New Data Build on Growing Evidence Supporting TEPEZZA (teprotumumab-trbw) Efficacy in Thyroid Eye Disease (TED), Including in Patients With Less Severe Disease and Longer Disease Duration - Seite 2

Findings suggest that TEPEZZA may offer benefits in patients with less severe TED:

• At Week 24, more TEPEZZA patients were proptosis (eye bulging) responders (≥2 mm reduction) in the fellow eye than placebo patients (63.1 percent vs. 8.0 percent, p<0.001), with a mean reduction in proptosis of 2.39 mm for TEPEZZA patients and a mean increase in proptosis of 0.15 mm for placebo patients (p<0.001).
• 30 patients (34.5 percent) in the placebo group had a worsening of proptosis at Week 24 in the fellow eye compared to 0 patients (0 percent) in the TEPEZZA group.
• CAS in the fellow eye decreased from baseline by a mean of -3.42 points in the TEPEZZA group compared to -2.00 points in the placebo group (p<0.001) at Week 24.
• More TEPEZZA patients (63.1 percent) than placebo patients (26.4 percent) had a CAS of 0 or 1 – signifying disease inactivation – in the fellow eye at Week 24 (p<0.001).

“We know from the clinical development program that TEPEZZA significantly reduces proptosis and Thyroid Eye Disease-related inflammation in patients with moderate-to-severe disease, and now with this new analysis of the Phase 2 and 3 data, we have evidence pointing to efficacy in patients with less severe disease as well,” said Raymond Douglas, M.D., Ph.D., study author and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center. “We believe this robust effect is the result of the mechanism of TEPEZZA that effectively targets the underlying molecular pathways that cause Thyroid Eye Disease.”

Additional Findings from the OPTIC 48-Week Follow-Up Study and OPTIC-X Clinical Trial

Long Term Assessment of Proptosis and Diplopia from the OPTIC Trial of Teprotumumab in Thyroid Eye Disease (PA038)

Additional data from the OPTIC Phase 3 confirmatory clinical trial and the OPTIC-X open-label extension clinical trial were also included in an abstract and presented during AAO, supplementing the topline results on proptosis response announced in July 2020. The OPTIC trial included a 24-week treatment period (treatment every three weeks for a total of eight infusions) and a 48-week off-treatment follow-up period. OPTIC-X evaluated TEPEZZA in patients who were enrolled in OPTIC and were either proptosis non-responders at Week 24 or were proptosis responders at Week 24 but flared during the 48-week off-treatment follow-up period.