Clinical trial data for nintedanib in patients with advanced IPF published
Results from the INSTAGE® trial have been presented at the 2018 European Respiratory Society (ERS) conference in Paris and published in the New England Journal of Medicine.1 The trial reports clinical data on a subset of patients with IPF and severe impairment in gas exchange, for whom only limited data exist. Data suggest that the efficacy and safety profiles of nintedanib in INSTAGE® were consistent with the profiles observed in patients with less advanced disease in the INPULSIS® and TOMORROW trials.1,2,4
INSTAGE® was conducted to investigate the efficacy and safety of nintedanib plus sildenafil vs. nintedanib monotherapy in patients with IPF and severely impaired gas exchange (DLco ≤ 35% predicted), who have largely been excluded from previous trials.1 Therefore INSTAGE® provides important clinical insights on this cohort. INSTAGE® was a randomised, double-blind, parallel-group trial with a total enrollment of 274 patients.1
The trial concluded that the addition of sildenafil on top of nintedanib did not provide significant improvement in change from baseline in SGRQ total score at week 12 (primary endpoint) compared to nintedanib therapy alone.1
“Numerically, changes in all health-related quality of life measures as well as lung function outcomes were in favour of the combination. Importantly, INSTAGE® has provided us with clinically relevant new insights about the use of nintedanib in this patient population. Changes in forced vital capacity (FVC) in patients treated with nintedanib alone in the INSTAGE® trial were highly consistent with the changes observed in patients treated with nintedanib in the INPULSIS® trials,” said Professor Martin Kolb, lead investigator of the study. “This suggests that nintedanib may have the same effect on reducing lung function decline in patients with more advanced IPF as that in patients with less advanced disease. Further, it was reassuring to note that the adverse events in these more severe patients were not different from the patients with milder disease”.
In the INSTAGE® trial, the change in FVC from baseline to 12 and 24 weeks in patients treated with nintedanib alone was −25.5 and -58.2 mL, respectively.1 This compares very well with the changes in FVC observed in the Phase III INPULSIS® trials.2 Although the study did not reach statistical significance in regards to the primary endpoint and the findings described above are considered exploratory, they provide clinically relevant new information.
No new safety signals were identified.1 The proportions of patients who reduced or interrupted nintedanib to manage adverse events, or who discontinued nintedanib prematurely due to adverse events, were similar to those in the INPULSIS® trials.1 Diarrhoea was the most frequent adverse event.1
“The INSTAGE® data are particularly important because in patients with severely impaired gas exchange, we previously only had limited data on the efficacy and safety of IPF treatments, including nintedanib,” said Dr Susanne Stowasser, Associate Head of Medicine Respiratory at Boehringer Ingelheim. “These results from the INSTAGE® trial further support the use of nintedanib across a broad range of IPF patients.”
Reassuringly, the safety and tolerability profiles of nintedanib in patients with severe impairment in gas exchange in INSTAGE® were consistent with those observed in patients with less advanced disease in earlier trials.1,2,3,4
Please click on the link below for ‘Notes to Editors’ and ‘References’:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.
Media + PR
Tel.: +49 (6132) 77-184531
Mobile: +49 (151) 68948378
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Warm welcome for ABB Formula E in Davos19.1.2019 09:00 | Pressemelding
Just a few days before the start of the World Economic Forum 2019, Davos is celebrating a world premiere: The latest ABB FIA Formula E racing car - dubbed Gen2 – was transported on a train from the iconic Swiss Rhaetian Railway to Europe’s highest city, where it will be an exciting eyecatcher during the coming week at the Davos Platz railway station. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190119005003/en/ ABB FIA Formula E racing car in Davos (Photo: Business Wire) From this Saturday until next Sunday, January 27, the Gen2 will be on display in a special glass case. Interested passersby can learn about the ABB FIA Formula E racing series as well as about the activities of ABB in e-mobility via an information system. With over 8,500 fast charging stations installed in 70 countries around the world, ABB is the global market leader for charging infrastructures. To watch the video, click here ABB (ABBN: SIX Swiss Ex) is
PMI’s Mission Winnow Goes Full Throttle with Ducati Corse for 2019 MotoGP™18.1.2019 17:00 | Pressemelding
Philip Morris International Inc. (PMI) (NYSE: PM) is pleased to announce that its Mission Winnow initiative is expanding in 2019 to include the Ducati Corse racing team. Mission Winnow is a PMI-led campaign to raise global awareness of our passion and determination to constantly improve and evolve, as well as highlight the power of science, technology and innovation to build a better future. PMI has partnered with Ducati Corse since 2002 and has extended the relationship for another three years until the end of 2021. As of the start of this year’s MotoGP season, the team will be officially known as Mission Winnow Ducati. Mission Winnow was first launched in October 2018 with Scuderia Ferrari Mission Winnow, which – like Ducati Corse – has a passion for innovation and a relentless drive to improve in the team’s pursuit of victory. Ducati Corse is one of the most inspiring and resilient teams in MotoGP, with a 70-year history in racing. Ducati fans form a passionate community who appreci
IFF’s Frutarom Division Completes Acquisition of 60% of Thailand-based Mighty18.1.2019 12:50 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF) (TASE:IFF), announced that its Frutarom Division has completed the acquisition of 60% of the share capital of The Mighty CO. LTD. (“Mighty”), a leading savory solutions provider in Thailand, thus continuing its growth strategy in Southeast Asia. Amos Anatot, President of IFF's Frutarom Division, said, “The completion of this deal with Mighty underscores that the Frutarom division will continue on its growth strategy and pursue attractive companies that create new opportunities or build on current capabilities.” Mr. Anatot continued, “And in this case, we are helping to grow our capabilities in savory solutions – already an area of strength for legacy Frutarom, now IFF." Mighty, founded in 1989, develops, produces and markets reaction flavors, with particular expertise in savory solutions. The company’s portfolio includes flavors, seasoning blends, marinades, and specialty functional raw materials f
LTI Q3 FY19: Constant currency revenue growth up 6.1% QoQ and 20.6% YoY; Net Profit jumps 32.8% YoY18.1.2019 12:02 | Pressemelding
Larsen & Toubro Infotech (BSE code: 540005, NSE: LTI), a global technology consulting and digital solutions company, announced its Q3 FY19 results today. In US Dollars: Revenue at USD 346.9 million; growth of 5.6% QoQ and 18.2% YoY Constant Currency Revenue growth of 6.1% QoQ and 20.6% YoY In Indian Rupees: Revenue at Rs 24,729 million; growth of 6.1% QoQ and 31.3% YoY Net Income at Rs 3,755 million; growth of (6.2%) QoQ and 32.8% YoY “We are pleased to deliver another strong quarter with 5.6% QoQ growth in USD revenues. Our broad-based revenue growth, superior margin delivery and steady cash generation in Q3 is a testimony of our focused execution and client centricity. We are also thrilled to welcome Ruletronics to LTI family. Ruletronics enables businesses to transform and evolve digitally by providing innovative BPM and CRM solutions leveraging Pega Platform.” - Sanjay Jalona, Chief Executive Officer & Managing Director, LTI Recent Deal Wins Nets, the leading payments company in th
Schlumberger Announces Full-Year and Fourth-Quarter 2018 Results18.1.2019 12:00 | Pressemelding
Schlumberger Limited (NYSE: SLB) today reported results for full-year 2018 and the fourth quarter of 2018. (Stated in millions, except per share amounts) Full-Year Results Twelve Months Ended Change Dec. 31, 2018 Dec. 31, 2017 Year-on-year Revenue $32,815 $30,440 8% Pretax operating income $4,187 $3,921 7% Pretax operating margin 12.8% 12.9% -12 bps Net income (loss) - GAAP basis $2,138 $(1,505) n/m Net income, excluding charges & credits* $2,261 $2,085 8% Diluted EPS (loss per share) - GAAP basis $1.53 $(1.08) n/m Diluted EPS, excluding charges and credits* $1.62 $1.50 8% Full-Year Consolidated Revenue by Area North America $11,984 $9,487 26% Latin America 3,745 3,976 -6% Europe/CIS/Africa 7,158 7,072 1% Middle East & Asia 9,543 9,394 2% Other 385 511 n/m $32,815 $30,440 8% North America revenue $11,984 $9,487 26% International revenue $20,446 $20,442 - North America revenue, excluding Cameron $9,668 $7,518 29% International revenue, excluding Cameron $17,675 $17,423 1% *These are non
FLIR Systems Awarded $89 Million Contract from French Armed Forces to Deliver Black Hornet Personal Reconnaissance System18.1.2019 11:00 | Pressemelding
FLIR Systems, Inc. (NASDAQ: FLIR) announced today it has been awarded a contract from the French Defense Procurement Agency (DGA) in support of the French Operational Pocket Drone (DrOP) program. The contract has a ceiling value of $89 million to provide the FLIR Black Hornet® 3 nano-unmanned aerial vehicle (UAV) and Personal Reconnaissance System (PRS) to support French Armed Forces operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190118005085/en/ The French Armed Forces awarded FLIR Systems a contract to deliver the Black Hornet Personal Reconnaissance System for military operations. (Photo: Business Wire) The Black Hornet PRS is the world’s smallest combat-proven nano-Unmanned Aerial System (UAS) and is currently deployed in more than 30 countries. The Black Hornet enables the warfighter to maintain situational awareness, threat detection, and surveillance no matter where the mission takes them. Equipped with el