Teprotumumab significantly improves proptosis in thyroid eye disease
KOLOA, Hawaii — Patients with thyroid eye disease treated with teprotumumab demonstrated a significant reduction in proptosis compared with those treated with placebo, according to phase 3 results from the OPTIC trial.
The ideal treatment for thyroid eye disease would decrease inflammation, reduce proptosis and double vision, improve quality of life, have minimal adverse effects and minimize the need for surgical treatment, Raymond S. Douglas, MD, PhD, director of the orbital and thyroid eye disease program at Cedars-Sinai Medical Center, said in a presentation on the topic at Hawaiian Eye 2020.
Additionally, this treatment would target the long-term manifestations of the disease rather than the short-term manifestations that are primarily targeted with steroids and other second line agents, he said.
“This type of treatment may be very much on the cusp of reality,” Douglas said.
The phase 3 OPTIC study was a 24-week, double masked, placebo-controlled trial. A total of 83 patients were randomized to receive teprotumumab intravenously or placebo every 3 weeks for eight infusion cycles.
“This was one of the first ever placebo-controlled trials in thyroid eye disease and certainly the largest for any biologic,” Douglas said.
The primary endpoint was the reduction of proptosis. Secondary endpoints included improvement in double vision and quality of life.
Results showed that proptosis responders, defined as the percentage of patients with a 2 mm or more reduction in proptosis from baseline, was significantly greater among patients treated with teprotumumab than those treated with placebo. Double vision, quality of life and clinical activity scores also markedly improved with teprotumumab.
“The more severe the disease the more improvement the patients received even if their disease was asymmetric,” Douglas said.
The responder rates improved as early as two doses after the infusion of teprotumumab. Overall, proptosis was reduced by about 3.3 mm.
Pooled data from both the phase 2 and phase 3 demonstrated a low percentage of serious adverse events. The treatment emergent adverse events greater than 5% were generally mild, according to Douglas.
“The reality is [teprotumumab] is very well tolerated compared to steroids ... but does it eliminate or minimize the need for surgical therapy?” Douglas asked. “I certainly think we are on the road to having a medical therapy that is comparable to surgical therapy.” – by Alaina Tedesco
Reference: Douglas RS. Teprotumumab as first line treatment for TED: Results from a randomized placebo-controlled clinical (OPTIC) study. Presented at: Hawaiian Eye 2020; Jan. 18-24, 2020; Koloa, Hawaii.
Disclosure: Douglas reports he is a consultant for Horizon.