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Treatment of rheumatoid arthritis with a DR4/1 peptide.

Publication ,  Journal Article
St Clair, EW; Cohen, SB; Lee, ML; Fleischmann, RM; Lee, SH; Moreland, LW; Olsen, NJ; Pratt, PW; Yocum, DE; Heck, L; Winkelhake, J; Shulman, MJ ...
Published in: J Rheumatol
August 2000

OBJECTIVE: To determine the safety and potential clinical efficacy of primary and booster injections of a DR4/1 peptide in patients with active rheumatoid arthritis (RA) despite methotrexate therapy. METHODS. Subjects with active RA were enrolled in a randomized, placebo controlled, double blind, dose-escalating clinical trial of synthetic DR4/1 peptide containing the shared epitope. The primary injection of the DR4/1 peptide in alum adjuvant was administered at one of 3 doses, 1.3, 4.0, and 13 mg, followed by up to 3 or 4 booster injections every 6 or 8 weeks at the same dose. The primary outcomes were the occurrence of adverse effects and changes in measures of immune function. Clinical efficacy was assessed using the American College of Rheumatology 20% criteria for clinical improvement. RESULTS: Fifty-three patients were entered into the trial, including 44 who completed the study. In the absence of any observations of a dose response to the DR4/1 peptide injections, the 3 dosage groups were combined for subsequent analysis into 3 groups: patients receiving DR4/1 peptide injections every 6 weeks, patients receiving DR4/1 peptide injections every 8 weeks, and a placebo group. At all doses and each dosing interval the primary and booster injections of synthetic DR4/1 peptide were well tolerated and did not produce any significant changes in lymphocyte counts or evidence of generalized immunosuppression. Analysis of clinical efficacy showed that the 6 week group had trends toward improvement in disease measures. CONCLUSION: Primary and booster injections of the DR4/1 peptide containing the shared epitope were safe and did not broadly suppress immune function.

Duke Scholars

Published In

J Rheumatol

ISSN

0315-162X

Publication Date

August 2000

Volume

27

Issue

8

Start / End Page

1855 / 1863

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • T-Lymphocytes
  • Safety
  • Receptors, Antigen, T-Cell, alpha-beta
  • Oligopeptides
  • Monocytes
  • Middle Aged
  • Methotrexate
  • Male
  • Lymphocyte Count
 

Citation

APA
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ICMJE
MLA
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St Clair, E. W., Cohen, S. B., Lee, M. L., Fleischmann, R. M., Lee, S. H., Moreland, L. W., … Shulman, M. J. (2000). Treatment of rheumatoid arthritis with a DR4/1 peptide. J Rheumatol, 27(8), 1855–1863.
St Clair, E. W., S. B. Cohen, M. L. Lee, R. M. Fleischmann, S. H. Lee, L. W. Moreland, N. J. Olsen, et al. “Treatment of rheumatoid arthritis with a DR4/1 peptide.J Rheumatol 27, no. 8 (August 2000): 1855–63.
St Clair EW, Cohen SB, Lee ML, Fleischmann RM, Lee SH, Moreland LW, et al. Treatment of rheumatoid arthritis with a DR4/1 peptide. J Rheumatol. 2000 Aug;27(8):1855–63.
St Clair, E. W., et al. “Treatment of rheumatoid arthritis with a DR4/1 peptide.J Rheumatol, vol. 27, no. 8, Aug. 2000, pp. 1855–63.
St Clair EW, Cohen SB, Lee ML, Fleischmann RM, Lee SH, Moreland LW, Olsen NJ, Pratt PW, Yocum DE, Heck L, Winkelhake J, Holcenberg JS, Shulman MJ. Treatment of rheumatoid arthritis with a DR4/1 peptide. J Rheumatol. 2000 Aug;27(8):1855–1863.

Published In

J Rheumatol

ISSN

0315-162X

Publication Date

August 2000

Volume

27

Issue

8

Start / End Page

1855 / 1863

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • T-Lymphocytes
  • Safety
  • Receptors, Antigen, T-Cell, alpha-beta
  • Oligopeptides
  • Monocytes
  • Middle Aged
  • Methotrexate
  • Male
  • Lymphocyte Count