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(¤@).250 mg Q2W(¨â¶g¤@°w) EASI-50 81.0%*** EASI-75 60.6%*** EASI-90 44.0%*** IGA0/1 44.6%**
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EASI-50 45.8% EASI-75 24.3% EASI-90 11.4% IGA0/1 15.3% ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1¶ ·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2020/7/3 ¤U¤È 12:41:28²Ä 2836 ½g¦^À³ ¥xÁÞ¤j¡A
LEOªºtralokinumab ¤T´ÁÁ{§É«ü¼Ð IGA¡A0/1¡A©M¹ï·Ó组¤ñ¤j约2:1 ¦ÓDupilumab ¤T´Á¦P«ü¼Ð3.8/4.5:1, ¥i¨£¦p¤½¥q©Ò»¡¡A§@¥Î¦bIL13ªº°tÅéA¡BDÃ줣¦pIL4¨üÅé¡C
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Significantly greater IGA 0/1 and EASI 75 response rates at week 16 were observed with tralokinumab with and without topical corticosteroids, when compared with placebo. In ECZTRA 1, 15.8% of patients taking tralokinumab had an IGA 0/1, compared with 7.1% on placebo (P = .002), and 25.0% had an EASI 75 versus 12.7% with placebo (P < .001). In ECZTRA 2, the IGA 0/1 proportion was 22.2% versus 10.9% (P < .001), and EASI 75 proportion was 33.2% versus 11.4% (P < .001). For ECZTRA 3, the respective proportions were 38.9% versus 26.2% (P = .015) for IGA 0/1 and 68.0% versus 36.7% (P < .001) for EASI 75.
For the ECZTRA 1 and 2 trials, a sensitivity analysis of nonresponders demonstrated superior outcomes among those on active therapy even in this group. Specifically, the proportion with an IGA 0/1 was 19.1% with active therapy versus 8.1% with placebo (P < .001) in ECZTRA 1 and 24.0% versus 12.4% (P < .001) in ECZTRA 2. For EASI 75, the respective proportions were 33.4% versus 17.3% (P< .01) and 37.9% versus 16.4% (P < .01).
Following the maintenance treatment period, the use of tralokinumab with and without topical corticosteroids successfully preserved IGA 0/1 and EASI 75. At 52 weeks, among responders who received tralokinumab every 2 weeks during maintenance, 51.3% had an IGA 0/1 and 59.6% had an EASI 75 in ECZTRA 1. For ECZTRA 2, the respective values were 59.3% and 55.8%. At week 32 in ECZTRA 3, 89.6% of responders receiving tralokinumab every 2 weeks during maintenance had an IGA 0/1 and 92.5% EASI 75. These response rates were only significantly greater than pla |
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finance.yahoo.com/news/merck-buy-arqule-2-7b-144202149.html
Merck to Buy ArQule for $2.7B to Boost Cancer Portfolio
Zacks Equity Research
Merck (MRK) offers to acquire ArQule for a deal value of $2.7 billion. The transaction will add ArQule¡¦s lead investigational candidate ARQ 531 to Merck¡¦s oncology portfolio.
December 10, 2019
Àq§JMerck (MRK)¥h¦~©³ 27»õ¬ü¤¸¨ÖÁÊArQule.
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----------------------------------------- dupilumab(dupixent) ý³Ý
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Asthma • The recommended dose of DUPIXENT for adults and adolescents (12 years of age and older) is: o an initial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week or o an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week
www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf
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As of 11 July 2020, 12pm, the Ministry of Health (MOH) has confirmed 170 new cases of COVID-19 infection in Singapore.
Among the cases:
Imported case: 1 1 Work Pass holder There is an imported case today involving an Indian national who returned to Singapore from India on 6 July. She is a Work Pass holder who is currently employed in Singapore. She had been placed on 14-day Stay-Home Notice (SHN) upon arrival in Singapore, and had been tested while serving SHN.
Cases in the community: 24 7 Singaporeans, 6 Work Pass holders, 11 Work Permit holders Of the 24 cases in the community, 19 were picked up as a result of MOH¡¦s proactive surveillance and screening, and 5 had already been placed on quarantine earlier. 20 of the cases are asymptomatic, and were all detected through our proactive testing. 15 of the community cases are linked to previous cases or clusters, 9 are currently unlinked.
Cases residing in dormitories: 145 Of the new cases, 94% are linked to known clusters, the rest are pending contact tracing.
246 more cases of COVID-19 infection have been discharged from hospitals or community isolation facilities. To date, 42,026 have fully recovered from the infection and have been discharged from hospitals or community isolation facilities.
Most of the 192 confirmed cases who are still in hospital are stable or improving. 1 is in critical condition in the intensive care unit.
3,539 cases who have mild symptoms, or are clinically well but still test positive for COVID-19 are isolated and cared for at community facilities.
26 have passed away from complications due to COVID-19 infection. www.gov.sg/article/covid-19-cases-in-singapore
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Significantly greater IGA 0/1 and EASI 75 response rates at week 16 were observed with tralokinumab with and without topical corticosteroids, when compared with placebo. In ECZTRA 1, 15.8% of patients taking tralokinumab had an IGA 0/1, compared with 7.1% on placebo (P = .002), and 25.0% had an EASI 75 versus 12.7% with placebo (P < .001). In ECZTRA 2, the IGA 0/1 proportion was 22.2% versus 10.9% (P < .001), and EASI 75 proportion was 33.2% versus 11.4% (P < .001). For ECZTRA 3, the respective proportions were 38.9% versus 26.2% (P = .015) for IGA 0/1 and 68.0% versus 36.7% (P < .001) for EASI 75.
Lebrikizumab 2b ¤¤-««×AD Á{§Éªº«ü¼Ð(2019/3¤ë¤½¥¬)
(¤@).250 mg Q2W(¨â¶g¤@°w) EASI-50 81.0%*** EASI-75 60.6%*** EASI-90 44.0%*** IGA0/1 44.6%**
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EASI-50 45.8% EASI-75 24.3% EASI-90 11.4% IGA0/1 15.3%
*p<0.05, **p<0.01, and ***p<0.001 versus placebo www.businesswire.com/news/home/20191017005896/en/Dermira-Presents-Data-Phase-2b-Study-Lebrikizumab |
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Primary Outcome Measures : To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to 12 weeks safety follow up ] Incidence of treatment-emergent adverse events (TEAEs) reported from the administration of study drug on Day 1 until the completion of the study.
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clinicaltrials.gov/ct2/show/NCT04090229
¦¸n«ü¼Ð: Secondary Outcome Measures : Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Percentage change from baseline in the Patient-Oriented Eczema Measure (POEM) weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Percentage change from baseline in percent body surface area (%BSA) affected weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] PK parameters throughout the dosing period, and serum concentrations by scheduled timepoints. [ Time Frame: Baseline to 12 weeks safety follow up ] Measurement of area under the curve (AUC) at Week 8 (AUC0-last), maximum observed concentration (Cmax) at Week 1, time to Cmax (tmax) at Week 1, Ctrough throughout the dosing period, and serum concentrations by scheduled timepoints.
Change from baseline in PD markers of allergic inflammation (TARC and total IgE) weekly up to Week 8. [ Time Frame: Baseline up to Week 8 ] Measurement of absolute values of TARC and total IgE in serum concentration and percentage of change
Measurement of ASLAN004 Anti-Drug Antibody over time. [ Time Frame: Baseline to 12 weeks safety follow up ] Measurement of ADA levels in serum
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