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Recent investigation into the use of high-dose biologics showed that dose escalation in patients with juvenile idiopathic arthritis (JIA) was effective in improving disease control, provided that specific biologic agents are used.

The study, led by Colleen K. Correll, MD, contributed to the increasingly popular trend of biologic use for the treatment of young patients, and was one of the first published studies to discuss the efficacy and safety of the process.

Correll and her colleagues found that within the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry, 20% of children with JIA received high-dose biologics, though the use of biologics varied by state.

The team considered biologics to be integral in the treatment of juvenile idiopathic arthritis, writing that pediatric rheumatologists may increase the dosage of biologics beyond standard range in order to achieve better disease control.

They conducted a retrospective study of patients with JIA enrolled in the CARRA Registry from June 30, 2015 to December 6, 2019.

The registry defined high-dose as 40% higher than the standard dose issued, and each dose was approved by the US Food and Drug Administration (FDA) whenever access was available.

The retrospective study contained 5352 patients, 20.1% (n = 1080) of whom ever received high-dose treatment prior to the study.

The levels of dosage within the group were standard, high, and low. Most participants (69%) continued standard dosing after enrollment in the Registry. Those who did change the dosage or switched to a new biologic tended to have higher disease activity scores.

The most used biologic in the high-dose group was adalimumab (68.3%), whereas among the switch biologic group, most participants were receiving etanercept (71.0%).

Investigators noted that weekly adalimumab had been demonstrated to be safe and effective in the treatment of other pediatric autoimmune diseases and adult rheumatoid arthritis (RA), which they believed explained why it was the most used biologic to be used (during high-dose studies.

However, high-dose etanercept has not been demonstrated to be effective in treating JIA, which resulted in participants switching to different biologic therapies.

Discontinuation rates and serious adverse events (SAE) were noted in all participant groups. While they did occur at a higher rate in high-dose and switched dose groups, the team considered them to be uncommon.

The 6-month outcomes observed by Correll and colleagues showed that participants with an increased dose, as well as those who switched to other biologic therapies, showed greater improvement.

“The 6-month outcomes were similar between the high-dose and biologic switch groups, and both groups had improvements in disease activity measures,” the team wrote. “These findings support the idea that if a patient with JIA has inadequately controlled disease, increasing to high-dose biologic is a reasonable option, as is switching biologics.”

High-dose participants were also compared to the standard, no-change group.

While a higher trend of SAEs was found in the high-dose group, investigators attributed it to the likelihood of more severe cases within the group. Allowing for that likelihood, they found the high-dose group to be a reasonable and preferred option for patients with inadequately controlled disease on standard doses.

Although the team lacked dose-comparison studies for the vast majority of drugs used in the study, they considered it to be successful.

As noted in the study, the dosing of biologic agents in children with pediatric rheumatic diseases had not been studied comprehensively in the past. However, the study showed a positive response to increased doses in patients with JIA.

Correll and her colleagues called for further studies to be made regarding biologic use in children, as well as comparative studies in adult patients. Despite this, the team considered high-dose biologic treatment to be safe and effective.

“Since children generally have fewer co-morbidities than adults and given our concern of active arthritis impacting the child’s growing skeleton, pediatric rheumatologists may have a greater willingness to use higher doses of biologics compared to adult rheumatologists,” the team wrote. “However, it would be important to compare studies similar to ours in adult patients if high doses are used in the real-world setting.”

Effectiveness and Safety of High-Dose Biologics in Juvenile Idiopathic Arthritis in the Childhood Arthritis and Rheumatology Research Alliance,”

 was published online in Arthritis Care and Research.

Articles

New research shows clinical effectiveness in increasing biologic doses in children, depending on the agent.

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Study Recommends Biologic Dose Escalation in Patients with Juvenile Idiopathic Arthritis

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

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American Society of Microbiology (ASM) 2021 World Microbe Forum

 infection (CDI) treatment resulted in a low recurrence rate when compared to placebo.

A team led by Colleen S. Kraft, MD, Emory University School of Medicine, evaluated the distribution of C difficile ribotypes and whether CDI recurrence was related to relapse or reinfection in patients with multiply rCDI.

The researchers previously tested an investigational microbiome therapeutic consisting of purified Firmicutes spores called SER-109 in an attempt to identify the typing of strains from infections to learn more about CDI disease and epidemiology.

“SER-109 may represent a paradigm shift in the clinical management of patients with recurrent CDI,” the authors wrote.

C difficile infections are generally caused by the disruption of the microbiome coupled with exposure to C difficile spores. The leading risk for infections is the exposure of broad spectrum antibiotics, which can cause collateral damage to beneficial microbes that normally reside in the gastrointestinal microbiome.

In addition, there is a current lack of antibiotics that target C difficile due to a lack of effect on C difficile spores that germinate within a disrupted microbiome, preventing a sustained response in the majority of patients.

The researchers previously found SER-109 was superior to placebo in reducing the recurrence of CDI during an 8 week phase 3 study (12.4% vs 39.8%; RR, 0.32; 95% CI, 0.18-0.58; 

Strain typing data is generally not available to assess whether recurrence is due to relapse or reinfection.

In the ECOSPOR III study, the researchers used selective media to isolate C difficile from baseline stool samples and stool samples from unscheduled visits for recurrence of diarrhea during a 24 week follow-up period. Each participant’s baseline stool sample was taken before randomization without regard to whether the patient had started or completed the standard-of-care antibiotic treatment.

The team also isolated C difficile from ethanol treated stool using C difficile selective agar—Cycloserine-cefoxitin-fructose agar with and without horse blood—as well as enrichment culture—Cycloserine Cefoxitin Mannitol Broth with Taurocholic Acid Lysozyme and Cysteine.

In addition, the investigators saved 1 C difficile isolate per stool sample and typed strains by PCR ribotyping.

In a post-hoc analysis, the researchers evaluated the distribution and prevalence of ribotypes in patients and determined whether the ribotype at recurrence was indicative of relapse or reinfection for up to 24 weeks.

In total, 122 patients (67%) yielded positive cultures at baseline, while 10 (5.5%) yielded no growth. In addition, 50 (27.5%) subjects did not contribute a sample. Overall, there were 33 different ribotypes at baseline with 020/014 the most common ribotype, which was identified in 18.9% of baseline patients.

Hypervirulent ribotypes 027 and 078 (0787/126) were also identified in 15.6% (n = 19) of the patient population at baseline.

A total of 47 recurrences were observed, 11 in the SER-109 arm and 36 in the placebo group. Of those, paired ribotypes were available for 32 recurrence events, including 9 in the treatment group and 23 in the placebo group.

Relapses were also more common in the study (n = 24; 75%).

However, relapse events were lower in patients treated with SER-109 (5 vs. 19). Reinfection events were comparable, but low (4 vs. 4).

“SER-109 significantly reduced CDI recurrence compared to placebo at 8 weeks after dosing with an observed safety profile comparable to placebo,” the authors wrote. “Multiple ribotypes were isolated, which is consistent with typically observed epidemiological studies. Low rates of recurrence with SER-109 observed in ECOSPOR III limit the ability to assess the impact of relapse versus reinfection; however, numerically, SER-109 demonstrated reduced rates of recurrence compared with placebo across ribotypes and protected against the dominant mode of recurrence (relapse) in patients with a history of multiply recurrent CDI.”

The researchers are currently enrolling patients with at least 1 episode of CDI for an open-label study.

Characterization of Ribotypes Among Study Participants in a Phase 3 Trial of Investigational Microbiome Therapeutic SER-109 to Reduce Recurrent Clostridioides difficile infection (rCDI)

Strain typing data is not often available to assess whether recurrence is due to CDI relapse or reinfection.

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SER-109 Reduces Rates of Recurrent C Difficile Infections

The US Food and Drug Administration (FDA) has approved dabigatran etexilate (Pradaxa) oral pellets for the treatment of children 3 months to <12 years old with 

With the indication, dabigatran etexilate is the first FDA-approved blood-thinning therapy for pediatric oral administration, with all previous agents available only in injection form. It was originally approved in 2010 for the reduction of stroke and systemic embolism risk in adult patients with non-valvular atrial fibrillation.

The therapy is specifically indicated for pediatric patients with VTE directly following injection blood thinner therapy for ≥5 days, and includes an indication for the prevention of recurrent clots in the same patient population who completed treatment for their first VTE.

The FDA additionally approved dabigatran etexilate in capsule form, for the treatment of blood clots in patients ≥8 years old with VTE directly after ≥5 days of blood thinner injection therapy, and to prevent recurrent clots in the same patient population after completing treatment for their first VTE.

The efficacy and safety of dabigatran etexilate in treating pediatric blood clots was assessed in a single open-label trial involving 267 patients aged ≤18 years old. Patients were randomized to either dabigatran etexilate or standard of care, with investigators comparing the treatment groups for number of patients to reach the composite endpoint:

Nearly half (n = 81; 45.8%) of patients administered dabigatran etexilate had achieved the composite endpoint, versus 42.2% (n = 38) of the 90 patients administered standard of care.

Another open-label, single-arm pediatric assessment of 214 patients with a history of blood clots evidenced the safety of the therapy, with just 1.4% (n = 3) patients treated with dabigatran etexilate experiencing a recurrence of blood clots.

The most common adverse events in treated pediatric patients included digestive system symptoms and bleeding. Pradaxa includes a boxed warning advising that early treatment discontinuation may be associated with increased risk of blood clots.

In a statement accompanying the approval, Ann Farrell, MD, director of the FDA’s Center for Drug Evaluation and Research’s Division of Non-Malignant Hematology, emphasized the importance of simplicity in treating a possibly fatal event risk in children.

"The FDA is committed to helping our youngest patients with serious medical conditions have treatments that are relatively easy to take,” Farrell said. "With today's approval of Pradaxa, pediatric patients have another therapeutic option to treat and prevent potentially deadly blood clots."

Dabigatran etexilate was approved in both oral pellet and capsule forms for varying pediatric patient populations.

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Venous Thromboembolism

FDA Approves Oral Blood-Thinning Drug For Children with VTE

This article was originally published in ContagionLive.

China has officially passed the 1 billion dose mark for 

 vaccinations administered, becoming 1 of the world’s fastest inoculation efforts.

Despite the high number of doses given out, the country is still remaining very strict with its elimination efforts.

The borders are still mostly closed off to international travel, and social distancing measures are still being strongly enforced in some areas.

China has also been offering millions of its vaccines to other countries, but many places, like Brazil, are refusing the shot in hopes of getting Pfizer or Moderna’s vaccine.

In Cuba, officials are reporting that their homegrown COVID-19 vaccine, Soberana 2, is showing promising results.

On Saturday, results from a late-phase trial were reported, showing the vaccine to be 62% effective with 2 out of its 3 recommended doses.

The country has shunned foreign-made vaccines, putting all of their hopes in their own. Cuba has partnered with Iran, which has also boycotted foreign made vaccines.

The Philippines has recently agreed to purchase 40 million doses of the Pfizer-BioNTech vaccine, which will provide a significant boost to the country which has been struggling with infections.

The order is set to be delivered through the third and fourth quarter of 2020.

Since the start of the pandemic, the Philippines has seen over 1.35 millions COVID-19 infections, with 23,500 deaths.

Data Table per Our World in Data (June 20, 2021, 12 AM EST)

In the United States, Rochelle Walensky, the director of the US Centers for Disease Control and Prevention, warned on Friday that the Delta variant is soon likely to become the dominant strain in the country. The more transmissible variant is likely to spread throughout the unvaccinated population.

Data Table per CDC COVID-19 Tracker (June 20, 2021, 6 AM EST)

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China Hits 1 Billion COVID-19 Vaccines Administered 

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Patients undergoing hemodialysis are prone to anxiety and depression, suggested investigators of a new study.

A team led by Fatima Al-Nashri RN, MN, of King Abdulaziz University, Saudi Arabia, performed a cross-sectional correlational study to further elucidate the relationship between mental health burden and quality of life in these patients. 

“Understanding these relationships is essential for developing interventions to improve the QOL and reduce symptoms among haemodialysis patients,” Al-Nashri and colleageus wrote.

“The findings from this research could provide further knowledge to aid in the development of nursing management strategies to reduce symptom frequency, and to improve the QOL amongst people undergoing haemodialysis therapy.”

They enrolled 114 patients from 2 dialysis centers. All patients were ≥18 years of age and presented with 

Patients who received a kidney transplant and commenced peritoneal dialysis were excluded from the study.

The investigators then collected clinical information, including data on dialysis-related factors. They also utilized the Kidney Disease and Quality of Life Survey (KDQOL-36), in addition to the Hospital Anxiety and Depression Scale (HADS), to assess mental health symptoms, individual experiences with dialysis, and patient quality of life.

“Among the 5 QOL domains, the highest domain scores were reported in the symptom problem list and effect of kidney disease, with a mean score of 60.1 ± 19.8 and 59.1 ± 18.8, respectively,” they reported.

“The lowest scores were found in burden of disease and physical function (mean score 42.5 ± 25.4 and 44.5 ± 25.9, respectively).

Based on predefined cut-off points, 50% of the participants had anxiety, and 44.7% had depression.

The team used Pearson’s correlation coefficient test to evaluate the correlation between anxiety, depression and patient quality of life. As such, they found that anxiety was negatively correlated with quality of life (r = -.599; 

“Comparing the median scores for each QOL domain among patients with or without anxiety and depression, we found that the median QOL score of each domain was significantly lower among patients with anxiety and depression,” they noted.

“In addition, the burden of disease and physical component scores were shown to be associated with poor QOL, and they were mostly affected by both anxiety and depression”

Pearson’s correlation coefficients revealed that anxiety and depression were also significantly correlated with kidney disease-specific quality of life domains, such as burden of disease, symptoms, and effect of kidney disease.

Linear regression showed that both depression and anxiety had impacts of kidney disease quality of life (depression, t = −4.021, 

In terms of patient characteristics, older patients (≥ 65 years) were generally had poorer quality of life (F = 16.074, 

Notably, female participants had a lower quality of life (T = 2.305, 

< .041) and higher depression levels (T = −2.155, 

 = .033). Divorced or widowed patients, those were illiterate, and those receiving government support also demonstrated worse scores.

In response to these findings, Al-Nashri and colleagues underscored the importance of psychological screening, particularly in patients about the undergo hemodialysis.

“Early detection and treatment of anxiety and depression may have a positive impact on disease outcomes,” they indicated. Even more, they continued, healthcare providers should seek ways to continue to build up relationships with patients and effectively monitor individual patients needs.

Impact of anxiety and depression on the quality of life of haemodialysis patients

Patients with chronic kidney disease reported poor quality of life, particularly in domains related to their condition.

Rare Disease Report®

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Hemodialysis Patients Likely to Experience Anxiety, Depression

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Columbia University College of Physicians and Surgeons

Panelists consider the importance of long-term approaches to monitoring hypoglycemic episodes and discuss the role of education and awareness, patient questionnaires, and effective communication with physicians. 

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Investigators suggest symptoms in asthmatic patients are more severe, although it does not result in higher mortality rates.

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Asthmatic Patients Experience Harsher Reaction to COVID-19

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Patient-reported scores showed no overall differences across 3- and 12- month follow-up. 

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Latest News

Study Recommends Biologic Dose Escalation in Patients with Juvenile Idiopathic Arthritis

SER-109 Reduces Rates of Recurrent C Difficile Infections

FDA Approves Oral Blood-Thinning Drug For Children with VTE

China Hits 1 Billion COVID-19 Vaccines Administered

Hemodialysis Patients Likely to Experience Anxiety, Depression