The Lancet Respiratory Medicine:New analysis shows only minority of COPD patients may benefit from inhaled corticosteroids
Boehringer Ingelheim today announced a new publication showing that levels of white blood cells called eosinophils can help identify patients with COPD who may and may not benefit from the addition of ICS treatment.1 In WISDOM, for 80 percent of patients, the use of ICS on top of Spiriva®‡ and a LABA** had no additional benefit in reducing the risk of exacerbations or ‘flare-ups,’ compared to Spiriva®‡ and a LABA** without ICS. The post-hoc analysis shows that these patients can be easily identified by measuring the level of eosinophils in their blood. Patients with levels lower than 4 percent (300 cells/µL) had no additional exacerbation benefit with the inclusion of ICS in their regimen.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160407006617/en/
The Lancet Respiratory Medicine: New analysis shows only minority of COPD patients may benefit from inhaled corticosteroids (Photo: Business Wire)
Exacerbations significantly contribute to the impact of COPD, often lead to the patient being admitted to hospital,2 and can increase the risk of a patient dying.3 GOLD recommends the use of ICS-containing therapy only in COPD patients with severe to very severe lung function impairment and/or at high risk of exacerbations (GOLD C/D)4 – the patient population studied in WISDOM. Even within this severe population, only a small minority of patients in the study benefited from the inclusion of ICS to reduce their exacerbation risk.1 It is recognised that long term use of ICS treatments may be associated with a risk of serious side effects including pneumonia, osteoporosis and diabetes onset and progression.5,6,7
The WISDOM post-hoc analysis demonstrates that using the simple and commonly performed eosinophil blood count may provide a practical tool to help doctors identify the small subset of patients who may benefit from the addition of ICS to Spiriva+LABA therapy. This post-hoc analysis is published online in the journal The Lancet Respiratory Medicine.
“Long acting bronchodilators are a mainstay therapy in COPD management, however in clinical practice ICS is widely used across all COPD stages,” said study investigator Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK. “Previously, it has been difficult to determine the subset of patients who respond to ICS. These findings will help physicians more confidently identify which patients may benefit from ICS therapy, helping minimise exposure to the risk of side effects related to long-term ICS use.”
The 52-week, large-scale WISDOM study evaluated the effect of ICS withdrawal in patients with severe to very severe COPD with a history of exacerbation, while receiving Spiriva®‡ and a LABA.8 This new post-hoc analysis from WISDOM found that the 20 percent of patients who benefited from a reduced exacerbation risk due to the continued use of ICS on top of a combination of Spiriva®‡ with a LABA had higher levels of blood eosinophils (≥300 cells/µL; more than 4 percent).1
“These results are thought-provoking and add to the current debate about the appropriate use of ICS therapy in COPD,” said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim. “We look forward to further discussion and investigation of this important topic.“
Future prospective studies are needed to provide further evidence to confirm these findings. In the WISDOM study population, complete ICS withdrawal was associated with a small reduction in trough FEV1. No relationship was observed between blood eosinophil count and change in lung function with ICS withdrawal.
COPD is a serious but manageable lung disease, which is estimated to affect 210 million patients worldwide.9 Total deaths from COPD are projected to increase by more than 30 percent in the next 10 years; COPD is predicted to become the third leading cause of death by 2030.10
For the full results please refer to The Lancet Respiratory Medicine paper here: http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(16)00100-4/abstract
For ‘Notes to Editors’ and ‘References’ please visit: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2016/08_april_2016_copd.html
* Inhaled corticosteroids
† Withdrawal of Inhaled Steroids During Optimised Bronchodilator Management
‡ Once-daily tiotropium 18µg administered via HandiHaler® (tiotropium bromide inhalation powder)
§ Long-acting beta2-agonist
** Twice-daily salmeterol 50µg
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
Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe23.3.2018 12:52 | Pressemelding
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fal
CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets23.3.2018 12:50 | Pressemelding
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies. “The recommendation
Janssen Announces Positive CHMP Opinion for JULUCATM▼ (dolutegravir/rilpivirine)23.3.2018 12:46 | Pressemelding
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for JULUCA™ (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).1 “We are delighted to be one step closer to bringing JULUCA™ to people living with HIV in Europe,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “Building on our 25-year c
Aitheon Executives Educate World Leaders on Benefits, Challenges of AI at the Annual World Government Summit in Dubai23.3.2018 12:00 | Pressemelding
Aitheon, makers of the world’s first blockchain-powered platform to solve real problems by integrating AI, robotics, IoT, human specialists and cryptocurrency, announced today that executives from the company held a series of high-level briefings with world leaders at the Annual World Government Summit in Dubai. Briefings covered the benefits and challenges of AI, and revolutionary new solutions to world challenges made possible by transformative new technologies. (Read the full release at www.aitheon.com/news) This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005269/en/ Aitheon founder and CEO, Andrew Archer, and Chief Strategy Officer, Ryan Burleson, were invited to brief leaders at the Summit by Cyrus Hodes, Co-founder and Director of the AI Initiative, an undertaking of the Future Society at Harvard University’s Kennedy School. Archer and Burleson addressed a variety of AI-related topics, including the impact of AI on
ViiV Healthcare Gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe23.3.2018 11:27 | Pressemelding
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The 2-drug regimen comprises dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen Sciences Ireland UC). Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare commented: “Today is an important milestone for people living with HIV in Europe. It takes us a step closer to offering the first, single-pill, 2-drug regi
Smiths Detection Hold Baggage Scanner Meets Highest Security Standards in EU23.3.2018 07:00 | Pressemelding
The Smiths Detection HI-SCAN 10080 XCT has achieved ECAC approval as a Standard 3.1 explosives detection system for hold baggage – the highest, defined security standard in the EU. This significant advance was made possible by using a dual-view, dual-energy line scanner with high resolution 3D Computed Tomography (CT) to deliver exceptional data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005050/en/ Smiths Detection HI-SCAN 10080 XCT (Graphic: Business Wire) This achievement gives airports currently upgrading to Standard 3 technology, the option to increase detection levels even further to 3.1; and any standard 3 systems already installed can be easily elevated to 3.1 via a software upgrade. The detection algorithms are interchangeable on a bag by bag basis depending on the destination and associated risk level. This offers additional flexibility and productivity. “With the capability to meet detection requirements