Treatment of rheumatoid arthritis with a DR4/1 peptide

E. W. St. Clair, S. B. Cohen, M. L. Lee, R. M. Fleischmann, S. H. Lee, L. W. Moreland, Nancy Olsen, P. W. Pratt, D. E. Yocum, L. Heck, J. Winkelhake, J. S. Holcenberg, M. J. Shulman

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1855-1863
Number of pages9
JournalJournal of Rheumatology
Volume27
Issue number8
StatePublished - Sep 14 2000

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Rheumatoid Arthritis
Peptides
Injections
Therapeutics
Epitopes
Placebos
Lymphocyte Count
Methotrexate
Immunosuppression
Clinical Trials
Safety

All Science Journal Classification (ASJC) codes

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

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. Journal of Rheumatology, 27(8), 1855-1863.
St. Clair, E. W. ; Cohen, S. B. ; Lee, M. L. ; Fleischmann, R. M. ; Lee, S. H. ; Moreland, L. W. ; Olsen, Nancy ; Pratt, P. W. ; Yocum, D. E. ; Heck, L. ; Winkelhake, J. ; Holcenberg, J. S. ; Shulman, M. J. / Treatment of rheumatoid arthritis with a DR4/1 peptide. In: Journal of Rheumatology. 2000 ; Vol. 27, No. 8. pp. 1855-1863.
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abstract = "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.",
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St. Clair, EW, Cohen, SB, Lee, ML, Fleischmann, RM, Lee, SH, Moreland, LW, Olsen, N, Pratt, PW, Yocum, DE, Heck, L, Winkelhake, J, Holcenberg, JS & Shulman, MJ 2000, 'Treatment of rheumatoid arthritis with a DR4/1 peptide', Journal of Rheumatology, vol. 27, no. 8, pp. 1855-1863.

Treatment of rheumatoid arthritis with a DR4/1 peptide. / St. Clair, E. W.; Cohen, S. B.; Lee, M. L.; Fleischmann, R. M.; Lee, S. H.; Moreland, L. W.; Olsen, Nancy; Pratt, P. W.; Yocum, D. E.; Heck, L.; Winkelhake, J.; Holcenberg, J. S.; Shulman, M. J.

In: Journal of Rheumatology, Vol. 27, No. 8, 14.09.2000, p. 1855-1863.

Research output: Contribution to journalArticle

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T1 - Treatment of rheumatoid arthritis with a DR4/1 peptide

AU - St. Clair, E. W.

AU - Cohen, S. B.

AU - Lee, M. L.

AU - Fleischmann, R. M.

AU - Lee, S. H.

AU - Moreland, L. W.

AU - Olsen, Nancy

AU - Pratt, P. W.

AU - Yocum, D. E.

AU - Heck, L.

AU - Winkelhake, J.

AU - Holcenberg, J. S.

AU - Shulman, M. J.

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N2 - 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.

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St. Clair EW, Cohen SB, Lee ML, Fleischmann RM, Lee SH, Moreland LW et al. Treatment of rheumatoid arthritis with a DR4/1 peptide. Journal of Rheumatology. 2000 Sep 14;27(8):1855-1863.