To develop an effective and safe therapeutic policy for Sandimmun-Neoral in order to prevent joint destruction, invalidation, achieve higher life quality in patients with systemic juvenile rheumatoid arthritis (SJRA).
The trial included 26 patients with SJRA aged 4-15 years. 12 of them had early SJRA, 14--late SJRA. 13 patients received Neoral for one year and the other 13 for 2-3.5 years. Markers of aggressive SJRA course in the debut were registered in all the patients. Previous treatment incorporated nonsteroid antiinflammatory drugs, intraarticular corticosteroids (all the patients), prednisolone (19 patients), methotrexate (3 patients). Before Neoral treatment 80% of the patients had structural alterations in the joints, signs of invalidation, low quality of life. SJRA activity was defined as the 3d degree. All the patients suffered from obesity, hypertrichosis, steroid spondylopathy, nanism.
Neoral recovered joint motility in 30% of patients, 60% were capable for self-service. Quality of life was assess as high in 80%, moderately reduced--in 20%. 35% of the patients achieved clinico-laboratory remission. The disease activity dropped to degree I-II in 65% of patients. Structural changes in the joints stopped progressing in 77%, regress of the anatomic stage was seen in 20% of patients. Prednisolone was discontinued in 7 and dose-reduced in 6 patients. Exogenic hypercorticism relieved and growth resumed in all the patients. Neoral proved effective both in early and late SJRA, inhibited destruction both in patients in remission and in active disease. Side effects were: hypertrichosis in 13 patients, moderate blood hypertension in 1 case.
Neoral can control the disease. It is indicated both in early and late SJRA in the presence of aggressive course markers, acute coxitis with aseptic necrosis of the head of the femur or free of it. Neoral treatment should be started as early as on the first year of the disease, before the structural changes in the joints. For safe long-term therapy it is valid to give cyclosporin A in monotherapy or in combination with voltaren in minimal doses. Corticosteroids are used on demand. The preference should be given to intraarticular or intravenous prolonged drugs but not oral prednisolone which may course such severe complications as obesity, hypertension, nanism.