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Back to Conference Highlights
Active psoriatic arthritis patients on Remicade?
achieve major clinical response
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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SAN DIEGO, CALIF., NOVEMBER 13, 2005 ? New data, including
two-year treatment duration, show a significantly higher
proportion of patients with active psoriatic arthritis receiving
REMICADE? (infliximab) achieved and sustained a high degree of
clinical improvement in arthritis, as assessed using the
rheumatoid arthritis (RA) definition for "major clinical
response," compared with patients receiving placebo.
"Major clinical response" is defined as maintenance of a 70
percent improvement in the American College of Rheumatology
score (ACR 70) for six continuous months. REMICADE maintenance
therapy also resulted in the inhibition of structural damage and
significant improvements in functional status and quality of
life as maintained over the course of one year. Investigators
will present these long-term Phase 2 and 3 study findings this
week at the American College of Rheumatology 2005 Annual
Scientific Meeting. REMICADE is currently indicated for reducing
signs and symptoms of active arthritis in patients with
psoriatic arthritis.
"Previous study findings have shown the rapidity and
therapeutic intensity of infliximab in treating the joint and
skin manifestations associated with active psoriatic arthritis,"
said Arthur Kavanaugh, MD, Director, Center for Innovative
Therapy, Division of Rheumatology, Allergy and Immunology,
University of California, San Diego, and lead study
investigator. "These data demonstrate the rapid efficacy of
infliximab can be sustained over time, especially as it relates
to the arthritic component of this complex disease."
An analysis of two double-blind, placebo-controlled trials,
Infliximab Multinational Psoriatic Arthritis Controlled Trial
(IMPACT) and Induction and Maintenance Psoriatic Arthritis
Clinical Trial 2 (IMPACT 2), followed patients for two years (98
weeks) and one year (54 weeks), respectively, and confirmed a
significant, high degree of clinical responses in the arthritic
component of the disease. Placebo patients in both studies
crossed over to active treatment by week 16 in IMPACT and week
24 in IMPACT 2. In IMPACT, 35 percent of all randomized patients
(including patients originally randomized to REMICADE and
placebo) entering the second year (27 out of 78) achieved an ACR
70 improvement at week 98. In IMPACT 2, 20 percent of REMICADE
randomized patients (20 out of 100) achieved this high degree of
improvement at week 54.
In both IMPACT and IMPACT 2, "major clinical response," a
post hoc analysis, was defined for REMICADE randomized patients
as maintenance of a 70 percent improvement in ACR 70 for six
continuous months anytime during the study. Placebo patients
were conservatively counted as achieving "major clinical
response" if they had achieved ACR 70 improvement at the last
visit before receiving REMICADE. In IMPACT, 31 percent of
patients randomized to REMICADE (16 out of 52) achieved a "major
clinical response" versus zero percent of patients receiving
placebo (P < 0.001).
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In IMPACT 2, 12 percent of REMICADE randomized patients (12 out
of 99) achieved a "major clinical response" versus two percent
of patients receiving placebo (P = 0.006). "Major clinical
response" identifies a high degree of sustained clinical
improvement in arthritis but does not currently account for the
skin disease associated with psoriatic arthritis.
REMICADE Inhibits Progression Of Radiographic Damage In
Patients With Active Psoriatic Arthritis: 1-Year Results From
IMPACT 2
According to one-year results from the IMPACT 2 trial,
radiographic analyses showed treatment with REMICADE resulted in
significantly less progression of structural damage, compared
with patients receiving placebo, as measured by the change in
baseline in van der Heijde-Sharp (vdH-S) score in which higher
scores indicate greater structural damage, while lower scores
indicate less structural damage. At as early as 24 weeks of
treatment, REMICADE patients experienced a mean change (+/-
standard deviation) in vdH-S score of -0.70 (+/- 2.53) from
baseline, compared with an average change of 0.82 (+/- 2.62) in
the placebo group (P < 0.001). At week 54, patients who received
a full 54-week regimen of REMICADE experienced a mean change of
-0.94 (+/- 3.40) from baseline, compared with an average change
of 0.53 (+/- 2.60) in patients who crossed over from placebo to
REMICADE (P = 0.001). REMICADE and crossover patients
experienced a total improvement of -0.24 (+/- 2.45) and -0.29
(1.98), respectively, from week 24 to 54.
"These radiographic findings are significant in the treatment
of active psoriatic arthritis, which like rheumatoid arthritis,
is a progressive immune-mediated inflammatory disease," said
Desiree van der Heijde, MD, PhD, Professor of Rheumatology,
University of Maastricht in the Netherlands and lead study
investigator. "The inhibition of joint destruction is critical
in the management of disease and these radiographic data show
the long-term, sustained effect of REMICADE therapy in the
course of the disease."
REMICADE Therapy Results In Sustained Improvement In
Functional Status And Quality Of Life In Patients With Psoriatic
Arthritis: 1-Year Results From The IMPACT 2 Study
One-year data presented from IMPACT 2 showed REMICADE-treated
patients experienced sustained improvement in health-related
quality of life, as assessed by the Short Form 36 (SF-36), a
questionnaire that assesses impact in the areas of physical
function, pain, social function and general health perceptions,
in which higher scores indicate better well-being. At week 14,
REMICADE patients showed significant improvement in the physical
component summary (PCS) and the mental component summary (MCS)
of the SF-36 compared with patients receiving placebo.
Additionally, REMICADE-treated patients showed a median increase
of 8.7 in PCS score, compared with a 1.0 increase in
placebo-treated patients (P < 0.001). Patients receiving
REMICADE also experienced a median improvement of 2.1 in MCS
score, compared with 0.5 in placebo-treated patients (P <
0.001). At week 54, median improvement from baseline in PCS and
MCS in the REMICADE group was 7.4 and 2.8, respectively, and the
median improvement in the placebo/REMICADE group, the group of
patients initially receiving placebo and crossed over to
REMICADE by week 24, was 10.2 and 1.9, respectively. At week 14,
the median improvement from baseline in Health Assessment
Questionnaire (HAQ) was 43 percent in the REMICADE group,
compared with no change in the placebo group (P < 0.001). This
improvement was maintained at week 54, with a 50 percent median
improvement from baseline in the group randomized to REMICADE,
indicating significantly improved physical function.
###
About Psoriatic Arthritis
Psoriatic arthritis involves joint pain and swelling that can
lead to debilitation coupled with inflamed, scaly, red patches
of psoriasis. Symptoms may include stiffness and tenderness of
the joints and surrounding tissue, reduced range of motion, nail
changes and redness and pain of the eye, uveitis. Joints of the
hands, wrists, knees, ankles, feet, lower back and neck are
commonly affected. Approximately one million Americans have
psoriatic arthritis, and the disease affects both men and women
equally, most commonly between the ages 30 and 50.
About IMPACT
IMPACT was a Phase 2b randomized, double-blind,
placebo-controlled study that involved 104 patients with active
psoriatic arthritis (defined as affecting at least five joints)
who failed at least one disease-modifying anti-rheumatic drug (DMARD)
and was conducted at nine study centers in the U.S., Canada and
Europe. The trial was designed to study the efficacy and safety
of REMICADE compared with placebo in patients with active
psoriatic arthritis. Patients received either REMICADE (5 mg/kg)
or placebo administered at weeks 0, 2, 6 and 14. The REMICADE
group continued on maintenance treatments every eight weeks.
Beginning at week 16, patients randomized to the placebo group
received an induction regimen of REMICADE followed by
maintenance treatment every eight weeks. A total of 78 patients
entered the second year open-label extension of the trial.
REMICADE was generally well tolerated in this study, with
similar proportions of patients experiencing adverse events (AEs)
in both REMICADE and placebo groups. No deaths, cases of
tuberculosis or other opportunistic infections were reported and
serious infections were uncommon. There were no serious infusion
reactions. Common side effects in the placebo-controlled period
were similar in both the groups and included upper respiratory
tract infection, headache, bronchitis and influenza-like
symptoms. Through year one, the most common AEs included upper
respiratory tract infection, nonproductive cough, headache and
influenza-like symptoms. The incidence and type of AEs observed
in year two were similar to those observed during the first year
of treatment. Two patients had serious AEs relating to
neoplasms, one a benign mucinous abdominal cystoma and a second
ductal adenocarcinoma of the pancreas three months after week
98, both considered unrelated to study medication.
About IMPACT 2
IMPACT 2 was a Phase 3 randomized, double-blind,
placebo-controlled study of 200 patients with active psoriatic
arthritis (defined as affecting at least five joints). The study
evaluated the safety and efficacy of REMICADE in patients who
had an inadequate response to DMARDs or nonsteroidal
anti-inflammatory drugs (NSAIDs). Patients received REMICADE
5mg/kg or placebo at weeks 0, 2, 6 and every 8 weeks until week
22. At week 16, placebo patients who had < 10% improvement from
baseline in both swollen and tender joint counts entered early
escape and received REMICADE.
At week 24, the remaining placebo patients crossed over to
REMICADE, and REMICADE patients continued on 5 mg/kg every eight
weeks through week 46.
Through 24 weeks, a similar proportion of patients
experienced AEs in each treatment group. No deaths, cases of
tuberculosis or other opportunistic infections or serious
infusion reactions were reported and serious infections were
uncommon. There were more patients with serious AEs through week
24 in the combined (those originally randomized to REMICADE and
placebo patients who entered early escape) REMICADE group (8.7
percent) than in the placebo group (6.2 percent). Laboratory
abnormalities were uncommon, with an elevation in liver function
tests being the most common abnormality. During the
placebo-controlled period, markedly abnormal alanine
aminotransferase (ALT) values (predefined as greater than 150 IU/L
and greater than or equal to 100 percent increase from baseline)
occurred in 5 (3 percent) of the subjects in the combined
REMICADE group compared with no subjects in the placebo group.
Within 24 weeks of treatment one placebo-treated patient was
diagnosed with basal cell carcinoma. During the continued
treatment with REMICADE beyond week 24, one REMICADE patient was
diagnosed with Hodgkin's lymphoma. See "Important Safety
Information" below.
About REMICADE
REMICADE is the global market leader among anti-tumor
necrosis factor alpha (TNF-alpha) therapies and has demonstrated
broad clinical utility in rheumatoid arthritis (RA), Crohn's
disease (CD), psoriatic arthritis (PsA), ulcerative colitis (UC),
and ankylosing spondylitis (AS). The safety and efficacy of
REMICADE have been well established in clinical trials over the
past 12 years and through commercial experience with over
600,000 patients treated worldwide.
In the U.S., REMICADE, in combination with methotrexate, is
indicated for reducing signs and symptoms, inhibiting the
progression of structural damage and improving physical function
in patients with moderately to severely active RA. REMICADE is
the only biologic indicated for the treatment of patients with
moderately-to-severely active CD who have had an inadequate
response to conventional therapy. REMICADE is also indicated for
reducing the number of draining enterocutaneous and rectovaginal
fistulas and maintaining fistula closure in patients with
fistulizing CD. In December 2004, REMICADE was approved for
reducing signs and symptoms in patients with active AS. On May
13, 2005, REMICADE was approved for reducing signs and symptoms
of active arthritis in patients with PsA. Additionally, on
September 15, 2005, REMICADE was approved for reducing signs and
symptoms, achieving clinical remission and mucosal healing, and
eliminating corticosteroid use in patients with moderately to
severely active UC who have had an inadequate response to
conventional therapy. This approval makes REMICADE the first and
only biologic approved for the treatment of moderate to severe
UC.
REMICADE is unique among available anti-TNF biologic
therapies. Unlike self-administered therapies that require
patients to inject themselves frequently, REMICADE is the only
anti-TNF biologic administered directly by caregivers in the
clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5
mg/kg), and UC (5 mg/kg), REMICADE is a two-hour infusion
administered every 8 weeks, following a standard induction
regimen that requires treatment at weeks 0, 2 and 6. As a
result, REMICADE patients may require as few as six treatments
each year. In AS (5 mg/kg), REMICADE is a two-hour infusion
administered every 6 weeks, following a standard induction
regimen that requires treatment at weeks 0, 2 and 6.
Important Safety Information
Many people with heart failure should not take REMICADE; so
prior to treatment you should discuss any heart condition with
your doctor. Tell your doctor right away if you develop new or
worsening symptoms of heart failure (such as shortness of breath
or swelling of your ankles or feet).
There are reports of serious infections, including
tuberculosis (TB), sepsis and pneumonia. Some of these
infections have been fatal. Tell your doctor if you have had
recent or past exposure to people with TB. Your doctor will
evaluate you for TB and perform a skin test. If you have latent
(inactive) TB, your doctor should begin TB treatment before you
start REMICADE. REMICADE can lower your ability to fight
infections, so if you are prone to or have a history of
infections, or develop any signs of an infection such as fever,
fatigue, cough, or the flu while taking REMICADE, tell your
doctor right away. Also tell your doctor if you have lived in a
region where histoplasmosis or coccidioidomycosis is common.
There have been rare cases of serious liver injury in people
taking REMICADE, some fatal. Contact your doctor immediately if
you develop symptoms such as jaundice (yellow skin and eyes),
dark brown urine, right-sided abdominal pain, fever, or severe
fatigue.
Blood disorders have been reported, some fatal. Tell your
doctor if you develop possible signs of blood disorders such as
persistent fever, bruising, bleeding, or paleness while taking
REMICADE. Nervous system disorders have also been reported. Tell
your doctor if you have or have had a disease that affects the
nervous system, or if you experience any numbness, weakness,
tingling, or visual disturbances while taking REMICADE.
Reports of a type of blood cancer called lymphoma in patients
on REMICADE or other TNF blockers are rare but occur more often
than expected for people in general. People who have been
treated for rheumatoid arthritis, Crohn's disease, ankylosing
spondylitis, or psoriatic arthritis for a long time,
particularly those with highly active disease may be more prone
to develop lymphoma. Cancers, other than lymphoma, have also
been reported. If you take REMICADE or other TNF blockers, your
risk for developing lymphoma or other cancers may increase. You
should also tell your doctor if you have had or develop lymphoma
or other cancers while you are taking REMICADE.
Serious infusion reactions have been reported with REMICADE,
including hives, difficulty breathing, and low blood pressure.
Reactions have occurred during or after infusions. In clinical
studies, some people experienced the following common side
effects: respiratory infections (that may include sinus
infections and sore throat), coughing, and stomach pain or mild
reactions to infusion such as rash or itchy skin.
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