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THRIVE

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Mudumbai R.C.
  • Schittkowski M.P.
  • Pío-Rendón J.B.
  • Eade E.
  • Nijhawan N.
  • Zhang-Nunes S.
  • Pajak A.
  • Narvekar A.
  • Tripuraneni R.
  • Garrido-Hermosilla A.M.
  • Muros M.M.
  • Leibowitz S.
  • Yen M.T.
  • Saeed P.
  • Bisschop P.
  • Mudumbai R.
  • Schittkowski M.
  • Horn M.
  • Cockerham K.
  • Abrams J.
  • Lee V.
  • Turbin R.E.
  • Vicente Andreu F.J.
  • Bertelmann E.
  • Sales-Sanz M.
  • Boisvert C.
  • Couch S.
  • Dairi M.
  • Arribas L.G.
  • Kossler A.L.
  • Douglas R.
  • Drui D.
  • Mandeville J.
  • Pers Y.-M.
  • Rodien P.
  • López A.R.
  • Sander D.
  • Tamhankar M.

Abstract

Purpose Thyroid eye disease (TED) is a debilitating autoimmune disease with significant unmet needs. This study’s objective was to assess the efficacy and safety of veligrotug, a full antagonist monoclonal antibody to the insulin-like growth factor-1 receptor, in patients with active TED. Design Veligrotug was assessed in THRIVE, a global, multicenter, randomized, double-masked, placebo-controlled phase 3 trial. Participants Adult patients with moderate-to-severe active TED (onset = 15 months, proptosis = 3 mm above normal, and clinical activity score [CAS] = 3) received either veligrotug or placebo. Methods Patients were randomized 2:1 to receive 10 mg/kg veligrotug or placebo administered every 3 weeks for a total of 5 IV infusions. Main Outcome Measures The primary end point at week 15 was the proptosis responder rate (PRR; = 2-mm reduction by Hertel exophthalmometry) or overall responder rate (ORR; PRR and = 2-point reduction in CAS), depending on geographic region. Efficacy and safety were assessed through week 52. Results A total of 113 patients received veligrotug (n = 75) or placebo (n = 38). Baseline characteristics were balanced between the 2 arms. Improvements were observed at week 3, with a significantly greater response at week 15 for veligrotug versus placebo ( P < 0.001) across all primary and secondary end points including: PRR by Hertel, 70% versus 5%; PRR by magnetic resonance imaging (MRI) or computed tomography (CT), 71% versus 9%; ORR, 67% versus 5%; mean proptosis reduction, 2.90 mm versus 0.48 mm (Hertel) and 2.96 mm versus 0.58 mm (MRI/CT); diplopia improvement, 59% versus 20%; and diplopia resolution, 49% versus 12%. At week 52, 70% of initial responders maintained proptosis response. Veligrotug was generally well tolerated, with a 4% treatment discontinuation rate. Most adverse events were mild and resolved, with no serious treatment-related adverse events and no changes in the safety profile through week 52. Conclusions A 5-infusion course of veligrotug administered over 12 weeks was generally well tolerated and led to rapid and significant improvements in diplopia, proptosis, and disease activity, with a durable response through week 52. Veligrotug may become a promising new treatment option for active TED. Financial Disclosure(s) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. © 2026 American Academy of Ophthalmology, Inc.

Datos de la publicación

ISSN/ISSNe:
0161-6420, 1549-4713

OPHTHALMOLOGY  ELSEVIER SCIENCE INC

Tipo:
Article
Páginas:
-
PubMed:
42223386
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
4,412 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 1

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Keywords

  • Diplopia; Graves’ ophthalmopathy; IGF-1 receptor antagonist; Proptosis; Thyroid eye disease

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