reduced infusion rate for the remaining 172 patients
resulted in one serious infusion-related case of urticaria.
The most common adverse events were Grade 1 and 2 rash, throat irritation, and dyspnea.
The rate of serious infections was the same in ofatumumab patients as in those getting
placebo.
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EULAR: Ofatumumab (HuMax-CD20) for RA Seems Effective in Phase I
Published on Rheumatology Network
(http://www.rheumatologynetwork.com)
"This first analysis of the potential of ofatumumab in rheumatoid arthritis is very encouraging
indeed," Dr. stergaard said, "showing the potential of this fully human, high-affinity antibody
for the future management of patients with this debilitating condition."
The study was supported by GlaxoSmithKline and Genmab A/S of Denmark, which are
developing the drug.
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