0000000000505410

AUTHOR

Roger A. Dailey

showing 3 related works from this author

Teprotumumab Efficacy, Safety, and Durability in Longer-Duration Thyroid Eye Disease and Re-treatment

2022

PURPOSE To evaluate teprotumumab safety/efficacy in patients with thyroid eye disease (TED) who were nonresponsive or who experienced a disease flare. DESIGN The Treatment of Graves' Orbitopathy to Reduce Proptosis with Teprotumumab Infusions in an Open-Label Clinical Extension Study (OPTIC-X) is a teprotumumab treatment and re-treatment trial following the placebo-controlled teprotumumab Phase 3 Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study (OPTIC) trial. PARTICIPANTS Patients who previously received placebo (n = 37) or teprotumumab (n = 14) in OPTIC. METHODS OPTIC nonresponders or …

DiplopiaMild hearing impairmentmedicine.medical_specialtygenetic structuresbusiness.industryEye diseaseThyroidmedicine.diseasePlaceboeye diseasesDisease courseSurgeryOphthalmologymedicine.anatomical_structureSafety riskmedicineIn patientmedicine.symptombusinessOphthalmology
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Teprotumumab for Thyroid-Associated Ophthalmopathy

2017

Thyroid-associated ophthalmopathy, a condition commonly associated with Graves' disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy.We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy. A total of 88 patients were randomly assigned to r…

AdultMalemedicine.medical_specialty030209 endocrinology & metabolismDiseaseAdult; Aged; Antibodies Monoclonal; Diabetes Complications; Double-Blind Method; Exophthalmos; Female; Graves Ophthalmopathy; Humans; Hyperglycemia; Immunologic Factors; Insulin-Like Growth Factor I; Intention to Treat Analysis; Logistic Models; Male; Middle Aged; Quality of LifeAntibodies Monoclonal HumanizedPlaceboAntibodiesReceptor IGF Type 1law.inventionDiabetes ComplicationsGraves' ophthalmopathy03 medical and health sciences0302 clinical medicineDouble-Blind MethodRandomized controlled triallawInternal medicineMonoclonalmedicineClinical endpointExophthalmosHumansImmunologic FactorsInsulin-Like Growth Factor IAgedIntention-to-treat analysisTeprotumumabbusiness.industryAntibodies MonoclonalGeneral MedicineMiddle Agedmedicine.diseaseIntention to Treat AnalysisGraves OphthalmopathyLogistic ModelsHyperglycemiaMonoclonalImmunologyQuality of Life030221 ophthalmology & optometryFemalebusinessmedicine.drugNew England Journal of Medicine
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Teprotumumab for the treatment of active thyroid eye disease

2020

Abstract Background Thyroid eye disease is a debilitating, disfiguring, and potentially blinding periocular condition for which no Food and Drug Administration–approved medical therapy is available...

Drugmedicine.medical_specialtyBlindingmedia_common.quotation_subjectEye diseaseMedizin030204 cardiovascular system & hematologylaw.invention03 medical and health sciences0302 clinical medicineRandomized controlled triallawOphthalmologymedicine030212 general & internal medicinemedia_commonTeprotumumabbusiness.industryThyroidGeneral Medicinemedicine.diseaseDermatologyeye diseasesClinical trialmedicine.anatomical_structuresense organsbusinessMedical therapymedicine.drug
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