Investigators reported today at the
American Academy of Dermatology annual meeting that patients with moderate
to severe plaque psoriasis receiving REMICADE(R) (infliximab) induction and
maintenance therapy experienced significant improvements in productivity at
week 10, which were sustained through week 50. After 10 weeks, patients
receiving REMICADE 3 mg/kg or 5 mg/kg achieved significant improvements in
work and daily activities (2.9 and 3.1, respectively, from baseline)
compared to little to no improvement (a mean decrease of 0.1) among
placebo-treated patients (P < 0.001), as measured by the Productivity
Visual Analogue Scale. Psoriasis is an inflammatory disorder characterized
by raised, inflamed, red lesions, or plaques, which can cause physical pain
and emotional distress. It is estimated that as many as 7.5 million people
in the U.S. have psoriasis,(1) which can present in various forms and can
range from mild to severe and disabling.
"These findings show a relationship between the significant
improvements REMICADE-treated patients experienced in psoriasis and
improvements in productivity," said Steven Feldman, M.D., Ph.D., professor
of dermatology, pathology and public health sciences, Bowman Gray School of
Medicine, Wake Forest University. "Such analyses offer further insight into
the impact of this chronic inflammatory disease on patient productivity and
the effect of intervening with an appropriate biologic treatment, like
REMICADE. We look forward to further studies to identify the economic
implications of such productivity analyses in a real-world setting."
In the Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy
and Safety Study (EXPRESS II), REMICADE-treated patients demonstrated a
statistically significant productivity increase of 2.9 and 3.1 in the 3
mg/kg and 5 mg/kg groups, respectively, from baseline compared with a mean
decrease of 0.1 with placebo as measured by the Productivity Visual
Analogue Scale (P < 0.001). The Productivity Visual Analogue Scale is a
10-cm scale with a score of zero indicating very impaired productivity and
a score of 10 indicating no impairment. Baseline productivity scores among
the REMICADE 3 mg/kg, REMICADE 5 mg/kg and placebo groups were comparable
at 5.7, 5.6 and 5.6, respectively, indicating impaired productivity.
Increased productivity scores paralleled significant improvements in
the role-physical domain (RP) and role-emotional domain (RE) scores of
SF-36, an eight-domain questionnaire widely used to assess patient
health-related quality of life. In EXPRESS II, at baseline, RP scores in
the REMICADE 3 mg/kg, REMICADE 5 mg/kg and placebo groups were relatively
low compared with the general population (47.5, 46.6 and 44.8,
respectively). At week 10, significant mean increases of 4.1 and 5.1 were
reported in the REMICADE 3 mg/kg and 5 mg/kg groups, respectively, compared
with little increase (0.8) in the placebo group (P < 0.001). At baseline,
RE scores were 47.4, 47.8, and 46.4, respectively. At week 10, significant
mean increases of 4.8 and 4.4 were reported in the REMICADE 3 mg/kg and 5
mg/kg groups, respectively, compared with little increase (0.9) in the
placebo group (P < 0.001).
At 14 weeks, patients in the REMICADE 3 mg/kg and 5 mg/kg induction
groups were randomized to receive scheduled treatment every eight weeks or
"as-needed" maintenance therapy with REMICADE. Improvement in productivity
scores was better maintained in the scheduled dosing groups versus the
as-needed dosing group. The greatest productivity improvement through week
50 was seen in the REMICADE 5 mg/kg every-eight-week maintenance group.
Additionally, placebo patients who transitioned to REMICADE treatment at
week 16 also achieved improvements in productivity through week 50.
Psoriasis is most commonly diagnosed between the ages of 20 and 30,
striking in the prime of people's lives, and the extent of skin involvement
varies from mild to severe and disabling. People with severe psoriasis may
have large areas of their body covered by lesions, which may crack and
bleed. The pain and embarrassment associated with such skin lesions may
prevent people from participating in social and work-related activities,
and the physical and mental effects of psoriasis have been compared to
those of other chronic illnesses such as rheumatoid arthritis,
hypertension, heart disease, diabetes and depression. Skin lesions
associated with psoriasis often result in feelings of sadness, despair,
guilt and anger, as well as in low self-esteem. A person's sense of
self-worth can be affected, and in some cases, this emotional turmoil can
lead to depression.
"This research further illustrates the correlation and impact of
psoriasis on work productivity and demonstrates the substantial physical
and emotional burdens faced by those living with this life-altering
disease," says Gail Zimmerman, president and CEO, National Psoriasis
Foundation. "We at the National Psoriasis Foundation encourage continued
research and stress the importance of access to effective therapies, which
may help manage a disease that often interferes with work and life
activities."
In September 2006, REMICADE was approved in the U.S. for the treatment
of adult patients with chronic severe (i.e. extensive and/or disabling)
plaque psoriasis who are candidates for systemic therapy and when other
systemic therapies are medically less appropriate. The recommended dose is
an infusion of 5 mg/kg followed by additional doses at two and six weeks
after the first infusion and then every eight weeks thereafter.
About EXPRESS II
The Evaluation of Infliximab for Psoriasis in a [REMICADE] Efficacy and
Safety Study (EXPRESS II) was a Phase 3, multi-center, randomized,
double-blind, placebo-controlled trial that evaluated the safety and
efficacy of REMICADE in 835 adult patients with chronic, stable plaque
psoriasis involving at least 10 percent BSA, a minimum PASI score of 12 and
who were candidates for phototherapy or systemic therapy. Patients were
randomized to induction doses of REMICADE 3 mg/kg or 5 mg/kg or placebo at
weeks 0, 2 and 6. Patients in the active induction treatment groups were
randomized again at week 14 to receive either scheduled or "as-needed"
maintenance treatment at the same dose administered during the induction
phase. Patients in the placebo group were crossed over at week 16 to
receive REMICADE 5 mg/kg at weeks 16, 18 and 22, then every 8 weeks through
week 46.
In EXPRESS II, through week 14 (the placebo-controlled period), adverse
events (AEs) occurred at a higher incidence in the REMICADE groups (63
percent and 69 percent with 3 mg/kg and 5 mg/kg, respectively), compared
with the placebo group (56 percent). The only clinically significant
laboratory abnormalities that occurred more frequently in the REMICADE
group compared with the placebo group were elevated liver enzymes. Serious
AEs occurred at rates of two percent in the placebo group, three percent in
the 5 mg/kg group and one percent in the 3 mg/kg group. AEs observed were
generally consistent with those described in the prescribing information,
including information regarding serious infections. Please see "Important
Safety Information" below.
About Psoriasis
Psoriasis is a chronic, immune-mediated disease, which results from
inflammation in the skin and overproduction of skin cells that accumulate
on the surface causing red, scaly plaques that may itch and bleed. This
chronic inflammation is driven in part by tumor necrosis factor alpha, or
TNF-alpha, a cytokine involved in the body's normal immune response.
TNF-alpha is found at increased levels in psoriatic plaques and plays a
crucial part in their formation and continued existence. It is estimated
that two percent of the U.S. population has psoriasis, and about 30 percent
of people with psoriasis have cases that are considered moderate to severe.
About REMICADE
REMICADE is the global market leader among anti-tumor necrosis factor
alpha (TNF-alpha) therapies and is the only anti-TNF-alpha treatment
approved in three different therapeutic areas: gastroenterology,
rheumatology and dermatology. REMICADE has demonstrated broad clinical
utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing
spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC),
pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and
efficacy of REMICADE have been well established in clinical trials over the
past 14 years and with more than 843,000 patients treated worldwide through
commercial experience.
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 reducing
signs and symptoms and inducing and maintaining clinical remission in adult
and pediatric 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 adult patients with fistulizing
CD. In December 2004, REMICADE was approved for reducing signs and symptoms
in patients with active AS. In May 2005, REMICADE was approved for reducing
signs and symptoms of active arthritis in patients with PsA. Additionally,
in September 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. In addition, on May 19, 2006, REMICADE was approved
for reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients with moderately to severely active Crohn's
disease who have had an inadequate response to conventional therapy. This
approval establishes REMICADE as the first and only biologic therapy
approved for the treatment of PCD. In August 2006, REMICADE received the
expanded indication for inhibiting the progression of structural damage and
improving physical function in patients with psoriatic arthritis. In
September 2006, REMICADE was approved for the treatment of adult patients
with chronic severe plaque psoriasis. In October 2006, REMICADE was
approved for maintaining clinical remission and mucosal healing in patients
with moderately to severely active UC, who have had an inadequate response
to conventional therapy.
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), UC (5 mg/kg), PCD (5 mg/kg), and PsO (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
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 TB 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, flu or warm, red or painful skin
while taking REMICADE, tell your doctor right away. Also, tell your doctor
if you are scheduled to receive a vaccine or if you have lived in a region
where histoplasmosis or coccidioidomycosis is common.
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, psoriatic arthritis, or
plaque psoriasis 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. Children and young adults who have been
treated for Crohn's disease with REMICADE have developed a rare type of
lymphoma that often results in death. These patients also were receiving
drugs known as azathioprine or 6-mercaptopurine. 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 or if you have a lung disease called chronic
obstructive pulmonary disease (COPD).
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, swelling of your ankles or feet, or
sudden weight gain.
Reactivation of hepatitis B virus has been reported in patients who are
carriers of this virus and are taking TNF blockers, such as REMICADE. Some
of these cases have been fatal. Tell your doctor if you know or think you
may be a carrier of hepatitis B virus or if you experience signs of
hepatitis B infection, such as feeling unwell, poor appetite, tiredness,
fever, skin rash and/or joint pain.
There have been rare cases of serious liver injury in people taking
REMICADE, some fatal. Tell your doctor if you have liver problems and
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, visual disturbances or seizures while taking
REMICADE.
Allergic reactions, some severe, have been reported during or after
infusions with REMICADE. Signs of an allergic reaction include hives,
difficulty breathing, chest pain, high or low blood pressure, swelling of
face and hands, and fever or chills. Tell your doctor if you have
experienced a severe allergic reaction. The most common side effects of
REMICADE are: respiratory infections, such as sinus infections and sore
throat, headache, rash, coughing, and stomach pain.
Please read the Medication Guide for REMICADE and discuss it with your
doctor.
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, ulcerative colitis, pediatric Crohn's disease and psoriasis.
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.
(1) National Institute of Arthritis and Musculoskeletal and Skin
Disorders. Questions and Answers About Psoriasis. U.S. Department of
Health and Human Services, National Institutes of Health; 2003. NIH
Publication No. 03-5040.
Centocor, Inc.
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View drug information on Remicade.
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