RESEARCH - Effects of Prosorba column apheresis in patients with chronic refractory RA

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J Rheumatol. 2004 Nov;31(11):2131-5.

Effects of Prosorba column apheresis in patients with chronic refractory

rheumatoid arthritis.

Roth S.

Arthritis Care and Research, Phoenix, Arizona, USA. sanfordroth_md@...

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.

PMID: 15517623

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

5517623

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