Efficacy and safety of combined parenteral and oral steroid therapy in Graves' orbitopathy.
OBJECTIVE
Glucocorticoids (GC) are the treatment of choice for moderate-to-severe and active Graves' orbitopathy (GO), but optimal treatment is still . The aim of the present study was to analyze the efficacy and tolerability of combined parenteral GC pulse therapy followed by oral GC in the interpulse period.


METHODS
The study included 50 patients (48 ± 10 years; 37 female) with untreated, active and moderate-to-severe GO. Patients received 500 mg of methylprednisolone in 500 ml of physiologic saline. Infusion was repeated after 48 h and then followed by tapering doses of oral prednisone and the cycle repeated each month for the next 5 months. The cumulative dose was 10.2g.Ophthalmic assessment was performed before and 6 months after start of treatment. Side effects of GC therapy were evaluated and recorded each month.


RESULTS
GC showed the greatest effectiveness on soft tissue changes (incorporated in the CAS). Median CAS values decreased from 4.5 to 2 (p>0.001). Improvement was demonstrated in 37 patients (74%), there was no change in 13 patients (26%) and none of the patients presented with deterioration of inflammatory status. Diplopia improved in 21 patients (42%), was unchanged in 28 patients (56%) and deteriorated in 1 patient (2%). Improvement in visual acuity occurred in 36% of patients. At 6 months, 33/50 patients (66%) demonstrated overall treatment response. Response to GC therapy was influenced by CAS, TSHRAb and smoking behavior. The only independent parameter associated with positive treatment response was CAS ≥ 4 (p<0.001). Side effects occurred in 35/50 patients (70%) and the vast majority of them were mild to moderate. During the 6-months follow-up period, 2/33 patients (6%) had relapsing GO.


CONCLUSIONS
With appropriate selection of patients and careful monitoring during and after treatment, combined parenteral and oral GC therapy is effective and safe.
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Serbia; Medical School, University of Belgrade; Serbia.
Biljana
B
Nedeljkovic Beleslin
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Serbia; Medical School, University of Belgrade; Serbia.
Jasmina
J
Ciric
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Serbia; Medical School, University of Belgrade; Serbia.
Milos
M
Zarkovic
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Serbia; Belgrade; Serbia.
Mirjana
M
Stojkovic
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Serbia; Belgrade; Serbia.
Slavica
S
Savic
Medical School, University of Belgrade; Clinic for Ophthalmology, Clinical Center of Serbia; Belgrade, Serbia.
Miroslav
M
Knezevic
Medical School, University of Belgrade; Clinic for Ophthalmology, Clinical Center of Serbia; Belgrade, Serbia.
Branislav
B
Stankovic
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Serbia; Medical School, University of Belgrade; Serbia.
Bozo
B
Trbojevic
D000284:Administration, Oral; D000328:Adult; D003941:Diagnostic Techniques, Ophthalmological; D016903:Drug Monitoring; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D049970:Graves Ophthalmopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D018579:Patient Selection; D011237:Predictive Value of Tests; D020551:Pulse Therapy, Drug; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D005938:Glucocorticoids; D008775:Methylprednisolone