Research insights: the latest updates from clinical papers

In our new monthly round-up, we review the latest clinical research from high-impact medical journals and draw out the findings most relevant to primary and community care nurses. Cahal McQuillan reports.

New treatment for rare epilepsy       

A new experimental drug for children with a hard-to-treat form of epilepsy – Dravet syndrome – is safe and can dramatically reduce seizures, finds a study in the New England Journal of Medicine.

Published on 4 March, this international clinical trial investigated the effects of zorevunersen in patients with Dravet syndrome and was led by researchers from Great Ormond Street Hospital and University College London.

A total of 81 children – aged between two and 18 years – with Dravet syndrome in the USA and UK were included in the trial. They were given up to 70mg of zorevunersen by lumbar puncture, either as a single dose or with additional doses two or three months later over a six-month period.

The researchers found those regularly administered zorevunersen had up to 91% fewer seizures. Given these results, the drug will likely progress to phase 3 trials in the near future.

Real-world data of risankizumab in Crohn’s disease

A large, real-world study found that risankizumab, an IL-23 inhibitor, induced rapid and sustained favourable clinical, endoscopic, and radiologic outcomes in patients with Crohn’s disease.

The study, which was published in The American Journal of Gastroenterology on 18 February, evaluated risankizumab in 520 patients with Crohn’s disease across 28 centres in Italy.

The trial included a heavily pre-treated group of patients whose disease had not responded to other treatments, with 55% of patients having received prior ustekinumab treatment, 51% failing three or more advanced therapies before the trial, and 60% having prior surgery.

By week 12 of risankizumab treatment, 60.8% of patients in the trial achieved steroid‑free clinical remission and 63.9% met the criteria for clinical remission. At week 52, 65.6% of patients maintained steroid-free clinical remission, 68.8% were in clinical remission, and 37.5% achieved endoscopic remission.

Risankizumab was effective even in patients with multiple prior treatment failures, with the authors suggesting it could be a viable option for these resistant cases. However, they highlighted that the therapy was less effective in patients with previous ustekinumab treatment.

Digital media use and child development

Digital media use was consistently associated with risks to child and adolescent health and development, particularly for social media, according to a recent study.

On 9 March, JAMA Pediatrics published a systematic review and meta-analysis of 153 studies involving 18,933 participants aged 18 years or younger, examining quantitative associations between digital media use and health or developmental outcomes.

The authors found evidence suggesting that social media use could be linked to harms, including poorer mental health, self-injurious thoughts, problematic internet use, and substance use – strengthening calls to safeguard children online.

Nevertheless, the authors acknowledge certain limitations of their analysis, noting that strong causal research methods were not adopted in most of the studies they synthesised, making causal links difficult to prove.

Smartphone use and eating disorder psychopathology

Sticking with the subject of digital media and health, a JMIR Mental Health study found that problematic smartphone use was associated with a higher risk of developing eating disorder symptoms, body image dissatisfaction, and broader disordered eating behaviours.

Published on 9 March, this systematic review of 35 studies and 52,584 participants established a significant and consistent association between problematic smartphone use – whereby an individual becomes behaviourally or psychologically reliant on their smartphone – and eating disorder symptom severity.

Their analysis of the data found that higher daily smartphone use was also related to greater food addiction symptoms, broader disordered eating behaviours like uncontrolled eating or emotional overeating, and body dissatisfaction in people with no diagnosis of an eating disorder.

Similar to the JAMA Pediatrics study, however, almost all included studies were cross-sectional, meaning causality cannot be established. This makes unclear whether problematic smartphone use drives eating disorder symptoms or if eating disorder vulnerability increases problematic smartphone use, or whether the relationship is two way.

Monthly HIV injections help with adherence challenges

Long-acting injectable antiretroviral therapy (ART) works better than daily oral ART for people with HIV who struggle with medication adherence, a new study finds.

Although oral ART is highly effective, viral suppression is often hindered by countless real-world barriers — such as, unstable housing, substance use, mental health conditions, and stigma — that make daily pill taking difficult.

Published in the New England Journal of Medicine on 18 February, this phase 3 randomised controlled trial, known as LATITUDE, set out to address the issue by investigating medication adherence in a real-world population of 453 adults often excluded from clinical trials — including those reporting injection drug use.

In step one of the study, participants took daily oral ART with adherence support and financial incentives. In step two, 306 participants who achieved viral suppression were randomised to either continue daily oral treatment or switch to monthly cabotegravir–rilpivirine injections.

After approximately 48 weeks of follow-up, the injectable treatment clearly outperformed daily oral therapy, with treatment failure occurring in 22.8% of participants receiving monthly injections, compared with 41.2% of those continuing daily oral therapy.

Alternative medicines and breast cancer

Patients with breast cancer who only use complementary and alternative medicine (CAM) are approximately 3.7-times more likely to die than those who chose traditional treatments, such as surgery, chemotherapy, and radiation, a new study has found.

The study, which was published in JAMA Network Open on 2 March, examined how CAM use is associated with survival in female breast cancer patients, using data from the National Cancer Database covering 2011–2021.

This large cohort of more than 2.1 million women was then divided into four groups: traditional therapy only, CAM only, a combination of both, and no treatment.

Survival outcomes differed markedly across treatment groups. Five-year survival was highest among patients receiving traditional therapy (85.4%), followed by those receiving a combination of CAM and traditional treatment (81.2%). Outcomes were substantially worse among patients using CAM alone (60.1%) or receiving no treatment (47.8%).

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A version of this article was first published on our sister title, The Pharmacist.