Southampton researchers will be at the heart of a national initiative to tackle disparities in maternity outcomes. The University of Southampton is one of the lead universities of the new NIHR Challenge: Maternity Disparities consortium. It was announced today by the National Institute for Health and Care Research (NIHR). The consortium brings together universities and partner organisations. Together, they will find new ways to provide better care and support before and between pregnancies. They will be supported by £50 million over five years. The leadership team includes Southampton’s Professor Keith Godfrey. He will spearhead a collaboration in the challenge. Disproportionate impact The risk of dying from pregnancy or childbirth in the UK is higher today than it was before 2000. There has been a rise in mental and physical health challenges faced by women and their partners before pregnancy. These have a disproportionate impact on women from minority backgrounds. Outcomes for those living in less advantaged areas are also significantly worse. Recent evidence suggests that maternal mortality for black women in the UK is almost three times higher than for white women.   Significant disparities also exist for Asian women. ‘Impactful work’ Prof Godfrey is a Professor of Epidemiology and Human Development. He is also a theme lead at the NIHR Southampton Biomedical Research Centre. Prof Godfrey said: “People who are healthier before they get pregnant have better outcomes for themselves and their babies. It is often too late to fix health problems once a woman is already pregnant. “This means we need to focus on improving health before pregnancy and between pregnancies.” Preconception refers to the time before a woman is pregnant. Interconception is the time between pregnancies. Prof Godfrey and colleagues will develop a ‘whole maternity’ journey for women and their partners. The focus is on improving health from preconception until after the baby’s birth. They will bring this thinking into public health strategies on nutrition, obesity, smoking and alcohol use. The 'whole maternity' journey will also address broader determinants of healthcare access. These include poverty and racism. This will create a fairer care system that addresses the needs of all women. In doing so, it will ensure healthier outcomes for future generations. “I am delighted that Southampton will lead a collaboration in this important NIHR Challenge”, Prof Godfrey added. “I look forward to continuing our impactful work with these partners." Collective knowledge The University of Southampton is partnering with University College London, NHS Bedfordshire, Luton and Milton Keynes Integrated Care Board, and NHS Hampshire and Isle of Wight Integrated Care Board. The collaboration brings a wealth of expertise and a combined research portfolio worth £147.6 million from 2019 to 2024, focused on tackling maternity disparities. Southampton and UCL have a well-established partnership. The universities have previously worked together in supporting the Department of Health and Social Care (DHSC) Maternity Disparities Taskforce in 2023. They also co-founded the UK Preconception Partnership together in 2018. The two Integrated Care Boards add further strength to the collaboration. They have extensive experience in co-developing and delivering preconception and interconception care. They have done so in areas with high levels of ethnicity-associated and coastal disparities. ‘Exceptional consortium’ Southampton is leading one of nine collaborations across the UK. They will work together to address the national challenge. Professor Marian Knight, Scientific Director for NIHR Infrastructure, said:   “We are delighted by the level of engagement shown by researchers with this important research priority. I am confident we have an exceptional consortium to tackle the challenge of maternity inequalities. They will do this in partnership with existing NIHR funded infrastructure and programmes.   “We look forward to working with the consortium and their collaborators across the UK. We will support them to develop the final plans for their ground-breaking new research projects over the next few months.”   Professor Joht Singh Chandan is the Consortium Co-lead for Research. He said:   "I am honoured to take on the role of co-lead for the NIHR Maternity Disparities Consortium.   “Tackling inequalities in maternity care is a critical priority. This consortium brings together a wealth of expertise to drive meaningful change. Our goal is to address disparities before, during, and after pregnancy. We will do this by focusing on research that leads to real improvements in care for families and their babies across the UK.   Prof Chandan added: “I am particularly looking forward to working alongside the communities most affected by these inequalities. We will ensure that their insights shape our work and lead to lasting, impactful solutions."   Professor Judith Rankin is the Consortium Co-lead for Research and Capacity Development. She said:   “I am delighted to be the co-lead for Research and Capacity Development. This exciting new consortium will help to make the step change we need to improve outcomes for women and their babies.   “The consortium will also invest in our future research leaders. This will ensure we have the capacity to deliver on improving pregnancy outcomes, access to, and experience of, care.”

Professor Keith Godfrey is supporting a new initiative to help children in Dorset stay a healthy weight. Academics and healthcare professionals across Wessex are working together to reduce obesity and excess weight. It builds on pioneering research and practice already underway in Southampton. ‘Enormous’ benefits In Dorset, 22% of children starting school, aged four to five years, are overweight or living with obesity. By the end of primary school, at age 10 to 11, this figure rises to 32%. Obesity in reception children is not decreasing and remains in line with pre-pandemic levels. These high prevalences have important consequences for individuals, society and the healthcare system. The issue is being treated as a top priority by health planners in the region. Obesity and excess weight in children can lead to other health conditions, and are linked to asthma, early puberty, diabetes and some cancers. They can also cause anxiety, poor self-esteem and eating disorders. If they continue to live with obesity in adulthood, these individuals will have a lower life expectancy. Professor Keith Godfrey, Theme Lead for Nutrition, Lifestyle and Metabolism at the NIHR Southampton Biomedical Research Centre, is supporting the initiative. He is drawing on his research understanding the causes of obesity in children and his experience running programmes at LifeLab aimed at tackling childhood obesity. LifeLab enables children and young people to learn first-hand the science behind the health messages. This means they can really understand the ‘why’ of healthy lifestyle changes. Professor Godfrey said: “Dorset is leading the way in its commitment to reducing the high levels of overweight in children. This will require policies that bring together those in the education, cultural, healthcare and local government sectors to promote diets of high quality, physical activity and healthy sleep habits. The challenge is not an easy one, but the benefits for health, wellbeing and economic prosperity in the county are enormous.” Collaborative effort The initiative brings together academics and healthcare professionals across the region, with funding from Wessex Health Partners. Christine McGrath, Managing Director of Wessex Health Partners, said: “We were keen to fund this initiative because it is such an excellent example of forming a new collaborative to tackle a pressing health issue. The new group will be well placed to apply for bigger funding – and this attracts inward investment into the Wessex area.” It is being led by NHS Dorset and Health Innovation Wessex. The aim is to learn from pioneering research and practice already underway in Southampton, and implement this in a way that works for people in Dorset. Heather Stacey, Senior Programme Manager at Health Innovation Wessex, said: “In Dorset, we really want to take an approach based on what’s already working elsewhere. We need to understand that children and young people often don’t have a lot of choice in this area. For them, losing weight isn’t as simple as eating less and moving more.” Tess Green, Senior Project Manager at NHS Dorset, said: “This is about children’s life chances, and it’s such an important issue to take forward. The impact of obesity on adults is immense, leading to life-long conditions. We need to get the messages right about healthy nutrition and looking after yourself, and how this affects you personally.” Image credit: World Obesity Federation

For 20 years Paul Bradley, a former powerlifter, only used his ‘good’ arm to reach above his head. An injury dislocated his shoulder and snapped the ligaments. This meant he couldn’t raise his right arm above shoulder height without considerable pain. Now, after receiving bespoke physiotherapy as part of a study, he is the world record holder in his category for pole sport. Rehabilitation research continues today to help patients recover from injuries, including through the NIHR Southampton Biomedical Research Centre (BRC). Using retraining exercises Paul took part in the Motor Control Retraining Exercises for Shoulder Impingement (MOCATS) study in 2012. This used new methods to assess shoulder blade movement and shoulder muscle function. Peter Worsley, Professor of Assistive Technology and Tissue Health at the University of Southampton (UoS), co-led the study. It was conducted by the university’s Active Living Research Group , led by Professor Maria Stokes. The team was able to pinpoint the cause of Paul’s shoulder impingement, where a tendon was catching on bone. From there, they identified exercises for Paul to improve his posture and teach his body to hold his shoulder in a corrected position. “It was amazing,” said Paul. “After all those years, it started to improve within a week. It then took several months to train my body to naturally hold my shoulder in the correct position. I was so happy, and I found I could start to do more and more exercises.” The study was supported by the Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis . A team of researchers worked with local physiotherapists to develop the intervention, including Dr Sarah Mottram, who initiated the idea for the study. ‘Transformed my life’ Shortly after starting the MOCATS trial, Paul discovered a love of pole sport after a friend invited him to try a class at Emma Simmonds’ Pole Performers Dance School in Southampton. “I thought I was fit and strong – but it was such a tough workout that I ached for nine days afterwards,” he recalls. “I couldn’t accept I wasn’t strong enough for all the moves, so I saw it as a challenge and took it up as a hobby. As the physio improved my shoulder and I improved at pole, I could do harder and harder moves that I could never have dreamed of before.” Paul is now a pole sport instructor and President of the British Pole and Aerial Sports Federation. He was previously Head of IT at Southampton’s National Oceanography Centre. He has travelled the world to compete in pole sport competitions, representing Great Britain at three world championships. In 2022 he was the male 60+ world champion, and today he is the over 60s male world record holder. “Paul’s experience is such a fantastic outcome of our study,” said Professor Worsley. “It’s wonderful to know that the work we did is still having a tangible impact today.” “If I hadn’t taken part in the MOCATS trial, I would never have achieved any of this,” said Paul. “I’m so grateful – it quite literally transformed my life for the better.” Continuing research “This research on shoulder rehabilitation created a new understanding of the mechanisms of musculoskeletal injury, enabling the team to give personalised exercises and interventions,” explains Professor Worsley. “We are continuing this research through the BRC, with a particular focus on promoting mobility and exercise in hospital to prevent muscle wasting.” The group’s work now focusses on other joints, mainly the hip and knee, in different sports and occupational groups. It helps prevent injury (prehabilitation) as well as aid recovery in rehabilitation. Professor Worsley is leading a project within the BRC’s Perioperative and Critical Care Theme, using the same concept of neuromuscular control. This will develop personalised programmes to optimise movement, to help patients prepare for and recover from surgery effectively. The aim is to preserve muscle quality and improve outcomes for patients undergoing a range of elective procedures. Photos credit: University of Southampton

An art project promoting vaccines in pregnancy was showcased in London last month. Visitors of all ages interacted with the Clothed with Protection  exhibition at the New Scientist Live festival. The event took place at ExCeL London in October. Clothed with Protection  is driving greater awareness that vaccines protect both mother and baby. Just as clothing protects us from the outside world, vaccinations create a layer of protection from infection. The project is funded by the IMmunising PRegnant women and INfants neTwork (IMPRINT). This exhibition was a public engagement activity as part of our Microbiology, Immunology and Infection theme. Exploring vaccines through art The event welcomed more than 26,000 visitors. At the festival, IMPRINT displayed several outfits and the inspiration behind them. The team invited people to try on some of the clothes and draw their own designs. Southampton’s Dr Chrissie Jones led the Clothed with Protection  project. She worked in collaboration with artist Luke Jerram. They commissioned ten fashion designers from Kampala, Uganda. The designers created clothing that highlights the importance of vaccination in pregnancy in Africa. The clothes were displayed in a fashion show and community event in Kampala. The exhibition has since been shown across the UK and in Berlin. A short film about the project is available to watch here . Inspiring conversations Dr Jones was joined at the festival by Dr Mary Kyohere, who was part of the project’s first exhibitions in Uganda. They were accompanied by clinical midwives who deliver vaccines in pregnancy, research midwives involved in vaccine trials and medical students. The team engaged with people of all ages over the course of three days. Visitors ranged from primary school children to older adults. Dr Jones is an Associate Professor in Paediatric Infectious Diseases and Immunology at the University of Southampton and an Honorary Consultant at University Hospital Southampton. She is also co-director of IMPRINT. Dr Jones said: “It was fantastic to reach such a broad audience at New Scientist Live. “Visitors were captivated by the designers’ intricate work and the creativity woven into each piece. This opened the door to meaningful conversations about the science behind vaccines and their role in protecting mothers and babies. “Through projects like Clothed with Protection , we hope to inspire greater awareness and support for ongoing research into vaccines in pregnancy.”

Children whose mothers took extra vitamin D during pregnancy continue to have stronger bones at age seven, according to new research. Southampton researchers led a national study that trialled vitamin supplements in pregnancy. It showed extra vitamin D can help increase children’s bone mass. Pregnant women in the UK are now routinely advised to take vitamin D supplements. This latest analysis shows that these benefits persist into mid-childhood. Researchers say this reinforces the importance of vitamin D supplementation in pregnancy as a public health strategy. Their findings are published in The American Journal of Clinical Nutrition . Importance of vitamin D Vitamin D regulates the amount of calcium and phosphate in the body. These minerals are essential for bones, teeth and muscle health. Building strong bones in childhood is important. It reduces the risk of osteoporosis and fractures in later life. Researchers from the University of Southampton and University Hospital Southampton NHS Foundation Trust (UHSFT) launched the MAVIDOS study in 2009. They  recruited over 1,000 women from Southampton, Oxford and Sheffield. During their pregnancy, the women were randomly allocated to two groups. One group took an extra 1,000 International Units per day of vitamin D. The other took a placebo (dummy) tablet each day. The pregnant women, and the doctors and midwives looking after them, did not know which group they were in. Results showed that bone mass was greater in children born to mothers who had had vitamin D supplementation during pregnancy compared with those who had not. New data The Southampton research team are part of the MRC Lifecourse Epidemiology Centre (MRC LEC) and the NIHR Southampton Biomedical Research Centre (BRC). Previous research assessed the children’s bone health at four years of age. In this latest study, they investigated whether the effects on bone health continued into mid-childhood. The team followed up with 454 children aged six to seven. These children were all born to mothers who took part in Southampton. Results confirmed that the beneficial effect on children’s bones was similar at ages four and six to seven. Bone density scans revealed that children born to mothers in the extra vitamin D group had greater bone mineral density. This means their bones contained more calcium and other minerals, making them stronger and less likely to break.   Dr Rebecca Moon, NIHR Clinical Lecturer in Child Health at the University of Southampton, led the analysis. She said: “Our findings show that the benefits of vitamin D supplementation during pregnancy persist into mid-childhood. “This early intervention represents an important public health strategy. It strengthens children’s bones and reduces the risk of conditions like osteoporosis and fractures in later life.” Collaborative research  The MAVIDOS trial has helped Southampton researchers understand possible mechanisms linking maternal vitamin D supplementation with offspring bone mass. They demonstrated that the vitamin D supplementation led to changes in the activity of genes forming part of the vitamin D pathway. In 2022, they found taking the supplements during pregnancy could substantially reduce the chances of babies up to a year old suffering from atopic eczema. They also observed that pregnant women given extra vitamin D were more likely to have a spontaneous vaginal delivery. Professor Nicholas Harvey is Director of the University’s MRC Lifecourse Epidemiology Centre, Professor of Rheumatology and Clinical Epidemiology and project lead. He said: “These findings add to the important knowledge generated through the MAVIDOS trial.  “We extend our heartfelt thanks to all the mothers and children involved. Their contributions have advanced our understanding of vitamin D supplementation and its role in supporting strong and healthy bones.” The research was funded by Versus Arthritis, the Medical Research Council, the National Institute for Health and Care Research and the Bupa Foundation.

Southampton researchers are advancing a handheld device to measure muscle health. Sarcopenia causes a loss of muscle mass and function in older age. As it progresses, people can become weak, frail and lose their independence. Researchers in our NIHR Southampton Biomedical Research Centre (BRC) are looking at how a smartphone-sized device, called MyotonPRO, could benefit patients. It has previously been used on astronauts. Paul Muckelt is driving the project forward. He shares his journey to date and what he hopes to achieve through a one-year BRC Postdoctoral Bridging Fellowship. How did you become interested in research? I became interested in research while I was doing my degree. The more I learned, the more I realised there was so much I didn’t know. I had lots of questions that I wanted to find answers to. I also decided that I wanted to work in healthcare so I could help make a difference. During my master’s degree, I had an internship at the University of Southampton (UoS) and got the chance to work on several PhD projects. I successfully applied for a position at the university when it came up, launching my career in research. I have been working at UoS for six years now and involved with the BRC for nearly a year. My research projects to date range from muscle properties in astronauts to the association between number of co-morbidities and the health of patients with arthritis. I’ve also investigated injury prevention in Royal Navy recruits and physical function in older golfers. What is the healthcare challenge that you are seeking to address? I am looking to expand our understanding of the mechanisms of sarcopenia. Specifically, I am looking at how we can monitor changes in muscle non-invasively - without having to go into the muscle - and quickly in routine care. Sarcopenia affects between 5-13% of people aged 60 and over. This rises to between 11-50% of those above 80. This is a growing problem - with an ageing population, the condition is only going to become more prevalent. What do you hope to achieve in your research at the BRC? As part of my fellowship, I am examining the feasibility of using the MyotonPRO device and muscle ultrasound to monitor changes in muscle properties. We’re also investigating how patients and clinicians view these devices to understand their potential in real-world settings. Our plan is to launch a larger study to assess mechanisms of sarcopenia, which will include MRI and muscle biopsies. The hope is that these measurements can be used in routine clinical care and inform interventions to prevent muscle wastage in hospital settings. How would you sum up your fellowship in three words? Non-invasive muscle measurements What's it like being an early career researcher in Southampton? I am enjoying working alongside NHS clinicians to introduce new technology and develop my understanding of specific diseases. The pace of life can be variable but flexible at times. Data collection can be quite intense and nearing deadlines can put the pressure on, but I feel well-supported by the team at UoS and within the BRC. I know I have people I can turn to for help or to bounce ideas off. What advice would you give other early career researchers? My advice is to find an area which interests you; pushing forward can become uninteresting otherwise.   Secondly, it is important to find a good team and strong mentors who will help you develop as a researcher. There is so much to learn beyond the subject matter. And finally, always say yes to good opportunities – even if you’re unsure how you’ll make it work. You can always figure it out later.

A first trial of an expanding pill has demonstrated the technology’s potential as a weight-loss treatment. The Sirona capsule is designed to aid weight loss by reducing hunger. Oxford Medical Products (OMP) partnered with the NIHR Southampton Biomedical Research Centre on the first-in-human trial. It was led by chief investigator Mr James Byrne, consultant surgeon at University Hospital Southampton. OMP reports the pill was safe and well tolerated by participants in the 12-week trial. A quarter of all participants who took the treatment lost over five percent of their body weight. The trial took place at the NIHR Southampton Clinical Research Facility. Tackling rising obesity Around one in four adults in the UK are now living with obesity, which means having a BMI of 30 or above. Obesity increases the risk of many other health conditions, including type 2 diabetes and some types of cancer. It costs the NHS billions of pounds each year. However, current treatments are expensive and resource-intensive in tackling the scale of the problem. The Sirona capsule works like a gastric balloon, but is designed to be safe to take at home. It aids weight loss by taking up space in the stomach to make the person feel full. Promising early results Overall, 40 adults with a BMI between 30 and 41 took part in the trial. They were randomly assigned to two groups, which took either Sirona or a placebo for 12 weeks.   The researchers found the treatment was safe, with no participants reporting any serious side effects. Any side effects they did have were mild.   One in four participants taking the treatment lost between five and 10 percent of their body weight. However, this result will need to be confirmed in larger trials.   Moving onto larger trials Following these initial promising results, the researchers now plan to test Sirona in a much larger trial. This will recruit participants at sites located in many different countries. “This first-in-human study of Sirona is a really exciting collaboration between the team at the NIHR Southampton Biomedical Research Centre and Oxford Medical Products,” said Mr Byrne. “Working with clinical research colleagues in Bristol and Milton Keynes, we have delivered a randomised study confirming safety, feasibility and tolerability of this completely new and first-in-class product as a tool to support those living with overweight and obesity. “I am delighted that our results clearly also demonstrate the potential of Sirona as an entirely new approach to weight loss and weight management. “Our team is looking forward now to the pivotal study planned for 2025 as the next step that will further assess the effectiveness of Sirona in a larger multinational randomised study.”

Southampton researchers are highlighting the need to identify people at risk of a common muscle-wasting disease. Sarcopenia is characterised by a loss of muscle strength, muscle mass and function, and is commonly seen in older age. As it progresses, people can become weak and frail, and it can lead to loss of independence. A new study by local researchers has found a large proportion of older adults living in their own homes in Southampton are at risk. With one in six people worldwide expected to be over the age of 65 years in 2050, identifying these patients will be crucial in years to come. This will mean they can be prioritised and treated before the condition has a large effect on their life. An ageing population Globally, the number of people aged 65 and above is expected to rise to 1.6 billion by 2050. The number of people over 80 years old is expected to triple. This means there will be more people at risk of developing age-related diseases like sarcopenia. Identifying and treating these people early will be important to prevent their condition worsening. To identify people most at risk in Southampton, a team of researchers aimed to find out how common signs of sarcopenia are in older adults living at home in the local area. Working with local GPs The team set up the Southampton Longitudinal Study of Ageing (SaLSA). Working with the Living Well Partnership (LWP), they identified a group of 480 participants (219 men and 261 women) around the age of 80 years. Researchers and GPs worked with participants to complete the SARC-F questionnaire. This asks if they have signs of sarcopenia, such as problems with strength, walking, rising from a chair, climbing stairs and a history of falls. The results were used to generate a score for each person. Those who had a score of four or more were considered likely to have sarcopenia, with further tests needed to confirm a diagnosis. Overall, 28 men (12.8%) and 60 women (23%) had probable sarcopenia. This suggests the disease is common among older people in Southampton. Men, and to a lesser extent women, who were married or living with a partner were found to be less likely to have sarcopenia. Women with a higher BMI or other medical conditions were more at risk. The results have been published in the journal JCSM Communications . Dr Harnish Patel, Associate Professor of Geriatric Medicine at the University of Southampton and Consultant in Medicine for Older People at University Hospital Southampton (UHS), was first author. He said: “It’s essential that we are prepared to be able to recognise sarcopenia. We will continue to work with this new Southampton-based group of older people to identify those most at risk in our local area and to identify ways we can mitigate the effects of sarcopenia. These patients should be prioritised for further in-depth assessment for sarcopenia. It’s important that we catch them early on, before their muscle loss impacts on their functional ability.”

Southampton researchers are exploring the effects of dietary fats on inflammation. Dr Helena Fisk and Dr Ella Baker from the University of Southampton (UoS) have secured funding from the RIPEN Innovation Hub. They are currently supported by Bridging Fellowships from the NIHR Southampton Biomedical Research Centre (BRC). Their new award will establish a new methodology to measure metabolites of dietary fatty acids. The body can convert (metabolise) fatty acids into signalling molecules called oxylipins. Previous research has shown that oxylipins generated from omega-3 fatty acids can reduce inflammation. This award will also strengthen an industry partnership with Natures Crop International. The company grow and produce a plant-based omega-3 oil called Ahiflower.  Innovative technique Oxylipins are found in blood and tissues, and made by certain cells in the body. They can be measured using a technique called liquid chromatography tandem mass spectrometry. This new award will enable the researchers to set up the technique at UoS. It will be one of just four institutes in the UK with this capability. Dr Fisk and Dr Baker will be the first to measure oxylipins that are unique to the blend of fatty acids found in Ahiflower oil. This will increase understanding of the omega-3 oil’s influence on inflammation. What is Ahiflower? Ahiflower is a naturally wild plant that was discovered growing in a hedgerow in the UK countryside. Unlike other plant-based sources, it contains stearidonic acid (SDA). The body can convert this into one of the most active omega-3 fats: eicosapentaenoic acid (EPA). EPA is mainly found in oily fish like salmon and sardines. Dr Fisk said: “This award will support experimental approaches to increase our understanding of dietary lipid signalling and inflammation. “This is a rapidly growing area of interest as oxylipins are implicated in multiple diseases. Establishing this analysis in Southampton will support interdisciplinary collaboration and accelerate research at the forefront of this field.” The researchers will also link this new data to ongoing work comparing the effects of Ahiflower oil and fish oil on immune cells. Dr Baker said: “We will identify how the fatty acids in Ahiflower oil influence lipid signalling metabolites and reduce inflammation. We aim to advance understanding of how it works and its potential health benefits. “This research will provide scientific support for Ahiflower oil as a sustainable alternative to marine-sourced omega-3s.” Fellowship support Dr Fisk and Dr Baker are part of the NIHR Southampton BRC’s Nutrition, Lifestyle and Metabolism theme. They were both awarded one-year Postdoctoral Bridging Fellowships. These fellowships support researchers while they apply for external funding. Professor Karl Staples, Academic Career Development Lead   at the NIHR Southampton BRC, said: “Congratulations to Ella and Helena on this fantastic achievement. We are delighted that the Bridging Fellowships have been a springboard to this important next step in their research. “The NIHR Southampton BRC is proud to provide opportunities for post-doctoral bridging funding. It reflects our commitment to helping researchers realise their full potential.”

Researchers have identified a much-needed treatment for patients with a fatal lung condition. Dr Sophie Fletcher led Southampton’s involvement in the global trial, recruiting patients with the rare lung disease idiopathic pulmonary fibrosis (IPF). It is the first phase III trial success for this disease in ten years. The results offer new hope for these patients, who currently have very few options. Short life expectancy IPF is a rare disease that causes scarring of the lungs. Patients experience shortness of breath that gets worse over time, to the point that they may need oxygen. Other symptoms include a dry and persistent cough, chest discomfort, fatigue and weakness. People diagnosed with this condition only have a life expectancy of 3-5 years from diagnosis. It currently has limited treatment options, which can only be prescribed by a specialist centre. Although considered rare, IPF affects approximately three million people worldwide. The disease primarily affects patients over the age of 50, and affects more men than women. FIBRONEER™-IPF was the largest trial ever run for IPF, with over a thousand patients taking part in more than 30 countries. University Hospital Southampton (UHS) was one of over 330 sites involved. IPF is one of the more common interstitial lung diseases (ILD). Prof Mark Jones leads the ILD service at UHS. He is also Professor of Respiratory Medicine at the University of Southampton. “There is a high unmet need for patients with IPF,” he said. “Current approved treatments at best halve the rate of disease progression, and frequently patients have side effects that prevent treatment continuation.” Trial success The trial results suggest that the medicine nerandomilast, developed by the biopharmaceutical company Boehringer Ingelheim, slows down the decline in lung function in patients with IPF. Patients with IPF who took part were randomly assigned to one of three groups. The first two groups both took a nerandomilast tablet twice a day, but they were different doses for each group. The third group took a placebo tablet, which looked the same but didn’t contain the active ingredient. A Forced Vital Capacity test measured their lung function. This records the maximum amount of air you can forcibly breathe out from your lungs after taking the deepest breath you can. The results showed that, after 52 weeks, patients taking nerandomilast had better lung function than those taking the placebo. Dr Sophie Fletcher is a Consultant Respiratory Physician and part of the UHS Research Leaders Programme. “The UHS Clinical Respiratory research team seeks out and delivers research trials that offer therapies to our patients, providing options where there are none,” she said, “benefiting both the participant and through the gain of knowledge guide improved patient care. “As a research team, we are proud to be part of such a positive landmark trial.” Getting it approved as a treatment Boehringer Ingelheim are now seeking approval from the US Food and Drug Administration and other Health Authorities worldwide for nerandomilast to become a new IPF treatment. The company are also conducting another trial of nerandomilast in patients with a second ILD, progressive pulmonary fibrosis (PPF). “This is the first IPF phase-III-trial in a decade to meet its primary endpoint,” said Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim. “Today’s announcement represents the next step in our long history in the research of this disease. IPF has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases.”

Professor Dame Wendy Hall is leading calls for global governance of artificial intelligence (AI) ahead of a new United Nations (UN) report. Dame Wendy leads the Data, Health and Society theme at our NIHR Southampton Biomedical Research Centre. Her warning came ahead of the release of a new UN report on the future of AI. Advising on global AI governance Last year, Dame Wendy became the only British expert to be appointed to the UN’s high-level advisory body on AI . She joined 31 other experts to analyse the international governance of AI. Dame Wendy is a Regius Professor of Computer Science at the University of Southampton and Director of its Web Science Institute. Her comments were part of a talk she gave ahead of the UN body’s release of the Governing AI for Humanity report  about the future of AI, to which she was a key contributor. “We are already seeing the impact of AI breakthroughs across health, energy controls, food production, education,” she said. “Artificial intelligence must be allowed to develop for the good of humanity – but, without governance, it has potential to evolve in ways that would be harmful to society. “At the very least, we hope this report will stimulate meaningful conversations and debate about global governance.” Minimising and mitigating risks The report includes a series of recommendations about the development of AI globally. These aim to help ‘reap the benefits of AI’, while ‘minimising and mitigating the risks.’ Their recommendations include: establishing a global dialogue among the major nations developing AI creating an AI standards charter that establishes regulation launching a fund to support countries in the global south to benefit from AI creating an Office for AI – born out of the UN’s AI advisory body Dame Wendy has been at the forefront of computer science development for 40 years from Southampton. She warned some countries risk being left behind if the tech remains unregulated. “Current global efforts to establish AI governance are insufficient,” she said. “We desperately need a global approach that will address the challenges of AI and ensure that it benefits everyone - not just the few nations leading its development.”

An international study has found widespread agreement that pregnant women with severe asthma can be treated with biologics. Biologics are antibody-based treatments that are usually given as an injection. The research sought to reach a consensus among those who treat patients with severe asthma. It was led by Dr Hitasha Rupani, Consultant Respiratory Physician at University Hospital Southampton and part of the NIHR Southampton Biomedical Research Centre. Researchers have published their findings in The Lancet Respiratory Medicine . Asthma and pregnancy Asthma is the most common medical condition during pregnancy. It is very important for women with severe asthma to control it well during pregnancy. This is because uncontrolled asthma is associated with an increased risk of complications in pregnancy and birth. These include pre-eclampsia, premature labour and low birthweight. However, asthma symptoms can change in pregnancy. This means some women find their symptoms get worse, and they need extra treatments to keep their asthma under control. Steroid tablets are the standard treatment for asthma attacks. However, these can have numerous side-effects, both for the mother and the baby.   Biologics as an alternative Asthma biologics improve asthma control and reduce the frequency of asthma attacks, without having any of the side effects associated with steroid tablets. These treat some types of severe asthma by helping to stop body processes that cause lung inflammation. They are widely used in non-pregnant people and  help to bring the person’s symptoms back under control. Pregnant women did not take part in the clinical trials of asthma biologics. This means there is a lack of clear evidence on their safety in pregnancy. However, early data from monitoring women who have taken biologics in pregnancy has not found an association with an increased risk of complications. Reaching a consensus Dr Rupani aimed to provide guidance on whether to prescribe biologics to pregnant women with severe asthma. She led an international study that asked relevant experts for their professional opinion. This drew upon their combined knowledge and experience. Known as a Delphi study, it used a systematic and structured process to help them reach a consensus. Overall, 141 experts from 32 countries completed two rounds of online surveys. All of them cared for patients with severe asthma. They included respiratory physicians, allergists, specialist nurses, pharmacists and obstetricians. They reached a consensus for 34 of 69 statements. These covered the use of asthma biologics during conception, pregnancy, and breastfeeding. They agreed that asthma biologics: do not need to be stopped while patients are trying to conceive can be continued throughout pregnancy can be started during pregnancy in line with national prescribing criteria, especially in people with frequent exacerbations (four or more in a 12-month period) can be started and continued while breastfeeding It was also agreed that asthma-related admissions to hospital and steroid side effects should lower the threshold for starting biologics. They emphasised that shared decision-making should underpin all decisions regarding the use of biologics in pregnancy and that it is also important to discuss potential risks and benefits with each patient. Dr Rupani said: “Due to the lack of evidence from randomised-controlled trials, there is huge variation and hesitancy in the use of asthma biologics in pregnancy. However, asthma biologics are fantastic at improving asthma control and reducing the use of oral steroids - treatments that have numerous, serious side effects. “It is important that pregnant women do not miss out from receiving asthma biologics, simply because they weren’t included in the clinical trials. “Therefore, it is excellent that a group of international clinical experts agreed that, provided potential risks and benefits had been discussed and basic asthma care optimised, asthma biologics can be initiated and/or continued during conception, pregnancy and breastfeeding. "We hope the results of our study will help shared decision-making and reduce variations in care.”