Major breakthrough-Benralizumab may independently control severe asthma without use of inhaled steroids

A landmark study has shown that severe asthma can be controlled using biologic therapies, without the addition of regular high-dose inhaled steroids which can have significant side effects.

The findings from the multinational SHAMAL study, published in The Lancet, demonstrated that 92% of patients using the biologic therapy benralizumab could safely reduce inhaled steroid dose and more than 60% could stop all use.

The study’s results could be transformative for severe asthma patients by minimising or eliminating the unpleasant, and often serious, side effects of inhaled steroids. These include osteoporosis which leads to increased risk of fractures, diabetes and cataracts.

Asthma is one of the most common respiratory diseases worldwide – affecting almost 300 million people – and around 3 to 5% of these have severe asthma. This leads to daily symptoms of breathlessness, chest tightness and cough, along with repeated asthma attacks which require frequent hospitalisation.

The SHAMAL study was led by Professor David Jackson, head of the Severe Asthma Centre at Guy’s and St Thomas’ and Professor of Respiratory Medicine at King’s College London.

Professor Jackson said: “Biological therapies such as benralizumab have revolutionised severe asthma care in many ways, and the results of this study show for the first time that steroid related harm can be avoided for the majority of patients using this therapy.”

Benralizumab is a biologic therapy that reduces the number of inflammatory cells called eosinophil. This is produced in abnormal numbers in the airway of patients with severe asthma and is critically involved in the development of asthma attacks. Benralizumab is injected every four to eight weeks and is available in specialist NHS asthma centres.

The SHAMAL study took place across 22 sites in four countries – the UK, France, Italy and Germany.

The 208 patients were randomly assigned to taper their high dose inhaled steroid by varying amounts over 32 weeks, followed by a 16 week maintenance period. Approximately 90% of patients experienced no worsening of asthma symptoms and remained free of any exacerbations throughout the 48 week study.

Similar studies to SHAMAL will be necessary before firm recommendations can be made regarding the safety and efficacy of reducing or eliminating high dose steroid use with other biologic therapies.

Reference:

Prof David J Jackson, Prof Liam G Heaney, Prof Marc Humbert, Brian D Kent, Anat Shavit, Lina Hiljemark, Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study, DOI:https://doi.org/10.1016/S0140-6736(23)02284-5.

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Vitamin D Deficiency Linked to Higher Risk of Noninfectious Uveitis

A recent systematic review and meta-analysis exploring the relationship between vitamin D levels and noninfectious uveitis have revealed a striking association. The findings suggest that individuals with vitamin D deficiency face more than a twofold increased risk of developing noninfectious uveitis compared to those without such deficiency. This study was published in the Autoimmunity Reviews journal.

Conducted by a team led by William Rojas-Carabali, MD, from Nanyang Technological University, the study involved a meticulous analysis of numerous studies from databases such as Embase, PubMed, and Lilacs. Among over 900 articles initially screened, 11 studies were included for review and analysis.

The investigation covered a spectrum of study designs, including case-control, cohort, and cross-sectional studies, encompassing data from 6082 individuals with noninfectious uveitis. The analysis indicated that patients with noninfectious uveitis displayed notably lower 25(OH)D levels in serum compared to control groups.

In-depth meta-analyses revealed compelling trends: those who developed uveitis showcased significantly reduced vitamin D levels compared to the control group. This disparity persisted even when examining studies that measured vitamin D levels one year before the onset of uveitis (Standardized Mean Difference [SMD], -0.37; 95% CI, -0.56 to -0.17). Moreover, a meta-analysis of studies reporting odds ratios (ORs) indicated patients with noninfectious uveitis had a greater likelihood of low vitamin D levels 1 year before disease onset (OR, 2.04; 95% CI, 1.55 to 2.68; P = .00001).

However, the investigators highlighted the study’s limitations, including its reliance on observational data, relatively smaller sample sizes, and inherent heterogeneity in the data. Despite these constraints, the findings strongly suggest a notable correlation between hypovitaminosis D and the elevated risk of noninfectious uveitis.

The study’s lead author emphasized the importance of further research in this area to corroborate and expand upon these findings. Additionally, the need for standardized measurement techniques and cutoff values for serum vitamin D was highlighted to enhance the consistency and reliability of future meta-analyses.

These findings indicate a potential preventive strategy in managing noninfectious uveitis through vitamin D supplementation, providing a direction for clinicians in considering vitamin D deficiency screening and management in patients at risk for this ocular condition.

Reference:

Rojas-Carabali W, Pineda-Sierra JS, Cifuentes-González C, et al. Vitamin D deficiency and non-infectious uveitis: A systematic review and Meta-analysis. Autoimmun Rev. Published online December 3, 2023. doi:10.1016/j.autrev.2023.103497 

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Cell therapy appears safe and effective for lymphoma in remission

A study led by researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine suggests that CAR-T immunotherapy remains a viable option for patients who have lymphoma that goes into remission before the cell therapy begins.

While the study doesn’t answer the question of whether cell therapy in remission is the right choice, it does say that it’s not the wrong choice.

“I don’t think it answers the question of: Should we give these patients cell therapy? But I think it answers the question that we can-that it’s safe and that it’s a reasonable strategy when you’re in that spot,” said Trent Wang, D.O., a Sylvester hematologist and cellular therapy specialist who will present study findings in an oral presentation at the 65th ASH Annual Meeting and Exposition, the American Society of Hematology’s conference taking place in San Diego, California, Dec. 9-12.

Most patients receiving cell therapy, a form of immunotherapy that uses immune cells engineered to recognize and attack the patient’s cancer, desperately need it. For some, it comes after many other treatments have failed. But Wang noticed an odd phenomenon in the past few years when treating lymphoma patients with this form of therapy: Some of his patients went into complete remission before the cells ever touched their bodies.

This uncommon scenario occurs during the process of getting to cell therapy, which in the case of Wang’s study uses a kind of engineered immune cell known as CAR-T cells. When a patient starts the process, there’s a waiting period of three to five weeks before they get the treatment. Insurance approval is needed, and the cells themselves need to be manufactured from the patient’s own cells. But many of these patients are very sick with their cancer, so physicians will often treat them with a short course of chemotherapy or other drugs to tamp down the symptoms.

A small handful of these patients end up in remission during this waiting period treatment, the clinicians have found.

“That prompted this dilemma: Now what are we supposed to do?” Wang said. “Should we change the plan or give the therapy anyway? We just didn’t have a lot of information on this scenario.”

Wang said more often than not his team would proceed with the cell therapy in these cases, mainly to prevent yet another stretch of time where the patients’ cancer might come back again. But it didn’t feel like a very informed decision.

Wang and his colleagues noticed that their patients who received the cells while in remission tended to fare well after their infusion. But they didn’t know if those results would hold up in an analysis of a larger group. They proposed a research study to the Center for International Blood & Marrow Transplant Research, a nationwide registry that tracks patients who have received transplants and/or cell therapies.

The study included data from 134 patients in the registry who had gone into complete remission in the waiting period before receiving their cell therapy. To find that group, the scientists screened the records for more than 5,000 cell therapy patients.

They found that this group of patients had a 43% probability of progression-free survival over the two years following their treatment, about the same percentage as patients in the registry who were not in remission when they received CAR-T. However, the patients in remission had very low levels of toxicities related to their cell therapies, namely an immune overreaction known as cytokine release syndrome and neurotoxicity, two side effects that can sometimes accompany CAR-T cell therapy.

The study used data from patients treated with CAR-T cell therapy between 2015 to 2021, and current frequencies of specific cell therapy use are slightly different from those that were used in practice just a few years ago, Wang said. Next, the researchers want to explore the data paralleling more recent treatment trends.

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Metabolic syndrome in women associated with carotid artery thickness regardless of obesity

A recent investigation examined the combined influence of metabolic syndrome (MetS) and obesity on markers of early atherosclerosis—carotid artery intima media thickness (cIMT) and adventitial diameter (AD). This study was published in the Menopause journal by Leis and colleagues.

Carotid ultrasound assessments conducted as part of the Study of Women’s Health Across the Nation (SWAN) between 2009 and 2013 were analyzed in a cross-sectional study involving 1,433 women. The findings of the study were as follows:

  • Increased Atherosclerotic Risk: Women with obesity showed an average cIMT increase of 0.051 mm, while those with MetS had a 0.057 mm larger cIMT compared to counterparts without these conditions (both P < 0.001).
  • Combined Impact: A significant interaction was observed between obesity and MetS (P = 0.011). Women affected by both conditions exhibited a higher model-adjusted predicted mean cIMT of 0.955 mm (95% CI, 0.897-1.013) compared to those with MetS alone (0.946 mm; 95% CI, 0.887-1.005), obesity alone (0.930 mm; 95% CI, 0.873-0.988), or neither condition (0.878 mm; 95% CI, 0.821-0.935). Similar patterns were observed in AD measurements.

This study underscores the importance of identifying and addressing atherosclerotic changes at early stages to prevent the development of significant cardiovascular disease. It suggests that the impact of obesity on carotid artery thickness appears to be limited when considering MetS alone.

The findings emphasize the heightened atherosclerotic risk associated with metabolic dysfunction, irrespective of an individual’s obesity status. It reinforces the notion that individuals affected by metabolic abnormalities warrant close attention due to their increased vulnerability to atherosclerosis-related changes.

Understanding the combined effects of MetS and obesity on arterial health provides crucial insights into risk stratification and preventive strategies for early atherosclerosis detection and intervention.

Reference:

Leis, A. M., Jackson, E. A., Baylin, A., Barinas-Mitchell, E., El Khoudary, S. R., & Karvonen-Gutierrez, C. A. Carotid intima media thickness and cardiometabolic dysfunction: the Study of Women’s Health Across the Nation. Menopause (New York, N.Y.),2023;30(12):1190–1198. https://doi.org/10.1097/gme.0000000000002273 

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AstraZeneca gets a CDSCO panel Nod To study Rilvegostomig

New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of the Rilvegostomig (AZD2936) concentrate for solution for infusion to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator’s choice of chemotherapy in participants with Biliary Tract Cancer after surgical resection with curative intent.

However, this approval is subject to the condition that they should include a surgical oncologist in the study team to confirm the criteria of surgical resectability.

This came after the drug major AstraZeneca presented the Phase III Clinical Study Protocol no. D7025C00001.

The above clinical study is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator’s choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil) or gemcitabine/cisplatin) as adjuvant treatment in participants with Biliary Tract Cancer after resection with curative intent.

This study will be conducted in patients with Biliary Tract Cancer who are at risk of recurrence after resection with curative intent.

AZD2936 is a monovalent, bispecific, humanized IgG1 antibody that specifically binds to human TIGIT and PD-1 with high affinity and enhances T cell activity within preclinical models.

At the recent SEC meeting for Oncology and Hematology held on 29 and 30 November 2023, the expert panel reviewed the Phase III clinical study protocol no D7025C00001 presented by AstraZeneca.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm “subject to the condition that they include a surgical oncologist in the study team to confirm the criteria of surgical resectability”.

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Haryana doctors threaten indefinite strike from December 29

The day following a two-hour pen-down strike at government health facilities, Haryana Health Department’s medical professionals announced on Sunday their intention to launch an indefinite strike from December 29 if their demands remained unmet within two weeks. This decision was reached during the core committee meeting of the Haryana Civil Medical Services Association (HCMSA), the collective body representing government medical practitioners. As per details, the protest will commence with a full-day strike on December 27.

For more news & updates, check out the link given below:

https://medicaldialogues.in/

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Deferred PCI equally safe whether treatment decision based on IVUS or FFR: Study

Korea: Deferral of percutaneous coronary intervention (PCI) based on intravascular ultrasound (IVUS) guided treatment decision showed a comparable risk of clinical events with fractional flow reserve (FFR)-guided treatment decision in patients with intermediate coronary artery stenosis, a recent study has shown.

Findings from the post-hoc analysis of 2-year data from the FLAVOUR trial were presented at the 2022 American College of Cardiology meeting and subsequently published online in Circulation: Cardiovascular Interventions.

In real-world practice, operators sometimes use IVUS in this way for left main lesions. However, FFR is considered a gold standard for treatment decision-making for most non-left main lesions, and this remains the case following FLAVOUR.

There is a continued accruing of positive data showing the benefits of intravascular imaging over angiography as a way to optimize stent placement. Still, controversy remains about whether these tools are warranted in all cases. Joo Myung Lee, Sungkyunkwan University School of Medicine, Seoul, Korea, and colleagues sought to compare the prognosis between deferred lesions based on IVUS and FFR-guided treatment decisions.

The researchers conducted a post hoc analysis of the FLAVOUR randomized trial that compared 2-year clinical outcomes between IVUS- and FFR-guided treatment decisions on intermediate coronary artery lesions using predefined criteria. In both the FFR and IVUS groups, vessels were classified into deferred or revascularized vessels, and patients were classified as those with or without deferred lesions.

Vessel-oriented composite outcomes (target vessel revascularization, target vessel myocardial infarction, or cardiac death) in deferred vessels and patient-oriented composite outcomes (myocardial infarction, death, or any revascularization) in patients with deferred lesions were compared between the IVUS and FFR groups.

The researchers reported the following findings:

  • A total of 1682 patients and 1820 vessels were analyzed, of which 922 patients and 989 vessels were deferred.
  • At 2 years, there was no difference in the cumulative incidence of vessel-oriented composite outcomes in deferred vessels between IVUS (n=375) and FFR (n=614) groups (3.8% versus 4.1%; hazard ratio, 0.91).
  • The risk of vessel-oriented composite outcomes was comparable between deferred and revascularized vessels following treatment decision by IVUS (3.8% versus 3.5%; hazard ratio, 1.09) and FFR (4.1% versus 3.6%; hazard ratio, 1.14).
  • In the comparison of patient-oriented composite outcomes in patients with deferred lesions, there was no significant difference between the IVUS (n=357) and FFR (n=565) groups (6.2% versus 5.9%; hazard ratio, 1.05).

“Patients whose PCI is deferred do equally well whether that’s a decision based on fractional flow reserve or intravascular ultrasound,” the researchers concluded.

The researchers suggest that FFR for treatment decision-making and IVUS for procedural optimization would be the best strategy for PCI. However, IVUS use for treatment decision-making and procedural optimization may be an alternative, especially cost-wise.

Reference:

Lee JM, Kim H, Hong D, Hwang D, Zhang J, Hu X, Jiang J, Nam CW, Doh JH, Lee BK, Kim W, Huang J, Jiang F, Zhou H, Chen P, Tang L, Jiang W, Chen X, He W, Kang J, Ahn SG, Yoon MH, Kim U, Ki YJ, Shin ES, Choi KH, Park TK, Yang JH, Song YB, Choi SH, Gwon HC, Koo BK, Kim HS, Tahk SJ, Wang J, Hahn JY; FLAVOUR Investigators. Clinical Outcomes of Deferred Lesions by IVUS Versus FFR-Guided Treatment Decision. Circ Cardiovasc Interv. 2023 Nov 29:e013308. doi: 10.1161/CIRCINTERVENTIONS.123.013308. Epub ahead of print. PMID: 38018840.

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Place AYUSH treatment on par with allopathic procedure: HC directs IRDAI

The Madras High Court recently asked the Insurance Regulatory and Development Authority of India (IRDAI) to treat AYUSH treatment on par with Allopathic treatment while reimbursing expenses incurred during treatment.

IRDAI has also been directed to reimburse the insurance amount on equal scales for both branches of medicine. “There shall be a direction to the third respondent to act upon the suggestion made by this Court to place AYUSH treatment on par with allopathic treatment and direct the insurance companies to reimburse the insurance amount on equal scales,” ordered the HC bench comprising Justice N. Anand Venkatesh.

For more details, check out the link given below:

AYUSH Treatment On Par With Allopathic Treatment For Reimbursements: HC

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Breakthrough in Melasma Treatment: Q-switched Nd:YAG Laser Emerges as Top Choice

Melasma, a challenging hyperpigmentation disorder, often poses therapeutic dilemmas due to its intricate pathogenesis, recurrence tendencies, and substantial morbidity impact. In a bid to revolutionize treatment outcomes, a comprehensive network meta-analysis (NMA) has scrutinized various laser-related therapies, shedding light on the most effective approaches for managing melasma.

This study was published in Journal Of Cosmetic Dermatology by Wenyi and colleagues. A comprehensive meta-analysis of 39 clinical studies, involving 1394 participants, has shed light on the most effective laser-related therapies for treating melasma. The study compared various approaches, revealing that Q-switched Nd:YAG laser with topical medications (QSND+TM) stands out as the top choice, significantly improving the melasma area severity index (MASI) score. Other notable contenders include oral tranexamic acid (oTA), microneedling with topical medications (MN+TM), Q-switched Nd:YAG laser with intense pulse light (QSND+IPL), and fractional carbon dioxide laser with topical medications (FCDL+TM).

  • Q-switched Nd:YAG Laser Dominates:

Superior Efficacy: The NMA unequivocally establishes the supremacy of Q-switched Nd:YAG laser with topical medications (QSND+TM). Its efficacy outshines Q-switched Nd:YAG laser alone, Er:YAG laser with topical medications, and picosecond laser with topical medications.

Significant Improvement: QSND+TM led to a notable decrease in the melasma area severity index (MASI) score, highlighting its prowess in addressing hyperpigmentation.

  • Microneedling Excels:

Effective Combination: Microneedling with topical medications (MN+TM) emerges as a formidable contender, surpassing picosecond laser and standalone topical medications.

Enhanced Curative Efficacy: MN+TM demonstrates superiority in improving the MASI score, presenting itself as a promising choice for melasma treatment.

  • Surface Under the Cumulative Ranking Curve (SUCRA) Rankings:

QSND+TM claims the top spot with an impressive SUCRA value of 85.9%, indicating its high efficacy.

Other noteworthy contenders include oral tranexamic acid (oTA), MN+TM, QSND+IPL, and fractional carbon dioxide laser with topical medications (FCDL+TM).

  • Clinical Recommendations:

First-Line Choice: The study recommends Qs-Nd:YAG laser with topical medications as the primary therapeutic choice, considering its top-ranking SUCRA value and significant efficacy.

Preferred Combination: MN+TM stands out as the superior choice among modalities like PICO and standalone topical medications, emphasizing its potential for enhancing curative outcomes.

  • Considerations for Clinical Decision-Making:

Adverse Effects: Clinical decisions should weigh the adverse effects of each modality, ensuring a tailored approach to patient care.

Patient Characteristics: The patient’s skin type, duration of the disease, and other relevant factors should inform the selection of the most suitable treatment strategy.

This meta-analysis not only advances our understanding of melasma treatment but provides clinicians with a roadmap for precision care. Armed with these insights, dermatologists can navigate the complex landscape of melasma therapeutics, offering patients tailored solutions for improved outcomes.

Reference:

Ma, W., Gao, Q., Liu, J., Zhong, X., Xu, T., Wu, Q., Cheng, Z., Luo, N., & Hao, P. Efficacy and safety of laser‐related therapy for melasma: A systematic review and network meta‐analysis. Journal of Cosmetic Dermatology,2023;22(11):2910–2924. https://doi.org/10.1111/jocd.16006 

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TN: GMC Kanyakumari Kickstarts its first breast milk bank

TN:  Government Medical College Hospital, located in Kanyakumari, has started its first breast milk bank in the hospital. Kanyakumari Collector said that this facility will be of great help to many neo-natal patients. Doctors at the hospital’s neo-natal department outlined the six stages of the breast milk collection process.

Also Read: TN Health Invites Online Applications for Post Basic Diploma in Critical Care Speciality Nursing, Neonatal Nursing Courses, details

On Thursday, December 07, 2023, Kanyakumari Collector P.N. Sridhar commenced Breast Milk Bank. Speaking to The Hindu, he said that “hospital was functioning on a par with many private hospitals. Both in human resources and in having modern equipment, the hospital excelled since its inception. The success rate of patients getting discharged was proof of the quality and dedication of the doctors and support staff”.

“The presence of the breast milk bank would go a long way in saving neo-natal patients from the region. Excess milk can make a world of difference to fragile infants, and providing such a facility in the public institution showed the government’s commitment”, Mr Sridhar further added.

The doctors of the Neo-Natal Department, led by Dean Prince Payas and other senior officials, mentioned the entire process of comprehensive breastfeeding management. The process involves six steps including examination of the donor mother and milk collection.

Unlike blood banks, breast milk banks will also be of great help to newborns and premature babies, said doctors. Surplus breast milk will also be preserved in the bank for needy children as mother’s milk is very important for children up to five years of age as it provides abundant strength and immunity to the children.

Lastly, Collector P.N. Sridhar concludes by urging the public to be generous in donating the organs to those in need as this will provide hope and light to those who need them.

Also Read: MD, MS in Tamil Nadu: Here is the stipend at Tamil Nadu Medical Colleges

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