Last July, I wrote a post airing my skepticism about the new drug, Benlysta. And several of my readers agreed with me.
Given, the news about the drug over the past several days, I find myself writing about it again, and singing a similar refrain.
I would love to be hopeful. I would love to be jumping up and down right now, and bouncing off the walls. But I’m not. After surviving my second lupus-related hospitalization in a little over a year, I am seriously questioning the efficacy of any and all medications at the moment.
I read a very interesting New York Times article that is at best equivocal about the benefits and risks of Benlysta.
Another interesting thing is that the stock of Human Genome Sciences, Inc., the maker of Benlysta, dropped yesterday after the FDA hearing, due to concerns expressed about the safety and efficacy of the drug. And Benlysta would be the first drug ever to make it to market for the company.
According to a Business Week article : “While the Food and Drug Administration advisers recommended approval of Benlysta yesterday, they raised enough concerns about safety that U.S. sales may be limited […].” Further, the article states that it“works well enough to outweigh risks of suicide, infection and cancer.”
I’m inclined to say, that’s all? That’s all we get? That likely wouldn’t have kept me out of the hospital. It wouldn’t keep me from having a throng of doctors. And would it minimize my medication regimen? Maybe. Maybe not.
What I really want is a cure. I don’t want to be sick anymore. I don’t want my number one job to be that of a patient. What I really want to be and feel is normal. I don’t want a powerful drug to create a veil of normalcy. I simply want to be. No matter how good this new drug is, it isn’t going to work for everyone. There will be side effects, which could potentially be worse than the disease, itself.
Overall, I feel like a lot of the story is missing. And I don’t think we yet have all the facts to make an educated decision about whether or not to utilize this drug if given the opportunity.
Medication decisions are extremely personal, and of course, need to take place in concert with medical professionals. But I do caution readers to remember that there are many players involved in this approval process, and I have to wonder if the patient is really first on the priority list when deciding the fate of this orphan drug.
I feel like I’m becoming a so-called lupus drug frequent flyer. I’ve been on plaquenil and prednisone since I first got sick. I was on CellCept (off-label), but it had limited efficacy. I’m on Methotrexate now, but I am questioning it, too. It seems like my body gets comfortable with drugs and they just kind of stop working. So would the same thing happen with Benlysta?
Again, I don’t want to get ahead of myself here. Right now, what I want the most is my pre-illness life back, and I fear that’s something that no drug will ever be able to give me.
So how do you feel about this latest news? Does it fill you with hope, fear, a combination of both?
Amen on the body getting used to drugs. I think that happened with MTX with me, but it made me tired so we were hesitant to up the dosage. Trying Arava now, but it's not working at all, and the warnings are scarier than the last drug I was on. Think I may ask for the MTX back and see how it goes next visit. I tell people I'd like a drug that works consistently, and allows me to: 1. Have babies (or at least not worry about maming babies if I accidently get preggers), 2. Allows for an occasional social drink, 3. Doesn't cause my hair to fall out, 4. Doesn't make me want to sleep almost as much as being sick does.
ReplyDeleteToo much to ask? I think not!
I've been on BenLysta 7 years and for me it has been wonderful. Before BenLysta I had too man days. Couldn't even comb the stairs at home much less travel or even go to work. Now, at 37 I am a full time student majoring in chemistry and biology hoping to pursue a doctorate in pharmacology. Yes, I still have lupus and I still need meds but my bad days are much fewer, there are more great days than awful ones and my daily meds are all at lower doses....and I'm not on prednisone or any other steroids. The only side affect I experience is being a little more tired than usual the day of my infusion and needing to rest that evening. No treatment will ever be perfect and no single treatment will work for everyone but this is a huge step forward in research and treatment for a very complicated disease and for that I am grateful. Finally and for the first time ever there is a treatment developed specifically for lupus. There is research being done and attention being paid to lupus. People are paying attention to lupus. It is a start and a huge step in the right direction.
ReplyDeleteYou wrote a lot of what I am thinking myself. Although my immunologist is really nice and always has time for me and my questions, she believes that I am doing well. For her 'well' means that I am not getting worse, she considers the last 10 months of immune suppression a success also because I can tolerate the drugs without too many side effects. She calls this 'stable progress', a euphemism for nothing much happening if you ask me. But maybe I am to harsh here. I just wish she would tell me openly that this is allI can hope for and not let me guess it between the lines.
ReplyDeleteJessica, I would love those four things, too!
ReplyDeleteMichelle, why aren't more of these stories public? Why aren't they being posted on blogs? Why aren't they getting more press?
I've had RA for ~7 years now and am in my 20s. I'm also a researcher focusing mainly on autoimmune diseases. So, fortunately or unfortunately, I see both sides of the treatment battle on a daily basis.
ReplyDeleteClassically, lupus has been one of the most difficult to treat and to approve drugs for. In fact, it's been decades since a new drug was FDA approved for the treatment of lupus. I was at a conference this past week listening to why new treatments often fail the efficacy test and aren't approved for lupus. A great deal of it is because lupus is such a heterogenous disease.
Researchers and doctors are now realizing that certain drugs do wonders in early disease while may worsen a disease in its later stages. There are also drugs that work better for people who are anti-Sm positive, but doesn't work for those that are anti-dsDNA or anti-RNP positive.
This is why so many efficacy trials have failed. A handful of people may have succeeded with the drug in the trial but were watered down with the others that failed. That being said, until we figure out how to personalize the drugs on a per-patient basis, don't give up hope yet. With each new drug, it may not look overwhelmingly good for the whole lupus population, but it may be that miracle drug for you. But, as it tends to be my motto lately, it's perfectly OK to be cautiously optimistic.