Comparison of efficacy and safety of parenteral versus parenteral and oral glucocorticoid therapy in Graves’ orbitopathy

Nedeljković-Beleslin, Biljana; Ćirić, Jasmina; Stojković, Mirjana; Savic, Slavica; Lalic, Tijana; Stojanović, Miloš; Miletić, Marija; Knežević, Miloš; Stanković, Branislav; Žarković, Miloš

doi:10.1111/ijcp.13608

Cited by 11 publications

(11 citation statements)

References 29 publications

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“…Infusion should be slow (1–2 h) under close surveillance [80]. If facilities are not available, oral GCs represent an acceptable alternative [205]. Response to treatment usually occurs early but may become evident in the second half of the course [206, 207].…”

Section: Assessmentmentioning

confidence: 99%

Current concepts regarding Graves’ orbitopathy

Bartalena

Tanda

2022

J Intern Med

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Section: Assessmentmentioning

confidence: 99%

Current concepts regarding Graves’ orbitopathy

Bartalena

Tanda

2022

J Intern Med

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“…Overall, 12 studies were included: 11 studies reported change from baseline in proptosis and 4 studies reported the proportion of patients with diplopia response. See eAppendix 2 and the eFigure in the Supplement for details …”

Section: Resultsmentioning

confidence: 99%

“…The MAIC analyses were conducted to compare IVMP and teprotumumab with each other and placebo for change from baseline in proptosis and diplopia response in 4 steps. First, data from the teprotumumab pooled trials were matched to the patient cohorts in the IVMP studies based on inclusion/exclusion criteria. Second, data were adjusted for outcome-specific prognostic factors (ie, patient characteristics that are associated with the outcomes) and treatment-effect modifiers (ie, patient characteristics that may affect the effectiveness of treatment on outcome) using inverse propensity score weighting.…”

Section: Methodsmentioning

confidence: 99%

Proptosis and Diplopia Response With Teprotumumab and Placebo vs the Recommended Treatment Regimen With Intravenous Methylprednisolone in Moderate to Severe Thyroid Eye Disease

Douglas

Dailey

Subramanian³

et al. 2022

JAMA Ophthalmol

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IMPORTANCE Thyroid eye disease can be a debilitating autoimmune disorder characterized by progressive proptosis or diplopia. Teprotumumab has been compared with placebo in randomized clinical trials, but not with intravenous methylprednisolone (IVMP), which sometimes is used in clinical practice for this condition.OBJECTIVE To conduct a matching-adjusted indirect comparison of teprotumumab vs IVMP vs placebo.DATA SOURCES Deidentified patient-level data from teprotumumab trials and aggregate-level data from literature on the most recommended regimen of IVMP.STUDY SELECTION PubMed and Embase were searched for randomized/observational studies using key terms and controlled vocabulary. Full texts of eligible articles were reviewed and cataloged. DATA EXTRACTION AND SYNTHESISConducted by 1 reviewer (R.A.Q.) and 1 verifier (R.B.), including study characteristics, eligibility criteria, baseline characteristics, and outcomes. MAIN OUTCOMES AND MEASURESChanges in proptosis by millimeter and diplopia response (percentage with Ն1 grade reduction) from baseline to week 12 in patients receiving IVMP and placebo, and to week 24 in patients receiving teprotumumab. RESULTSThe search identified 1019 records, and 6 through manual searches, alerts, and secondary references. After excluding duplicates and screening full-text records, 12 IVMP studies were included in the matching-adjusted indirect comparison (11 for proptosis change [n = 419], 4 for diplopia response [n = 125], and 2 teprotumumab [n = 79] and placebo [n = 83] comparator studies). Treatment with IVMP resulted in a proptosis difference of −0.16 mm (95% CI, −1.55 to 1.22 mm) from baseline to week 12 vs placebo. The proptosis treatment difference between IVMP and teprotumumab of −2.31 mm (95% CI, −3.45 to −1.17 mm) favored teprotumumab. Treatment with IVMP (odds ratio, 2.69; 95% CI, 0.94-7.70) was not favored over placebo in odds of diplopia response; however, teprotumumab was favored over IVMP (odds ratio, 2.32; 95% CI, 1.07-5.03). CONCLUSIONS AND RELEVANCEThis meta-analysis suggests that use of IVMP is associated with a small, typically not clinically relevant, change from baseline in proptosis vs placebo, with modest changes in diplopia. While this nonrandomized comparison suggests that use of teprotumumab, compared with IVMP, is associated with greater improvements in proptosis and may be twice as likely to have a 1 grade or higher reduction in diplopia, randomized trials comparing these 2 treatments would be warranted to determine if 1 treatment is superior to the other to a clinically relevant degree.

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“…A total of 87 consecutive patients with clinically manifest TAO were recruited. All patients were regularly treated at the tertiary University Clinical Center of Serbia (Clinic for Endocrinology, Diabetes and Metabolic Diseases) according to the current guidelines and protocols [17] [18] [19] . Hormone analysis was carried out in all patients and the diagnosis was classified as Graves' disease (GD), Hashimoto's thyroiditis and euthyroid TAO.…”

Section: Methodsmentioning

confidence: 99%

Sensitivity of three thyrotropin receptor antibody assays in thyroid-associated orbitopathy

Matutinović¹,

Diana²,

Beleslin³

et al. 2022

J Med Biochemistry

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Background: Thyrotropin receptor autoantibodies (TSH-R-Ab) are indispensable biomarkers in the laboratory assessment of thyroid-associated orbitopathy (TAO). Clinical sensitivity of three different assays for TSH-R-Ab determination was evaluated in patients with TAO. Methods: 87 consecutive TAO patients were enrolled and their serum samples analyzed in parallel with three assays. An ECLIA competitive binding and a chemiluminescent bridge immunoassay were used to measure total and binding TSH-R-Ab concentration, while their functional activity was determined using a stimulatory TSH-R-Ab (TSAb) cell-based bioassay. Results: Compared to the two binding assays (ECLIA p<0.001, bridge p=0.003), the TSAb bioassay was more sensitive pertaining to the positive detection of TSH-R-Ab in TAO patients. No difference (p=0.057) was noted between the ECLIA and bridge assays regarding sensitivity rate. All patients with active and/or moderate-to-severe TAO tested positive in the TSAb bioassay (100% and 100%, respectively), while the positivity rates for bridge and ECLIA binding assays were 89.7% and 82.1% for active TAO, and 90.2% and 86.3% for severe TAO, respectively. Negative predictive values of the bioassay, bridge, and ECLIA assays were 100%, 75%, and 71%, respectively for active TAO, and 100%, 86%, and 71%, respectively for moderate-to-severe TAO. The superiority of the bioassay was most prominent in euthyroid (ET) TAO. Positivity rates of the TSAb bioassay, bridge and ECLIA binding assays were 89.6%, 75%, and 64.6%, respectively for inactive TAO; 86.1%, 69.4%, and 52.8%, respectively for mild TAO; 87.5%, 62.5%, and 12.5%, respectively for euthyroid TAO. The bridge assay correlated better with the ECLIA binding assay (ρ=0.893, p<0.001), compared to the bioassay (ρ=0.669, p<0.001). Conclusions: In patients with TAO of various activity and severity, the TSAb bioassay demonstrates a superior clinical performance compared to both ECLIA and bridge binding assays.

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Comparison of efficacy and safety of parenteral versus parenteral and oral glucocorticoid therapy in Graves’ orbitopathy

Cited by 11 publications

References 29 publications

Current concepts regarding Graves’ orbitopathy

Current concepts regarding Graves’ orbitopathy

Proptosis and Diplopia Response With Teprotumumab and Placebo vs the Recommended Treatment Regimen With Intravenous Methylprednisolone in Moderate to Severe Thyroid Eye Disease

Sensitivity of three thyrotropin receptor antibody assays in thyroid-associated orbitopathy

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