Dr. Castro and Dr. Rizzo discuss the evolving world of monoclonal antibodies for severe asthma. Plus, the ALA team discusses September's annual Asthma Peak Week, and what it means for reopening schools.

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Listen to an expert discuss the heterogenous, and potentially fatal, lysosomal storage disorder.

The Rare Disease Report Podcast: Niemann-Pick Disease

The vitiligo expert discusses new tactics and therapeutic options in treating inflammatory skin disorders like vitiligo, alopecia areata, and atopic dermatitis.

John E. Harris, MD, PhD: The Current State of Vitiligo and Alopecia Areata Research

Manesh Patel, MD, kicks off his first podcast by discussing HFpEF findings in EMPEROR-Preserved, the GUIDE-HF trial and more with his Duke colleague.

New Heart Failure Data from ESC 2021 with Marat Fudim, MD

On this episode of Coping After COVID, Dr. Yamalis Diaz explained just how challenging this year has been for patients with ADHD.

Coping After COVID: Challenging Circumstances for ADHD Patients

The first iteration of Crisis Point addresses the obesity crisis in the United States and beyond, with expert interviews and discussion.  

Crisis Point - Obesity Crisis

 (SCD) can experience vaso-occlusive crises (VOC) unexpectedly. Because it’s a very painful experience, they’re also commonly known as “pain crises” and can be triggered by a multitude of factors.

Phillip Okwo, a sickle cell patient, exemplified the intensity of a pain crisis in his theatrical production,

. Okwo created, and performed in, Life Interrupted to show how many different ways a single pain crisis can impact someone’s life, based on his real-life experiences.

The final moments in the last scene were especially emotional, for viewers, as well as for Okwo, as he’s shown writing a goodbye letter to his wife from the hospital. This scene was a real-life experience for Okwo, one that he lived through, but wasn’t sure he would.

The prognosis for him, when he was born, was that he’d likely not make it through adolescence. During his life, in that final scene, he was married with children on the way. He remembered that a part of him, in that moment, was at peace--he’d made it that far, at least.

“But having to go back and relive it,” Okwo said, “especially now on this side, and having 2 amazing kids, and thinking about how close--at least that I felt--I had come to potentially not even meeting them, that part is very, very emotional and kind of gut wrenching.”

He invited 5 doctors to take a front row seat and watch the performance. After the 4 scenes were over, Okwo came down off the stage and listened to each doctor’s reaction.

"By the time it got to the end, I was really emotional," Titilope Fasipe, MD, PhD, Assistant Professor of Pediatric Hematology-Oncology, Baylor College, said in an 

Not only does Fasipe have experience treating sickle cell disease in patients, but she lives with the disease too.

Many people who live with sickle cell disease also live with the anxiety that comes from anticipating a pain crisis. Okwo shared that anxiety-management is a big part of his sickle cell regimen.

Once a pain crisis begins, so does the stress of deciding whether or not to go to the emergency room, which is particularly anxiety-inducing for people with sickle cell disease. Research has shown that with more anxiety comes more pain in these situations, according to Okwo.

“So, it’s key for those of us, as warriors, to keep that anxiety in check,” Okwo said, “but it’s also incumbent on healthcare providers to really have an understanding of what we’re dealing with, so that we don’t feel anxiety about coming into the emergency room, or other settings, to be cared for.”

Watch the full performance of Life Interrupted followed by a thoughtful discussion about sickle cell disease in the video below.

Videos

A sickle cell patient takes center stage to share with healthcare providers what it’s truly like living through a vaso-occlusive crisis.

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Phillip Okwo: The Crisis of Living Life Interrupted by Sickle Cell Disease

Armand Butera is the assistant editor for 

. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining 

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A new investigation from Denmark found that patients with moderate-to-severe 

who were treated with the immunoglobulin G4 monoclonal antibody tralokinumab were prone to increased incidences of conjunctivitis compared to placebo.

However, most cases of conjunctivitis were mild and transient.

In previous studies, the monoclonal antibody had been used to effectively reduce moderate-to-severe atopic dermatitis when given every 2 weeks.

The investigators, led by Marjolein de Bruin-Weller, MD, PhD, University Medical Center Utrecht, Utrecht, the Netherlands, noted that conjunctivitis had been identified as an important adverse event (AE) in this patient population since the introduction of dupilumab as a potential treatment.

In the present study, the investigators characterized the occurrence of and risk factors for conjunctivitis in a large pool of patients with moderate-to-severe atopic dermatitis from 5 phase 2 and phase 3 trials of tralokinumab.

The investigators obtained data from 5 completed double-blind, randomized, placebo-controlled, phase 2 and phase 3 trials of tralokinumab in patients with atopic dermatitis.

Overall, there were 3 phase 3 trials (ECZTRA 1, 2, and 3), 1 phase 2 trial (ECZTRA 5) and 1 phase 2b dose-finding trial.

Eye disorders were predefined as an adverse event of special interest (AESI) in the ECZTRA trials based on potential and established areas of safety interest for monoclonal antibodies in treating atopic dermatitis.

Eye disorder AESI categories included conjunctivitis, keratoconjunctivitis, and keratitis.

Events by preferred terms were captured by AESI status (yes/no) from the adverse event form for the ECZTRA trials and classified retrospectively for the phase 2b dose-finding trial using a pre-specified MedDRA search.

Assessments of severity were made according to the investigator’s judgement and ranged from mild, moderate, or severe. Additionally, the history of allergic conjunctivitis and atopic keratoconjunctivitis was requested for each participant at screening.

The analysis featured all randomized patients exposed to tralokinumab or placebo during the initial treatment period.

A total of 2285 adults with atopic dermatitis were studied for up to 16 weeks, and Cochran-Mantel-Haenszel weights were applied to calculate adjusted adverse-event incidences.

Of the total number of patients, 1605 were treated with tralokinumab 200 mg every 2 weeks, and 680 were treated with placebo.

Bruin-Weller and colleagues reported that incidences of conjunctivitis were higher (7.5%) with tralokinumab compared to placebo (3.2%), with most events having been mild or moderate in severity.

Of the total patient population, 147 reported at least 1 conjunctivitis AESI, with 126 patients belonging to the tralokinumab group and 21 patients in the placebo group. A total of 179 eye disorder AESI occurred during the initial treatment period, with 168 events having been classified as conjunctivitis AESI.

Overall, 78.6% and 73.9% of events resolved during the trial in the tralokinumab and placebo groups, respectively.

Regardless of treatment group, an increased incidence of conjunctivitis was associated with more severe baseline atopic dermatitis, as well as a history of allergic conjunctivitis/atopic keratoconjunctivitis and several atopic comorbidities.

To the investigators’ knowledge, this was the first study to show that some atopic comorbidities had greater influence on conjunctivitis risk than others.

Though the results showed that patients treated with tralokinumab had higher incidence rates of conjunctivitis, they believed continued research was warranted on the implications of ocular complications in patients with atopic dermatitis.

“A greater understanding of the mechanisms causing ocular complications in patients with AD, and the risk factors associated with conjunctivitis in these patients, will help identify those who are likely to develop conjunctivitis AEs with tralokinumab,” the team wrote.

“Conjunctivitis in adult patients with moderate-to-severe atopic dermatitis: results from five tralokinumab clinical trials,”

 was published online in the British Journal of Dermatology.

Articles

Patients treated with the monoclonal antibody had increased incidences of conjunctivitis, though many of these incidences were considered mild and were resolved by the end of the study.

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Tralokinumab Linked to Ocular Diseases in Patients with Atopic Dermatitis

Connor Iapoce is an assistant editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Although diabetic foot ulcers (DFU) are considered both a major cause of patient suffering and high healthcare costs in the treatment of 

, low predictive power of DFUs makes primary prevention practices extremely limited for clinicians and patients.

Stemming from this challenge, a recent study examined incidence rates (IR) and changes over time for the first DFU in patients with diabetes seen in primary care in the United Kingdom.

Led by Frank de Vries, PharmD, PhD, Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, investigators observed a decline in diabetic foot ulcers (DFU) in patients with type 2 diabetes (T2D), but no changes were observed in patients with type 1 diabetes (T1D).

Investigators used data from the Clinical Practice Research Datalink (CPRD) GOLD, which contains medical records of 674 primary care practices in the United Kingdom.

Criteria for inclusion consisted of a diagnosis of either T1D or T2D with a prescription of either insulin or a non-insulin anti-diabetic drug (NIAD) from the start of the database (1987) until the end of the study period (2017).

The primary outcomes consisting of the average yearly IR of first registered DFU in people with T1D and T2D and changes over time were analyzed from 2007 and onwards. Additionally, secondary outcomes included hospitalization-risk in relation to the first registered DFU.

At inclusion, data on sex, age, body mass index (BMI), smoking status, and history of diabetes related complications (neuropathy, retinopathy, nephropathy, and Charcot neuroarthropathy) were collected.

In terms of statistical analysis, changes over time in the IRs were described through Poisson regression expressed as incidence rate ratio per year (IRR) and logistic regression expressed as odds ratios (OR).

A total of 129,624 people with diabetes were identified through a prescription for insulin or an NIAD.

During the study period, the yearly IR of first registered DFU varied from 1.0 (95% CI, 0.4 - 2.6) to 2.4 (95% CI, 1.3 - 4.7) per 1000 person-years in patients with T1D. In patients with T2D, it varied from 1.4 (95% CI, 1.2 - 1.7) to 3.6 (95% CI, 3.2 - 4.1) per 1000 person-years.

de Vries and colleagues noted that the mean IR of first registered DFU was 2.5 (95% CI, 2.1 - 2.9) per 1000 person-years for patients with T2D and 1.6 (1.3 - 1.9) per 1000 person-years for patients with T1D.

Over time, no change in IR was observed in patients with T1D (IRR: 0.96; 95% CI, 0.89 - 1.04), but IRs declined for patients with T2D (IRR: 0.97; 95% CI, 0.96 - 0.99).

Additionally, the average proportion of patients with T2D hospitalized with first registered DFU was 8.2% (SD: 4.8) out of the total population with first DFU. The average 1-year mortality-risk for people with T2D and first registered DFU was 11.7%.

Over time, both average hospitalizations (OR: 0.89; 95% CI, 0.84 - 0.94) and mortality (OR: 0.94; 95% CI, 0.89 - 0.99) declined.

“The decline in DFUs, hospitalizations and mortality, suggests that prevention and care of the first ulcer has improved for this group in primary care in the UK,” investigators wrote.

Incidence, hospitalization and mortality and their changes over time in people with a first ever diabetic foot ulcer

The mean IR of first registered DFU was 2.5 per 1000 person-years for patients with T2D and 1.6 per 1000 person-years for patients with T1D. 

Diabetes

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Decline in Diabetic Foot Ulcers Observed in Patients with Type 2 Diabetes

Investigators in France developed and validated a dermatologic specific burden score called the Vitiligo Impact Treatment (VIT) score.

 population and patient acceptable symptom state (PASS) was calculated and defined to help identifying patients overwhelmed by the treatment.

Investigators led by Julien Senechal, MD, PhD, Service de Dermatologie, Centre de Référence des Maladies Rares de la Peau, Hôpital Saint André, CHU de Bordeaux, believed the questionnaire would be used to develop patient-centered approaches to vitiligo management involving the personalized adaptation of treatment regimens to find a balance between treatment benefit and burden.

They also noted the “devastating” impact on the quality of life and self-esteem and psychiatric comorbidities vitiligo can have on the 0.1% to 2% of the world’s population who are affected by the disease, and the challenges regarding appropriate treatment.

Their study occurred in the framework of an ongoing e-cohort project called ComPare. In it, the investigators aimed to develop and validate a patient reported measurement of the burden of treatment in vitiligo patients.

Senechal and colleagues utilized a multistep method to develop a questionnaire to measure the burden of patients with vitiligo.

The investigators initially conducted a literature search on PebMEd to identify published questionnaires or scoring systems related both to the quality-of-life impact and burden of treatment of vitiligo.

Among vitiligo quality of life scales, several instruments such as the vitiligo impact scale, the vitiligo impact patient scale, and the vitiligo life quality index related to treatment burden.

As of December 2020, the ComPaRe cohort consisted of 42,000 patients with chronic conditions. A total of 343 adult patients with vitiligo from the cohort were included in the current study.

Each participant from the cohort was tasked with answering an online survey with open ended questions that explored the different aspects of vitiligo. Their responses would be analyzed and used to identify 24 themes related to the burden of the disease.

Each theme was transformed in a questionnaire and evaluated with a 4-point Likert scale: "Disagree" (1), “Slightly agree" (2), "Agree" (3), "Strongly Agree" (4) and "Not concerned" (0).

Construct validity of the instrument was assessed by comparing the instrument’s score to the Dermatology Life Quality Index (DLQI), Vitiligo Impact Patient score (VIPs) and Treatment Burden Questionnaire (TBQ) scores.

By the end of the study, a 19-item questionnaire was developed that assessed the burden of treatment in patients with vitiligo through 4 pertinent dimensions: finding a doctor, topical treatments, light treatment, and impact on outdoor activities and photoprotection.

The team noted that their instrument complemented existing measures of dermatologic quality of life such as the DLQI and VIP, and that they believed their score fulfilled an unmet need in the clinical research of vitiligo by defining the burden of treatment as the core outcome.

Additionally, they believed it could be used in clinical practice as a validated global score that is easy to calculate to identify patients overwhelmed by their treatment and demonstrated that patients with a VITs score above 48.5 (PASS) were at risk of being overwhelmed.

Though the study was conducted based on the burdens of vitiligo, Senechal and investigators stated that “future studies could explore how our patient reported instrument could be generalized to other chronic inflammatory skin diseases.”

“Vitiligo Treatment Impact score (VITs): development and validation of a vitiligo burden of treatment questionnaire using the ComPaRe Vitiligo e-cohort,”

 was published online in the Journal of The European Academy of Dermatology and Venereology.

Investigators believe the new instrument could be generalized to other chronic inflammatory skin diseases in future studies. 

Vitiligo

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Investigators Develop New Vitiligo Impact Treatment Score

New data presented at the CHEST 2021 Annual Meeting suggested that appropriate use and timing of the selective oral IP prostacyclin receptor agonist selexipag could result in the optimization of 

), especially for patients who are not at treatment goal.

The data were presented by leading study author Vallerie McLaughlin, MD, director of the Pulmonary Hypertension Program, University of Michigan.

Selexipag had previously been approved for the treatment of PAH to delay disease progression and reduce the risk of hospitalization.

The agonist also achieved a greater reduction in the risk of a morbidity/mortality event compared to placebo in phase 3 of the GRIPHON trial.

In the present analysis, McLaughlin described data from SPHERE, an ongoing, US, multicenter, prospective registry of patients treated with selexipag. The registry collected data on demographic and disease characteristics, as well as outcomes and dosing regimens.

The team evaluated the clinical characteristics and treatment patterns in patients with World Health Organization (WHO) Group 1 PAH initiating selexipag from the time of initiation since diagnosis.

A total of 829 patients were enrolled in the study, 652 of whom were previously diagnosed with PAH and 107 who were newly diagnosed.

Of the total number of patients, 759 were diagnosed with WHO group 1 PAH patients, the majority of whom initiated selexipag more than 24 months (58.8%) after initial diagnosis. All but 2 of those patients had at least 1 follow-up assessment.

Data were collected regarding selexipag initiation and quarterly at routine clinic visits for up to 18 months.

Clinical characteristics were analyzed in patients grouped by time on initiation since their diagnosis and change in risk post-initiation was summarized by time since diagnosis.

One-year mortality risk was based on the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) 2.0 risk calculator, and risk scores were calculated for every patients irrespective of missing variables.

Investigators reported that the median duration of selexipag treatment was 18.5 months, and disease characteristics indicated that PAH was severe in the overall population.

Risk was higher in newly diagnosed patients at the initiation of selexipag; investigators noted that risk was low in 23%, intermediate in 32%, and high in 45% of newly diagnosed patients.

In previously diagnosed patients, risk was low in 46%, intermediate in 30%, and high in 25%.

Additionally, during the follow up, risk scores improved in 32% and 18% of newly and previously diagnosed patients, respectively.

McLaughlin and colleagues recorded some differences in the use of non-PAH-specific medication at baseline, such as fewer patients in the newly diagnosed subgroups were prescribed a selective serotonin reuptake inhibitor (7.5% versus 15.2%, respectively).

Overall, newly diagnosed patients had PAH that was more severe than expected to be treated with an oral therapy, more severe disease and higher risk status, had received less combination therapy, and had a higher proportion of patients with improvement in risk status following selexipag initiation.

“These findings demonstrate that there are opportunities to improve PAH treatment in real-world clinical practice, especially for patients who are not at target risk status,” the team wrote.

A higher proportion of newly diagnosed patients with PAH showed improved risk status after the initiation of the oral prostacyclin receptor agonist.

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Newly Diagnosed PAH Patients Benefit from Selexipag Treatment

Women who delivered preterm had a greater than 1.6-fold risk of hypertension and women who delivered extremely preterm had a 2.2-fold risk within the next 10 years. 

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Preterm Delivery Associated with Risk of Chronic Hypertension in Women

New study finds that patients with neuropathic pain may benefit from cannabis-based medicine or medical cannabis. 

Pain

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Neuropathic Pain Patients Find Relief in Cannabis-Based Treatments

Investigators noted that the agonist was particularly effective in patients with severe PAH who were receiving spironolactone.

Macitentan Effective in Management of Pulmonary Arterial Hypertension

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

There was a correlation between anxiety scores and COVID-19 cases. 

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Anxiety, Depression Severity Scores Waned as Pandemic Raged On

The agent is administered through a single-dose, pre-filled syringe that delivers 5 milligrams through intramuscular or subcutaneous injection.









Opioid-Induced Constipation

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FDA Approves 5mg Naloxone Hydrochloride Injection to Treat Opioid Overdose 

Recurrent CDI, severe CDI, and the number of stools were linked to lower Cdiff32 scores.

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C Difficile Infections Linked to Poor Quality of Life Scores

The novel method of administration is a first of its kind for the common chronic eye condition.

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FDA Approves Varenicline Nasal Spray for Dry Eye Disease

Travel issues related to COVID-19 were responsible for the delay in the approval of the Biologics License Application.

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FDA Delays Approval of Bimekizumab for Plaque Psoriasis

The approval was supported by promising phase 3 data of the VOLTAIRE-X clinical trial.

Latest News

Phillip Okwo: The Crisis of Living Life Interrupted by Sickle Cell Disease

Tralokinumab Linked to Ocular Diseases in Patients with Atopic Dermatitis

Decline in Diabetic Foot Ulcers Observed in Patients with Type 2 Diabetes

Investigators Develop New Vitiligo Impact Treatment Score

Newly Diagnosed PAH Patients Benefit from Selexipag Treatment