-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Immune thrombocytopenia (ITP) is a rare disease with an adult incidence rate of 2.
9 per 100,000 persons per year
.
Increased platelet consumption and decreased platelet production in ITP are due to antibody and cell-mediated autoimmune attacks of platelets and megakaryocytes, involving disorders of autoreactive T and B lymphocytes
.
ITP can be divided into new diagnosis (<3 months), continuous (3-12 months) or chronic (>12 months) according to the course of the disease
.
ITP can also be classified as primary or secondary
.
The first-line treatment for adult ITP is high-dose glucocorticoids, but it can bring side effects such as mood swings, sleep difficulties, weight gain, high blood pressure, diabetes, stomach irritation, skin thinning, and osteoporosis
.
In addition, another problem with high-dose glucocorticoid therapy is the heterogeneity of response.
About 20%-30% of patients have no response (refractory disease).
Most patients who respond are reduced or stopped in the dose of glucocorticoid.
Relapse sometime later
.
Overall, only about 20% of patients receiving high-dose glucocorticoid therapy can achieve long-term remission
.
Mycophenolate mofetil (MMF) is widely used as a second-line treatment for ITP in the UK and is cheaper than many alternative treatments
.
Retrospective research results show that the remission rate of MMF as a second-line treatment of ITP is 50%-80%
.
Based on this, a researcher conducted a study to evaluate the efficacy of MMF combined with glucocorticoid versus glucocorticoid alone in newly diagnosed patients with ITP
.
Research method The FLIGHT trial is a multi-center, open-label, randomized, controlled clinical study comparing MMF combined with glucocorticoid and glucocorticoid alone as the first-line treatment of ITP
.
Patients with ITP who are more than 16 years old, platelet count less than 30×109/L and need first-line treatment clinically are eligible for enrollment
.
The study recruited and followed up patients in the department of hematology in a British hospital
.
The patients were randomized to receive MMF combined with glucocorticoid or glucocorticoid alone at a ratio of 1:1
.
After 6 months of MMF treatment, the dose of all patients with complete remission of MMF (platelet count>100×109/L) was reduced by 250 mg per month.
The goal is to continue to use the lowest dose (>30× 109/L), and to ensure that patients with spontaneous remission will not continue to take drugs indefinitely
.
The main outcome of the FLIGHT trial is treatment failure, defined as platelet count <30×109/L and second-line treatment started
.
Research results 1 Patient characteristics Among the 123 patients who were recruited and received randomization, 3 were excluded before receiving the assigned trial treatment; a total of 113 patients were included in the quality of life analysis
.
The demographics and baseline variables of the study are detailed in Table 1
.
The overall average age was 54 years (range 17-87 years), 54% of patients were male, and the baseline average platelet count before treatment was 7×109/L
.
Those over 70 years old accounted for 27.
5%, and those over 75 years old accounted for 15.
8%
.
There were slight differences between the two treatment groups in the distribution of patients aged> 65 years, non-white, male, obese, and secondary ITP
.
The cutoff for the analysis of treatment failure was 2 years, the median follow-up time of patients in the MMF combined treatment group was 1.
30 years, and the median follow-up time of the glucocorticoid group alone was 1.
10 years
.
Table 1: Baseline characteristics of patients 2 Main study results From randomization to the end of follow-up, a total of 40 treatment failures were recorded, 13 cases (22%) in the MMF combined treatment group, and 27 cases (44%) in the glucocorticoid group alone
.
The time-to-event curve drawn on the Kaplan-Meier diagram is shown in Figure 1
.
The hazard ratio (HR) estimated using the Cox proportional hazards model was 0.
41 (95% CI, 0.
21-0.
80; P = 0.
008)
.
In the subsample that excluded patients with secondary ITP and controlled for age, gender, and obesity, the adjusted HR was 0.
44 (95% CI, 0.
22-0.
86)
.
A sensitivity analysis involving the entire sample and controlling age, gender, obesity, and ITP (primary or secondary) yielded an adjusted HR of 0.
40 (95% CI, 0.
20-0.
78)
.
Figure 1: Main findings of the FLIGHT trial patients and 3 secondary findings.
Overall, the patients assigned to the MMF combined treatment group had a higher treatment response rate than the patients in the glucocorticoid group alone (see Table 2 for details)
.
After treatment, the proportion of patients with platelet count>100×109/L was 91.
5% and 63.
9% in the MMF combined treatment group and the glucocorticoid group alone; the proportion of patients with platelet count>30×109/L was in the two treatments The percentages in the two treatment groups were 93.
2% and 75.
4%, respectively; the proportion of patients who failed the treatment was 6.
8% and 24.
6% in the two treatment groups, respectively
.
Patients in the two treatment groups had similar response to treatment at 2 weeks, and the incidence of side effects, bleeding episodes, and the need for salvage treatment or hospitalization were also similar (Table 2)
.
However, patients in the MMF combination treatment group reported worse quality of life results regarding physical function and fatigue than those in the glucocorticoid-only group
.
Table 2: Responses, side effects, bleeding events, and salvage treatment of patients in the FLIGHT trial.
Research conclusions.
The addition of MMF as the first-line treatment of ITP on the basis of glucocorticoids has a higher remission rate and significantly reduces the development of refractory The risk of sexual or recurrent ITP, but the quality of life has declined
.
References: Charlotte A Bradbury, Julie Pell, Quentin Hill, et al.
Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia.
N Engl J Med.
2021 Sep 2;385(10):885-895.
Stamp "Read the original text" , We make progress together
9 per 100,000 persons per year
.
Increased platelet consumption and decreased platelet production in ITP are due to antibody and cell-mediated autoimmune attacks of platelets and megakaryocytes, involving disorders of autoreactive T and B lymphocytes
.
ITP can be divided into new diagnosis (<3 months), continuous (3-12 months) or chronic (>12 months) according to the course of the disease
.
ITP can also be classified as primary or secondary
.
The first-line treatment for adult ITP is high-dose glucocorticoids, but it can bring side effects such as mood swings, sleep difficulties, weight gain, high blood pressure, diabetes, stomach irritation, skin thinning, and osteoporosis
.
In addition, another problem with high-dose glucocorticoid therapy is the heterogeneity of response.
About 20%-30% of patients have no response (refractory disease).
Most patients who respond are reduced or stopped in the dose of glucocorticoid.
Relapse sometime later
.
Overall, only about 20% of patients receiving high-dose glucocorticoid therapy can achieve long-term remission
.
Mycophenolate mofetil (MMF) is widely used as a second-line treatment for ITP in the UK and is cheaper than many alternative treatments
.
Retrospective research results show that the remission rate of MMF as a second-line treatment of ITP is 50%-80%
.
Based on this, a researcher conducted a study to evaluate the efficacy of MMF combined with glucocorticoid versus glucocorticoid alone in newly diagnosed patients with ITP
.
Research method The FLIGHT trial is a multi-center, open-label, randomized, controlled clinical study comparing MMF combined with glucocorticoid and glucocorticoid alone as the first-line treatment of ITP
.
Patients with ITP who are more than 16 years old, platelet count less than 30×109/L and need first-line treatment clinically are eligible for enrollment
.
The study recruited and followed up patients in the department of hematology in a British hospital
.
The patients were randomized to receive MMF combined with glucocorticoid or glucocorticoid alone at a ratio of 1:1
.
After 6 months of MMF treatment, the dose of all patients with complete remission of MMF (platelet count>100×109/L) was reduced by 250 mg per month.
The goal is to continue to use the lowest dose (>30× 109/L), and to ensure that patients with spontaneous remission will not continue to take drugs indefinitely
.
The main outcome of the FLIGHT trial is treatment failure, defined as platelet count <30×109/L and second-line treatment started
.
Research results 1 Patient characteristics Among the 123 patients who were recruited and received randomization, 3 were excluded before receiving the assigned trial treatment; a total of 113 patients were included in the quality of life analysis
.
The demographics and baseline variables of the study are detailed in Table 1
.
The overall average age was 54 years (range 17-87 years), 54% of patients were male, and the baseline average platelet count before treatment was 7×109/L
.
Those over 70 years old accounted for 27.
5%, and those over 75 years old accounted for 15.
8%
.
There were slight differences between the two treatment groups in the distribution of patients aged> 65 years, non-white, male, obese, and secondary ITP
.
The cutoff for the analysis of treatment failure was 2 years, the median follow-up time of patients in the MMF combined treatment group was 1.
30 years, and the median follow-up time of the glucocorticoid group alone was 1.
10 years
.
Table 1: Baseline characteristics of patients 2 Main study results From randomization to the end of follow-up, a total of 40 treatment failures were recorded, 13 cases (22%) in the MMF combined treatment group, and 27 cases (44%) in the glucocorticoid group alone
.
The time-to-event curve drawn on the Kaplan-Meier diagram is shown in Figure 1
.
The hazard ratio (HR) estimated using the Cox proportional hazards model was 0.
41 (95% CI, 0.
21-0.
80; P = 0.
008)
.
In the subsample that excluded patients with secondary ITP and controlled for age, gender, and obesity, the adjusted HR was 0.
44 (95% CI, 0.
22-0.
86)
.
A sensitivity analysis involving the entire sample and controlling age, gender, obesity, and ITP (primary or secondary) yielded an adjusted HR of 0.
40 (95% CI, 0.
20-0.
78)
.
Figure 1: Main findings of the FLIGHT trial patients and 3 secondary findings.
Overall, the patients assigned to the MMF combined treatment group had a higher treatment response rate than the patients in the glucocorticoid group alone (see Table 2 for details)
.
After treatment, the proportion of patients with platelet count>100×109/L was 91.
5% and 63.
9% in the MMF combined treatment group and the glucocorticoid group alone; the proportion of patients with platelet count>30×109/L was in the two treatments The percentages in the two treatment groups were 93.
2% and 75.
4%, respectively; the proportion of patients who failed the treatment was 6.
8% and 24.
6% in the two treatment groups, respectively
.
Patients in the two treatment groups had similar response to treatment at 2 weeks, and the incidence of side effects, bleeding episodes, and the need for salvage treatment or hospitalization were also similar (Table 2)
.
However, patients in the MMF combination treatment group reported worse quality of life results regarding physical function and fatigue than those in the glucocorticoid-only group
.
Table 2: Responses, side effects, bleeding events, and salvage treatment of patients in the FLIGHT trial.
Research conclusions.
The addition of MMF as the first-line treatment of ITP on the basis of glucocorticoids has a higher remission rate and significantly reduces the development of refractory The risk of sexual or recurrent ITP, but the quality of life has declined
.
References: Charlotte A Bradbury, Julie Pell, Quentin Hill, et al.
Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia.
N Engl J Med.
2021 Sep 2;385(10):885-895.
Stamp "Read the original text" , We make progress together
