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Introduction: Research data shows that injection of Teprotumumab every 3 weeks within 24 weeks can reduce the exophthalmos of most patients with thyroid eye disease by at least 2mm, and long-term treatment effects have been observed in 67% of the participants.
The clinical symptoms of thyroid eye disease and Teprotumumab thyroid eye disease mainly include inflammation, refractory exophthalmos and diplopia.
Teprotumumab is a fully human IgG1κ monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R).
It was approved by the US FDA on January 21, 2020, based on two random Controlled study.
In this analysis, the researchers evaluated the overall short- and long-term response to Teprotumumab in patients in these two trials, focusing on exophthalmos and diplopia.
Study description The researchers analyzed these two similarly designed randomized, double-blind, placebo-controlled trials.
One trial was conducted at 15 centers in Europe and included adult patients aged 18-75, and the other was in the United States.
13 centers, including adult patients 18-80 years old.
The participants were all patients with Graves' disease and had newly-onset active thyroid eye disease.
Participants were randomly assigned to the Teprotumumab treatment group (N=84, Teprotumumab was injected intravenously every 3 weeks for a total of 8 times for 24 weeks) and the placebo group (N=87).
77% vs.
15%, Teprotumumab can reduce exophthalmos and improve diplopia.
Compared with placebo, patients who received Teprotumumab had a significantly greater reduction in exophthalmos ≥ 2mm at 24 weeks (77% vs.
15%; P<0.
0001).The average protrusion reduction in the Teprotumumab group was -3.
14mm, and the average protrusion reduction in the placebo group was -0.
37mm.
Compared with placebo, all subgroups of the Teprotumumab group had greater improvement in protrusions, and the degree of improvement was similar between the subgroups.
Figure 1 Proportion of eyeball reduction ≥ 2mm at 24 weeks In the Teprotumumab group, 70% of patients achieved grade 1 improvement in diplopia at 24 weeks, compared with 31% in the placebo group.
Compared with placebo, a greater proportion of the Teprotumumab group achieved relief of diplopia (53% vs.
25%; P=0.
0007).
The subjects treated with Teprotumumab showed improvements in clinical activity scores and exophthalmos at each time point.
Compared with the placebo group, the Teprotumumab group also had a greater improvement in the Graves quality of life score for ophthalmopathy.
Good long-term results.
Long-term follow-up data show that 67% of patients can maintain the improvement of exophthalmos, and 83% of patients have observed an improvement in comprehensive ophthalmology results.
The quality of life score of patients in the Teprotumumab group still improved within 72 weeks.
Adverse reactions At 24 weeks, most adverse events in the placebo group and Teprotumumab group were mild to moderate.
Seven of the 84 patients treated with Teprotumumab had serious adverse events, of which 3 serious adverse events may be related to Teprotumumab, leading to the discontinuation of the study.
The risk of muscle cramps in the teprotumumab group was 18% higher than that in the placebo group, the risk of hearing loss was 10% higher, and the risk of hyperglycemia was 8% higher.
The researchers said: "Teprotumumab has a good benefit-risk ratio, and further safety studies have been carried out.
In addition, further studies are needed to explore the efficacy of the drug in patients with chronic eye diseases.
According to the current results, the Medications can improve the long-term results of thyroid eye disease.
Given that Teprotumumab selectively targets insulin-like growth factor I receptors, this treatment program may significantly change the clinical course of thyroid ophthalmopathy.
"References: [1] George J Kahaly, Raymond S Douglas, Robert J Holt, et al.
Lancet Diabetes Endocrinol.
2021; doi:10.
1016/S2213-8587(21)00056-5.
[2] Michael Monostra.
Teprotumumab improves short- and long-term clinical outcomes in thyroid eye disease[EB/OL].
thyroid-eye-disease, 2021-4-23.
Introduction: Research data shows that injection of Teprotumumab every 3 weeks within 24 weeks can reduce the exophthalmos of most patients with thyroid eye disease by at least 2mm, and long-term treatment effects have been observed in 67% of the participants.
The clinical symptoms of thyroid eye disease and Teprotumumab thyroid eye disease mainly include inflammation, refractory exophthalmos and diplopia.
Teprotumumab is a fully human IgG1κ monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R).
It was approved by the US FDA on January 21, 2020, based on two random Controlled study.
In this analysis, the researchers evaluated the overall short- and long-term response to Teprotumumab in patients in these two trials, focusing on exophthalmos and diplopia.
Study description The researchers analyzed these two similarly designed randomized, double-blind, placebo-controlled trials.
One trial was conducted at 15 centers in Europe and included adult patients aged 18-75, and the other was in the United States.
13 centers, including adult patients 18-80 years old.
The participants were all patients with Graves' disease and had newly-onset active thyroid eye disease.
Participants were randomly assigned to the Teprotumumab treatment group (N=84, Teprotumumab was injected intravenously every 3 weeks for a total of 8 times for 24 weeks) and the placebo group (N=87).
77% vs.
15%, Teprotumumab can reduce exophthalmos and improve diplopia.
Compared with placebo, patients who received Teprotumumab had a significantly greater reduction in exophthalmos ≥ 2mm at 24 weeks (77% vs.
15%; P<0.
0001).The average protrusion reduction in the Teprotumumab group was -3.
14mm, and the average protrusion reduction in the placebo group was -0.
37mm.
Compared with placebo, all subgroups of the Teprotumumab group had greater improvement in protrusions, and the degree of improvement was similar between the subgroups.
Figure 1 Proportion of eyeball reduction ≥ 2mm at 24 weeks In the Teprotumumab group, 70% of patients achieved grade 1 improvement in diplopia at 24 weeks, compared with 31% in the placebo group.
Compared with placebo, a greater proportion of the Teprotumumab group achieved relief of diplopia (53% vs.
25%; P=0.
0007).
The subjects treated with Teprotumumab showed improvements in clinical activity scores and exophthalmos at each time point.
Compared with the placebo group, the Teprotumumab group also had a greater improvement in the Graves quality of life score for ophthalmopathy.
Good long-term results.
Long-term follow-up data show that 67% of patients can maintain the improvement of exophthalmos, and 83% of patients have observed an improvement in comprehensive ophthalmology results.
The quality of life score of patients in the Teprotumumab group still improved within 72 weeks.
Adverse reactions At 24 weeks, most adverse events in the placebo group and Teprotumumab group were mild to moderate.
Seven of the 84 patients treated with Teprotumumab had serious adverse events, of which 3 serious adverse events may be related to Teprotumumab, leading to the discontinuation of the study.
The risk of muscle cramps in the teprotumumab group was 18% higher than that in the placebo group, the risk of hearing loss was 10% higher, and the risk of hyperglycemia was 8% higher.
The researchers said: "Teprotumumab has a good benefit-risk ratio, and further safety studies have been carried out.
In addition, further studies are needed to explore the efficacy of the drug in patients with chronic eye diseases.
According to the current results, the Medications can improve the long-term results of thyroid eye disease.
Given that Teprotumumab selectively targets insulin-like growth factor I receptors, this treatment program may significantly change the clinical course of thyroid ophthalmopathy.
"References: [1] George J Kahaly, Raymond S Douglas, Robert J Holt, et al.
Lancet Diabetes Endocrinol.
2021; doi:10.
1016/S2213-8587(21)00056-5.
[2] Michael Monostra.
Teprotumumab improves short- and long-term clinical outcomes in thyroid eye disease[EB/OL].
thyroid-eye-disease, 2021-4-23.
