Steroid micro dose therapy in rheumatoid arthritis patients: clinical and biochemical study

ABSTRACT

The anti-inflammatory and immunosuppressive properties of GCs have prompted their extensive use in the management of various diseases including RA[1]. However, the benefits derived from the use of GCs may be offset by the occurrence of GCs related side effects. One of the most important side effects of long-term use of GCs is osteoporosis. Steroid Microdose therapy [simply called Microdose Therapy], a university-spin-off technology, is a physician-supervised, 3-step, education program for teaching patient control of GCs for controlling chronic inflammation in arthritic patients. This Microdose therapy uses very low dose of prednisone [Therapy in Egyptian rheumatoid arthritis [RA] patients as regards disease control and glucocorticoids [GCs]-induced adverse effects with special attention to the adverse effects on bone metabolism. This study was carried out on 40 RA patients diagnosed according to the American college of Rheumatology criteria. 10 healthy volunteers of matched age and sex were included as a control group. Patients were subjected to the following clinical assessments [1] duration of morning stiffness [hours], [2] number of tender joints, [3] number of swollen joints, [4] physician global assessment score and [5] patient global assessment score. All patients and controls underwent the following lab investigations complete blood picture, serum rheumatoid factor, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], liver and renal function tests, serum alkaline phosphatase, serum osteocalcin, serum interleukin [EL]-6, and urinary pyridinoline [Pyr] and Deoxypyridinoline [Dpyr]. Clinical assessment of RA disease activity and lab assessments were carried out at the beginning [during the first week], and at the end [after the twelfth week] of the study. During this twelve-week study, patients were subjected to Microdose Therapy program which consisted of 3 steps: step I [Begin the program]; one week, during which patient education about the program and baseline evaluation were carried out, step 2 [Create the remission]; 3 weeks during which patients were given prednisone shower, minocycline [antibiotic], and restricted diet, and step 3 [Maintain the remission]; eight weeks, during which patients were given rnicrodoses of prednisone [5 mg/day] in addition to minocycline and restricted diet. The results of the present study revealed that at base line, patients showed high clinical RA disease activity [high tender and swollen joint scores, morning stiffness, and high physician and patient global assessment scores] as well as significantly higher biochemical disease activity parameters [ESR, CRP, and IL-6] compared to the control group [P<0.0001 for all]. Baseline liver and renal functions, bone formation markers [serum alkaline phosphatase and osteocalcin] and bone resorption markers [Urinary Pyr and Dpyr] showed insignificant change compared to the control group. At the end of the study, patients showed significant improvement of all clinical and biochemical disease activity parameters compared to baseline values [P<0.05 for all]. However, bone formation markers, bone resorption markers and liver and renal functions showed insignificant change compared to baseline values. Minimal or no adverse effects of Microdose Therapy were encountered during this study. It is concluded that Microdose Therapy is an effective and safe regimen of steroid therapy in RA patients with no or minimal adverse effects on one and other body systems