A ‘life-changing’ potential new drug could be available to lupus patients in the future thanks to ‘breakthrough’ research.
The results of the TULIP II study have been published in the New England Journal of Medicine (NEJM), one of the most prestigious, peer-reviewed medical journals in the world.
TULIP stands for ‘Treatment of Uncontrolled Lupus via the Interferon Pathway’, and the programme incorporated two studies, TULIP I and TULIP II, which evaluated the efficacy and safety of a potential new drug, anifrolumab, in patients with moderately to severely active Systemic Lupus Erythematosus (SLE). The results of TULIP I were published in the Lancet Rheumatology last month. Anifrolumab is being developed by AstraZeneca.
Professor Ian Bruce, Director of NIHR Manchester Biomedical Research Centre (BRC) Consultant Rheumatologist at Manchester Royal Infirmary (MRI), and Chair in Rheumatology at The University of Manchester chaired AstraZeneca’s Anifrolumab SLE Steering Committee for the TULIP programme and co-authored the NEJM paper, which was published today.
Professor Bruce said: “This drug is a real breakthrough for people with lupus, a long-term condition causing inflammation to the joints, skin and other organs.
“There is currently no cure for lupus. Symptoms include joint pain and stiffness, extreme tiredness and skin rashes – often over the nose and cheeks. Lupus can be a painful condition often, with a debilitating psychological impact.
“Basic research has shown that proteins called interferons, which we normally use to fight viral infections such as the flu, are increased in patients with lupus. Anifrolumab was designed to block the effects of interferons.
“The results demonstrate that anifrolumab achieved a statistically significant reduction in overall disease activity, as well as statistically significant reductions in both the requirement to use oral steroids and the extent and severity of skin rashes – all of which is fantastic for patients.”
Fiona Northrup has been treated at the Kellgren Centre for a number of years and has experienced an unprecedented improvement in her lupus symptoms as a result of receiving the drug as part of the trial and the subsequent extension study.
The 41-year-old was first diagnosed with lupus when she was 23 and the condition has had a significant impact on her life, including the requirement to use high dosages of steroids for more than 20 years.
“I genuinely don’t know what would have happened if I hadn’t taken part in this trial,” said Fiona, who lives in Bolton.
“I had tried everything by the time I heard about the TULIP II trial and it really was my last resort, I had such a bad skin rash that it was peeling away from my body – I looked like I had been in a fire.
“Within around three weeks of being on the drug my rash completely cleared and the stiffness in my joints has eased hugely. I have been on steroids for such a long time I will always require a maintenance dose, but we have managed to get my dosage down to the lowest level in 20 years which has helped so much.”
TULIP II was a phase III trial, meaning the drug has passed the early trial phases successfully and these results now pave the way for applications to be made for anifrolumab to be licensed for use in lupus patients. In the UK, this potential drug will also then have to be assessed by NICE before being made widely available on the NHS.