Category Archives: Immunology

Paracetamol use in infancy may increase the risk of asthma

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A study has found that paracetamol use in infancy, as well as genetic factors, may increase the likelihood of developing asthma.

A study by researchers from the University of Melbourne, Australia identified how infants who take paracetamol during the first two years of life could be at a higher risk of developing asthma in their late teens.

Xin Dai, a PhD candidate at the University, and her colleagues explained how the link between paracetamol use and asthma seemed to be the strongest in individuals with a particular variant of the glutathione S-transferase (GST) gene, GSTP1.

GSTP1 is part of a gene family which encodes gene crucial for some life processes, detoxification and toxification mechanisms. The genes are upregulated in response to oxidative stress, and are overexpressed in tumours.

GST genes contain the information needed to make the antioxidant glutathione, which clears the effect of exposure to toxins in the body and the lungs.These actions help to prevent damage to cells and inflammation.

“Paracetamol, on the other hand, consumes glutathione, reducing the body’s capacity to deal with toxic exposure,” said Ms Dai. “We hypothesised that people who did not have full GST enzyme activity because of common genetic variations or deletions may be more susceptible to adverse effects on the lungs from paracetamol use.”

The researchers investigated 620 children who had been followed form birth to the age of 18, as part of the Melbourne Atopy Cohort Study. These children were selected before birth, as it was deemed that they had a high risk of developing an allergy-related disease. At least one family member (father, mother or sibling) had a self-reported allergic disease, such as asthma, eczema, hay fever or a severe food allergy.

After the birth of each child, a nurse rang the family every four weeks for the first 15 months, and then at 18 months and at two years old to ascertain the number of time the infant was given paracetamol. As the child reached the age of 18, a blood or saliva sample was given and tests were conducted to identify variants of GST genes.

The participants were also assessed for asthma, and a spirometry test measured the amount of air inhaled and exhaled when breathing through a mouthpiece.

“We found that children with the GSTP1 Ile/Ile variant had 1.8 times higher risk of developing asthma by the age of 18 years for each doubling of the days of paracetamol exposure when compared to children who were less exposed,” said Ms Dai. “In contrast, increasing paracetamol exposure in children who had other types of GSTP1 did not alter the risk of asthma.

In addition, we found some weak evidence that paracetamol use in the first two years of life may be associated with reduced lung function in adolescence regardless of which variants of the GST genes the children had.”

The researchers stressed that the study showed an association between paracetamol and asthma, and not that one caused the other. To establish this, further research would be necessary.

She concluded: “Our findings provide more evidence that paracetamol use in infancy may have an adverse effect on respiratory health for children with particular genetic profiles and could be a possible cause of asthma. However, these findings would need to be confirmed by other studies and the degree of adverse effect better understood before this evidence could be used to influence practice and before guidelines on paracetamol use are altered.

“There is mounting evidence that the GST superfamily of genes, including three major classes -GSTM1, GSTT1 and GSTP1 – are associated with various diseases, including cancers, asthma, atherosclerosis, allergies, Alzheimer’s and Parkinson’s disease. Our study adds to this body of evidence.”

The study was presented at the European Respiratory Society International Congress.

SOURCE: www.europeanpharmaceuticalreview.com/news/79189

New C.diff drug to be tested on patients for first time

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A new drug aimed at treating potentially deadly Clostridium difficile (C. diff) infections is set to be tested on patients for the first time.

Glasgow-based life sciences firm MGB Biopharma (MGB) said it was preparing to launch a Phase II clinical trial of its anti-bacterial agent MGB-BP-3.

The trial is expected to involve 30 patients based in North America.

All have been diagnosed with C.diff-associated disease (CDAD).

C.diff infections can cause diarrhoea and fever.

They have been a major problem in hospitals around the world, with thousands of deaths in the US alone linked to the bug each year.

The bacteria are able to take over the gut when a course of antibiotics kills off the bugs that normally live there.

MGB’s announcement came after it raised £1.3m from investors for trials of the new drug, which was invented at the University of Strathclyde.

The funding round was led by Edinburgh-based Archangels, with co-funding from a range of sources, including the Scottish Investment Bank, Barwell and Melrose-based Tri Capital.

The cash supplements a £2.7m grant awarded earlier this year by Innovate UK.

MGB said its trial would “evaluate safety and tolerability, efficacy and in particular look for improvement in global (or sustained) cure rates”.

Chief executive Dr Miroslav Ravic said: “We are already witnessing renewed interest in our new anti-bacterial agent and its trial in key medical centres in North America where CDAD is particularly prevalent.

“This offers opportunities both to progress the study rapidly and to attract increased attention to the results for this important trial.”

The company said it was aiming to start the trials in areas of the US and Canada with a high incidence of CDAD early next year.

SOURCE: www.bbc.co.uk/news/

Celgene’s Otezla produces “meaningful benefits” beyond beyond traditional metrics in plaque psoriasis

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Celgene made its voice heard amongst the chorus of new psoriasis data emerging from the European Academy of Dermatology and Venereology (EADV) Congress in Paris, revealing that Otezla (apremilast) achieved “meaningful improvements” in outcomes of patients with moderate to severe plaque psoriasis that may not be captured by common metrics that focus only on skin clearance, such as the Psoriasis Area Severity Index (PASI).

“Only considering skin clearance may not fully capture the effect a treatment may have on an individual’s disease burden and its impact on daily life,” explained Dr Denis Jullien, Department of Dermatology and Venereology at Edouard Herriot Hospital, and an author of the study. “For example, itching, which is not accounted for by PASI, is cited by over a third of patients as their overriding quality-of-life issue. These new analyses of Otezla studies can help inform both prescribers and patients when evaluating treatment decisions.”

The new findings included a post hoc sub-analysis of the phase 3 ESTEEM 1 trial, examining moderate to severe plaque psoriasis patients who did not achieve a PASI score of 75 after either 32 or 52 weeks of treatment with Otezla during the trial. In this group, over half achieved a 50% reduction in PASI score over the same periods – findings that Celgene argues “may more reliably indicate clinically meaningful benefit” when taken together with disease-specific quality-of-life measures.

For example, the data showed that itching was reduced from baseline by around 30% during weeks 4 to 52 for those who started treatment of Otezla, and during weeks 20 to 52 in patients who were switched form placebo at week 16. Additionally, patients reported an increase of at least five points in the Dermatology Life Quality Index (DLQI) over the same period.

“The ESTEEM and UNVEIL clinical trials continue to provide important learnings about Otezla for the treatment of psoriasis as well as quality of life for people who live with this chronic condition,” said Volker Koscielny, Vice President of Global Medical Affairs, Inflammation & Immunology at Celgene. “These sub-analyses of UNVEIL and ESTEEM suggest that appropriate patients with moderate to severe plaque psoriasis who experience manifestations beyond skin may benefit from treatment with Otezla.”

SOURCE: www.pharmafile.com/news/518748

Boehringer Ingelheim joins the crowd and goes all-in on oncolytic viruses, buying ViraTherapeutics in $244M deal

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Boehringer Ingelheim decided 3 years ago it that would take an active role in fostering the oncolytics virus biotech ViraTherapeutics.

The German company’s venture arm invested in the fledgling’s biotech’s tiny $4 million A round in the summer of 2015. BI execs came back with a $230 million discovery deal — building in a buyout option — and then added a second program. And this morning they’re going all in, buying the company in a deal valued at $244 million.

BI is keeping the company — a spinout of Austria’s Medical University of Innsbruck — right where it is, adding the group and the regional connections they have on campus as a subsidiary as they look to jump into the clinic with a lead program.

Boehringer first tied up with ViraTherapeutics just months ahead of Amgen’s landmark approval of T-Vec, the world’s first marketed oncolytic virus. And since then the field has exploded with new research projects as dozens of new players brewed up to beat the pioneer.

Earlier this year J&J executed one of its classic billion-dollar deals to buy BeneVir. Merck’s R&D chief Roger Perlmutter — who steered the T-Vec deal at Amgen — bagged Viralytics for $394 million. A recent study from the Cancer Research Institute found 69 OVs in clinical development and another 95 in a preclinical program.

What’s the big deal?

Oncolytic viruses are the Trojan horse of immuno-oncology. The viruses are designed to infect cancer cells, invading the disease, and then exploding them, which subsequently signals the immune system to mount an attack on the survivors. There’s a clear clinical track record showing how they work. And now a host of rivals like PsiOxus and many, many others believe that systemic administration will do a better job.

ViraTherapeutics execs — led by MorphoSys vet Heinz Schwer — have also been busy engineering an OV therapy that they believe can do a better job of initially evading detection by the immune system, avoiding triggering any antibodies and theoretically making it possible to do repeat administrations.

Not surprisingly, BI also plans to whip up a pipeline of combination approaches, arming their OV with cancer drugs that can both amp up the immune system attack and charge directly at cancer cells.

SOURCE: www.endpts.com

Gilead, Galapagos JAK inhibitor clears phase II test

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A mid-stage trial of Gilead and Galapagos’ JAK1 inhibitor filgotinib has set up a phase III programme for the drug in ankylosing spondylitis as it chases down two already-marketed dugs from Pfizer and Eli Lilly – and a late-stage rival from AbbVie.

In the TORTUGA trial, filgotinib met its clinical objective of reducing disease activity scores compared to placebo in patients with AS, a severe form of arthritis affecting the spine, with more patients achieving the target 20% improvement with the drug (76%) than in the control group (40%).

The drug is also in development for rheumatoid arthritis (RA), ulcerative colitis and Crohn’s disease with phase III trials already underway in those indications and results due in the coming weeks.

The drug was generally well-tolerated in TORTUGA but one case of deep vein thrombosis gave investors some cause for concern, putting some pressure on Gilead and Galapagos’ share price yesterday before share staged a partial recovery.

DVT is a recognised side effect with Eli Lilly’s JAK1 inhibitor Olumiant(baricitinib), which finally made it to market for rheumatoid arthritis in Europe last year but was rejected in the US at its first filing attempt over the safety issue. Gilead said that in the phase II AS trial the patient had an inherited condition that raised the risk of blood clots and the DVT was not thought to be drug-related.

First-to-market JAK inhibitor Xeljanz (tofacitinib) from Pfizer has already achieved $1bn-plus sales in RA, and with Olumiant somewhat hamstring by the safety issue on its label analysts are viewing the tussle between filgotinib and AbbVie’s upadacitinib as the next big battleground in the JAK inhibitor market.

AbbVie is a little ahead in the race to market, with phase III data in hand showing that upadacitinib is more effective than AbbVie’s $18bn-a-year injectable TNF blocker Humira (adalimumab) in RA when it comes to clinical responses gauged by doctors and patients. Like filgotinib, upadacitinib is also being tested in a string of other indications, including psoriatic arthritis, Crohn’s disease, ulcerative colitis and atopic dermatitis.

The rivalry is particularly strong as AbbVie was formerly Gilead’s partner for filgotinib, before ducking out of the collaboration and throwing its weight behind its in-house candidate.

SOURCE: http://www.pmlive.com/pharma_news

Novartis’ CAR T therapy Kymriah to become available on the NHS

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Novartis’ Kymriah is set to become the first CAR T therapy to become available on the NHS after it was revealed that the cancer treatment will be offered to children and young adults up to the age of 25 years old with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

While both Gilead and Novartis’ CAR T therapy were awarded marketing authorisation in the European Union just last week, NICE were quick to reject Gilead’s CAR T therapy Yescarta on the grounds that it was too expensive.

However Novartis’ one time cancer treatment is now set to become available through the UK’s national healthcare system.

Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland, said: “This decision to make our revolutionary CAR-T therapy, Kymriah (tisagenlecleucel) available so soon after being licensed is the result of our close collaboration with NHS England and NICE, with flexibility shown by all parties to ensure young patients can access this life-saving treatment as quickly as possible.”

The custom made treatment, which uses an individual’s own immune cells to combat cancer, has the potential to extend survival and significantly improve quality of life for children and young adults whose prognosis is poor.

However the cancer therapy comes with a high price tag, costing $475,000 in the United States. Meanwhile the list price for Gilead’s alternative Yescarta is just $373,000 in the US. Nevertheless the price that has been negotiated between Novartis and NICE will be kept confidential.

SOURCE: www.pharmafile.com/news/518554

Discovery could lead to higher immunotherapy response rates for bladder cancer patients

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Mount Sinai researchers have discovered that a particular type of cell present in bladder cancer may be the reason why so many patients do not respond to the groundbreaking class of drugs known as PD-1 and PD-L1 immune checkpoint inhibitors, which enable the immune system to attack tumors.

In a study published in August in Nature Communications, the Mount Sinai team reported that stromal cells, a subset of connective tissue cells often found in the tumor environment, may be preventing immune cells known as T-cells from seeking out and destroying the invading cancer. The researchers showed that expression of a set of genes that are typically linked to more aggressive cancers was actually more commonly linked to stromal cells rather than bladder cancer cells themselves. They also showed that tumors with increased expression of these genes, known as epithelial mesenchymal transition genes, did not respond well to immune checkpoint inhibitors. The researchers also found that in such tumors, T-cells were more likely to be separated from cancer cells by the stromal cells, suggesting that the stromal cells may be hindering the ability of the immune cells to reach and eradicate the cancer cells.

“Some bladder cancers may not respond to immunotherapy, even though the body has developed an immune response against them, because the T-cells are prevented from reaching the tumor by stromal cells that create an inhospitable ‘neighborhood,'” said Matthew Galsky, MD, Professor of Medicine and Director of Genitourinary Medical Oncology at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and senior author of the study.

Dr. Galsky and his colleagues are now trying to validate the gene expression identified in their study as a biomarker that could help refine clinical trials and treatment in the future by predicting the level of response or resistance to PD-1/PD-L1 inhibitors. In addition, according to Dr. Galsky, the group is identifying ways to “counteract the negative impact of the stromal cells and make that neighborhood more friendly to immune cells so they can finish their job.”

Since they were made available to patients about four years ago, immune checkpoint inhibitors have changed the treatment landscape for many types of cancer, particularly metastatic bladder cancer, which had gone several decades without significant therapeutic advances. While five different PD-1 and PD-L1 inhibitors have since been approved by the U.S. Food and Drug Administration, responses are achieved in only 15 percent to 25 percent of patients. Cancer researchers have turned their attention to attempting to learn why and, more specifically, to discovering ways to increase the proportion of patients with positive results.

The Mount Sinai team used several data sets for their study, including genomic data from The Cancer Genome Atlas’ bladder cancer dataset from the National Cancer Institute. In addition, in collaboration with researchers from Bristol-Myers Squibb, they demonstrated the potential clinical relevance of their findings in a large clinical trial dataset derived from patients with metastatic bladder cancer treated with the PD-1 inhibitor nivolumab.

“Our biologists and biostatisticians were able to harness ‘big data’ to generate valuable insights into responses and resistance to PD-1 therapies,” noted study co-author Jun Zhu, Ph.D., Professor in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mount Sinai and Head of Data Sciences at Sema4, a Mount Sinai venture. “We strongly believe those results will inform future studies at Mount Sinai and elsewhere.”

Dr. Galsky added, “What our group has done is add another important piece to a larger jigsaw puzzle about why PD-1/PD-L1 inhibitors don’t work in some patients. Through our work we have supported and extended important observations made by other researchers, and this makes us more confident than ever that we are on the right track to addressing a huge unmet need for patients with bladder cancer.”

Explore further: Simultaneous chemo and immunotherapy may be better for some with metastatic bladder cancer

SOURCE: www.medicalxpress.com/news

LEO Pharma to develop and commercialise JW Pharmaceutical’s JW1601

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Denmark-based LEO Pharma has entered into a global licensing agreement to develop and commercialise South Korean JW Pharmaceutical’s JW1601 drug candidate in a deal worth approximately $402m.

Under the terms of the deal, LEO Pharma will get exclusive global rights to JW1601. However, JW Pharmaceutical will retain its exclusivity in South Korea.

JW Pharmaceutical’s JW1601 is a new drug candidate for the treatment of atopic dermatitis. It was developed by one of the company’s affiliates C&C Research Laboratories.

Last year, JW Pharmaceutical acquired the exclusive rights to develop and commercialise the drug candidate globally. An investigational new drug application for a Phase I clinical trial is expected to be submitted over the coming months.

JW1601 is designed to prevent the activation and migration of immune cells that cause atopic dermatitis. The therapeutic selectively targets the histamine H4 receptor and inhibits histamine signalling responsible for itching.

The anti-pruritic and anti-inflammatory effects are expected to deliver better efficacy, while the selectivity towards H4 receptor is expected to show a good safety profile.

LEO Pharma Global R&D executive vice-president Kim Kjoeller said: “At LEO Pharma, we continuously seek to expand our pipeline with new innovative solutions with the ultimate aim of bringing real life-changing medicines to the many patients we serve.

This compound is a perfect fit with our existing biologics currently in phase III (Tralokinumab) and phase I (LP0145) and our topical Delgocitinib currently in phase II.”

As part of the agreement, JW Pharmaceutical will receive an upfront fee of $17m, followed by up to $385m in stepwise development and sales milestones.

In addition to the milestone payments, LEO Pharma will pay royalties on net sales of the drug candidate.

SOURCE: www.pharmaceutical-technology.com/news

Seven million euros for research into chronic inflammatory bowel conditions

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A new collaborative research centre/Transregio 241 ‘Immune-epithelial communication in inflammatory bowel diseases’ is due to commence its research at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) in July 2018.

In conjunction with the Charité hospital in Berlin, doctors and biotechnologists at FAU will be conducting research in order to better understand the interaction between cells in mucous membranes and immune cells in the bowel and to develop more effective therapy methods for chronic inflammation. The German Research Foundation (DFG) is providing funding worth 11.5 million euros for the first funding period until 2022, and FAU has been allocated nearly 7 million euros of this amount.

Number of patients with IBD is increasing

Severe diarrhoea, stomach pain, cramps – these are the most common symptoms of inflammatory bowel disease (IBD) such as Morbus Crohn or Colitis ulcerosa. Around 40,000 people in Germany suffer from IBD and this number continues to rise. Patients of IBD often suffer from flare-ups of their condition, which severely affects their quality of life and physical capabilities. ‘Despite the use of strong medication, chronic inflammatory bowel conditions remain difficult to treat’, says Prof. Dr. Christoph Becker, lead researcher at the Department of Medicine 1 at FAU’s Universitätsklinikum Erlangen and spokesperson of the collaborative research centre. ‘Acute flare-ups are often treated with corticosteroids that ease symptoms only in some cases. Many patients have to take several immunosuppressive substances.’ In addition, their symptoms are often accompanied by other conditions such as arthritis, acute inflammation of fatty tissue and chronic inflammation of the biliary tract in the liver.

Little research to date on molecular and cellular mechanisms

IBD is difficult to treat because the interactions between various cell populations in the bowel are not yet fully understood. ‘Newer findings show that the intestinal mucosa cannot be regarded as merely a physical barrier. In fact, it is highly-dynamic tissue that reacts to a large number of environmental stimuli including intestinal flora and local or systemic signals,’ explains Christoph Becker. ‘The immune system in the intestine regulates the barrier function of the intestinal wall and the composition of intestinal flora and vice versa as the intestinal barrier influences the immune system.’ However, there is a lack of knowledge of how the interactions between the epithelium and immune cells influence the long-term cellular reactions that contribute to controlling chronic inflammation processes.

New concept for new therapies

This is the starting point for the researchers from Erlangen and Berlin. During the next few years, they aim to integrate findings about the regulation and function of the immune system in the bowel and current data about anti-microbial defence on the mucous membrane barrier into a new concept. The individual projects will focus in particular on the role of misdirected communication between epithelium and immune cells during the pathogenesis of IBD. The researchers’ long-term aim is to develop medication that targets the causes of bowel inflammation while retaining the ability of the immune system to fight infections and cancer cells. In addition, they hope to find diagnostic methods that predict patients’ response to therapies – a goal that not only serves to relieve symptoms quickly, but should also contribute to lowering treatment costs.

Researchers from Erlangen involved in 14 projects

The scientific programme of CRC/TRR 241 is divided into three research areas: Area A ‘Immune regulation of intestinal barrier functions’, comprises projects focusing on the effects of acute and chronic inflammation on epithelial cells, in particular on their cell homeostasis and barrier-forming functions. Area B ‘The epithelium as a regulator of immunity and inflammation in the bowel’ examines the effects of disruptions to the barrier function and antigen translocation on the mucosal immune system. The objective of research area C ‘Diagnosis and therapeutic intervention of IBD’ is to develop innovative therapeutic and diagnostic approaches and evaluate them in a clinical setting. CRC/TRR 241 comprises a total of 22 projects, 14 of which are either based in Erlangen or involve researchers from Erlangen. The Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology, Department of Medicine 3 – Rheumatology and Immunology, the Department of Surgery and the Department of Dermatology and the Institute for Medical Biotechnology are all involved. 23 jobs and 9 scholarships are being funded during the next four years with the nearly 7 million euros allocated to the FAU.

SOURCE: www.eurekalert.org/pub_releases

Eczema drug effective against severe asthma

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Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies.

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies. Dupilumab, an injectable anti-inflammatory drug, was approved in 2017 by the Food and Drug Administration as a treatment for eczema, a chronic skin disease.

The more than 2,000 patients enrolled in the studies suffered from moderate to severe asthma. All used standard asthma inhalers, and some also took oral steroids to control their severe asthma symptoms.

In one study, the rate of asthma exacerbations was almost cut in half for those taking dupilumab compared with those taking a placebo. On average, patients taking a placebo had close to one exacerbation per day during the year of the study. Exacerbations are periods of sudden worsening of asthma symptoms such as wheezing, coughing, shortness of breath and tightness in the chest.

Although the drug significantly reduced asthma symptoms for all patients, dupilumab worked particularly well in patients with high numbers of a specific type of white blood cell, called eosinophils, circulating in the bloodstream. For those patients, asthma exacerbations were cut by two-thirds.

“This drug not only reduced severe symptoms of asthma, it improved the ability to breathe,” said Dr Mario Castro, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology and Critical Care Medicine. “That’s important because these patients have a chronic disabling disease that worsens over time with the loss of lung function. So far, we do not have a drug for asthma that changes the course of the disease. Current drugs for severe asthma help reduce trips to the emergency room, for example, but they don’t improve lung function.”

The first study included about 1,900 patients of at least 12 years of age and with moderate to severe asthma requiring they use at least three different inhalers to control their symptoms. One inhaler contained a corticosteroid that reduces inflammation, another contained a long-acting bronchodilator that relaxes airway muscles, and the third was a “rescue” inhaler filled with albuterol, a short-acting bronchodilator that quickly opens up the airway in the event of a more severe asthma attack.

Patients taking these inhaled medications then were randomly assigned to receive either dupilumab or a placebo for one year. Patients receiving dupilumab — an injectable antibody — also were randomly assigned to a higher or lower dose of the drug. Neither patients nor their doctors knew whether they were receiving the drug or the placebo.

In addition to reduced symptoms, the patients receiving dupilumab showed improved lung function in a test of “forced expiratory volume.” This test measures the amount of air a person can force from the lungs during a deep exhale. Patients receiving dupilumab, regardless of dose, improved their lung function by approximately 130-200 millilitres greater than those receiving the placebo. In general, there were no significant differences between the patients receiving high and low doses of dupilumab.

Rates of emergency room (ER) visits and hospitalisations also were improved for patients receiving the drug. In the placebo group (with 638 patients), on average, 6.5 percent of the patients required an emergency room visit or hospitalisation due to asthma during the study. In the dupilumab group (with 1,264 patients), on average, 3.5 percent of patients needed emergency care or hospitalisation due to asthma.

Based on the second study, Dr Castro said another benefit of the drug could be the ability to wean severe asthma patients off of chronic oral steroids, which can cause debilitating long-term side effects, including stunted growth, diabetes, cataracts and osteoporosis. The second study included about 200 patients using the same inhaled asthma medications as patients in the larger trial, plus additional oral steroids — usually prednisone — to control their more severe symptoms. Half of the patients receiving dupilumab in this study were able to completely eliminate prednisone use. And 80 percent of dupilumab-treated patients were able to at least cut their doses in half. Patients on placebo also reduced prednisone use but to a lesser degree, likely because the protocols of participating in a clinical trial help asthma control generally.

Dr Castro said doctors would like to help patients rely less on steroids for asthma control because those with severe asthma can be forced to take these drugs for decades to enable them to breathe.

“I have patients who have had to stop working and go on disability because their asthma symptoms are so severe they can no longer function in the workplace,” Dr Castro said. “I’m excited about the potential of dupilumab because I have so many patients who have maxed out on available therapies and they still can’t breathe. It can become a very disabling disease.”

Patients receiving dupilumab did experience known side effects of the drug, including pain and swelling at the injection site and a short-term bump in the number of eosinophil cells in the blood. Five patients who received dupilumab and three patients who received placebo died during the study period. According to the investigators and descriptions of these patients’ medical histories, all suffered from multiple severe medical conditions, and none of the deaths was deemed related to the study protocol.

The studies will be published online in The New England Journal of Medicine.

SOURCE: www.europeanpharmaceuticalreview.com/news/75890