The first thyroid eye medicine! IGF-1R Targeted Monoanti-Tepezza Effect Strong and Long-Lasting: Significantly Improved Eye Protrusion!

!--webeditor:page title"--TED (Photo: mister-sign.info) August 03, 2020 // Horizon Pharma is a pharmaceutical company focused on developing and commercializing innovative drugs to meet the therapeutic needs of rare and rheumatic diseases.
, the company recently released positive top-line data from two clinical trials, providing increasing evidence of the efficacy and safety of Tepezza's treatment of thyroid eye disease (TED).
(detailed: New TEPEZZA Topline Data Over-TheU.
TED is a rare autoimmune disease that is a serious, progressive, and threatening vision, associated with sudden eye (eye swelling), double vision, blurred vision, pain, inflammation, and facial defects.
Tepezza is an all-human monoclonal antibody and insulin-like growth factor-1 receptor (IGF-1R) target formulation that was approved by the U.S. FDA on January 21, 2020.
previously, the FDA had granted teprotumumab the orphan drug qualification, fast-track qualification, breakthrough drug qualification, and priority review status for therapeutic active TED.
OPTIC Phase 3 Confirmed Clinical Trial and OPTIC-X Open Label Extended Clinical Trial spartauny are part of Horizon's development project, which evaluates the safety and efficacy of TEPezza treatment of TED patients.
OPTIC Phase 3 confirmed clinical trial included a 24-week treatment period and a 48-week discontinued follow-up period, in which a 24-week treatment period was evaluated for a total of 8 injections of Tepezza or placebo injections every 3 weeks, with the main endpoint being the 24th week experimental eye eye protrusion (eye swelling) with a baseline reduction of 2 mm (no deterioration of the side eye).
at the 24th week, patients with sudden eye responses entered the 48-week discontinued follow-up period and did not receive additional TED treatment, including Tepezza.
OPTIC-X trials evaluated the safety and efficacy of Tepezza in TED patients in the group, either in the sudden-eye non-responders at the 24th week of treatment, or had a sudden eye response at the 24th week but relapsed during the 48-week suspension.
non-responders are defined as eye protrusions at the 24th week with a baseline improvement of 2 mm.
recurrence is defined as patients who lose at least 2 mm of eye protrusion improvement during the 48 weeks of follow-up after treatment (even if their eye protrusion is still better than at baseline) or a patient whose eye protrusion does not worsen during the 48 weeks of treatment.
patients may relapse at any time during the 48-week suspension of drug follow-up during the OPTIC trial.
top line results were as follows: (1) in patients who received a placebo in the OPTIC-X trial and then entered the Tepezza treatment, 89% (33/37) achieved the primary endpoint of a reduction of eye protrusion by 2 mm (an average reduction of 3.5 mm) during the 24th week of treatment.
this is consistent with the results of the OPTIC trial: in the 24th week of treatment, 83% of patients treated with Tepezza (n-41) had a significant reduction of eye highlights by 2 mm (an average reduction of 3.3 mm).
other endpoint results of the OPTIC-X trial, including double vision and clinical activity score (CAS) results similar to those observed in the OPTIC trial.
- Patients who received a placebo in the OPTIC trial and the first course of Tepezza treatment in the OPTIC-X trial had an average TED diagnosis of one year and up to 16 months, while in the OPTIC trial, the average Time for TED diagnosis was 6 months.
- During the 48-week follow-up period of the OPTIC trial, most of the Tepezza patients with sudden eye response at week 24 of the OPTIC trial remained active in their eye at 72 weeks without receiving additional TED treatment.
of the 15 patients rated as not maintaining a sudden eye response, 8 were at least 2 mm better than the baseline level during the last assessment of the 48-week discontinued drug follow-up period of the OPTIC trial.
of these 15 patients, 4 patients who prematurely discontinued the study, 2 patients who had slightly deteriorated but did not meet the OPTIC-X recurrence criteria, and 9 met the OPTIC-X recurrence criteria before the 72nd week of the end of discontinued treatment (of which 8 were retreated with OPTIC-X and 1 was not in the OPTIC-X group).
- In the 48-week drug-stopping period at OPTIC, from week 24 to week 72, the persistence of other endpoints is similar, including double vision and CAS.
in relapsed patients who underwent an additional course of Tepezza retreatment, more than 60% of patients with eye protrusions at the 24th week improved by more than 2 mm compared to the XOPTIC baseline.
in the OPTIC trial, only 5 cases completed the entire course of Tepezza treatment did not achieve a sudden eye response.
, two cases received an additional course of Tepezza therapy or eye protrusion improvement of 2 mm in the OPTIC-X trial.
- No new safety issues were found during the OPTIC-X or OPTIC 48-week discontinuation follow-up period, including in patients receiving additional Tepezza treatment.
detailed data on the two trials will be released at a future medical conference. Dr Elizabeth H.Z. Thompson, Vice President of the
Horizon Group, said: "The data from the OPTIC-X trial provide evidence that Tepezza effectively reduces the significant eye ball potential of TED patients who have been sickened for longer than initial lying in Phase 2 and Phase 3 clinical trials.
in addition, the data show that some patients may benefit from additional courses of Tepezza therapy, and the data show that these patients can experience improved treatment without increasing safety problems.
we are learning more about the early efficacy of the Tepezza project and the safety of patients with Tepezza treatment. "
The results of patients treated with Tepezza in the OPTIC trial were similar and effective compared to those receiving Tepe treatment in the OPTIC trial, " said Dr. Raymond Douglas, co-lead investigator of the study, "!--/eweb !--editor."
previously, patients diagnosed with TED without FDA-approved treatments may undergo multiple surgeries to restore vision and life-changing symptoms for years at the same time. Data from
and OPTIC-X clinical trials, as well as our observations in the real world after FDA approval, provide a compelling reason for completely changing treatment expectations in TED patients.
"thyroid eye disease (TED) is a progressive, decaying autoimmune disease with limited active disease windows during which treatment can be done without surgical intervention.
Although TED often occurs in patients with hyperthyroidism or Grave's hyperthyroidism, it is a unique disease caused by an IGF-1R-mediated signal complex activated by its own antigen in the cells in the eye socket.
this can lead to a series of negative effects, resulting in long-term, irreversible damage.
active TED lasts for up to 3 years and is characterized by inflammation and tissue dilation behind the eye.
as TED progresses, it can cause serious damage, including eye protrusion (eye protrusion), squint (eye dislocation), double vision (both visions), and, in some cases, blindness.
previously, patients had to undergo active TED until the disease became inactive (which often leaves permanent and visually impaired consequences) before they could undergo complex and expensive surgery, which may never restore vision or appearance.
TED patients often experience long-term functional, psychological and financial burdens, including inability to work and engage in daily activities.
Tepezza's active drug ingredient teprotumumab is an all-human IgG1 monotophode, targeting insulin-like growth factor-1 receptors (IGF-1R) and developed for the treatment of moderate to severe thyroid eye disease (TED), which is usually associated with Grave's disease (Grave's disease, hyperthyroidism).
optic study, patients treated with teprotumumab have seen an unprecedented reduction in eye highlights, which are currently surgically operated only after the end of the active disease.
Tepezza's approval, the first drug to be given to clinicians to reduce eye protrusion during active TED, in addition to treating other painful symptoms.
Horizon will also conduct a post-market study to assess the safety of Tepezza in a larger patient population, as discussed at the DODAC meeting on December 13, 2019.
study will also assess the relationship between re-treatment rates and the length of treatment patients. original source of the
() Original origin: New Topline TEPEZZA (teprotumumab-trbw) Data Shaller Effic itacy in Longer Longer Duration, Long-Term Durab and Potential for Retreatment in People Living Eye Disease (tED) !--/ewebeditor page: