Rehumatology Estrogens

Basic & Clinical Research

Title: Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)

Investigators: Jill P. Buyon, M.D.; H. Michael Belmont, M.D.; Susan Cotton, R.N.

Funding: NIH - NIAMS

Dates: 1996 - 2000

Summary: Oral contraceptives (OCs) and estrogen replacement therapy (ERT) are generally not prescribed to women with SLE due to the widely-held view that they can activate SLE. Recent studies suggest that the rate of flare is not significantly increased in patients taking OCs or ERT, and may not warrant the dismissal of an important birth control option or the use of exogenous estrogens to prevent (1) osteoporosis (postmenopausal or steroid-induced) and (2) coronary artery disease. Two randomized double-blind placebo-controlled trials will attempt to define the effect on disease activity in women with SLE: (1) OCs containing low dose synthetic estrogens and progestins; (2) hormonal replacement with conjugated estrogens and cyclic low-dose medroxyprogesterone acetate. In a collaboration among 15 major rheumatology centers, patients with inactive, stable or moderate disease will receive hormones for 1 year.

Publications:

1. Buyon JP, Kalunian KC, Skovron ML, Petri M, Lahita R, Merrill J, Sammaritano L, Yung C, Licciardi F, Belmont HM, Hahn BH. Can women with systemic lupus erythematosus safely use exogenous estrogens? J Clin Rheum 1:205-212 (1995).

2. Buyon JP, Nelson, JL, Lockshin MD. The effects of pregnancy on autoimmune diseases. Clin Immunol Immunopath 78:99-104 (1996).

3. Buyon JP, Belmont HB, Kalunian KC. Postmenopausal hormone therapy and systemic lupus erythematosus. Annal Intern Med 123:961, 1995 (letter).

4. Buyon JP, Dooley MA, Meyer WR, Petri M, Licciardi F. Recommendations for exogenous estrogen to prevent glucocorticoid-induced osteoporosis in premenopausal women with oligo- or amenorrhea: comment on the American College of Rheumatology Recommendations for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis [letter]. Arthritis Rheum 1997; 40:1548-1549.

5. Tseng C, Petri M, Merrill J, Buyon J, Belmont M, Hahn B, Kalunian K, Lahita R, Sammaritano L. Plasma levels of plasminogen-activator inhibitor type 1 (PAI-1) in ostmenopausal lupus patients (abstract). Arthritis Rheum. 1997; 40 (suppl):S302.

6. Petri M, Buyon J, Skovron ML, Kim M, Belmont M, Hahn B, Kalunian K, Lahita R, Merrill J, Sammaritano L. Disease activity and health status (SF-36) in post-menopausal systemic lupus erythematosus: the SELENA trial (abstract). Arthritis Rheum. 1997; 40 (suppl):S208.

7. Buyon JP. Hormone replacement therapy in postmenopausal women with systemic lupus erythematosus. J Am Women's Med Assoc 1998; 53:13-17.

8. Petri M, Buyon J, Kim M for the SELENA Group (Belmont M, Hahn B, Kalunian K, Lahita R, Lockshin M, Merrill J, Sammaritano L). Differences in pre- vs. post-menopausal SLE: the SELENA Trial [abstract]. Arthritis Rheum. 1998; 41(suppl):S67.

9. Petri M, Buyon J, Skovron ML, Kim M for the SELENA Study Group (Belmont M, Hahn B, Kalunian K, Lahita R, Lockshin M, Merrill J, Sammaritano L). Reliability of SELENA SLEDAI and flare as clinical trial outcome measures [abstract]. Arthritis Rheum. 1998; 41(suppl): S218.

10. Merrill JT, Schappert J, Shriky RC, Zhang HW, Petri M, Buyon JP (for the SELENA Group: Kalunian K, Belmont HM, Sammaritano L, Hahn B, Lahita R). Decreased anticoagulant protein S and the homologous sex hormone binding globulin in patients enrolled in the SELENA (estrogen safety) Study [abstract]. Arthritis Rheum. 1998; 41(suppl):S139.

11. Sammaritano L, Patterson K, Lockshin M for the SELENA Group (Belmont M, Buyon JP, Hahn B, Kalunian K, Lahita R, Merrill J, Petri M). Current use of estrogen replacement therapy (ERT) in postmenopausal systemic lupus erythematosus (SLE) patients: increase since inception of the SELENA Trial [abstract]. Arthritis Rheum. 1998; 41(suppl):S65

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