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Take a look at a selection of our recent media coverage:

New protocol for IBD referral triage reduces diagnostic delays, say researchers

24th April 2024

Patients with suspected inflammatory bowel disease (IBD) could avoid unnecessary colonoscopy tests and speed up diagnosis by using multiple home testing kits, a new study has found.

Researchers from the University of Birmingham, UK, have developed a unique testing protocol to improve IBD referral triage by combining a new 13-point symptom checker with the results of multiple faecal calprotectin (FCP) tests.

Obtaining a second FCP result prevented patients from undergoing unnecessary colonoscopies. The findings could reduce the need for expensive and intrusive investigations, speed up diagnosis for many IBD patients, and support self-diagnosis to secondary care. This would, in turn, reduce the burden on primary care.

The study, published in the journal Frontline Gastroenterology, is the first in the UK to prospectively examine the symptoms of IBD and levels of faecal calprotectin (FCP) from the onset of the condition. 

Patients with IBD, including Crohn’s disease and ulcerative colitis, often have a long wait until diagnosis, and the researchers note that the current testing system is under immense strain. Diagnostic delays for IBD can result in adverse outcomes for patients.

The two-year study, which took place between January 2021 and August 2023, involved 767 participants. Over half of those who took part (n=423, 55%) were diagnosed with IBD: 208 with Crohn’s disease and 215 with ulcerative colitis.

A 13-point symptom history was taken prediagnosis, and clinical indices such as repeat FCP were collected prospectively.

The most common symptoms, which were not always easily distinguished from non-IBD symptoms, were abdominal pain (84%), looser stools (84%) and fatigue (79%) for Crohn’s disease and per-rectal bleeding (94%), urgency of stools (82%), and looser stools (81%) for ulcerative colitis.

The researchers found blood in the stools and weight loss to be the strongest predictors of IBD. The results showed that a person with blood in their stools was over four times more likely than those without to have Crohn’s disease (based on a measurement of an odds ratio (OR) of 4.38 with a 95% confidence interval and a range of 2.40 to 7.98) and over three times more likely to have weight loss (OR 3.39; 2.14–5.38).

Patients diagnosed with ulcerative colitis were 33 times more likely to experience blood in their stools and over two times more likely to have weight loss (OR 33.68; 15.47–73.33 and OR 2.33; 1.37–4.00, respectively).

Serial FCP measurements were found to be more useful than a single test for predicting IBD accurately.

Two FCP measurements, where one is greater than 100 µg/g and the other greater than 200 µg/g, were shown to be associated with the diagnosis of IBD. However, a second result, ≥220 µg/g, when considered alone and regardless of the first result, was more accurate at predicting IBD.

Some patients with elevated FCP levels and were suspected of having IBD were re-tested and showed a reduction in levels since the first measurement, indicating the initial elevated levels of FCP were not due to IBD.

Using the findings, the researchers have developed a rapid-access pathway for suspected IBD patients outside of the urgent ‘two-week wait’ criteria, with patients triaged by utilising a combination of FCP results and symptom history. 

The researchers suggest that the results from home FCP testing can be coupled with a review of symptoms to form the foundation of effective self-referral pathways. Based on the study findings, patients with two FCPs >200 µg/g could be streamed directly to colonoscopy, while those with two FCPs >100 µg/g could be reviewed in clinic.

A second result ≥220 µg/g is deemed more accurate than dual-result thresholds and can indicate that a patient should be referred directly for a colonoscopy. The researchers observed that only 20% of patients had two samples submitted before referral to secondary care.

Dr Peter Rimmer, academic clinical lecturer in gastroenterology at the University of Birmingham’s National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC) and corresponding author of the study said: ‘Using a comprehensive 13-point symptom checker and multiple FCP tests, we have been able to identify much more accurately patients who had IBD and other diseases.

‘The rollout of this protocol could reduce the time taken to get a diagnosis and start treatment for IBDs as much more of the screening and testing can be done through primary care. The sensitivity of multiple FCP tests can be used to flag those patients who urgently need referral into secondary care.’

The researchers hope the study will improve referral triage for IBD patients and open new care pathways for them. A large follow-up study will explore the latter.

Efficiencies in the diagnosis of Barrett’s oesophagus have also recently been identified with a successful pilot project using a capsule sponge test found to reduce the need for invasive endoscopy.

Anti-IL17 peptide shows high clinical efficacy for immune-related inflammatory diseases

23rd August 2023

An anti-IL17 peptide sequence has demonstrated high clinical efficacy in models of immune-mediated inflammatory conditions, warranting further clinical evaluation.

Researchers from the University of Birmingham, together with colleagues from the University of Naples Federico II, developed a novel anti-IL17 peptide sequence with greater activity and potentially fewer side effects than existing biologic therapies for immune-mediated inflammatory conditions.

Biologic therapies targeting interleukins, such as anti-IL-17, anti-IL12/23 and anti-IL23, have become established therapies in the treatment of immune-mediated inflammatory conditions such as psoriasis, rheumatoid arthritis and inflammatory bowel disease. However, these novel agents often show low therapeutic efficacy and immunogenicity in certain patient subgroups, thereby limiting their effectiveness.

Writing in the Annals of Rheumatic Disease, the researchers set out to improve the coverage and efficacy of antibodies targeting IL-17A and/or IL-17F.

Anti-IL17 peptide

Using murine and human IL-17A/F protein sequences, the researchers identified a bioactive 20-amino acid IL-17A/F-derived peptide that mimicked the pro-inflammatory actions of the full-length proteins.

Once this sequence had been determined, the team generated a novel anti-IL-17 neutralising monoclonal antibody directed against the sequence, which they named Ab-IPL-IL17™.

Using tissue and animal studies, the researchers were able to demonstrate that Ab-IPL-IL-17 was capable of effectively reversing the pro-inflammatory, pro-migratory actions of not only the 20-amino acid peptide sequence but also IL-17A/F.

In addition, when compared with secukinumab – the current gold-standard biologic – the anti-IL17 peptide gave rise to less off-target immune-related effects. There was also no reduction in platelet counts or an increase in the level of lymphocytes.

In a proof-of-concept study for rheumatoid arthritis, the anti-IL17 antibody inhibited the pro-inflammatory actions of chronically inflamed fibroblasts within the rheumatoid joint.

Similarly, using serum samples from treatment naive inflammatory bowel disease patients, their novel antibody was able to deplete plasma IL-17A, suggesting a potential to alleviate pathological pro-inflammatory changes.

The authors described how Ab-IPL-IL-17, which did not generate immunogenicity, lymphocytosis or thrombocytopenia properties, highlighted potential clinical superiority over current therapies.

They called for future clinical trials to address the varying requirements of Ab-IPL-IL17 as an alternative biological therapy for treating patients with immune-mediated inflammatory diseases.

New IBD awareness campaign encourages innovative treatment access

19th May 2023

A new campaign focusing on treatment access for inflammatory bowel disease (IBD) has been launched by Celltrion Healthcare to mark today’s World IBD Day.

Entitled ‘Where’s CC? (Crohn’s and Colitis)’, and based on the ‘Where’s Wally?’ concept, the campaign encourages people to find hidden characters in the campaign imagery to learn more about the unique challenges faced by people diagnosed with Crohn’s disease and ulcerative colitis. Based on real-life patient insights, the campaign’s aim is to support all patients so they feel represented and able to access high-quality care and innovative treatment options.

A collaboration with the leading patient organisation the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA), Where’s CC? also highlights the fact that IBD can affect anyone of any age.

Over 10 million people worldwide are living with IBD and while it is most commonly diagnosed between the ages of 10 and 40, some 10-15% of newly diagnosed cases of IBD are in people over the age of 60. However, clinical research, education and understanding however do not reflect this, according to Celltrion Healthcare.

‘Every IBD patient, no matter their age, deserves to feel understood and have access to high quality care and effective, innovative treatments,’ said Kevin Byoung Seo Choi, senior vice president and head of marketing division at Celltrion Healthcare. ‘Innovations in treatments, including advances in treatment administration that enable people to access at-home injectable treatment allows people to have an improved quality of life whilst managing their condition.’

Salvo Leone, EFCCA chairman, commented: “This World IBD Day, we are delighted to have partnered with Celltrion Healthcare to spotlight some of these challenges to raise awareness and improve care for IBD patients across the world. The Where’s CC? campaign includes important patient resources, and we encourage everyone to spread the word as we work towards a situation where all IBD patients can have a good quality of life.”

IBD patients develop new gastrointestinal symptoms with COVID-19

12th August 2021

New gastrointestinal symptoms in patients with irritable bowel disease is a feature of infection with COVID-19 rather than a disease flare.

The presence of gastrointestinal (GI) symptoms among those infected with COVID-19, occurs in around 17.6% of patients. Whether or not the presence of GI symptoms is prognostic for more severe disease, however, remains unclear except perhaps for abdominal pain. In contrast, other studies have indicated that the development of GI symptoms could even attenuate any COVID-19 associated inflammation. The term inflammatory bowel disease (IBD) is essential an umbrella term which covers both Crohn’s disease and ulcerative colitis although typically, both groups of patients will experience symptoms of diarrhoea, abdominal pain, fatigue, rectal bleeding and weight loss. Some evidence indicates that among those with IBD infected with COVID-19, there is a higher incidence of both diarrhoea and abdominal pain, compared to non-IBD patients. In fact, in a review of 1028 patients with IBD infected with COVID-19, 20% experienced diarrhoea. Given that infection with COVID-19 can lead to gastrointestinal symptoms in nearly a fifth of patients without IBD, researchers from the Henry D Janowitz Division of Gastroenterology, Icahn School of Medicine, New York, US, decided to examine the extent of symptoms experienced by IBD patients using data held within a global disease registry. The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry, created to monitor the outcomes of COVID-19 in both adults and children with IBD. Clinicians are advised to the voluntarily report all cases of PCR-confirmed infections in all their IBD patients onto the registry to enable the capture of data related to those with IBD. Using this registry, the team sought to determine the association between any new GI symptoms with the odds of death due to COVID-19.

Data were available for 2917 IBD patients who had COVID-19, of whom, 26.4%, with a mean age of 43 years (55.5% female) developed new GI symptoms when infected with the virus. There was no significant difference in the incidence of new GI symptoms in those with Crohn’s disease or ulcerative colitis. Moreover, new gastrointestinal symptoms occurred more frequently in those with active disease compared to those in remission (29.4% vs 23.3%, p < 0.01). The pattern of symptoms however, was broadly similar apart from abdominal pain. For instance, diarrhoea occurred in 83% vs 76% (active disease vs remission) and nausea in 24% vs 25% (active disease vs remission). The greatest disparity was in abdominal pain (44% vs 26%, active disease vs remission). In addition, patients with IBD experiencing new GI symptoms were more likely to be hospitalised because of COVID-19 (31.4% vs 19.2%, p < 0.01) although the development of new symptoms was not associated with a higher risk of death.

The authors discussed how the development of new gastrointestinal symptoms were unlikely to represent a disease flare, because a large number of those in remission also experienced new symptoms after becoming infected. They concluded that the presence of new gastrointestinal symptoms in a patient with IBD should clinicians to consider infection with COVID-19 although the team also felt that further studies were needed to determine if infection could trigger an IBD flare or even alter the subsequent course of the disease.

Ungaro RC et al. New Gastrointestinal Symptoms Are Common in Inflammatory Bowel Disease Patients With COVID-19: Data from an International Registry. Inflamm Bowel Dis 2021

Infliximab attenuates COVID-19 antibody response

29th March 2021

Immunosuppressant therapy affects an individual’s immune response but how this impacts on the COVID-19 antibodies is uncertain.

The production of an effective immune response after infection with COVID-19 is of paramount importance in preventing further bouts of infection. Moreover, biologicals such as infliximab, which target tumour necrosis factor (TNF), are known to impair protective immunity following a number of viral infection vaccinations including influenza, viral hepatitis and pneumococcus, thereby increasing the risk of serious infection. Hence in the early part of the COVID-19 pandemic, patients prescribed immunosuppressant therapy were advised to shield. Fortunately, information derived from international registry data indicates that the rates of severe infection among patients prescribed immunosuppressants are similar to the background population rates. However, whether anti-TNF drugs actually impair the immune response in those who have already been infected with COVID-19 is uncertain. This prompted a team from the Department of Gastroenterology, Royal Devon and Exeter Trust, UK, to examine the subsequent immune response in those with inflammatory bowel disease (IBD) after infection with COVID-19 and treated with infliximab. In an effort to test whether the immune response was blunted, the team retrospectively compared antibody responses in those treated with either infliximab or vedolizumab, a gut selective anti-integrin alpha4beta7 monoclonal antibody, for at least 6 weeks. Consecutive patients at the hospital were recruited when attending their infusion appointments and those who had participated in any of the COVID-19 vaccine trials were excluded. The primary outcome was the proportion of patients with a positive COVID-19 test and a secondary outcome was the magnitude of the antibody response between the two treatment groups, in those who tested positive. The team collected several additional pieces of information including demographics as well as information on IBD disease activity and mental health wellbeing and anxiety assessment and used this to construct multivariate logistic regression analysis.

A total of 6935 patients were included in the analysis of whom, 67.6% were prescribed infliximab with a mean age of 37.1 years (45.5% female). The majority of those prescribed infliximab had Crohn’s disease (66.6%) or ulcerative colitis (31.1%). In contrast, most of those (60.1%) prescribed vedolizumab had ulcerative colitis. There were a similar proportion of patients in both groups who either reported COVID-19 symptoms (8.3% vs 8.9%, infliximab vs vedolizumab) or tested positive (5.2% vs 4.3%) or who were hospitalised (0.2% vs 0.2%) because of their infection. Overall, the prevalence of COVID-19 antibodies was 4.3% but this was significantly lower in those using infliximab (3.4% vs 6%, p < 0.0001). Additionally, among those with PCR confirmed COVID-19 infection, seroconversion was observed in fewer patients treated with infliximab (48% vs 83%).

In a discussion of their findings, the authors noted how infliximab appeared to attenuate the subsequent serological response to the virus despite a similar level of rates of either symptoms or positive tests. They also described how as the action of TNF is to stimulate B cells, the effect of infliximab was biologically plausible.

They concluded that their work had important implications for vaccinating those prescribed infliximab and called for serological surveillance to detect suboptimal vaccine responses.

Kennedy NA et al. Anti-SARS-CoV-2 antibody responses are attenuated in patients with IBD treated with infliximab. Gut 2021