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Dupilumab could yield higher rates of clinical remission for patients with moderate-to-severe 

A team, led by Ian Pavord, MD, NIHR Oxford Biomedical Research Centre, University of Oxford, presented new data from an post hoc analysis of LIBERTY ASTHMA QUEST during the A

merican Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Annual Meeting.

In the study, the researchers assessed how dupilumab effects patients with uncontrolled, moderate-to-severe asthma using a multi-component endpoint that represented various dimensions of clinical asthma remission.

Asthma treatment response is categorized by improvement in more than 1 key asthma outcome, such as exacerbations, symptom control, or lung function.

Using clinical asthma remission components—no exacerbations/ 5-item Asthma Control Questionnaire [ACQ-5] total score <1.5/postbronchodilator FEV

80%—the researchers assessed the status of each patient at week 24 and week 52.

Overall, there were 348 patients treated with either 200 mg or 300 mg of dupilumab every 2 weeks, as well as a control group that included 195 matched placebo treatments.

Each patient included in the study had baseline post-bronchodilator FEV

 of at least 25 ppb, and eosinophils of at least 150 microL.

The investigators found a higher proportion of patients treated with dupilumab were exacerbation free compared to placebo (Week 24, 83.3% vs. 61.0%; Week 52, 72.2% vs. 46.2%).

In addition, more dupilumab-treated patients were exacerbation-free with an ACQ-5 score less than 1.5 compared to the placebo group (Week 24, 57.5% vs. 27.2%; Week 52, 43.1% vs. 21.5%).

The investigators also found 29.6% (n = 103) dupilumab-treated patients were exacerbation free at week 24 compared to 7.7% (n = 15) of the placebo group, with an ACQ-5 score of less than 1.5 and post-bronchodilator FEV1 of at least 80%, classified as clinical remission. At week 52, 20.1% (n = 70) in the dupilumab group achieved clinical remission, compared to 4.6% (n = 9) in the placebo group.

For the patients who did not achieve clinical remission, the dupilumab group still had fewer exacerbations compared to the placebo group (adjusted annualized rate of severe exacerbations at Week 24/Week 52, 0.63/0.56 vs 1.51/1.46) and improved lung function and asthma control (LS mean change at Week 24/Week 52: 0.20/0.22L vs 0.02/0.03L [FEV

] and 21.33/21.51 vs 21.00/21.11 [ACQ-5 score]).

“Dupilumab treatment could enable patients with uncontrolled moderate-to-severe asthma to achieve a stringent and novel multicomponent endpoint representing clinical asthma remission,” the authors wrote. “Dupilumab substantially reduced exacerbations and improved lung function and asthma control in patients who did not achieve clinical remission.”

Dupilumab is a fully human VelocImmune-derived monoclonal antibody that blocks the shared receptor component for IL-4 and IL-13, both known as central drivers of type 2 inflammation in multiple diseases.

In 2018, the US Food and Drug Administration (FDA) approved dupilumab as an add-on maintenance therapy for adults and adolescents aged 12 years or older, with an eosinophilic phenotype or with oral corticosteroid-dependent 

The study, “Dupilumab Treatment Leads to Clinical Asthma Remission in Patients With Uncontrolled Moderate-to-Severe Asthma With Type 2 Inflammation,” was published online by 

Articles

In data presented at AAAAI 2021, researchers present new data from the LIBERTY ASTHMA QUEST trial.

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Dupilumab Helps Treat Uncontrolled Asthma

A new report suggests that COVID-19 may lead to severe craniofacial pain in a subset of patients with diabetes.

The paper comes from a team of investigators from Egypt, the Czech Republic, and Italy. They report that, between April and August 2020, 21 patients of the 5,730 

 who sought outpatient care at their clinics sought specialist care for pain in their facial regions.

Most of the 21 consecutive patients were in relatively good health prior to their infections and 76% had their diabetes under control. The mean hemoglobin A1c (HbA1c) level of the group was 6.7. The patients had an average age of 51.71 years, were mostly male (66.67%), and had a mean body mass index of 21.76. 

Six of the patients had no systemic comorbidities, but 3 had cardiac conditions, 4 had renal impairment, and 8 had asthma. The patients were taking a variety of antidiabetic drugs, including thiazolidinediones, sodium-glucose cotransporter 2 inhibitors, metformin, and insulin.

The patients’ reported COVID-19 cases were not severe. Most (18 patients) had mild cases and the remaining patients (3) had moderate cases. Only 3 patients had a fever, and it was considered mild in all cases. Four patients had a dry cough, and 2 patients had a sore throat. Two patients reported myalgia.

COVID-19 symptoms were generally unremarkable

, one key feature of their clinical representation was unique: they reported severe pain in the masseter (12 patients) and temporalis (4 patients) regions, or in both regions (5 patients). For 10 patients, the pain was bilateral. For the remaining 11 patients, it was focused on one side or the other. 

When asked to rank the pain from 0 (no pain) to 10 (pain as bad as you can imagine), the patients chose an average severity of 7.4. For most patients (85.7%), the pain was made worse when they touched the affected region, and when they chewed (52.4%).

When asked what provided relief, more than half of the patients (62%) said hot fomentation helped. Paracetamol gave relief to 24% of patients, and ibuprofen and diclofenac potassium aided 5% each.

Corresponding author Abanoub Riad, DDS, of Masaryk University, in the Czech Republic, and colleagues, wrote that many potential explanations for the craniofacial distress experienced by these patients could be excluded.

For instance, diabetic neuropathies were unlikely to be the cause since those are mainly caused by long-standing hyperglycemia, and these 21 patients had their blood glucose levels under control. Another possible cause could be paid due to increases in psycho-emotional stress associated with the pandemic, which could increase bruxism and temporomandibular disorders. However, none of the patients in the series had a history of bruxism or orofacial pain.

That left Riad and colleagues to conclude that the coronavirus infection must play a key role in the pain. They pointed to a number of potential factors at play.

“In addition to the well-known pathophysiologic mechanisms by which the diabetic patients are imposed to a greater risk of viral infections such as impaired neutrophil chemotaxis and phagocytosis; the increased expression of angiotensin-converting enzyme 2 in pancreatic islets and the persistent hyperglycemia in [severe acute respiratory syndrome] patients indicated transient damage to beta cells,” Riad and colleagues wrote.

They also noted that viral infections can amplify the cytokine response in adipose tissues, which could lead to craniofacial inflammation.

“Given that our cases’ median age was 49 years old, the relationship between diabetes and pain in the orofacial muscles can be related to glutamate’s role whose neurotoxicity is mediated by the NMDA receptors found on neuronal tissues and peripheral non-nueruonal tissues and cells as β-cells,” they said.

The authors concluded that their cases are the first reported evidence suggesting a link between COVID-19 and pain in the craniofacial tissues. They said the link warrants further investigation.

Craniofacial pain in COVID‐19 patients with diabetes mellitus: Clinical and laboratory description of 21 cases

The authors of a research letter say a small minority of patients with diabetes have facial pain that cannot otherwise be easily explained.

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The US Food and Drug Administration (FDA) has approved the first and only Acetaminophen Injection flexible PAB IV Bags available in multiple doses.

The approval, awarded to B Braun Medical, is earmarked for the injections in both 1000 mg in 100 mL and 500 mg in 50 mL doses in bags not made with PVC, DEHP, or latex.

"With the approval of Acetaminophen Injection, we are pleased to offer healthcare providers a safe, effective and affordable treatment option," said Angela Karpf, MD, Corporate Vice President of Medical Affairs, in a 

. "The convenient PAB IV container, which is not made with PVC, DEHP or latex, adds another layer of safety for patients, healthcare workers and the environment."

The company uses dual-sourced Active Pharmaceutical Ingredients (API) to mitigate potential supply risk.

"Acetaminophen Injection is the first of multiple injectable drugs B. Braun plans to launch in the coming years to help meet the needs of patients for medications in high demand," said Leigh Nickens, Director of Marketing, Fluid Therapy & Injectable Drugs, in a statement. "It represents our commitment to improve the security of supply by manufacturing pharmaceuticals in the United States at our newly expanded and modernized facility in Irvine, California."

The injection bags will be available in 1000 mg in 100 mL doses, as well as in 500 mg in 50 mL doses.

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FDA Approves New Acetaminophen Injections in Multiple Doses

A new study suggests mobile health interventions among those with opioid use disorder may help increase uptake of 

A team led Karli Hochstatter, MPH, PhD, School of Social Work, Columbia University, used the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), a smartphone-delivered relapse prevention system, to provide HCV-related and educational content to patients.

“The growing epidemic of opioid use disorder and associated injection drug use has resulted in a surge of new HCV infections, wrote Hochstatter and colleagues. “Improving HCV awareness and increasing screening among people with opioid use disorder are critical.”

The investigators enrolled 416 patients with opioid use disorder between April 2016 and April 2020.

Patients were then randomly assigned 1:1 to receive medications for addiction treatment (MAT) alone or MAT plus A-CHESS platform.

Those in the intervention cohort received private messages tailored to the individuals’ stage of HCV care—ranging from having never been tested for HCV to receiving HCV antiviral therapy and considered cured by a physician.

Patients also had access to a public discussion forum on the platform.

Among all participants, quarterly telephone interviews were conducted from baseline to month 24 so that the investigators could assess risk behaviors as well as HCV testing history.

Hochstatter and team used cox proportional hazards regression to evaluate whether participants in the intervention A-CHESS cohort were tested for HCV at a higher rate compared to the control cohort.

“To assess the effect of A-CHESS on subsets of participants at the highest risk for HCV, additional analyses were performed to examine the effect of the intervention among participants who injected drugs and shared injection equipment,” the investigators indicated.

In the participant population, 85.8% were non-Hispanic White and 54.8% were male participants. The mean age was 37 years.

Furthermore, 44.2% were HCV Ab positive and 25.5% were considered untested at baseline.

The team noted no significant difference in HCV testing uptake between the intervention and control cohort.

However, among 109 participants who engaged in injection drug use, those in the intervention group (n = 63) had a greater rate of HCV testing uptake compared with those in control group (89% vs 85%, respectively; hazard ratio [HR]: 1.34; 95% CI, 0.87-2.05; 

This trend was even more pronounced in the subset of 32 patients (23 intervention, 9 control) who reported sharing injections (87% intervention vs 56% control; HR, 2.92; 95% CI, 0.959-8.86; 

“An overall improvement in the HCV care continuum between baseline and month 24 was observed, where a smaller proportion of participants were untested and a higher proportion had tested HCV negative and achieved sustained virologic response,” wrote Hochstatter and colleagues.

“These trends appeared among both intervention and control participants, suggesting that there may be external factors influencing changes in the HCV care continuum,” they continued.

Nevertheless, the acknowledged that A-CHESS may be most useful in increasing testing rates among those with the highest risk of infection, as suggested by the findings.

They also indicated that higher powered studies are needed to detect differences in HCV testing among these highest-risk groups.

And, of course, evolving technologies can have widespread implications on healthcare screening and treatment practices.

“Advancements in mHealth technology offer the opportunity to provide information and services for the treatment of both opioid use disorder and HCV infection simultaneously,” the investigators wrote.

Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial

Those who injected drugs and shared needles were more likely to have been screened for HCV if using mobile A-CHESS platform. 

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FDA Approves New Acetaminophen Injections in Multiple Doses

mHealth Intervention May Help Increase HCV Testing Among High-Risk Opioid Users