Between November 2015 and November 2020, 200 patients were randomly assigned to receive either BoNTA (n=100) or a placebo (n=100). Following withdrawals before injections, 96 patients received BoNTA, and 95 patients received the placebo. The primary endpoint was the number of faecal incontinence and urgency episodes per day, assessed using 21-day patient bowel diaries three months after treatment.

The findings revealed a significant decrease in the mean number of episodes in the BoNTA group from 1.9 at baseline to 0.8 at 3 months post-injections, compared to a decrease from 1.4 to 1.0 in the placebo group. The adjusted mean group difference at 3 months was estimated at -0.51 (95% CI -0.80 to -0.21, p=0.0008), highlighting the remarkable effectiveness of BoNTA injections.

The study demonstrated no serious treatment-related adverse events. Constipation was the most frequently reported non-serious adverse event, observed in 40% of patients receiving both BoNTA and placebo injections.

Lead researcher Anne-Marie Leroi, PhD, highlighted the significance of BoNTA injections as an efficacious treatment for urge faecal incontinence. Despite these promising results, further research is warranted to optimize selection criteria, dosage, injection site, frequency of re-injection, and long-term outcomes.

These findings mark a significant advancement in the treatment landscape for faecal incontinence, offering hope to individuals who have faced challenges with existing treatment options. The study’s success in significantly reducing episodes of faecal incontinence and urgency with minimal adverse effects positions BoNTA injections as a potential breakthrough therapy in this field.

The study’s results could pave the way for further research aiming to refine treatment protocols and assess the sustained effectiveness of BoNTA injections in managing urge faecal incontinence, ultimately improving the quality of life for affected individuals.

Reference:

Leroi, A.-M., Queralto, M., Zerbib, F., Siproudhis, L., Vitton, V., Amarenco, G., Etienney, I., Mion, F., Bridoux, V., Philip, J., Brochard, C., Damon, H., Lacroix, E., Gillibert, A., & Gourcerol, G. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. The Lancet. Gastroenterology & Hepatology,2023. https://doi.org/10.1016/s2468-1253(23)00332-1

Mumbai: The Brihanmumbai Municipal Corporation (BMC) on Tuesday directed all major hospitals in Mumbai to implement the biometric system which will be linked to doctors’ salary, aiming to reduce long queues of patients.

Meanwhile, a biometric fingerprint system has also been installed in hospitals on Wednesday.

According to the circular, it states “Commencing at 8:00 am, all major medical municipal hospitals will enforce mandatory biometric registration for doctors upon entry and exit. This biometric attendance system will be intricately tied to the salary of every doctor through SAP”.

This initiative was taken after the visit of Additional Municipal Commissioner Dr Sudhakar Shinde to several municipal hospitals on Tuesday. During the visit, he observed a huge queue at the OPD for registration and consultation with doctors. Speaking to the Indian Express Dr Shinde said, “We are streamlining the process. Introducing biometric attendance will enhance transparency regarding the availability of doctors. Moreover, with early registrations, we anticipate a reduction in lengthy queues at the OPD”.

The move has been initiated due to inconsistency in the attendance of doctors, leading to delays in the morning outpatient department (OPD) schedule. Late arrival of doctors at the hospital causes inconvenience to patients coming from far-flung areas like Palghar and Navi Mumbai. It has been observed that KEM, Sion, Nair and Cooper hospitals receive more than 10,000 patients from different parts of Maharashtra. Of these, 40% of these patients come from outside Mumbai. “We received complaints about patients facing long waiting periods in OPDs due to delays in starting the OPD. We have instructed the deans to ensure the biometric system is followed and OPDs are started on time”, mentioned Dr Shinde to Hindustan Times.

However, according to officials, biometric facilities were already there in the hospitals but it was stopped during the Covid-19 pandemic. On this, Dr Neelam Andrade the director of major civic hospitals, said “The biometric was earlier not linked to the salary. If the doctor reports late to the OPD, it will now directly affect their salary”.

On the first day after the implementation of the plan, the crowd of patients in the hospital reduced by noon, which usually remained even after 1 pm. Due to this, patients often had to return from the hospital as the OPD timings used to get over. Besides, all the washrooms in the OPD building were also cleaned.

Many complaints have been received from the patients regarding the late arrival of doctors, especially senior doctors, in OPD. It has been alleged that many senior doctors maintain private clinics close to the hospitals where they work. They often reached the OPD early and left before time, leaving the entire workload on the junior resident doctors. When Indian Express asked Dr Sudhakar Shinde on this matter, he said, “We will initiate serious action if such allegations are proven.”

Hesham Abdullah, SVP, Global Head Oncology, R&D, GSK, said, “B7-H3 is highly expressed in a broad range of solid tumours where there remains a significant need for novel treatment options. We look forward to progressing this potential new treatment across several indications and in future potential combination approaches with our established portfolio.”

This agreement provides GSK with a second clinical-stage ADC that complements GSK’s existing capabilities and strengths in developing medicines to address unmet medical needs in various solid tumours. HS-20093 is currently being investigated in ongoing phase I and II trials in China. Data from the ARTEMIS-001 phase I trial (NCT05276609), for HS-20093 in advanced solid tumours, was presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting in which initial clinical activity was observed in small cell lung cancer, non-small cell lung cancer and sarcoma with multiple confirmed responses and a manageable safety profile.

Eliza Sun, Executive Director of Board, Hansoh Pharma, said, “HS-20093 is a novel B7-H3 targeting antibody-drug conjugate showing encouraging early clinical signals in lung cancer. We are excited to enter this new license agreement with GSK, our existing licensee on HS-20089, furthering Hansoh’s goal of bringing a potentially transformative treatment option to cancer patients globally.”

GSK plans to begin phase I trials for HS-20093 outside of China in 2024.

In October 2023, GSK and Hansoh entered into an agreement for HS-20089, a B7-H4 targeted ADC currently in phase II clinical trials in China. HS-20089 has best-in-class potential in ovarian and endometrial cancer with opportunities in other solid tumours.

Under the terms of this agreement, GSK will pay $185 million upfront. In addition, Hansoh will be eligible to receive up to $1.525 billion in success-based milestones for HS-20093. Upon commercialisation of HS-20093, GSK will pay tiered royalties on global net sales outside of China’s mainland, Hong Kong, Macau, and Taiwan.

This agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US.

Aizawl: The new government in Mizoram is planning to hand over the state’s lone airport and its only medical college to the Centre, an official said on Monday.

At the meeting of the council of ministers on December 14, it was decided that the state government would take steps to hand over the Lengpui airport to the Airports Authority of India (AAI), he said.

The Lengpui airport and ZMC are owned and operated by the state government.

Lengpui is located about 29 km west of Aizawl, while ZMC is located at Falkawn which is about 16 km from the state capital.