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This article is only for medical professionals to read and review the research progress of interleukin pathway biologics.
Recently, the American Digestive Disease Week (DDW) was held online from May 21-23.
This conference brings together all the cutting-edge research progress in digestive fields this year.
Among them, in the field of inflammatory bowel disease (IBD) treatment, the application exploration, efficacy comparison, and long-term safety data of a variety of new biological agents have been announced.
The progress of interleukin pathway biological agents has been attracting attention.
What are the research progress of interleukin pathway biologics in this conference? Next, let the editor take everyone to review it together.
The first-line use of interleukin pathway biologics is aimed at comparing the efficacy of first-line biologics in IBD.
A multi-center, randomized double-blind controlled study-SEAVUE, whose initial results are shared in this meeting [1].
The purpose of this study is to compare the efficacy and safety of Uselnumumab and Adalimumab in patients with moderate to severe active Crohn’s disease (CD) who have not used Bio-naïve for one year.
A total of 386 patients were randomly assigned to treatment with Uselnumumab or Adalimumab at a ratio of 1:1.
At week 52, the clinical remission rates of the patients in the usnumab treatment group and adalimumab treatment group reached 65% and 61%, respectively (Δ=4.
0%; 95% CI, -5.
5%, 13.
5%; P =0.
417).
The 52-week endoscopic SES-CD score of the Uselumumab treatment group improved compared with baseline compared with that of the adalimumab group (4.
1 vs 3.
1, p=0.
046).
Both drugs showed a good endoscopic response rate (41.
9%).
vs 36.
9%, p=0.
349), the clinical response rate was higher for 52 weeks of maintenance treatment with ussinumumab (88.
6% vs 78.
0%, p=0.
016). 52-week UST and ADA endoscopic improvement results.
This study further fills in the clinical evidence of Uselnumumab in the Bio-naïve patient population.
As a first-line drug for the treatment of CD, Uselnumumab has good efficacy and safety.
The efficacy of Uselnumab in the treatment of patients with refractory Crohn’s disease in the real world SUCCESS This conference also announced the efficacy and analysis results of Uselnumab for 12 months of treatment [2], research 1113 patients with refractory CD (90% anti-TNF therapy history, 56% used more than two types) were enrolled in 1113 patients.
After 12 months of treatment with Useltuzumab, cumulative clinical remission, no hormonal remission, endoscopy and radiology The relief was 40%, 32%, 39%, and 30%, respectively.
Multivariate analysis suggested that with the increase in the types of biologics used in the past, the clinical and endoscopic remission rates decreased.
The previous use of anti-TNF (HR, 0.
72; 95% CI: 0.
49, 0.
99) and veldrizumab were both consistent with the use of anti-TNF (HR, 0.
72; 95% CI: 0.
49, 0.
99).
Low endoscopic remission rate (HR, 0.
72; 95% CI: 0.
49, 0.
99; HR, 0.
65; 95% CI: 0.
48, 0.
88) was associated.
The KM curve of the number of previous exposures to biological agents and the cumulative failure of patients who achieved clinical remission.
In addition, 152 (152/681; 22.
3%) patients who did not achieve remission after standard uzumumab dose treatment were optimized for dose optimization.
40.
1% (61/152) achieved clinical remission.
The study further confirmed that Uselnumumab is an effective choice for the treatment of IBD in routine clinical practice.
The clinical research progress of new interleukin pathway biologics is currently on the market and is the first to be used in psoriasis.
As a fully human anti-IL-23 antibody, it can effectively inhibit the inflammatory factors and inflammatory factors in the intestines of IBD patients.
The release of chemokines achieves the purpose of treating intestinal inflammation.
The current phase 2 study of GUS-GALAXI showed that GUS treatment of moderately to severely active CD patients effectively improved the endoscopic response, cure and remission rate at 8 weeks; in the population of patients with traditional treatment failure, nearly half of GUS at 12 weeks Patients in the group received an endoscopic response (GUS vs PBO: 44.
6% vs 10.
7%) [3]. In the GALAXI study at 12 weeks, patients with moderate to severe active CD who received GUS intravenous induction therapy had C-reactive protein (CRP) and fecal calprotectin (FeCal) at 12 weeks compared with patients who received placebo.
The reduction is greater, and the proportion of biomarkers that should be normalized is higher [4].
How to make better use of existing interleukin pathway biologics.
Studies have shown that the disease characteristics of different diseased locations of CD may be different, and the drug efficacy may be related to the patient’s course of disease.
Although IL-12/23 inhibitors have a definite efficacy in IBD patients, However, how to improve the effectiveness of drugs is still a topic that needs to be paid attention to in the field of IBD treatment.
This conference also has research on who and when to use Uselnumab.
Will the use of ulinumumab in the early stage of the disease enhance the patient's benefit? The demographic data of the SUCCESS study shows that there are fewer disease complications in the early disease population (32 years old vs 40 years old), but many patients do not use biologics intervention early (18.
3% vs 6.
4%), and use it in the early stage of CD disease Uselnumab can significantly improve cumulative disease remission, hormone-free clinical remission, endoscopic remission and imaging remission rate (HR, 1.
282, 95% CI: 1.
007, 1.
633; HR, 1.
711, 95% CI: 1.
088, 2.
689 ; HR, 1.
680, 95% CI: 1.
241, 2.
273; HR, 2.
110, 95% CI: 1.
120, 3.
976), this analysis also obtained similar results in the patient population activated within 2 years of diagnosis [5].
Through the combined analysis of the UNITI study, the phase III trial of usnumab, the disease activity index (CDAI), the inflammatory bowel disease questionnaire (IBDQ) and the concise health questionnaire 36 (SF- 36) The score report is analyzed afterwards to evaluate the difference in disease characteristics of different CD onset locations [6].
Among them, colon type patients have a higher average daily soft/loose stool frequency (6.
0 vs 4.
6 vs 5.
6; P<0.
01), the total IBDQ score is lower, and patients with ileal or ileocolonic type will experience more severe abdominal pain (P=0.
04) ), which indicates that the disease phenotype has a greater impact on the patient’s health-related quality of life (HRQoL), especially the participation in work, social activities and other social activities related to personal life.
Therefore, there may be a better treatment plan for us in different parts of CD, and the corresponding analysis results will be announced in the future.
In summary, the research reported in this DDW conference shows that Uselumumab has significant effects and good safety for both Bio-naïve or refractory patients with moderate to severe CD.
GUS, an IL-23 inhibitor that is gradually being used in IBD, has a definite effect and is expected to become a new star in the field of IBD treatment.
In addition, attention should also be paid to the better use of current drugs.
The use of biological interventions in the early stages of the disease, or the proposal of more precise treatment plans for CD patients with different intestinal inflammation sites, may become a way to further improve the efficacy of interleukin pathway biologics.
.
For more DDW 2021 latest developments, please pay attention to the series of live broadcasts of "Explaining DDW 2021: Focusing on the Forefront of IBD".
Well-known IBD experts are specially invited to conduct in-depth interpretations on research evidence, treatment strategies and treatment goals. At 16:00 pm on May 29, 2021 (this Saturday), Professor Ran Zhihua from Shanghai Renji Hospital will interpret the latest research data on biologics on DDW in detail; at 19:30 pm on June 9, 2021, Xiangya Second Hospital Professor Xiaoping Wu from Beijing will bring the latest advances in precision treatment and optimal management of IBD; at 19:30 on June 19, 2021, Professor Xiaoqi Zhang from Nanjing Gulou Hospital will focus on the long-term goals of IBD treatment and share relevant long-term clinical prognosis and The latest data on improving the quality of life, exciting content not to be missed! References: 1.
Bruce E.
Sands et al.
DDW 2021 Poster.
Ustekinumab versus Adalimumab for induction and maintenance therapy in moderate-to-severe Crohn's disease: the SEAVUE study 2.
Amanda Johnson et al .
DDW 2021 Poster.
The Real-World Effectiveness of Ustekinumab in the Treatment of Crohn's Disease3.
G D'Haens et al.
DDW 2021 Poster.
The Effect of Guselkumab Induction Therapy on Endoscopic Outcome Measures in Patients with Moderately to Severely Active Crohn's Disease: Week 12 Results From the Phase 2 GALAXI 1 Study4.
BE Sands et al.
DDW 2021 Poster. If you are not a medical and health professional, please do not participate or spread it.
-End-This article is only used to provide scientific information to medical and health professionals, and does not represent the platform's position
Recently, the American Digestive Disease Week (DDW) was held online from May 21-23.
This conference brings together all the cutting-edge research progress in digestive fields this year.
Among them, in the field of inflammatory bowel disease (IBD) treatment, the application exploration, efficacy comparison, and long-term safety data of a variety of new biological agents have been announced.
The progress of interleukin pathway biological agents has been attracting attention.
What are the research progress of interleukin pathway biologics in this conference? Next, let the editor take everyone to review it together.
The first-line use of interleukin pathway biologics is aimed at comparing the efficacy of first-line biologics in IBD.
A multi-center, randomized double-blind controlled study-SEAVUE, whose initial results are shared in this meeting [1].
The purpose of this study is to compare the efficacy and safety of Uselnumumab and Adalimumab in patients with moderate to severe active Crohn’s disease (CD) who have not used Bio-naïve for one year.
A total of 386 patients were randomly assigned to treatment with Uselnumumab or Adalimumab at a ratio of 1:1.
At week 52, the clinical remission rates of the patients in the usnumab treatment group and adalimumab treatment group reached 65% and 61%, respectively (Δ=4.
0%; 95% CI, -5.
5%, 13.
5%; P =0.
417).
The 52-week endoscopic SES-CD score of the Uselumumab treatment group improved compared with baseline compared with that of the adalimumab group (4.
1 vs 3.
1, p=0.
046).
Both drugs showed a good endoscopic response rate (41.
9%).
vs 36.
9%, p=0.
349), the clinical response rate was higher for 52 weeks of maintenance treatment with ussinumumab (88.
6% vs 78.
0%, p=0.
016). 52-week UST and ADA endoscopic improvement results.
This study further fills in the clinical evidence of Uselnumumab in the Bio-naïve patient population.
As a first-line drug for the treatment of CD, Uselnumumab has good efficacy and safety.
The efficacy of Uselnumab in the treatment of patients with refractory Crohn’s disease in the real world SUCCESS This conference also announced the efficacy and analysis results of Uselnumab for 12 months of treatment [2], research 1113 patients with refractory CD (90% anti-TNF therapy history, 56% used more than two types) were enrolled in 1113 patients.
After 12 months of treatment with Useltuzumab, cumulative clinical remission, no hormonal remission, endoscopy and radiology The relief was 40%, 32%, 39%, and 30%, respectively.
Multivariate analysis suggested that with the increase in the types of biologics used in the past, the clinical and endoscopic remission rates decreased.
The previous use of anti-TNF (HR, 0.
72; 95% CI: 0.
49, 0.
99) and veldrizumab were both consistent with the use of anti-TNF (HR, 0.
72; 95% CI: 0.
49, 0.
99).
Low endoscopic remission rate (HR, 0.
72; 95% CI: 0.
49, 0.
99; HR, 0.
65; 95% CI: 0.
48, 0.
88) was associated.
The KM curve of the number of previous exposures to biological agents and the cumulative failure of patients who achieved clinical remission.
In addition, 152 (152/681; 22.
3%) patients who did not achieve remission after standard uzumumab dose treatment were optimized for dose optimization.
40.
1% (61/152) achieved clinical remission.
The study further confirmed that Uselnumumab is an effective choice for the treatment of IBD in routine clinical practice.
The clinical research progress of new interleukin pathway biologics is currently on the market and is the first to be used in psoriasis.
As a fully human anti-IL-23 antibody, it can effectively inhibit the inflammatory factors and inflammatory factors in the intestines of IBD patients.
The release of chemokines achieves the purpose of treating intestinal inflammation.
The current phase 2 study of GUS-GALAXI showed that GUS treatment of moderately to severely active CD patients effectively improved the endoscopic response, cure and remission rate at 8 weeks; in the population of patients with traditional treatment failure, nearly half of GUS at 12 weeks Patients in the group received an endoscopic response (GUS vs PBO: 44.
6% vs 10.
7%) [3]. In the GALAXI study at 12 weeks, patients with moderate to severe active CD who received GUS intravenous induction therapy had C-reactive protein (CRP) and fecal calprotectin (FeCal) at 12 weeks compared with patients who received placebo.
The reduction is greater, and the proportion of biomarkers that should be normalized is higher [4].
How to make better use of existing interleukin pathway biologics.
Studies have shown that the disease characteristics of different diseased locations of CD may be different, and the drug efficacy may be related to the patient’s course of disease.
Although IL-12/23 inhibitors have a definite efficacy in IBD patients, However, how to improve the effectiveness of drugs is still a topic that needs to be paid attention to in the field of IBD treatment.
This conference also has research on who and when to use Uselnumab.
Will the use of ulinumumab in the early stage of the disease enhance the patient's benefit? The demographic data of the SUCCESS study shows that there are fewer disease complications in the early disease population (32 years old vs 40 years old), but many patients do not use biologics intervention early (18.
3% vs 6.
4%), and use it in the early stage of CD disease Uselnumab can significantly improve cumulative disease remission, hormone-free clinical remission, endoscopic remission and imaging remission rate (HR, 1.
282, 95% CI: 1.
007, 1.
633; HR, 1.
711, 95% CI: 1.
088, 2.
689 ; HR, 1.
680, 95% CI: 1.
241, 2.
273; HR, 2.
110, 95% CI: 1.
120, 3.
976), this analysis also obtained similar results in the patient population activated within 2 years of diagnosis [5].
Through the combined analysis of the UNITI study, the phase III trial of usnumab, the disease activity index (CDAI), the inflammatory bowel disease questionnaire (IBDQ) and the concise health questionnaire 36 (SF- 36) The score report is analyzed afterwards to evaluate the difference in disease characteristics of different CD onset locations [6].
Among them, colon type patients have a higher average daily soft/loose stool frequency (6.
0 vs 4.
6 vs 5.
6; P<0.
01), the total IBDQ score is lower, and patients with ileal or ileocolonic type will experience more severe abdominal pain (P=0.
04) ), which indicates that the disease phenotype has a greater impact on the patient’s health-related quality of life (HRQoL), especially the participation in work, social activities and other social activities related to personal life.
Therefore, there may be a better treatment plan for us in different parts of CD, and the corresponding analysis results will be announced in the future.
In summary, the research reported in this DDW conference shows that Uselumumab has significant effects and good safety for both Bio-naïve or refractory patients with moderate to severe CD.
GUS, an IL-23 inhibitor that is gradually being used in IBD, has a definite effect and is expected to become a new star in the field of IBD treatment.
In addition, attention should also be paid to the better use of current drugs.
The use of biological interventions in the early stages of the disease, or the proposal of more precise treatment plans for CD patients with different intestinal inflammation sites, may become a way to further improve the efficacy of interleukin pathway biologics.
.
For more DDW 2021 latest developments, please pay attention to the series of live broadcasts of "Explaining DDW 2021: Focusing on the Forefront of IBD".
Well-known IBD experts are specially invited to conduct in-depth interpretations on research evidence, treatment strategies and treatment goals. At 16:00 pm on May 29, 2021 (this Saturday), Professor Ran Zhihua from Shanghai Renji Hospital will interpret the latest research data on biologics on DDW in detail; at 19:30 pm on June 9, 2021, Xiangya Second Hospital Professor Xiaoping Wu from Beijing will bring the latest advances in precision treatment and optimal management of IBD; at 19:30 on June 19, 2021, Professor Xiaoqi Zhang from Nanjing Gulou Hospital will focus on the long-term goals of IBD treatment and share relevant long-term clinical prognosis and The latest data on improving the quality of life, exciting content not to be missed! References: 1.
Bruce E.
Sands et al.
DDW 2021 Poster.
Ustekinumab versus Adalimumab for induction and maintenance therapy in moderate-to-severe Crohn's disease: the SEAVUE study 2.
Amanda Johnson et al .
DDW 2021 Poster.
The Real-World Effectiveness of Ustekinumab in the Treatment of Crohn's Disease3.
G D'Haens et al.
DDW 2021 Poster.
The Effect of Guselkumab Induction Therapy on Endoscopic Outcome Measures in Patients with Moderately to Severely Active Crohn's Disease: Week 12 Results From the Phase 2 GALAXI 1 Study4.
BE Sands et al.
DDW 2021 Poster. If you are not a medical and health professional, please do not participate or spread it.
-End-This article is only used to provide scientific information to medical and health professionals, and does not represent the platform's position
