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Laura is the vice president of content for 

) and all its brands, including Population Health, Equity & Outcomes; Evidence-Based Oncology™; and The Center for Biosimilars

She has an MA in business and economic reporting from New York University. You can connect with Laura on 

Articles

During the Reshaping Rx: Navigating 2025 Drug Pricing Policies webinar, panelists discussed the Most Favored Nation executive order, bills aimed at pharmacy benefit managers (PBMs), and other drug pricing policies.

The Future of Drug Pricing: Most Favored Nation, PBMs, and Patient Access

Skylar is an associate editor for The American Journal of Managed Care® (AJMC®) and The Center for Biosimilars®, and joined AJMC® in 2020. She is responsible for covering all aspects of the ever-changing global biosimilar industry and produces content that is accessible and informative for all health care stakeholders.

She has a BA in journalism and media studies from Rutgers University. You can connect with Skylar on 

The Trump administration's policies reshape global health dynamics, presenting Europe with both challenges and opportunities for leadership in health governance.

Trump’s Global Health Pullback Creates Leadership Opportunity for Europe

. Her work focuses on disparities and systemic inequities in care and access to the health system, as well as the impacts of health policy on various racial, gendered, and socioeconomic communities. She seeks perspectives from experts in internal medicine, health equity, community outreach, clinical research, mental health, and legislative policy.

, she delved into rare disease coverage at HCPLive

, a sister publication, where she fostered connections that extended beyond the research community into that of health advocacy, paving the way to her current role. Her work has been featured in 

NewsBreak, CHEST Today, Contemporary Pediatrics, Contemporary OB/GYN, Dermatology Times, Drug Topics, Managed Healthcare Executive, RamaOnHealthcare, and CGTLive.

Long-term exposure to water contaminants, even below the regulatory limits, significantly increases the risk of chronic kidney disease.

Drinking Water Contaminants Linked to Higher Chronic Kidney Disease Risk

Cameron Santoro is an associate editor for 

), AJMC.com, and The Center for Biosimilars

Air pollution exposure, both before and after birth, significantly escalates the risk of respiratory infections in children.

Elevated Respiratory Infection Risk in Pediatric Populations Associated With Ambient Air Pollution

The American Journal of Managed Care provides insights into the latest news and research in managed care across multimedia platforms.

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Early intervention is essential in treating hidradenitis suppurativa (HS) due to its progressive nature and potential for severe physical and psychological impact. HS, a chronic inflammatory skin condition, often begins with painful nodules that can worsen without timely treatment, leading to abscesses, scarring, and sinus tract formation. 

In this episode, Jerry Bagel, MD, Schweiger Dermatology, explains why delaying intervention increases the risk of complications and decreases the effectiveness of available therapies, making symptoms harder to manage over time. Updated guideline recommendations encouraging early intervention can help slow disease progression, alleviate pain, and improve quality of life. 

Listen above or on one of these podcast services:

Prompt care supports mental well-being, as hidradenitis suppurativa is often associated with depression and anxiety due to its physical and social challenges.

Breaking the Cycle: The Importance of Early Intervention in Hidradenitis Suppurativa

Many patients value conversations with their rheumatologists and oncologists more than just reading information from a website.

Patients With RA and Cancer Seek More Clarity, Collaboration in Treatment Decisions

The lifestyle intervention included a whole-food plant-based diet, exercise, sleep, and stress management components.

Plant-Based Diet May Improve Stress-Related Metrics in Rheumatoid Arthritis

High infection rates among younger adults suggest they either delay routine dental care and only seek treatment when conditions become severe, or face more barriers.

Dental Infections Pose Risks for Hospitalized Patients With Rheumatoid Arthritis

Researchers called for standardized health outcome descriptors to help bridge communication gaps in rheumatology care and improve shared decision-making.

Patient Materials for Rheumatoid Arthritis Often Miss Crucial Information

Osteoarthritis leads the burden, projected to affect 50% of postmenopausal women by 2045.

Musculoskeletal Disorders in Postmenopausal Women Are Rising Worldwide

 Jeffrey Stark, MD, vice president, head of medical immunology, UCB.

Jeffrey Stark, MD, vice president, head of medical immunology, UCB, highlighted the additional evidence being generated on bimekizumab-bkzx (Bimzelx; UCB) through ongoing clinical trials, real-world data projects, and pediatric studies.


Stark hinted at exploring bimekizumab-bkzx's potential in other IL-17–driven autoimmune and autoinflammatory diseases. He also discussed addressing unmet needs through significant research and development investment, underscoring an exciting pipeline of therapies for conditions like lupus and atopic dermatitis.


This transcript has been lightly edited; captions were auto-generated.

Is bimekizumab-bkzx (Bimzelx) being investigated for other indications that you can discuss at this time?

That's a great question. We actually have quite a lot going on in terms of additional evidence generation for Bimzelx. Some of that is through the continuation of the clinical trial programs, and so those are continuing. For example, this year we will see 3-year data in the rheumatology indications of psoriatic arthritis and axial spondyloarthritis, and 5-year data for psoriasis. It is exciting to be able to share the very long-term efficacy and safety profile of the drug, but we recognize that clinical trials don't answer all of the questions of the community.

The other big effort that is underway in the area of evidence generation for Bimzelx is in developing a body of real-world data. We recognize that in a real-world setting, there are complexities that don't happen in a clinical trial, but those complexities reflect more the experience that a real patient in a real clinic has, and so those data are important. We've launched a number of projects, both outside of the US and within the US, that are helping to generate some of that real-world data about Bimzelx.

Now to get to your final question, we are committed to pediatric programs, and some of those are getting underway as we speak. We recognize that these diseases that we've been talking about don't only occur in adults; they occur in pediatric patients as well. Developing a body of data that speaks to that need is important also, and those studies are underway.

Then, perhaps, I'll just hint at the fact that IL-17 is an important driver of inflammation in many autoimmune and autoinflammatory diseases. Those certainly extend beyond the five indications that Bimzelx has today. While I'm not free to share details just yet, we are very actively exploring a number of those conditions and thinking about if there is potential in those other disease states that are driven by IL-17A and [IL-17]F for a medication like bimekizumab to provide value.

What are some approaches to addressing unmet patient needs, and what can we expect from research and development efforts in the future?

I think just to say that UCB is really committed to unmasking need and meeting that in a way that's novel. For some years now, UCB has invested very heavily in research and development, putting back a very large percentage, actually a unique percentage of revenue, into research and development.

I think it's very exciting to see that investment over many years prior beginning to yield fruit. UCB has an exciting pipeline that extends beyond Bimzelx to medications that are targeting other disease states, like systemic lupus, for example, like atopic dermatitis, areas where we still perceive unmet need, and the opportunity to bring new solutions.

Just another topic on which I would say, stay tuned, because that pipeline and that investment in research and development over years, I am looking forward to it continuing to bear fruit for the patients who need those solutions.

Videos

Jeffrey Stark, MD, vice president, head of medical immunology, UCB, discusses ongoing clinical trials and the development of real-world data to understand the effectiveness of bimekizumab-bkzx in a broader context.

Real-World Data and Ongoing Research Into Bimekizumab-bkzx

Jeffrey Stark, MD, vice president and head of medical immunology at UCB.

Jeffrey Stark, MD, vice president and head of medical immunology at UCB, discusses the Bimzelx Navigate program and several of its key components such as the Bimzelx Navigate bridge, the copay assistance program, the nurse navigator program, and the digital patient portal.


Stark emphasizes that the program aims to empower patients and address their diverse needs beyond simply providing the medication. He expresses satisfaction with the positive feedback received, particularly regarding the nurse navigator program.


Can you tell us more about Bimzelx Navigate and how it helps ensure that patients can access and afford their prescribed treatment? What feedback have you received from users of this program?

We recognized that to meet the needs of patients, it's necessary not only to bring a therapy to market and market that therapy to the community, but also to meet the more holistic needs that patients may have. That was really the idea behind the Bimzelx Navigate program. It is a comprehensive and holistic patient support program that has several components that are important to it.

One of those is the Bimzelx Navigate bridge, and this means that patients who are either commercially insured but whose prescription may be delayed for some reason [or patients who experience] difficulty in achieving insurance coverage, for example,

those patients can receive Bimzelx [bimekizumab-bkzx]
at $15 per dose for up to 2 years or until their commercial coverage is approved, whichever comes first. That's an important aspect of the program that allows patients to proceed with their therapy when they and their treating provider feel like they need it, and surmount some of those barriers that they may experience.

In addition, once insurance approves Bimzelx, there is a co-pay assistance program so that those commercially insured patients can pay as little as $5 per dose. Recognizing that even in the setting of insurance coverage there are patients who struggle with financial difficulties in affording their medications, this provides patients with additional support that they may need.

One of the parts, though, that I think I'm very excited about with the Navigate program is actually the nurse navigator program, which provides patients with a single point of contact to help them with a diverse body of needs that they may have. This nurse navigator is not someone who provides medical advice. In fact, those questions are always deferred right back to the treating provider who is the appropriate person to make those decisions. But if the patient has questions about insurance coverage, the status of seeking coverage for their medication, injection training, financial assistance, even just talking through things and offering the emotional support that that patient may need in the moment, this is something that those nurse navigators are able to provide. We've been really happy to see that going well and to hear positive stories of that from the nurse navigator program.

Then finally, as part of the Bimzelx Navigate program, there is a digital patient portal as well, which offers a variety of support tools, resources, educational resources, for example; medication dosing reminders; the ability of the patient to track their medication shipment, etc. It's really about meeting the needs of the patient and also putting them in the driver's seat when it comes to their therapy.

Jeffrey Stark, MD, vice president and head of medical immunology at UCB, analyzes the Bimzelx Navigate program, a comprehensive support system developed to empower patients prescribed bimekizumab-bkzx (Bimzelx; UCB). 


Enhancing Patient Access Through Navigation Assistance

How Nipocalimab Targets Unmet Needs in Autoimmune Care

To conclude our discussion with Katie Abouzahr, MD, vice president, Autoantibody Diseases, and Maternal-Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine, we learn of nipocalimab’s potential associated risks and how the neonatal Fc receptor blocker addresses treatment gaps for patients living with 

You can also revisit these earlier interview segments:

Understanding gMG: Autoantibodies and Life-Altering Muscle Weakness

How FcRn Blockade Targets Myasthenia Gravis Autoantibodies

Nipocalimab’s Promising Potential in Advancing gMG Care

What potential risks and adverse effects are associated with nipocalimab?

In the Vivacity phase 3 study [NCT04951622], nipocalimab safety and tolerability were consistent with our other nipocalimab studies. And we saw in the phase 3 registrational study of nipocalimab in generalized myasthenia gravis that the overall incidence of adverse events, serious adverse events, and adverse events leading to discontinuation were similar to that in the placebo-plus-standard-of-care group. So we are excited about what this means for patients in terms of benefit-risk in this disease.

What treatment gaps currently exist for adult patients, and how might this approval them?

Potentially if approved, we think that we're looking at addressing some of the unmet need in this space. It's essentially our guiding principle as to how we think about what diseases we go into and how we design our studies. I think some areas that are really important to patients are, 

, being able to have sustained, predictable, uninterrupted disease control. That's why we designed the Vivacity study with a primary end point week 22 to 24, so through looking at 6 months of sustained efficacy that's uninterrupted. We think that's an area of unmet need, and we think it's really important to patients.

The other area that we think is sort of an area of unmet need is being able to potentially offer treatment to patients in a broad population—so broad antibody-positive patients, AChR [acetylcholine receptor], MuSK [muscle specific kinase], LRP4 [lipoprotein receptor–related protein 4]—and then, of course, we have also shared data 

, 12 to 17 years old. Again, I think that's an area of unmet need where we're looking for approvals of some advanced therapies in this space and where we have publicly shared some of our data in that population.

We go where the actionable science is, where the unmet need is. Nipocalimab is actually being developed across 3 segments of autoantibody-driven diseases. So we've talked about myasthenia gravis, which is a sort of directly autoantibody-driven 

. And in that segment, we're so excited about data in generalized myasthenia gravis.

We're excited about the maternal-fetal segment of development for nipocalimab. As I mentioned earlier, one of the mechanisms of action of FcRn blockade with nipocalimab is that it prevents passage of IgG [immunoglobulin G], including in some of these alloimmune diseases of pregnancy, pathogenic IgG from mom to baby. We were so excited to receive breakthrough designation for our phase 2 data in hemolytic disease of the fetus and newborn.

And then the third segment is in the rheumatic space where, again, we're really excited to have been the only therapy to receive breakthrough designation for our phase 2 data in Sjogren disease and where we're excited to have gone forward with a phase 3 program based on robust phase 2 data.

In part 4 of our interview, we learn more about nipocalimab’s safety profile and how this investigative agent might address unmet needs for patients with generalized myasthenia gravis.

Jeff Stark, MD, vice president, head of medical immunology, UCB.

Jeffrey Stark, MD, vice president and head of medical immunology at UCB, explained dosing bimekizumab-bkzx (Bimzelx) is tailored to the specific inflammatory condition being treated. He suggested lower doses are recommended for certain arthritic conditions based on dose-finding studies, and higher doses are recommended for 

Stark highlighted his excitement toward the drug's 5 FDA approvals in a year but acknowledges the challenges that remain in expanding access, including navigating a crowded market, educating about lesser-known conditions, and explaining its novel dual IL-17A/F inhibition mechanism.

This transcript has been lightly edited; captions are auto generated.

Can you explain why a lower dose of bimekizumab-bkzx (Bimzelx) is recommended for psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis?

Absolutely, when we study these diseases, we study them individually for a reason. We recognize that the aberrations going on with a patient's immune system may vary from one disease state to another. As we do these clinical trials, not in the phase 3 studies that look at a larger number of patients, but in the earlier phases of those studies, we do what are called "dose-finding" or "dose-ranging" studies.

In those earlier studies, we look at a variety of doses and look not only at how well they work with the efficacy of those doses but what the safety profile of those doses is for the particular disease states. By studying these disease states individually, the most appropriate dose for an individual disease state may vary from one condition to another. In general, we try and choose, from those dose-finding studies, the lowest dose that provides the most efficacy and the best safety profile.

For the conditions you mentioned, like psoriatic arthritis and axial spondyloarthritis, 160 mg doses were the doses that emerged from those earlier studies. We did see that larger doses of 320 mg were helpful for patients with psoriasis, patients with hidradenitis suppurativa, as well as patients with PsA [psoriatic arthritis] who might also have moderate to severe plaque psoriasis as well.

With 5 FDA-approved indications for Bimzelx in just over a year, what has been the most significant challenge in expanding access to this treatment across different inflammatory conditions?

That was an exciting little more than a year. It's not often that a single drug will receive 5 indications and a new dosing device, all in the course of a year. It's a very busy and exciting year, but exciting in the sense that we were thrilled to be able to bring Bimzelx to market as a new option for patients with these inflammatory diseases. There have been challenges associated with that, most certainly. I think all of your listeners will recognize that the biologic marketplace for these diseases, especially for conditions like psoriasis, is very crowded. Bimzelx is the 13th biologic to come to market in that space.

We also recognize that for other disease states that are maybe a little less well known. For example, hidradenitis suppurativa, there's not only the bringing the medication to market, but there's a burden of needing to educate along with that and to raise awareness of diagnostic delays, patient unmet needs, and helping the community understand the burden of disease as well as appreciate the value that Bimzelx may bring to those patients as a potential therapy.

Finally, bringing a medication with a novel mechanism of action to market is another task that has to be taken head on. Bimzelx is the first inhibitor of both IL-17A and IL-17F.

Along with bringing that therapy to patients and to the medical community, there has certainly been a need to educate about the immunology of disease, the role that IL-17F plays, even insights, for example, that IL-17F is over expressed compared with IL-17A in some disease states, like psoriasis and HS [hidradenitis suppurativa].

All of that has been a challenge, but I will say a fun challenge in that, ultimately, at the end of the day, it serves the need of bringing new treatments to patients who need them.

Jeffrey Stark, MD, vice president and head of medical immunology at UCB, discusses tailored dosing of bimekizumab-bkzx (Bimzelx) for various inflammatory conditions, highlighting its 5 FDA approvals and the remaining challenges.

Approvals Launches

Bimekizumab-bkzx Expands Treatment Options for Inflammatory Conditions

Interview with Amit Garg, MD, Northwell Health

Long-Term Bimekizumab Data Offer New Hope for HS Management

Speaking to the data that support UCB’s supplemental biologics license application for bimekuzimab (Bimzelyx) for the drug’s approval in moderate to severe hidradenitis suppurativa (HS), Amit Garg, MD, founding chair, Department of Dermatology, Northwell Health, stated, “These are patients that get their lives back, and that's a truly remarkable outcome...We don't get to say that often to patients.”

In part 2 of our interview with Garg, who is also senior vice president for the Dermatology Service line at Northwell Health and professor, Center for Health Innovations and Outcomes Research, Feinstein Institutes for Medical Research, at Northwell Health, he discusses the dual interleukin-17A and 17F inhibitor’s potential to dramatically change outcomes for patients.

The interview has been edited for clarity.

UCB submitted a supplemental biologics license application for bimekuzimab (Bimzelyx) to the FDA in April for the drug’s approval in moderate to severe hidradenitis suppurativa (HS).


Immunology

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