Trialled by University of 野狼社区 and 野狼社区 University NHS Foundation Trust doctors and scientists, in conjunction with Liverpool Clinical Trials Centre, pirfenidone could offer a much-needed viable treatment for heart failure with preserved ejection fraction (HFpEF).

But larger scale trials are needed to confirm the findings for the drug, produced by Roche Products Limited, before it can be licensed for use in the NHS.

The study, funded by the National Institute for Health Research, is published in Nature Medicine today (Thursday 12 August).

Heart failure means that the heart is no longer able to pump blood around the body properly, causing shortness of breath, swelling and extreme fatigue.

Around a million people in the UK live with heart failure, and many more are at risk of developing it.

Just under a third of 55-year-olds will develop heart failure, and 2 to 3 of every 10 people diagnosed die within a year.

In about half of patients with heart failure, the forward pumping function of the heart is normal. This is called heart failure with preserved ejection fraction, or HFpEF.

While a number of processes lead to heart failure, scarring - or fibrosis - of the heart muscle is thought to be an important mechanism in around half to two-thirds of patients with HFpEF and is associated with adverse outcomes.

Dr Chris Miller, National Institute for Health Research Clinician Scientist at The University of 野狼社区 and Consultant Cardiologist at 野狼社区 University NHS Foundation Trust led the study.

He said: “Heart failure is as devastating an illness as some of the most common cancers, however its profile its much lower and treatment options for HFpEF are very limited.

“Using cardiac MRI, we were able to select patients in whom heart scarring is important. Pirfenidone then reduced that scarring.”

Pirfenidone works by inhibiting the biological processes involved in scar formation.

The study enrolled patients with heart failure, normal forward pumping function of the heart and evidence of fluid retention.

Eligible patients had cardiac MRI scanning, and those who had evidence of heart scarring, as indicated by a measurement called ‘extracellular volume’, were randomly assigned to take pirfenidone or a placebo daily. 94 patients were randomised, with 47 assigned to each treatment group.

At one year, patients underwent a second cardiac MRI to measure change in heart scarring. Extracellular volume declined by 1.21% on average in patients who took pirfenidone compared with those receiving placebo.

“Based on data from previous studies, this amount of reduction in heart scarring could translate into a substantial reduction in rates of death and admission to hospital for heart failure, however larger trials are needed to determine this,” said Dr Miller.

Fluid retention, measured using a blood test called NT-proBNP, also improved in patients taking pirfenidone compared to those receiving placebo.

Dr Miller added: “Though further investigation is required, the associated improvement in fluid retention provides support for heart scarring having a causal role in heart failure and being an effective treatment target”.

The most common side effects were nausea, insomnia and rash, which are similar to that which lung patients can experience when taking Pirfenidone.

Dr Miller said: “These findings are exciting and suggest that pirfenidone could benefit patients with this condition, however further trials are required.”

The paper Pirfenidone in heart failure with preserved ejection fraction: a randomized phase 2 trial is published in Nature Medicine

The University of 野狼社区 and Salford Royal NHS Foundation Trust led studies on Bimekizumab , both published in the prestigious New England Journal of Medicine today, were funded by UCB Pharma; the company that developed the treatment which could be available in as little as 12 months.

Given as an injection under the skin, Bimekizumab is a monoclonal antibody and the first to block both Interleukin 17A and Interleukin 17F which are overexpressed in psoriasis.

Interleukin 17A and Interleukin 17F are two types of special proteins called cytokines which regulate the immune system. Other psoriasis drugs have only been able to block 17A.

One trial called BE RADIANT, compared the drug with Secukinumab, an IL17 A blocker: 743 patients were enrolled and 373 patients were assigned to Bimekizumab

The BE SURE trial compared Bimekizumab with Adalimumab: of the 478 patients enrolled, 319 patients were assigned to Bimekizumab.

Bimekizumab in both studies was given every 4 weeks for 16 weeks after which two maintenance schedules were possible: continue at every 4 weeks or go to an 8-week schedule .

Secukinumab and Adalimumab were given as per label.

The team assessed the efficacy of the treatments using the Psoriasis Area Severity Index (PASI) with PASI 100 indicating clear skin.

At week 16 in the BE RADIANT trial, 230 patients (61.7%) on Bimekizumab reached complete skin clearance (PASI 100) whereas only 181 (48.9%) on Secukinumab achieved the same result.

At week 16 in the BE SURE trial, 275 or 86.2% of the patients on Bimekizumab achieved a PASI 90, one of the primary endpoints of the study where only 75 of the patients on Adalimumab-(47.2%) had the same result.

After approximately a year, there was no difference in outcomes for patients receiving Bimekizumab every 4 weeks, or every 8 weeks.

Side effects were rare, though oral candidiasis- usually an easily treatable mouth infection - occurred in some patients.

Professor Richard Warren from The University of 野狼社区 is also a Consultant Dermatologist at Salford Royal NHS Foundation Trust.

He has been leading some parts of the Bimekizumab development programme over the last 5 years as well as working with others on the design of the phase 3 programmes.

He said: “These trials show that Bimekizumab offers much hope to patients with moderate to severe psoriasis.

“The higher rates of skin clearance under Bimekizumab compared with Secukinumab and Adalimumab were very impressive.

“This drug sets a new bar for psoriasis treatment and we are hopeful that trials in treating other diseases triggered by over active Interleukin 17A and Interleukin 17F will also lead to improvements in patient care .”

The papers Bimekizumab versus Adalimumab in Plaque Psoriasis and Bimekizumab versus Secukinumab in Plaque Psoriasis are published in New England Journal of Medicine