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Back to Conference Highlights
Golimumab (CNTO 148) shows clinical benefit in
active rheumatoid arthritis
12/11/05 - 17/11/05, San Diego, USA
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Highlights of the American College of Rheumatology 70th Annual
Scientific Meeting - Nov. 12-17, San Diego, USA.
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Results from a Phase 2 rheumatoid arthritis (RA) study
assessing the safety and efficacy of golimumab (CNTO 148), a
fully-human anti-TNF-alpha therapy, showed that it achieved the
primary endpoint of the study. In this dose-ranging trial, more
than 60 percent of patients with moderately to severely active
RA treated with golimumab and methotrexate (MTX) experienced at
least 20 percent improvement in arthritis symptoms at week 16.
Additionally, one-quarter of patients receiving golimumab and
MTX achieved remission as evaluated by Disease Activity Score 28
(DAS28). These findings will be presented this week at the
American College of Rheumatology 2005 Annual Scientific Meeting.
"When treating a debilitating disease like RA, it is
important to have several treatment options, and we are
encouraged by the safety and efficacy data we have seen thus far
for golimumab," said Jonathan Kay, MD, Director, Clinical
Trials, Rheumatology Unit, Massachusetts General Hospital,
Associate Clinical Professor of Medicine, Harvard University
School of Medicine and lead study investigator.
Golimumab, developed by Centocor, Inc. and Schering-Plough,
is a fully-human anti-TNF-alpha IgG1 monoclonal antibody that
targets and neutralizes both the soluble and the membrane-bound
form of TNF-alpha. Golimumab is currently being investigated for
administration by either subcutaneous (SC) injection or
intravenous (IV) infusion.
Data from the study showed that significantly more patients
in all groups receiving SC injections of golimumab plus MTX
achieved ACR 50 response (marked improvement in arthritis
symptoms according to the American College of Rheumatology
scoring criteria) versus patients receiving placebo plus MTX.
Adults with active RA for at least three months' duration
despite MTX therapy were randomized to one of five treatment
groups: placebo every two weeks or golimumab 50 or 100 mg every
two weeks or every four weeks. All patients received stable
doses of MTX of greater than or equal to 10 mg/week. After just
16 weeks of treatment, 62 percent of all patients receiving
golimumab (combined golimumab treatment groups) experienced at
least 20 percent improvement in arthritis symptoms (ACR 20),
compared with 37 percent of placebo-treated patients (P =
0.008). Additionally, at week 16, 31 percent of patients in the
combined golimumab treatment groups achieved ACR 50, and 12
percent achieved ACR 70, compared with six percent and zero
percent, respectively, of patients in the placebo group. All
individual golimumab treatment groups achieved higher ACR 20
response rates than placebo. Golimumab 50 mg every four weeks
(63 percent) and golimumab 100 mg every two weeks (79 percent)
were statistically significantly more effective than placebo (37
percent) in achieving an ACR 20 response (P = 0.031 and P <
0.001, respectively).
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Patients in the golimumab plus MTX treatment group also achieved
remission, as assessed by DAS 28, which measures tender and
swollen joints, inflammation and overall disease activity
including measurement of serum C-reactive protein (CRP) levels.
After 16 weeks of treatment, 27 percent of patients in the
combined group achieved remission as assessed by DAS28 compared
with six percent of patients receiving MTX alone (P = 0.007).
Adverse events in the golimumab groups were similar to those
in the MTX group. Serious adverse events were reported in eight
percent of patients in the combined golimumab group, compared
with six percent in the MTX group. No deaths, cases of
tuberculosis or other opportunistic infections were reported and
serious infections were uncommon. One case each of lung cancer,
congestive heart failure, cardiac tamponade, and two cases of
pneumonia were reported among patients treated with golimumab.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic, progressive disease
and research demonstrates that a critical therapeutic window
exists within the first two years of disease onset when the rate
of radiographic progression of the disease can be "reset." 1,2,3
Radiographic changes occur within two years of disease onset in
50 percent to 70 percent of RA patients.4 The American College
of Rheumatology suggests control of disease progression should
start early to limit joint damage in RA.3 RA is associated with
substantial disability and economic losses, and one study showed
that one-third of patients in the United Kingdom who were
employed became work-disabled within two years of disease
onset.5 Rheumatologic disorders also account for 25 percent of
Social Security disability payments in the United States.6
About Centocor
Centocor is harnessing the power of world-leading research
and biomanufacturing to deliver innovative biomedicines that
transform patients' lives. Centocor has already brought
innovation to the treatment of Crohn's disease, rheumatoid
arthritis, ankylosing spondylitis, psoriatic arthritis and
ulcerative colitis.
The world leader in monoclonal antibody production and
technology, Centocor has brought critical biologic therapies to
patients suffering from debilitating immune disorders. Centocor,
Inc. is a wholly owned subsidiary of Johnson & Johnson, a
worldwide manufacturer of healthcare products.
###
References:
1 Landewe RB, Boers M, Verhoeven AC, et al. COBRA combination
therapy in patients with early rheumatoid arthritis: long-term
structural benefits of a brief intervention. Arthritis Rheum.
2002;46:347-356.
2 Egsmose C, Lund B, Borg G, et al. Patients with rheumatoid
arthritis benefit from early 2nd line therapy: 5 year follow up
of a prospective double blind placebo controlled study. J.
Rheumatol. 1995;22:2208-2213.
3 American College of Rheumatology Subcommittee on Rheumatoid
Arthritis Guidelines, 2002 Update.
4 van der Heijde DM. Joint erosions and patients with early
rheumatoid arthritis. Br J Rheumatol. 1995;34(suppl 2):74-78.
5 Barrett EM, Scott DGI, Wiles NJ, Symmons DPM. The impact of
rheumatoid arthritis on employment status in the early years of
disease: a UK community-based study. Rheumatology.
2000;39:1403-1409.
6 Social Security Disability Insurance Program.
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