A new investigation form the University of Pennsylvania Perelman School of Medicine offered additional data on 

Generalized pustular psoriasis is a rare, chronic orphan disease with limited epidemiological data and, to date, no standard treatment.

Investigators led by Joel M. Gelfand, MD, MSCE, Departments of Dermatology and Epidemiology, University of Pennsylvania Perelman School of Medicine, found that the condition was associated with continued health care utilization over time.

In their study, Gelfand and colleagues detailed the clinical charaxteristics, treatments, longitudinal disease course, and disease-specific health care utilization among patients with generalized pustular psoriasis across the United States.

The retrospective, longitudinal case series focused on adult patients 18 years or older with a diagnosis of generalized pustular psoriasis that had been confirmed by a dermatologist.

Data on this patient population was gathered from January 1, 2007 to December 31, 2018. A total of 20 participating sites’ electronic health records were utilized, along with site-specific databases.

Only patients who met the European Rare and Severe Psoriasis Ex- pert Network (ERASPEN) consensus definition of generalized pustular psoriasis were eligible for the study.

As such, investigators enrolled a total of 95 adult patients, 67 (70.5%) of whom were women with a mean age of 50.3 years.

The index date (called the “initial encounter” in the study) was the first date of active disease within the reporting institution. Information on demographics, medical history, and disease course were collected for each patient.

Further, descriptive statistics were used to summarize baseline characteristics, past medical history, and information regarding clinical encounters and treatments, and duration of therapy was calculated for each patient and each systemic therapy for all patient-drug combinations with at least 1 subsequent visit after initiation of therapy.

Finally, logistic regression was used to evaluate the as- sociation of age and sex with hospitalization or emergency de- partment visit during follow-up.

During the initial encounter, investigators reported that 35 patients (36.8%) were hospitalized, 9 (9.5%) of whom presented with the condition at the emergency department. A total of 64 (67.4%) patients were treated with systemic therapies.

Among 57 patients who had no prior history of generalized pustular psoriasis, 29 (50%) were inpatient admissions or emergency department encounters.

Gelfand and colleagues added that most patients had pustules on the trunk and extremities. Pustules were also reported on the scalp, face, genitals, nail unit, and mucous membranes in a minority of patients.

Symptoms were common, with 59 patients (62.1%) reporting skin pain and 25 (26.2%) reporting joint pain. Additionally, tachycardia and fever were recorded in 16 (16.8%) and 9 (9.5%) of patients, respectively.

The most common comorbidities identified in the study were hypertension, depression, diabetes, chronic kidney disease, and hypothyroidism.

Regarding therapies, systemic antibiotics were used in 15 patients (15.8%), while systemic steroids were given to 19 (20%). Additionally, 23 patients (24.2%) received acitretin, 21 (21.1%) cyclosporine; 13 (13.7%), methotrexate; and 6 (6.3%) phototherapy. Of biologic treatments, 4 patients received infliximab, 4 adalimumab, and 3, ustekinumab.

Finally, 19 patients (35.8%) were hospitalized for generalized pustular psoriasis symptoms experienced a median rate of 0.5 hospitalizations per year (IQR, 0.4-1.6). 

With their study, Gelfand and colleagues suggested that continued research was needed.

“Further prospective research is necessary to better understand treatment efficacy in patients with GPP,” the team wrote.

“Evaluation of a Case Series of Patients With Generalized Pustular Psoriasis in the United States,” 

Articles

The condition is rare, with limited epidemiological data and no standard treatment.









New Study Details Generalized Pustular Psoriasis

In approaching the end of another full year within the 

 pandemic, there's still much being learned about the dangerous respiratory virus that has seized the world. Developments in the last 12 months include greater confirmation that wearing masks do help to stop the spread, the virus can affect even the healthiest individuals long-term, and the first available vaccines offer extensive, but not complete, protection.

For certain populations, the protection offered by receiving a vaccine is even more limited. This year, 

 found this to be the case for their patients who are on immunosuppressants or immunomodulatory treatments—a realized concern 1 year after learning the severity by which immunosuppressed patients can be affected by COVID-19.

An array of studies have been performed in hopes of gaining a better understanding on this topic. The research revealed some great insight, but an important takeaway was that patients who are on immunosuppressants or immunomodulatory treatments still benefit from receiving the vaccine, even if it's not as effective as it is in the general population.

Earlier this year, Ruth Fernandez-Ruiz, MD, MS, Division of Rheumatology, Department of Medicine, New York University Grossman School of Medicine, conducted a study that 

evaluated the immune response and disease status in patients with systemic lupus erythematosus (SLE)

American College of Rheumatology 2021 Convergence

, Fernandez-Ruiz explained that all the phase 3 trials that were performed for the COVID-19 vaccines excluded patients who were taking immunosuppressants or immune-modifying drugs within 6 months from the time of enrollment.

“At the time we initiated the study,” Fernandez-Ruiz said, “the data on rheumatic disease patients was virtually absent.”

Previous research looked at this phenomenon with other vaccines, like the flu vaccine, and found that taking immunosuppressants did impact vaccine efficacy.

Prior to this study, Fernandez-Ruiz also collaborated on research that examined antibody responses in patients with lupus who had natural infection of SARS-COV-2.

“We found that most patients were able to generate and maintain an antibody response after COVID-19 disease,” Fernandez-Ruiz said. “So overall, it wasn’t really clear how our patients were going to respond to the COVID-19 vaccine, and there was a real need to study rheumatic disease patients.”

Charalampos Papagoras, MD, PhD, Assistant Professor of Rheumatology at Department of Medicine, Democritus University of Thrace, led research on the outcomes of COVID-19 in vaccinated patients compared with unvaccinated patients who have systemic rheumatic diseases.

 concluded that the severity of breakthrough COVID-19 cases depended on the vaccination status of the patient.

Aside from vaccination status, there were no differences in demographics, systemic rheumatic disease type, treatment or comorbidities between the 3 groups. However, hospitalization and mortality rates were higher in the unvaccinated group (29.3% and 4.1%, respectively), even when compared with the partially vaccinated group (21% and 0%).

Of course, patients who were fully vaccinated had the best outcome when faced with a COVID-19 breakthrough infection (10.3% and 0%).

Learning What This Means for Lupus Patients

The CDC was unclear if there were any disease-specific factors that could play a role in vaccine responses, Fernandez-Ruiz mentioned. Therefore, the team of investigators were compelled to focus particularly on the lupus population.

Their results showed approximately 30% of patients with lupus had a decrease in COVID-19 antibody responses and microneutralization titers compared to controls. Additionally, a correlation was found between circulating antibody levels against the spike protein and interfering gamma production by immune cells.

A low vaccine response was defined as less than or equal to 100 units per ml, which is the lowest value seen in controls.

After a patient’s vaccine response level was defined, the investigators further compared the 26 lupus patients who had a low response to the 64 lupus patients who had adequate response.

“We found that a normal anti-double stranded DNA antibody, and taking any immunosuppressant medication, other than antimalarials like hydroxychloroquine, were associated with a decreased vaccine response,” Fernandez-Ruiz said,

This particular study she led didn’t have a large enough sample size to look at the effect of each individual medication, but Fernandez-Ruiz emphasized that research in this area has grown.

“We do know now,” she said, “that other studies have shown that medications like methotrexate, mycophenolate mofetil, B-cell depleting agents like rituximab, and systemic steroids are likely playing a major role in blunting antibody response to the vaccine.”

A study led by Jean Liew, MD, MS, Assistant Professor, Rheumatology, Boston University School of Medicine, found that most of the patients with rheumatic disease who had to be hospitalized for COVID-19, despite being vaccinated, were the patients taking B-cell depletion therapy medication.

SARS-COV-2 Infections Among Vaccinated Individuals with Rheumatic Disease: Results from the COVID-19 Global Rheumatology Alliance Provider Registry

,” noted that of the 87 fully-vaccinated patients with rheumatic disease, 22 of them had breakthrough cases so severe they needed to be hospitalized.

 that these results weren’t exactly surprising because they were in line with other laboratory-based studies she read.

While the findings are meaningful, the other side to these data are equally enlightening. B-cell depleting medications like rituximab, and antimetabolites like mycophenolate appeared as treatments in the hospitalized group, but what about the treatment options that were absent from this group?

“Overall, the results should be reassuring,” Liew explained, “that other medication classes that are immunomodulatory that we use for rheumatic disease patients, like TNF inhibitors and other biologics that target specific cytokines, they’re not really represented in the people who were hospitalized after they were fully vaccinated.”

For the highest risk patients, it’s imperative to continue to look at other prophylactic strategies pre or post exposure, like monoclonal antibodies or the potential antiviral oral medication, according to Liew.

Patients in this particular high-risk population, and the providers that treat them, have to walk a thin line.

For them, the only option for treatment is ultimately limited to the immunomodulatory or immunosuppressive medication that leaves them vulnerable to a breakthrough COVID-19 infection.

Adjusting or switching to another treatment simply wouldn’t be effective at maintaining control of the disease and would then leave the patient vulnerable to a disease flare, which in turn could lead to poor outcomes if they were to be infected with COVID-19.

“There’s not really an alternative therapy for these people,” Liew said, “which makes the implication here that we need to think about what other things we can do in addition to vaccinating them.”

Fernandez-Ruiz’s study monitored for disease flare and found that 11% of vaccinated patients had a lupus flare.

“Only 1 of these patients had a severe flare,” she explained, “which means that this was overall rare, and these findings really support the safety of the COVID-19 vaccine in patients with lupus.”

The line may be thin, but it can be walked.

The American College of Rheumatology continuously updates their guidelines surrounding the COVID-19 vaccines with new data that arise. They recommend withholding most immunosuppressant medications after vaccination for a period of time.

Fernandez-Ruiz emphasized that these are guidelines, and rheumatologists have to make individualized decisions with each patient. The patient’s disease, the medication they’re on, the disease activity at the time, are all factors that need to be considered when discussing this with a patient.

“I’ve encountered situations where the disease activity, or the specific manifestations we’re treating, they’re life-threatening or they’re organ-threatening, so we can’t have the luxury of just simply holding the medication,” she said.

It’s a process to be taken step-by-step. And Fernandez-Ruiz is already working on the next one.

Along with a team of investigators, Fernandez-Ruiz said she is currently studying the frequency and severity of breakthrough infections.

“We also need to better understand whether holding immunosuppressants post-vaccination, and administering an additional dose of the vaccines, actually leads to improved humoral and cellular immunity to these vaccines,” she said.

Even though approximately 30% of patients showed a relatively low response, we don’t know if that response is enough to protect them from very poor outcomes of COVID-19. We think about infection prevention in general as an ideal outcome but also preventing hospitalization, oxygen requirement, ICU admission, intubation, these are all great things that we should aim for.

This year, we have certainly expanded our knowledge and understanding on the various ways COVID-19 has affected our lives and we’re on the path to continue doing so.

“You can see it either way,” Fernandez-Ruiz said. “We saw 30% of patients had a low-vaccine response, but 70% of patients had a pretty good response, and this is without the booster or third dose shot, the additional dose that we’re recommending now, so that’s actually pretty good.”

Investigators found about 70% of rheumatology patients had a good antibody response to the COVID-19 vaccines. 

Rheumatologists Navigate Treatment Plans in the Era of COVID-19 Vaccines

Due to shortcomings associated with the pro re nata (PRN) approach in the treatment of 

, including destabilization of the disease, the treat-and-extend regimen was developed to address regimental limitations.

However, a lack of evidence on the ideal treatment regimen led to a recent study, which assessed the efficacy of treat-and-extend anti-VEGF therapies for the treatment of macular edema secondary to RVOs.

Led by Varun Chaudhary, MD, Hamilton Regional Eye Institute, St. Joseph’s Healthcare Hamilton King Campus, a team of investigators observed treat-and-extend regimens supported treatment protocol for macular edema secondary to RVOs, without the treatment burden of monthly assessments.

Chaundhary and colleagues searched the Ovid MEDLINE, Ovid EMBASE, and CENTRAL were searched in February 2021.

They included data from studies examining the use of anti-VEGF therapy for treatment of macular edema associated with RVO in a T&E dosing regimen, including randomized controlled trials, cohort studies, case-control studies, and case series.

The primary outcome was considered the change in Early Treatment Diabetic Retinopathy Score (ETDRS) letters from baseline. If studies reported Snellen, data was converted to ETDRS using a published protocol.

Investigators extracted data on best-corrected visual acuity (BCVA), anatomic outcomes, number of intravitreal injections (IVIs), number of clinic visits, and serious adverse events. Outcomes were measured at the 12-month and 24-month time points.

They assessed the certainty of evidence utilizing the Grading of Recommendations Assessments, Development, and Evaluations (GRADE) guidelines.

A total of 377 full texts were reviewed and of these, 16 were included in the analysis. The total population included 786 eyes from 784 patients, with a mean age of 73.9 years and 54% were male. The anti-VEGF agent aflibercept was utilized more frequently, followed by ranibizumab and bevacizumab.

The meta-analysis demonstrated a mean improvement of 15.7 (95% CI, 13.3 - 18.0, I

 = 83%) ETDRS letters from baseline at 12 months.

A subgroup analysis showed the heterogeneity was in-part explained by drug type, duration of loading phase (≤3 months and >3 months), location of RVO and treatment naive status.

Data show studies with loading phases >3 months had a greater improvement at 12 months compared to studies with loading phases ≤3 months (20.5; 95% CI, 17.7 - 23.3 versus 15.0; 95% CI, 12.3 - 17.6)

Then, at 12 months, a total of 6 studies reported central retinal thickness (CRT) improved 269.7 μm (95% CI, 233.64 - 305.90, I

Studies with loading phases >3 months showed greater improvement in CRT compared to studies with loading phases ≤3 months (48.13 μm, 95% CI, 439.7 - 522.9 versus 25.1 μm, 95% CI, 221.6 - 280.6).

Additionally, at 12 months, central macular thickness (CMT) improved 285.1 μm (95% CI, 201.3 - 368.9, I

 = 94%) in 3 studies, while central subfield thickness (CST) was reported 342.9 μm (95% CI, 280.0 - 405.8,  I

Further, at 12 months, IVI was performed 8.1 times (95% CI, 7.4 - 8.7, I2 = 97%) at 12 months and 13.1 times (95% CI, 9.4 - 16.8, I

Investigators observed low frequency of adverse events and a low GRADE certainty of evidence across all outcomes.

“Our results suggest that treat-and-extend regimens can reduce the frequency of patient visits and injections compared to fixed regimens while still improving functional and anatomic outcomes,” investigators wrote.

Treat-and-extend regimens of anti-vascular endothelial growth factor therapy for retinal vein occlusions: a systematic review and meta-analysis

The meta-analysis showed a mean improvement of 15.7 ETDRS letters and central retinal thickness of 269.7 μm at 12 months. 

Treat-and-Extend Regimen Viable In Treatment Of Macular Edema Secondary To RVO

There are a number of reasons why individuals with lived homeless experiences are unable to receive hepatitis C virus (HCV) screenings and treatments.

School of Nursing and Midwifery, University of Plymouth,

identified and described the barriers and facilitators for screening and treating HCV for adults with lived experience of homelessness in highly developed countries.

Individuals who have been homeless at 1 point in time are often at an increased risk of HCV infections than the general population. With access to HCV care and screenings limited in this population, treatment uptake is notoriously low.

In the study, the research combed various databases for studies and identified 12 papers or reports in the final analysis. There several interacting factors shown to influence access to HCV testing and case for the patient population, some of which mirror the general population.

Of the final 12 studies, 9 were qualitative and 3 were quantitative, 1 of which was a randomized controlled trial. In addition, 6 studies took place in the US, 5 studies took place in the UK, and 1 study took place in Ireland. The studies were also conducted in a variety of different settings or contexts, including clinics within a program of healthcare for people experiencing homelessness (n = 1), homeless shelters (n = 3), research cohorts (n = 4), and outreach hepatitis C testing and intervention (n = 1).

Other settings included outreach services for drug use and homelessness offering point of care HCV, hepatitis B virus and HIV testing (n = 1); an outreach HCV treatment clinic established within a primary care facility (n = 1), and a community-based partnership offering HCV treatment and support to people who inject drugs in a drug and alcohol support program with a community-based HCV outreach service (n = 1).

The research team included a peer advocate, a hepatology nurse, and a community volunteer. Each member has significant experience promoting and engaging in HCV care and outreach with individuals experiencing homelessness.

Overall, the conditions related to homelessness and the rigidity of the hospital settings, as well as a lack of awareness were deemed the dominant barriers.

Other factors included flexibility, outreach, effective communication, tailoring and integration of services.

In addition, there is not much evidence found involving a minority population.

“People experiencing homelessness face multiple barriers in accessing and completing HCV treatment, relating to both their lived experience and characteristics of health systems,” the authors wrote. “Although some barriers are readily amenable to change, others are more difficult to modify.”

The study results could influence policy decisions moving forward.

“The facilitators identified could inform future targeted measures to improve HCV diagnosis and treatment for people experiencing homelessness,” the authors wrote. “Research is warranted into successful models to promote screening, diagnosis and treatment.”

In 2015 there was an estimated 71 million individuals with a chronic HCV infection worldwide. One of the main causes of infection is intravenous drug use, which is also highly prevalent among the homeless community.

Barriers and facilitators to hepatitis C screening and treatment for people with lived experience of homelessness: A mixed-methods systematic review

The rigidity of hospital settings and a lack of awareness prevents better hepatitis C virus diagnoses in the homeless population.

Multiple Barriers Prevent Better HCV Care for Homeless Population

New data from Egypt confirmed that interleukin (IL)-38 serum levels were significantly higher in patients with 

Additionally, higher IL-38 serum level was associated with both vitiligo severity and signs of activity.

The study, led by Radwa El-Sayed Mahmoud Marie, MD, Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Suez Canal University, was the first of its kind: No previous studies had investigated the expression of IL-38 in patients with vitiligo.

Marie and investigators noted that IL-38, a member of the IL-1 family of cytokines, has been linked to the suppression of T-helper (Th)1 and Th17 activation, which attack against melanocytes in the body and are directly related to vitiligo.

With their study, Marie and colleagues evaluated IL-38 serum level in patients with vitiligo and examined the association between IL-38 level and vitiligo severity and activity.

The case-control study consisted of 42 patients in total, 21 of whom had vitiligo and were recruited from the Dermatology Outpatient Clinic, and 21 healthy controls.

All laboratory assays were conducted at the Medical Biochemistry Laboratory, with the study itself having been conducted from August 2020 to March 2021.

Demographic and other relevant clinical data were obtained for each patients, and dermatological examinations were performed to assess the location, extent, and pattern of a patients’ vitiligo.

Severity of the condition was evaluated via the Vitiligo Extent Score (VES) and Vitiligo Disease Activity (VIDA) Score was used to evaluate vitiligo activity, and were graded accordingly: +4: activity within the previous 6 weeks or less, +3: activity within the previous 6 weeks to 3 months, +2: activity within the previous 3–6 months, +1: activity within the previous 6–12 months, 0: stability for 1 year or longer, and −1: stability for one year or longer with occasional re-pigmentation.

Regarding clinical features of patients with vitiligo, 11 (52.4%) patients presented with generalized vitiligo, 5 (23.8%) had acrofacial vitiligo, 4 (19%) patients had focal vitiligo, and 1 (4.8%) presented with segmental vitiligo.

Marie and investigators reported that patients with vitiligo had significantly higher serum level of IL-38 (mean 49.644 ± 20.359 pg/ml, range 22.517–95.314 pg/ml) than Hcs (mean 12.416 ± 2.824 pg/ml, range 7.347–18.873 pg/ml) (

Additionally, those with the highest serum level of IL-38 tended to be patients with signs of activity (

= 0.048), especially those who had ill-defined border (

Further, Marie and colleagues found a strong, positive correlation between serum level of IL-38 and VES (

< 0.001), and significant negative correlations were recorded between serum level of IL-38 and the age of patients (

Clinical features of vitiligo such as gender, clinical pattern, disease duration, and VIDA score did not influence IL-38 serum levels.

The investigative team cited several limitations to their study including a small sample size and a lack of assessment of IL-38 expression in vitiligo skin lesions versus perilesional skin and healthy controls skin, among others.

“Our results provide preliminary data that IL-38 may play a role in the immune dysregulation implicated in vitiligo, and is related to vitiligo disease activity and severity,” the team wrote. “Nevertheless, more future research with a larger sample size is required to identify the expression of IL-38 in vitiligo lesions and its molecular roles in vitiligo.”

“Interleukin 38 serum level is increased in patients with vitiligo, correlated with disease severity, and associated with signs of disease activity,” 

was published online in the Journal of Cosmetic Dermatology.

According to investigators, no previous studies had investigated the expression of IL-38 in patients with vitiligo.





Higher IL-38 Serum Levels Recorded in Patients with Vitiligo

education methods found that peer-led asthma self-management education more effective than adult-led programs in improving asthma outcomes, with improvements being sustained for up to 15 months.

The findings suggested that the disproportionate asthma burden in racial and ethnic minority adolescents living in urban communities could be addressed through peer-led self-management programs.

Prior to the study, the long-term effectiveness of peer-led asthma programs was not established, though they were found to be effective in improving quality of life in school-based studies outside of the United States.

In a multi-site randomized clinical trial led by Hyekyun Rhee, PhD, University of Rochester, a team of investigators examined the long-term effects of a peer-led program on asthma outcomes in adolescents living in urban areas compared to a conventional adult-led approach in 3 US metropolitan communities.

The study was conducted in Buffalo, New York, as well as Baltimore, Maryland, and Memphis, Tennessee, between 2015 and 2019.

Recruitment was conducted at clinical practices (29.7%) as well as schools (22.5%), word of mouth (20%), and through advertisements (10.3%).

Eligible criteria required that participants were 12 to 17 years of age, in a urban residency, asthma diagnosis for at least 1 year, persistent asthma defined by the Expert Panel Report-3 (EPR-3)criteria or current use of a controller medication, asthma-related health care utilization in the past 12 months, and proficiency in the English language.

In the end, a total of 320 adolescents participated in the study, a majority of whom were Black ir African American (78.4%), with public health insurance (72.5%).

Of the 320 enrolled, 303 participants were included in the longitudinal analysis.

Participants were divided between intervention and control groups, though all participants attended a day camo where a manualized asthma self-management program was implemented.

The intervention group attended a camp where trained peer leaders delivered the program to a small group of 4 to 8 adolescents, with peer leaders conducting bimonthly contacts occurring every other month using a standardized script for 12 months.

Adult leaders (asthma educators or nurse practitioners) led the control group and delivered identical educational content at the same venue as the intervention group.

Investigators utilized the Pediatric Asthma Quality of Life Questionnaire to measure symptoms, activity limitations, and emotional functioning of each participant in the past 2 weeks. This was considered the primary outcome of the study.

Secondary outcomes included asthma control, asthma self-management, and lung function.

Though uality of life improved over 15 months for both groups for all 3 subscales in the study, the intervention group showed greater improvement than the control group in overall quality of life (AMD at 15 months, 0.75 vs 0.37; between-group AMD, 0.38; 95% CI, 0.07-0.63).

Asthma control also improved over time for both groups, though the improvement was greater in the intervention group than in the control group (15-month AMD, −0.59 vs −0.31; between-group AMD, −0.28; 95% CI, −0.51 to −0.01).

Investigators noted that male participants had better controlled asthma regardless of group.

Overall, the investigative team found that program effects were greater when led by peer leaders than health care professionals, which suggested that peer-led approaches acted as a “promising strategy” when delivering asthma self-management education for racial and ethnic minority adolescents living in urban areas.

“A peer-led asthma program implemented in venues such as schools, houses of worship, or clinics can improve access to asthma education, ameliorating the disproportionate burden of asthma morbidity in racial and ethnic minority adolescents residing in large US urban communities,” the team wrote.

The study, “Long-term Effectiveness of a Peer-Led Asthma Self-management Program on Asthma Outcomes in Adolescents Living in Urban Areas :A Randomized Clinical Trial,” was published online in JAMA Open Network.

Investigators suggested that peer-led asthma program implemented in venues such as schools, houses of worship, or clinics can improve access to asthma education.





Peer-led Asthma Programs Preferred by Adolescents Living in Urban Areas

Whether it is new treatments in development or new guidelines in managing 

 infections (CDI), there is plenty to discuss in this field.

That is why it is so important for experts to come together to discuss new research and different perspectives.

State of Science program, a group of 4 C difficile investigators and clinicians discussed several different portions of CDI care and research.

The program, called Institutional Perspectives in Infectious Diseases: Management of C. Difficile and led by Bincy Abraham, MD, MS, Houston Methodist, was held on Nov. 9.

Also joining the panel were Eamon Quigley, MD, Daniel Bushyhead, and Kerri L. Glassner, DO, all of Houston Methodist.

Videos

Bincy Abraham, MD, led the State of Science program on C difficile infections.

The State of C Difficile Care

If ABX464 eventually gains US Food and Drug Administration (FDA) approval for patients with 

, it could spark future research testing the treatment for other indications, including Crohn’s disease, rheumatoid arthritis, and potentially others.

In fact, the treatment was once thought to be a potential medication for cancer.

Recently, there was data released showing the novel, orally administrated small molecule treatment resulted in 82.1% (n = 23) of patients who went into an ongoing, phase 3, maintenance trial in clinical remission remained in remission with the once-daily oral 50 mg treatment.

In addition, 49.3% (n = 36) of patients who were not in clinical remission at the end of the induction phase achieved a de novo clinical remission during the first year of maintenance.

, Hartmut J. Ehrlich, MD, CEO of Abivax and Philippe Pouletty, MD, chairman of the board of directors at Abivax, said an ulcerative colitis approval from either the US or European regulatory bodies could yield future research in the other diseases mentioned.

“Clearly, when you show safety and efficacy in 1 disease like ulcerative colitis,” Ehrlich said. “From the mechanism of disease propagation, Crohn’s disease is very similar. In the end, for the regulators what is important is for every disease, you are showing the required efficacy and safety data.”

The treatment also has potential in Crohn's disease and rheumatoid arthritis.

Ulcerative Colitis Study Could Forecast Future Success of ABX464

 with elevated levels of metabolic abnormalities and systemic inflammation, an alteration in the macronutrient composition of diets in patients with diabetes may result in a change in these abnormality levels.

Led by Faisal Ali, Department of Clinical Nutrition and Dietetics, University of Science and Technology, Sana’a, a team of investigators investigated changes in plasma lipid profile, in order to identify potential inflammatory mediators after following dietary approach stop hypertension (DASH) diet and omega-3 fatty acid capsule supplementation.

They observed in patients with T2D, fish oil intervention and DASH diet partially altered lipid metabolism, production of inflammatory mediators, with no statistically significant effect shown on glycemic control and adiposity.

The study was presented at the The Metabolic Institute of America (TMIOA) 2021 World Congress Insulin Resistance Diabetes & Cardiovascular Disease (WCIRDC) Meeting.

Study investigators noted that omega-3 fatty acids contain two long-chain fats, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), found in oily fish.

The study was a randomized controlled trial, with 2 parallel groups. Each followed a DASH diet for 12 weeks, with 1 group consuming 6 placebo capsules per day (n = 15) and the other consuming 6 capsules of 1000mg EPA/DHA per day (n = 17).

Investigators measured fasting blood samples and clinical parameters at baseline and post-intervention.

Data show that compared to the placebo group, there were significant differences observed in body weight, body mass index (BMI), blood pressure, and interleukin-6 and necrosis factor-α in both groups. However, triglyceride (TG) levels and VLDL-cholesterol-significantly decreased in only the fish oil groups (

Additionally, investigators observed no significant difference within and between the placebo and fish oil groups for adiponectin and leptin at 5.53% and 6.48%, respectively.

Finally, data show no statistically significant effect for fasting glucose, fasting insulin, HOMA of insulin resistance levels, HbA1c, total or LDL, HDL cholesterol in both groups.

Ali and colleagues noted fish oil intervention plus DASH had partial alteration on lipid metabolism and inflammatory mediators, but further study is necessary to determine the overall benefit.

“The nutritional therapy of omega-3 fatty acids supplements may be further investigated by lipidomics and genomics analysis on both type 1 and 2 diabetic patients,” investigators wrote.

“Omega-3 Fatty Acids intervention and DASH Diet Ameliorates Metabolic profiling in Patients with Diabetes Mellitus Type 2,” was presented online at WCIRDC.

Fish oil intervention and DASH diet show no statistically significant effect on
glycemic control and adiposity. 

Fish Oil, DASH Diet Partially Alters Lipid Metabolism in Patients with Type 2 Diabetes

 are not known, investigators are concerned by what is called “long-haul” COVID-19, particularly from a cardiovascular point of view.

During last month’s American Heart Association (AHA) 2021 conference, Aaron Baggish, MD, Director of the Cardiovascular Performance Program, Massachusetts General Hospital, presenting on how clinicians should focus on cardiovascular disease prevention in this patient population.

, Baggish said so far basically every cardiovascular symptom imaginable has been presented in some way as part of long-haul COVID-19 cases, including chest pain, palpitations, exercise intolerance, and even some heart failure symptoms. 

The diverse set of symptoms makes it challenging for cardiologists and there is still a lot unknown about how the virus will impact patients from a cardiovascular perspective in the years to come.

“I think the only thing we can say with certainty about COVID is that we still have a lot to learn,” Baggish said. “Certainly we have seen patients that have extended complexes after their initial acute COVID-19 infection that have lasted weeks or several months and many of them have recovered. There are a small subset of people that seem to have durable long-haul COVID symptoms throughout many months and really don’t understand why that is.”

Several different cardiovascular symptoms have presented in patients with COVID-19. 

Aaron Baggish, MD: Making Sense of the Cardiovascular Risks of COVID-19

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