Physical Activity Reduces Gout Risk in Hyperuricemia Patients, Says Machine Learning Study

Using machine learning models researchers have found in a new study that increased physical activity and reduced sedentary time significantly lower the risk of developing gout in individuals with hyperuricemia.

Individuals with hyperuricemia (HUA) are widely recognized as being at increased risk for gout. This study aimed to investigate how physical activity (PA) duration and sedentary duration impact gout risk in individuals with HUA and to develop predictive models to assess their risk of developing gout. They retrospectively collected clinical characteristics of 8057 individuals with HUA from the National Health and Nutrition Examination Survey (NHANES) consortium for the period 2007–2018. By developing and comparing four classic machine learning algorithms, the best-performing Random Forest (RF) model was selected and combined with the SHAP interpreting algorithm to analyze the dose–response relationship between PA duration, sedentary time, and gout risk. Additionally, the RF model was used to identify the most critical factors influencing gout risk and to develop a free online tool for predicting gout risk in HUA individuals. Results: The RF model outperformed others, achieving a Receiver Operating Characteristic (ROC) of 0.957 in the training cohort and 0.799 in the testing cohort. In the test cohort, it demonstrated an accuracy of 0.778, a Kappa of 0.247, a sensitivity of 0.701, a specificity of 0.785, a positive predictive value of 0.224, a negative predictive value of 0.967, and an F1 score of 0.340. SHAP analysis revealed the following insights: (1) hypertension, serum uric acid, age, gender, and BMI were identified as the top five factors for gout risk; (2) factors such as higher serum uric acid levels, age, BMI, creatinine, sedentary duration, lower PA, hypertension, male sex, and diabetes were associated with an elevated risk of gout; and (3) a PA duration of 1–7 h per week was linked to a lower risk of gout, while sedentary time exceeding 6 h per day increased gout risk, regardless of age, sex, or comorbidities. They encourage individuals with HUA to engage in 1–7 h of PA per week and limit daily sedentary time to less than 6 h to reduce gout risk. The developed prediction model is freely available as a web-based app at: https://sasuki.shinyapps.io/GoutRisk/.

Reference:

Jiao, Y., Cheng, Z., Lan, Z., Kan, S. and Du, Y. (2025), Exploring the Impact of PA and Sedentary Behavior on Gout Risk in Hyperuricemia: Insights From Machine Learning and SHAP Analysis. Int J Rheum Dis, 28: e70238. https://doi.org/10.1111/1756-185X.70238

Keywords:

Physical, Activity, Reduces, Gout, Risk, Hyperuricemia, Patients, Says Machine, Learning, Study, International Journal of Rheumatic Diseases, Jiao, Y., Cheng, Z., Lan, Z., Kan, S. and Du, Y

Powered by WPeMatico

Bharat Serums Gets CDSCO Panel Nod for Phase III Trial of IVIG in Chronic ITP

New Delhi: Bharat Serums and Vaccines has received approval from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial of Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% Solution.

This came after the firm presented the revised protocol — updated as per the recommendations given by the committee during the SEC meeting held on February 11, 2025 — for the proposed Phase III clinical trial titled:

“An Open-Label, Multicenter, Phase III Clinical Study in India to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous Use (IVIG) in Chronic Immune Thrombocytopenia (ITP)”, vide Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0, dated April 17, 2025.

Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% solution is a plasma-derived product containing primarily IgG antibodies, used to enhance immunity in individuals with immune deficiencies or autoimmune disorders. Administered intravenously, it helps the body fight infections and regulate immune responses.

At the recent SEC (Hematology) meeting held on June 10, 2025, the expert panel reviewed the revised protocol and, after detailed deliberation, “recommended the grant of permission to conduct the Phase III clinical trial as per revised Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0 dated 17.04.2025.”

Also Read: Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC

Powered by WPeMatico

SEC Clears Hemopurifier Device for Cancer Study in Indian Patients

New Delhi: In a step toward advancing medical device-based cancer care, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has granted permission to conduct a pilot clinical investigation of the Hemopurifier device in India.

The proposal, submitted by Qualtran Consulting, was reviewed during the 19th SEC (Oncology) meeting held on 5th June 2025 at CDSCO headquarters, New Delhi.

The firm presented Study Protocol No. AEMD-2024-01-Oncology-India, dated 24th May 2024, a proposal for grant of permission to conduct Pilot Clinical Investigation on proposed medical device Hemopurifier in the country on Indian population before the committee.

After detailed deliberation the committee recommended for;

“The grant of permission to conduct of Pilot Clinical Investigation to prove safety and feasibility of the device in removing circulating exosomes of individuals with solid malignancies on Indian Population as per Study Protocol no. AEMD-2024-01-Oncology-India dated 24.05.2024.”

The Hemopurifier is a blood filtration medical device designed to selectively remove circulating exosomes and tumor-derived particles from the bloodstream. These components are known to play a role in tumor progression, immune evasion, and resistance to cancer therapies.

Also Read: 58 Drug Batches, Including Dexona Fail CDSCO Quality Standards

Powered by WPeMatico

AI in health care needs patient-centered regulation to avoid discrimination, say experts

A new commentary published in the Journal of the Royal Society of Medicine warns that current risk-based regulatory approaches to artificial intelligence (AI) in health care fall short in protecting patients, potentially leading to over- and undertreatment as well as discrimination against patient groups.

Powered by WPeMatico

Newborns require better care to improve survival and long-term health, global report says

More effective platforms for drug and medical device development and better cross-sector engagement are urgently required to prevent the ‘unacceptably high’ newborn death rate, according to a global report.

Powered by WPeMatico

Surgery plus speech therapy linked to improved language after stroke

Combining neck surgery with intensive speech therapy is associated with greater improvements in a person’s ability to communicate after a stroke than intensive speech therapy alone, finds a clinical trial published by The BMJ.

Powered by WPeMatico

GP performance pay fails to drive lasting changes in quality of care, finds study

Introducing performance-related pay for UK general practices initially improved quality of care, but did not seem to provide lasting improvements beyond that expected by previous trends, finds a study published by The BMJ.

Powered by WPeMatico

Focusing on weight loss alone for obesity may do more harm than good, say experts

Focusing solely on achieving weight loss for people with a high body mass index (BMI) may do more harm than good, argue experts in The BMJ .

Powered by WPeMatico

ICMR Expands Mobile BSL-3 Laboratories to boost Outbreak Response

New Delhi: The apex research regulator, the Indian Council of Medical Research (ICMR), is set to strengthen outbreak response and bolster public health delivery by procuring two more Mobile BSL-3 (MBSL-3) laboratories, targeting especially remote and inaccessible areas.

Called RAMBAAN, there are currently two such laboratories – each stationed at ICMR’s two institutes, the National Institute of Virology in Pune and the RMRC in Gorakhpur, UP.

RAMBAAN is the first of its kind, Rapid Action Mobile BSL-3 laboratory and is fully indigenous. It is field-deployable and designed to meet enhanced diagnostic demands during outbreaks of known and unknown high-risk pathogens.

Also Read:Newborn screening, early treatment cut Sickle Cell Anaemia Mortality below 5 per cent: ICMR study

An initiative of ICMR, it was developed in partnership with Klenzaids Contamination Controls Private Limited, Mumbai, under the patronage of Pradhan Mantri-Ayushman Bharat Health Infrastructure Mission, Ministry of Health and Family Welfare, the apex research institute said, reports PTI.

The MBSL-3 was successfully deployed and operationalised for the first time during the Nipah virus (NiV) outbreak in Kozhikode, Kerala, in September 2023 and again in Malappuram district of the state in July 2024, it said.

This “laboratory on wheels” is built on a heavy-duty Bharat Benz vehicle chassis, compliant with BS-VI norms, designed to operate at extreme temperatures and altitudes and bears a maximum load capacity 17,000 kgs.

It is classified as a Type-IV Rapid Response Mobile Laboratory (RRML) as per WHO GOARN RRML laboratory network classification.

The laboratory is designed to maintain a negative air pressure environment and is equipped with an advanced heating, ventilation, and air conditioning (HVAC) system with HEPA filters.

It also features a double-door autoclave and a biological liquid effluent decontamination (BLED) and hydrogen peroxide (H2O2) fogger system for biological waste management.

The MBSL-3 laboratory’s work area is divided into four zones — zone-1 (driver and outer change room), zone-2 (shower and inner change room), zone-3 (main laboratory), and zone-4 (material staging and decontamination area).

Key installations within these zones include biological safety cabinets (Class II A2), an intelligent programmable logic controller system, a dynamic pass box, and an entry-exit shower system with biometric control.

The laboratory’s power supply can be from a direct electric supply or a diesel generator, with an uninterrupted power supply (UPS) and petrol generators for backup. Communication within the laboratory is facilitated by walkie-talkies and real-time surveillance through CCTVs.

Also Read:NAKSHATRA to strengthen preparedeness for future pandemics: ICMR NIV Director

Powered by WPeMatico

AstraZeneca-Daiichi Sankyo Datroway gets USFDA accelerated nod for previously treated advanced EGFR-mutated non-small cell lung cancer

Cambridge: AstraZeneca and Daiichi Sankyo have announced that Datroway (datopotamab deruxtecan or Dato-DXd) has received accelerated approval from the Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The approval follows Priority Review and Breakthrough Therapy Designation by the Food and Drug Administration (FDA) based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial.

Jacob Sands, MD, Medical Oncology, Dana-Farber Cancer Institute and investigator in both trials, said, “Addressing disease progression in patients with advanced EGFR-mutated lung cancer after prior targeted therapy and chemotherapy is very challenging with limited later-line treatment options available. The US approval of datopotamab deruxtecan introduces a novel and needed treatment option to patients with advanced disease.”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said, “This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation. We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community.”

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc, said, “With the accelerated approval, Datroway is now the first TROP2-directed medicine available for certain patients in the US living with lung cancer. We remain committed to our extensive clinical development programme to further identify where Datroway may be used in other types of lung and breast cancer.”

Andrea E. Ferris, President and CEO, LUNGevity, said, “For people with advanced EGFR-mutated non-small cell lung cancer whose disease progresses on initial treatments, additional options are limited. The approval of Datroway offers a new treatment option for patients whose disease has progressed following treatment with an EGFR-directed therapy and chemotherapy.”

In TROPION-Lung05 and TROPION-Lung01, Datroway demonstrated a confirmed ORR of 45% (95% confidence interval [CI]: 35-54) in patients with previously treated locally advanced or metastatic EGFR-mutated NSCLC (n=114) as assessed by blinded independent central review (BICR). Complete responses were seen in 4.4% of patients and partial responses were seen in 40% of patients. The median DoR was 6.5 months (95% CI: 4.2-8.4).

The safety profile of Datroway was evaluated in a pooled analysis of 125 patients in the TROPION-Lung05, TROPION-Lung01 and TROPION-PanTumor01 trials. The safety profile observed across these trials was consistent with the known profile of this medicine with no new safety concerns identified.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo are evaluating Datroway alone and with Tagrisso (osimertinib) in other advanced or metastatic EGFR-mutated NSCLC settings in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

Following approval in the US, an amount of $45 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the locally advanced or metastatic EGFR-mutated NSCLC indication. Sales of Datroway in the US are recognized by Daiichi Sankyo
Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 87% of cases. Approximately 10 to 15% of patients with NSCLC in the US and Europe, and 30 to 40% of patients in Asia have an EGFR mutation. The majority of EGFR mutations occur in tumours of nonsquamous histology. TROP2 is a protein broadly expressed in the majority of NSCLC tumours.

For patients with tumours that have an EGFR mutation, the established 1st-line treatment in the metastatic setting includes EGFR-directed therapy with or without platinum-based chemotherapy. While these therapies have improved outcomes in earlier lines of treatment, most patients eventually experience disease progression and receive subsequent therapies.

Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 30 countries worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

Powered by WPeMatico