Healthcare is in a state of flux. As extraordinary measures are taken to stem the spread of the coronavirus, regular medical care—from routine checkups and screenings to in-office treatments and procedures—has been subject to significant disruptions and challenges. Social distancing requirements of the 

 pandemic have created new limitations on in-person physician visits. 

Office closures and safety concerns have resulted in the delay or cancelation of medical appointments for some patients. Compounding matters is the dynamic and uncertain nature of the pandemic. The issues that patients and physicians are confronting today have evolved since the COVID-19 shutdowns began in March—and further change is undoubtedly on the horizon.

 patients and their eye care professionals, the pandemic has led to an array of stressors, given the progressive but indolent nature of a disease that can lead to blindness and requires close ongoing monitoring and treatment. The current health environment is particularly worrisome for elderly patients because they are most at risk for vision loss from glaucoma and are also among the highest risk groups for COVID-19 mortality.

To better understand the concerns and experiences of glaucoma patients during the pandemic, the Glaucoma Research Foundation (GRF) commissioned an online survey in May 2020. The aim was to gain valuable, real-time patient input that can help eye care professionals better address patients’ emotional needs as they adapt to the new, and continually changing, care requirements of COVID-19. 

The GRF survey, which was supported by Aerie Pharmaceuticals, assessed patients’ confidence in their disease management during the pandemic; specific disease management concerns; patients’ experience with telemedicine; and patients’ comfort in returning to eye professionals’ offices. The survey drew a national response, with 1051 adult glaucoma patients from 49 states participating in the questionnaire.

The survey findings bring to light several key considerations for ophthalmology practices evolving glaucoma care in the COVID-19 environment.

Notably, the survey found that more than half of respondents (53%) had to delay and/or cancel an eye care appointment during the first months of the pandemic. These disruptions seem to have significantly impacted patients’ confidence in their disease management, with approximately one-third (36%) of glaucoma patients surveyed saying they were not confident that their disease was well-managed. Those who had the lowest confidence levels in their glaucoma management were 30% more likely to have had an eye care appointment delayed or canceled.

This feedback highlights the central role of communication in enhancing glaucoma care and the importance of nurturing the physician-patient relationship during the pandemic. With physician offices open again, personal and direct doctor-patient communication is paramount to helping patients understand their unique level of risk and rebuild confidence in their disease management. 

Without scaring patients, it’s important that they understand the consequences of delaying an office visit and the real risk it may have for further, even permanent, vision loss.

At my practice in San Francisco, we went through every patient record that had an appointment during the early phase of the pandemic and conducted a risk assessment. We then communicated with each patient to make them aware of their particular situation and the risk of not coming in to be evaluated when our office reopened.

The first step was to speak with our staff about our responsibility to be safe, not just in the office, but also outside of work, with specifics about how to minimize risk. I sought their input and we developed together an action plan with new office protocols.

We also invested in an expansion of our office team. With this increased staff, we are able to directly answer more patient calls and engage in longer, in-depth conversations. In addition, we have placed a greeter at our main entrance who screens patients, which includes basic health questions, a temperature check, and a check for an appropriate mask. 

After completing these safety protocols, the greeter asks patients to use hand sanitizer prior to entering the clinic. These new measures have played a valuable role in boosting our patients’ confidence in their disease management during the pandemic.

The “COVID-19 Office” and Telemedicine

The survey also reveals that glaucoma patients place high value on being able to see their physician in person. Six in 10 (63%) respondents said they are comfortable returning to their eye doctors’ offices as long as social distancing measures, such as face masks and less crowded waiting rooms, are implemented. This preference for in-person physician visits, coupled with technology challenges, make patients largely uninterested in telemedicine. A vast majority (87%) of glaucoma patients surveyed said they would rather wait six weeks for an in-person office visit than have a telemedicine visit in two weeks.

While telemedicine has been a valuable tool in other medical specialties during the pandemic, it has significant limitations for standard diagnostic procedures in glaucoma care. Since intraocular pressure (IOP) checks, visual field evaluation, and other tests cannot be easily conducted virtually, practitioners may lose considerable clinical information by trying to manage glaucoma via telemedicine.

During these unprecedented times, the safety and well-being of patients is the principal concern of all eye care professionals. It is also important to consider the needs of your staff as well. At my center, we have modified several standard procedures that not only have enhanced patient safety during COVID-19 but have also made us operate more efficiently and safely as an eye care practice. 

I have found that when members of my office team feel safe at work, their calmness and confidence extend to the patient-provider relationship, helping patients feel more comfortable about the visit. By fostering a caring and professional approach to glaucoma care in the midst of uncertainty, we can all navigate the COVID-19 pandemic while continuing to protect the vision of our patients.

Andrew Iwach, MD, is Executive Director of the Glaucoma Center of San Francisco, Associate Clinical Professor of Ophthalmology at the University of California, San Francisco, and a faculty instructor at the California Pacific Medical Center Department of Ophthalmology. 

The article reflects the views of the author, not necessarily those of the publication.

A new survey assessed patients’ confidence in their disease management during the pandemic, specific disease management concerns, and experiences with telemedicine.

Managing Glaucoma During COVID-19: Patients Point the Way to Improved Care

Andrew Iwach, MD

 What’s really important—and we’re not here to give advice to the manufacturer of inclisiran—is the reputation a drug develops when it’s brought to the marketplace. It sticks. To Dean’s point, if you look at data published by Seth Baum and others, they found that the utilization of PCSK9 was somewhere about 0.3% of those who were eligible.

What happened was you had the insurance payers creating these incredible speed bumps. It didn’t really matter. The manufacturers of PCSK9 inhibitors cut their price in half. As Dean, Manesh, and Linda have said, the access to the PCSK9 inhibitors has certainly become easier. But the doctors just aren’t interested in prescribing. As far as they’re concerned, it’s a drug that’s very difficult for patients to access. It’s an “expensive” drug. I urge the manufacturer of inclisiran to think the process through, so that when this drug finally comes to market, it is accessible. 

Otherwise, you’re going to have the same issues that we face with PCSK9 inhibitors. Perhaps we need to inject some artificial intelligence into value-based care instead of what seems to be artificial insanity. We need to be able to count on really good algorithms to determine appropriate use for these compounds.

I still have heterozygotes being turned down for PCSK9 inhibitors. It’s insanity out there. What we really need is really good artificial intelligence, not artificial insanity, in terms of making sure these drugs are being used in the appropriate patient at the appropriate time.

 Norman, that was a wonderful take-home message. In fact, I’m going to start with Dean, Manesh, and Linda; you’ll be last. Give me a similar take-home message, something you think our audience needs to hear from you. Dean?

 In secondary prevention, the LDL [low-density lipoprotein] goal is less than 70 mg/dL and probably lower for all our patients. That’s going to require combination therapy, the best statin dose you can get them on, and then other drugs.

If the cost of the medicine is too expensive, then use ezetimibe. For primary prevention, family history, pay attention to risk-enhancing factors in the guidelines and calcium scoring. That’s how we can get these patients treated earlier, so we’re not in the situation where they’ve already had events and you’ve got to be that much more intensive with regard to their treatment.

 We’re at the age where we have an explosion of possible therapies for our patients, which is great. The take-home message for me is this isn’t about cardiology or specialty care; it’s about primary care. This is about getting the message and the care pattern and the access to the primary care. That’s how we’re going to affect the population health, by getting these therapies—statin, inclisiran if it comes on the market, PCSK9 as we’ve just heard—into the hands of our primary care doctors and getting them comfortable with having the conversation with patients to get the therapies to them.

 That’s a great comment. Linda, you have the last take-home.

I just want to reemphasize lifestyle. Diet is absolutely critical. You can have somebody who is not at goal and they’re eating a terrible diet, and they can have really good results from changing that diet. Using our licensed nutrition folks and getting these people to improve their diet is very much a part of the picture.

 Thank you very much. I’m Dr Keith Ferdinand for HCPLive®. We’ve had a rich and informative discussion. Linda, Dean, Norm, and Manesh have given us a wealth of ideas and information, reviewed data, and given some opinions on where we are now with the intent of lowering risk in patients who are high risk, including the FH [familial hypercholesterolemia] patients, patients with ASCVD [atherosclerotic cardiovascular disease].

If you enjoyed watching this HCPLive® Peer Exchange, if you enjoyed the content, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your in-box. Thank you very much for listening to this program.

Final thoughts from expert KOLs regarding treatment decisions and how they relate to patient accessibility when manage dyslipidemia. 

Treatment Decisions and its Relation to Patient Accessibility  

Dean Karalis, MD

For what it’s worth, I interview a lot of doctors. I’ve done a lot of panels. What struck me about you folks—the folks who deal with diabetics every day, or people with diabetes—I’m informed that diabetics is not the best term.

Not good—so, people with diabetes, people dealing with this disease. What I noticed is that you listen. Every 1 of you talks about listening to people. Doctors are bad at that, as a group, but not you. Did you select this because you like listening, or did you learn to listen because that’s what you do? I don’t know. It was just an observation. Call it a hunch. Look, we have come to the end of this discussion, but I don’t want to leave without giving each of you an opportunity to say something that you feel we may have omitted or something that you want to leave our audience with. Why don’t we go around, and each of you can take about 30 seconds and give us some final thoughts. Why don’t we start with you, Elaine?

 I’m just thinking back on the patients that I saw today. One of the biggest challenges of diabetes, and dealing with highs or lows, is that you could do everything perfectly Monday to Monday. With other things like saving money, or training for a marathon, you have something to build on. Maybe on the eighth day you can take a day off. That’s not the case with diabetes. You’ve got to start all over again that eighth day and do it all over again, and it may be the worst day of the eight. It’s such a marathon to run, and you don’t have an end line, or point, to look forward to. As a provider, you have to place yourself in that reality. You have to see through the patient’s eyes every day, and if you don’t do that, then you won’t understand their struggles and you miss the boat. That’s what I strive to do every day for them.

Wow, that was well said. Thank you. We really need to understand that, as Elaine has said, diabetes never gives the patient a break; it’s 24-7. Hypoglycemia is incredibly scary and really does limit so much of what the patient can and can’t do if we aren’t careful with educating our patients, assisting with quality of life, and making sure patients have a good understanding of their medications. We need to provide good education on prevention and treatment, and the use of continuous glucose monitoring [CGM] to try and help patients prevent hypoglycemia. We all need to take it seriously and make sure that we ask the right questions every time we touch the patient, so that hopefully we can have a better outcome for them.

I’m going to say something completely different, but I agree with what Elaine and Davida said. I want a system in which the pharmacist tells the patient and me every 2 years when their glucagon is going to expire, so I know to write a new prescription. Because what makes me crazy is when I’ve forgotten and the patient has forgotten to ask, and then they have a bad low and they don’t have their glucagon. Why can’t the pharmacists do this? I get bugged all the time about everything. Why can’t the pharmacist just say, “Patient X needs a prescription for glucagon”? That’s no skin off my back. They should probably just do it without a prescription. Why does this even have to require a prescription? That’s another issue. We need a system so patients and providers are reminded to do the refills. I don’t know why it doesn’t exist, so we need to create that solution.

Could that be built into the EMR [electronic medical record]?

When you click the prescription, it should pop up in 2 years.

 It should just say, “This is due.” Why not?

Jay Shubrook, DO, FACOFP, FAAFP, BC-ADM: 

Hypoglycemia is certainly something that’s very important to our patients, and most providers underestimate the frequency of it. Please ask your patient and the family at every visit about hypoglycemia. There’s no better time than today because we have plenty of tools to identify hypoglycemia, such as CGM, or continuous glucose sensors. We have ways that we can help patients have less hypoglycemia—particularly patients with type 2 diabetes—with novel therapies, and we have very effective treatments that can abort a hypoglycemic episode. Making sure you use the right treatment at the right time really is going to empower your patients not to be paralyzed by hypoglycemia but to be an informed and active crusader to prevent it and treat it earlier.

I want to thank all of you for being with us. This has been eye-opening for me because I don’t treat diabetes on a daily basis. I always thought, “It’s about sugar, for sure; usually it’s about hyperglycemia.” This hypoglycemic problem is real, significant, and tricky. These new therapies that I’ve learned about from you are strikingly interesting. Thank you all for being here.

I want to thank all of you at home for watching this 

. If you enjoyed the content, I want you to subscribe to our e-newsletter to receive upcoming Peer Exchanges and other great content right in your in-box.

Thought leaders in diabetes provide closing remarks about the importance of continuous awareness of glycemic control in patients as well as the need for effective communication between patients and providers. 

Final Thoughts: Awareness and Communication in Diabetes 

Elaine Apperson, MD, University of South Carolina School of Medicine  

University of Rhode Island College of Pharmacy

 In the little time that we have left, I want to go around and get some final thoughts from each one of you. I would like you to address the whole issue of using naloxone. How do you address this with patients? How do you address this with clinicians, and what is your view about going forward? How is this going to change the landscape of opioid use in the United States? Why don’t we start with Jeremy, and we will keep going from there? Take 30 seconds, and we will just keep going.

 I think we have covered a lot of ground today. We know, and have known for a long time, that opioids have certain risks. They pose risks to patients, and they pose risks in the community when they are taken unsupervised or misused. From a safety measure perspective, there are things we can do. We can do a better job identifying the patients at risk or when identifying those patients who should or should not receive opioids. At the same time, I think we need more community awareness, and we can do this by using the naloxone program or some of the other programs discussed today. Rhode Island sounds amazing, and I am interested to learn more about what is happening out there. The tools we have today can enhance the safety of what we are doing on the medical side and help out there in the community with the substance misuse and illicit side. That is outside of the reach for some of us who do not work in settings where one can reach out to the community, but I think that these types of tools are underutilized. If these tools are utilized on a more frequent basis, and in a more normalized way, we have the potential to reverse what we have seen here with opioids and the subsequent harm caused by them.

 While acknowledging that opioids are still commonly used as part of a multidisciplinary approach to pain management and that opiates are still being misused illicitly, we need to have strategies that emphasize the availability of naloxone so that people can be as safe as possible. As Dr Adler said, this must be normalized, and we need to realize, when we think about this, it is going to take more years than we would like before it will become normalized, but we need to step it up and work toward that.

 I cannot agree more with my colleagues. I think that, when it comes to normalizing naloxone, we need to take the lessons we have learned from what successfully normalizes this method of treatment. Whether it is enacting policy interventions, having naloxone everywhere, putting up billboards, or getting that access. What we are doing is studying people, saying what makes you dispense naloxone, to pharmacists? Saying what makes you dispense it, to primary care physicians? What makes you want to give it, to a caregiver? What are those barriers? How do we break them down? I look forward to the day of over-the-counter naloxone that is still covered by insurance so we do not have financial barriers. There is a lot that we know, areas where we have been successful, and I think that yes, it is going to be around a long time. We have seen how COVID-19 has created these divisions. I think, by solving those divisions during COVID-19, we will solve some of the divisions in access to care for people with opioid use disorder or people who use opioids.

I see naloxone as one part of the puzzle here, one part of the comprehensive approach that we try to take in the emergency department [ED], and that is decreasing the barriers that patients need to overcome to get naloxone. This is improving their access to naloxone not only in the ED but also in other areas of life where they have access to health care, and in their daily lives. Having it available works, whether it is having a naloxone box sitting next to an AED [automated external defibrillator] box somewhere or offering it to patients proactively and not requiring them to have to ask for it.

Additionally, I think that, as science for medication-assisted treatment continues to be redefined every day—how effective that is for treatment—it is our responsibility to not only make sure that our patients are safe as they go out and use this, or that their community is safer because naloxone is out there. But we also need to provide multiple opportunities for patients to get linked to treatment, to be linked to peers, and to have access to medication-assisted treatment. I think this is equally important and should be offered as routinely as possible.

Theresa, some people hate to be the last one to speak when all the good stuff is taken.

Theresa Mallick-Searle, MS, RN-BC, ANP-BC:

heresa Mallick-Searle, MS, RN-BC, ANP-BC: 

As the token nurse on the platform here, I am really big into listening to my patients. It is not that my colleagues are not, but I want to hear what is important to the patient. I want to be able to have them partner with me in their health care. I want to be able to encourage my peers to look at the bigger community and be in it for the long term, to decrease the amount of fear out there. As a health care provider, for anything that we do, we are trying to do the best we can to take care of our patients.

Thank you all very much. I want to thank you at home as well for watching this HCPLive® Peer Exchange. If you enjoyed this content, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your inbox.

I am Dr Peter Salgo, and I will see you again next time.

The multidisciplinary panel of experts share final thoughts on strategies to normalize naloxone and decrease barriers to its obtainment and utilization. 

Final Thoughts on the Opioid Crisis and Normalizing Naloxone

Jeffrey Bratberg, PharmD, FAPhA, University of Rhode Island College of Pharmacy 

Jeremy Adler, DMSc, PA-C, DFAAPA, Pacific Pain Medicine Consultants 

Margaret Bobonich, DNP, FNP-C, DCNP, FAANP: 

What do we do? How can we assist our colleagues in helping them look at one, how do we choose therapies, and when do we collaborate and refer these patients, and what kind of patient education can we provide for these patients?

Well, I think just to kind of bring this all the way back around, first off an accurate diagnosis always leads to successful treatments. So, make the diagnosis. Familiarize yourself with the different presentations of atopic dermatitis and the neonate versus the toddler versus the teen versus the elderly. And I think have a high clinical index of suspicion. If it is coming back, if it is very pruritic, if it’s life-altering, even if it doesn’t look like classic atopic dermatitis, it likely is a phenotypic presentation of that even if it’s not what’s inside your dermatology textbook. So, get the right diagnosis because the right diagnosis will then lead you to begin to move into the more, what I call the empathic side of treating this How is this impacting your life? How would your life change, how are the treatments that you’ve been using working? And so, begin that dialogue with patients and just kind of let them open up a little bit. It doesn’t have to be two-hour long visits for them to really feel like why this is different than other people have seen. Just asking a few questions lets them know that you're into the diagnosis, that you're not just going to run for a cream and send them out the door, and that you can make a difference. And if you don’t have that time to really tell them everything; you're not going to unload everything on the first visit. Tell them about comorbidities, tell them about every single systemic option, you're going to get their acute flare under control with topicals. And then you're going to bring them back in, you're going to earn their trust, you're going to continue to talk to them about it, and then you're going to begin – I’m always introducing non-steroidal options to patients right up front. If I feel like I have to use a topical steroid to calm it down – I may not need to once we get this new topical JAK out but I’m always introducing the idea of us moving off the topical steroids. I don’t use them much but systemics onto these new treatments. So it’s kind of a progressive revelation of talking to them about the disease, what you believe it is, how you want to open up the box and let them know that you know how this impacts you and the family, that we’ve got good treatments out there, we’re going to start off with this, but it’s important for me to see you back because we want to look into other treatments that are on the horizon that can control this for long periods of time without having to lead the anxiety about when am I going to break out next time. 

You know I think you summarized it very well Doug. I think it’s exciting where we’ve been and where we’re going. We don’t have to use systemic agents with these high toxicities that are really rescue agents, like the cyclosporine. We have choices now. And letting the patients know that and one of the interesting things is I’ve heard people say well that’s an injection. But guess what, let’s let our patients make that choice. Let’s give a fair representation of all the treatment options that we have and the ones that are coming because the truth is that an injection may be nothing compared to the quality of life that atopic dermatitis is having on these patients. A lot more to come for us especially our adult, some of the newer agents will be anticipated FDA-approved for adults. Some of the resources you like to give your patients Doug, what are they? 

Well certainly the National Eczema Association, the NEA, I think is an excellent resource with information about clinical trials that we may have mentioned in this presentation, great patient support, practical data that’s there, practical recommendations on bathing and moisturizing. I really, really like the NEA as a great resource. Do you have others? 

Margaret Bobonich, DNP, FNP-C, DCNP, FAANP:

 The National Eczema Foundation is my choice. But I think as far as resources for you as clinicians, I think one of the best ammunitions I would have for you is if you're in primary care or if you're in derm and you're not comfortable with prescribing some of these agents that are here now or the newer ones that we anticipate that will be FDA-approved in the near future, if you're not comfortable, reach out to a local dermatologist or dermatology NPPA and let us help you. One, we’ll help you with that patient and supporting them and getting them the best treatment and optimal outcomes, but also to help you learn about it. We really, really want to support you as colleagues and that’s my suggestion. Any last words Doug? 

 I just want to echo that. You know the study is a few years old, but it showed that only 19 percent of patients with severe atopic dermatitis got referred from primary care to dermatology. I think that’s improved, especially with some of the commercials that have been out about eczema and dupilumab’s campaigns. But we just want to say that this is – our medicine is a collaborative effort. We’re not living in silos here. We want to – we in dermatology want to partner with our primary care providers, we want to partner with our allergy specialists, we want to partner with the folks that are going to help us out too. I want to tell Margaret, you're helping your patients and you're helping yourself because these folks are living with infections, they’re living with scratching, they’re living with anxiety and depression. And we now have treatments out there that can radically change and improve that. So that’s the biggest message of today’s time together is that there is help out there, that we can get these medicines covered by most insurances, and that they can really change patients’ lives. 

 Thank you so much Professor Doug. This is why we call him Professor Doug. And thank you so much. Thank you for watching 

. If you’ve enjoyed this content, please subscribe to our newsletters to receive the upcoming programs and great content right in your inbox. So thank you everyone. Be safe and live well.

Experts in dermatology discuss patient education and clinical pearls to assist colleagues in the management of atopic dermatitis.  

Care Collaboration in Atopic Dermatitis 

Margaret Bobonich, DNP, FNP-C, DCNP, FAANP

COVID-19 has obviously presented significant challenges in our clinical work, particularly in the evaluation, diagnosis, and treatment of patients with ADHD [attention-deficit/hyperactivity disorder] of all ages. What we’ve all done, of course, is acclimate to this, largely through the use of telemedicine, telepsychiatry for a lot of our patients. Although more recently, I’ve gone back to more of a hybrid model where I am seeing some patients live and some via telepsychiatry. 

There are significant challenges. Some of those challenges include the fact that it’s a little more difficult to do an evaluation and to collect all the nonverbal information that you might get from being in the room with a person. Part of the problem is you may be seeing only a portion of the patient’s body. You may not be seeing the lower half of the body if you’re on a virtual call. You might not see some of the fidgeting or hyperactivity, for instance.

Also, what I find is patients either do really well with virtual telepsychiatry or don’t. They have trouble focusing. They get distracted. It’s really important to try to individualize care for our patients. Some people try to do in-person meetings. Ideally, this may be helpful for the initial evaluation so we can collect as much information as possible. When you’re dealing with children, you’d like to have collateral information, so you’d like to have parents and caregivers involved. That can be a little harder too, although it can be done virtually.

As far as prescribing medications, that can present a challenge. Although now, states are going to e-prescribing. In Florida, we now have to e-prescribe all controlled substances. That makes it easier, not having to handwrite a prescription and somehow get it to the patient in a COVID-19 environment.

The other thing I find is that sometimes children do a little better in this virtual environment, but many with ADHD struggle more. There’s a lot more stress and difficulty in school. Obviously, there’s more isolation, so fewer social relationships, fewer extracurricular activities, and maybe less access to exercise, which has been shown to be very beneficial for ADHD. These are some of the challenges that we’re trying to negotiate in the era of COVID-19.

Tele-prescribing of stimulants presents some unique challenges in the era of COVID-19. Part of the challenge is making sure you can e-prescribe appropriately. Most of us have figured out how to do that. Also, you want to make sure the pharmacy is available and shows up on your e-prescribing software. It is required, when we prescribe stimulants, that we monitor certain things. This can be more challenging in this environment, particularly when assessing vital signs, height, and weight. Blood pressure, heart rate, height, and weight can be a challenge in the virtual environment. This is when I may sometimes have the patient come to the office, just for the vital signs and height and weight checks. Or the patient can get 1 of the home monitoring devices, which you can get at many pharmacies. These devices can monitor blood pressure and heart rate. Your patients can check those periodically and report the results to you. Or you can certainly have them email that to you or communicate electronically.

As far as monitoring for abuse and possibility of diversion, this is something we also need to keep our eyes on. We can do this in various ways, including by checking prescribing databases, which can certainly be done online.

As far as monitoring for other issues and problems, such as the emergence of psychotic or manic symptoms or the possibility of vasoconstriction or cardiovascular issues, this is where taking a very careful history and evaluation and trying to look at the patient and evaluate them as best you can on camera really seems to help.

It’s important to understand that when evaluating and treating ADHD, comorbidity is the rule. Three-quarters of patients with ADHD will have a least 1 other comorbid condition. This is important because sometimes our core treatments for ADHD can help alleviate these other conditions. For instance, secondary anxiety or secondary depression. Sometimes, however, we do have to institute specific treatment in addition to the ADHD treatment to address a comorbid condition.

Rakesh Jain, MD, MPH: When parents and their children first come to see me for an evaluation for ADHD, there’s often a lot of confusion. We have a lot of myths in our heads. “Is this bad parenting?” “Was this just because one of us got divorced?” Is it because I had too many Diet Cokes when I was pregnant?” 

My first job is to offer parents and children a combination of sympathy and encouragement. I offer sympathy for the suffering they have gone through and encouragement that, if we do the right thing, we can make a pretty significant difference in all the challenges your child is having and you’re having as parents and caregivers. I have found that injection of enthusiasm, support, and knowledge to be as useful as anything I do.

The second step is really a pretty quick but accurate increase in knowledge base about the disease. Most people are quite surprised to know that it is a neurobiologically active condition. It is an inherited condition. It is a brain-based condition. Even though behavior is what they might see, the child is not being a “bad” child. 

Finally, we need to give an explanation of why interventions work or why a combination of nonpharmacological and pharmacological interventions is best explained in the context of neurobiology. 

When I offer that whole package of information, from sympathy to increasing their enthusiasm and encouragement to disease-state knowledge and then finally medication and nonmedication knowledge, you can see the parents and the child breathe a sigh of relief. “I’ve got a direction. There’s something I can do. I feel empowered.” That is precious. As a clinician, once I see that, I know I have established a solid therapeutic relationship that will lead to good outcomes.

Optimizing care and managing challenges for patients with ADHD during the COVID-19 pandemic and advice for clinicians educating patients and families on disease management. 

Optimizing Care for ADHD During COVID-19 

Rakesh Jain, MD, MPH, Texas Tech University School of Medicine

One of the issues has been that there does appear to be a therapeutic ceiling with all our agents. We’re seeing about 40% to 60% clinical remissions along those lines, depending on where these drugs are positioned. Both of us have been very aggressive about trying to get these drugs earlier in the course to prevent complications. If you look in the clinical trials with ustekinumab or vedolizumab, the average duration of Crohn disease is 10 years. Patients with 10 years of disease are already developing the problems that we’re trying to prevent. One of the things that I would like to focus on in the future is earlier intervention with these highly effective therapies that we’ve been discussing. What other unmet needs do you see in the pediatric and adult populations for IBD [inflammatory bowel disease]?

 I also have a very keen interest in preconception and fertility in the management of women’s reproductive health, which does tie in to everything we’re talking about. The message to all our female patients is that it’s all about safety and being able to have your disease under control. It is paramount that having anti-inflammatories onboard is what is most important. We know the risk benefit profiles associated with therapies and how to use these therapies in pregnancy, particularly the biologics. We need to be focused on teaching the right thing to our physician partners and patients, that it’s all about controlled inflammation. 

Chronic pelvic inflammation can never end well. That is something I’m vocal about within my preconception clinic, and I counsel women appropriately. But it does have to do with some of these small molecules. We’ll add a layer of complexity when we are looking at bringing these therapies to the clinic. With some therapies, such as the small molecules, we don’t have a lot of real-world experience on the impact in the first trimester because they cross the placenta. That is the question that we need to get more data on. For example, with ozanimod, it will be in the label to stop 3 months before conception. With JAKs you need to stop it. It does add a layer of complexity—we’ve become ob-gyns in terms of figuring out how to use these therapies. An unmet need is also understanding the safety of these therapies in women of reproductive age.

 Did that also apply to pediatric patients? Are there other unmet needs besides improving the efficacy and maintaining a good safety profile in kids?

Marla Dubinsky, MD: It’s a similar concept once you get beyond the VEO [very early onset] IBD. We have the same principles. Similar to what you talked about, whether those extraintestinal manifestations were activity linked or not, the same applies to growth. For all our therapies, just because you heal the intestine, does not equate to growth improvement. We don’t know. We need more data. Does gut-specific therapy have the same impact as systemic therapies? These are things that we need to see from our clinical trials.

There are a couple of unmet needs that you made me think about. I do believe, as I noted before, the future is combination therapy. It could be diet plus biologic. It could be small molecule plus biologic. It could be fecal restorative therapy. It doesn’t matter. The concept of combination means that 1 therapy alone is not going to be the answer. I was addressing your plateau. This is the way I’m thinking about it. Also, sequence will be a hugely important topic to address, meaning understanding the sequence over the long lifetime of a patient who has an evolving immune system based on the therapies we’re using.

I have to plug something that both you and I believe strongly. The plateau may also be the fact that we are not addressing the emotional or behavioral well-being of our patients in clinical trials or the real world, so we can understand how social determinants of behavior, mental health, and comorbidities impact outcomes. We may see a different percentage of remission at week 52. That is an important unmet need that we need to focus on.

I want to amplify your recognition of the social determinants. Certainly in 2021, we’ve seen social determinants of COVID-19 infections and increasingly recognize the disparities of health care in treating chronic illnesses such as ulcerative colitis, Crohn disease, inflammatory bowel disease. We really need to address these disparities and try to improve, whether it’s with psychology, social workers, diet, and education. All these combinations—as your group and our group have shown—really impact patients. They keep them out of the emergency department. Keep them out of the hospital. We need our systems to help us address these disparities. As practitioners, it’s challenging for us and our staff to address this full spectrum of the patients’ needs, from diet to psychological or behavioral support. Economically, 1 of the biggest issues we all have is access to these highly effective therapies. We’re dealing with different insurance programs that may not allow us to use these drugs in the most effective manner that we think we could.

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Current treatment limitations in inflammatory bowel disease and the rationale for earlier initiation and use of newer therapies to manage pediatric and adult patients.

Addressing Current Treatment Gaps in Pediatric and Adult IBD 

Stephen B. Hanauer, MD, Northwestern University Feinberg School of Medicine

Takeda Pharmaceuticals

In the pivotal studies, we were missing endoscopies for patients on both vedolizumab and ustekinumab, so you’re treating symptoms and we didn’t have that piece of information. The SEAVUE trial came out recently, and it showed similar outcomes with adalimumab in the treatment of Crohn, which we know is a good drug. Ustekinumab is also an option, including similar rates of endoscopic healing. We know that class of drugs and ustekinumab are safer, so that strengthens my way of thinking. If you have a patient that has significant alteration, or somebody whom you would ordinarily give a TNF [tumor necrosis factor] blocker or 2—that trial, to me, says, “If you wanted to emphasize safety, you could give ustekinumab as a first-line treatment and expect the similar amount of efficacy that you’re going to get with the TNF blocker.” I like that. I agree, the positioning by payers is problematic part of the time, but in a perfect world, that’s a great fit for first-line therapy because of the mixture of safety and efficacy.

We already touched on the SEAVUE trial, but we should unpack it and address the significance that it may have in clinical practice. The SEAVUE trial was a head-to-head trial of ustekinumab and adalimumab per label, so there was no dose escalation. It included an early patient population that was bio-naive. Arguably, endoscopic activity was less than what we would usually see in a typical patient with moderate to severe Crohn disease. With that being said, powered for superiority, we didn’t see any difference in either the clinical or endoscopic outcomes. From each one of you, what is your overall take on it and how is it going to change your clinical practice? I’ll start with Jessica. Did you have any expectations going in?

Yes; I’m not surprised by the results. It shows what would potentially be considered a well-known first-line agent, adalimumab, in the treatment of Crohn disease; ustekinumab performed just as well, and this agent has a superior safety profile. I don’t think that’s arguable, and you give it less frequently: Dosing is every 8 weeks compared to 2 weeks. In that sense, when you see that data as a prescriber, you might say, “Why wouldn’t I go with the more convenient, safer choice if the efficacy is essentially equivalent?” That’s the takeaway for me from that study; all things—payers and whatnot—being considered, they’re both injectables, so you have that convenience factor, but there’s less dosing with ustekinumab. In the end, even though there wasn’t a superior result for ustekinumab, from an efficacy standpoint, that’s still a positive outcome.

 Yes; there were hints in there that, for most end points, they were the same. There were hints of some favorability of ustekinumab regarding safety. The number of people who discontinued the trial due to adverse events was almost twice as high in the adalimumab arms. It was 11% vs 6%. Then, among the week 16 responders, the percentage of patients who were doing well at week 52 was about 10 percentage points higher in the ustekinumab group. That fits with the sense that there is less drop-off. If you’re a responder, you tend to maintain your response with ustekinumab—there’s less loss of response. Those are the hints that those are some of the positive features of ustekinumab. I view it as a win-win because these are probably the 2 most common drugs I use in the treatment of Crohn disease, so they’re both good drugs. In an ideal world, if we didn’t have insurance barriers or cost access, sure, you would use the ustekinumab all the time. In the real world, it’s twice as expensive, so that plays a role. Anecdotally, I do feel that it has a bit of a target on its back lately. Since the first of the year, it seems like we have had much more pushback in issues related to either starting ustekinumab or changing the dose of ustekinumab, including right here. It is an issue, and it’s only going to get worse in 2 years when we get 6 biosimilars hanging out, waiting for activation.

I would like to press you on 2 things; I see it the same way you guys do. The only other thing is the issue around dose escalation. I’m helping the launch of this therapeutic drug monitoring [TDM] stuff. I feel like there’s an epidemic of dose escalation that’s not adding a lot of value. With ustekinumab, that adequacy of dosing is good for most patients. If you looked at the pharmacokinetic and pharmacodynamic paper that we published in 

, for both UC [ulcerative colitis]and Crohn, 75% of the patients plateau efficacy at about the 25th percentile of drug concentration for the labeled dose. Most patients have enough of the drug, and I don’t see much utility in empirically dose escalating for something that’s never been shown to work. You take an expensive drug and make it mega expensive, and we don’t know if it works. If you measure the drug level, you get off the hook for dose escalating 75% of the time. With adalimumab, there’s much more of it. Now we have the SERENE trials that show it doesn’t work well in terms of more intensive dosing, but it’s an inconvenient fact in the way that we’ve built our practice guidelines and come to practice now. I feel less pressure to dose escalate with ustekinumab, which I like. I don’t know how you guys see all that.

It is interesting; we do a lot of dose escalating up here [Brigham and Women’s Hospital] and we have looked at this. One of our fellows, Rahul S. Dalal, MD, published a few things on this at DDW [Digestive Disease Week] this year. Essentially, what we found is if you’re a primary nonresponder to ustekinumab, there’s absolutely 0 utility in dose escalating. However, there does seem to be some recapture in the patients who had an initial response and then lost response. We saw about 50% recapturing clinical response. There seemed to be no difference between Q6 and Q4, so how people decide the level that they’re escalating to is provider dependent. There are no data that suggests that one is better than the other, but we saw some recapture and we’re studying this prospectively now, so we shall see. There might be some utility in some of those secondary nonresponders, but I don’t know how to use TDM for ustekinumab in my practice. I don’t routinely check levels. I don’t know what to do with them. If the patient does lose response, I’m almost reflexively dose escalating to try to recapture response with a low threshold to move on if it doesn’t work.

Do you think the results of some of these new trials are going to influence how we prescribe biologics in bio-naive patients? Is the SEAVUE trial going to change anything?

I do think these head-to-head trials are important. When the VARSITY trial was published, it was a pivotal moment in this space. We have been asking for these head-to-head trials to try to understand positioning and we’re finally starting to get them, and we are going to get more. Having data like these and seeing the results can influence practice patterns. I appreciate having data with these head-to-heads to understand how I’m going to position therapies in my own practice. These things matter. We have been guessing at positioning and using things like network meta-analyses to try to understand. Until we have actual biomarkers or actual tests where we can test patients up front and say, “This is the therapy you need to be on first,” this is the type of data that we need to help inform our practices.

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Details of the head-to-head SEAVUE study of ustekinumab vs adalimumab for induction and maintenance therapy in patients with moderate to severe Crohn disease.

Authors