Plasmapheresis / Guillain-Barre syndrome
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Date: 02/23/05
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Date: 23 Feb 2005 10:39:51 -0800
J Rheumatol. 2004 Nov;31(11):2131-5. Related Articles, Links
Effects of Prosorba column apheresis in patients with chronic
refractory rheumatoid arthritis.
Roth S.
Arthritis Care and Research, Phoenix, Arizona, USA.
sanfordroth_md@cox.net
OBJECTIVE: Since the approval of Prosorba column apheresis therapy
(PCT) for rheumatoid arthritis (RA) in 1999 there have been multiple
requests for additional information on the response rate of PCT used
commercially in rheumatology practice settings. METHODS: Data were
collected in a noninterventional prospective fashion on patients with
RA who qualified for the PCT treatment per the package insert. There
were 91 patients who completed the 12 prescribed treatments. There was
no washout of other drugs [i.e., disease modifying antirheumatic drugs
(DMARD), biologics]. An initial baseline assessment was performed prior
to first treatment and then up to 4 additional assessments were
performed at Weeks 9, 16, 20, and 24. Criteria for ACR20 were noted in
order to assess response rate, and commercial adverse event reporting
was used to record serious/unanticipated adverse events. RESULTS: There
was a response rate of 53.8% (measured as ACR20 response or better) in
these patients with previously refractory RA. The individual criteria
showed a much greater improvement than reflected by ACR20; for example,
this response included a 52% improvement in joint tenderness, 40%
improvement in swelling, 42% improvement in patient's pain, 38%
improvement in patient's global response, and 48% improvement in
physician's global scores (76% of responders had measured ACR20 by Week
16 and 100% by Week 24). The actual measurement of an ACR response
generally occurred during assessments at Week 16; however, most
patients who respond will state they felt improvement some time between
Weeks 8 and 12. There were no assessments between Weeks 9 and 16 so the
actual week of improvement could not be identified by ACR criteria.
Some patients stated that they felt improvement began closer to the 6th
week. Most responders were concurrently taking biologics or DMARD,
e.g., methotrexate and etanercept, despite previously inadequate RA
response to those medications. CONCLUSION: This postmarketing study of
PCT used commercially in 59 rheumatology practice settings supports the
safety and efficacy of this treatment regime in selected patients with
RA and compares favorably with the initial sham controlled clinical
trial. PCT is a relatively underutilized choice for the management of
active, aggressive RA.
Publication Types:
Clinical Trial
Clinical Trial, Phase IV
PMID: 15517623 [PubMed - indexed for MEDLINE]
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