Clinical Rheumatology

, Volume 13, Issue 1, pp 60–69 | Cite as

Randomized trial of switching rheumatoid arthritis patients in remission with injectable gold to auranofin

  • P. E. Prete
  • J. Zane
  • M. Krailo
  • M. Bulanowski


This prospective unblinded 24-month-study compared the therapeutic value of oral gold with injectable gold to maintain rheumatoid arthritis (RA) patients in clinical remission and prevent the progression of erosive disease. Forty-six patients with definite RA in remission with injectable gold were randomized into two groups: a control group, continued on maintenance injectable gold (Solganal, aurothioglucose, 50–100 mg, intramuscularly, 2 to 4 weeks); and an experimental group, switched to oral gold (6–9 mg auranofin by mouth daily).

Only 29% of the original 24 oral gold patients remained on assigned treatment at 24 months compared with 64% of the injectable gold group. By six months, over one-half of the oral gold patients had electively stopped their randomized therapy. Sixty-seven percent of the oral gold patients had adverse reactions, mostly gastrointestinal complaints, compared with one proteinuria in the injectable gold group. The oral gold group experienced significantly more deterioration in all the primary measures of treatment effect over the follow-up period. At the termination of the trial, 88% of the group had increases of 5 or more points in radiographic scores suggesting progression of erosive disease compared with only 29% of the control group.

These data suggest that oral gold is not an effective substitute for injectable gold in maintaining remission in rheumatoid arthritis.

Key words

Oral Gold Auranofin Rheumatoid Arthritis Solganal 


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  1. 1.
    Research subcommittee of the Empire Rheumatism Council. Gold therapy in rheumatoid arthritis: report of a multicentre controlled tiral. Ann Rheum Dis 1960, 19, 95–119.Google Scholar
  2. 2.
    Research subcommittee of the Empire Rheumatism Council. Gold therapy in rheumatoid arthritis: final report of a multicentre controlled trial. Ann Rheum Dis 1961, 20, 315–334.Google Scholar
  3. 3.
    Cooperating clinics committee of the ARA: A controlled trial of gold salt therapy in rheumatoid arthritis. Arthritis Rheum 1973, 16, 353–358.Google Scholar
  4. 4.
    Ward, J.R., Williams, H.J., Egger, M.J., Reading, J.C., Bouce, E., Altz-Smith, M., Samuelson, C.O., Wilkens, R.F., Solsky, M.A., Hayes, S.P., Block, K.L., Weinstein, A., Meenan, R.F., Guttaduria, M., Kaplan, S.B., Kippel, J. Comparison of auranofin, gold sodium thiomalate and placebo in the treatment of rheumatoid arthritis: a controlled clinical trial. Arthritis Rheum 1983, 26, 1303–1315.PubMedGoogle Scholar
  5. 5.
    Blodgett, R.C. Jr., Heuer, M.A., Pietrusko, R.G. Auranofin: a unique oral chrysotherapeutic agent. Sem Arth Rheum 1984, 13, 255–273.Google Scholar
  6. 6.
    Davis, P. Auranofin. Clin Rheum Dis 1984, 10, 369–383.PubMedGoogle Scholar
  7. 7.
    Heuer, M.A., Pietrusko, P.G., Morris, R.W., Scheffler, B.J. An analysis of worldwide safety experience with auranofin. J Rheum 1985, 12, 695–699.PubMedGoogle Scholar
  8. 8.
    Williams, H.J., Dahl, S.L., Ward, J.R., Karg, M., Wilkens, R.F., Meenan, R.F., Altz-Smith, M., Clegg, D.O., Mikkelsen, W.M., Kay, D.R., Weinstein, A., Guttaduria, M., Paulus, H., Kaplan, S. One-year experience in patients treated with auranofin following completion of a parallel, controlled trial comparing auranofin, gold sodium thiomalate and placebo. Arthritis Rheum 1988, 31(1), 9–14.PubMedGoogle Scholar
  9. 9.
    Schattenkirchner, M., Broll, H., Kaik, B., Muller-Fassbender, H., Rau, R., Zeidler, H. Auranofin and gold sodium thiomalate in the treatment of rheumatoid arthritis: a one-year, double-blind, comparative multicenter study. Klinische Wochenschrift 1988, 66(4), 174–176.Google Scholar
  10. 10.
    Davis, P., Menard, H., Thompson, J., Harth, M., Beaudet, F. One-year comparative study of gold sodium thiomalate and auranofin in the treatment of rheumatoid arthritis. J Rheum 1985, 12, 60–67.PubMedGoogle Scholar
  11. 11.
    Thompson, M.S., Read, J.L., Hutchings, H.C., Paterson, M., Harris, E.D. Jr. The cost effectiveness of auranofin: results of a randomized clinical trial. J Rheum 1988, 15(1), 35–42.PubMedGoogle Scholar
  12. 12.
    Anderson, J.J., Felson, D.T., Meenan, R.F., Williams, H.J. Which traditional measures should be used in rheumatoid arthritis clinical trials? Arthritis Rheum 1989, 32(9), 1093–1099.PubMedGoogle Scholar
  13. 13.
    Ropes, M.W., Bennett, G.A., Cobb, S., Jacox, R., Jessar, R. Revision of diagnostic criteria for rheumatoid arthritis. Bull Rheum Dis 1958, 9, 175–176.PubMedGoogle Scholar
  14. 14.
    Pinals, R.S., Masi, A.T., Larsen, R.A. Preliminary criteria for clinical remission in rheumatoid arthritis. Arthritis Rheum 1981, 24(10), 1308–1315.PubMedGoogle Scholar
  15. 15.
    Sharp, J.T., Young, D.Y., Bluhm, G.B., Brook, A., Brower, A.C., Corbett, M., Decker, J.L., Genant, H.K., Gofton, P., Goodman, N., Larsen, A., Lidskey, M.D., Pussila, P., Weinstein, A.S., Weissman, B. How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis. Arthritis Rheum 1985, 28, 1326–1334.PubMedGoogle Scholar
  16. 16.
    Snedecor, G.W., Cochran, W.G. Statistical Methods. Iowa State University Press. Ames, IA, 1967.Google Scholar
  17. 17.
    Kalbfleisch, J.D., Prentice, R.L. The Statistical Analysis of Failure Time Data. John Wiley and Sons, New York, 1980.Google Scholar
  18. 18.
    Hand, D.H., Taylor, C.C. Multivariate Analysis of Variance and Repeated Measures. Chapman and Hall, New York, 1987.Google Scholar
  19. 19.
    Bishyop, Y.M.M., Feinberg, S.E., Holland, P.M.W. Discrete Multivariate Analysis. MIT Press, Cambridge, MA, 1975.Google Scholar
  20. 20.
    Lee, Y.J., Ellenberg, J., Hirtz, G., Nelson, K.B. Analysis of clinical trials by treatment actually received. Is it really an option? Stat Med 1991, 10, 1595–605.PubMedGoogle Scholar
  21. 21.
    Sharp, J.T. Radiologic assessment as an outcome measure in rheumatoid arthritis. Arthritis Rheum 1989, 32, 221–229.PubMedGoogle Scholar
  22. 22.
    Scott, D.L., Dawes, P.T., Fowler, P.D., Gundulis, K.A., Shadforth, M., Bacon, P.A. Antirheumatic drugs and joint damage in rheumatoid arthritis. Q J Med 1985, 54, 49–59.PubMedGoogle Scholar
  23. 23.
    Iannuzzi, L., Dawson, N., Zein, N., Kushner, I. Does drug therapy show radiographic deterioration in rheumatoid arthritis? NEJM 1984, 309(17), 1023–1028.Google Scholar
  24. 24.
    Sharp, J.T., Wolfe, F., Mitchell, D.M., Bloch, D.A. The progression of erosion and joint space narrowing score in rheumatoid arthritis during the first twenty-five years of disease. Arthritis Rheum 1991, 34(6), 660–668.PubMedGoogle Scholar
  25. 25.
    Sigler, J.W., Bluch, G.B., Duncan, H., Sharp, J.F., Ensign, D.C., McGrum, W.R. Gold salts in the treatment of rheumatoid arthritis: A double-blind study. Ann Int Med 1974, 80, 21–26.PubMedGoogle Scholar
  26. 26.
    Luukkainen, R. Chrysotherapy in rheumatoid arthritis: With particular emphasis on the effect of chrysotherapy on radiographical changes and on the optimal time of initiation of therapy. Scan J Rheum (Suppl) 1980, 34, 1–56.Google Scholar
  27. 27.
    Singh, G., Fries, J.F., Leigh, J.P., Bloch, D.A., Williams, C.A. From experiment to experience: The effectiveness of auranofin in clinical practice. Arthritis Rheum 1990, 33(9), S82.Google Scholar
  28. 28.
    Dahl, S.L., Samuelson, C.O., Williams, H.J., Ward, J.R., Karg, M. Second-line antirheumatic drugs in the elderly with rheumatoid arthritis: a post hoc analysis of three controlled trials. Pharmacother 1990, 10(2), 79–84.Google Scholar
  29. 29.
    Wenger, M.E., Bernhard, G.L., Heuer, M.D., Obrien, W.M., Reese, R.W., Rosenthal, S.H., Weiss, T.E., Schoffler, B.J. Therapy for rheumatoid arthritis: Transforming treatment from injectable gold to auranofin. Auranofin proceedings from the SK&F International Symposium, Amsterdam. Eds.: Capell, H.A., Cole, D.S., Maahani, K.K., Morris, R.W. In: Excerpta Medica. Elsevier Science Publishing, 1983, 201–209.Google Scholar
  30. 30.
    Hull, R.O., Morgan, S.H., Parke, A.L., Childs, L., Goldman, M., Hughes, G.R.V. A double-blind comparison of auranofin and myochrisin in patients previously stabilized on myochrisin. Auranofin Proceedings of the SK&F International Symposium, Amsterdam. Eds.: Capell, H.A., Cole, D.S., Maahani, K.K., Morris, R.W. In: Excerpta Medica. Elsevier Science Publishing 1983, 211–225.Google Scholar
  31. 31.
    Blackburn, W.D. Jr. Auranofin: its use in patients with rheumatoid arthritis maintained with parenteral chrysotherapy. J Rheumatol 1987, 14(4), 863–864.PubMedGoogle Scholar
  32. 32.
    Felson, D.T., Anderson, J.J., Mennan, R.F. The comparable efficacy and toxicity of second line agent drugs in RA. Results of two meta analyses, Arthritis Rheum 1990, 33(10), 1449–1461.Google Scholar
  33. 33.
    Grootveld, M., Blake, D.R., Sahinoglu, T., Claxson, A.W., Mapp, P., Stevens, C., Allen, R.E., Furst, A. Control of oxidative damage in rheumatoid arthritis by gold(I)-thiolate drugs. Free Radical Research Communications 1990, 10(4–5), 199–220.PubMedGoogle Scholar
  34. 34.
    Kopicky-Burd, J.A., Kagey, Sobotka, A., Peters, S.P., et al. Characterization of human synovial mast cells. J Rheum 1988, 15(9), 1326–1333.PubMedGoogle Scholar

Copyright information

© Clinical Rheumatology 1994

Authors and Affiliations

  • P. E. Prete
    • 1
    • 2
  • J. Zane
    • 1
    • 2
  • M. Krailo
    • 3
  • M. Bulanowski
    • 1
    • 2
  1. 1.The Section of RheumatologyThe University of California at Irvine
  2. 2.the Department of Veterans Affairs Medical CenterLong Beach
  3. 3.Childrens Cancer GroupArcadia

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