Boehringer Ingelheim at the recently held ERS Congress in Amsterdam presents clinical trial data of Spiolto Respimat and OFEV, which will help the company grow in the respiratory segment. Usha Sharma reports
Germany-based pharmaceutical company Boehringer Ingelheim (BI) presented clinical trial data on Spiolto Respimat (tiotropium/ olodaterol) and OFEV (nintedanib) at the recently held European Respiratory Society (ERS) International Congress 2015 in Amsterdam.
New data presented at ERS supported the role of Spiolto Respimat as a first line maintenance therapy and showed superiority over steroid containing therapy. The company’s new data of OFEV (nintedanib) showed slowing disease progression and safety in patients with Idiopathic Pulmonary Fibrosis (IPF).
Allan Hillgrove, Corporate Board Division Pharma Marketing and Sales, Boehringer Ingelheim informed that this is a landmark year for BI in the respiratory segment. The company is conducting a lot of research in the respiratory area and many initiatives are being taken to make patients’ life more healthier. Boehringer Ingelheim’s focus is not only on developing new products but also on developing devices for the respiratory segment. Respimat was launched in 2004 and works by delivering a unique mist, requiring the patient to take a long slow deep breath.
Professor Luca Richeldi, Professor of Respiratory Medicine at the University of Southampton, United Kingdom showcased the changing path of IPF, highlighting the need for alternative, advanced treatment methods. Richeldi shared the story of a 57-year-old patient who never smoked but was still diagnosed with IPF. While informing about the clinical trial data of OFEV, Richeldi mentioned that data from the last four clinical trials was progressive and impressive, as 70 per cent patients who smoked enrolled for the trial. He feels that this could become the only treatment method to reduce adjudicated acute IPF.
“The safety and efficacy data presented for OFEV is very reassuring with regards to the long-term outcomes of treatment with OFEV and its effect on slowing the disease progression. They add further weight to the growing body of evidence in support of OFEV as an effective and manageable treatment for IPF. When managing IPF, it is important that physicians discuss with their patients what to expect from the treatment and which is right for them,” said Richeldi.
He also mentioned that this is the first time that OFEV has been included in the international treatment guidelines for IPF.
Prof Ronald Dahl, Dermato-venerology and Allergy Centre, Odense Research Centre for Anaphylaxis (ORCA), addressed the unmet need in systematic asthma patients. He highlighted that despite availability of current treatment, Spiriva Respimat are improved methods for asthma treatment.
Prof Dave Singh, Clinical Pharmacology and Respiratory Medicine, University of Manchester and Kai Michel Beeh, Medical Director, Respiratory Research Institute demonstrated meaningful improvement methods in COPD. He presented new data on Spiolto Respimat and how they work effectively against placebo and help improve quality of life of patients.
“ICS-containing therapies certainly have a role in the management of COPD but questions remain regarding when to use these treatments. The ENERGITO results further support the potential benefit of Spiolto Respimat as a COPD maintenance therapy and the notion that steroid-containing therapies may only be required in a population of patients with more severe stages of the disease and frequent exacerbations,” said Beeh.
“These two trials further characterise the relevant benefits provided by Spiolto Respimat compared to two commonly prescribed maintenance treatments: Spiriva Respimat and a LABA/ICS FDC. The lung function and quality of life improvements shown in these trials add to the growing body of evidence supporting the benefit of using Spiolto Respimat at the initiation of maintenance therapy for COPD,” said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine, BI.
These results adds to the recently published OTEMTO 1&2 data in Respiratory Medicine which show that Spiolto Respimat provide consistent improvements in lung function, breathlessness and quality of life over Spiriva Respimat (tiotropium) or placebo. The data also shows that Spiolto Respimat provide a safety profile similar to Spiriva Respimat or placebo. Incidence of adverse events (AEs) was broadly similar across treatment groups, with a higher incidence of AEs leading to discontinuation in the placebo groups compared to the treatment groups.
An interim analysis of the INPULSIS-ON extension trial has confirmed the efficacy and safety of OFEV (nintedanib) previously observed in the INPULSIS trials. It confirms that OFEV has a long-term effect on slowing disease progression and a manageable side effect profile in patients with IPF. This new data is important in light of the fact that IPF is a life-threatening and progressive disease, requiring patients to be on long-term treatment.
(The reporter was in Amsterdam on invitation from Boehringer Ingelheim)
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