Northwestern University Feinberg School of Medicine

Peter A. Lio, MD, Northwestern University Feinberg School of Medicine 

discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

The Safety and Efficacy of Adalimumab Biosimilars in Inflammatory Diseases

This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.

The discussion shifts to the safety and efficacy of biosimilars across various inflammatory diseases. The VOLTAIRE-RA trial, featuring an approved interchangeable biosimilar, demonstrates safety, tolerability, and efficacy within predefined primary endpoints, extending to conditions like psoriatic arthritis, ankylosing spondylitis, and uveitis. Biosimilars have also gained approval for psoriasis and hidradenitis suppurativa, indicating their versatility across disease states.

The conversation highlights the reassuring performance of biosimilars across different populations and conditions, underscoring their equivalence to originator drugs. Data from randomized trials show comparable patient outcomes and safety between originator and biosimilar therapies, providing clinical reassurance.

Extrapolating findings from one disease area to another, like from rheumatoid arthritis to inflammatory bowel diseases or psoriasis, enhances clinical accuracy and accessibility. With nearly a decade of biosimilar experience, studies consistently demonstrate no loss of efficacy and robust safety profiles, as evidenced by FDA data encompassing various therapeutic areas, including oncology and immunology.

Overall, the accumulated evidence fosters confidence in biosimilar use in the United States, supporting their integration into clinical practice across a spectrum of inflammatory diseases.

Video synopsis is AI-generated and reviewed by HCPLive editorial staff.

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Specialists in rheumatology, dermatology and gastrointestinal disease discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

We’ve had a great conversation about treating atopic dermatitis. We all see a lot of patients. What I’d like to do is ask each of you: In your practice in dealing with these patients, do you have some kernels of truth that you’ve relied on that have helped set your patients up for success, or something you can give our audience that they can take back and utilize to have the best possible outcomes? Matt, I’m going to start with you.

 Linda, I’m going to give you the spiel that I give a patient once I’ve gotten through disease education and we’re now selecting therapy. I’m a believer that setting them up for success means shared decision-making so that they’re not taking what I think they should be on, they’re taking what they think they should be on. It can be really simple. I believe that shared decision-making needs to be really simple: 2 options, at most 3 bullet points per option.

Here’s my spiel: “Luckily for you, we have great options now, they’re not steroids, you’re going to stay on them long term. I’m going to give you some choices, and you’re going to tell me which one sounds better. First, we can treat you with a pill. It’s going to start working in 2 or 3 days, but it does weaken your immune system. Or we could give you a shot that starts working in a week or two but does not weaken your immune system. You have to keep giving yourself a shot every 2 weeks or once a month. So again, a pill works that in a couple days, no shots but weakens your immune system, or a shot every 2 weeks that starts working in a week or two and does not weaken your immune system. Which one sounds better to you?”

Most patients have a very clear either, “I couldn’t imagine giving myself a shot” or “I wouldn’t want to do anything that might weaken my immune system.” If they say pill, then I’m going to talk about the boxed warning. “I do have to tell you it’s going to have some things that sound really scary.” The advice I have for everybody is when you’re talking about the boxed warning, don’t start with heart attack, stroke, death, and cancer. Start with, “Some things sound really scary. The data we have about this medication haven’t shown an increased rate of these things. But the FDA wants you to know about them because a different medication used in people who don’t have eczema that’s distantly related to this medication did slightly increase the chances of these scary things. But again, for this medication, none of the information we have about it has shown an increased rate.”

I do want you guys to know and our viewers, I didn’t say it doesn’t increase the rate. I said the information we have has not shown any increased rate. I said scary things a couple of times. I’ve said distantly related medication, people who don’t have eczema. Then I say, “The scary things, just so you’re not surprised when you get it, are things like heart attacks, strokes, and blood clots, and cancer. But again, all the information we have about this medication has not actually shown an increased rate of those things happening.” That makes people more comfortable with the JAK [inhibitors], and I don’t feel like I’ve said anything inaccurate. If that was taped and played in court, everything I said was right, and I stand behind everything I said. My pearl is shared decision-making and how I talk about the JAK boxed warnings.

 It makes me think about a quote that is often attributed to Confucius. It might be apocryphal because people attribute a lot of quotes to Confucius. But it’s, “Because the newer treatments are good, it does not follow that the old ones were bad. For if our worshipful and honorable ancestors had not recovered from their ailments, you and I would not be here today.” But they are really nice, and to have some new treatments and be able to talk about these with our patients has changed the game. I think this is the beginning of a new era in atopic dermatitis. We can now promise things and deliver in a way that we’ve never been able to before. I’m really excited about this, and also excited to see where it’s going.

 I would add that the patients who present to our office who are most undertreated are still those moderate patients. I would say my pearl would be looking, as we’ve all said today, at the patient holistically, not just the BSA [body surface area] of that patient on one day and time but considering other factors like the impact of itch. Sometimes I look at something called the BSA of itch, where you’re saying, “Your skin disease is 5% today, but where are you itchy? How is this impacting your life?” The moderate patients are as impacted quality of life-wise by their disease as our severe patients, if you look at the studies. So, make sure you are presenting your options.

I like what Aaron said, even when you have a mild patient in the office, I often say, “You look good today, but I want to show you the runway, which is very different than it was 5 or 10 years ago. If your disease control is to change, if your satisfaction about your treatment or something about your life is to change, if your disease is to change in some ways, I want you to know that other treatments exist.” Because for so many years for these patients, they didn’t. Still, I think there’s lack of awareness of our advanced therapies for atopic dermatitis. It’s capturing the moderate patients, it’s getting all of our patients to higher levels of disease control. I agree with Peter, I feel so lucky to take care of these patients in the year 2023, and I think we’ll only feel that amplified in the years to come.

This has been a fantastic discussion. I think we’ve all learned from each other. I want to thank each of you for this informative discussion. And I want to thank you all for watching this 

. If you’ve enjoyed the content, please subscribe to our e-newsletters to receive upcoming peer exchanges and other great content right in your inbox. Thanks so much.

Experts in dermatology share practice pearls and takeaways for treatment of atopic dermatitis.

Pearls for Atopic Dermatitis Management

Aaron, I’m going to come back to you. We have all these wonderful tools, but we know if the patient doesn’t do what we’re hoping they’re going to do, that turns out to be a problem. What do you find, how do you assess that, how do you keep them on track?

Patient adherence is critical in this disease, and there are good data already out there, most recently one paper looking at insurance claim data as well as diagnosis between 2017 and 2019. We recognized that topicals are still the most commonly used treatment. They didn’t dive in exactly into which topicals, but we know that when you get to greater levels of efficacy and you move into the biologics as well as the JAK inhibitors, you’re going to have improved adherence because you’re also going to have better efficacy. It is difficult with these patients with the overall mindset of “I’m better.” As Peter was saying, when do we stop these treatments and these therapies? It almost doesn’t matter what we have to say, it’s what the patients are going to do.

As we get new treatments that work really quickly, I’ve seen some patients adjusting the way they are utilizing these therapies. It’s our job to educate our colleagues, as well as our patients, that this is a lifelong disease, although hopefully not. There is some question about disease modification that’s getting even more exciting, but we don’t have time to discuss that today. Adherence is of course of the utmost importance and making sure this fits into the patient’s daily life.

Ali, do you have any special tricks or tips you use to make sure the patient stays on task?

 I find my [patient] visits in atopic dermatitis sometimes are opposite to those in psoriasis because a lot of the patients with atopic dermatitis are less familiar with the chronic and systemic nature of their disease. Atopic dermatitis is a chronic, and for most patients, a lifelong systemic, inflammatory disease. The conversation about long-term control, and in some cases the need for systemic control-long term, becomes easier when they understand their disease as inflammation that’s going on underneath the surface even when they feel better. When they can accept it as a systemic condition, just like we understand many ailments in medicine, that conversation about systemics—like if you stop insulin in a diabetic, your diabetes would still be there–it becomes easier to understand.

I always say, “Let’s get you clear and then we’ll reassess.” That needle might move, and that’s due to some of the exciting things coming through the pipeline. But for now, setting them up to say, “This is a great time to have atopic dermatitis. For the first time, I can offer you something safe for you to stay on long term that is going to get you to a better level of control.” It was not something we could say before. It’s made that conversation much easier.

 That’s an important point. Patients present to us in a variety of different ways. I’m finding now some obviously are presenting 

, new with disease, and so we’re able to get these better treatments to them earlier. Sometimes the discussion is easier with a patient who has had atopic dermatitis for 10 years, and for whatever reason they weren’t offered or maybe they didn’t consider some of these other more advanced treatments. It’s sort of a different discussion with each of these patients.

 It’s a disease state re-education. A point that Matt brought up, which I completely agree with, is that flare anticipation. It’s not only the parents feeling desperate that they can’t manage their child’s atopic dermatitis, it’s that adult patient saying, “Why can’t I get this under control? Why can’t I just be clear for a while?” It’s saying, “because it’s out of your control. This is completely not dictated by that allergy you’re trying to find, but because it’s a systemic disease.” Once that acceptance happens, I feel like the conversation becomes easier. That dominates a lot of my initial visit time and is why I run behind all the time.

Expert dermatologists discuss treatment discontinuation as a barrier to achieving desired outcomes in atopic dermatitis.

Patient Adherence in Atopic Dermatitis

Aaron, we have some other players now in the biologic realm. We have tralokinumab, which has been already FDA approved, and we have lebrikizumab, which is soon to be FDA approved. Can you comment a bit on what we expect from these?

 As we all talked about, it’s a great time to have atopic dermatitis because we’re going to have more treatments coming down the pipeline. So lebrikizumab, which we’re not going to talk about in depth today just because it’s still being studied, and there are even a few more beyond that. But we cannot forget about tralokinumab, another very important first-line agent. It is an IL-13 [interleukin-13 inhibitor]. Again, when you look at the studies, it’s very efficacious, very safe. The important key part here is that not every drug is going to work for every patient, and so it is important to have these different options. As Matt has already discussed, dupilumab works great, but there are some adverse events. When those happen, what are we going to do? I need other options, and that’s where tralokinumab comes in. It’s another great option to have for us in treating these patients.

Do you feel or are there data to show that if somebody doesn’t reach where they need to be or has an issue with dupilumab, that we shouldn’t consider something that is potentially an IL-13, or is that a viable option?

 That’s a very important point. Obviously, these are different drugs, and they bind differently as well, even on the same molecules. It is important to recognize that if you do switch, you may get different efficacy. It’s not to say one is superior or inferior, it’s just that people are different, their diseases are different, and we need different treatment options. Another thing that Matt had mentioned is EASI-75 [75% reduction in the Eczema Area and Severity Index], and what about those higher numbers like EASI-90? Getting full clearance, I know we haven’t talked about it, but that really is our goal. That’s really what I want for our patients. I want an IGA [Investigator’s Global Assessment score] of 0.

I want it to be completely clear, not almost completely clear, but completely clear. Because not just in the eczema disease state but other disease states, what have we learned, what have we recognized? Sure, if you get them 75% clear, it’s going to have a huge impact on their life. You can have even more of an impact when you get them to 90%, or the holy grail, get them completely clear. As somebody with very significant allergies myself, you start to just live with these symptoms. You think, well, this is maybe as good as it’s going to get. Matt, I came into your office, I’m OK, I’m doing all right. But wait, I can get even more clear? I didn’t even realize how great that would feel. I can actually breathe now. So really pushing the next line of treatments, including utilizing a variety of the ones that we have now, sometimes even in combination, is very important.

I want to give a realistic illustration of the difference between an EASI-75 and an EASI-90. One of the ways I like to explain it is, when you’re bad, as a moderate to severe patient, you can’t go to Macy’s and try on clothes. Because if you try on that white blouse, you’re going to bleed through and then you’re going to have to buy it because you bled on it. So you think about the fact that I can’t go do an activity that I would love to do. When you get to EASI-75, I can now go and try on clothes. I’m not going to bleed on them. I’m going to be able to go in the dressing room and be OK. But you get to an EASI-90, I can now put on a bathing suit and go out to the pool or the beach and nobody’s going to look at me funny and wonder what’s wrong with me.

 There was a series of about 28 patients from a European center who either had an inadequate response or an adverse effect from dupilumab and got transitioned to tralokinumab. If you did not respond adequately to dupilumab, there was a 50-50 chance you would respond adequately to tralokinumab. Now on the other hand, the red face that we sometimes see with dupilumab, that pretty much went away in everybody when they switched onto tralokinumab. The conjunctivitis, again, was kind of 50-50.

We need those data. We keep encouraging them to please show us, tease out those data of patients who are in one similar category to the next.

Aaron S. Farberg, MD, comments on use of different treatments for atopic dermatitis when a patient does not respond to treatment.

Peter A. Lio, MD, Northwestern University Feinberg School of Medicine

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