A pill for rheumatoid arthritis being developed by Eli
Lilly and Co and Incyte Corp maintained its effectiveness in reducing painful
symptoms through 24 weeks of treatment in a midstage extension study, according
to data presented at a medical meeting on Tuesday (Nov. 13). A sub-study of
patients taking part in the trial of the drug, baricitinib, also showed that
the two highest doses tested helped to reduce joint damage, based on Magnetic
Resonance Imaging (MRI) tests.
The companies in June released positive data from the
301-subject Phase II study after 12 weeks of treatment in patients with mild to
moderate RA who had an inadequate response to methotrexate. Data from the
ongoing extension study, presented Tuesday at the American College of
Rheumatology meeting in Washington, measured baricitinib treatment through the
24 weeks. Based on the data collected from its Phase II programs, Lilly said it
has moved into late-stage testing of the drug.
Four Phase III RA studies of baricitinib using the 2
milligram and 4 mg doses are planned for patients who have not previously been
treated with methotrexate or injectable biotech drugs and also in patients who
did have prior treatment with biologics, or drugs made from living organisms or
their products, the companies said. Those studies will form the basis of the
data package used to seek approval of the drug.
After 24 weeks, 73 percent of patients who received 8
mg of the Lilly drug once daily achieved the ACR20 goal, or a 20 percent
improvement in rheumatoid arthritis symptoms. That compared with 78 percent who
hit ACR20 at 12 weeks. For the 4 mg dose, 78 percent of patients hit ACR 20 at
24 weeks, up from 75 percent at week 12. The 2 mg dose that failed to show
statistical significance compared with a placebo at 12 weeks had 63 percent of
patients achieve ACR20 by week 24 of treatment, the data showed.
The study also measured ACR50 and ACR70 rates, or 50
percent and 70 percent improvement. All three doses showed improvement at 24
weeks from measurements taken at 12 weeks. "These data are important
because collectively they show patients experienced improvement with
baricitinib as early as week two that was sustained through week 24," Dr.
Mark Genovese, co-chief of the division of immunology and rheumatology at
Stanford University School of Medicine, said in a statement. "Also of note
is that the percentage of patients achieving ACR50 and ACR70 increased over
time and no unexpected safety findings emerged with continued dosing,"
said Genovese, a member of the steering committee for the study.
Baricitinib belongs to a hot new class of oral
medicines called Jak inhibitors that aim to compete with the injected
rheumatoid arthritis drugs that currently dominate the market with billions in
sales. Pfizer Inc last week became the first company to bring one of the new
drugs to market with the U.S. approval of tofacitinib, which will be sold under
the brand name Xeljanz. Jak inhibitors block enzymes believed to be involved in
the inflammatory process.
In the sub-study of 154 patients who underwent MRI
testing, there was a statistically significant improvement in measures of
inflammation and joint damage at the 4 mg and 8 mg doses after 12 weeks
compared with placebo, the companies said. The effects persisted through 24
weeks, they said. In order to compete with the biologic blockbuster injected
drugs, such as Abbott Laboratories' $8 billion a year Humira, the Jak
inhibitors must show that they can prevent or delay joint deterioration as well
as alleviate symptoms.
Source: Chicago Tribune
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