Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus.
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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 J, 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
Аннотация
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.