alt=a person examines a biologic pen, wondering if it is working

Is My Biologic Working?

I use a biologic agent that costs about $15,000 every four months to administer. I have used it for 7 years and I have generally been pleased, but despite evidence to the contrary, I am asking the question, "does it still work?"

The evidence is mixed. From blood work, we would say so far, so good. My numbers are low. My anti-cyclic citrullinated peptide (anti-CCP) antibodies, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) are all in the expected range. If anyone looked at it, they would say we have it under control, count our blessings, and keep going.

However, I know something has changed and I am not doing as well as I was 1 year ago. I can't prove it and my rheumatologist is skeptical, but I know something is not working. Morning stiffness is growing. Pain in the night is an increasing concern, and I am moving more slowly. I lack energy, and generally, I am exhausted most of the time.

How do I know if my biologic is still working?

That question nags many of us who have used biologic medications for a long time. How would I know if it was not working? Has my body changed, adapted, or developed resistance? Is it time to burn the bridge to this biologic? It is a fair question, and when I turn to science for the answer, I get blank stares from my doctors.

I am not blaming my doctors for shrugging their shoulders. I would do the same. RD is a multifaceted 10-headed monster, and doctors must rely on what is provided. Besides, here is the main question. Where would we go if we knew it wasn't working as well as it should? What would be the next step?

Biologic medications are like that. We try them; sometimes they work, other times not, and sometimes they stop working for no apparent reason. It is enough to make most of us change-averse when it comes to our use of biologic medications.

Hoping for some answers

What if there was a pathway to tell us if these expensive medications are likely to work? Wouldn't that be a powerful tool? We have used these medications for RA for more than 20 years. They are wonderful medications and they saved my life, but using these medications is a guessing game. Will it work? Has it stopped? Do we need to adjust the timing or amount of the dose? The answer I get is that it is a clinical judgment. The art of rheumatology.

My question is, why don't we have these tests? Why don't we have specific tests that demonstrate if a medication is likely to succeed? Maybe something like a blood test developed by the same companies that produce biologics to tell our doctors and us if the biologic might be expected to work in our case.

There is a multitude of biologic medications, and it is easier than ever to bring them to market. Why don't companies take the extra step and let us know the probability of a treatment working before we try it or the likelihood of whether a biologic is about to fail?

Looking forward to future advancements

It may not be possible today, but I found 2 articles that give some hope. The first is a study using machine learning to predict if current biologic treatment is about to fail for people who use medications to treat Psoriasis. This wide-ranging Danish study used machine learning to predict the probability that current biologic medicines would fail.1

The second is a paper detailing the possibility of using today's technology to predict if a TNF inhibitor will work for an individual. This paper details what is known and where this line of study might go.2

Both papers are worthwhile reading, and I recommend them if you want to catch up on where we are and what must be done. Therefore, we can know whether these expensive medications are likely to work before we use them.

When biologic medications were new and we had few options, it made sense to allow these medications to come to market without taking this additional step. In those days, we wanted those medications approved so we could try them to see if they worked. We have a very different situation today. I think the manufacturers should take the extra step to help patients not waste time and money trying them out when marginal gains might be expected.

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