Document 0115
 DOCN  M94A0115
 TI    Treatment of systemic lupus erythematosus with lobenzarit: an open
       clinical trial.
 DT    9412
 AU    Hirohata S; Ohnishi K; Sagawa A; 2nd Department of Internal Medicine,
       Teikyo University School of; Medicine, Tokyo, Japan.
 SO    Clin Exp Rheumatol. 1994 May-Jun;12(3):261-5. Unique Identifier :
       AIDSLINE MED/94349650
 AB    An open clinical trial was designed to examine the efficacy and safety
       of lobenzarit (CCA), a newly developed disease modifying anti-rheumatic
       drug, in combination with conventional treatment with prednisolone for
       patients with systemic lupus erythematosus (SLE). Fifteen patients with
       SLE were given CCA 40 mg b.i.d. for the first 2 weeks, 80 mg b.i.d. for
       the next 4 weeks, and 80 mg t.i.d. or b.i.d. until the end of the
       12-month trial, in addition to prednisolone, whose doses were kept
       unchanged throughout the trial. The patients' clinical responses to CCA,
       including alterations in various laboratory parameters and the
       development of complications, were evaluated at the end of 12 months.
       Fourteen of the 15 patients completed the 12-month trial. Significant
       increases in the white blood cell count and CD4/CD8 ratio, as well as
       decreases in serum anti-DNA antibody, were noted after the trial. Five
       patients presented with adverse effects, including mild liver
       dysfunction, gastrointestinal symptoms and dizziness. Only one patient
       who developed dizziness withdrew at 9 months. Eleven patients could be
       reevaluated after discontinuation of CCA, and only 2 of them have
       experienced recurrence of active disease 6 months after discontinuation.
       In one additional patient who had not responded to prednisolone 35 mg
       daily, administration of CCA resulted in improvement of the disease
       activity. These results indicate that CCA in combination with
       corticosteroids is a useful adjunct in the treatment of SLE. A
       placebo-controlled study will be necessary to confirm these results.
 DE    Adolescence  Adult  Anthranilic Acids/ADVERSE
       EFFECTS/STANDARDS/*THERAPEUTIC USE  Anti-Inflammatory Agents,
       Non-Steroidal/ADVERSE EFFECTS/STANDARDS/  *THERAPEUTIC USE  Antibodies,
       Antinuclear/BLOOD  CD4-CD8 Ratio  Dose-Response Relationship, Drug  Drug
       Therapy, Combination  Female  Human  Leukocyte Count/DRUG EFFECTS
       Leukocytes/DRUG EFFECTS/PATHOLOGY  Lupus Erythematosus,
       Systemic/BLOOD/*DRUG THERAPY/IMMUNOLOGY  Male  Middle Age
       Prednisolone/THERAPEUTIC USE  Support, Non-U.S. Gov't  CLINICAL TRIAL
       JOURNAL ARTICLE

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