TEV ‘749 Survey Shows Many Nurses Prefer Intramuscular Injections, with Andrew Cutler, MD

Teva Pharmaceuticals announced new TEV- ‘749 data on March 31, 2025, finding that more than 90% of patients, 87% of nurses, and 73% of physicians reported satisfaction about the initiation regimen, monthly dosing schedule, and dosing options of this once-monthly subcutaneous olanzapine long-acting injectable (LAI) for schizophrenia.

The survey was conducted via the phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS), an 8-week, randomized (1:1:1), double-blind, placebo-controlled trial evaluating TEV- ‘749. These findings followed other promising SOLARIS data, including the statistically significant mean differences in the Positive and Negative Syndrome Scale (PANSS) total score from baseline, as well as the improvements in social functioning and quality of life.

HCPLive spoke with SOLARIS investigator Andrew J. Cutler, MD, clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer at Neuroscience Education Institute, about Teva’s prospective, cross-sectional, observational, online study completed by 70 patients, 11 physicians, and 24 nurses who reported their attitudes on and experiences with LAI treatment, delivery of care, and treatment satisfaction. Cutler discussed the drivers behind the 

, unexpected findings, and what are the next steps for advancing TEV- ‘749 toward regulatory approval.

“One of the things that was a little surprising was there were some of the doctors and some of the nurses who actually didn't prefer subcutaneous—they felt more comfortable with an intramuscular injection,” Cutler said. “Some of that is simply their familiarity with intramuscular. They trust it. They know it can work, and they maybe haven't quite yet had enough experience with a subcutaneous delivery to trust it and to feel it was going to be as effective.”

The survey revealed 50% and 45.5% of nurses and physicians preferred intramuscular injections, respectively, opposed to most patients preferring a subcutaneous injection (78.6%).

Cutler explained how certain patient populations may benefit the most from TEV- ‘749, including those who do not adhere to their current treatments. Often, LAIs are not offered to patients until later in their treatment regimen, after they have had multiple relapses. However, as Cutler said, frequent relapses damage the brain and decrease function; Cutler suggests offering these patients LAIs after failing to adhere to 1 or 2 oral medications.

He said the steps for research is studying long-term safety in a certain number of patients to prove TEV- ‘749 is not associated with a risk of Post-Injection Delirium/Sedation Syndrome (PDSS). Cutler added that, until the discovery of new mechanisms of action, the most effective way to maximize an anti-psychotic class’s potential is to use an LAI.

“Sometimes you haven't seen the magic of an LAI until you've seen a consistent therapeutic blood level over time, and the really best way—maybe only way to deliver that—is through a long-acting injection,” Cutler said. “I think we have a lot of work to do on convincing clinicians of the value of LAIs to and overcome some of the barriers to LAI usage, which can include all kinds of things like the formulation, the initiation regimen… [and] some systemic issues.”

New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable. Teva. March 31, 2025. 

https://www.tevausa.com/news-and-media/press-releases/new-data-strengthens-tevas-schizophrenia-portfolio-including-phase-3-solaris-trial-survey-results-demon/

Derman, C. Phase 3 Data Shows TEV-‘749 Injection Improves Social Function in Schizophrenia. HCPLive. November 6, 2024. 

https://www.hcplive.com/view/phase-3-data-shows-tev--749-injection-improves-social-function-in-schizophrenia

Derman, C. TEV- ‘749 Once-Monthly LAI Yields High Satisfaction in Phase 3 Trial, with Andrew J. Cutler, MD. HCPLive. April 21, 2025. 

https://www.hcplive.com/view/tev--749-once-monthly-lai-yields-high-satisfaction-in-phase-3-trial-with-andrew-j-cutler-md

Teva Pharmaceuticals' TEV-‘749, a once-monthly subcutaneous olanzapine long-acting injectable (LAI) for schizophrenia, demonstrated high satisfaction among patients, nurses, and physicians in the phase 3 SOLARIS trial. Despite some healthcare professionals' preference for intramuscular injections, patients favored subcutaneous delivery. The study highlighted the potential benefits of LAIs for patients with adherence issues, suggesting earlier intervention could prevent relapses. Future research will focus on long-term safety and addressing barriers to LAI adoption, emphasizing the importance of consistent therapeutic blood levels for maximizing antipsychotic efficacy.

Cutler told HCPLive it was surprising that a new survey on subcutaneous TEV- ‘749 revealed 50% and 45.5% of nurses and physicians, respectively, preferred intramuscular injections.


Andrew Cutler, MD

How Pollen Food Allergy Syndrome Contributes to EoE, with Antonella Cianferoni, MD, PhD

Antonella Cianferoni, MD, PhD, from Children’s Hospital of Philadelphia, told 

 that ≥ 90% of cases of eosinophilic esophagitis (EoE) are linked to allergic rhinitis, often triggered by pollen

 As a result, patients with EoE face a high risk of developing pollen food allergy syndrome.

“If you have any eosinophilic esophagitis that is not controlled…foods that cause the pollen Food Allergy syndrome can cause an acute reaction in your esophagitis,” Cianferoni said.

Along with an itchy mouth and swollen lips, patients may experience reflux symptoms or a constriction in their chest. This chest restriction symptom appears to be more frequent in adults but rarer in children.

“What is not completely clear is if these food[s] related with the pollen syndrome can really cause the eosinophilic esophagitis [alone],” Cianferoni said.

Cianferoni presented “Pollen Food Allergy Syndrome (PFAS) in Immunoglobulin E (IgE) and Non-IgE Mediated Food Allergies” at the 

2025 American Academy of Allergy, Asthma, & Immunology (AAAAI)

 annual meeting in San Diego on Friday, February 28. Her presentation covered the 

molecular diagnosis of pollen food allergy syndrome

, the management of pollen food allergy syndrome in IgE-mediated food allergies, and the role of pollen food allergy syndrome in EoE. 

 sat down with Cianferoni at the meeting to discuss these subject matters.

Pollen food allergy syndrome cases have increased in the past 10 – 20 years. Although this is a mild form of food allergy, Cianferoni said the syndrome can sometimes, although rarely, lead to a more severe reaction. Patients may need to carry epinephrine and strictly avoid foods.

For the management of pollen food allergy syndrome, Cianferoni said the options are either avoiding or cooking vegetables or fruits. Pollen immunotherapy, either injectable or sublingual, could be another treatment option but needs further exploration.

Some studies have shown pollen immunotherapy could be effective for pollen food allergy syndrome, but some studies showed the opposite. Cianferoni said it is recommended to give a patient pollen immunotherapy only if it targets the allergic rhinitis. By treating the allergic rhinitis, it may, in the long run, treat the pollen-associated food allergy.

“But [with] pollen allergy in the respiratory tract, it's more debatable if doing immunotherapy with the pollen can really treat the pollen allergy syndrome,” Cianferoni said.

Nowak-Wegrzyn A and Cianferoni A. 1502 - Pollen Food Allergy Syndrome (PFAS) in Immunoglobulin E (IgE) and Non-IgE Mediated Food Allergies. Presented at AAAI 2025 in San Diego on February 28 at 11:30 am.

Derman, C. Pollen Food Allergy Syndrome vs Other Allergies, with Antonella Cianferoni, MD, PhD. HCPLive. March 10, 2025. 

https://www.hcplive.com/view/pollen-food-allergy-syndrome-vs-other-allergies-with-antonella-cianferoni-md-phd

Cianferoni discusses how pollen food allergy syndrome contributes to eosinophilic esophagitis (EoE) and potential management strategies.

Antonella Cianferoni, MD, PhD

Benjamin Gold, MD, is a staff physician of pediatric gastroenterology at Children's Healthcare of Atlanta and a pediatric gastroenterologist and partner of GI Care for Kids.

Social Determinants of Health in Eosinophilic Esophagitis, with Benjamin Gold, MD

New research is shedding light on the growing clinical burden of 

, highlighting longstanding disparities in diagnosis and care driven by social determinants of health.

Findings from the retrospective, longitudinal cohort study of US health insurance claims data were presented at Digestive Disease Week (DDW) 2025 by Benjamin Gold, MD, a staff physician of pediatric gastroenterology at Children's Healthcare of Atlanta and a pediatric gastroenterologist and partner of GI Care for Kids.

, Gold describes increases in EoE incidence and prevalence across all age groups, with a significant burden on patients ranging from social limitations in children to frequent healthcare utilization and missed work in adults. He notes diagnosis remains dependent on endoscopy with biopsy, contributing to this burden. He also describes how appropriate testing is not done in all patient populations, contributing to misconceptions about who is truly affected by EoE, which is widely regarded as a disease that only affects White males.

“In order to understand what social determinants of health are and their impact, you need to look at large populations,” Gold explained, describing the 2 large databases retrospectively examined in this research. “It was able to look at two large different types of populations that had definitive EoE and then look at where they came from and what might be barriers in order for them to get care.”

Looking ahead, Gold says future research should focus on populations that may not have access to health care, may not have the literacy, but may also have an incredible burden of EoE.

“I can't tell you how many African American children I see who have horrible eczema, horrible asthma, and never get to the gastroenterologist because nobody asks them about GI symptoms,” Gold said.

He also describes the importance of defining the natural history of EoE, suggesting that enrolling clinical trials be used for follow up to help address this gap in knowledge. Gold additionally calls attention to the importance of expanding education and outreach in underrepresented communities, breaking down structural barriers to care, and conducting more inclusive research to understand how EoE may manifest differently across racial and ethnic groups.

Gold BD, Jensen ET, Goodwin B, et al. DEMOGRAPHICS AND SOCIAL DETERMINANTS OF HEALTH FOR PATIENTS WITH EOSINOPHILIC ESOPHAGITIS: A RETROSPECTIVE COHORT STUDY OF US HEALTH INSURANCE CLAIMS DATA. Abstract presented at Digestive Disease Week 2025 in San Diego, CA, from May 3 - May 6, 2025.

Gold explains misconceptions about who is affected by EoE and describes the importance of understanding the impact of SDoH in this patient population.

Disparities in Eosinophilic Esophagitis Diagnosis and Care, with Benjamin Gold, MD

Benjamin Gold, MD

Eric Lawitz, MD, is the medical director of the Texas Liver Institute and a clinical professor of medicine at the University of Texas Health San Antonio.

Trivedi and Lawitz review long-term data from the phase 3 open-label ASSURE study and explain what they add to our understanding of seladelpar for PBC.

Insights from Long-Term ASSURE Data for Seladelpar

 treatment landscape has long been limited to just a handful of agents with limited efficacy, 2024 saw a major shift in PBC management with the addition of 2 new second-line therapies.

Seladelpar (Livdelzi), a proliferator-activated receptor (PPAR) delta agonist, was one of these recent additions to the PBC treatment armamentarium and was a major topic of discussion at 

The Liver Meeting 2024 from the American Association for the Study of Liver Diseases (AASLD)

Findings from a 2.5-year interim analysis of the ongoing open-label phase 3 ASSURE study were presented in a late-breaking abstract at the meeting and highlight seladelpar’s sustained efficacy and long-term safety for the treatment of PBC.

In this segment, which is the final installment of a 4-part series, experts Palak Trivedi, MD, PhD, and Eric Lawitz, MD, discuss the long-term ASSURE data and what they add to our understanding of seladelpar’s safety and efficacy for PBC.

Trivedi begins by emphasizing the significance of seladelpar’s long-term safety profile, calling attention to the lack of new treatment-emergent adverse events or concerning safety signals. While acknowledging the inherent limitations of safety extension studies without matched control groups, he describes how the ASSURE data provide confidence in the drug’s sustained biochemical response and tolerability, additionally advocating for real-world studies to validate these findings and establish whether seladelpar improves transplant-free survival over time beyond its biochemical markers.

Similar to Trivedi, Lawitz highlights the importance of long-term follow-up in chronic therapies. He notes that the ASSURE data not only confirm the stability of seladelpar’s safety profile but also reveal a potential increase in efficacy with extended treatment. He notes the consistent durability and lack of unexpected toxicities offer clinicians greater confidence in prescribing seladelpar for prolonged use.

: associate professor and honorary consultant hepatologist and clinical research director for industry engagement at the University of Birmingham

: medical director of the Texas Liver Institute and a clinical professor of medicine at the University of Texas Health San Antonio

Relevant disclosures for Trivedi include Bristol Myers Squibb, Gilead, Intercept, CymbaBay, and others. Relevant disclosures for Lawitz include 89Bio, Boehringer Ingelheim, Merck, Novo Nordisk, Sagimet Biosciences, AstraZeneca, Bristol Myers-Squibb, Cymabay, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Intercept, Ipsen, Madrigal, Novartis, Regeneron, Takeda, Terns, Viking Therapeutics, AbbVie, and others.

Brooks A. FDA Grants Accelerated Approval to Seladelpar (Livdelzi) for Primary Biliary Cholangitis. HCPLive. August 14, 2024. Accessed December 4, 2024. 

https://www.hcplive.com/view/fda-grants-accelerated-approval-to-seladelpar-livdelzi-for-primary-biliary-cholangitis

Brooks A. Seladelpar (Livdelzi) Demonstrates Long-Term Benefit for Primary Biliary Cholangitis. HCpLive. November 15, 2024. Accessed December 4, 2024. 

https://www.hcplive.com/view/seladelpar-livdelzi-demonstrates-long-term-benefit-primary-biliary-cholangitis

The treatment landscape for primary biliary cholangitis (PBC) has evolved with the introduction of new second-line therapies, including seladelpar, a PPAR delta agonist. At The Liver Meeting 2024, findings from the ASSURE study highlighted seladelpar's sustained efficacy and long-term safety. Experts Palak Trivedi and Eric Lawitz emphasized the drug's stable safety profile and potential increased efficacy over time. They advocated for real-world studies to further validate these findings and assess seladelpar's impact on transplant-free survival beyond biochemical markers.

Eric Lawitz, MD

Nearly half of all adults in the United States are living with hypertension, or blood pressure above 130/80 mmHg. Despite its prevalence, managing high blood pressure 

remains a major challenge in healthcare settings

Hypertension management can be challenging for a number of reasons, explains Benjamin Gallagher, MD, a hypertension specialist and assistant professor of medicine at Yale School of Medicine (YSM). Aside from difficulties patients may have sticking to their recommended medication regimens, clinicians 

 regarding complicated hypertension cases.

For these reasons, Gallagher and his colleagues have been working over the past two years to address this issue by developing a 

 for internal medicine residents at YSM. The curriculum covers advanced topics in hypertension management, including hypertensive urgency, a condition marked by blood pressure over 180/110 mmHg but without damage to vital organs.

Recently, Gallagher, along with Donna Windish, MD, MPH, professor of medicine (general medicine) at YSM, and Natasha Cigarroa, MD, hospital resident at Yale New Haven Hospital, tested how the curriculum impacted residents’ treatment of hypertensive urgency in the outpatient setting. The 

Modifying hypertensive urgency management

The study involved 104 residents who see patients at the New Haven Primary Care Consortium. While all residents received background training on hypertension, only some of them received the hypertensive urgency curriculum, which involved a half-day workshop with lectures and educational materials. Gallagher and his colleagues then compared residents’ notes from appointments with patients diagnosed with hypertensive urgency and measured the frequency of appropriate clinical actions taken by residents from each group. The research team found that the curriculum had a positive impact on residents’ performance: those who received the new curriculum were more likely to increase their patients’ blood pressure medications and/or counsel their patients on medication adherence.

“We were able to show a small but meaningful change in clinicians’ behavior as a result of an educational intervention,” Gallagher says. “At least for a brief period of time after residents received this curriculum on hypertensive urgency, there was an uptick in appropriate management of that condition.”

Given the high incidence of hypertension and how difficult it is to manage, the curriculum could be a helpful tool not only for residents, but also for highly experienced clinicians, including those who might already feel confident in their hypertension management skills, Gallagher says. In fact, a version of the curriculum is available online through the 

Society of General Internal Medicine’s learning portal, GIMlearn

There were some challenges associated with introducing the specialized curriculum, Gallagher notes. “How do you convince people that they need to learn more about something that they think they already know how to do well—and do that without antagonizing or belittling them and making them feel like they are inexperienced?” Gallagher adds. “A lot of the aspects of the curriculum were about protocolized care, using easy-to-follow protocols and couching it in a way of trying to make things easier for clinicians.”

Hypertension affects nearly half of U.S. adults, posing significant management challenges. To address this, a specialized curriculum for internal medicine residents at Yale School of Medicine was developed, focusing on advanced hypertension management, including hypertensive urgency. A study involving 104 residents demonstrated that those who received the curriculum showed improved management of hypertensive urgency, such as increased medication adjustments and patient counseling. The curriculum, available online, aims to enhance clinicians' skills without undermining their confidence, emphasizing protocolized care to simplify clinical decision-making.

New research tested how specialized hypertennsion medical curriculum impacted residents’ treatment of hypertensive urgency in the outpatient setting.

Hypertensive Urgency: Teaching Improved Care for an Acute Form of High Blood Pressure

Eva Cornman

Let’s talk about the elephant in the room. We’ve been bouncing around it a little. Let’s talk about vaccine hesitancy and how you guys address that in education standpoints as well as how that can impact vaccination compliance or resistance. What’s your language? What’s your methodology around noticing that? Do you notice it? Do people say it to you? Do you feel it? How do you work down that road to try to convince people to get a vaccine?

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP:

 This is my baby. This is my doctoral work, so I love this stuff. A couple of things that I want people to know is that studies are pretty clear these days that even people who are vaccine proponents now feel the need to question science and vaccines. Every provider should expect what used to be a 30-second recommendation to now take 5 minutes because people feel the need to ask the questions about it. Even though they’re going to take it, they feel the need. There’s more vaccine hesitancy out there.

The other thing is that we talked about strong recommendations. We call it presumptive vs participatory. In a study, they followed providers who asked, “How do you feel about getting your shots today?” It shouldn’t surprise you that less than 10% of people took their shots. But when the provider said, “You’re due for 2 shots today. It’s okay to give them together,” 80% of people took those vaccines.

My last point on vaccine hesitancy is that you have to be prepared that people are going to ask about it. Take a deep breath and answer their questions. There are going to be the 4% of the population who are vaccine refusers. I’ve learned from all of my research that you will never move those folks. They believe in something that none of us can even fathom, but they come up with it. If they want to believe something, they’re going to google it and find research to support their beliefs. You’re never going to move them.

It’s the movable middle that we have to focus on. That’s the 20% to 40% of the population who will go based on a trusted source, as JAM [Jacinda Abdul-Mutakabbir, PharmD] mentioned. If they trust you and you make that recommendation, they’ll listen. Focus on the movable middle. The ones who march in and say, “What vaccines do I need? Give them to me,” are a provider’s dream. “Sure, give me everything I need.” With people in the middle, we have to take a breath, meet them where they’re at, be honest with them, give them what they’re asking, and don’t go into too much detail.

 Yes. I’ve also seen people talk about how sometimes it takes more than 1 interaction with a patient to convince them. Maybe they come in and you tell them, “You need this vaccine today,” and they say, “Absolutely not.” But by the end of the appointment, they say, “Tell me more about it and I’ll think about it for next time.” We see this with patients in the clinic with other vaccines as well. “I’m not ready to get 5 vaccines today, but I’ll get 1 next time.” We think, “OK, we’ll take what we can get. Let’s just start off on the right foot.” Sometimes it takes persistence and patience, which we don’t all have at this point in the pandemic. But there are people who can be swayed if we take the time, ask them multiple times, and not give up on them.

 Yes. We use a Z code in our charts for vaccine refusal by patient or parent. That’s a signal to the nurse practitioner who sees them next that there’s been a vaccine that they didn’t get the last time, and to take a look at the note and try to follow up on that conversation.

Wendy Wright, DNP, ANP-BC, FNP-BC, FAANP, FAAN, FNAP, and Madeline King, PharmD, BCIDP, provide insight on vaccine hesitancy among patients and the importance of increasing vaccine uptake to protect against SARS-CoV-2.

Addressing Vaccine Hesitancy and Uptake for SARS-CoV-2

Jacinda Abdul-Mutakabbir, PharmD

John Salgo, MD

We have heard the statistics many times. There are more than 7000 

 and for more than 90%, there are no treatments available. Our organization supports a community affected by one of the 90%—Niemann-Pick Disease including ASMD and NPC, both rare genetic, progressive, and often-fatal lysosomal storage disorders.

There are fewer than 2000 known cases worldwide, many affecting children. Symptoms include cognitive impairment, clumsiness and difficulty walking, enlarged spleen and liver, difficulty swallowing and eating, fatigue, increased fracture risk, and early satiety. There are currently no approved treatment options in the US.

The great news for the Niemann-Pick community is that promising treatments are in the later stages of clinical development with the potential for regulatory approval in the coming year. Achieving this milestone would be a significant victory for patients and their families who face significant challenges living with Niemann-Pick. But this potential good news also highlights an important consideration in planning for the introduction of new treatments for patients who are in desperate need. How do you prepare patients and families to transition from an era of no hope to one where treatment is available?

Much of our work at the National Niemann-Pick Disease Foundation (NNPDF) in recent years has focused on meeting this challenge head on and our approach in many ways serves as a template that other rare disease communities might consider.

From our earliest days, NNPDF has provided support services to patients living with Nieman-Pick Disease and their families. These efforts have focused on building broader awareness of the disease and helping to identify and expand the services and resources that families need.

We have also taken steps to keep families updated about the range of clinical research programs that have been initiated in recent years to try to develop new treatments. Our recent annual conference included a full schedule of presentations and updates on these clinical research programs, and we had more participants in our virtual meeting this year than ever before.

As we continue our focus on disease awareness and patient support, we have also in recent years had to expand our efforts to include both information and education to prepare the Niemann-Pick community to transition to an era when treatment might be available. In addition to helping families learn about and understand the process for developing and approving drugs in the US, we are also now providing resources to help them better understand and manage issues related to their healthcare coverage, reimbursement, patient access and industry-sponsored financial assistance programs.

We are helping them understand that there will be indications and eligibility criteria for different treatments and that NNPDF is working to ensure that access to treatment through healthcare coverage is available to as many patients as possible. We are also developing new resources that outline the important questions and topics that patients and families should discuss with their medical provider to empower them to take a more active role in often complex treatment decisions.

While availability of treatment is good news, many of the issues associated with patient access can cause stress and confusion. An important goal in developing programs related to the introduction of an approved treatment is to help reduce anxiety and outline a clear path forward in accessing care. For many rare disease communities, another daunting but welcome challenge for many families may be the need to reconsider many longstanding plans for the future once approved treatment is available.

In many cases, an approved treatment will mean major changes in how patients think about their own health, plan for their care, and engage with their medical teams. Treatment may present new challenges that require careful planning and monitoring. Patients and caregivers might need to reassess plans related to education, careers, job training, and living independently. Once again, our goal must be to provide the insights and support services that can help reduce any challenges associated with making important life decisions at every stage.

The final focus in supporting patients is often related to helping them manage expectations. In many cases, treatments for rare diseases will have some limitations in areas including efficacy, safety and cost. Advocacy leaders can play a role in helping their communities work with their healthcare teams to assess, understand, and address all the factors related to treatment so that patients and caregivers can make informed decisions.

In some cases, patients and caregivers may need very targeted services to support their psychological and emotional health. Peer-to-peer connections can be especially effective in helping patients handle the emotional impact of the transition to treatment.

Of course, none of these challenges should dampen the new hope that a first approved treatment can bring to a rare disease community. A first treatment is both a milestone and a sign that research is advancing and could lead to more personalized treatment options or combination therapies in the years ahead.

By recognizing the needs of patients and families whenever a new treatment becomes available, advocacy organizations can continue to lead in bringing them the targeted information and support they need to access care and thrive. The key is recognizing that an approved treatment and a new standard of care is not the end of the road in patient advocacy. It is a new direction and the beginning of a new era of hope that requires careful planning, new resources and very customized support.

Joslyn Crowe, MSW, MA, is executive director of the National Niemann-Pick Disease Foundation, Inc., a non-profit, unbiased patient advocacy and family support organization dedicated to supporting and empowering patients and families affected by Niemann-Pick disease, through education, collaboration and research.

The views expressed in this piece are those of the author, not necessarily those of the publication.

Healthcare experts and clinicians interested in contributing to HCPLive may contact the editorial staff 

Getting a Treatment Is Not the End of the Road in Rare Diseases

Joslyn Crowe

 I want to give us all an opportunity to give some advice or practice pearls to all of our viewers including other hematologists, maybe focusing a bit on red blood cell health or other areas that you think are important including decreasing long term organ damage. I’ll start with you Elna. What advice or practice pearls do you have for our audience?

 I think it is the shifting paradigm that yes sickle cell is an anemia and it causes pain, but the thing that reduces survival and still has maintained the early mortality in sickle cell disease patients compared to the general population is not necessarily the pain or the pain episodes. It is the progressive organ dysfunction and so we should slowly move away from the deception of sickle cell being a mild disease. We should consider it like diabetes or hypertension and that the organ damage is also a silent killer. If we shift that paradigm the way we approach them and how we approach our practice even towards them, we will shift an emphasis in embracing and offering disease-modifying agents to almost all of our patients and having the discussion of the impact of end organ dysfunction and damage in overall longevity and mortality.

 Thank you so much, Elna. Nirmish, you’re next.

 I would just extend the conversation in the sense that educate and be real, continue to educate. I love the descriptions that came up in our conversation today. As I told Matt, I’m going to use some of those. I’m very graphic about drawing pictures and being in the room and getting them to really understand and see what’s happening inside of them because that gives them a little bit of control of knowing what’s happening to themselves. Otherwise, it’s a chronic disease that they have no control of. What control can you give them? It’s educating them about the disease and being able to tell others about what’s happening to them. I think the pearl for me is to educate them and that includes education about these new therapies, and the new drugs that are available now. I even actually started to talk to them about the new drugs that potentially could come.

When we talk about gene therapy, I still kind of give a teaser about it. We’re not there yet. It’s all about being real with them. We don’t have the data. I’m trying to get them to understand that’s why research studies are occurring; this is what we hope that patients can be involved enough with. The patients, I can’t say this enough, they’re really smart. They’re really savvy about connecting to others and they want the information. They just take it up and soak up this information and I think it’s good for the community. Those are some of the pearls. And I mentioned it before, talk about these new medicines when they don’t need it. Talk about everything but pain until you have to talk about pain. Elna brought this up, that there might be the pediatrician inside of us trying to think about the whole world and not the adult side, but I think that our adult colleagues, and I know Biree you do this as well, I think we’re understanding that the quality of life is a big deal. Thus, I think those are some things to consider as we have our colleagues continue to see patients with these new drugs.

 I’ll leave you with 2 more images or analogies that I use because I think that there’s nothing sexy about having a chronic disease and a lot of it is just persistence of the patients, families, and providers in meeting the treatment goals and treatment plan. As I tell families when they’re going for their annual ophthalmology visit or their annual TCD [Trans Cranial Doppler], there’s nothing sexy about this. It’s like changing the oil in your car. It’s a pain. It’s annoying. It costs a little money. But if you don’t do it, what happens to the car? All the kids know the answer to that. It breaks down. Thus, that’s why [there is] this constant persistent pressure to keep on the plan is really very important.

The other one that I find useful to try and sometimes improve adherence to the treatment plan is the idea that organs are like a rock on the beach and the waves every day hit the beach, and they hit that rock and every day you don’t see anything. It’s just like the damage which is done every day with sickling even though you have no symptoms. There’s some clinical inexorable accrual of organ damage is what my mentor used to call it. There’s a little bit of damage every day that’s imperceptible. When you come back to that beach at the end of high school and you see the rock there, it’s still getting pounded by the wave and then you go away to college and then you have kids and you come back and all of a sudden there’s no rock on the beach. It’s just sand. It’s that daily pounding of that rock by a wave that you don’t notice the rock changes, but it’s becoming sand slowly and that’s what we’re trying to prevent with the daily damage of sickle cell disease on your organs.

Hydroxyurea and other disease-modifying agents are trying to prevent that from the daily point of view so that, as Nirmish pointed out or Elna pointed out, we’re trying to improve the overall health and organs of our patients who we present to our adult colleagues so that they can ultimately hopefully have a prolonged life and that sickle will no longer be an either immediately life-threatening or life-limiting disease, but hopefully have normal lifespan and quality of life. That’s really the goal. It’s hard. It’s hard to do that as a child, as a teen, and as an adult with so many other pressures on us but to encourage them to continue to follow the treatment plan with what we have while also being cognizant of what’s coming and what might be until something better comes along, as I say. Let’s follow this plan now. My promise is to keep them informed of what’s potentially available, both experimental and approved, and then they can choose collaboratively with us to potentially take on some of those new therapies.

Thank you, Matt. I really love the imagery in those analogies. I think we’ll all start to use them. I just wanted to add that I think when I speak to colleagues, clinicians of any specialty, patients, the community, family members who help to support their loves ones living with sickle cell disease; I really tell them that the tide is changing in sickle cell disease and it’s changing pretty quickly. Not only do we have more therapies available now, but our understanding of new potential targets is also growing exponentially and we’re seeing that playing out in the clinical trials that are available and that will be emerging in the near future. I think that sickle cell disease as we know it is changing. It is changing. Our patients may not feel that way today, but I do talk to my pediatric colleagues including some of you on the webinar today and I’m always heart-warmed when I hear the hydroxyurea story, for example. My colleagues say that ever since we’ve been giving it to babies starting at 9 months of age, we have such a healthier kindergarten class when we see those 5-year-old’s go off. That just warms my heart.

I think as an adult practitioner I’ve not yet begun fully to that extent to see the effects of novel agents or disease-modifying therapies or even transplant for that matter because we don’t do enough of it in the adult world. But I think that that tide is really changing. Just like hemophilia, for example, where we’ve come a long way, the expectation in hemophilia management is no leads. When we think about HIV care and we were making people toxic, sick with therapy as we knew it a few decades ago, and now people can be on 1 pill once a day. I think that there’s the potential in the very near future, hopefully in all of our lifetimes, to see that amazing impact on those affected by sickle cell disease. I’d say the future is definitely bright. I want to thank Elna, Nirmish, and Matt. And I want to thank you all for watching this 

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A panel of experts in hematology discuss the future directions for sickle cell disease and share practice pearls for disease management. 

Practice Pearls for the Management of SCD

Nirmish Shah, MD

 – In what has been a transformative year for ulcerative colitis (UC) treatment, the IL-23 class has solidified its role as a key therapeutic treatment option. With Johnson & Johnson’s Tremfya now joining AbbVie’s Skyrizi and Lilly’s Omvoh, gastroenterologists have three powerful IL-23 options at their disposal.

The IL-23 class has rapidly gained significant momentum, capturing one-tenth of the advanced systemic UC market over the course of 2024, according to Spherix’s 

 service. This rapid growth is fueled by the strong reputation of IL-23 inhibitors, reinforced by Skyrizi’s success and Tremfya’s recent approval, positioning IL-23s as the leading mechanism of action for UC in the eyes of physicians (n=106)—a trend Spherix has closely monitored over the past two years.

The study also shows that Tremfya has made a strong debut, with a large majority of gastroenterologists aware of its September 11

 approval in UC. Over one-fifth of gastroenterologists have already prescribed Tremfya, surpassing early trial rates for Lilly’s Omvoh at a similar post-launch timeframe, but falling short of what was tracked for Skyrizi. In the coming six months, gastroenterologists project Tremfya’s growth to outpace Omvoh, positioning it as the likely second most-prescribed IL-23 therapy.

Differentiation among the IL-23 therapies will be essential as Tremfya and Omvoh vie for position against Skyrizi, the current frontrunner. Already, a majority of gastroenterologists view the IL-23 agents as clinically distinct, with Skyrizi emerging as the preferred option. AbbVie, Johnson & Johnson and Lilly are making efforts to differentiate their agents. Omvoh, for instance, stands out for its impact on bowel urgency—a symptom highlighted by Lilly’s CONFIDE study. Tremfya is noted for its dual mechanism that binds not only to IL-23 but also to CD64, a receptor on IL-23-producing cells. Skyrizi distinguishes itself with an on-body injector device and its earlier approval for Crohn’s disease, which gave physicians valuable experience with the drug before its approval for UC.

As 2024 closes, Spherix anticipates an equally dynamic 2025 as IL-23s continue to shape the competitive landscape in UC. Spherix’s gastroenterology team will continue to monitor UC market developments through its 

 service in addition to tracking each specific launch closely in its 

 is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

 is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle.

The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community.

As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth.

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https://clientportal.spherixglobalinsights.com

Jim Hickey, Gastroenterology Franchise Head

: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorse.

The IL-23 class has emerged as a pivotal treatment option for ulcerative colitis (UC), with Johnson & Johnson's Tremfya joining AbbVie's Skyrizi and Lilly's Omvoh. This class has captured a significant market share, driven by the success of Skyrizi and Tremfya's recent approval. Differentiation among these therapies is crucial, with Skyrizi leading due to its unique features. Spherix Global Insights anticipates continued growth and competition in the UC market, providing strategic guidance through its RealTime Dynamix™ and Launch Dynamix™ services to monitor these developments.

Future intensified intra-class competition among Omvoh, Skyrizi and Tremfya is expected as each brand attempts differentiation.

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