Novel insecticide paint may help curb outbreaks of Malaria, Zika and dengue fever: Study

Spain: A recent study published in Frontiers in Tropical Diseases has suggested insecticide paints to be an effective innovation strategy for mosquito control.

“The strategy could be implemented as a reinforcement of the measures carried out by the vector control program in the city of Praia and throughout the country,” the researchers wrote. 

Malaria and other illnesses caused by parasites, viruses, and bacteria transmitted by organisms that spread infectious pathogens account for more than 17% of all infectious diseases worldwide. These vector-borne diseases, typically transmitted by insects like mosquitoes, flies, and ticks, disproportionally affect the poorest populations in tropical and subtropical regions.

In Cabo Verde, an island nation off west Africa, vector-borne disease has been prevalent for centuries, in part due to the island’s geographical location and climate. Now, researchers in Cabo Verde and Spain set out to test the efficacy of three insecticide paint formulations to reinforce the existing national program aiming to minimize the occurrence of disease outbreaks. 

“Here we show that VESTA insecticide paint is effective at killing Aedes aegypti, the yellow fever mosquito, in the city of Praia for at least one year,” said lead author Dr Lara Ferrero Gómez, who coordinates a research group on tropical diseases at the Jean Piaget University of Cabo Verde. “We also found it has good acceptance in the population, with 98% confirming the decrease in mosquitoes in their residences after paint application.”

Mosquito control for up to a year

In a large-scale field trial, trained volunteers painted 228 houses in two Praia neighborhoods that are particularly vulnerable to diseases transmitted by mosquitoes. This is due to insufficient drainage which leads to flooding in the rainy season and poor wastewater management. Additionally, many residences in Cabo Verde store water due to insufficient and disrupted water supply, and water storage is often unsafe.

After one, three, six, and 12 months, WHO cone bioassays were conducted at two randomly selected houses in each neighborhood. “Bioassays record the mortality of A. aegypti mosquitoes after exposing them for half an hour to the insecticidal paint. This allows us to directly evaluate the effectiveness of the insecticidal paint,” Ferrero Gómez explained.

All three insecticide paint mixtures lead to complete mortality of A. aegypti mosquitoes one month after the houses were painted. Three months after painting, all formulations still exceeded the WHO efficiency threshold, which lies at 80%. At month six, two formulations fell below this threshold. The VESTA formulation, however, also met WHO requirements at months six and 12. “The paint works by releasing very small quantities of insecticide over a long period, which makes it more sustainable and eco-friendlier,” Ferrero Gómez pointed out.

The researchers did not register any serious effects of the paint on residents’ health. Adverse effects reported by few residents included mild eye or nose irritation (10%) and headache (4%).

Malaria free – what’s next?

At the beginning of the year, Cabo Verde was the third country in Africa to be declared free of Malaria by the WHO. The challenge to stop its reoccurrence, however, remains. The researchers said that insecticidal paint is also a promising strategy to strengthen the prevention and control of malaria cases at a household level since insecticide paint is effective for any type of vector disease transmitted by mosquitos, not just zika and dengue fever.

While the researchers face certain limitations, such as the need to meticulously apply the paint in two layers to ensure it does not lose its effectiveness, the TINTAEDES project is expected to extend to more locations across Praia, which is a hotspot for vector-borne diseases, as well as across all of Cabo Verde.

Reference:

Lara Ferrero Gómez, Hélio D. Ribeiro Rocha, Ignacio Gil Torró, Irene Serafín Pérez, Deinilson Conselheiro Mendes, Keily L. Fonseca Silva, Davidson D. Sousa Rocha Monteiro, Jailson P. Tavares Dos Reis, Silvânia Veiga Leal, Mendez, Basilio Valladares Hernández, Insecticide paints: a new community strategy for controlling dengue and zika mosquito vectors in Cabo Verde, Frontiers in Tropical Diseases, https://doi.org/10.3389/fitd.2024.1321687.

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New research sheds light on mycophenolate and azathioprine efficacy in interstitial lung disease

Italy: A systematic review and meta-analysis published in BMJ Open Respiratory Research assess whether the administration of mycophenolate mofetil (MMF) or azathioprine (AZA) in interstitial lung disease (ILD) was associated with changes in pulmonary function and gas transfer.

The researchers reported an unclear benefit of MMF on interstitial lung disease. They found no significant difference in outcome compared with placebo or standard of care.

“We observed a minor increase in percent predicted forced vital capacity and diffusion lung capacity of carbon monoxide from baseline in MMF. Studies on AZA were limited,” Francesco Lombardi, Pulmonary Medicine, Policlinico Universitario Agostino Gemelli, Roma, Italy, and colleagues wrote.

Mycophenolate mofetil and azathioprine are two immunomodulatory drugs used for treating connective tissue disease, with both drugs having mechanisms that target lymphocytes. They are being increasingly used to treat ILD, but the evidence is limited for the efficacy of AZA or MMF in improving outcomes. Therefore, Dr. Lombardi and colleagues sought to evaluate the MMF or AZA efficacy on pulmonary function in ILD.

The population included any interstitial lung disease diagnosis, interventions included AZA or MMF treatment, and the outcome was delta change from baseline in percent gas transfer (diffusion lung capacity of carbon monoxide, %DLco) and predicted forced vital capacity (%FVC). The study’s primary endpoint compared outcomes relative to the placebo comparator; the secondary endpoint evaluated outcomes in treated groups only.

Prospective observational studies and randomized controlled trials (RCTs) were included. No language restrictions were applied. Studies with high-dose concomitant steroids and retrospective studies were excluded.

A systematic search of online databases was conducted on May 9. Meta-analyses were specified according to drug and outcome with random effects, I2 evaluated heterogeneity, and Grading of Recommendations, Assessment, Development, and Evaluation evaluated certainty of evidence.

Primary endpoint analysis was restricted to RCT design, secondary endpoint included subgroup analysis according to prospective observational or RCT design.

Following were the key findings:

  • Out of 2831 publications screened, 12 were suitable for quantitative synthesis.
  • Three MMF RCTs were included with no significant effect on the primary endpoints (%FVC 2.94; %DLco −2.03).
  • An overall 2.03% change from baseline in %FVC was observed in MMF, and the RCT subgroup summary estimated a 4.42% change from baseline in %DLCO.
  • AZA studies were limited.
  • All estimates were considered very low-certainty evidence.

In conclusion, there were limited RCTs of AZA or MMF, and their benefit on interstitial lung disease was of very low certainty. MMF may support the preservation of pulmonary function, but the confidence in the effect was weak.

“To support high certainty evidence, RCTs should be designed to directly assess the efficacy of mycophenolate mofetil in ILD,” the researchers wrote.

Reference:

Lombardi F, Stewart I, Fabbri L REMAP-ILD Consortium, et alMycophenolate and azathioprine efficacy in interstitial lung disease: a systematic review and meta-analysisBMJ Open Respiratory Research 2024;11:e002163. doi: 10.1136/bmjresp-2023-002163

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Betamethasone not effective for at risk for preterm delivery to reduce treatment of neonatal respiratory distress

Betamethasone administered in the late preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress suggests a new study published in the Obstetrics & Gynecology.

A study was done to evaluate the efficacy of antenatal corticosteroids in reducing neonatal respiratory complications when administered to those at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. This was a single-centre, triple-blind, randomized, placebo-controlled trial in southern India enrolling pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. Computer-generated block randomization was used with participants randomized to either one course of intramuscular betamethasone or placebo. The primary outcome was a composite of treatment for respiratory distress in the neonate, defined as the need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Neonatal secondary outcomes were transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycemia, stillbirth, and early neonatal death; maternal secondary outcomes were chorioamnionitis, postpartum haemorrhage, puerperal fever, and length of hospitalization. All analyses were based on intention to treat.

A sample size of 1,200 was planned with 80% power to detect a 30% reduction in rates of respiratory distress. After a planned interim analysis, enrollment was stopped for futility. RESULTS: From March 2020 to August 2022, 847 participants were recruited, with 423 participants randomized to betamethasone and 424 participants randomized to placebo. There were 22 individuals lost to follow-up. There was no statistically significant difference in the primary outcome (betamethasone 4.9% vs placebo 4.8%, relative risk 1.03, 95% CI, 0.57–1.84, number needed to treat 786). There were no statistically significant differences in secondary neonatal or maternal outcomes. Betamethasone administered in the late preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress.

Reference:

Yenuberi, Hilda MD; Ross, Benjamin DM; Sasmita Tirkey, Richa MS; Benjamin, Santosh Joseph MS; Rathore, Swati MS; Karuppusami, Reka MSc; Lal, Aadarsh MSc; Thomas, Niranjan MD, FRACP; Mathew, Jiji Elizabeth MS. Late Preterm Antenatal Steroids for Reduction of Neonatal Respiratory Complications: A Randomized Controlled Trial. Obstetrics & Gynecology ():10.1097/AOG.0000000000005520, February 8, 2024. | DOI: 10.1097/AOG.0000000000005520

Keywords:

Yenuberi, Hilda MD; Ross, Benjamin DM; Sasmita Tirkey, Richa MS; Benjamin, Santosh Joseph MS; Rathore, Swati MS; Karuppusami, Reka MSc; Lal, Aadarsh MSc; Thomas, Niranjan MD, FRACP; Mathew, Jiji Elizabeth MS, Obstetrics & Gynecology, preterm, Antenatal, Steroids, Reduction, Neonatal Respiratory Complications

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Treatment of H. pylori infection may reduce risk of colorectal cancer and associated mortality: Study

Although H. pylori infection does not itself cause illness but, chronic infection is associated with long-lasting inflammation in the stomach, which can cause complications like atrophic gastritis and stomach cancer.

According to a study published in the Journal of Clinical Oncology, H. pylori-positive individuals may exhibit a small yet statistically significant increase in the incidence and mortality rates of colorectal cancer (CRC). Untreated individuals, especially those with active infections, seem at the most significant risk.
Helicobacter pylori is the most common cause of infection-associated cancer worldwide. This study evaluated the impact of H. pylori infection and treatment on CRC incidence and mortality.
The study included patients in the US who completed H. pylori testing between 1999 and 2018. They conducted a retrospective cohort analysis among adults within the Veterans Health Administration who completed testing for H. pylori. The primary exposures were H. pylori test results (positive/negative) and treatment (untreated/treated) among H. pylori-positive individuals. The primary outcomes were CRC incidence and mortality. Follow-up started at the first H. pylori testing and continued until the earliest incident or fatal CRC, non-CRC death, or December 31, 2019.
Key findings of the study are:
  • 25.2 % of individuals among 812,736 tested positive for H. pylori.
  • Being H. pylori–positive versus H. pylori–negative was associated with higher CRC incidence and mortality.
  • H. pylori treatment versus no treatment was associated with lower CRC incidence and mortality through 15-year follow-up.
  • Being H. pylori–positive versus H. pylori–negative was associated with an 18 % and 12% higher incident and fatal CRC risk, respectively. The aHR was 1.18 and 1.12, respectively.
  • Individuals with untreated versus treated H. pylori infection had 23% and 40% higher incident and fatal CRC risk, respectively, with aHR of 1.23 and 1.40.
  • The results were more pronounced in the analysis restricted to individuals with nonserologic testing.
Concluding further, they said that H. pylori infection is linked to a higher incidence and mortality rate for colorectal cancer (CRC), particularly in those with active infections and who are untreated. The association is small but significant, they added.
Reference:
Shailja C. Shah et al. Impact of Helicobacter pylori Infection and Treatment on Colorectal Cancer in a Large, Nationwide Cohort. JCO 0, JCO.23.00703
DOI:10.1200/JCO.23.00703

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Plant-based diet intake over time appears beneficial in reducing hip fracture risk, finds study

Fractures are a concern for older adults due to age-related bone loss, especially in women after menopause. Globally, 1 in 3 women over 50 will suffer a fragility fracture, leading to long-term health issues. Proper nutrient intake is crucial for maintaining bone health. According to previous studies, calcium, vitamin D, and K are linked to reduced bone loss.

According to an original investigation on Nutrition, Obesity, and Exercise published in JAMA Network Open, researchers concluded that adhering to a plant-based diet did not affect the risk of hip fracture among postmenopausal women in the US. However, women with a recent healthy plant-based diet had a 21% lower fracture risk. In contrast, the most recent intake of an unhealthy plant-based diet was associated with a 28% higher fracture risk.
Previous studies have linked vegetarian diets to lower bone mineral density and higher fracture risk but failed to differentiate between the quality of plant-based foods. This study investigated the relationship between the quality of plant-based diets (omnivorous and vegan options) and hip fracture risk in postmenopausal women from the Nurses’ Health Study. The study analyzed data from 70,285 participants between 1984 and 2014, with analysis conducted in 2023.
Hip fractures were reported on biennial questionnaires, and diet was assessed every four years using a validated food frequency questionnaire. The healthy Plant-Based Diet Index (hPDI) and the unhealthy Plant-Based Diet Index (uPDI) were used to assess plant-based diet quality. Healthy plant foods received positive scores, while less healthy plant and animal foods received reversed scores. The quintile scores of 18 food groups were summed, resulting in a theoretical range of 18 to 90 for both indices. Cox proportional hazards regression was used.
Key findings of the study are:
· The study had 70 285 participants, and 2038 cases of hip fracture were ascertained during the study and for up to 30 years of follow-up.
· Neither the hPDI nor the uPDI for long-term diet adherence was associated with hip fracture risk.
· Examining recent intake for the highest vs lowest quintiles, the hPDI was associated with a 21% lower risk of hip fracture and the uPDI was associated with a 28% higher risk with HR of 0.79 and 1.28 respectively, large sample size and extended follow-up, repeated assessment of diet and lifestyles were the main strengths of the study.
They said long-term adherence to a plant-based diet was not associated with hip fracture risk.
Reference:
Sotos-Prieto M, Rodriguez-Artalejo F, Fung TT, et al. Plant-Based Diets and Risk of Hip Fracture in Postmenopausal Women. JAMA Netw Open. 2024;7(2):e241107. doi:10.1001/jamanetworkopen.2024.1107

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Single-use versus reusable ureteroscopes yield similar outcomes in intrarenal surgery for urinary stones: Study

Brazil: A systematic review and meta-analysis published in Urolithiasis compared the performance of single-use versus reusable flexible ureteroscopes in retrograde intrarenal surgery for urinary stones.

The researchers found that both scopes demonstrated similar outcomes in operative time, stone-free rates, incidence of post-operative fever, and UTIs. The results indicate that the choice between the two hinges on factors, such as cost, availability, and surgeon preference.

Flexible ureterolithotripsy is a frequent urological procedure, usually used for stone removal from the kidney and upper ureter. For that procedure, reusable uretero-scopes were the standard tool, but recent concerns regarding sterility and maintenance and repair costs created the opportunity to develop new technologies.

The first single-use digital flexible ureteroscope was introduced in 2016. Since then, other single-use ureteroscopes have been developed, and studies compared them with reusable ureteroscopes and yielded conflicting results. Therefore, Mikhael Belkovsky, Surgical Technique & Experimental Surgery Department, Universidade de São Paulo, São Paulo, Brazil, and colleagues aimed to describe the literature that compares the performance of single-use and reusable flexible ureteroscopes in retrograde intrarenal surgery for urinary stones.

For this purpose, the researchers performed a systematic review in October 2022 according to the PRISMA (Preferred Reporting Items for Systematic Reviews and MetaAnalyses) and Cochrane Handbook. A search in online databases retrieved 10,039 articles. After screening, twelve articles were selected for the Meta-Analysis.

Based on the review, the researchers reported the following findings:

  • No differences were found in stone-free rate (OR 1.31), operative time (MD 0.12), incidence of post-operative fever (OR 0.64), or incidence of post-operative urinary tract infection (OR 0.63 ).
  • No differences were observed in the studied variables.

In conclusion, both scopes demonstrated comparable outcomes in operative time, stone-free rates, the incidence of postoperative fever, and UTIs.

“Hence, the device choice should rely on the cost analysis, availability, and surgeons’ preference,” the researchers wrote.

Reference:

Belkovsky M, Passerotti CC, Maia RS, de Almeida Artifon EL, Otoch JP, Da Cruz JAS. Comparing outcomes of single-use vs reusable ureteroscopes: a systematic review and meta-analysis. Urolithiasis. 2024 Feb 28;52(1):37. doi: 10.1007/s00240-024-01537-8. PMID: 38413490.

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Impacted lower third molar extraction: Lingual position of IAN near LTM ups risk of neurosensory deficits, study finds

Austria: A recent study published in the Journal of Clinical Medicine, for the first time, has distinguished between short-term (7 days postoperatively) and enduring (at least 12 months) sensory deficits after the extraction of lower third molars (LTMs).

The researchers reveal an increased risk of neurosensory deficits when the inferior alveolar nerve (IAN) is directly positioned lingually to the tooth roots, and the use of cone-beam CT improves the risk assessment and comprehensive presurgical anatomic information.

“The overall incidence rate of acute neurosensory deficits of the mandibular nerve within the first seven days after the extraction of an LTM was 5.9%, with IAN impairment constituting 48.5% of cases and lingual nerve deficits constituting 36.4%,” the researchers reported.

The incidence rate of persisting deficits of the mandibular nerve was 1.3% of the removed teeth, impacting the IAN and lingual nerve in 0.8% and 0.5% of cases, respectively.

Neurosensory deficits are one of the leading complications that occur after impacted lower third molar extraction resulting in an impaired patient’s quality of life. Marcus Rieder, Medical University of Graz, Graz, Austria, and colleagues aimed to evaluate the incidence of neurosensory deficits after lower third molar extraction and compare it radiologically to the corresponding position of the inferior alveolar nerve.

For this purpose, the researchers compiled all patients who underwent impacted lower third molar extraction between January and December 2019 in a retrospective study. Therefore, they assessed clinical data as well as preoperative radiological imaging.

The study led to the following findings:

  • The study included 418 patients who underwent lower third molar extractions (n = 555). Of these, 5.9% had short-term (i.e., within the initial seven postoperative days) and 1.3% long-term (i.e., persisting after 12 months) neurosensory deficits documented.
  • The inferior alveolar nerve position concerning the tooth roots showed apical position in 27%, buccal position in 30.8%, lingual position in 35.4%, and inter radicular position in 6.9%

The occurrence of neurosensory deficits at the mandibular nerve after lower third molar surgery is relatively rare.

According to the authors, their results are consistent with the majority of published studies found. “A lingual position of the IAN close to the LTM significantly increases the risk of nerve deficits. In this context, cone beam computed tomography scan use appears promising as it can improve risk assessment and provide comprehensive preoperative patient information,” the researchers wrote.

“It is noteworthy that in our study, no decreased quality of life was observed in patients with persistent nerve deficits,” they concluded.

Reference:

Rieder, M., Remschmidt, B., Schrempf, V., Schwaiger, M., Jakse, N., & Kirnbauer, B. (2022). Neurosensory Deficits of the Mandibular Nerve Following Extraction of Impacted Lower Third Molars—A Retrospective Study. Journal of Clinical Medicine, 12(24), 7661. https://doi.org/10.3390/jcm12247661

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Dexmedetomidine reduces cardiac surgery-associated AKI by reducing oxidative stress: Study

China: Dexmedetomidine (Dex) reduces cardiac surgery-associated (CSA) acute kidney injury (AKI) by regulating metabolic disorders and reducing oxidative stress, findings from a prospective clinical trial have shown. The findings were published online in Revista Española de Cardiología, the official publication of the Spanish Society of Cardiology.

Cardiac surgery-associated acute kidney injury is a well-recognized complication resulting in higher mortality-morbidity after cardiac surgery. In its most severe form, it increases the odds ratio of operative mortality 3–8-fold, length of stay in the Intensive Care Unit (ICU) and hospital, and care costs. Early diagnosis is important for the optimal treatment of this complication.

Xiaohong Li, Department of Anesthesiology, First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China, and colleagues aimed to evaluate the impact of dexmedetomidine on cardiac surgery-associated acute renal failure, kidney function, and oxidative and metabolic stress in patients undergoing coronary artery bypass grafting (CABG) with heart-lung machine support.

For this purpose, they conducted a randomized double-masked trial with 238 participants (50-75 years) undergoing CABG from January 2021 to December 2022. The participants were categorized into Dex (n = 119) and normal saline (NS) groups (n = 119). Dex was administered at 0.5 mcg/kg over 10 minutes, then 0.4 mcg/kg/h until the surgery’s end; the NS group received equivalent saline.

Urine and blood sampling were done at several time points pre-and post-surgery. The study’s primary outcome measure was the incidence of CSA-AKI, defined as the AKI occurrence within 96 hours after surgery.

The researchers reported the following findings:

  • The incidence of CSA-AKI was significantly lower in the Dex group than in the NS group (18.26% vs 32.46%).
  • There were substantial increases in the estimated glomerular filtration rate value at T4–T6 and urine volume 24 hours after surgery.
  • There were marked decreases in serum creatinine level, blood glucose level at T1–T2, blood urea nitrogen level at T3–T6, free fatty acid level at T2–T3, and lactate level at T3–T4.

In conclusion, dexmedetomidine mitigates acute kidney injury after coronary artery bypass grafting.

“Dexmedetomidine reduces cardiac surgery-associated-acute kidney injury, potentially by reducing oxidative stress and regulating metabolic disorders,” the researchers wrote.

Reference:

Zhang, C., Zhang, Y., Liu, D., Mei, M., Song, N., Zhuang, Q., Jiang, Y., Guo, Y., Liu, G., Li, X., & Ren, L. (2024). Dexmedetomidine mitigates acute kidney injury after coronary artery bypass grafting: A prospective clinical trial. Revista Española de Cardiología (English Edition). https://doi.org/10.1016/j.rec.2024.02.005

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Gout patients with negative dual-energy CTs generally have milder illness and lower comorbidities: Study

Dual-energy computed tomography (DECT) is used in the imaging of gouty arthritis. It has become increasingly widely used in recent years. DECT is a non-invasive method for visualizing, characterizing, and quantifying monosodium urate crystal deposits, aiding clinicians in early diagnosis, treatment, and follow-up of the condition.

Victor Laurent and colleagues, in their recent study, concluded that the correlation between the 0.1 cm3 threshold and clinical presentation and evolution was stronger than that of the 0.01 cm3 threshold. Gout patients with negative DECTs generally have milder symptoms and a lower burden of comorbidity. While they may not have particularly easy-to-treat hyperuricaemia, they may have a lower risk of flares.

This study is published in Rheumatology.
The study investigated the relationship between dual-energy CT (DECT) thresholds and MSU crystal deposition in gout patients starting urate-lowering therapy (ULT) and to determine which threshold is more clinically significant.
Researchers selected CRYSTALILLE cohort patients diagnosed with gout naïve to ULT with baseline DECT scans of the knees and feet. The study examined two thresholds for detecting MSU crystal deposition via DECT: <0.01 cm3 and <0.1 cm3. Baseline characteristics and the likelihood of achieving SU levels <6.0 and 5.0 mg/dl and experiencing flares at 6, 12, and 24 months were compared between patients with negative and positive DECT scans.
Key findings from the study are:
• 211 patients with a median age of 66.2 years with three years of median symptom duration were included in the study.
• 18 % and 43 % had negative DECT scans for the 0.01 and 0.1 cm3 thresholds, respectively.
• Younger age, shorter symptom duration and an absence of heart disease for both volume thresholds were factors associated with negative DECT scans.
• 23.1%, 11.5% and 5.6% of patients with <0.1 cm3 MSU crystals had flares at 6, 12 and 24 months, respectively, when compared with 40%, 25 % and 11.1% of patients with ≥0.1 cm3.
• 68.3% reached SU levels <6.0 mg/dl, and 48.9% reached levels <5.0 mg/dl, without any difference between positive and negative DECTs, with ULT dosages that tended to be lower in patients with negative DECTs.
In conclusion, the study results suggest that the 0.1 cm3 threshold correlates better with clinical presentation and evolution than the 0.01 cm3 threshold. Gout patients with negative DECTs generally have milder illness and lower comorbidities. They do not have particularly easy-to-treat hyperuricaemia but may have a lower risk of flare-ups.
Reference:
Victor Laurent et al. Are gout patients with negative dual-energy computed tomography for monosodium urate crystal deposition easy to treat? Rheumatology, 2024;, keae061, https://doi.org/10.1093/rheumatology/keae061

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Add on batoclimab tied to sustained improvement in activities of Daily Living score in Myasthenia Gravis : JAMA

MG is caused by autoantibodies disrupting the neuromuscular junction. The neonatal fragment crystallizable receptor (FcRn) antagonists, efgartigimod and rozanolixizumab, reduce circulating immunoglobulin G (IgG) levels and alleviate symptoms in generalized MG cases.

A recent study found that batoclimab led to a sustained improvement in the Myasthenia Gravis Activities of Daily Living score compared to the placebo group. No severe side effects were reported. This suggests that batoclimab, an FcRn inhibitor, could be an important addition to the limited treatments available for Myasthenia gravis (MG).
This original investigation was published in JAMA Neurology.
The clinical trial was conducted at 27 centres in China from September 15, 2021, to June 29, 2022. It enrolled adult patients who tested positive for antibodies. These patients received either batoclimab or a placebo in addition to standard treatment. Each cycle consisted of six weekly subcutaneous injections of batoclimab or placebo, followed by four weeks of observation. A second cycle was given to those who required ongoing treatment. The primary outcome was a 3-point or greater improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score for at least four consecutive weeks in individuals with antibodies to acetylcholine receptors or muscle-specific kinase.
Key findings from the study are:
• The study population included 43 men and 88 women, the mean age being 43, with a history of generalized myasthenia gravis.
• The study was carried out in 27 hospitals in China.
• The rate of sustained MG-ADL improvement in the first cycle in antibody-positive patients in the placebo and batoclimab groups was 31.3% (20/ 64) and 58.2% (39/ 67), respectively, with an odds ratio of 3.45.
• The MG-ADL score diverged between the two groups as early as week 2.
• The rates of treatment-related and severe treatment-emergent adverse events in patients were 36.9% and 7.7% in the placebo group vs 70.1% and 3.0% in the batoclimab group, respectively.
Study strengths include a more significant number of participating centres and a broad representation of the overall generalized MG patient population.
Study limitations include limited treatment cycles, lack of data on long-term safety, and enrolment of only one patient with negative AChR/MuSK antibodies.
Concluding further, batoclimab resulted in a higher rate of sustained MG-ADL improvement in adult patients with generalized MG than placebo.
Reference:
Yan C, Yue Y, Guan Y, et al. Batoclimab vs Placebo for Generalized Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. Published online March 04, 2024. doi:10.1001/jamaneurol.2024.0044

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