News From The Annals Of Internal Medicine: June 19, 2012, Online

Main Category: Alzheimer’s / Dementia
Also Included In: Arthritis / Rheumatology
Article Date: 19 Jun 2012 – 3:00 PDT

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1. Hospitalization Often Catastrophic for Alzheimer Patients

Hospitalization of patients with Alzheimer disease (AD) often leads to complications such as delirium, loss of independence, institutionalization, and death. Researchers theorized that AD patients who suffer an episode of delirium during hospitalization are at increased risk for adverse outcomes. In a prospective study, researchers reviewed 15 years of medical records for a cohort of 771 patients aged 65 or older with a clinical diagnosis of AD to determine which patients, and under what circumstances, had hospitalization, delirium, death, and/or institutionalization. The records showed that 48 percent of the study patients were hospitalized and 25 percent developed delirium during their stay. While hospitalized patients without delirium had a substantially increased risk for death and institutionalization, those with delirium had an even higher risk. Further research is needed to understand whether delirium is only a signal that precedes decline for patients with AD or if preventing it can reduce adverse outcomes.


2. Osteoarthritis Treatment, Flavocoxid, Linked to Significant Liver Injury

Osteoarthritis is a common and potentially debilitating joint disorder caused by aging and regular wear and tear. Painkillers prescribed for osteoarthritis offer limited pain relief and are associated with adverse events. Flavocoxid is a proprietary medical food that is marketed to treat osteoarthritis. A medical food is a specially formulated supplement used to manage diseases with specific nutritional requirements that cannot be met through normal diet. Unlike drug treatments, medical foods can be marketed without clinical trials proving safety and efficacy. In this case series, the authors describe characteristics of patients with acute liver injury that is suspected to have been caused by flavocoxid. Among 877 patients enrolled in the Drug-Induced Liver Injury Network Prospective Study, four developed symptoms and signs of liver injury within three months after initiating flavocoxid. The four patients – all females between the ages of 57 and 68 – were evaluated to determine the likely cause of their liver injury. The researchers concluded that flavocoxid was very likely to be the cause in three patients and was possibly the cause in one patient. For all four patients, the liver injury resolved within weeks of cessation. According to the authors of an accompanying editorial, patients often consider medical foods and food supplements to be “natural”, so they may not disclose use of medical foods with their physician. The editorialists caution that physicians should discourage their patients from using any kind of medical food or supplement until policies related to marketing are changed to include safety and efficacy trials.


3. Patients with Alcoholic Cirrhosis Probably Won’t Die from Liver Cancer

Screening These Patients for Liver Cancer Not Likely to Save Lives, Unlikely to be Cost-effective

Patients with alcoholic cirrhosis have an increased risk for liver cancer. It has been suggested that screening for liver cancer in this population may save lives, yet no randomized trials have examined the effect of liver cancer screening on total mortality or liver cancer-related mortality in patients with alcoholic cirrhosis. Researchers in Denmark studied a nationwide registry of patients hospitalized with a first-time diagnosis of alcoholic cirrhosis from 1993 to 2005. Among 8,482 patients, 169 developed liver cancer, and 5,734 died, 151 of whom had liver cancer. The incidence and mortality of liver cancer was no greater in the alcoholic cirrhosis patients than those in the nationwide cohort. The researchers conclude that screening for liver cancer in alcoholic cirrhosis patients would not decrease the high mortality in this population, nor would it be cost-effective.

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Nanoparticle Exposure Linked To Rheumatoid Arthritis And Other Autoimmune Diseases

Editor’s Choice
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Main Category: Arthritis / Rheumatology
Also Included In: Immune System / Vaccines
Article Date: 18 Jun 2012 – 7:00 PDT

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According to a study published in the journal Nanomedicine, researchers have found an association between exposure to nanoparticles and rheumatoid arthritis and the development of other serious autoimmune disease. In addition, the team discovered new cellular targets for developing potential drug therapies to treat autoimmune diseases.

Findings from the study, conducted by researchers at Trinity College Dublin, indicate that there are health and safety implications for the manufacture, utilization, and disposal of nanotechnology products and materials.

Smoking, carbon particles emitted by car exhaust, and inhalation of dust over the long-term are all risk factors which cause chronic inflammation of the lungs. In addition, researchers have also established an association between smoking and autoimmune diseases, such as rheumatoid arthritis.

In this study, the authors identified similar risks cause by nanotechnology products, which may produce new types of airborne pollutants that can impact global health if not handled appropriately.

In order to determine whether there was a common underlying mechanism contributing to the development of autoimmune diseases in human cells when exposed to nanoparticles, Professor of Molecular Medicine Yuri Volkov and his Nanomedicine and Molecular Imaging team at Trinity College Dublin’s School of Medicine, applied a wide range of nanomaterials to human cells derived from the lining of the airway passages, and to so-called phagocytic origin – cells that are more exposed to inhaled foreign particles or are responsible with eliminating them from the body.

The nanomaterials involved included, carbon nanotubes, ultrafine carbon black, and silicon dioxide particles of different sizes, ranging from 20 to 400 nanometers.

Amino acid transforms, triggering autoimmune disease

Meanwhile, scientists from the Health Effects Laboratory Division, National Institute for Occupational Safety Health, Morgantown, WV, USA, conduced studies on mice exposed to long term inhalation of air contaminated with single walled carbon nanotubes.

In both the TCD and US study, the researchers found that all types of nanoparticles caused an identical response in the lungs of mice and in human cells, resulting in the specific transformation of the amino acid arginine into the citrulline molecule, which can trigger autoimmune diseases.

Human proteins which incorporate citrulline are unable to function normally and are destroyed and disposed of by the body’s defense system. Once citrullinated proteins are eliminated, the immune system begins to attack its own organs and tissues, thus causing the development of autoimmune diseases.

Professor Volkov explained:

“The research establishes a clear link between autoimmune diseases and nanoparticles. Preventing or interfering with the resulting citrullination process looks therefore as a promising target for the development of future preventative and therapeutic approaches in rheumatoid arthritis and possible other autoimmune conditions.”

Written by Grace Rattue

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

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Link Between Nanoparticles And Autoimmune Diseases Such As Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Immune System / Vaccines;  Water – Air Quality / Agriculture
Article Date: 13 Jun 2012 – 0:00 PDT

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New groundbreaking research by scientists at Trinity College Dublin has found that exposure to nanoparticles can have a serious impact on health, linking it to rheumatoid arthritis and the development of other serious autoimmune diseases. The findings that have been recently published in the international journal Nanomedicine have health and safety implications for the manufacture, use and ultimate disposal of nanotechnology products and materials. They also identified new cellular targets for the development of potential drug therapies in combating the development of autoimmune diseases.

Environmental pollution including carbon particles emitted by car exhaust, smoking and long term inhalation of dust of various origins have been recognised as risk factors causing chronic inflammation of the lungs. The link between smoking and autoimmune diseases such as rheumatoid arthritis has also been established. This new research now raises serious concerns in relation to similar risks caused by nanotechnology products which if not handled appropriately may contribute to the generation of new types of airborne pollutants causing risks to global health.

In their research, the Nanomedicine and Molecular Imaging team at Trinity College Dublin’s School of Medicine led by Professor of Molecular Medicine, Yuri Volkov investigated whether there was a common underlying mechanism contributing to the development of autoimmune diseases in human cells following their exposure to a wide range of nanoparticles containing different physical and chemical properties.

The scientists applied a wide range of nanomaterials including ultrafine carbon black, carbon nanotubes and silicon dioxide particles of different sizes, ranging from 20 to 400 nanometres, to human cells derived from the lining of the airway passages, and to the cells of so-called phagocytic origin – those cells that are most frequently exposed to the inhaled foreign particles or are tasked with cleaning up our body from them. At the same time, collaborating researchers from the Health Effects Laboratory Division, National Institute for Occupational Safety Health (Morgantown, WV, USA) have conducted the studies in mice exposed to chronic inhalation of air contaminated with single walled carbon nanotubes.

The result was clear and convincing: all types of nanoparticles in both the TCD and US study were causing an identical response in human cells and in the lungs of mice, manifesting in the specific transformation of the amino acid arginine into the molecule called citrulline which can lead to the development of autoimmune conditions such as rheumatoid arthritis.

In the transformation to citrulline, human proteins which incorporate this modified amino acid as building blocks, can no longer function properly and are subject to destruction and elimination by the bodily defence system. Once programmed to get rid of citrullinated proteins, the immune system can start attacking its own tissues and organs, thereby causing the autoimmune processes which may result in rheumatoid arthritis.

Commenting on the significance of the findings, TCD’s Professor Volkov says: “The research establishes a clear link between autoimmune diseases and nanoparticles. Preventing or interfering with the resulting citrullination process looks therefore as a promising target for the development of future preventative and therapeutic approaches in rheumatoid arthritis and possibly other autoimmune conditions.”

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Avoiding Healthcare Service Reimbursement Gaps

Main Category: Pharma Industry / Biotech Industry
Also Included In: Medicare / Medicaid / SCHIP;  Conferences
Article Date: 12 Jun 2012 – 9:00 PDT

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Healthcare Chief Financial Officers (CFOs) cannot do much about the reimbursement rates that Medicare has set, but they can make sure their organization is paid for all services provided, says Lloyd R. Vaughan, Founder, Vaughan Holland Consulting, Inc.

From a solution provider company at the upcoming marcus evans National Healthcare CFO Summit Fall 2012, in Dallas, Texas, October 21-23, Vaughan discusses how to maximize reimbursement for healthcare services through better billing practices.


How has the reimbursement environment changed in recent months?

Recovery Audit Contractors (RACs) are placing a lot more emphasis on finding overbilling and taking money back from hospitals, causing a lot of consternation and demanding a lot of time from hospital folks to come up with the requested records and to challenge take backs. This is definitely a strong trend that has picked up in the last year.

Medicare intermediaries that process bills are also becoming more difficult to work with. We help hospitals submit corrected bills and are constantly facing road blocks, of intermediaries making us submit paper documents that pretty much disappeared 15 or 20 years ago.


How could hospitals avoid reimbursement errors from the start?

Healthcare CFOs need to be more vigilant with what types of patients are admitted as inpatients. RACs are challenging many inpatient claims, saying that they could have been done on an outpatient basis. There are specific guidelines to determine who should be admitted as an inpatient, with some level of judgment involved, but it takes experienced case managers to guide patients to the right setting. If this is done right on the front end, it would help hospitals avoid disputes with Medicare.

Secondly, when RACs take money back, hospitals are allowed to appeal. Some hospitals are challenging every single case, while others are not. I think they should challenge all of them aggressively and put RACs on notice, so if they do submit adjustments, they make sure to be right about them.


Should certain services or types of patients be prioritized to maximize reimbursement? How can they avoid services falling through the reimbursement gap?

First, they need to know what their services cost and have a good cost accounting system. In order to know what to charge and how much reimbursement to pursue, they must know what the services cost and how much Medicare and other payers actually pay for them. In some cases, reimbursement may be too little compared to the time and effort that would need to go into it. Hospitals may need to re-evaluate some of their services. Outsourcing certain services or collaborating with other organizations might be better.

It is hard for any hospital, no matter how big or sophisticated, to provide every service in a way that is cost effective, so CFOs have to be more open minded about the alternatives.


Any final thoughts?

CFOs cannot do much about the rates that Medicare has set, but they can make sure their organization is paid for all services provided. That requires someone to come in and take a look at the claims, and make sure they are paid for everything.

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Contact: Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division

Tel: + 357 22 849 313
Email: press@marcusevanscy.com

About the National Healthcare CFO Summit Fall 2012

This unique forum will take place at The Westin Stonebriar, Dallas, Texas, October 21-23, 2012. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on increasing efficiency in an era of accountable care, growth strategies for today’s market, healthcare reforms and reinvigorating revenue cycle performance.

For more information please send an email to info@marcusevanscy.com or visit the event website at http://www.healthcare-summit.com/LloydRVaughanInterview2

About Vaughan Holland Consulting, Inc.

Vaughan Holland Consulting, Inc. specializes in recovering lost revenue for hospitals. Since 1996 the company has done specialty audits of Medicare, Medicaid and contracted payers. The company has approximately 200 hospital clients. http://www.vhci.net

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit http://www.marcusevans.com

All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com

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News From The Annals Of Internal Medicine: June 12, 2012 Online Issue

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Public Health;  Arthritis / Rheumatology
Article Date: 12 Jun 2012 – 1:00 PDT

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1. Hospital Noises Disrupt Sleep, Hinder Healing, and Have Negative Impact on Cardiovascular Health

For hospitalized patients, adequate sleep is imperative to the healing process. However, hospital noise frequently disrupts patients’ sleep. In a recent national survey, patients revealed that noise levels in and around rooms at night was one of the most significant factors affecting quality-of-care. Researchers studied 12 healthy participants in a sleep laboratory setting to determine how specific hospital noises, and at what levels, disrupted sleep according to type of sleep stage. Sleep stages include REM, or rapid-eye-movement sleep, and the three progressively deeper stages of non-REM sleep. Over three nights, patients in the lab were exposed to hospital-recorded acoustic stimuli. Noises included those that were external to the building (airplane noises, traffic); those that were within the hospital (telephone ringing, paging system, IV alarm sounding); and those that were outside the patient room (conversations, ice machine, laundry cart rolling by). The researchers found that louder sounds were more apt to cause sleep disruption, especially those that were engineered to alert. However, noises such as ice machines, laundry carts, and overhead paging were arousing at relatively low sound levels. Patients achieving REM sleep were less likely to arouse. The researchers noted that the sleep-disruption effects of noise include hypertension, incidence of cardiovascular and coronary heart disease, impaired immune function, elevated stress hormone responses, attention and memory deficits, and depressed mood, making noise reduction an important factor in improving patient care. Noise-conscious policies, procedures, and building design could lead to improved patient sleep and quality-of-care.


2. Viscosupplementation Ineffective for Treating Knee Osteoarthritis, Linked to Serious Adverse Events

Osteoarthritis of the knee is a common and potentially debilitating condition where joint fluid breaks down, removing the cushion the knee joint needs to function properly. Typically, non-steroidal anti-inflammatory drugs (NSAIDs) are prescribed to reduce pain and restore function. Viscosupplementation injections are an alternative treatment option prescribed to patients who do not respond to NSAIDs. Viscosupplementation injections use naturally-occurring lubricants to replace missing fluid. Researchers reviewed 177 reports describing 89 trials to assess the benefits and harms of viscosupplementation for adults with symptomatic knee osteoarthritis. The researchers found that the benefit of viscosupplementation on pain and function in patients with symptomatic osteoarthritis of the knee was minimal (pain) or non-existent (function). Adverse reactions were common and serious. Most frequently, patients experienced adverse events related to the gastrointestinal system, cardiovascular system, cancer, and musculoskeletal system. According to the researchers, the low efficacy and increased risk of serious adverse events and local adverse events (inflammation) should discourage physicians from administering viscosupplemention injections.

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Early Menopause Predicts A Milder Form Of Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Menopause;  Immune System / Vaccines
Article Date: 11 Jun 2012 – 0:00 PDT

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A new study presented at EULAR 2012, the Annual Congress of the European League Against Rheumatism, shows that early menopause predicts a milder form of rheumatoid arthritis (RA). New insights on factors influencing RA are good news for sufferers of the chronic inflammatory disease that currently affects over 2 million women in Europe. 1,2

The study, based on 134 incident RA cases, found that patients aged over 45 years with a history of early menopause were 50% less likely to develop severe RA (16% versus 35%) and more likely to develop a mild/moderate rheumatoid factor (RF) negative phenotype (58% versus 20%). There was no major difference in RA severity depending on oral contraceptive use or history of breast feeding. This study highlights that hormonal changes may influence pathways that are distinct from those leading to severe, progressive disease.

Dr. Mitra Pikwer from Skåne University Hospital, Sweden, and lead study author commented: “We already know that hormonal factors may influence the risk of RA, but this is the first study we know of that investigates the impact of menopausal age on the severity of RA. This is an important breakthrough, both in helping us understand the impact that hormones may have on the development of this disease and potentially also in helping us predict the long-term prognosis for our patients.”

The study identified patients who answered a questionnaire in a community based health survey (conducted between 1991 and 1996) and later developed RA. Information on hormonal predictors including breastfeeding history, history of oral contraceptive use and menopausal age (early menopause ≤45 years or normal/late menopause 45 years) was obtained via the questionnaire. By a structured review of the patients medical records, relevant information such as use of disease modifying anti-rheumatic drugs (DMARDs) including biological treatment, radiographic erosions, rheumatoid factor (RF) status as well as Health Assessment Questionnaire (HAQ*) data was collected. These variables were added to the SPSS TwoStep Cluster Analysis in order to reveal natural groupings of RA severity.

RA is a chronic inflammatory disease with female predominance. Hormonal factors such as breast-feeding history, use of oral contraceptives and menopausal age have all been suggested to influence the risk of RA. As yet the underlying mechanisms and their impact on disease progression are unknown.

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76 Percent Of Rheumatoid Arthritis Patients On Oral JAK1/JAK2 Inhibitor Plus DMARDS Achieve ACR20 Response At Week 12

Main Category: Arthritis / Rheumatology
Article Date: 11 Jun 2012 – 0:00 PDT

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Data from a Phase IIb study presented at EULAR 2012, the Annual Congress of the European League Against Rheumatism, show that 76% of patients with active rheumatoid arthritis (RA) receiving either 4mg or 8mg of baricitinib, an oral JAK1/JAK2 inhibitor, plus stable methotrexate (MTX) achieved ACR20* response compared with 41% of placebo-treated patients (p less than or equal to 0.001) at 12 weeks. The 4mg and 8mg doses of baricitinib demonstrated statistical superiority to placebo in all clinical outcomes measured, including ACR20/50/70*, DAS28**-CRP and DAS28-CRP

Results of the 12-week primary endpoint analysis conducted in 301 patients with moderate to severe RA and inadequate responses to MTX demonstrate that 35% and 23% of patients taking the 4mg achieved ACR50/70 responses respectively; 40% and 20% of patients taking the 8mg dose achieved ACR50/70, compared to 10% and 2% in the placebo groups respectively. Greater proportions of patients achieved disease remission as judged by the DAS28-CRP

“The JAK1/JAK2 signalling pathway has been shown to be important in the pathobiology of RA and no other JAK1/JAK2 inhibitor treatments have yet been approved for the treatment of RA,” said Dr Edward Keystone, University of Toronto, Canada and lead author of the study. “There is still a large proportion of patients that have inadequate responses to currently approved treatments for RA and baricitinib could represent a new, viable treatment option for this group of patients. The results of this study would suggest that the compound appears worthy of future Phase III investigation.”

According to the researchers, onset of efficacy was rapid for ACR20, ACR50, ACR70, and DAS28-CRP, with statistically significant differences seen after two weeks of therapy. Dose dependent decreases in hemoglobin, small increases in serum creatinine, and increases in low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol were seen. Patients were randomized to receive either placebo or one of four once-daily doses (1, 2, 4, or 8mg) for 12 weeks. The study population was 83% female, with a mean age of 51 years and a mean duration of RA of five to seven years.

Whilst the majority of AEs reported were mild, there were seven serious AE’s reported in six patients (two events in the placebo group, four in the 2mg group, one in the 8 mg group). No deaths or opportunistic infections occurred in the active treatment groups. One patient in the placebo group was diagnosed with an opportunistic infection of toxocariasis. A similar rate of infection was observed in the placebo group (12%) and the combined treatment groups (14%), representing the most common treatment emergent AE.

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Predicting Risk Of Serious Infection In Rheumatoid Arthritis Patients Using Rabbit Risk Score

Main Category: Arthritis / Rheumatology
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 11 Jun 2012 – 0:00 PDT

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Results of a study presented at EULAR 2012, the Annual Congress of the European League Against Rheumatism, suggest that the newly developed RABBIT Risk Score, which calculates the risk of serious infections in patients with rheumatoid arthritis (RA) who are treated with anti-tumour necrosis factor drugs (anti-TNFs) or conventional disease modifying anti-rheumatic drugs (DMARDs) is a valid and effective tool for rheumatologists to predict risk of serious infection.

The German study used data from 2,603 patients enrolled in the RABBIT register at the start of treatment with anti-TNFs (n=1,327) or conventional DMARDs (n=1,276). The likelihood of serious infection based on individual risk profiles was calculated using the RABBIT risk score. The score was developed by the same group of researchers on a different patient sample.

There was good agreement between observed and expected rates of serious infections. In the anti-TNF group, expected number of infections was 31.5 versus actual number observed which was 33. For conventional DMARDs, the expected number of infections was 14.8 versus the actual number observed which was 13.

“The results of our study validate the RABBIT Risk Score as a useful tool to help identify RA patients at high risk of developing infections when treated with anti-TNFs or DMARDs,” said Professor Angela Zink from the German Rheumatism Research Centre in Berlin, Germany. “This tool could help rheumatologists identify at-risk patients and avoid treatment combinations that have a higher risk of infectious complications. This could also help reducing costs associated with treating the infections.”

In patients who had ≥1 risk factor, including chronic lung disease, chronic renal disease, and age above 60 years, the RABBIT Risk Score also successfully predicted infection (10.0 expected vs 9.0 observed in DMARD group, 6.4 expected vs 6 observed in anti-TNF group).

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In Patients With Rheumatoid Arthritis, Smoking Negatively Affects Response To Anti-TNF Treatment

Main Category: Arthritis / Rheumatology
Also Included In: Smoking / Quit Smoking
Article Date: 11 Jun 2012 – 0:00 PDT

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A new study presented at EULAR 2012, the Annual Congress of the European League Against Rheumatism, reinforces current thinking that smoking negatively affects treatment response in rheumatoid arthritis (RA) patients treated with anti-tumour necrosis factor (anti-TNF) drugs.

This American study, the largest of its kind, followed 2,811 treatment naïve patients initiated onto anti-TNF therapy. Of the study group, 19% (n=521) were smokers and 81% (n=2,290) were non-smokers. Smokers had significantly higher scores on the Clinical Disease Activity Index (CDAI)* and DAS28** at six months than non-smokers. There was no significant difference in the odds of smokers versus non-smokers in achieving at least moderate EULAR*** response at six months and no difference in the change of mHAQ****.

Professor Ozlem Pala from the University of Miami Miller School of Medicine, USA and lead author of the study said: “There have been several studies which have investigated factors affecting response to anti-TNFs, but this is the first study to investigate response factors in such a large cohort of people. Being able to better predict response rates to treatment means that rheumatologists can discuss the findings with their patients who smoke and strongly encourage them to quit. This may also motivate them to develop successful strategies for smoking cessation in order to maximize effect of this expensive group of medications and potentially increase quality of life for these patients.”

Disease activity measures at baseline were similar for DAS28 (approximately 3.7, standard deviation [SD]: 1.6) for both groups but higher for CDAI (17.1, SD: 13.8 vs 15.5, SD: 12.9) and mHAQ (0.5, SD: 0.5 vs 0.4, SD: 0.4) in smokers and non-smokers, respectively.

Patients were taken from the Consortium of Rheumatology Researchers of North America (CORRONA) registry. Mean duration of follow-up per patient was 3.4 years (SD: 2.6). Patients enrolled in the study were followed for up to 10.2 years. Biologic naïve patients were followed for six months after initiation of an anti-TNF and outcomes of interest included DAS28, CDAI, mHAQ and EULAR response criteria after six months on therapy.

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