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

IBD and type I diabetes increase chances of developing rheumatoid arthritis

16th June 2019

A study has shown increased rates of type I diabetes and inflammatory bowel disease (IBD) in patients that go on to develop rheumatoid arthritis (RA).1 
 
Results of the study demonstrate that the RA group reported significantly more cases of inflammatory bowel disease (1.9% vs. 0.5%, p<0.001) and type I diabetes (1.3% vs. 0.4%, p=0.01) versus controls.1
 
“While it is common for patients to have both type I diabetes and rheumatoid arthritis, our results suggest that inflammatory bowel disease and type I diabetes may predispose to rheumatoid arthritis development, which merits further study,” said Vanessa Kronzer, MD, Mayo Clinic School of Graduate Medical Education, Minnesota, USA. 
 
Although the number of comorbidities was the same between groups in the timeframe prior to RA diagnosis, in the time period after RA diagnosis there were significantly more comorbidities reported in the RA group versus controls (median 5.0 vs. 4.0, p<0.001). In addition, between group differences were significant for several comorbidities. 
 
Interestingly, there were significantly more cases reported in the RA group for venous thromboembolism (VTE) (10% vs. 6%, p<0.001) and epilepsy (3% vs. 1%, p=0.003) versus controls, indicating that they may be novel comorbidities for patients with RA. Heart attacks were more common in the RA group versus controls (3.8% vs. 1.2%, p<0.001) but high cholesterol was less common (11.4% vs. 16.4%, p=0.004). Cancer was not more common in either group, even among all cancer subtypes.1
 
”These results are important because understanding the timeline of comorbidity development in patients with rheumatoid arthritis will inform our knowledge of the disease progression and help identify targets for improving outcomes,” said Professor Hans Bijlsma, President, EULAR. 
 
The study included 821 patients with RA from a biobank, each with a further three matched controls based on age, sex, and location of residence at the time of the biobank survey. The survey included the self-reported presence/absence and age of onset for 77 comorbidities. The mean age was 62 years, and 73% were female.1
 
Reference
  1. Kronzer V et al. Comorbidities as risk factors for rheumatoid arthritis (RA) and accrual after RA diagnosis. EULAR 2019; Madrid: Abstract OP0088. 

Vagus nerve stimulation study shows significant reduction in RA symptoms

15th June 2019

The results of a study suggest that electro stimulation of the vagus nerve could provide a novel treatment approach for patients with rheumatoid arthritis.1 
 
“This is a really exciting development. For many patients suffering from rheumatoid arthritis, current treatments don’t work, or aren’t tolerated,” said Professor Thomas Dörner, Chairperson of the Scientific Programme Committee, EULAR. 
 
“These results open the door to a novel approach to treating not only rheumatoid arthritis, but other chronic inflammatory diseases. This is certainly an area for further study.” 
 
The vagus nerve is the longest and the most complex of the 12 pairs of cranial nerves that originate from the brain. The name ‘vagus’ comes from the latin word for ‘wandering’. This is because the vagus nerve wanders from the brain into the organs of the neck, chest and abdomen.2
 
Recent advances in neuroscience and immunology have mapped circuits in the brain that regulate immune responses. In one of the circuits, the ‘inflammatory reflex’, signals are transmitted in the vagus nerve that inhibit the production of cytokines including tumour necrosis factor (TNF), an inflammatory molecule that is a major therapeutic target in rheumatoid arthritis. It is thought that, by stimulating the activity of this inflammatory reflex, innate immune responses can be modulated without abolishing them or producing significant immunosuppression.3
 
In this pilot study, a novel miniaturised neurostimulator called a MicroRegulator was implanted into 14 patients with rheumatoid arthritis who had failed on at least two biologics or targeted oral therapies with different mechanisms of action. Patients were randomised to three groups who were either placebo, stimulated once daily, or stimulated four times a day for 12 weeks. At the end of the study, the patients who received once-daily stimulation were shown to have a better response than those on four-times-daily stimulation with two thirds meeting the EULAR good or moderate response criteria and a mean change in DAS28-CRP of -1.24. The mean change in DAS28-CRP in the placebo group was 0.16.1 
 
Cytokines (a broad and loose category of small proteins that are important in cell signalling) were also measured in the study with the actively stimulated groups showing a decrease of more than 30% in levels of interleukin (IL) 1β, IL-6, and TNF-α. Implantation and stimulation were generally well tolerated with no device or treatment-related SAEs and two surgery-related adverse events that resolved without clinically significant effects.1
 
“Our pilot study suggests this novel MicroRegulator device is well tolerated and reduces signs and symptoms of rheumatoid arthritis,” said Mark Genovese, MD, James W. Raitt Endowed Professor of Medicine, Stanford University, Stanford, California, USA. 
 
“These data support the study of this device in a larger placebo-controlled study as a novel treatment approach for rheumatoid arthritis and possibly other chronic inflammatory diseases.” 
 
This study follows a proof-of-concept study which used reprogrammed epilepsy stimulators on the vagus nerve to demonstrate reduced systemic inflammation and improved disease activity in 17 patients with rheumatoid arthritis.4
 
The study included 14 patients with active rheumatoid arthritis who had had an insufficient response to more than two biological disease modifying anti-rheumatic drugs (bDMARDs) or JAK inhibitors with more than two modes of action. All patients remained on stable background of methotrexate. The first three patients were implanted and stimulated after three weeks, following safety review board approval, the remaining 11 patients were implanted and randomised to one minute of stimulation once-daily, one minute of stimulation four times daily, or one minute of placebo stimulation.1
 
References
  1. Genovese MC et al. First-in-human study of novel implanted vagus nerve stimulation device to treat rheumatoid arthritis. EULAR 2019; Madrid: Abstract LB0009. 
  2. The Vagus Nerve (CNX). Teach Me Anatomy. Available at https://teachmeanatomy.info/head/cranial-nerves/vagus-nerve-cn-x/ [Last accessed June 2019]. 
  3. Andersson U, Tracey KJ. Reflex Principles of Immunological Homeostasis. Annu Rev Immunol 2012;30:313–35.  
  4. Koopman FA et al.  Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016;113(29):8284–9.  

EULAR launches Time2Work campaign

14th June 2019

EULAR has launched the Time2Work campaign to raise awareness of the impact rheumatic and musculoskeletal diseases (RMDs) have, not only on individuals, but wider society, productivity and our economies and what can be done to improve this situation.
 
Affecting one quarter of the EU population (120 million), RMDs are the biggest cause of sick leave and premature retirement due to physical disability. As one of the main causes of physical disability, RMDs contribute considerably to loss of productivity in the workplace.
 
“Work is a critical part of building self-esteem and it’s a tragedy that so much talent is lost from the workforce,” said Professor Iain McInnes, EULAR President Elect. “Today we call for three things – greater access to early interventions to limit the pain, tiredness and immobility that make it difficult to keep working, greater awareness of the challenges people with rheumatic diseases face and a review of the way we work. Small adjustments like flexible hours, improved access, home working and standing desks could make all the difference. EULAR is committed to increasing the participation of people with RMDs in work by 2023 and the Time2Work campaign is an important part of helping us achieve this goal.”
 
Time2Work is part of EULAR’s ongoing Don’t Delay, Connect Today campaign which is committed to raising awareness of the importance of early diagnosis of RMDs. Early diagnosis, early referral to a rheumatologist and early access to effective treatments are known to improve outcomes, quality of life and the ability to work, but diagnosis is often delayed or never received.
 
“Keeping people with rheumatic and musculoskeletal diseases in work not only benefits individuals, but also the whole of society,” says Marios Kouloumas, EULAR Campaign Lead and President of the Cyprus League Against Rheumatism. “We need to ensure that people who develop RMDs are diagnosed early and have access to the latest, most effective treatments and the right support to help them remain in work. We also need to encourage employers to adopt inclusive practices and universal designs – workplaces that are good for people with disabilities are good for everyone.”
 
EULAR’s Time2Work campaign calls for the RMD community to come together to help people with RMDs access and remain in work. The campaign encompasses all three pillars of EULAR: People with Arthritis and Rheumatism in Europe (PARE), Health Professionals in Rheumatology (HPR), and Scientific Societies across Europe.

Significant gaps in essential RA care across Europe and between European countries revealed

The results of a large pan-European survey presented at EULAR 2019 investigated significant gaps in rheumatoid arthritis care across 16 patient-centred Standards of Care (SoC) in rheumatoid arthritis.1  
 
Results reveal ‘diagnosis within six weeks’ as the most concerning SoC, with 52% (weighted means across countries) of patients and 59% of rheumatologists reporting problematic gaps. The next highest were; information about patient organisations (40% and 38%), training on aids, devices and ergonomic principles (39% and 34%), vaccination-related information (38% and 27%), receiving a schedule of regular assessment (33% and 23%), information on adequate physical exercise (35% and 20%), and availability of treatment plan (35% and 18%). The least frequent problematic SoC for both patients (8%) and rheumatologists (3%) was adequate disease-modifying anti-rheumatic drug received.1  
 
“It is concerning to see so many problematic gaps reported across many essential aspects of rheumatoid arthritis care,” said Rachelle Meisters, PhD, Care and Public Health Research Institute (CAPHRI), Maastricht University, The Netherlands. “We hope these results act as a loud wake up call to services across Europe.” 
 
Analysis of the data reveals patients with higher education and lower self-reported health report problematic gaps more frequently. Among rheumatologists, patterns in determinants across SoCs were less consistent.1  
 
Country disparities by GDP 
However, for about half of the SoCs, rheumatologists from lower gross domestic product (GDP) countries identified problematic gaps more often than those from medium or high GDP countries. Additionally, large variation remained across countries for patient analyses, and most rheumatologist analyses, despite adjustment for individual characteristics.1  
 
The survey included 1422 patients from 27 European countries, and 1,044 rheumatologists from 33 European countries. The mean age was 57.2 and 47.7 for patients and rheumatologists respectively, with 74% and 53% being female. The 16 SoCs were those developed by Eumusc.net, a EULAR and EU supported initiative to raise and harmonise quality of care for patients across Europe. Participants were asked to rate each SoC on the level of care standard that was achieved (1-10), and on level of importance (1-10). The distance of level of care from the maximum was multiplied by the level of importance and was defined as problematic when this score was greater than 30 and the importance score was six or more.1 
 
An additional study presented today at EULAR 2019 analysed the quality of care of patients with systemic lupus erythematosus in Germany. They also revealed significant gaps as on average only 61% of relevant care aspects were fulfilled. In a second step, the study analysed whether the quality of care was associated with disease outcomes.2
 
Results showed that fulfilling more quality measures in 2013 was predictive for high disease-related quality of life (p=0.004), low progress in disease-related damage (p=0.048) and low disease activity (p=0.046) in the subsequent years.2
 
“Our results show that consistent consideration of these care parameters, recommended in several management guidelines, yield a positive effect on outcome,” said Dr. Med. Anna Kernder, Policlinic of Rheumatology & Hiller-Research Unit, Heinrich-Heine-University Düsseldorf, Germany.  
 
Data derived from the LuLa study, collecting annual data from a representative cohort of patients with SLE in Germany. In 2013 they additionally inquired about clinical care as a main topic. From 21 clinical care parameters, 10 were evaluated in univariate analysis. 
 
The fulfillment varied between 22.8% having fat metabolism counseling to 97.6% receiving osteoporosis protection with a glucocorticoid. The others were antimalarials, vaccination, blood pressure, yearly testing of urine and blood, treatment of fat metabolism disorder, osteoporosis, and hypertension. Linear regression was used to examine the relationship between quality measures calculated in 2013 and outcome parameters in subsequent years adjusted for age, disease duration and gender.2
 
References
  1. Meisters R et al. Standards of care for rheumatoid arthritis: gaps in implementation experienced by patients and rheumatologists across 33 European countries. EULAR 2019; Madrid: Abstract OP0307. 
  2. Kernder A et al. Quality of care predicts outcome in systemic lupus erythematosus – cross sectional analysis of a German long-term study (LuLa  cohort, 2011-2015). EULAR 2019; Madrid: Abstract OP0308. 

Suicidal thought related to pain in one in ten patients with rheumatic or musculoskeletal disease

A survey has highlighted the significant impact of rheumatic and musculoskeletal diseases (RMDs) on mental health and a worrying lack of psychological care.1
 
“Not enough is being done to identify mental health issues and provide the support needed to RMD  patients,” said Professor Thomas Dörner, Chairperson  of the Scientific Programme Committee, EULAR. “This survey highlights the huge importance of pain on the psychological well-being of RMD patients and the critical need to improve the support on offer. These results should act as a wake-up call to services across Europe.”
 
A survey of over 900 RMD patients revealed that pain had caused one in ten to have suicidal thoughts within the previous four weeks. Pain had also caused 58% to feel that everything was unmanageable for them.1
 
Another important finding was a reciprocal relationship between sleep and pain where 69% identified the quality of their sleep as having a negative influence on their pain. In return, two thirds of patients rarely or never feel fully rested when they wake up in the morning, with 36% taking painkillers to improve their sleep.1
 
“Our study indicates that pain and poor quality of sleep have a huge impact on a patient’s daily life, especially on their mental health,” said Lene Mandrup Thomsen, the Danish Rheumatism Association, Denmark. “We are using the results of this study in our political work to help campaign for  better  treatment and support for patients with chronic pain in our  healthcare system.”
 
Of the participants, 83% have  pain  daily  or  several  times  a  week and 46%  have received strong painkillers over the  last  year. Despite a strong focus from Danish authorities on reducing their prescription, less than a quarter of respondents had been offered an alternative to strong painkillers.
 
Results of another survey, also presented at EULAR 2019, support these findings by revealing a worrying lack of psychological care for patients with rheumatoid arthritis and adult juvenile idiopathic arthritis (AJIA) in the UK.2
 
In this survey, a quarter of the 1620 people with rheumatoid arthritis or AJIA were experiencing clinical levels of anxiety or depression. Over half of these had never received a formal diagnosis. However, most concerningly half of the respondents with rheumatoid arthritis and a third of those with AJIA who had either clinical levels or a formal diagnosis of anxiety or depression had never received any psychological support.2
 
“Our results highlight that, despite guidelines, many patients in the UK are not receiving the psychological support they need,” said Dr Hayley McBain,  Health  Psychologist, City, University of London, UK. “It is imperative for rheumatology services to routinely measure anxiety and depression in order to intervene before the individual is in crisis.”
 
The survey was  conducted  by  the National Rheumatoid Arthritis Society in the UK and was designed by patients and researchers. Participants were recruited via social media platforms, membership and non-membership lists and in newsletters and forums. Recruitment was focused on those diagnosed with rheumatoid arthritis or AJIA aged 18 years and over.2
 
References
  1. Mandrup Thomsen L. The influence of pain on sleep problems, mental health and use of strong painkillers among patients with arthritis. EULAR 2019; Madrid: Abstract OP0347-PARE.
  2. McBain H, Bezzant M, Bosworth A. Is psychological support reaching those in most need? a survey of people with rheumatoid arthritis and adults with juvenile idiopathic arthritis. EULAR 2019; Madrid: Abstract OP0318-HPR.

Medicines project delivers £11 million savings

13th June 2019

Pharmacies in Cheshire and Merseyside in the UK are being notified by their local hospital when a patient is discharged who might need help understanding changes to their medicines following their stay.
 
The initiative, called Transfer of Care Around Medicines, is improving patient safety and quality of care by providing support for patients and their carers following a hospital discharge – and saved the NHS in Cheshire and Merseyside an estimated £11 million over the three years to summer 2019 through a reduction in hospital readmissions.
 
All 635 community pharmacies in Cheshire and Merseyside are participating, and this has been shown to help reduce the number of avoidable bed days in hospital in what is thought to be the most comprehensive rollout of the programme in the country. 
 
Some patients leaving hospital need advice and support to help them take their medicines correctly and safely. Around 60 per cent of patients have three or more changes made to their medicines during their stay in hospital, and only 10 per cent of older patients are discharged with the same medication they were taking before they went into hospital.
 
In 2016 NHS England in Cheshire and Merseyside in partnership with the Innovation Agency, the Academic Health Science Network for the North West Coast, received funding to help introduce new systems enabling the transfer of care from hospitals to community pharmacies. A secure digital system allows a hospital’s pharmacy team, with the patient’s consent, to inform their local pharmacy of the patient’s medicines on discharge and the reasons for any changes so the pharmacist can follow up with advice and services.
 
As of May 2019, Transfer of Care Around Medicines in Cheshire and Merseyside has been implemented in 10 trusts, including 11 hospitals, two mental health trusts and all 635 community pharmacies – the fastest adoption and widest spread of the initiative in any region in England.
 
By March of this year there had been 17,686 referrals to community pharmacists resulting in an estimated reduction of 6,008 bed days to the NHS as well as improved patient safety and quality of care.
 
Una Harding, pharmacist at Day Lewis Pharmacy in Aintree, said: “We now get notifications on our system on a daily basis, it’s a platform we use every day. New discharges or referrals are the first thing you see when you log on. If we see a patient has recently been in hospital we can make a note to speak to them about their medication when they next come in.
 
“Patients now understand we can deliver more for them. There’s a culture now where people are realising that their GP doesn’t always have to be the first port of call. They know now that if they come into the pharmacy we can talk to them about the changes to their medication.
 
“It’s fabulous. Finally we’re getting more information so we can make more clinical decisions without having to hunt for information from different sources.”
 
Hassan Argomandkhah, Chair of Pharmacy Local Professional Network NHS England Cheshire and Merseyside, said: “This initiative started as an ambitious idea but we’ve managed to achieve it, and even if we’ve made just one small change in the quality of life of one patient in the past two years it’s been well worth it. None of this would have happened without the dedication of the pharmacists and their teams – whether in NHS England, in the community pharmacies, or in the hospital pharmacy teams – and all the other ancillary staff surrounding them. Without that support and encouragement we wouldn’t have achieved this.”
 
Dr Liz Mear, Chief Executive of the Innovation Agency, said: “The scale and speed of the adoption of Transfer of Care Around Medicines in Cheshire and Merseyside is an inspiring example of the region’s healthcare professionals collaborating to improve the quality of care for patients and the efficiency of our health services.
 
“The initiative demonstrates the value of community pharmacies as a key part of our healthcare infrastructure. Transfer of Care Around Medicines has been adopted by the AHSN Network nationally as one of our key innovation programmes and I hope that Cheshire and Merseyside will be an exemplar to other regions, supporting the spread of this invaluable collaboration.”

No link between cancer and TNF inhibitor use in psoriatic arthritis

The results of a study presented EULAR 2019 suggest that overall cancer risk is not linked to tumour necrosis factor inhibitor (TNFi) use in psoriatic arthritis.1 
 
The study analyses the risk of primary cancer in over 8000 TNFi-treated psoriatic arthritis patients from Sweden, Denmark, Iceland, and Finland. Results demonstrated no increase in risk of all cancer, as well as site specific cancers including colorectal, lung, malignant melanoma, pancreas, brain, female breast, endometrial, and prostate.1
 
“TNF inhibitors have a well-established efficacy and safety profile in patients with psoriatic arthritis and we welcome these data which contribute to our understanding in the complex area of cancer risk,” said Professor Hans Bijlsma, President, EULAR. 
 
There was a significant increase in malignant lymphomas observed within the trial (standardised incidence ratio: 1.84, 95% confidence interval: 1.20-2.82).1 However, it is not clear if this is due to the psoriatic arthritis disease or the TNFi treatment. There is limited data on lymphoma risk in psoriatic arthritis, however, an excess risk has been reported for several other chronic inflammatory rheumatic diseases with a well-established doubled average risk in patients with rheumatoid arthritis.2
 
“Our study provides convincing evidence that the use of TNF inhibitors does not increase the risk of overall cancer in patients with psoriatic arthritis,” said Professor Lene Dreyer, Aalborg University Hospital, Aalborg, Denmark. “Further analysis is needed to assess whether the observed increase in malignant lymphomas is due to the psoriatic arthritis disease or the TNFi treatment.” 
 
Psoriatic arthritis is a chronic inflammatory disease that affects the joints, causing pain and disability. The disease often causes swelling of the fingers and toes, mainly because of joint inflammation. Tumour necrosis factor inhibitors have been shown to be efficacious in psoriatic arthritis. However, tumour necrosis factor (TNF) also plays a complex role in the development and progression of cancer and so the use of TNFi may theoretically increase the risk of tumour development. 
 
This population-based cohort study includes 5218, 2039, 270 and 526 TNFi-treated psoriatic arthritis patients from ARTIS (Sweden), DANBIO (Denmark), ICEBIO (Iceland), and ROB-FIN (Finland) respectively. Patients were followed from first registration with TNFi-treatment and linked to the national cancer registry in each country (patients with a history of cancer were excluded). The cancer rates were compared with the general population standardised to age, sex and calendar period within each country. Standardised incidence ratios were estimated for both any cancer and site-specific cancers of interest.1
 
References
  1. Ballegaard C et al. Incidence of overall and site-specific cancers in TNF inhibitor treated patients with psoriatic arthritis: a population-based cohort study from 4 Nordic countries. EULAR 2019; Madrid: Abstract OP0005. 
  2. Hellgren K et al. Ankylosing spondylitis, psoriatic arthritis, and risk of malignant lymphoma: a cohort study based on nationwide prospectively recorded data from Sweden. Arthritis Rheumatol 2014;66(5):1282-90. 

New biomarkers for cardiovascular risk in juvenile-onset SLE

The results of a study presented at EULAR 2019 identify ApoB:A1 ratio and metabolomic lipoprotein signatures as potential  biomarkers for cardiovascular risk in patients with  juvenile-onset systemic lupus erythematosus (JSLE).1
 
In depth metabolomics was used to investigate dyslipidaemia and cardiovascular risk in a cohort of patients with  JSLE. Unbiased hierarchical clustering stratified patients by metabolomic profile and revealed three distinct groups.
 
Groups One and Two were identified as high and low cardiovascular risk respectively  based on their  unique lipoprotein profile, immune cell phenotype and clinical presentation. Further analysis identified ApoB:A1 ratio as a highly predictive biomarker distinguishing between these high and low cardiovascular risk groups. Longitudinal analysis revealed that the ApoB:A1 ratio biomarker remained stable overtime.1
 
“Our study identifies ApoB:A1 ratio and metabolomic lipoprotein signatures as potential new biomarkers to predict cardiovascular risk in patients with juvenile-onset SLE,” said Dr George Robinson, Senior Research Associate, Centre for Adolescent Rheumatology Versus Arthritis, University  College London, UK.
 
“Patient stratification using these biomarkers could provide an opportunity for tailored disease treatments using lipid modification therapy and lifestyle interventions.”
 
The patients in Group One were identified as high cardiovascular risk due to their lipoprotein profile (decreased  high  density  lipoproteins  (HDL)  and  increased  very low and low density lipoproteins (VLDL/LDL)). 
 
Group One had a significant increase in plasmablasts and activated T-cells  compared  to  matched  healthy controls and had clinical  features  associated  with increased  disease  activity. These immunopathogenic properties were not seen in the low cardiovascular risk Group Two which also had the opposite lipoprotein profile (increased HDL and  decreased  VLDL/LDL). Group  Three had  an  intermediate  CVR  but a pro-inflammatory immune cell profile.1
 
“Regular assessment for traditional and disease-related risk factors for cardiovascular disease is very important in patients with SLE,” said Tanita Wilhelmer, Chair, Young PARE. “We welcome these data to support the identification of those at greatest risk.”  
 
Reference
  1. Robinson G et al. Metabolomics in juvenile-onset SLE: identifying new biomarkers to predict cardiovascular risk. EULAR 2019; Madrid: Abstract OP0148.  

Study debunks theoretical risks of live-attenuated vaccines in paediatric rheumatic disease

A study presented at EULAR 2019, jointly organised with the Paediatric Rheumatology Society (PReS), demonstrate no vaccine infections, and no disease flare, in the 234 rheumatic patients who received live-attenuated booster vaccination while taking immune suppressing therapies.1
 
There are estimated to be over 75,000 children living with rheumatic diseases in Europe.2 Safe and effective vaccination is crucial given their increased risk of infections, however, in patients who  are on high  doses  of therapies that suppress the  immune  system, it  is  currently recommended  to  withhold live-attenuated vaccines (although  this can be  considered on  a case-to-case  basis). This is due to a theoretical, but not proven, risk of developing  the infection.3
 
Live-attenuated vaccines contain viruses or bacteria that have been weakened, but not  destroyed,  in  a  laboratory.They cannot  cause  disease  in  healthy  people  but  can  still produce a strong immune response.4 Some doctors already vaccinate their patients with rheumatic disease on immune suppressing therapies with the live-attenuated MMR (measles, mumps, rubella) or MMRV (MMR, varicella) booster. This is because, in light of recent measles epidemics in Europe and in the US, they feel the theoretical risk  of  vaccination  is  much  lower  than  the  risk  of  disease.This study identified 234 such patients  from  13 centres  across 10 countries and found no vaccine infections and low rates of adverse events.1
 
“Patients with rheumatic and musculoskeletal diseases have an increased risk of infection and so it is vital to vaccinate where possible to save lives,” said Professor Hans Bijlsma, President, EULAR. 
 
“There is a lot of ‘fake news’ surrounding vaccination in the media  and online and therefore we welcome these data presented today which should help dispel some of the public worries.”
 
In the study, the live-attenuated MMR or MMRV booster vaccine was given to 110 cases on methotrexate with three reporting mild injection-site reactions, 76 cases on methotrexate plus anti-tumour necrosis factor (anti-TNF) with seven reporting mild transient AEs; and 39 cases on anti-TNF alone with one reporting fever. Other biologic therapies were used on the remaining  patients, three were on  tocilizumab,  seven  on  anakinra, and five  on canakinumab. The vast majority had juvenile idiopathic arthritis (n=206) with disease activity considered low, moderate and high in 38%, 7% and 2% respectively.1
 
“The  positive  results  of  our  study  suggest  live-attenuated  MMR  and  MMRV  booster vaccination  is  safe  in  children  with  rheumatic  diseases,”  said Prof Yosef Uziel, paediatric department, Meir Medical Center, Sackler School of Medicine, Tel Aviv University, and PreS working party on vaccination, Israel. 
 
“Current recommendations are cautious due to low levels of  evidence  and  so  we  are  launching a prospective study on safety and efficacy of MMR booster vaccine in paediatric rheumatology patients treated with immunosuppressive therapy, including biological therapy.” 
 
The flu vaccine is not live-attenuated and is recommended in all patients affected by rheumatoid arthritis, regardless of treatment. However, there is data showing that patients are not being vaccinated as recommended and hence putting themselves at risk.5
 
The first real-world study of the flu vaccine in patients with autoimmune rheumatic diseases (AIRDs) was presented at EULAR 2019. The study included 14,928 AIRD cases and found no association between the flu vaccine and disease activity, prescription of corticosteroid, or vasculitis. In fact, results  demonstrate the flu vaccine is associated  with  a significant reduction in fatigue in the 2-3 months post vaccination, and a significant reduction in primary-care consultations for joint pain in the three months post-vaccination period.6
 
“Our results clearly support the use of the flu vaccine in rheumatic patients and should dispel any fears people have about reported links to disease activity or vasculitis,” said Dr Georgina Nakafero, Academic Rheumatology, University of Nottingham. 
 
Another reason cited for not vaccinating against flu in patients with rheumatic diseases taking immune suppressing therapies is that, because the body has a weakened immune system, the response to the vaccine may not be big enough to protect the patient from a subsequent flu infection.6
 
A third study, also presented today during EULAR 2019, reveals that, in order to prevent one case of flu, you only need to vaccinate 10 people with rheumatoid arthritis on a tumour necrosis factor inhibitor whereas you need to vaccinate 71 healthy  individuals.  This  is  because, although the immunity developed in response to the vaccine may not be as strong in these patients, their increased risk of infection means more cases are prevented.7
 
“Our analysis provides further evidence on the effectiveness of flu vaccination in patients affected by rheumatoid arthritis receiving treatment with tumour necrosis factor inhibitor sand should represent a call-to-action for all rheumatologists to consider vaccination in such patients,” said Dr Giovanni Adami, University of Verona, Rheumatology Unit.
 
References
  1. Uziel Y et al. Live attenuated vaccines in pediatric rheumatic diseases are safe: multi-center, retrospective data collection. EULAR 2019; Madrid: Abstract OP0205.
  2. Clemente D et al. Transitional care for rheumatic conditions in Europe: current clinical practice and available resources. Pediatr Rheumatol Online J.2017;15:49.
  3. Heijstek MW et al. EULAR recommendations for vaccination in paediatric patients with rheumatic diseases Ann Rheum Dis. 2011;70:1704-1712.
  4. NHS. Vaccine ingredients. Available at: https://www.nhs.uk/conditions/vaccinations/vaccine-ingredients/[Last accessed May 2019]
  5. Loubet P et al. Attitude, knowledge and factors associated with influenza and pneumococcal vaccine uptake in a large cohort of patients with secondary immune deficiency. Vaccine. 2015;33(31):3703-8.
  6. Nakafero G et al. Inactivated influenza vaccination does not associate with disease flares in autoimmune rheumatic diseases: a self-controlled case series study using data from the clinical practice research datalink. EULAR 2019; Madrid: Abstract OP0260
  7. Adami G et al. Effectiveness of influenza vaccine in TNF inhibitors treated patients. EULAR 2019; Madrid: Abstract OP0230

Pixuvri approved for use in Europe

Servier has announced that the European Commission (EC) has approved the conversion of the conditional approval of Pixuvri® (pixantrone) into a standard marketing authorisation as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.
 
“There are limited treatment options for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma,” said Prof Pier Luigi Zinzani from the University of Bologna Institute of Hematology and Medical Oncology in Bologna, Italy. “Pixuvri has demonstrated efficacy in late stage disease and the EC approval confirms Pixuvri as a treatment option for these patients.”
 
The EC approval is based on data from the global clinical development of Pixuvri.
 
The pivotal study, PIX301 was an open-label, randomised, Phase III study comparing Pixuvri monotherapy with physician’s choice of treatment in 140 patients with relapsed or refractory aggressive non-Hodgkin lymphoma, 50% of whom had been previously treated with rituximab. Pixuvri was shown to be beneficial in these patients: 20% of patients responded completely to Pixuvri compared with 5.7% of patients receiving other agents (p=0.021).1,2
 
To satisfy requirements of the conditional authorisation, a further Phase III clinical study, PIX306, was completed to provide additional efficacy data to confirm the benefit of Pixuvri in patients that had received prior treatment regimens containing rituximab. In the study PIX306, all patients were previously treated with rituximab. While the superiority of Pixuvri with rituximab compared to gemcitabine with rituximab was not met, both progression-free survival and overall survival results in patients with ≥ 2 prior treatment lines were similar, when indirectly compared to the PIXUVRI treated population in the pivotal study PIX301.2,3
 
“At Servier, we work diligently to develop and deliver medicines that address critical unmet medical needs in diseases such as multiply relapsed or refractory aggressive non-Hodgkin lymphoma,” said Patrick Therasse, Head of Servier Research and Development Oncology. “Pixuvri has been benefitting patients since its conditional approval in 2012 but today’s decision brings reassurance to patients and clinicians that this medicine remains a relevant treatment option in this indication.”
 
The most common side effects with Pixuvri are neutropenia, leukopenia, lymphopenia, anaemia, thrombocytopenia, nausea, vomiting, skin discolouration, alopecia, chromaturia and asthenia.1
 
References
  1. European Medicines Agency. Pixuvri SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/pixuvri-epar-… [last accessed May 2019].
  2. Pettengell R et al. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol 2012;13:696–706.
  3. Salles GA et al. Results of a phase 3 randomized multicenter study comparing pixantrone + rituximab with gemcitabine + rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation. American Society Hematology Annual Congress 2018;P4189.

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