Liz Lightstone, MBBS, PhD, FRCP, professor of renal medicine for the Faculty of Medicine, Imperial College London, discussed how the potential teratogenic effects of novel therapies being investigated for lupus nephritis can impede clinical trial recruitment for women of childbearing age.
Clinical trial recruitment and determining the efficacy and safety of novel therapies for lupus nephritis in women of childbearing age are challenging, as the risk of pregnancy and potential teratogenic effects of these drugs are not well established, said Liz Lightstone, MBBS, PhD, FRCP, professor of renal medicine for the Faculty of Medicine, Imperial College London.
Transcript
Can you discuss the challenge of pregnancy for women with lupus nephritis participating in clinical trials?
So, it's really hard, because all the studies say these women have got to use 2 forms of contraception, they can't get pregnant, etc. We're tending in trials to elongate the primary endpoint. So, 2 years—so you cannot get pregnant for 2 years. You might be in a very good remission and you might be 38, so are you really going to go into a study when you have no prospect of being allowed to get pregnant? Of course, the other thing that happens is they do get pregnant and then they're pregnant on a drug that's not tested in pregnancy. So, I think it's a real issue.
I understand the caution of a brand new drug; you don't want to suddenly find you've got a teratogenic drug. But I think we need to be a little bit more pragmatic, if the preclinical studies really show no reason for any damage. Whereas for MMF [mycophenolate mofetil], we could have predicted from the studies that went before, there were some data to suggest it was going to be teratogenic.
Cyclophosphamide we predicted would be teratogenic, whereas I'm not sure something like voclosporin [would be], unless it's so different from the other CNIs [calcineurin inhibitors]. We use them in pregnancy all the time; we use cyclosporine tacrolimus all the time, perhaps that will be fine.
And we're so cautious about it where I think you can give women risk-benefit ratios. But I think it's very hard, and the demographic you're treating [for] lupus nephritis is women of childbearing age. So, I find the women who are more willing to go in are either very young—that's quite difficult—and who are not really contemplating pregnancy or who've completed their families. And that group in between who you really want to know how the drug works won't go into a study.
Tackling Health Inequality: The Power of Education and Experience
April 30th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our final episode of this limited series and our conversation with Janine Jelks-Seale, MSPPM, director of health equity at UPMC Health Plan.
Listen
Initiating BP Medication Linked to Higher Fall, Fracture Risks in Nursing Home Residents
May 2nd 2024Among over 60,000 nursing home residents who initiated antihypertensive medication, rates of excess fractures due to falls per 100 person-years were as high as 5 among certain patient groups, such as those with dementia and high blood pressure (BP).
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen