With the first-in-class drug guselkumab (Tremfya), patients living with active 

 achieved efficacy for joint and axial symptoms that was sustained through a 2 year 

. Results show that the treatment offered continuous improvement across measures of health-related quality of life.

Investigator, Philip Mease, MD, Director of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health, and Clinical Professor, University of Washington, School of Medicine, explained that when the cumulative research concluded, not only did guselkumab provide durable efficacy across joint and axial symptoms, an established safety profile, but also improvements in fatigue, pain, and work productivity.

"Psoriatic arthritis is a complex disease with multiple dimensions to it, whether it's the arthritis or the enthesitis, or the skin disease, I liken it, when I'm talking with the patient, to an orchestra you're listening to," Mease said. "At times, every section in the orchestra is playing pretty small and then other times, it's just the piccolo section, or just the timpani that's playing, and so you've got to be attentive, when you're following up with patients, that each of these domains is being covered. And it appears that's the case with this drug."

He emphasized that overall, patients rank symptoms of pain and fatigue as the 2 most important factors when addressed in focus groups. Mease makes it a priority to question patients about their levels of fatigue, but many seem suprised, or tell him he's the first clinician to ask them that.

While he understands the reluctance that clinicians might have regarding these unquantifiable symptoms of psoriatic arthritis, he stated that fatigue is "a very important biological phenomenon."

"These patient-focused, or patient-centric issues, are really important for us to inquire about to see if our drugs are treating it," Mease said.

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With guselkumab, patients with active psoriatic arthritis achieved efficacy that was sustained through a 2 year clinical trial. Results show that the treatment offered continuous improvement across measures of health-related quality of life.

Philip Mease, MD: Guselkumab Addresses the Complexities of Treating Psoriatic Arthritis

Post-traumatic stress disorder (PTSD) was associated with accelerated cognitive decline in middle-aged 

, according to new data from a large-scale perspective cohort study.

Though PTSD has been strongly associated with a decline in cognitive function in previous research, few longitudinal studies had been conducted regarding this association, especially as it relates to women.

On average, an estimated 8.6% of women in the United States will develop PTSD in their lifetime. Likewise, US women have a 21.1% lifetime risk of Alzheimer disease, which has been strongly associated with cognitive decline.

As such, an investigative team led by Andrea L. Roberts, PhD, MPH, of Harvard T.H. Chan School of Public Health, assessed the association between PTSD and decline in cognitive function over a 2-year period.

Roberts and colleagues featured participants from the Nurses’ Health Study II, which featured 116,429 US female nurses 25-42 years old who had completed various biennial questionnaires.

In 2008, supplemental questionnaires regarding trauma exposure and PTSD were sent to 60,804 women who had previously completed the 2007 questionnaire. Among these women, 54,763 had returned the questionnaire.

Following further cognitive assessments, a total of 12,270 trauma-exposed women with a mean age of 61.1 years were enrolled in the current study,

Between March 1, 2008, and February 28, 2010, lifetime trauma exposure and PTSD symptoms were assessed through the lens of exposure to 16 traumatic events including physical assault and natural disaster.

Seven prominent symptoms of PTSD were assessed via the Short Screening Scale for Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) PTSD, with a score of 4 or higher signaling PTSD cases with sensitivity of 85% and specificity of 93%.

Women were separated into 4 groups including no PTSD symptoms, 1-3 PTSD symptoms, 4-5 PTSD symptoms, and 6-7 PTSD symptoms. Afterward, cognitive function was examined from October 3, 2014, to July 30, 2019, via the Cogstate Brief Battery, which included 4 tasks regarding detection, identification, one card learning, and one back.

Though the cohort was predominantly non-Hispanic White participants (95.9%), 125 (1.0%) women were Asian, 75 (0.6%) were Black, and 156 (1.3%) were Hispanic.

A total of 8218 women (67%) reported experiencing PTSD symptoms. Among them, 5058 had 1-3 symptoms, 151 had 4-5 symptoms, and 60 had 6-7 symptoms. Naturally, a higher number of symptoms was associated with worse cognitive trajectories.

Investigators observed that women with the highest symptoms level experiences significantly worse rates of change regarding learning and working memory (β = −0.08 SD/y; 95%CI, −0.11 to −0.04 D/y) (P < .001), in addition to psychomotor speed and attention (β = −0.05 SD/y; 95%CI, −0.09 to −0.01 SD/y) (P = .02), compared to women with no symptoms.

"These findings also highlight the importance of PTSD prevention and treatment to ensure heathy cognitive aging and suggest the value of earlier cognitive screening among women with PTSD," the team wrote.

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Women with the highest PTSD symptoms level experienced significantly worse rates of change regarding learning and working memory.

PTSD Significantly Associated with Cognitive Decline in Middle Age Women

Quality of life outcomes may have better odds of improvement following invasive management in patients with less advanced 

Among the study population with chronic coronary disease (CCD), the event rates were inversely proportional to kidney function.

“Invasive management was associated with an increase in stroke and procedural myocardial infarction and a reduced risk in spontaneous myocardial infarction, and the effect was similar across CKD stages with no difference in other outcomes, including death,” wrote study author Sripal Bangalore, MD, New York University Grossman School of Medicine.

The investigators noted the guideline recommendations on the treatment of patients with CCD are therefore not predicated according to underlying kidney function or CKD stage. Thus, they aimed to evaluate clinical and quality of life outcomes across the spectrum of CKD following conservative and invasive treatment strategies.

Participants with moderate or severe ischemia on stress testing, with and without advanced CKD, were randomized in the ISCHEMIA-CKD and ISCHEMIA trials, respectively. They were categorized based on baseline kidney function into CKD

stage 1 (estimated glomerular filtration rate [eGFR] 90 mL/min/1.73m2 or greater)

stage 5 (eGFR less than 15 mL/min/1.73m2 or receiving dialysis)

The initial invasive management of coronary angiography and revascularization with guideline-directed medical therapy (GDMT) was compared to the initial conservative management of GDMT alone. Enrollment occurred between July 2021 and January 2018.

The primary clinical outcome was considered the composite of death or nonfatal myocardial infarction (MI), while the primary quality of life outcome was the Seattle Angina Questionnaire (SAQ) summary score.

A total of 5956 participants were included in the analysis (mean age, 64 years; 1410 [24%] female and 4546 [76%] male). From the total population, 1889 (32%) were in CKD stage 1, 2551 (43%) in stage 2, 738 (12%) in stage 3, 311 (5%) in stage 4, and 467 (8%) were in stage 5.

The self-report of demographics saw 18 participants (<1%) were American Indian or Alaska Native, 1676 (29%) were Asian, 267 (5%) were Black, 861 (16%) were Hispanic or Latino, 18 (<1%) were Native Hawaiian or other Pacific Islander, and 3884 (66%) were White. A total of 13 participants (<1%) were multiple races or ethnicities.

Investigators observed an increase in the risk of primary endpoint (3-year rates, 9.52%, 10.72%, 18.42%, 34.21%, and 38.01%, respectively), death, cardiovascular death, myocardial infarction, and stroke in individuals with higher CKD stages).

Moreover, they found invasive management was associated with an increase in stroke (3-year event rate difference, 1%; 95% CI, 0.3 to 1.7) and procedural MI (1.6%; 95% CI, 0.9 - 2.3), with a decrease in spontaneous myocardial infarction (-2.5%; 95% CI, -3.9 to -1.1). This was noted to be similar across CKD stages.

Heterogeneity of treatment effect for quality of life outcomes was observed. Invasive management improved angina-related quality of life in patients with CKD stages 1 to 3 and not in those with CKD stages 4 to 5.

Clinical and Quality-of-Life Outcomes Following Invasive vs Conservative Treatment of Patients with Chronic Coronary Disease Across the Spectrum of Kidney Function

Event rates were inversely proportional to kidney function in patients with chronic coronary disease.

 Invasive Management Shows No QoL Benefit in Patients with Poorer Kidney Function 

New research shows very little difference in the risk of hepatocellular carcinoma (HCC) for patients with chronic 

 (HBV) treated with tenofovir compared to patients treated with entecavir.

A team, led by Darren Hun Hao Tan, Yong Loo Lin School of Medicine, National University of Singapore, reconstructed individual patient data to estimate the comparative risk of HCC between patients with chronic HBV treated with tenofovir or entecavir.

Past research largely through conventional meta-analyses with aggregated study-level data, has been conflicting for comparing the effectiveness of tenofovir disoproxil fumarate with entecavir in reducing the risk of hepatocellular carcinoma in patients with chronic HBV.

In the study, the investigators searched databases for relevant studies from inception to October 6, 2021 and identified 3435 articles, 14 of which used propensity score matching to balance baseline characteristics. 

The final analysis of the 14 studies included 24,269 total patients, 10,534 of which were treated with tenofovir and 13,735 of which were treated with entecavir. The mean age of the patient population was 49.86 years (95% CI, 48.35-51.36) and 65% of the patient population (95% CI, 58.60-71.00%) was male.

The team followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline and reconstructed individual patient data from Kaplan-Meier curves.

They also evaluated the risk of HCC using random-effects hazard ratios (HR) through a shared-frailty model and a Cox proportional hazards model stratified by study group.

Finally, they conducted a restricted mean survival time (RMST) analysis to account for varying estimated treatment effect across time.

The investigators sought main outcomes of the comparative risk of HCC in patients treated with tenofovir compared to patients treated with entecavir.

Overall, tenofovir was linked to a decreased incidence rate of HCC compared to entecavir (stratified Cox HR, 0.85; 95% CI, 0.76-0.94 at 5 years; 

However, the investigators did not find a significant difference in their subanalysis of clinical cohort studies (stratified Cox HR, 0.92, 95% CI, 0.80-1.06 at 5 years; 

After examining administrative database studies, the team validated proportionality, while hazard ratios could not be obtained through Cox proportional hazards-based models.

They also found the mean time to developing HCC in the RMST analysis was 2.8 weeks longer (95% CI, 1.8-3.7; 

 <.001) in the tenofovir group than it was in the entecavir group at 5 years.

In other subgroups, there was either insignificant or minimal differences (<3 weeks) in the mean time to HCC at 5 years.

“In this meta-analysis, there was no clinically meaningful difference in the risk of HCC between patients who received entecavir and patients who received tenofovir,” the authors wrote. “There was no difference between tenofovir and entecavir among clinical cohort studies, whereas the mean time to HCC development was less than 3 weeks longer for patients who received tenofovir vs those who received entecavir at year 5 among administrative database studies. The choice between tenofovir or entecavir should be decided based on patient convenience and tolerability.”

Risk of Hepatocellular Carcinoma With Tenofovir vs Entecavir Treatment for Chronic Hepatitis B Virus

Tenofovir was linked to a decreased incidence rate of HCC compared to entecavir. However, this difference was not considered statistically significant.

Assessing the Risk of HCC for Hepatitis B Treatments

A team of investigators conducted a study to determine if the presence of sickle cell trait (SCT) was associated with worse outcomes of COVID-19. An increased risk of mortality and acute kidney failure was observed in patients with SCT after experiencing COVID-19. 

Further understanding of the relationship between SCT and the prepandemic health conditions in individuals of the Million Veteran Program (MVP), as well as  the assessment of the severity and consequence of COVID-19 were the research motivations.

According to the results, individuals with SCT who previously had COVID-19 also had various preexisting kidney conditions that were associated with poor outcomes.

"Our findings support the inclusion of SCT as an adverse prognostic factor for COVID-19 and development of SCT-tailored interventions. Our work has broad implications for the detection and clinical management of SCT," investigators wrote. 

Lead author, Anurag Verma, PhD, Corporal Michael J. Crescenz VA Medical Center, included 2729 individuals with sickle cell trait, and 129,848 indiviudals who did not have the trait in this genetic association study. Of those with SCT, 353 had COVID-19, and 13,488 who were SCT-negative had experienced COVID-19.

The aim was to identify any associations between SCT and COVID-19 outcomes. To examine this, investigators implemented firth regression. Analyses were performed by ancestry and adjusted for sex, age, age squared, and ancestral principal components to account for population stratification. 

More specifically, 4 COVID-19 outcomes were evaluated in regard to the World Health Organization (WHO) severity scale. Phenotypes were then derived from codes in the electronic records of 

It was revealed that sickle cell trait correlated with increased COVID-19 mortality and as well as multiple preexisting chronic medical conditions in individuals of African ancestry.

Among the 132 577 MVP participants with COVID-19, data displayed the mean age at the index date was 64.8 (standard deviation: 13.1) years and sickle cell trait was present in 7.8% of individuals of African ancestry and associated with a history of chronic kidney disease, diabetic kidney disease, hypertensive kidney disease, pulmonary embolism, and cerebrovascular disease. 

When the 4 clinical outcomes of COVID-19 we're assessed, SCT was associated with an increased COVID-19 mortality in individuals of African ancestry (n = 3749; odds ratio, 1.77; 95% CI, 1.13 to 2.77; 

Additionally, investigators reported that the 60 days following COVID-19, SCT was associated with an increased incidence of acute kidney failure. An estimation by counterfactual mediation framework showed that on average, 20.7% (95% CI, −3.8% to 56.0%) of the total effect of SCT on COVID-19 fatalities was due to acute kidney failure.

"In this genetic association study, SCT was associated with increased COVID-19 mortality and a number of preexisting chronic medical conditions in African ancestry individuals. Our findings support the inclusion of SCT as an adverse prognostic factor for COVID-19 and development of SCT-tailored interventions. Our work has broad implications for the detection and clinical management of SCT," investigators concluded.

Association of Kidney Comorbidities and Acute Kidney Failure With Unfavorable Outcomes After COVID-19 in Individuals With the Sickle Cell Trait"

Study Suggests Sickle Cell Trait as an Adverse Prognostic Factor for COVID-19

Atheroscleortic plaque was highly prevalent in older adults in China, with a substantial proportion of individuals reaching stenosis of 50% or greater, according to new findings published in 

“This study set the basis for the evaluation of atherosclerosis progression and risk stratification for future vascular events with longitudinal follow-up data,” wrote study author Yongjun Wang, MD, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University and and Tiemin Wei, MD, Department of Cardiology, Lishui Hospital, Zhejiang University School of Medicine. 

Investigators noted that previous data show subclinical carotid atherosclerosis and coronary artery calcification increased the risk of vascular events. However, there are limited findings on the prevalence, vascular distribution, and burden of polyvascular atherosclerosis in the arterial system with intracranial, coronary, and peripheral vascular territories.

As a result, the current cross-sectional study evaluated the prevalence, vascular distribution, and burden of polyvascular atherosclerosis in a community population based on a baseline survey of the Polyvascular Evaluation for Cognitive Impairment and Vascular Events (PRECISE) study.

It enrolled community-dwelling adults who were aged 50 - 75 years based on cluster sampling from 6 villages and 4 living communities of Lushui city in southeast China between May 2017 - September 2019.

The investigators assessed atherosclerotic plaque and stenosis at baseline in multiple vascular territories. It included brain vessel wall magnetic resonance imaging (MRI) for intracranial and extracranial arteries and computer tomography angiography (CTA) for coronary, subclavian, aorta, renal, and iliofemoral arteries. At baseline survey, they performed ankle-brachial index.

Then, the extent of atherosclerosis was assessed according to the number of these 8 vascular sites that were affected, while polyvascular arterosclerotic lesions were defined as ≥2 affected sites in these arteries.

There were a total of 3433 of 4202 invited individuals who consented to participate in the study. Following exclusions, including 366 participants with contraindications for MRI or CTA scanning, a total of 3067 community-dwelling adults were enrolled.

Data show the mean age was 61.2 years, including 1640 (53.5%) women and 74 (2.4%) had prevalent atherosclerotic cardiovascular disease (ASCVD). Most participants (n = 2546; 84.0%) had at least 1 traditional risk factor, while 892 (29.1%) had 2 and 654 (21.3%) had 3 or more risk factors.

Most of the participants (n = 2870 [93.6%]) were found to have atherosclerotic plaque in at least 1 vascular territory. Moreover, atherosclerotic plaques were mostly detected in the aorta (n = 2419 [79.6%]) and iliofemoral arteries (n = 2312 [75.8%]).

This was followed by subclavian (n = 1500 [49.8%]), coronary (n = 1366 [44.9%]), extracranial (n = 1110 [36.4%]), renal (n = 873 [28.7%]), and intracranial (n = 542 [17.7%]) arteries.

Additionally, polyvascular atherosclerotic plaque was observed in 2541 participants (82.8%), with 1436 (46.8%) with plaque affecting 4 or more vascular territories. Polyvascular stenosis was observed in 412 patients (13.4%).

The study, “Prevalence and Vascular Distribution of Multi Territorial Atherosclerosis Among Community-Dwelling Adults in Southeast China,” was published in 

A substantial number of individuals (nearly 40%) reached arterial stenosis of at least 50%, according to the findings. 

Atherosclerotic Plaque Found Highly Prevalent in Older Population in China 

New phase 2 data shows vurolenatide could be an effective agent in treating 

The data, announced by 9 Meters Biopharma, comes from preliminary topline results of the VIBRANT study (

), a multicenter, double-blind, placebo-controlled parallel group study testing the safety, efficacy, and tolerability of the proprietary, long-acting GLP-1 receptor agonist.

The trial included 4 parallel treatments arms of vurolenatide 50 mg weekly, 50 mg every other week, vurolenatide 100 mg every other week, and placebo.

The results are based on the complete randomization block, with the study ongoing and blinded to collect additional safety data and potentially enable the use of the complete data to support a New Drug Application (NDA) in the future.

The data is from 11 randomized patients with appropriate distribution across 4 different arms of the VIBRANT study. The investigators believe they have identified the most effective and tolerable dose and dosing interval to further test in the planned phase 3 trial.

In the preliminary results, 7 participants met the primary efficacy definition of total stool output (TSO) responder of greater than or equal to a 10% reduction from baseline in a 24 hour span over the 6-week efficacy evaluation period.

The investigators anticipate a mean reduction in TSO of greater than 25% taken into the upcoming phase 3 trial.

The team also sought a secondary endpoint of parenteral support volume over the 6-week treatment period and found 3 of the 5 patients in the study with a parenteral support requirement showed a mean decrease of greater than or equal to 20% in their parenteral support volume after being randomly assigned to the active drug.

For safety, vurolenatide was well-tolerated, without only mild to moderate and transient side effects identified. This included nausea and vomiting, which are typical side effects for GLP-1 agonists. Overall, there were no adverse events that led to an early withdrawal from the study.

There were a pair of serious adverse events found, which the investigators did not relate to vurolenatide as they were both central catheter infections, common in patients with a central line.

The company has scheduled an end-of-Phase 2 meeting with the US Food and Drug Administration in the coming months.

"Given the severity and life-threatening nature of SBS, as well as the significant impact on quality of life, we are very pleased to have identified a vurolenatide dose and dosing interval to progress into Phase 3 development,” Patrick H. Griffin, MD, FACP, Chief Medical Officer at 9 Meters, said in a 

. “Vurolenatide may offer a novel and alternative approach to treating appropriate individuals with SBS as it has been shown to decrease total stool output and reduce parenteral support needs which are critical to the health and well-being of individuals with short bowel syndrome."

The majority of patients in the phase 2 study met the primary efficacy endpoint of a greater than or equal to a 10% reduction in total stool output over the 6-week efficacy evaluation period.

Vurolenatide Showing Promise Treating Short Bowel Syndrome

New findings suggest maternal deaths in the United States increased substantially at the onset of the 

This figure (33.3%) was higher than a 22% overall excess death estimate associated with the pandemic itself and the increases were highest for Hispanic and non-Hispanic Black women.

“Change in maternal deaths during the pandemic may involve conditions directly related to COVID-19 (respiratory of viral infection) or conditions exacerbated by COVID-19 or other health care disruptions (diabetes or cardiovascular disease), but could not be discerned from the data,” wrote study author Marie E. Thoma, PhD, Department of Family Science, School of Public Health, University of Maryland.

Between 2019 and 2020, data from the National Center for Health Statistics (NCHS) reported an 18.4% increase in US maternal mortality. As such, the relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

To examine the role of the pandemic in maternal death rates, investigators used deidentified NCHS mortality and natality files from 2018 to 2020. Analyses were limited to maternal deaths based on underlying causes of death. They did not exclusively identify COVID-19 as the cause, even when it was a factor in maternal death.

Therefore, investigators noted COVID-19 was ascertained as a secondary cause from the multiple causes of death area, remaining consistent with other reports on excess mortality from COVID-19. The deaths were stratified by month and year of death into before (2018, 2019, and January - March 2020) or during (April - December 2020) the pandemic

Data show a total of 1588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic vs 684 deaths (25.1 per 100,000 live births) during the pandemic, at a relative increase of 33.3%. The findings additionally show late maternal mortality increased by 41%.

Moreover, the absolute and relative changes were highest for Hispanic (8.9 per 100,000 live births; 40.2%) and non-Hispanic Black (16.8 per 100,000 live births; 40.2%) women, compared to non-Hisapnic White (2.9 per 100,000 live births; 17.2%) women.

Investigators found the secondary code for COVID-19 was listed in 14.9% (102 of 684) of maternal deaths in quarters 2 to 4, with 0% reported in quarter 1 of 2020. The percentage was highest among Hispanic women (32.1%), followed by non-Hispanic Black (12.9%) and non-Hispanic White (7.3%) women.

Regarding underlying cause-of-death codes, data show the largest relative increase was among indirect causes (56.9%). The relative increases in direct causes (27.7%) were mostly associated with diabetes in pregnancy (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

Meanwhile, COVID-19 was often listed as a secondary condition with other viral diseases (16 of 16 deaths [100%]) and diseases of the respiratory system (11 of 19 deaths [57.9%]).

“Future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19,” Thoma concluded.

All-Cause Maternal Mortality in the US Before vs During the COVID-19 Pandemic

The increase was highest for Hispanic and non-Hispanic Black Women. 

Maternal Deaths in US Saw Substantial Increase at Onset of COVID-19 Pandemic

Despite having no prior history of psoriasis, data from a new Danish cohort revealed that some patients with immune-mediated inflammatory diseases who were treated with tumor necrosis factor-a inhibitor (TNFi) or other conventional therapies developed nonpustular types of psoriasis.

Though not as common, patients in the cohort who developed pustular types of psoriasis had the highest relative risk.

Broadly speaking, biologics have been shown to be highly effective for a number of inflammatory diseases such as psoriasis, inflammatory bowel disease (IBD), and rheumatoid arthritis. However, TNFi-associated psoriasis has developed in a myriad of patients during treatment, and studies regarding the epidemiology of these events are rare.

As such, an investigative team led by Alexander Egeberg, MD, PhD, from the University of Copenhagen, sought to determine the risk of new-onset psoriasis in patients with IBD or RA throughout TNFi treatment compared to conventional nonbiologic therapies.

The team utilized data from the Danish National Patient Registry, the Danish Register of Medicinal Product Statistics, and the National Population Registry to identify all patients in Denmark with IBS or RA from 1995-2018.

Patients with a history of any type of psoriasis prior to treatment or those who did not receive relevant pharmacotherapy after 18 years of age were excluded.

Relevant treatments were defined as either biological or nonbiological, with a distinction in the former being made between TNFi treatment and non-TNFi biological therapy.

Among the 109,085 patients enrolled in the cohort study, 108,024 received conventional therapy while 20,910 received TNFi treatment.

Throughout the follow-up period, 1471 (1.4%) patients developed a type of new-onset psoriasis. Of these patients, 1332 (91%) developed nonpustular psoriasis, and 139 (9%) developed pustular psoriasis. Among the patients who developed pustular psoriasis, 127 (91%) would go on to develop palmoplantar pustulosis, and 12 (9%) developed generalized pustulosis.

Meanwhile, the incidence rates for new-onset psoriasis per 1000 patient years were 3 for conventional therapy and 7.8 for TNFi treatment.

Regarding nonpustular andpustular psoriasis, the incidence rates for conventional therapy was 2.8 and 0.2, respectively. Incidence rates for TNFi treatment, however, was 6.5 and 1.3, respectively,

Investigators noted that 241 patient-years were required for 1 additional patient to be for any type of TNFi-associated psoriasis, while 342 patient-years were needed for nonpustular psoriasis, and 909 patient-years were needed for pustular psoriasis.

Despite an increased risk of new-onset psoriasis from TNFi treatment, investigators considered the absolute risk to be “modest” with 241 patient-years of exposure needed for 1 additional event.

“Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” they wrote,

“Absolute and Relative Risk of New-Onset Psoriasis Associated With Tumor Necrosis Factor-α Inhibitor Treatment in Patients With Immune-Mediated Inflammatory Diseases,” 

Despite an increased risk of new-onset psoriasis from TNFi treatment, investigators considered the absolute risk to be “modest”, with 241 patient-years of exposure needed for 1 additional event.

Increased Risk of TNFi-Related Psoriasis Observed in Patients with IBD, Rheumatoid Arthritis 

The inclusion of twice-daily 1 mg varenicline in smoking cessation programs for patients with 

 may result in prolonged abstinence without serious adverse events, according to new findings published in 

The findings suggest the agent was efficacious at weeks 12, 24, and 52 of the randomized clinical trial, in comparison to placebo.

“The findings suggest that substantial changes in smoking habits may occur among patients with type 2 diabetes who intend to stop smoking, leading to prolonged abstinence from smoking,” wrote study author Riccardo Polosa, MD, PhD, Centro per la Prevenzione e Cura del Tabagismo, Azienda Ospedaliero Universitaria Policlinico-V. Emanuele dell’Università di Catania.

Prior observations have noted that stopping smoking has been associated with reduced mortality risk in patients with T2D, so providing counseling on quitting smoking should be a component of routine diabetes care. Varenicline has been shown to be efficacious in smokers with cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), or depressive disorders, but it has not been studied in smokers with diabetes.

The multicenter, double-blind, placebo-controlled RCT included patients from 6 outpatient clinics in 5 hospitals in Italy. Investigators screened eligibility of patients with T2D who were receiving treatment in an outpatient diabetic clinic, smoking ≥10 cigarettes a day, and intending to quit smoking.

It consisted of a 12-week treatment phase followed by a 40-week follow-up, non-treatment phase, with intention-to-treat analysis was performed from December 2020 - April 2021. The primary efficacy endpoint was the continuous abstinence rate (CAR) at weeks 9 to 24.

A total of 300 patients were randomized to either varenicline (n = 150) or placebo (n = 150) treatment, with a mean age of 57.4 years. There were 117 men [78.0%] in the varenicline group and 119 men [79.3%] in the placebo group. Investigators noted the baseline characteristics were comparable between groups and treatment discontinuation was frequent (approximately 30%).

Data show the CAR at weeks 9 to 24 were significantly higher for the varenicline group versus the placebo group (24.0% vs 6.0%; odds ratio [OR], 4.95; 95% CI, 2.29 - 10.70; 

Moreover, the CARs at weeks 9 to 12 (31.3% vs 7.3%; OR, 5.77; 95% CI, 2.85 - 11.66; 

 <.001) and weeks 9 to 52 (18.7% vs 5.3%; OR, 4.07; 95% CI, 1.79 - 9.27; 

 <.001) were also significantly higher for varenclinice, as were the 7-day point prevalence of abstinence at weeks 12, 24, and 52.

Few adverse events were reported (n = 380) and only a few withdrawals from the study occurred as a result (n = 11), according to the investigators. The most frequent adverse events occurring in the varenicline group compared with the placebo group were nausea (41 [27.3%] vs 17 [11.4%], insomnia (29 [19.4%] vs 19 [12.7%], abnormal dreams (19 [12.7%] vs 5 [3.4%]), anxiety (17 [11.4%] vs 11 [7.3%]), and irritability (14 [9.4%] vs 8 [5.4%]).

“These findings support the notion that patients with type 2 diabetes who smoke have greater difficulty quitting when provided with only cessation counseling,” Polosa concluded.

Efficacy and Safety for Varenicline for Smoking Cessation in Patients with Type 2 Diabetes: A Randomized Clinical Trials

Varenicline was efficacious at weeks 12, 24, and 52 of the trial compared with placebo in a smoking cessation program. 

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