Fri Aug 06, 2004
Back in business!
As you all have noticed, there has been total silence in this site, and I have received many emails about it. Mostly very kind and concerned emails asking about the reason for this.
Thanks for those! And yes I have been away from all this for a couple of months. The reason is that I have been quite OK for couple of months and suddenly got worse early this spring..... I had to stop one kind of treatment (Kineret) because it was fading in effect but (Remicade) slowly got me back in business. Then I was on vacation to southern europe for a month, but now I am back in the saddle and hope to catch up what I have missed. Dont hesitate to email me if you have any questions about this.
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Sun May 09, 2004
A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis
Newswise — A promising new therapy for rheumatoid arthritis (RA) developed by researchers at the University of California, San Diego (UCSD) School of Medicine re-educates the body's immune system to prevent an attack against healthy joint tissue.
Read the whole artricle here:
http://www.newswise.com/articles/view/504426/
More...
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Tue Mar 30, 2004
First infusion of Remicade
Well, it has been a while
So maybe it is time to do a update. Some of you might remember that I started with Kineret i august last year. It was a like a miracle to me and I felt so much better. After about 3 month I had some flares and I also got some cortisone injections. I slowly got worse and in january I had to admit to my self that Kineret didnt work anymore. My lab tests were back normal junk and I just felt awful. I could hardly work anymore.
Now the good news (there is aways a good side of it all... right) is that there have been some studies of those TNF-alfablockers and the fear of enhanced cancer. (I had cancer 3 years ago) Among others a group of swedish scientist in Lund (where Nina lives) now have established that it is exactly the opposite. TNF-alfa blockers seems to reduce the risk of cancer.
So after all.... TNF-alfablockers is an alternative for me, and last week i got the first infusion of Remicade. Within 2 hours after it was done I started to notice improvements and now after a couple of days I feel rather good. Yesterday my wife and I took a short walk in the woods and felt real good in the warm sunshine! (spring is coming quickly here in sweden)
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Sun Nov 16, 2003
NEJM -- Treatment of Rheumatoid Arthritis by Selective Inhibition of T-Cell Activation with Fusion Protein CTLA4Ig
Background Effective new therapies are needed for rheumatoid arthritis. Current therapies target the products of activated macrophages; however, T cells also have an important role in rheumatoid arthritis. A fusion protein — cytotoxic T-lymphocyte–associated antigen 4–IgG1 (CTLA4Ig) — is the first in a new class of drugs known as costimulation blockers being evaluated for the treatment of rheumatoid arthritis. CTLA4Ig binds to CD80 and CD86 on antigen-presenting cells, blocking the engagement of CD28 on T cells and preventing T-cell activation. A preliminary study showed that CTLA4Ig may be effective for the treatment of rheumatoid arthritis
http://content.nejm.org/cgi/content/short/349/20/1907
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Fri Nov 07, 2003
More about milk Thistle
http://www.supplementwatch.com/supatoz/supplement.asp?supplementId=203
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Sun Nov 02, 2003
RemedyFind: patient ratings of Kineret (Anakinra) for Arthritis: Rheumatoid
http://www.remedyfind.com/rm-3029-Kineret.asp
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Rheumatoid Arthritis - disease causing joint pain - drugs and treatments
http://www.remedyfind.com/hc-Rheumatoid-Arthritis.asp
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Preventing joint damage as the best measure of biologic drug therapy
Bresnihan, B. "Preventing joint damage as the best measure of biologic drug
therapy." Journal of Rheumatology - Supplement. 65(2002): 39-43 UI 12236622.
Joint damage occurs progressively in patients with rheumatoid arthritis (RA),
leading to functional decline and disability. The proinflammatory cytokines interleukin
1 (IL-1) and tumor necrosis factor-alpha (TNF-alpha) are thought to play a key role
in promoting cartilage and bone erosion in the rheumatoid joint. In randomized
clinical trials, inhibitors of these cytokines significantly slowed the rate of progressive
joint damage as assessed by radiographic techniques. The IL-1 receptor antagonist
anakinra significantly reduced erosions, joint space narrowing, and total joint
damage when a modified Sharp score was used to evaluate serial hand radiographs.
The maximum benefit of anakinra on joint space narrowing was achieved within the
first 24 weeks and was maintained during continued treatment, whereas the slowing
of erosions by anakinra increased with continued treatment beyond 24 weeks. In
terms of TNF-alpha inhibition, infliximab significantly reduced joint damage in
patients with long-standing RA, when used in combination with methotrexate (MTX),
whereas etanercept significantly reduced erosions relative to MTX in patients with
early stage disease. Comparisons among the cytokine inhibitors are made
problematic by differences in the designs, patient populations, and outcome
measures of these trials. Nevertheless, these studies demonstrate that IL-1 or TNFalpha
inhibition effectively suppresses the pathophysiological mechanisms associated
with cartilage degradation and bone erosion, resulting in a slowing of further
radiographic progression. [References: 16]
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Wed Oct 29, 2003
Moral of this study use Biologics early don't wait!
Clinical Response to Biological Therapies in 309 RA Patients with
Maximum Dose Methotrexate Failure at a Single Centre
Category: 17 RA—treatment
Sarah J. Bingham, Maya H. Buch, Yohei Seto, Victoria Bejerano, Sally
L. Smith, Paul Emery. University of Leeds, Leeds, United Kingdom
Presentation Number: 795
Poster Board Number: 190
Purpose:
Infliximab, etanercept, anakinra and adalimumab are now available for
patients with severe active RA. As a regional centre, we have assessed
and treated a large cohort of patients with state funded biologics. To
qualify for treatment, patients were required to have failed
escalating treatment with full dose methotrexate (MTX) including
parenteral. Hence, this permits evaluation of safety and efficacy of
biological therapies in these severe 'resistant' cases.
Methods:
Patients who had failed escalation of conventional therapy (including
combination of MTX / sulphasalazine / hydroxychloroquine) and 25 mg /
week MTX including a switch to parenteral MTX were eligible for
treatment with biologics; >60% had also failed treatment with
leflunomide. Components of the DAS28 and ACR response scores and RAQol
were collected at baseline and subsequently at 12-weekly intervals.
Reasons for discontinuation were documented.
Results:
133 patients were commenced on infliximab, 89 on etanercept, 48 on
anakinra and 39 on adalimumab. (1) Demographics: Infliximab: mean age
53 yrs, 81% female, 75% RF+. Etanercept: mean age 52 yrs, 74% female,
89% RF+. Anakinra: mean age 57 yrs, 65% female, 77% RF+. Adalimumab:
mean age 48 yrs, 70% female, 50% RF+ (2) Outcome and Efficacy: See
table. Few Anakinra and no Adalimumab patients had yet reached 24
weeks. Around 60% of patients continued therapy after 6 months. (3)
Major Toxicity: One patient receiving etanercept died from
complications following an infected bedsore. One patient on anakinra
died from congestive cardiac failure.
Conclusions:
In this group of patients with late severe resistant disease and true
methotrexate failure, the efficacy of biologics appears to be
comparable with that seen in previous clinical trials and the
different biologics appear to have similar efficacy. Although most
patients benefit, 40% of patients discontinue treatment by 6 months,
which will lead to a large group of patients who have failed biologics
and require further therapies. The resistant nature of this cohort and
administration of drug in late disease may contribute to these
findings, as other studies have shown that biologics are highly
efficacious in early disease. Waiting until late disease before
treatment may not be an effective strategy.
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Safety Data From 48 weeks Follow-Up of a Randomised Controlled Trial
Safety Data From 48 weeks Follow-Up of a Randomised Controlled Trial
of Rituximab in Patients with Rheumatoid Arthritis
Category: 17 RA—treatment
L. Szczepanski1, J. Szechinski2, A. Filipowicz-Sosnowska3, P. Emery4,
J. C. W. Edwards5, F. Magrini6, P. B. Lehane6, T. M. Shaw6. 1Medical
University of Lubin, Lubin, Poland; 2Medical University School of
Wroclaw, Wroclaw, Poland; 3Institute of Rheumatology, Warsaw, Poland;
4Leeds General Infirmary, Leeds, United Kingdom; 5University College
London, London, United Kingdom; 6Roche Products Ltd, Welwyn Garden
City, United Kingdom
Presentation Number: 204
Poster Board Number: 204
Background: Rituximab (Rituxan® /MabThera®) is an anti-CD20 chimeric
monoclonal antibody which binds specifically to the CD20 antigen
expressed on mature B cells. In a 24 week, randomised,
placebo-controlled trial in patients with active RA rituximab was
shown to be effective and well tolerated.
Purpose: Given the duration of peripheral B-cell depletion produced by
rituximab, this follow-up was designed to provide safety information
beyond 24wks.
Methods: 161 patients with active RA who had an inadequate response to
methotrexate were randomised to one of four treatment groups: MTX
alone; rituximab alone (1g i.v. on days 1 and 15); rituximab plus CTX
(750mg i.v. on days 3 and 17); rituximab plus continuing MTX. All
groups also received a 17-day course of corticosteroids (100mg i.v.
methylprednisolone on day 1, 3, 15 and 17; 60mg p.o. on day 2 and 4-7;
and 30mg p.o. prednisone on day 8-14). B-cell (CD19) populations and
immunoglobulin (Ig) levels were measured at regular intervals. Safety
data were collected continuously.
Results: Overall the safety profile indicates that all three rituximab
regimens were well tolerated with similar incidence and types of
adverse events compared to the MTX alone control arm. The majority of
adverse events were reported during the first rituximab infusion and
were considered to be mild to moderate in severity. At week 48, the
incidence and types of events, including infections, were evenly
balanced between all groups. Since week 24 and up to week 48, a total
of 4 additional serious adverse events were reported. These included 2
serious infections (arytenoiditis in the rituximab+CTX group and viral
gastroenteritis in the rituximab alone group). The other events were
goitre (rituximab alone) and replacement of a renal stent (rituximab +
MTX). Throughout the 48 week period median CD19 levels in all groups
receiving rituximab remained reduced, and there was evidence of B cell
return from week 32 onwards. Nevertheless at wk 48 median CD19 levels
remained only 20-40% of their pre-treatment baseline. Mean Ig levels
remained within normal limits for each isotype. IgM showed the
greatest proportional changes, which correlated with the patients'
reduction in rheumatoid factor.
Conclusions: These data indicate that rituximab is well tolerated with
a good safety profile in this patient population that extends to at
least 48 weeks. During this period rituximab induced an almost
complete and sustained reduction of peripheral CD19+ B cells through
to wk 48, however, this does not appear to be associated with an
increase in adverse events (including infections). Ig levels were only
minimally affected with mean levels remaining within normal limits
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Tue Oct 28, 2003
Good news! Therapy with Biologic Agents is not Associated with an Increased Risk
Therapy with Biologic Agents is not Associated with an Increased Risk
of Cancer Recurrence in Patients with Rheumatoid Arthritis
Category: 17 RA—treatment
Melissa Hawkins-Holt1, Marc C. Hochberg1, Stanley B. Cohen2, Kaleb
Michaud3, Fred Wolfe3. 1University of Maryland School of Medicine,
Baltimore, MD; 2Radiant Research, Dallas, TX; 3National Data Bank for
Rheumatic Disease, Wichita, KS
Presentation Number: 806
Poster Board Number: 201
Background: Tumor necrosis factor (TNF) blocking agents are effective
biologic treatments for patients with rheumatoid arthritis (RA). The
immunological alterations induced by anti-TNF therapy, however, may
lead to side effects, including reactivation of tuberculosis, possible
development or activation of immunological disorders (e.g., SLE and
multiple sclerosis), and other conditions. There is also concern that
RA patients receiving anti-TNF therapy could have an increased risk of
cancer (e.g., lymphoma) and/or cancer recurrence. It is not clear how
clinicians should advise patients with active RA who have a history of
cancer regarding the use of anti-TNF therapy.
Purpose: To determine if anti-TNF therapy increases the rate of cancer
recurrence among patients with RA.
Methods: Among 19,072 patients with RA enrolled in a longitudinal data
bank begun in 1988, 1,592 (8.3%) reported having cancer at time of
enrollment or during follow-up. These 1,592 patients were contacted in
the 2nd half of 2002, and 915 (57.5%) provided information to validate
the diagnosis of cancer. Responses are pending from an additional 407
patients, 120 have died, and the remainder refused to participate or
were unavailable for various reasons. Patients who began anti-TNF
therapy prior to developing their primary cancer were excluded, as
were patients whose cancer recurrence began prior to data bank
enrollment. Patients whose cancer subsided or ‘remitted’ after initial
treatment and then recurred were counted as recurrences. Time to
development of recurrence began at data bank enrollment. Analyses
utilized Kaplan-Meier life tables and Cox proportional hazard
regression with the outcome being time to recurrence. Biologic therapy
consisted of infliximab and etanercept.
Results: Of the 915 patients with cancer, the most common was breast
cancer (N=283). The relative hazard for breast cancer recurrence in
patients receiving anti-TNF agents was 0.45 (95% CI 0.15, 1.35). Small
sample size limited the analysis of other individual cancers.
Therefore, all cancers were pooled and the analysis performed on the
combined set. There were 57 patients with recurrence of whom 43 met
criteria for analysis. The relative hazard for the effect of anti-TNF
therapy on recurrence of any primary cancer was 0.33 (95% CI 0.14,
0.77). This protective effect remained significant after adjusting for
age and calendar period.
Conclusions: Patients on anti-TNF therapy had a reduced rate of cancer
recurrence. These data should be interpreted with caution as the
results among non-participants might have altered the overall findings
and other potential confounders were not adjusted for in the analysis.
Even so, these data fail to support the hypothesis that treatment with
anti-TNF agents increases the risk of cancer recurrence in patients
with RA.
OASIS - Online Abstract Submission and Invitation System™ ©1996-2003,
Coe-Truman Technologies, Inc.
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New study on Kineret safety profile
Kineret seems to have an excellent safety profile.
Long-Term Safety of Anakinra (Interleukin-1 Receptor Antagonist) in
Patients Receiving Standard Treatments for Rheumatoid Arthritis: A
36-Month Update from a Large Phase 3 Study
Category: 17 RA—treatment
Roy M. Fleischmann1, John R. P. Tesser2, Pirow Bekker3, Deborah Bell3,
Lifen Zhou3, Dennis Modafferi3. 1Division of Rheumatology, St Paul
Medical Center, Dallas, TX; 2Phoenix Center for Clinical Research,
Phoenix, AZ; 3Amgen Inc., Thousand Oaks, CA
Presentation Number: 783
Poster Board Number: 178
Objective: To evaluate the long-term safety of anakinra (100 mg/day,
subcutaneous injection) in subjects receiving other background
treatments for Rheumatoid Arthritis (RA).
Methods: 1399 subjects (283 placebo and 1116 anakinra) were initially
treated in a randomized, double-blind, placebo-controlled trial for up
to 6 months, and subsequently those who completed the 6 months of
treatment were rolled over to receive open-label anakinra for an
additional 30 months (n=1103). Following is a report of the 36 month
data. Entry criteria were designed to enroll patients typical of those
seen in clinical practice and included: =3 tender/painful (T/P) and =3
swollen joints or morning stiffness =45 minutes; RA duration =3
months; age =18 years; DMARDS stable =2 months; corticosteroids/NSAIDs
stable =1 month. Changes in baseline RA medications were allowed and
new medications were added during the study, if clinically indicated
(anti-TNF drugs were not allowed).
Results: The two treatment groups had similar demographics, disease
status, and use of concomitant RA medications at baseline. The
majority of subjects in the study received RA medications at baseline
(79% DMARDs, 58% corticosteroids, and 87% NSAIDs) while 11% of
subjects did not use either corticosteroids or DMARDs. A total of 1346
subjects received anakinra for up to 36 months. The total exposure to
anakinra was 2273.0 patient-years.
No patients with serious infection had neutrophil counts below 1.5 ×
109/L. None of the serious infections were fatal. An age, race and sex
adjusted SEER analysis of cancer incidence rates indicated 20.4
expected cases in the general population, while 18 were observed in
this study. The observed vs. expected standardized cancer incidence
ratio was 0.88 (95% CI = 0.52, 1.39).
Conclusions: The overall safety profile of anakinra seen in this study
was consistent with that seen in earlier studies. No notable changes
in the exposure-adjusted event rates were observed with increasing
exposure to anakinra. This long-term safety study revealed no new
safety issues and demonstrated that anakinra is generally well
tolerated in patients receiving other standard RA treatments.
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Kineret safety study
Kineret seems to have an excellent safety profile.
Long-Term Safety of Anakinra (Interleukin-1 Receptor Antagonist) in
Patients Receiving Standard Treatments for Rheumatoid Arthritis: A
36-Month Update from a Large Phase 3 Study
Category: 17 RA—treatment
Roy M. Fleischmann1, John R. P. Tesser2, Pirow Bekker3, Deborah Bell3,
Lifen Zhou3, Dennis Modafferi3. 1Division of Rheumatology, St Paul
Medical Center, Dallas, TX; 2Phoenix Center for Clinical Research,
Phoenix, AZ; 3Amgen Inc., Thousand Oaks, CA
Presentation Number: 783
Poster Board Number: 178
Objective: To evaluate the long-term safety of anakinra (100 mg/day,
subcutaneous injection) in subjects receiving other background
treatments for Rheumatoid Arthritis (RA).
Methods: 1399 subjects (283 placebo and 1116 anakinra) were initially
treated in a randomized, double-blind, placebo-controlled trial for up
to 6 months, and subsequently those who completed the 6 months of
treatment were rolled over to receive open-label anakinra for an
additional 30 months (n=1103). Following is a report of the 36 month
data. Entry criteria were designed to enroll patients typical of those
seen in clinical practice and included: =3 tender/painful (T/P) and =3
swollen joints or morning stiffness =45 minutes; RA duration =3
months; age =18 years; DMARDS stable =2 months; corticosteroids/NSAIDs
stable =1 month. Changes in baseline RA medications were allowed and
new medications were added during the study, if clinically indicated
(anti-TNF drugs were not allowed).
Results: The two treatment groups had similar demographics, disease
status, and use of concomitant RA medications at baseline. The
majority of subjects in the study received RA medications at baseline
(79% DMARDs, 58% corticosteroids, and 87% NSAIDs) while 11% of
subjects did not use either corticosteroids or DMARDs. A total of 1346
subjects received anakinra for up to 36 months. The total exposure to
anakinra was 2273.0 patient-years.
No patients with serious infection had neutrophil counts below 1.5 ×
109/L. None of the serious infections were fatal. An age, race and sex
adjusted SEER analysis of cancer incidence rates indicated 20.4
expected cases in the general population, while 18 were observed in
this study. The observed vs. expected standardized cancer incidence
ratio was 0.88 (95% CI = 0.52, 1.39).
Conclusions: The overall safety profile of anakinra seen in this study
was consistent with that seen in earlier studies. No notable changes
in the exposure-adjusted event rates were observed with increasing
exposure to anakinra. This long-term safety study revealed no new
safety issues and demonstrated that anakinra is generally well
tolerated in patients receiving other standard RA treatments.
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Mon Oct 27, 2003
Roche, Genentech Drug Helps Arthritis Long-Term
Roche, Genentech Drug Helps Arthritis Long-Term
Sun 26 October, 2003 20:34 BST
LONDON (Reuters) - A blockbuster drug for cancer also offers long-term
relief to rheumatoid arthritis sufferers, according to results of an
intermediate Phase II clinical study released on Sunday.
Patients given just two doses of MabThera, also known as Rituxan,
continued to show a substantial improvement in symptoms for up to 48
weeks, data presented to the American College of Rheumatology and
released in London showed.
Previous clinical trials had demonstrated the benefits of the drug
lasting 24 weeks, but the fact the effects can be sustained for nearly
a year will increase prospects of its use in the new disease area.
The monoclonal antibody is already one of the world's most successful
cancer medicines, through its use in the treatment of non-Hodgkin's
lymphoma, the most common form of blood cancer.
It is marketed as MabThera in Europe by Swiss healthcare group Roche
Holding AG and as Rituxan in the U.S. by biotechnology firm Genentech
Inc, which co-developed the product with IDEC Pharmaceuticals Corp.
The medicine has grown to become Roche's biggest seller, with sales of
2.3 billion Swiss francs ($1.75 billion) in 2002. Earlier this year,
Roche predicted peak sales would reach 4.5 billion in cancer treatment
alone, before allowing for potential use in arthritis.
Data from the trial, which involved 161 patients who had previously
failed to respond to other therapies, showed MabThera relieved their
symptoms when tested by itself or in combination with other
treatments.
At 48 weeks, 65 percent of patients receiving a combination of
MabThera and methotrexate showed at least a 20 percent improvement in
symptoms and 35 percent had at least a 50 percent improvement, Roche
said in a statement detailing the results.
Rheumatoid arthritis is a condition affecting an estimated one percent
of the population, two-thirds of them women, in which the body's
overactive immune system attacks joints and causes crippling pain.
MabThera, which is given by infusion, works by targeting white blood
cells called B lymphocytes that are believed to spawn antibodies that
attack the body's joints.
If eventually approved for rheumatoid arthritis it would compete
against Amgen Inc.'s Enbrel and Johnson & Johnson's Remicade, two
popular new drugs that treat rheumatoid arthritis by blocking an
inflammation-causing protein called tumor necrosis factor. ($1=1.315
Swiss Franc)
http://story.news.yahoo.com/news?tmpl=story
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Sat Oct 25, 2003
Today's News pills with TNF-alfa antibody
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-22-2003/0002041677&EDATE=
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