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 What prompts you to step up? Where do you pull the trigger when you see somebody who’s not doing so well? What do you focus on for step-up treatment?

 I focus on a couple of things. If I see a patient who’s already on a medium-dose ICS [inhaled corticosteroid], plus or minus a LABA [long-acting beta-agonist] or a LAMA [long-acting muscarinic antagonist], and they’re still uncontrolled, I look at asthma control. I look at exacerbations. I also want to make sure, before stepping up, that the patient is using their inhaler correctly. The other day, I had a patient who I wanted to step up, but then I went back. I work in a county hospital where I can go and look at the prescription refills. The patient hasn’t refilled her controller for 3 months. When I asked her, in a nice way—patients don’t like it when you confront them—it seemed like she hadn’t, and there was no reason because at a county hospital, they’re paid for.

There are lots of reasons why adherence may be a big issue, so I urge my colleagues—and we’re all doing it—before stepping up, ask: Is the patient taking their inhaler? Because we know, even for inhaled steroids, there is a plateau effect. It’s not like the higher, the better all the time. This is definitely a benefit in some patients of doubling the inhaled steroid. At some point, you reach a plateau and you have to ask: What else can I do? By increasing the dose, you may also increase risk of topical adverse effects and systemic effects. To answer your question, I look at asthma control, asthma exacerbation, and adherence. I want to make sure all the comorbidities are taken care of—especially the nose—and then I step up, and I have to bring them back to see how they do. Of course, we can’t just step up and leave them on a high-dose ICS forever.

I certainly embrace that approach quite well. I’m sure Sid and Geoff have similar aspects. But I’d highlight that when we take that and understand control, we can use objective measures like the Asthma Control Test [ACT] and filter that into our EMR [electronic medical record] so that we longitudinally track the ACT score, which gives us some objective measures. Sid, in that last section, we really drilled down into high T2 and low T2, more in a global physiological or pathophysiological approach. How do you take those learnings and practically implement them in therapeutic approach? What’s your approach, Sid?

 I’m glad this question came up on the heels of our last comments when we were talking about stepping down. Indeed, many asthmatics, it’s been shown, just don’t respond to those steroids, and they are predominantly in that T2/non-T2 category. One of the things we need to be brave enough to do is step down. Often, they’re on oral corticosteroids. It’s not doing any good. The other thing is, very often, that T2 pathways can be masked by the corticosteroid. For example, eosinophils are very sensitive to the steroids, and they may be high in a patient put on larger doses of oral corticosteroid. For example, you check: Is this a T2 patient? No, eosinophils are low, and FeNO [exhaled nitric oxide] is low. This is another area where you may want to consider that step down. That’s the approach I would take. As we know, we have a really limited armamentarium against the non-T2. When patients, as Nic was saying, are following their Asthma Control Tests and exacerbation rates, you get to the point where you’re looking at a patient saying, “This isn’t working. You’re on high-dose corticosteroids. We need to go to the next step.”

Thank you for watching this HCP Live® 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. It comes to you wherever you’re at: on your phone, in your office, or in your home. I want to thank everyone and our sponsors for this wonderful opportunity. Have a wonderful day, and be safe. Thank you.

Videos

Nicola Hanania, MD, MS, and Sidney Braman, MD, discuss step-up treatment and when it’s best to practically implement TH2-high and TH2-low into a therapeutic approach.  

Asthma

Step-Up Treatment for Severe Asthma 

The choice of therapy is highly individualized to optimize our treatment plan. It depends on what predominant symptoms the patients are experiencing, what organs are involved, any response to previous therapies—perhaps in that same class—as well as the patient’s disease activity and severity. The adverse effects of these agents and patients’ preferences and comorbidities should also considered when determining therapies.

There’s a tremendous unmet need in this field. We lag behind medications that have been approved for rheumatoid arthritis and arthropathies. However, there are some exciting new medications and novel mechanisms that are being investigated. Specifically, in lupus we have recent approval of a structurally modified calcineurin inhibitor with a dual mechanism of action leading to increased integrity in the immunosuppression of T-cell activation. There’s also a monoclonal antibody, anifrolumab, designed to treat systemic lupus. Here it binds to type 1 and 2 interferon receptor, which should include interferon-alpha and interferon-beta. So it’s an exciting time with new medications on the horizon hopefully addressing unmet needs for our patients.

Another medication I’m excited about is obinutuzumab, which is used for chronic lymphocytic leukemia. This is a fully humanized monoclonal antibody that binds the epitope of CD20, and it partially overlaps with the epitope recognized by rituximab. We’re excited to have newer MOAs [mechanisms of action] and newer monoclonal antibodies available for these conditions. We’re still trying to understand these rare diseases. Attacking them from multiple angles with different pathways may lead to exciting outcomes.

With novel agents on the horizon, this is an exciting time for our rheumatologic patients and rheumatologist alike. Treating rare systemic autoimmune diseases is a very complex process, and having new treatment options and novel mechanisms of action might provide better outcomes and new opportunities for many patients who, for too long, may have been undertreated.

Thank you for taking the time to listen. I hope this has been a useful presentation. I look forward to seeing my colleagues again soon.

A thought leader in rheumatology, Kostas N. Botsoglou, MD, highlights the importance of individualizing therapy for SARDs and shares insight into novel treatments on the horizon that may address current unmet needs.  

Inflammation

The Future of Individualized Therapy in SARDs 

Putting it all together, how do you decide what you’re going to tackle for any given person or anybody you see in clinic around cardiovascular risk reduction. I think about the things I can have the biggest effect on, and some of them are the hardest. If the patient is smoking, we know that quitting is the single biggest thing they can do to reduce their cardiovascular risk. If the patient has high blood pressure—30% of the people with cardiovascular disease do—that’s the next most modifiable risk factor that will lead to global population improvement and improvement for our patients at cardiovascular risk. 

Let’s go to the next potentially treatable version, which is usually our cholesterol lipid. For those patients who aren’t at goal, who are at high risk, a moderate-intensity to high-intensity statin should be given, specifically in those patients with diabetes or those with high risk for future cardiovascular events. If my patients have had cardiovascular disease, we know the disease is present. If they’ve had a heart attack or a stroke, then they’ve got coronary artery disease [CAD], they’ve got peripheral artery disease [PAD], they might have had a limb event. In patients for whom we should have been doing those other things, but now they’ve still had the event, I’ve started to think about using what I’ll call the dual-pathway therapy: either a low-dose rivaroxaban plus aspirin, or I’ll come up with other ways to use specific agents. Often it’s the dual pathway, but if the patient just had an angioplasty or an MI [myocardial infarction], it may occasionally be dual-antiplatelet therapy [DAPT] to reduce their risk. Finally, for those patients with diabetes, we have an armamentarium of new agents, like SGLT2 inhibitors. That’s a lot of stuff to give a patient at once. I figure out what the patient’s highest-risk issues are and try to tackle those. Some patients have all those risk factors but may have some very specific ones you can home in on.

 We’ve learned a lot about the risk profile of patients with peripheral artery disease and coronary artery disease, particularly in polyvascular disease. These are high-risk patients, and their risk profiles and their response to therapy differ depending on who they are. What I’ve learned about antithrombotic therapy and either long-term DAPT or long-term dual pathway with aspirin and rivaroxaban is that both have utility. I think of dual-antiplatelet therapy in high-risk patients with ACS [acute coronary syndrome] that we may continue long term. However, I see a lot of patients with chronic vascular disease who haven’t had a recent MI or who are on aspirin alone. In that setting, adding rivaroxaban has shown the greatest net benefit. 

For example, for the polyvascular patient with PAD and CAD or the patient with high-risk chronic coronary disease who hasn’t had a recent MI or vascular intervention, the dual-pathway therapy has very good efficacy, the bleeding appears to be tolerable, and there’s a net benefit overall if you exclude patients who are very high bleeding risk. Patients with PAD, particularly those who don’t have coronary disease—about two-thirds of them—are very different. They’re very high risk. The risk is driven by limb outcomes, and in that setting it’s different from coronary disease. 

We really have no data to support dual-antiplatelet therapy as a strategy. There was a trial called CASPER that looked at aspirin and clopidogrel vs aspirin alone in patients with PAD after intervention. There was no benefit but more bleeding. We also know that warfarin doesn’t work here. This becomes quite clear. The patient with PAD, particularly without CAD, who has undergone an intervention, really the only choice is aspirin and rivaroxaban vs aspirin alone. As an alternative, there are other agents that have been studied in the past like vorapaxar, but the most commonly available agent that is labeled for this chronic PAD patient population is aspirin and rivaroxaban. 

In my practice, we need to do more for antithrombotic prevention with CAD and PAD and the combination of both. We need to be more thoughtful about risk even in patients who appear to be stable because we know that they’re not. They’re stably unstable, if you will. We have different strategies we can turn to that have shown efficacy: DAPT, aspirin and rivaroxaban, and for chronic PAD or CAD, I tend to reach for aspirin or rivaroxaban.

I like to individualize my approach to patient care and engage in and share decisions with my patients. So I tend to risk stratify. There are some very complicated risk-stratification algorithms. I tend not to do that. I use a more simplified approach. The first thing I think about when I see a patient in the clinic is their vascular risk. If they have symptomatic coronary disease, they’re at high risk. If you add something to that—like diabetes, heart failure, multivascular disease, CKD [chronic kidney disease]—then they’re very high risk. I know that patients with peripheral artery disease are high risk, particularly for adverse limb events, particularly if they have concomitant coronary disease. If they’ve ever had an intervention to their limbs or an amputation, then they’re at very high risk of limb outcomes. Those are the patients I really worry about.

I obviously want to think about bleeding risk. If they’re a high bleeding risk, I’m probably not going to add more intensive antithrombotic therapy. But if they’re not at high bleeding risk, I’ll usually add something. In the case of acute coronary syndrome, a patient who is tolerating DAPT may continue that long term. That’s reasonable. But most of these patients are on aspirin alone, so I’ll try to add a second agent. That tends to be low-dose rivaroxaban for polyvascular patients with PAD.

Drs Marc P. Bonaca and Manesh R. Patel discuss the rationale for individualized treatment plans for patients with type 2 diabetes at high risk for cardiovascular disease.

Diabetes

Diabetes condition center page is a comprehensive resource for clinical news and insights on diabetic and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for type 1 and type 2 diabetes, as well as related endocrinological conditions and illnesses. 

Individualizing Treatment to Reduce Risks of CVD 

 In terms of avoiding complications, a family that is well educated about the disease, the treatments available, the preventive strategies for complications, including nonmedicinal strategies explicitly, such as mindfulness, good eating habits, exercise within moderation, and good sleep habits, they are going to do far better than the family that does not have these in their lives. Most providers are not well informed about sickle cell disease. Thus, a well-informed parent or adult with the disease who provides information in a nonthreatening fashion can improve their own health care. I would stay abreast of the research as another strategy, because treatment of sickle cell disease in 2020 is vastly different than treatment of sickle cell disease in 2010, and I would wager that curative therapy options in the next decade will be better. We will have improved outcomes with less toxicity. 

Lastly, I would consider all the FDA-approved drugs as potential options for treatment. Particularly for those individuals with hemoglobin SS and S beta-zero thalassemia, with each passing year, we learn more about the benefit of this drug. In my opinion, by far this drug should be in the stable of anyone with hemoglobin SS and S beta-zero thalassemia because the benefits far outweigh any of the toxicities or complications in taking the medication. For the other drug, I think it will take time before the research will demonstrate what the specific benefits are in decreasing the rate of CNS [central nervous system] disease, heart, lung, and kidney disease, as well as potentially priapism and other complications of the disease. But I would say stay tuned because we will learn more about how these additional drugs will prevent complications in organ function in the next decade. 

The first recognition for decreasing opioid dependency is acknowledgment that pain occurs. There should be trust between the provider and the patient, and the patient needs to develop a strategy to manage the pain that is not dependent on opioids but is dependent on first, understanding the triggers, and understanding how to use mindfulness and other strategies to decrease the severity and intensity of the pain. Then, the goal is to learn enough about their disease and enough about their treatment to use a stepwise approach to managing their disease when it comes to acute vaso-occlusive pain. That would include the use of nonsteroidal drug, the use of hydrocodone as a stepwise approach, and then eventually morphine. After the pain subsides, it’s important to stop the medications I just mentioned so the use of pain medications will not result in other complications.

Strategies to avoid complications of sickle cell disease and ensure non-dependency on opioids when treating patients for pain as a result of the disease. 

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

Unmet Needs in Sickle Cell Disease Management 

We heard a lot in that first segment, but we’re going to transition to currently available therapy. This is really important because this landscape has changed remarkably. Sid, you’re going to take this first question. What did the GINA [Genetic Information Nondiscrimination Act] and NHLBI [National Heart, Lung, and Blood Institute] guidelines recommend for the treatment? What are the current therapies?

 Had you asked me this question 30 years ago, I would probably be giving you the same answer I am today. Clearly the foundation of treatment for asthma is inhaled corticosteroids [ICSs], as it was back then. We’ve had some nuances, which we’ll discuss. But also, we’ve sort of forgotten those guidelines. In addition to the approach of treatment, and while you’re doing it, you need an objective measurement. You need that environmental control as part of the whole treatment package. Certainly, we know about the pharmacological treatments: the inhaled corticosteroid and then adding on. Plus the partnership you get with the patient, hoping they’ll understand their disease, understand why they’re taking the medication, and understand the potential adverse effects. Some of the most brilliant things that occurred in those early guidelines, which persist even today, are the concepts of step-up therapy and minimal persistent inflammation. I’m not going to delay this, but I was amazed when I was a young fellow or a young faculty member and there was a study showing inhaled corticosteroid and bronchial biopsies, and most of those eosinophils melted away in 3 months. But not all of them. There was continued inflammation, and this is something we’re constantly telling our patients, even if they’re feeling better: Use inhaled corticosteroids. So that step up and step down is probably 1 of the most important contributors to the asthma field by these guidelines.

You hit a really important point, and certainly the step-wise approach is the dynamic approach. Nic, I’d like you to comment on this: Failure to step down, and the step down, can occur when you add a new intervention, like a biologic, that’s effective. Are you stepping down therapy or are you looking at this dynamic approach bidirectionally?

 Absolutely. Stepping down is certainly harder to do. Stepping up, you can throw the kitchen sink on the patient and see what happens. We tend to forget that with inhaled steroids—I agree with Sid, they still are the magic for asthma. At the same time, there are dose-dependent adverse effects. So if you have somebody on high-dose inhaled steroid, or even worse, oral steroid, then you definitely need to step down. How often? Every 6 to 8 weeks, you have to assess asthma control. You look at lung function. I don’t like to step down by looking only at symptoms because some patients may have poor perception of airway obstruction. I usually like to look at spirometry as well as asthma control before stepping down. I usually step down the inhaled steroid dose first. Although if you look at the guidelines and FDA, they suggest maybe even stepping down on the LABAs [long-acting beta-agonists] if they’re added to an inhaled steroid.

That would be my next step after stepping down the inhaled steroid. But I’ve rarely ever taken them off inhaled steroids, unless they have very mild asthma that’s seasonal. As an asthma specialist, I don’t see those patients, but they do exist. Some patients may not need inhaled steroids year-round, and this is maybe even more true in younger patients—in pediatrics as well—who they can use inhaled steroids only in the season when asthma flares up. 

We’ve done some changes. The NHLBI also released its latest reiteration of the guidelines recently. I agree with Sid that things haven’t changed too much, but 1 of the things that has changed is pushing the envelope of using as-needed inhaled steroid with a rescue medication, rather than a regular inhaled steroid in the milder population. I don’t think the jury is set on this, but it’s something that’s relatively new, and we’re looking at how to implement these strategies.

That’s a beautiful segue to the next question. We talked about controllers and relievers and relievers and controllers. Geoff, how about you describe the new world. We get a fuzzy boundary, right? What do you think? How do you define controller reliever?

 What Nic has raised is creating a lot of complexity in the United States for multiple reasons. No. 1 reason is it’s a bit of a step away from a personalized approach to patients. It may be lumping together individuals who have very mild disease, who just need a reliever medication—classically, albuterol. Used on an as-needed basis, individuals who have more persistent disease don’t flare and have normal lung function. They have risk of flares, which require systemic steroids. Of course, for that group—it’s a very interesting approach—ICS long-acting beta-agonists are a good thing. 

The other thing is that there’s going to be some slow uptake in the United States because of insurance companies. I’m not sure it’s going to be easy for patients to get ICS LABA as a rescue therapy in this country at this point in time. It’s going to take a long time for us to retrain physicians and patients on this approach, so there are some complexities to this. I believe that GINA has allowed for the classic approach. They have both the preferred approach, as well as an alternative approach, which is still what we classically use: albuterol for rescue, inhaled steroid for control, and then step-up-therapy to LABA–LAMA [long-acting muscarinic antagonist] triple therapy, and then biologic therapy and systemic corticosteroids. But probably on the horizon is a better ICS bronchodilator, which is an ICS–SABA [short-acting beta-agonist]. This is probably what we should have in the clinic for patients who require frequent or systemic ICS use or have risk of flares. We have a little more work to do in this category, but that’s my answer to the question.

This whole concept of as-needed use of an ICS, an ICS LABA or SABA, is really interesting. You know what it’s really embracing? What our patients already do. We believe patients use controllers less as we prescribe them, but let’s be honest, they’re doing this approach already because the moment they get their disease under control, many of my patients say, “I don’t need this medication. I down dose.”

. 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. It comes to you wherever you’re at: on your phone, in your office, or in your home. I want to thank everyone and our sponsors for this wonderful opportunity. Have a wonderful day, and be safe. Thank you.

A review of the current available treatment options for severe asthma and a look into the GINA/NHLBI guidelines. 

Current Treatment for Severe Asthma 

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

It could take up to 10 years to develop new treatments for inflammatory bowel disease.

News

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Conference

Gastroenterology

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, IBS and IBD, Crohn's disease, and more.

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Internal Medicine

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Jean-Frederic Colombel, MD: The Commitment to Biologics for IBD

Implications for treating patients at risk of cardiovascular disease with rivaroxaban plus aspirin based on the COMPASS and VOYAGER PAD clinical trials. 

Reducing CV Risk With Dual Antiplatelet/Anticoagulation Therapy 

Armand Butera is the assistant editor for 

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Articles

Investigators suggest symptoms in asthmatic patients are more severe, although it does not result in higher mortality rates.

Pulmonology

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Asthmatic Patients Experience Harsher Reaction to COVID-19

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 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Patient-reported scores showed no overall differences across 3- and 12- month follow-up. 

Pain

Opioid-Induced Constipation

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No Significant Difference in Low-Back Pain Stratified Care Compared to Usual Care

The treatment was well-tolerated with a safety profile consistent with previous clinical trials. 

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Zuranolone Reduces Depressive Symptoms in Phase 3 Trial

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This past year has brought unique challenges for sickle cell disease patients and communities of color. The ongoing vaccination campaign is yet another challenge that healthcare communities must find ways to overcome. 

Rare Disease Report®

Pediatrics

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Kim Smith-Whitley, MD: The Importance of World Sickle Cell Day

Younger individuals and those with specific sickle cell genotypes led to earlier predictions for fetal risk of sickle cell disease.

Women's Health

Hospital Medicine

New Model Identifies High Risk Sickle Cell Patients During Pregnancy

A new study builds upon previous insights and contributes to the growing trend of probiotic treatment in young patients.

Allergy

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Probiotic Mixtures Effective in Managing Atopic Dermatitis in Children 

Investigators considered myocarditis favorable to COVID-19 infection, with resolution of symptoms in all patients. 

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Latest Clinical News

Step-Up Treatment for Severe Asthma

The Future of Individualized Therapy in SARDs

Individualizing Treatment to Reduce Risks of CVD

Unmet Needs in Sickle Cell Disease Management

Current Treatment for Severe Asthma