Hi. Please help. I am terrified and need to tell my story because I might be making a huge mistake, thanks for listening. I am 40 and homeschool my Mensa smart kids ages 6 and 7. I get a very mild case of shingles and exactly one week later with the flip of a switch I woke up 8 weeks ago with excruitiating pain in my shoulders, elbows, wrists, hips and knees. I am (was?) a weight lifter and serious cardio freak in excellent shape and set the highest physical goals for myself. A week passes and I think this is some silly something and it will pass. It progresses to my hands and feet, they swell and hurt. Hurt a LOT. Primary Physician puts me on 10 mg Pred since I am bipolar II and she didn't want to mess with my head. No effect one week later and see her again. Pred now to 60 mg and get Tramadol. Neither Work. Referred to Rheumie and put on alternative Pred, forget name. Also get Dilaudid. No effect for either. Eventually upped to pain patch and Morphine. They just make me sick and constipated. He gives me Nucynta and it's just touching the pain. He admits to desperation to dx me and is baffled. I also see an Infectious Disease doc and test + for ANA then - 2x. My pinkies are starting to deform. He refers me to Virginia Mason here in Seattle and my new Rheumie runs every test on EARTH while I am there. He wants me to start Enbrel and dx me with either reactive or ankylosing spondylitis - we are waiting for tests to confirm. He suspects I have some liver damage too. My husband wanted to do some NSAID experiments while waiting for test results and insurance approval for Enbrel. I went on Aleve for 2.5 days and it helped a lot, not 100% and still swollen. Now I am off that and will start Ibuprophen in 2 days. First, I am skeptical I have this disease but something is clearly wrong and every test is negative. Friends think I have all sorts of other things and I don't know what to think. I never get sick and have nothing wrong except this familial bipolar II. I take Lithium, Tegretol and Lamicatal - all at low doses. I am a lifelong insomniac and take Ambien 15-20 mg. Also some supplements - vitamins and such. I need your advice, badly.
Enbrel first biologic with up to 9 years rheumatoid arthritis safety, sustained efficacy data
THOUSAND OAKS, Calif., November 12, 2006 -- Amgen (NASDAQ: AMGN) today announced that Enbrel? (etanercept) is the first biologic with published data to show improvements in multiple measures of efficacy that were sustained in rheumatoid arthritis (RA) patients completing up to nine years of therapy. These new data are being presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.
"The current data in Rheumatoid Arthritis suggest that Enbrel is both effective and safe in long-term use," said Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, California. "These findings are significant because they provide a degree of reassurance to both the patient and the physician that unexpected safety concerns do not appear to be developing after nine years of use."
ENBREL continues to have a strong safety profile for extended periods of use. In the studies presented at ACR, rates of serious adverse events and serious infections remained low and were consistent with controlled portions from the double-blind phases of the studies. The overall number of observed malignancies (excluding nonmelanoma skin cancers) were similar in type and number to what would be expected in the general population.
Additionally, data showed that 77 early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid arthritis (LRA) patients who completed ENBREL treatment for up to eight years experienced substantial improvements in their ACR scores. Additionally, 73 LRA patients who completed ENBREL treatment for up to nine years experienced similar improvements. ACR scores are a composite measure of improvement in RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
Data being presented at ACR showed that ENBREL provided sustained improvement in the signs and symptoms of RA, in those patients who continued in the study, regardless of duration of disease. Following eight years of ENBREL therapy: 75 percent of ERA patients and 76 percent of LRA patients achieved ACR 20; 60 percent of ERA patients and 52 percent of LRA patients achieved ACR 50; 35 percent of ERA patients and 26 percent of LRA patients achieved ACR 70. Further, for those patients with LRA who received ENBREL treatment for nine years, 74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22 percent achieved ACR 70.
The ability to perform daily activities is an important goal for many people with RA, and data presented at ACR showed that treatment with ENBREL may help them achieve this goal. Through eight years of treatment with ENBREL, data showed that 73 to 85 percent of patients with ERA and 53 to 72 percent of patients with LRA achieved a clinically significant improvement in the Health Assessment Questionnaire (HAQ) score, a patient questionnaire that measures disability. A clinically significant improvement in HAQ was defined as at least a 0.22 improvement from baseline.
"Before I was diagnosed with RA, the pain, stiffness and fatigue stopped me from doing many of the activities I enjoyed," said Gloria Treece, a participant in the study. "Since starting ENBREL treatment approximately nine years ago, I'm now able to take part in many activities with my family."
These studies were designed to assess the safety and long-term efficacy of ENBREL in adult LRA patients who have failed to respond to at least one disease-modifying antirheumatic drug, and adult patients with ERA (defined as less than or equal to three years of disease duration). Patients with RA who participated in controlled clinical trials of ENBREL were eligible to enroll in open-label extension studies (LRA, N=644; ERA, N=207).
Believe those who are seeking the truth. Doubt those who find it.
Believe those who are seeking the truth. Doubt those who find it.
Andre Gide
Enbrel first biologic with up to 9 years rheumatoid arthritis safety, sustained efficacy data
THOUSAND OAKS, Calif., November 12, 2006 -- Amgen (NASDAQ: AMGN) today announced that Enbrel? (etanercept) is the first biologic with published data to show improvements in multiple measures of efficacy that were sustained in rheumatoid arthritis (RA) patients completing up to nine years of therapy. These new data are being presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.
"The current data in Rheumatoid Arthritis suggest that Enbrel is both effective and safe in long-term use," said Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, California. "These findings are significant because they provide a degree of reassurance to both the patient and the physician that unexpected safety concerns do not appear to be developing after nine years of use."
ENBREL continues to have a strong safety profile for extended periods of use. In the studies presented at ACR, rates of serious adverse events and serious infections remained low and were consistent with controlled portions from the double-blind phases of the studies. The overall number of observed malignancies (excluding nonmelanoma skin cancers) were similar in type and number to what would be expected in the general population.
Additionally, data showed that 77 early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid arthritis (LRA) patients who completed ENBREL treatment for up to eight years experienced substantial improvements in their ACR scores. Additionally, 73 LRA patients who completed ENBREL treatment for up to nine years experienced similar improvements. ACR scores are a composite measure of improvement in RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
Data being presented at ACR showed that ENBREL provided sustained improvement in the signs and symptoms of RA, in those patients who continued in the study, regardless of duration of disease. Following eight years of ENBREL therapy: 75 percent of ERA patients and 76 percent of LRA patients achieved ACR 20; 60 percent of ERA patients and 52 percent of LRA patients achieved ACR 50; 35 percent of ERA patients and 26 percent of LRA patients achieved ACR 70. Further, for those patients with LRA who received ENBREL treatment for nine years, 74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22 percent achieved ACR 70.
The ability to perform daily activities is an important goal for many people with RA, and data presented at ACR showed that treatment with ENBREL may help them achieve this goal. Through eight years of treatment with ENBREL, data showed that 73 to 85 percent of patients with ERA and 53 to 72 percent of patients with LRA achieved a clinically significant improvement in the Health Assessment Questionnaire (HAQ) score, a patient questionnaire that measures disability. A clinically significant improvement in HAQ was defined as at least a 0.22 improvement from baseline.
"Before I was diagnosed with RA, the pain, stiffness and fatigue stopped me from doing many of the activities I enjoyed," said Gloria Treece, a participant in the study. "Since starting ENBREL treatment approximately nine years ago, I'm now able to take part in many activities with my family."
These studies were designed to assess the safety and long-term efficacy of ENBREL in adult LRA patients who have failed to respond to at least one disease-modifying antirheumatic drug, and adult patients with ERA (defined as less than or equal to three years of disease duration). Patients with RA who participated in controlled clinical trials of ENBREL were eligible to enroll in open-label extension studies (LRA, N=644; ERA, N=207).
Enbrel first biologic with up to 9 years rheumatoid arthritis safety, sustained efficacy data THOUSAND OAKS, Calif., November 12, 2006 -- Amgen (NASDAQ: AMGN) today announced that Enbrel? (etanercept) is the first biologic with published data to show improvements in multiple measures of efficacy that were sustained in rheumatoid arthritis (RA) patients completing up to nine years of therapy. These new data are being presented at the American College of Rheumatology (ACR) Scientific Meeting in Washington, D.C.
"The current data in Rheumatoid Arthritis suggest that Enbrel is both effective and safe in long-term use," said Mark Genovese, M.D., Stanford University Medical Center, Palo Alto, California. "These findings are significant because they provide a degree of reassurance to both the patient and the physician that unexpected safety concerns do not appear to be developing after nine years of use."
ENBREL continues to have a strong safety profile for extended periods of use. In the studies presented at ACR, rates of serious adverse events and serious infections remained low and were consistent with controlled portions from the double-blind phases of the studies. The overall number of observed malignancies (excluding nonmelanoma skin cancers) were similar in type and number to what would be expected in the general population.
Additionally, data showed that 77 early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid arthritis (LRA) patients who completed ENBREL treatment for up to eight years experienced substantial improvements in their ACR scores. Additionally, 73 LRA patients who completed ENBREL treatment for up to nine years experienced similar improvements. ACR scores are a composite measure of improvement in RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
Data being presented at ACR showed that ENBREL provided sustained improvement in the signs and symptoms of RA, in those patients who continued in the study, regardless of duration of disease. Following eight years of ENBREL therapy: 75 percent of ERA patients and 76 percent of LRA patients achieved ACR 20; 60 percent of ERA patients and 52 percent of LRA patients achieved ACR 50; 35 percent of ERA patients and 26 percent of LRA patients achieved ACR 70. Further, for those patients with LRA who received ENBREL treatment for nine years, 74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22 percent achieved ACR 70.
The ability to perform daily activities is an important goal for many people with RA, and data presented at ACR showed that treatment with ENBREL may help them achieve this goal. Through eight years of treatment with ENBREL, data showed that 73 to 85 percent of patients with ERA and 53 to 72 percent of patients with LRA achieved a clinically significant improvement in the Health Assessment Questionnaire (HAQ) score, a patient questionnaire that measures disability. A clinically significant improvement in HAQ was defined as at least a 0.22 improvement from baseline.
"Before I was diagnosed with RA, the pain, stiffness and fatigue stopped me from doing many of the activities I enjoyed," said Gloria Treece, a participant in the study. "Since starting ENBREL treatment approximately nine years ago, I'm now able to take part in many activities with my family."
These studies were designed to assess the safety and long-term efficacy of ENBREL in adult LRA patients who have failed to respond to at least one disease-modifying antirheumatic drug, and adult patients with ERA (defined as less than or equal to three years of disease duration). Patients with RA who participated in controlled clinical trials of ENBREL were eligible to enroll in open-label extension studies (LRA, N=644; ERA, N=207).
Believe those who are seeking the truth. Doubt those who find it.
Andre Gide
Enbrel first biologic with up to 9 years rheumatoid arthritis safety, sustained efficacy data THOUSAND
OAKS, Calif., November 12, 2006 -- Amgen (NASDAQ: AMGN) today announced
that Enbrel? (etanercept) is the first biologic with published data to
show improvements in multiple measures of efficacy that were sustained
in rheumatoid arthritis (RA) patients completing up to nine years of
therapy. These new data are being presented at the American College of
Rheumatology (ACR) Scientific Meeting in Washington, D.C.
"The
current data in Rheumatoid Arthritis suggest that Enbrel is both
effective and safe in long-term use," said Mark Genovese, M.D., Stanford
University Medical Center, Palo Alto, California. "These findings are
significant because they provide a degree of reassurance to both the
patient and the physician that unexpected safety concerns do not appear
to be developing after nine years of use."
ENBREL continues to
have a strong safety profile for extended periods of use. In the studies
presented at ACR, rates of serious adverse events and serious
infections remained low and were consistent with controlled portions
from the double-blind phases of the studies. The overall number of
observed malignancies (excluding nonmelanoma skin cancers) were similar
in type and number to what would be expected in the general population.
Additionally,
data showed that 77 early rheumatoid arthritis (ERA) and 280
long-standing rheumatoid arthritis (LRA) patients who completed ENBREL
treatment for up to eight years experienced substantial improvements in
their ACR scores. Additionally, 73 LRA patients who completed ENBREL
treatment for up to nine years experienced similar improvements. ACR
scores are a composite measure of improvement in RA symptoms, including
joint swelling and tenderness, pain, level of disability, overall
patient and physician assessment, and an objective marker of
inflammation, such as erythrocyte sedimentation rate.
Data being
presented at ACR showed that ENBREL provided sustained improvement in
the signs and symptoms of RA, in those patients who continued in the
study, regardless of duration of disease. Following eight years of
ENBREL therapy: 75 percent of ERA patients and 76 percent of LRA
patients achieved ACR 20; 60 percent of ERA patients and 52 percent of
LRA patients achieved ACR 50; 35 percent of ERA patients and 26 percent
of LRA patients achieved ACR 70. Further, for those patients with LRA
who received ENBREL treatment for nine years, 74 percent achieved ACR
20, 41 percent achieved ACR 50, and 22 percent achieved ACR 70.
The
ability to perform daily activities is an important goal for many
people with RA, and data presented at ACR showed that treatment with
ENBREL may help them achieve this goal. Through eight years of treatment
with ENBREL, data showed that 73 to 85 percent of patients with ERA and
53 to 72 percent of patients with LRA achieved a clinically significant
improvement in the Health Assessment Questionnaire (HAQ) score, a
patient questionnaire that measures disability. A clinically significant
improvement in HAQ was defined as at least a 0.22 improvement from
baseline.
"Before I was diagnosed with RA, the pain, stiffness
and fatigue stopped me from doing many of the activities I enjoyed,"
said Gloria Treece, a participant in the study. "Since starting ENBREL
treatment approximately nine years ago, I'm now able to take part in
many activities with my family."
These studies were designed to
assess the safety and long-term efficacy of ENBREL in adult LRA patients
who have failed to respond to at least one disease-modifying
antirheumatic drug, and adult patients with ERA (defined as less than or
equal to three years of disease duration). Patients with RA who
participated in controlled clinical trials of ENBREL were eligible to
enroll in open-label extension studies (LRA, N=644; ERA, N=207).
Enbrel first biologic with up to 9 years rheumatoid arthritis safety, sustained efficacy data
THOUSAND OAKS, Calif., November 12,
2006 -- Amgen (NASDAQ: AMGN) today announced that Enbrel? (etanercept)
is the first biologic with published data to show improvements in
multiple measures of efficacy that were sustained in rheumatoid
arthritis (RA) patients completing up to nine years of therapy. These
new data are being presented at the American College of Rheumatology
(ACR) Scientific Meeting in Washington, D.C.
"The current data in Rheumatoid
Arthritis suggest that Enbrel is both effective and safe in long-term
use," said Mark Genovese, M.D., Stanford University Medical Center, Palo
Alto, California. "These findings are significant because they provide a
degree of reassurance to both the patient and the physician that
unexpected safety concerns do not appear to be developing after nine
years of use."
ENBREL continues to have a
strong safety profile for extended periods of use. In the studies
presented at ACR, rates of serious adverse events and serious infections
remained low and were consistent with controlled portions from the
double-blind phases of the studies. The overall number of observed
malignancies (excluding nonmelanoma skin cancers) were similar in type
and number to what would be expected in the general population.
Additionally, data showed that 77
early rheumatoid arthritis (ERA) and 280 long-standing rheumatoid
arthritis (LRA) patients who completed ENBREL treatment for up to eight
years experienced substantial improvements in their ACR scores.
Additionally, 73 LRA patients who completed ENBREL treatment for up to
nine years experienced similar improvements. ACR scores are a composite
measure of improvement in RA symptoms, including joint swelling and
tenderness, pain, level of disability, overall patient and physician
assessment, and an objective marker of inflammation, such as erythrocyte
sedimentation rate.
Data being presented at ACR showed
that ENBREL provided sustained improvement in the signs and symptoms of
RA, in those patients who continued in the study, regardless of duration
of disease. Following eight years of ENBREL therapy: 75 percent of ERA
patients and 76 percent of LRA patients achieved ACR 20; 60 percent of
ERA patients and 52 percent of LRA patients achieved ACR 50; 35 percent
of ERA patients and 26 percent of LRA patients achieved ACR 70. Further,
for those patients with LRA who received ENBREL treatment for nine
years, 74 percent achieved ACR 20, 41 percent achieved ACR 50, and 22
percent achieved ACR 70.
The ability to perform daily
activities is an important goal for many people with RA, and data
presented at ACR showed that treatment with ENBREL may help them achieve
this goal. Through eight years of treatment with ENBREL, data showed
that 73 to 85 percent of patients with ERA and 53 to 72 percent of
patients with LRA achieved a clinically significant improvement in the
Health Assessment Questionnaire (HAQ) score, a patient questionnaire
that measures disability. A clinically significant improvement in HAQ
was defined as at least a 0.22 improvement from baseline.
"Before I was diagnosed with
RA, the pain, stiffness and fatigue stopped me from doing many of the
activities I enjoyed," said Gloria Treece, a participant in the study.
"Since starting ENBREL treatment approximately nine years ago, I'm now
able to take part in many activities with my family."
These studies were designed to assess
the safety and long-term efficacy of ENBREL in adult LRA patients who
have failed to respond to at least one disease-modifying antirheumatic
drug, and adult patients with ERA (defined as less than or equal to
three years of disease duration). Patients with RA who participated in
controlled clinical trials of ENBREL were eligible to enroll in
open-label extension studies (LRA, N=644; ERA, N=207).
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