Biologic, biosimilar use in psoriatic arthritis awaiting real-world data
Healio spoke with M. Elaine Husni, MD, MPH, vice chair and director of the Arthritis & Musculoskeletal Center in the department of rheumatic and immunologic diseases at Cleveland Clinic, about using biologics and biosimilars, the importance of early detection and treatment and the need for more data on whether switching between biologics and biosimilars will result in cost-savings and better outcomes for patients with psoriatic arthritis.
Healio: What has been your experience with biosimilars in PsA?
Husni: Biosimilars is a very interesting topic. The development of biosimilars are exponentially increasing, especially with the earlier biologics such as the anti-TNF. There’s a lot more of these anti-TNF biosimilars that are out.
Regarding whether or not I’m actually prescribing them, in my particular practice, in this hospital-based practice, I’m only familiar with anti-TNF medication. The switch is really being done on a higher level than an individual physician level, so people who have been on a Remicade anti-TNF (infliximab, Jannsen) get switched over to a biosimilar called Renflexis (infliximab-abda, Merck).
Currently, we don’t have enough time on the switch where I can tell you detail-by-detail and patient-by-patient whether or not it has a similar side effect profile or not.
It does seem efficacy-wise, patients are doing well with the switch, but in terms of those nuances I don’t have all the detail. That’s really going to be coming where more people are going to be placed on biosimilars and we can do comparative analysis.
Healio: Biosimilars seem to be less expensive than biologics – is this a game changer for patients? Will this prompt more patients to ask for biosimilars?
Husni: Biosimilars came to the market because of their potential to be cheaper than the current medication. Unfortunately, the current biologic disease-modifying agents are probably the most expensive medications that we have on the market right now that we use in both rheumatoid arthritis and psoriatic arthritis. With the excess cost and value-based care, we are looking for options for our patients where we can provide more reasonable pricing on medications.
Biosimilars came to the market under that pretense, so of course, as a physician, I would like to see a huge discount for my patients.
Unfortunately, sometimes we’re only seeing a 15% to 20% lowering from the original price. When I’m thinking of my patients, I want greater than a 15% difference, and we’re not really seeing that in the biosimilar pricing. I understand there are a lot of nuances to that depending on what practice is negotiating for these medications, so I can’t speak as a whole to what’s happening. But from what I can see, I would prefer a much bigger savings. That will likely dampen some of the enthusiasm that is related to it.
Also, we are still waiting for some real-world data between biosimilars and the original compound. When those come out, we’ll perhaps be more evidence-based about switching and how helpful a 15% discount will be.
Healio: Can biosimilars be used with other treatments?
Husni: In general, in psoriatic arthritis, we are probably not as good at understanding monotherapy vs. combination therapy with methotrexate. In the rheumatoid arthritis world, the data are pretty clear that combination with methotrexate has better outcomes. In psoriatic arthritis, there’s a challenge.
In certain cases, methotrexate does appear to have some increased benefit, and in some trials, we see that there really is no benefit whether you’re on monotherapy biologic vs. a combination of a biologic and methotrexate. We need more data to look at that.
What I’m doing in practice, if a patient is doing really well on a biologic and they’re looking not to switch, or because they’ve switched to so many other medications in the past, I do add methotrexate to that regimen to see if I can get some better coverage and then vice versa. If they started on methotrexate, they’ve added a biologic and they’re very stable, I may de-escalate. When I do, I may de-escalate the methotrexate first to see how they do before I de-escalate the biologic.
Healio: Use of biologic therapy to treat psoriasis and psoriatic arthritis has increased over time along with the use of systemic corticosteroids. What are the implications for clinicians?
Husni: Even a 6-month delay in diagnosis can lead to poorer outcomes in psoriatic arthritis, so there has been a philosophy that earlier diagnosis and treatment can lead to better outcomes. We obviously want to decrease functional impairment and decrease comorbidities that are associated with uncontrolled disease and with that comes the ability to treat with these newer medications to get them under better control and to treat them earlier.
The other important study that we know of is what we call tight control or treat-to-target, which is basically treating to a target. This is a concept that is very common in rheumatoid arthritis and now being looked at in psoriatic arthritis. Treating to a low disease activity measure does improve outcomes compared with usual care. What that means is many of these biologic drugs are able to control a patient’s moderate-to-severe psoriatic arthritis disease and therefore get you closer to your target and fulfilling the treat-to-target strategy. Perhaps I can see how that can increase the use of biologics in the moderate to severe category.
It’s important to understand what types of patients that the studies include. In the mild group of psoriatic arthritis, we still have really good treatment — anywhere from topicals to oral medications — that we’re still using that does really well in patients. In the moderate to severe group where we know there’s more comorbidities, poorer outcomes and especially when there’s a lag in diagnosis and treatment, there are probably more biologics being used and there should be in that group.
I don’t know if I would be comfortable saying that should be what we do for all patients with psoriatic arthritis.
Healio: To your knowledge, why do you think biosimilars have not taken off the way many expected them to?
Husni: The data show that biosimilars can be used in certain conditions. The issue is probably more the cost-saving side. If you’re telling me that I have two very similar drugs and if one is a lot less expensive, would be more of a draw. If the savings are minimal, then why are we learning about prescribing a new drug or switching all our drugs to something that only has little benefit?
We have to look at incremental benefits. We’re so familiar with our current drug treatments, so for us to just change over items for a small savings, we have to understand that these are still different protein compounds that we are subjecting our patients to and I’m not sure we have the data that switching back and forth doesn’t cause any long-term differences in a patient’s outcome as well.
As time goes on, we’ll learn more about these agents and how to use them.
Disclosures: Husni reports being on advisory boards for AbbVie, Amgen, BMS, Gilead, Janssen, Lilly, Novartis, Pfizer and UCB, and royalties from the PASE questionnaire.
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