The Prosorba column for treatment of refractory rheumatoid arthritis: A randomized, double-blind, sham-controlled trial

David T. Felson, Michael P. La Valley, Andrew R. Baldassare, Joel A. Block, Jacques R. Caldwell, Grant W. Cannon, Chad Deal, Stephen Evans, Roy Fleischmann, R. Michael Gendreau, E. Robert Harris, Eric Lawrence Matteson, Sanford H. Roth, H. Ralph Schumacher, Michael H. Weisman, Daniel E. Furst

Research output: Contribution to journalArticle

102 Citations (Scopus)

Abstract

Objective. To evaluate the efficacy and safety of the Prosorba column as a treatment for rheumatoid arthritis (RA) in patients with active and treatment-resistant (refractory) disease. Methods. A sham-controlled, randomized, double-blind, multicenter trial of Prosorba versus sham apheresis was performed in patients with RA who had failed to respond to treatment with methotrexate or at least 2 other second-line drugs. Patients received 12 weekly treatments with Prosorba or sham apheresis, with efficacy evaluated 7- 8 weeks after treatment ended. Patients were characterized as responders if they experienced improvement according to the American College of Rheumatology (ACR) response criteria at the efficacy time point. A data safety monitoring board (DSMB) evaluated interim analyses for the possibility of early completion of the trial. Results. Patients in the trial had RA for an average of 15.5 years (range 1.7-50.6) and had failed an average of 4.2 second-line drug treatments prior to entry. After the completion of treatment of 91 randomized patients, the DSMB stopped the trial early due to successful outcomes. Of the 47 patients in the Prosorba arm, 31.9% experienced ACR- defined improvement versus 11.4% of the 44 patients in the sham-treated arm (P = 0.019 after adjustment for interim analysis). When results from 8 additional patients, who had completed blinded treatments at the time of DSMB action, were added to the analysis (n = 99), results were unchanged. The most common adverse events were a short-term flare in joint pain and swelling following treatment, a side effect that occurred in most subjects at least once in both treatment arms. Other side effects, although common, occurred equally as frequently in both treatment groups. Conclusion. Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.

Original languageEnglish (US)
Pages (from-to)2153-2159
Number of pages7
JournalArthritis and Rheumatism
Volume42
Issue number10
DOIs
StatePublished - Oct 1999

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Rheumatoid Arthritis
Clinical Trials Data Monitoring Committees
Blood Component Removal
Therapeutics
Arthralgia
Rheumatology
Patient Safety
Methotrexate
Pharmaceutical Preparations
Multicenter Studies
Safety

ASJC Scopus subject areas

  • Immunology
  • Rheumatology

Cite this

Felson, D. T., La Valley, M. P., Baldassare, A. R., Block, J. A., Caldwell, J. R., Cannon, G. W., ... Furst, D. E. (1999). The Prosorba column for treatment of refractory rheumatoid arthritis: A randomized, double-blind, sham-controlled trial. Arthritis and Rheumatism, 42(10), 2153-2159. https://doi.org/10.1002/1529-0131(199910)42:10<2153::AID-ANR16>3.0.CO;2-W

The Prosorba column for treatment of refractory rheumatoid arthritis : A randomized, double-blind, sham-controlled trial. / Felson, David T.; La Valley, Michael P.; Baldassare, Andrew R.; Block, Joel A.; Caldwell, Jacques R.; Cannon, Grant W.; Deal, Chad; Evans, Stephen; Fleischmann, Roy; Gendreau, R. Michael; Harris, E. Robert; Matteson, Eric Lawrence; Roth, Sanford H.; Schumacher, H. Ralph; Weisman, Michael H.; Furst, Daniel E.

In: Arthritis and Rheumatism, Vol. 42, No. 10, 10.1999, p. 2153-2159.

Research output: Contribution to journalArticle

Felson, DT, La Valley, MP, Baldassare, AR, Block, JA, Caldwell, JR, Cannon, GW, Deal, C, Evans, S, Fleischmann, R, Gendreau, RM, Harris, ER, Matteson, EL, Roth, SH, Schumacher, HR, Weisman, MH & Furst, DE 1999, 'The Prosorba column for treatment of refractory rheumatoid arthritis: A randomized, double-blind, sham-controlled trial', Arthritis and Rheumatism, vol. 42, no. 10, pp. 2153-2159. https://doi.org/10.1002/1529-0131(199910)42:10<2153::AID-ANR16>3.0.CO;2-W
Felson, David T. ; La Valley, Michael P. ; Baldassare, Andrew R. ; Block, Joel A. ; Caldwell, Jacques R. ; Cannon, Grant W. ; Deal, Chad ; Evans, Stephen ; Fleischmann, Roy ; Gendreau, R. Michael ; Harris, E. Robert ; Matteson, Eric Lawrence ; Roth, Sanford H. ; Schumacher, H. Ralph ; Weisman, Michael H. ; Furst, Daniel E. / The Prosorba column for treatment of refractory rheumatoid arthritis : A randomized, double-blind, sham-controlled trial. In: Arthritis and Rheumatism. 1999 ; Vol. 42, No. 10. pp. 2153-2159.
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abstract = "Objective. To evaluate the efficacy and safety of the Prosorba column as a treatment for rheumatoid arthritis (RA) in patients with active and treatment-resistant (refractory) disease. Methods. A sham-controlled, randomized, double-blind, multicenter trial of Prosorba versus sham apheresis was performed in patients with RA who had failed to respond to treatment with methotrexate or at least 2 other second-line drugs. Patients received 12 weekly treatments with Prosorba or sham apheresis, with efficacy evaluated 7- 8 weeks after treatment ended. Patients were characterized as responders if they experienced improvement according to the American College of Rheumatology (ACR) response criteria at the efficacy time point. A data safety monitoring board (DSMB) evaluated interim analyses for the possibility of early completion of the trial. Results. Patients in the trial had RA for an average of 15.5 years (range 1.7-50.6) and had failed an average of 4.2 second-line drug treatments prior to entry. After the completion of treatment of 91 randomized patients, the DSMB stopped the trial early due to successful outcomes. Of the 47 patients in the Prosorba arm, 31.9{\%} experienced ACR- defined improvement versus 11.4{\%} of the 44 patients in the sham-treated arm (P = 0.019 after adjustment for interim analysis). When results from 8 additional patients, who had completed blinded treatments at the time of DSMB action, were added to the analysis (n = 99), results were unchanged. The most common adverse events were a short-term flare in joint pain and swelling following treatment, a side effect that occurred in most subjects at least once in both treatment arms. Other side effects, although common, occurred equally as frequently in both treatment groups. Conclusion. Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.",
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T2 - A randomized, double-blind, sham-controlled trial

AU - Felson, David T.

AU - La Valley, Michael P.

AU - Baldassare, Andrew R.

AU - Block, Joel A.

AU - Caldwell, Jacques R.

AU - Cannon, Grant W.

AU - Deal, Chad

AU - Evans, Stephen

AU - Fleischmann, Roy

AU - Gendreau, R. Michael

AU - Harris, E. Robert

AU - Matteson, Eric Lawrence

AU - Roth, Sanford H.

AU - Schumacher, H. Ralph

AU - Weisman, Michael H.

AU - Furst, Daniel E.

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N2 - Objective. To evaluate the efficacy and safety of the Prosorba column as a treatment for rheumatoid arthritis (RA) in patients with active and treatment-resistant (refractory) disease. Methods. A sham-controlled, randomized, double-blind, multicenter trial of Prosorba versus sham apheresis was performed in patients with RA who had failed to respond to treatment with methotrexate or at least 2 other second-line drugs. Patients received 12 weekly treatments with Prosorba or sham apheresis, with efficacy evaluated 7- 8 weeks after treatment ended. Patients were characterized as responders if they experienced improvement according to the American College of Rheumatology (ACR) response criteria at the efficacy time point. A data safety monitoring board (DSMB) evaluated interim analyses for the possibility of early completion of the trial. Results. Patients in the trial had RA for an average of 15.5 years (range 1.7-50.6) and had failed an average of 4.2 second-line drug treatments prior to entry. After the completion of treatment of 91 randomized patients, the DSMB stopped the trial early due to successful outcomes. Of the 47 patients in the Prosorba arm, 31.9% experienced ACR- defined improvement versus 11.4% of the 44 patients in the sham-treated arm (P = 0.019 after adjustment for interim analysis). When results from 8 additional patients, who had completed blinded treatments at the time of DSMB action, were added to the analysis (n = 99), results were unchanged. The most common adverse events were a short-term flare in joint pain and swelling following treatment, a side effect that occurred in most subjects at least once in both treatment arms. Other side effects, although common, occurred equally as frequently in both treatment groups. Conclusion. Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.

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