Effects of prasterone on corticosteroid requirements of women with systemic lupus erythematosus: a double-blind, randomized, placebo-controlled trial.

Abstract

OBJECTIVE:

To evaluate whether treatment with prasterone (dehydroepiandrosterone [DHEA]) would allow the dosage of prednisone (or an equivalent corticosteroid) to be reduced to < or = 7.5 mg/day for 2 months or longer while maintaining stable or reduced disease activity in steroid-dependent women with systemic lupus erythematosus (SLE).

METHODS:

In a double-blind, randomized trial, 191 female SLE patients receiving prednisone (10-30 mg/day) were treated daily with either placebo, 100 mg of oral prasterone (an adrenal androgen), or 200 mg of oral prasterone for 7-9-months. At monthly intervals, corticosteroid dosages were reduced by algorithm in patients whose SLE Disease Activity Index (SLEDAI) score was stable or improved. Patients for whom a sustained reduction in the dosage of prednisone (< or = 7.5 mg/day) was achieved for at least the last 2 months of the 7-9-month treatment period were classified as responders.

RESULTS:

Response rates were 41% in the placebo group, 44% in the 100-mg prasterone group, and 55% in the 200-mg group (P = 0.110, 200 mg versus placebo). Among the 137 subjects (45 in the placebo group, 47 in the 100-mg group, and 45 in the 200-mg group) who had active disease at baseline (defined as SLEDAI score >2), 29%, 38%, and 51%, respectively, were responders (P = 0.031 for 200 mg prasterone versus placebo). Acne was the most common adverse event but was generally mild. Clinical and laboratory changes primarily reflected androgenic effects of prasterone.

CONCLUSION:

Among women with lupus disease activity, reducing the dosage of prednisone to < or = 7.5 mg/day for a sustained period of time while maintaining stabilization or a reduction of disease activity was possible in a significantly greater proportion of patients treated with oral prasterone, 200 mg once daily, compared with patients treated with placebo.

• Authors: Michelle A Petri, Robert G Lahita, Ronald F Van Vollenhoven, Joan T Merrill, Michael Schiff, Ellen M Ginzler, Vibeke Strand, Arlene Kunz, Kenneth J Gorelick, Kenneth E Schwartz, GL601 Study Group
• Journal: Arthritis and rheumatism (Arthritis Rheum) Vol. 46 Issue 7 Pg. 1820-9 (Jul 2002) ISSN: 0004-3591 [Print] United States
• PMID: 12124866 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenal Cortex Hormones
• Dehydroepiandrosterone
• Prednisolone

Topics

• Administration, Oral
• Adolescent
• Adrenal Cortex Hormones (administration & dosage)
• Adult
• Dehydroepiandrosterone (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Lupus Erythematosus, Systemic (drug therapy)
• Multicenter Studies as Topic
• Prednisolone (administration & dosage)
• Treatment Outcome