New biologics for CD bring better safety

A review of the safety of drugs for Crohns’ disease has found that newer biologics such as vedolizumab and ustekinumab appear to be safer options than anti-TNF agents.

The review said adverse events associated with vedolizumab appear to be mainly upper respiratory tract infections and nasopharyngitis with no serious risk of opportunistic infections or malignancy.

More evidence on adverse pregnancy outcomes in women treated with vedolizumab was required but it was suggested that active disease rather than the drug was the most likely cause of miscarriages.

The researchers said despite there being no published cases of progressive multifocal leukoencephalopathy (PML) in people prescribed vedolizumab alone, it continued to be monitored closely.

“Given that HIV infection increases the risk of PML, however, we suggest performing baseline HIV serological testing prior to starting vedolizumab in the rare event of PML being diagnosed later,” the study authors said.

Co-author Professor Rupert Leong, from Concord Hospital, told the limbic they were surprised with the paucity of data in the literature on elderly patients.

There was some evidence vedolizumab was well tolerated in the elderly but no data for ustekinumab or methotrexate.

“Everyone appears to be ignoring what happens to elderly patients. Their physiology is very different, they are on multiple medications that can interact, they are sicker and they have other diseases.”

He said IBD prevalence was increasing in the elderly as the disease was well controlled in Australia and people typically lived with IBD rather than dying from it.

“Despite having a high prevalence of IBD in the elderly, we don’t have a different strategy to treat IBD in the elderly,” he said.

The main risks were opportunistic infections and cancers.

“A lot of clinicians are slow adopters which means they are using the same drugs they have used all along – most likely using anti-TNF agents which have been around for 15-20 years. That’s what they are used to and that is what they keep prescribing.”

“Our point is that the new drugs use different pathways that are less immunosuppressive – they seem to be more specific and therefore their efficacy is very similar to anti-TNFs but their safety profile is a lot better.”

“We have these new drugs available and we should be looking at safety in our patients not just efficacy. We need to have both.”

The study said ustekinumab had been shown to be safe over longer periods of time in psoriasis and psoriatic arthritis populations, “albeit at a lower maintenance dose”.

Disclosure: Professor Leong has served on advisory boards for a number of pharmaceutical companies including Janssen and Takeda.

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