Risk Assessment

Dr. Z’s phone call got me out of bed yesterday morning. My local neurologist apologized for disturbing me at an early hour—but he knew he wouldn’t have any time to spare once he started his rounds for the day.
“It’s about Ocrevus.”
Of course it was.
I’d chosen Ocrevus at our appointment a few days before. I’ve been spoiled—I’d been on Zinbryta, one of the most effective drugs for multiple sclerosis out there, until it was pulled from the market. I didn’t want to downgrade. Ocrevus has an associated cancer risk; I’d asked Dr. Z if I could still consider it, even with the recent revelation of my elevated risk of breast cancer. Dr. Z had said the risk didn’t look too bad, nothing to inspire a black box warning; the numbers were more in the neighborhood of correlation than that of causation.
I’d left the appointment with greater clarity than I’d had walking in. Apparently, Dr. Z. left with a nagging feeling of uncertainty. And so he called the drug company (as only a conscientious doctor would do.) The company deferred answering his question, advising him to wait for their big product announcement in May. I am scheduled to get my first infusion in mid-April. Dr. Z thinks it would be reckless to start me on the drug without gathering all the information the company has collected about the drug through its first year on the market. He also thinks it would be reckless for me to wait additional weeks to get treatment. My last dose of Zinbryta was in mid-February. And my MS has proven to be fairly savage if left untouched by anything less powerful than a monoclonal antibody. He didn’t want me vulnerable to an MS relapse. He is a little too fond of telling me that I don’t have much brain left to lose.
Dr. Z suggested I try Tysabri next. Tysabri has been found to be fairly effective, though it comes with an elevated risk of PML, a potentially fatal brain infection. There is a blood test I can take to see if I’d be susceptible to PML. I don’t know which risk I will take if the blood test is positive. I risk a relapse if I hold out for Ocrevus and wait too long. I risk a relapse and potentially harmful side effects if I choose the wrong medication.
And yet, I am cautiously optimistic.
His phone call confirmed I’ve made one good choice already: I’ve chosen a neurologist with integrity. I also have a great resource in my neurologists at the NIH, who throughly answer my questions every time I find myself at a crossroads in this perilous landscape of multiple sclerosis. These researchers are working to make decisions like mine less agonizing. That’s a worthwhile cause, indeed.

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3 thoughts on “Risk Assessment

  1. Lisa – I love ” cautiously optimistic.” Because I love your spirit, and your knowledge that you do indeed have an ethical, good and very intelligent neurologist who is looking out for your best interests; so good to know that in the quest for what’s best, and what is least harmful, you have a strong ally. We’ll see you later this month, and maybe by then some decisions will have been made and you’ll have begun a new regimen. I look forward to seeing your beautiful self soon!

  2. Okay – I read the Phase 3 paper sections on neoplasms, and I’d be concerned, too. The thing that disturbed me isn’t so much that in all the trials the Ocrevus people had a markedly higher (though still really small, 0.5-2.4% v. 0.2-0.8% for IF/placebo) rate of cancer – it’s that in the year following, new trial members who’d had Ocrevus were still popping up with new cancers at a higher rate than those who’d had placebo or interferon. Including breast cancer.

    The first phase 3 was a 96-week trial, and then there was the year-long followup after the trial was over. What that says to me is that even a first-year guinea-pig population isn’t going to give your doc the answers he’s after (though it may turn out that the incidence of cancer is higher). The thing I’d want to know about is the 5-year, even the 10-year cancer risk — along with drug efficacy over that span.

    I’d also — just looking at current numbers — be looking at your own numbers. What was it, 11% risk of breast cancer over ten years? How does 25% sound? Of course, you don’t know that it will translate that way — that’s where I’d want to talk to an oncology risk person, to see whether that’s a sensible way of looking at the risk multiplier in Ocrevus.

    If it were me, and if best info we have on Ocrevus really does does look to boost breast-cancer risk from around 10% to around 25% over 10 years, and if there were another, better-known drug that had no increased cancer-risk profile but did a good job, I’d likely go with that, partly because we don’t know yet about Ocrevus’s efficacy over more than a couple of years. But I’m quite conservative that way, and I’m not currently living with any debilitating diseases.

    1. As it happens, all MS drugs are less effective as patients age. The effectiveness flatlines at age 53. I am fifty. More on that in another post.

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