Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus: Results of a multicenter randomized, double-blind, placebo-controlled trial

Michelle A. Petri, Philip J. Mease, Joan T. Merrill, Robert G. Lahita, Mark J. Iannini, David E. Yocum, Ellen M. Ginzler, Robert S. Katz, Oscar S. Gluck, Mark C. Genovese, Ronald Van Vollenhoven, Kenneth C. Kalunian, Susan Manzi, Maria W. Greenwald, Jill P. Buyon, Nancy Olsen, Michael H. Schiff, Arthur F. Kavanaugh, Jacques R. Caldwell, Rosalind Ramsey-GoldmanE. William St. Clair, Allan L. Goldman, Rita M. Egan, Richard P. Polisson, Kevin G. Moder, Naomi F. Rothfield, Robert T. Spencer, Kathryn Hobbs, Barri J. Fessler, Leonard H. Calabrese, Larry W. Moreland, Stanley B. Cohen, Betty J. Quarles, Vibeke Strand, Marc Gurwith, Kenneth E. Schwartz

Research output: Contribution to journalArticle

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Abstract

Objective. To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. Methods. Women with active SLE were treated with prasterone 200 mg/day plus standard SLE treatments or with placebo plus standard SLE treatments for up to 12 months in this randomized, double-blind investigation conducted at 27 centers. Standard SLE treatments included prednisone (≤10 mg/day), antimalarials, and immunosuppressive agents; dosages were required to be stable for ≥6 weeks prior to enrollment and remain unchanged during protocol treatment. Responders were patients who experienced no clinical deterioration and had improvement or stabilization over the duration of the study in 2 disease activity measures (the SLE Disease Activity Index [SLEDAI] and the Systemic Lupus Activity Measure) and 2 quality of life measures (patient's global assessment and the Krupp Fatigue Severity Scale). Results. A total of 381 women with SLE were enrolled. Among patients with clinically active disease at baseline (SLEDAI score >2), 86 of 147 in the prasterone group (58.5%) demonstrated improvement or stabilization without clinical deterioration, as compared with 65 of 146 in the placebo group (44.5%) (P = 0.017). Acne and hirsutism were reported in 33% and 16%, respectively, of the prasterone group and in 14% and 2%, respectively, of the placebo group (P < 0.05 for both comparisons). However, most cases of acne and hirsutism were mild and did not require withdrawal from therapy. Myalgias and oral stomatitis were reported less frequently in the prasterone group (22% and 15%, respectively) than in the placebo group (36% and 23%, respectively) (P < 0.05 for both comparisons). Serum levels of high-density lipoprotein cholesterol, triglycerides, and C3 complement significantly decreased, while levels of testosterone and, to a lesser extent, estradiol increased in the prasterone group. Conclusion. In adult women with active SLE, administration of prasterone at a dosage of 200 mg/day improved or stabilized signs and symptoms of disease and was generally well tolerated.

Original languageEnglish (US)
Pages (from-to)2858-2868
Number of pages11
JournalArthritis and rheumatism
Volume50
Issue number9
DOIs
StatePublished - Sep 1 2004

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Dehydroepiandrosterone
Systemic Lupus Erythematosus
Placebos
Hirsutism
Acne Vulgaris
Stomatitis
Complement C3
Myalgia
Antimalarials
Therapeutics
Immunosuppressive Agents
Clinical Protocols
Prednisone
HDL Cholesterol
Signs and Symptoms
Fatigue
Testosterone
Estradiol
Triglycerides
Quality of Life

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Pharmacology (medical)

Cite this

Petri, Michelle A. ; Mease, Philip J. ; Merrill, Joan T. ; Lahita, Robert G. ; Iannini, Mark J. ; Yocum, David E. ; Ginzler, Ellen M. ; Katz, Robert S. ; Gluck, Oscar S. ; Genovese, Mark C. ; Van Vollenhoven, Ronald ; Kalunian, Kenneth C. ; Manzi, Susan ; Greenwald, Maria W. ; Buyon, Jill P. ; Olsen, Nancy ; Schiff, Michael H. ; Kavanaugh, Arthur F. ; Caldwell, Jacques R. ; Ramsey-Goldman, Rosalind ; St. Clair, E. William ; Goldman, Allan L. ; Egan, Rita M. ; Polisson, Richard P. ; Moder, Kevin G. ; Rothfield, Naomi F. ; Spencer, Robert T. ; Hobbs, Kathryn ; Fessler, Barri J. ; Calabrese, Leonard H. ; Moreland, Larry W. ; Cohen, Stanley B. ; Quarles, Betty J. ; Strand, Vibeke ; Gurwith, Marc ; Schwartz, Kenneth E. / Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus : Results of a multicenter randomized, double-blind, placebo-controlled trial. In: Arthritis and rheumatism. 2004 ; Vol. 50, No. 9. pp. 2858-2868.
@article{3c3a7a5f95614dfb9dc0a61cde605839,
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abstract = "Objective. To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. Methods. Women with active SLE were treated with prasterone 200 mg/day plus standard SLE treatments or with placebo plus standard SLE treatments for up to 12 months in this randomized, double-blind investigation conducted at 27 centers. Standard SLE treatments included prednisone (≤10 mg/day), antimalarials, and immunosuppressive agents; dosages were required to be stable for ≥6 weeks prior to enrollment and remain unchanged during protocol treatment. Responders were patients who experienced no clinical deterioration and had improvement or stabilization over the duration of the study in 2 disease activity measures (the SLE Disease Activity Index [SLEDAI] and the Systemic Lupus Activity Measure) and 2 quality of life measures (patient's global assessment and the Krupp Fatigue Severity Scale). Results. A total of 381 women with SLE were enrolled. Among patients with clinically active disease at baseline (SLEDAI score >2), 86 of 147 in the prasterone group (58.5{\%}) demonstrated improvement or stabilization without clinical deterioration, as compared with 65 of 146 in the placebo group (44.5{\%}) (P = 0.017). Acne and hirsutism were reported in 33{\%} and 16{\%}, respectively, of the prasterone group and in 14{\%} and 2{\%}, respectively, of the placebo group (P < 0.05 for both comparisons). However, most cases of acne and hirsutism were mild and did not require withdrawal from therapy. Myalgias and oral stomatitis were reported less frequently in the prasterone group (22{\%} and 15{\%}, respectively) than in the placebo group (36{\%} and 23{\%}, respectively) (P < 0.05 for both comparisons). Serum levels of high-density lipoprotein cholesterol, triglycerides, and C3 complement significantly decreased, while levels of testosterone and, to a lesser extent, estradiol increased in the prasterone group. Conclusion. In adult women with active SLE, administration of prasterone at a dosage of 200 mg/day improved or stabilized signs and symptoms of disease and was generally well tolerated.",
author = "Petri, {Michelle A.} and Mease, {Philip J.} and Merrill, {Joan T.} and Lahita, {Robert G.} and Iannini, {Mark J.} and Yocum, {David E.} and Ginzler, {Ellen M.} and Katz, {Robert S.} and Gluck, {Oscar S.} and Genovese, {Mark C.} and {Van Vollenhoven}, Ronald and Kalunian, {Kenneth C.} and Susan Manzi and Greenwald, {Maria W.} and Buyon, {Jill P.} and Nancy Olsen and Schiff, {Michael H.} and Kavanaugh, {Arthur F.} and Caldwell, {Jacques R.} and Rosalind Ramsey-Goldman and {St. Clair}, {E. William} and Goldman, {Allan L.} and Egan, {Rita M.} and Polisson, {Richard P.} and Moder, {Kevin G.} and Rothfield, {Naomi F.} and Spencer, {Robert T.} and Kathryn Hobbs and Fessler, {Barri J.} and Calabrese, {Leonard H.} and Moreland, {Larry W.} and Cohen, {Stanley B.} and Quarles, {Betty J.} and Vibeke Strand and Marc Gurwith and Schwartz, {Kenneth E.}",
year = "2004",
month = "9",
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doi = "10.1002/art.20427",
language = "English (US)",
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Petri, MA, Mease, PJ, Merrill, JT, Lahita, RG, Iannini, MJ, Yocum, DE, Ginzler, EM, Katz, RS, Gluck, OS, Genovese, MC, Van Vollenhoven, R, Kalunian, KC, Manzi, S, Greenwald, MW, Buyon, JP, Olsen, N, Schiff, MH, Kavanaugh, AF, Caldwell, JR, Ramsey-Goldman, R, St. Clair, EW, Goldman, AL, Egan, RM, Polisson, RP, Moder, KG, Rothfield, NF, Spencer, RT, Hobbs, K, Fessler, BJ, Calabrese, LH, Moreland, LW, Cohen, SB, Quarles, BJ, Strand, V, Gurwith, M & Schwartz, KE 2004, 'Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus: Results of a multicenter randomized, double-blind, placebo-controlled trial', Arthritis and rheumatism, vol. 50, no. 9, pp. 2858-2868. https://doi.org/10.1002/art.20427

Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus : Results of a multicenter randomized, double-blind, placebo-controlled trial. / Petri, Michelle A.; Mease, Philip J.; Merrill, Joan T.; Lahita, Robert G.; Iannini, Mark J.; Yocum, David E.; Ginzler, Ellen M.; Katz, Robert S.; Gluck, Oscar S.; Genovese, Mark C.; Van Vollenhoven, Ronald; Kalunian, Kenneth C.; Manzi, Susan; Greenwald, Maria W.; Buyon, Jill P.; Olsen, Nancy; Schiff, Michael H.; Kavanaugh, Arthur F.; Caldwell, Jacques R.; Ramsey-Goldman, Rosalind; St. Clair, E. William; Goldman, Allan L.; Egan, Rita M.; Polisson, Richard P.; Moder, Kevin G.; Rothfield, Naomi F.; Spencer, Robert T.; Hobbs, Kathryn; Fessler, Barri J.; Calabrese, Leonard H.; Moreland, Larry W.; Cohen, Stanley B.; Quarles, Betty J.; Strand, Vibeke; Gurwith, Marc; Schwartz, Kenneth E.

In: Arthritis and rheumatism, Vol. 50, No. 9, 01.09.2004, p. 2858-2868.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus

T2 - Results of a multicenter randomized, double-blind, placebo-controlled trial

AU - Petri, Michelle A.

AU - Mease, Philip J.

AU - Merrill, Joan T.

AU - Lahita, Robert G.

AU - Iannini, Mark J.

AU - Yocum, David E.

AU - Ginzler, Ellen M.

AU - Katz, Robert S.

AU - Gluck, Oscar S.

AU - Genovese, Mark C.

AU - Van Vollenhoven, Ronald

AU - Kalunian, Kenneth C.

AU - Manzi, Susan

AU - Greenwald, Maria W.

AU - Buyon, Jill P.

AU - Olsen, Nancy

AU - Schiff, Michael H.

AU - Kavanaugh, Arthur F.

AU - Caldwell, Jacques R.

AU - Ramsey-Goldman, Rosalind

AU - St. Clair, E. William

AU - Goldman, Allan L.

AU - Egan, Rita M.

AU - Polisson, Richard P.

AU - Moder, Kevin G.

AU - Rothfield, Naomi F.

AU - Spencer, Robert T.

AU - Hobbs, Kathryn

AU - Fessler, Barri J.

AU - Calabrese, Leonard H.

AU - Moreland, Larry W.

AU - Cohen, Stanley B.

AU - Quarles, Betty J.

AU - Strand, Vibeke

AU - Gurwith, Marc

AU - Schwartz, Kenneth E.

PY - 2004/9/1

Y1 - 2004/9/1

N2 - Objective. To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. Methods. Women with active SLE were treated with prasterone 200 mg/day plus standard SLE treatments or with placebo plus standard SLE treatments for up to 12 months in this randomized, double-blind investigation conducted at 27 centers. Standard SLE treatments included prednisone (≤10 mg/day), antimalarials, and immunosuppressive agents; dosages were required to be stable for ≥6 weeks prior to enrollment and remain unchanged during protocol treatment. Responders were patients who experienced no clinical deterioration and had improvement or stabilization over the duration of the study in 2 disease activity measures (the SLE Disease Activity Index [SLEDAI] and the Systemic Lupus Activity Measure) and 2 quality of life measures (patient's global assessment and the Krupp Fatigue Severity Scale). Results. A total of 381 women with SLE were enrolled. Among patients with clinically active disease at baseline (SLEDAI score >2), 86 of 147 in the prasterone group (58.5%) demonstrated improvement or stabilization without clinical deterioration, as compared with 65 of 146 in the placebo group (44.5%) (P = 0.017). Acne and hirsutism were reported in 33% and 16%, respectively, of the prasterone group and in 14% and 2%, respectively, of the placebo group (P < 0.05 for both comparisons). However, most cases of acne and hirsutism were mild and did not require withdrawal from therapy. Myalgias and oral stomatitis were reported less frequently in the prasterone group (22% and 15%, respectively) than in the placebo group (36% and 23%, respectively) (P < 0.05 for both comparisons). Serum levels of high-density lipoprotein cholesterol, triglycerides, and C3 complement significantly decreased, while levels of testosterone and, to a lesser extent, estradiol increased in the prasterone group. Conclusion. In adult women with active SLE, administration of prasterone at a dosage of 200 mg/day improved or stabilized signs and symptoms of disease and was generally well tolerated.

AB - Objective. To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. Methods. Women with active SLE were treated with prasterone 200 mg/day plus standard SLE treatments or with placebo plus standard SLE treatments for up to 12 months in this randomized, double-blind investigation conducted at 27 centers. Standard SLE treatments included prednisone (≤10 mg/day), antimalarials, and immunosuppressive agents; dosages were required to be stable for ≥6 weeks prior to enrollment and remain unchanged during protocol treatment. Responders were patients who experienced no clinical deterioration and had improvement or stabilization over the duration of the study in 2 disease activity measures (the SLE Disease Activity Index [SLEDAI] and the Systemic Lupus Activity Measure) and 2 quality of life measures (patient's global assessment and the Krupp Fatigue Severity Scale). Results. A total of 381 women with SLE were enrolled. Among patients with clinically active disease at baseline (SLEDAI score >2), 86 of 147 in the prasterone group (58.5%) demonstrated improvement or stabilization without clinical deterioration, as compared with 65 of 146 in the placebo group (44.5%) (P = 0.017). Acne and hirsutism were reported in 33% and 16%, respectively, of the prasterone group and in 14% and 2%, respectively, of the placebo group (P < 0.05 for both comparisons). However, most cases of acne and hirsutism were mild and did not require withdrawal from therapy. Myalgias and oral stomatitis were reported less frequently in the prasterone group (22% and 15%, respectively) than in the placebo group (36% and 23%, respectively) (P < 0.05 for both comparisons). Serum levels of high-density lipoprotein cholesterol, triglycerides, and C3 complement significantly decreased, while levels of testosterone and, to a lesser extent, estradiol increased in the prasterone group. Conclusion. In adult women with active SLE, administration of prasterone at a dosage of 200 mg/day improved or stabilized signs and symptoms of disease and was generally well tolerated.

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