Methylprednisolone pulse therapy for patients with moderately severe Graves' orbitopathy: a prospective, randomized, placebo-controlled study

Abstract

Objective: To assess whether methylprednisolone (MP) pulse therapy is efficacious in the treatment of moderately severe Graves' orbitopathy (GO). Design: Prospective, placebo (PL)-controlled, double-blind, randomized study. Methods: Fifteen previously untreated patients with active, moderately severe GO participated in the study; 6 patients received MP and 9 patients a PL. Moderately severe disease was defined using the NOSPECS classification of clinical signs of GO . Activity was measured with the clinical activity score (CAS). A dose of 500 mg MP or only solvent was administered intravenously, over three consecutive days, in four cycles at 4 weekly intervals (6 g of MP in total). Qualitatively, a successful treatment outcome was defined as an improvement in one major and/or two minor criteria in the worst eye at week 48. The major criteria were: improvement in diplopia grade; improvement in eye movement; a decrease in CAS of three points. The minor criteria were: decrease of eyelid retraction; decrease of proptosis; improvement in grade of soft tissue swelling; a decrease in CAS of two points. Results: The qualitative treatment outcome was successful at the end of the trial in five out of six (83%) patients receiving MP and in one out of nine (11%) patients given the PL (relative riskZ7.5; (95% confidence interval 1.1-49.3), PZ0.005). The treatment was well tolerated. Conclusions: In spite of the small number of patients, a significant difference in outcome was observed between MP-and PL-treated patients. We conclude that MP pulse therapy appears to be an effective treatment for active, moderately severe GO.European Journal of Endocrinology 158 229-237

Comparison of two different regimens of intravenous methylprednisolone for patients with moderate to severe and active Graves’ ophthalmopathy: a prospective, randomized controlled trial

“…Monthly regimen is not a commonly used strategy in the treatment of GO [5] and characterized by a larger dose at each cycle (1.5 g iv MP) and a long interval (4 weeks) between any two cycles [18]. Clinical trials [6,7] have showed that with the same administration method, a better response was proportional to receiving larger doses of iv MP in the range of safe dosage.…”

“…Eligible patients meeting the inclusion criteria were randomly assigned to the monthly regimen (MR) [18] group or weekly regimen (WR) [1,5] group according to a random number table. The MR was as follows: 0.5 g iv MP daily for three consecutive days (pulse therapy on days 1, 2, and 3 in weeks 1, 5, 9, and 13) over 4 cycles at 4 weekly intervals, for a total dose of 6.0 g over 3 months.…”

“…Evaluation of treatment outcomes included three major criteria and six minor criteria of response adapted from previous studies [18,19]. The three useful marker for predicting the response to iv MP.…”

“…major criteria: (1) improvement in diplopia by at least 1 grade according to the adapted NOSPECS classification 4 [18], (2) improvement of eye movement in any direction of 8° or more, (3) improvement in CAS by at least 2 points. The six minor criteria: (1) reduction of proptosis by at least 2 mm, (2) improvement in the grade of soft tissue involvement, according to the modified NOSPECS class 2 [16], (3) improvement in visual acuity by at least 1.0 Snellen line, (4) decrease in CAS of 1 point, (5) decrease in palpebral aperture by at least 2 mm, (6) improvement in duction or diplopia failing to meet 1 grade.…”

Wcześniejsze leczenie choroby Gravesa lekami tyreostatycznymi lub radiojodem nie wpływa na skuteczność leczenia immunosupresyjnego orbitopatii tarczycowej

“…The efficacy and safety of different IV glucocorticosteroid therapy protocols are still under debate. Presently, there are no generally accepted recommendations or guidelines for treatment of GO [20,[34][35][36].…”