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Take a look at a selection of our recent media coverage:

Stereotactic radiotherapy equivalent to standard care in localised prostate cancer, study finds

6th October 2023

Stereotactic radiotherapy courses for men with intermediate risk, localised prostate cancer is as effective as standard care, according to the findings of a new trial presented at the recent American Society for Radiation oncology (ASTRO) annual meeting.

The phase 3 PACE B (Prostate Advances in Comparative Evidence) study found that using stereotactic body radiation therapy (SBRT) was non-inferior to standard treatment with moderately fractionated radiation in men with non-metastatic prostate cancer. SBRT had a five-year disease control rate of 96% compared to 95% for conventional radiation.

Researchers from the Royal Marsden Hospital in London, enrolled 874 men with a median age of 69.8 years from 38 centres in Canada and the UK.

Participants were randomly assigned to receive either SBRT (n = 443), which involved the delivery of five fractions over one to two weeks (36.25 Gy total dose), or a standard course of radiation (n = 441) with 39 fractions over 7.5 weeks (78 Gy) or 20 fractions over four weeks (62 Gy). The men were then followed for a median of 73.1 months.

The trial explored whether patients remained free of biochemical clinical failure (BCF), which was defined as an increase in PSA levels, distant metastases or other evidence that the cancer was returning, or death from prostate cancer.

SBRT treatment times have ‘huge implications‘

After five years after treatment with either modality, men treated with SBRT had a BCF-event-free rate of 95.7%, compared to 94.6% for those treated with standard care radiation. This demonstrated that SBRT was non-inferior to CRT (p-value for non-inferiority = 0.007).

Side effects were low in both groups, and not significantly different between treatment arms. At five years post-treatment, 5.5% of patients who received SBRT experienced grade 2 or higher side effects affecting the genital or urinary organs, compared to 3.2% in the conventional group (p = 0.14). Only one person in each arm of the study experienced grade 2 or higher gastrointestinal side effects (p = 0.99).

In discussing these findings, Professor Nicholas van As, consultant clinical oncologist, medical director of The Royal Marsden NHS Foundation Trust and the study lead, said: ‘Standard radiation treatment is already highly effective and is very well tolerated in people with localised prostate cancer.

‘But, for a healthcare system and for patients, to have this treatment delivered just as effectively in five days as opposed to four weeks has huge implications.‘

Stereotactic radiotherapy delivers treatment with high precision from a number of different angles around the body and helps to reduce adverse effects in the surrounding tissue. A study from earlier in 2023 found MRI-guided stereotactic radiotherapy reduced physician-reported toxic GU and gastrointestinal adverse effects than CT-guided stereotactic radiotherapy in men with prostate cancer.

Methotrexate gives more sustained control than ciclosporin in children with severe atopic dermatitis

28th September 2023

Methotrexate (MTX) is an effective treatment for children with severe atopic dermatitis and provides more sustained disease control than ciclosporin (CyA) upon discontinuation, according to the findings of a recent randomised controlled trial.

In the TREAT trial, published in the British Journal of Dermatology, a team led by King’s College London, set out to examine the safety and efficacy of these two main first-line conventional systemic immunosuppressive therapies in children and young people with severe atopic dermatitis.

The parallel group, assessor-blinded randomised trial included 103 participants aged between two and 16 years of age whose atopic dermatitis was unresponsive to potent topical treatment.

The participants were randomised to receive either 4 mg/kg/day of CyA or 0.4 mg/kg per week of MTX for a total of 36 weeks. They were also followed up for 24 weeks.

The co-primary endpoints were the change from baseline to 12 weeks in the Objective Severity Scoring of Atopic Dermatitis (o-SCORAD) and time to a first significant flare (relapse) after treatment cessation.

Among the 52 participants assigned to CyA, there was a greater improvement in disease severity by 12 weeks (mean difference o-SCORAD = -5.69 p = 0.01). In fact, more participants reached o-SCORAD-50 at 12 weeks in the CyA arm compared to the MTX (Odds ratio, OR = 2.60, 95% CI 1.23 – 5.49, p = 0.01).

However, by week 60, MTX was superior (OR = 0.33, 95% CI 0.13 – 0.85, p = 0.02). Furthermore, participant-reported post-treatment flares were higher in the CyA arm (OR = 3.22, 95% CI 0.42 – 6.01, p = 0.025) and both treatments gave rise to a similar level of serious adverse events.

The researchers also highlighted that MTX is significantly cheaper than CyA and concluded that MTX is a useful and safe treatment in paediatric patients with severe atopic dermatitis and a good alternative to CyA, especially in settings where healthcare resources are limited.

Methotrexate is potential gold standard

Until now, there has been no adequately powered randomised clinical trial evidence in relation to the safety and treatment success of methotrexate and ciclosporin for paediatric patients with atopic dermatitis. With new high-cost therapies being introduced, establishing a gold standard for treatment with the conventional systemic therapies like methotrexate and ciclosporin is deemed necessary.

Commenting on these findings study author Professor Carsten Flohr, chair in dermatology and population health sciences at King’s College London and consultant dermatologist at St John’s Institute of Dermatology, part of Guy’s and St Thomas’ NHS Foundation Trust, said: ‘This is the largest paediatric trial using conventional immuno-modulatory treatments in severe atopic dermatitis and was conducted across 13 centres in the UK and Ireland and is likely to change our treatment paradigm around this condition, not just for patients in the UK but also internationally.‘

Inappropriate cuff size leads to ‘strikingly inaccurate‘ blood pressure measurements

14th August 2023

Using the incorrect cuff size when taking blood pressure measurements can lead to significant over and under-estimations, according to the findings of a randomised trial by US researchers.

Although clinical practice guidelines recommend the selection of an appropriately sized cuff based on mid-arm circumference before taking a blood pressure (BP) reading, the extent to which miscuffing affects readings was previously uncertain.

Now, in a study published in the journal JAMA Internal Medicine, researchers from Johns Hopkins University School of Medicine in Baltimore, Maryland, revealed that miscuffing results in ‘strikingly inaccurate‘ BP measurements.

In the randomised crossover trial of community-dwelling adults with a wide range of mid-arm circumferences, the researchers determined the effect of using a regular BP cuff versus an appropriately sized BP cuff on automated BP readings. Participants underwent four sets of triplicate BP measurements, with the initial three sets using an appropriate, too-small or too-large BP cuff in random order. In the fourth and final set of triplicate measurements, an appropriate BP cuff was used.

The team set the primary outcome as the difference in mean blood pressure when measured with a regular BP cuff compared with an appropriate BP cuff. The secondary outcome was the difference in BP when using too-small or too-large BP cuffs versus an appropriate BP cuff across all cuff sizes.

Miscuffing and blood pressure readings

A total of 195 adults with hypertension were included in the study.

Among those requiring a small BP cuff, the use of a regular BP cuff led to a statistically significant lower BP reading (mean systolic BP difference, MSBPD = -3.6 mmHg).

However, for those who required a large cuff, use of a regular BP cuff resulted in a statistically significant higher BP reading (MSBPD = 4.8 mmHg). Similarly, where an extra-large cuff was required, there was an even higher discrepancy (MSBPD = 19.5 mmHg).

For the secondary outcome, BP differences with over-cuffing and under-cuffing by one and two cuff sizes were greater among those requiring larger BP cuffs. The results were consistent in stratified analyses by systolic BP and body mass index.

The researchers noted that it was particularly concerning for settings where one regular BP cuff size is routinely used in all individuals, regardless of arm size, and called for a renewed emphasis on individualised BP cuff selection.

Cardiac dysfunction reduced by atorvastatin in anthracycline-based chemotherapy

11th August 2023

The use of atorvastatin prior to anthracycline-based chemotherapy in lymphoma patients reduces the subsequent development of cardiac dysfunction, according to the findings of a randomised trial.

Provision of the cholesterol lowering drug atorvastatin before starting anthracycline-based chemotherapy for the treatment of lymphoma, lowered the risk of developing a reduction in left ventricular ejection fraction.

Published in the journal JAMA, the study was designed to test whether atorvastatin was associated with a reduction in the proportion of patients with lymphoma receiving anthracyclines who develop cardiac dysfunction.

The Statins to Prevent the Cardiotoxicity of Anthracyclines, STOP-CA trial, was a multicentre, double-blind, randomised, placebo-controlled trial of 40 mg daily of atorvastatin administered to patients receiving anthracyclines for lymphoma. It enrolled lymphoma patients who were scheduled to receive anthracycline-based chemotherapy, but it excluded those already treated with a statin or who had clinical indication for a statin.

Prior to chemotherapy, all participants underwent a baseline assessment of heart rate, blood pressure, weight, blood tests and left ventricular ejection fraction (LVEF). Individuals were then randomised in a 1:1 ratio to receive oral atorvastatin or placebo, commencing prior to the first scheduled anthracycline infusion and then continued for 12 months. Echocardiographic measures of LVEF were performed on anonymised images in a core laboratory at the University of Pennsylvania.

The primary endpoint was the proportion of participants in each group with an absolute decline in LVEF of 10% or greater from prior to chemotherapy to a final value of less than 55% over the 12-month study period.

A secondary endpoint was the proportion of participants with an absolute decline in LVEF of ≥5% from prior to chemotherapy to a final value of <55% over 12 months.

Atorvastatin and decline in LVEF

Of the 300 participants, 286 completed the trial. Among the entire cohort, the baseline mean LVEF was 63% and the follow-up LVEF was 58%.

At the 12-month follow-up, the incidence of the primary endpoint was 9% in the atorvastatin group and 22% in the placebo group (p = 0.002). The researchers calculated that the odds of a 10% or greater decline in LVEF to a final value of less than 55% after anthracycline treatment was almost three times greater for participants randomised to placebo (odds ratio, OR = 2.9 95% C 1.4 – 6.4).

In addition, compared with placebo, atorvastatin also reduced the incidence of the secondary endpoint (13% vs 29%; p = 0.001). The number of serious related adverse events was low and similar between groups.

Based on the results, the authors wrote that these finding may support the use of atorvastatin in patients with lymphoma at high risk of cardiac dysfunction due to anthracycline use.

AI-supported mammography found to reduce radiologist workload in randomised trial

9th August 2023

Using an AI-supported mammography screening tool results in a similar breast cancer detection rate compared with standard double reading but with a substantially lower screen-reading workload, according to the interim safety findings of a new randomised controlled trial.

Making use of AI-supported software, researchers from Lund University in Sweden, have shown that a screening mammography avoids the need for double reading of all mammograms, without increasing false positives and almost halving radiologists‘ screen-reading workload.

Although previous retrospective analyses have indicated that combining AI with a radiologist improves the accuracy of breast cancer detection and reduces radiologist workload, there have been no randomised trials evaluating this approach until now.

Commenting on the findings, lead author Dr Kristina Lång said: ‘These promising interim safety results should be used to inform new trials and programme-based evaluations to address the pronounced radiologist shortage in many countries. But they are not enough on their own to confirm that AI is ready to be implemented in mammography screening.

‘We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology’.

AI vs standard double reading

Published in The Lancet Oncology, the Mammography Screening with Artificial Intelligence (MASAI) trial enrolled 80,033 Swedish women aged 40-80 years who were eligible for mammography screening. Participants were randomly allocated 1:1 to either AI-supported screening (the intervention group, n = 40,003) or standard double reading without AI (the control group, n = 40,030).

The primary outcome measure of the MASAI trial was the interval cancer rate. Secondary outcomes examined included early screening performance (cancer detection rate, recall rate, false positive rate) and screen-reading workload (number of screen readings and consensus meetings).

The AI-supported system provided an examination-based malignancy risk score on a continuous scale ranging from 1 to 10. These examination were then categorised as either low risk (risk score 1 to 7), intermediate risk (risk scores 8 and 9) or high risk (risk score 10). In the intervention group, examinations with risk scores of 1 to 9 underwent single reading, whereas examinations with risk scores of 10 underwent double reading.

The cancer detection rate (per 1,000 screened women) was broadly similar, with a rate of 6.1% for the AI group and 5.1% in the control group. Similarly, recall rates were also not significantly different (2.2% vs 2.0%) and neither were the false positive rates (1.5% in both arms).

The number of screen readings was considerably lower for the AI-supported group (46,345 vs 83,231), representing a 44.3% workload decrease for reading screening mammograms.

Domiciliary transcutaneous electrical stimulation may help patients with obstructive sleep apnoea 

Domiciliary transcutaneous electrical stimulation of the hypoglossal nerve could be used to reduce the severity of symptoms experienced by patients with obstructive sleep apnoea (OSA), according to the findings of recent study.

Patients treated with transcutaneous electrical stimulation showed improvements in nocturnal breathing and a significant reduction of daytime exhaustion.

The TESLA open-label phase 3 trial, which was published in eClinical Medicine and led by researchers from King’s College London and Guy’s & St Thomas’ NHS Foundation Trust, examined whether domiciliary transcutaneous electrical stimulation would control OSA and provide health benefits. Traditionally used for arthritis and during child labour, this study marked the first time the device has been used for OSA.

Participants with an apnoea-hypopnoea-index (AHI) of 5 to 35 (i.e. mild-to-severe disease) and a body mass index of 18.5 to 32, together with a documented lack of adherence to continuous positive airway pressure (CPAP) therapy, were included. Individuals were then randomised 1:1 to receive domiciliary transcutaneous electrical stimulation or usual care with ongoing CPAP therapy.

The primary outcome of the trial was the change in AHI at three months. Secondary outcomes included sleepiness – based on the Epworth Sleepiness Scale (ESS) – and the 4% oxygen desaturation index (ODI).

Transcutaneous electrical stimulation impact

A total of 56 participants were enrolled and randomly assigned to domiciliary transcutaneous electrical stimulation (29 participants, of which 27 completed the trial) or usual care (27 participants) and followed for a median of three months. The two groups were similar in terms of age, gender and body mass index.

At follow-up, the AHI had improved in the transcutaneous group (p = 0.006) compared to baseline, but not in the usual care group (p = 0.69). The unadjusted group difference in the AHI was −11.5, which was statistically significant (p = 0.016). However, when adjusted for the baseline value, this difference was no longer significant (p = 0.12).

Despite this, the mean group difference in the ESS at the end of the trial was significant after adjustment for the baseline value (p = 0.020), favouring the intervention. Similarly, adjusted mean difference in ODI was also significant (p = 0.036).

Minor adverse events were found in one of the participants who developed mild headaches related to the intervention.

The authors concluded that domiciliary transcutaneous electrical stimulation for patients with OSA without significant comorbidities is feasible, safe and reduces disease severity.

Professor Joerg Steier, consultant in respiratory and sleep medicine at Guy’s & St Thomas’ and professor of respiratory and sleep medicine at King’s College London’s School of Basic and Medical Biosciences, said: ‘A TENS machine is non-invasive, has little side effects and is cheap. The TESLA trial shows us the potential of a new therapeutic option, transcutaneous electrical stimulation, and it will be interesting to see how the method can be used in clinical practice.‘

OSA is a common condition affecting up to one billion people worldwide. It is diagnosed based on several symptoms including excessive daytime sleepiness, snoring, fatigue and witnessed breathing pauses (apnoeas), gasping, or choking while sleeping. Last year, evidence emerged that OSA may be diagnosed using machine learning diffusion tensor imaging models.

Flexible-dose subcutaneous ketamine safe and effective in treatment-resistant depression

20th July 2023

A flexibly dosed, twice-weekly subcutaneous injection of ketamine over four weeks led to higher levels of clinical remission compared to midazolam in patients with treatment-resistant depression, according to a new phase III trial.

The trial by Australian researchers, which was published in the British Journal of Psychiatry, compared racemic ketamine with midazolam in two patient cohorts: one with fixed dosing and a second with a more flexible regimen.

The trial was initially designed to compare twice-weekly subcutaneous racemic ketamine (0.5 mg/kg) or midazolam (0.025 mg/kg) for four weeks, with at least three days between treatments. Data for these findings were referred to in the study as cohort one.

The dosing schedule was revised after a Data Safety Monitoring Board recommendation to flexible-dose ketamine 0.5–0.9 mg/kg or midazolam 0.025–0.045 mg/kg, with response-guided dosing increments. Data for these findings were referred to in the study as cohort two.

The primary outcome was remission, characterised by a Montgomery-Åsberg Rating Scale for Depression score of less than 10, after four weeks of treatment.

Subcutaneous ketamine and treatment outcomes

The final analysis comprised 68 patients in the fixed-dose cohort one and 106 in the flexible-dose cohort two.

Ketamine was found to be significantly more efficacious than midazolam in cohort two at achieving remission (odds ratio, OR = 12.1, 95% CI 2.1 – 69.2, p = 0.005). However, there was no significant different between the two treatments when given as a fixed dose in cohort one (OR = 1.3, 95% CI 0.2 – 8.2, p = 0.76).

In terms of safety, serious adverse events were rare and most were unrelated to the study drug. For instance, in cohort one, there were two serious adverse events in the midazolam group – a suicide attempt and mood deterioration – but both unrelated to the study medications. There were no serious adverse events in the ketamine group.

Among those in cohort two, there were three serious adverse events in the midazolam group: a suicide attempt, increased suicidal ideation and a wrist injury, which, again, were unrelated to the study treatments. In contrast, there were two serious adverse events in the ketamine group: one major dissociative episode and auditory hallucination, both of which were deemed to be related to treatment. No deaths were reported throughout the study. 

Failing to respond to an adequate course of two or more treatments is referred to as treatment-resistant depression, and ketamine is a novel highly effective and rapidly acting treatment. It is available as an intravenous infusion of a racemic mixture and as a commercially developed single enantiomeric intranasal spray containing S-ketamine.

Monthly eblasakimab dosing effective in moderate to severe atopic dermatitis

18th July 2023

Eblasakimab is the first biologic treatment for moderate to severe atopic dermatitis to show a competitive efficacy profile when given as a once-monthly dose, according to data released by the manufacturer, Aslan pharmaceuticals.

The novel monoclonal antibody targets the interleukin-13 (IL-13) receptor subunit of the Type 2 receptor, that is a key pathway in several allergic inflammatory diseases, including atopic dermatitis.

The findings, while yet to be published, relate to the phase 2b TREK-AD study, which randomised patients to one of five eblasakimab dosing arms for a total of 16 weeks: 300 mg every two weeks, 400 mg every two weeks, 400 mg every four weeks, 600 mg every four weeks or a placebo.

The study’s primary endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 16 versus placebo. The study also included a validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) score of 0/1 (i.e. clear or almost clear).

Eblasakimab efficacy

A total of 289 patients were randomised and treated in the intent-to-treat (ITT) population across the five dosing arms. Patients treated with eblasakimab 600mg, 400mg and 300mg, all saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in EASI score by Week 4.

When assessed at Week 16, some 62.7% of eblasakimab patients given 600 mg monthly achieved a reduction of at least 75% from baseline (EASI-75) compared to 30.7% given the placebo (p = 0.0041).

In addition, 34.1% of eblasakimab patients receiving the 600 mg dose, achieved an EASI90, compared to only 10.1% on the placebo (p = 0.0088).

Finally, 31.2% of these patients achieved vIGA-AD score of 0 or 1 compared to 15.1% with the placebo (p = 0.0502).

No new safety signals were seen in the study, and the frequency of adverse events was comparable between the active eblasakimab treatment and placebo arms, with the most frequently observed adverse events being nasopharyngitis (13.4% vs 8.8% for placebo), atopic dermatitis (8.6% vs 7.0% for placebo), headache (6.9% vs 7.0% for placebo) and upper respiratory tract infection (6.5% vs 5.3% for placebo).

Commenting on these findings, Eric L. Simpson, lead investigator in the TREK-AD study and Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University, said: ‘This is the first time we’ve seen a once-a-month treatment option deliver competitive efficacy data, which would be a game-changer for patients with atopic dermatitis.

‘We haven’t seen much in the way of advancement since the launch of dupilumab, and there remains a huge unmet burden of disease experienced by patients. These results support eblasakimab’s potential to be a leading therapy for the treatment of atopic dermatitis, if approved.‘

Oral penicillin challenge comparable to standard of care in low-risk allergy patients

Use of a direct oral penicillin challenge in patients with a low-risk of penicillin allergy has been shown to be non-inferior to the standard-of-care skin testing in the recent PALACE randomised trial.

Removing the label of being allergic to penicillin involves intra-dermal skin testing followed by an oral penicillin challenge. Now, an international research group has shown that a direct oral penicillin challenge in those with a low-risk penicillin allergy is equally as safe as the current standard-of-care assessment.

In the parallel, two-arm, non-inferiority, open-label, randomised trial, patients with a PEN-FAST score below three, were randomly allocated to either the intervention group who had a direct oral challenge with penicillin, or the control group who received the standard of care.

The primary outcome of interest was a physician-verified positive immune-mediated oral penicillin challenge within one hour after the intervention. Researchers set the non-inferiority margin as a risk difference of less than five on a one-sided 95% confidence interval.

Oral penicillin challenge

The trial recruited a total of 382 adults who were randomised, although only 377 patients with a median age of 51 years (65.5% female) were included in the final analysis. Among these, 187 were allocated to the intervention group. Most patients had a PEN-FAST score of 0 or 1.

The primary outcome occurred in only a single patient in both groups, giving a risk difference of 0.0084, which was below the non-inferiority margin.

In the five days following the oral penicillin challenge, a total of nine immune-mediated adverse events were recorded in the intervention group and 10 in the control group. None of these were deemed to be serious.

Dr Ana-Maria Copaescu, first author of the study and associate investigator in the Infectious Diseases and Immunity in Global Health Program at the Research Institute of the McGill University Health Centre in Quebec, said: ‘The biggest takeaway from the PALACE study is that patients with a low-risk penicillin allergy, like a childhood rash, can safely have a test dose of penicillin to determine if they are still allergic.

‘This will change the way doctors test for penicillin allergy in the future. Millions of patients worldwide… will be able to have their penicillin allergy disproved by a safe single oral test dose following a carefully risk-validated risk assessment.‘

Antibiotics such as penicillin are widely used in clinical practice although a true allergy to these drugs is rare with an estimated frequency of anaphylaxis at one to five per 10,000 cases. Hypersensitivity reactions are significantly more common, resulting in symptoms such as nausea, vomiting, pruritus, urticaria and wheezing.

Milestone reached as donanemab shown to slow progress in early Alzheimer‘s disease

Donanemab has been found to slow the progression of early symptomatic Alzheimer’s disease after 76 weeks of treatment, according to the findings of a phase 3 randomised trial.

The monoclonal antibody donanemab, which targets the insoluble, modified, N-terminal truncated form of β-amyloid present only in brain amyloid plaques, was given to patients with early symptomatic Alzheimer disease with amyloid and tau pathology. Nearly half of those given the drug showed no signs of disease progression after 12 months.

Commenting on the research, Dr Richard Oakley, associate director of research and innovation at the Alzheimer’s Society, said:  ‘This is truly a turning point in the fight against Alzheimer’s and science is proving that it is possible to slow down the disease. Treatments like donanemab are the first steps towards a future where Alzheimer’s disease could be considered a long-term condition alongside diabetes or asthma.‘

Published in the Journal of the American Medical Association, participants of the TRAILBLAZER-ALZ 2 trial were categorised as having either low/medium or high tau pathology and randomised 1:1 ratio to receive donanemab or a placebo intravenously every four weeks for 72 weeks. 

The primary outcome of interest was the change in integrated Alzheimer Disease Rating Scale (iADRS) score from baseline to 76 weeks. There were a number of secondary outcomes, one of which was the change in the sum of boxes of the Clinical Dementia Rating Scale (CDR-SB) score.

Donanemab and disease progression

A total of 1,736 participants (57.4% women) with a mean age of 73.0 years were recruited. Some 68.1% had low/medium tau pathology and 76% completed the trial.

The least-squares mean (LSM) change in iADRS score at 76 weeks was −10.2 with donanemab and −13.1 with placebo (difference = 2.92, p < 0.001) for the combined population. In addition, the LSM change in CDR-SB score at 76 weeks was 1.72 with donanemab and 2.42 with placebo (difference = −0.7 p <0 .001) in the combined population.

Furthermore, an estimated 47% of participants receiving donanemab had no change in the CDR-SB at one year (i.e. no disease progression) compared with 29% of participants receiving the placebo.

The trial also revealed how donanemab treatment significantly reduced brain amyloid plaque at all time points assessed, with 80% (low/medium tau population) and 76% (combined population) of participants achieving amyloid clearance at week 76.

The level of clearance beyond 76 weeks, as well as levels of Alzheimer disease biomarkers, are currently being studied in an ongoing extension phase.

In subgroup analysis, among participants with mild cognitive impairment, donanemab slowed decline by 60% on iADRS and 46% on CDR-SB. Additionally, in an analysis based on participant’s age, in those under 75 years, donanemab slowed decline by 48% on iADRS and 45% on CDR-SB, whereas the drug slowed decline by 25% on iADRS and 29% on CDR-SB in those over 75 years.

Liana Apostolova, distinguished professor in Alzheimer’s Disease research and professor in neurology, radiology, medical and molecular genetics at Indiana University School of Medicine, said: ‘These results demonstrate that diagnosing and treating people earlier in the course of Alzheimer’s disease may lead to greater clinical benefit. The delay of disease progression over the course of the trial is significant and will give people more time to do such things that are meaningful to them.‘

Dr Oakley added: ‘It’s also important to note that side effects did occur, although serious side effects only occurred in 1.6% of people receiving the drug. Regulators will need to balance these side effects against the benefits of the drug.

‘We should also note that the majority of people who took part in this trial were white – it’s crucial that in future trials we see more diversity to prove that new drug treatments have similar effects for everyone living with Alzheimer’s disease.‘

Early diagnosis imperative

Highlighting the ‘defining moment for dementia research‘, Kate Lee, Alzheimer’s Society CEO, added: ‘New treatments could mean nothing if we don’t fix dementia diagnosis. We estimate around 720,000 people in the UK could potentially benefit from these emerging new Alzheimer’s disease treatments if they’re approved for use here. But the NHS is simply not ready to deliver them.

‘Everyone living with dementia deserves access to a speedy, accurate diagnosis to get the support and treatments they need, now and in the future.‘

This comes shortly after news that diagnosing Alzheimer’s disease through the use of blood biomarkers could transform care for patients after new proposed guidelines were presented at the International Alzheimer’s Congress in Amsterdam.

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