This was published 6 years ago
Warning over commonly prescribed immunosuppressant after two die
By Liam Mannix
Patients taking a commonly prescribed immunosuppressant are being urged to consult their doctor after two people using it died during a clinical study.
Methylprednisolone, first used in the 1950s, is a commonly prescribed drug for a wide range of conditions including arthritis, allergies and cancer. But it also has potentially dangerous side-effects.
Methylprednisolone was first used in the 1950s.
Experts say anyone using it should continue, as it is dangerous to stop using the drug suddenly.
But Professor Vlado Perkovic, one of the authors of the study, which was released last month, advised users to see their doctor to "ask if the benefits of this treatment outweigh the risk".
The clinical study involved researchers from the NSW-based George Institute for Global Health partnering with researchers in China. The study set out to test whether methylprednisolone was an effective treatment for IgA nephropathy, a kidney disease also known as Berger's disease.
The immunosuppressant is sometimes used to treat the condition, despite there being no convincing clinical trials supporting its use.
IgA nephropathy is a common autoimmune condition affecting 1 to 2 per cent of the population. It damages the filtering ability of the kidneys; sufferers often find blood in their urine. In about 30 per cent of cases it leads to kidney failure.
Despite a lot of work, specific treatments for the condition are still lacking.
The researchers followed 262 IgA patients from Australia and China for three years. Half were given the drug and half were given a placebo. They planned to eventually enrol 1300 patients.
But the trial had to be stopped early when 20 people in the methylprednisolone group suffered "serious adverse events". Among this group two died, 11 contracted serious infections, two suffered gastrointestinal bleeding and two suffered bone-tissue death.
"Participants were more prone to catching infections, and if they got an infection it was much stronger than it otherwise would have been," Professor Perkovic said.
"Two patients treated ended up dying," he said.
"We weren't expecting risks anywhere near this large."
The study, published in the peer-reviewed Journal of the American Medical Association, found the rate of serious adverse effects was five times higher in the group taking the treatment. However, the study also found evidence the drug might prevent serious kidney damage in IgA nephropathy.
Independent experts say the study reinforces what is known about methylprednisolone: it is effective but potentially dangerous.
"The results are not surprising," said Monash Medical Centre director of nephrology Professor Peter Kerr.
"One of the reasons we have not used it in the past is the treatment may be worse than the disease.
"Like many medications when you give it, it has a risk-benefit assessment. If you had someone who was deteriorating quickly, you might use it."
Kidney Health Australia's clinical director Dr Shilpa Jesudason encouraged anyone using the drug to consult their doctor to ensure it was still right for them.
"This study is a good reminder that we should be assessing the risk profile of methylprednisolone every time before it is administed."