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Jaime is a freelance writer for The American Journal of Managed Care® (AJMC®), where she previously worked as an assistant editor.

She has a BA in print journalism from Penn State University. You can connect with Jaime on 

Articles

This analysis found that the 3000 patients with hemophilia had higher rates of pain, depression, and anxiety medication use.

Use of Pain, Depression, Anxiety Meds Higher Among Patients With Hemophilia

Former NBA star Magic Johnson has partnered with GSK to educate the public about this virus, specifically in seniors and those at high-risk for contracting a severe form of RSV.

 Raising Awareness About RSV in Older Adults

Mary is the associate editorial director for The American Journal of Managed Care® (AJMC®), The Center for Biosimilars®, and Evidence-Based Oncology™. She joined AJMC® in 2013 and oversees speaker recruitment and panel preparations for AJMC®'s premier annual oncology meeting, Patient-Centered Oncology Care®.

She has a BA in communications and philosophy from Loyola University New Orleans. You can connect with Mary on 

Based on promising results, the biotech IMV has moved into phase 2b trials with a cancer vaccine composed of survivin epitopes that uses the company’s proprietary delivery system to elicit persistent immune responses.

Delivery Matters: In Early Studies, DPX Technology Allows  Vaccines to Persist When Cancer Pushes Back 

Between 2019 and 2020, there were 97 reported shortages among sponsor-reported antiseizure medications in Australia, 93% of which were generic brands.

Shortages of Antiseizure Meds Continue, More Common Among Generics: Australian Report

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

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1rem

Compendium

 Lupus compendium is a comprehensive resource for clinical news and expert insights for the inflammatory disease that occurs when the immune system attacks its own tissues.

The top 5 most-read articles on lupus of 2022 included the role of B cells in systemic lupus erythematosus (SLE), the diagnostic journey of women with SLE, future therapies for cutaneous lupus erythematosus (CLE), and more.

Case Report Details Rare Case of SLE With Cutaneous Leukocytoclastic Vasculitis

Aerobic capacity and cardiovascular risk both improve when people with systemic lupus erythematosus (SLE) exercise regularly, according to a new systematic review.

Physical Activity Benefits People With SLE, but Many Do Not Meet WHO Guidelines

The data could help clinicians better identify patients who are good fits for belimumab after rituximab.

New Data Suggest Biomarker for SLE Therapy Response

A systematic review and meta-analysis presented at ACR Convergence 2022 provide insight into the effects of belimumab in patient populations with cutaneous lupus erythematosus, with or without systemic lupus erythematosus (SLE).

Belimumab Provides Benefit in Cutaneous Lupus Erythematosus, With or Without SLE

Discrepancies in how we manage women’s health impacts the diagnosis of 

 and causes certain symptoms of the disease to be overlooked, said Liz Lightstone, MBBS, PhD, FRCP, professor of Renal Medicine for the Faculty of Medicine, Imperial College London.

What is a misconception on lupus nephritis among patients and clincians?

I don't know. I mean, there are assumptions about who gets it. So, if you see a young Black woman with a rash and joint pains, you may well think of lupus. But equally I would say they're often underdiagnosed. So, the biggest problem I face is that because it's women, and it's women of childbearing age, a lot of their early symptoms are, you're tired, you're busy with your kids, it's your hormones—all that rubbish that comes into the discrepancies in how we look after women, which we know now impact on cardiovascular disease, impact on everything.


So, that sexism if you like, everyday sexism, that impacts on how someone who's coming in saying I'm really not well, and somebody listening and hearing that there's a pattern and this is out of the ordinary. Just doing a blood test and dipping the urine, you might find you've got an answer. I also think people find lupus really difficult. So, in a way that would be good if they then just refer them to someone who didn't find it so difficult. But if you hang on to the patient and you're not treating them properly, you're doing them in enormous disservice. And the biggest problem I have is people who will just stick someone on sterapred and a few weeks later refer them, and you sit there and go, oh you could have done better.

Videos

Liz Lightstone, MBBS, PhD, FRCP, professor of Renal Medicine for the Faculty of Medicine, Imperial College London, discussed how sexism and other factors cause certain symptoms of lupus nephritis to be overlooked, contributing to delays in diagnosis and care.

Dr Liz Lightstone: Lupus Nephritis Misconceptions Contributing to Underdiagnosis, Low-Value Care

 It’s nice to have 2 new data sets, which we haven’t had for at least 40 years, with respect to the treatment of these patients. We recognize that MMF [mycophenolate mofetil] took a role from the data from [the University of] Miami, and Dr [Gabriel] Contreras and Dr [Gerald] Appel. It was found to be noninferior to Cytoxan therapy, which is the original therapy from the 1980s that was approved by the NIH [National Institutes of Health]. The complications of Cytoxan therapy led to significant problems.

Around 2009, MMF took the role as the mainstay of adjunct therapy along with steroids. But as far as steroid therapy in combination with MMF or other types of regimens, we’ve known data from 2016 or 2017 that high-dose systemic steroids lead to significant end-organ complications. In particular, about 74% of new end-organ target damage occurs with steroid therapies greater than 7.5 mg per day. These data aren’t new. They’ve been out for a while. We’ve just been implementing it with the new data that have been set forward.

We recognize that steroid therapy is sometimes needed as induction therapy, but long-term usage of these drugs has led to the complications we recognize: not just as cataracts or glaucoma but also sodium retention, hypertension accelerations, and endovascular acceleration of atherosclerosis, leading to mortality of these patients with steroids. Therefore, we’re glad to see that new conventional therapies and studies have shown that we’re able to treat these patients with these new regimens but with minimal steroids in the long term. We now have other options. For T-cell or B-cell suppression, both studies are quite intriguing and have a role in the treatment of these patients, depending on your interpretation and how your outcomes are. We’re glad to have belimumab as well as MMF and voclosporin in the new regimen for our patients going forward. In the Spiriva trial, only 8.3% of patients had a complete remission, although they had different sets of guidelines. But we’re able to accomplish far better outcomes in these patients with these new types of B-cell and T-cell suppression drugs.

 When we diagnose a patient with lupus nephritis, it can be a little overwhelming [for them]. Think about a 32-year-old who recently married, had a couple of kids, and is being hit in the face with this diagnosis. It can be a little overwhelming. It’s even more overwhelming when we talk about medications. They hear some of the adverse effects of these drugs, and they say, “These adverse effects sound worse than my disease.” I tell them, “If we don’t control your disease and get you under control as quickly as possible, we’re going to see this disease progress.” We think about the structure inside the kidney called the nephron. I like what some of my nephrology colleagues say: “For patients with lupus nephritis, time is nephrons.” I should act very quickly to get the disease under control.

When a patient has proteinuria in their urine at baseline, we want to see a 25% decrease at 3 months and a 50% decrease at 6 months. That’s the target. If you aren’t getting there by 6 months, you need to adjust your treatment. In my practice, we start several agents up front to get patients under control. As they get better, we start pulling away drugs. The No. 1 drug we want to decrease and stop if possible is corticosteroids.

The treatment landscape is changing, but we have more long-term data supported by randomized controlled clinical trials, so the guesswork is no longer needed. You don’t have to worry about whether a drug is going to work while using older drugs that we thought worked from transplant literature and other data. Those days are gone. We now have a group of drugs that worked in clinical trials to get these patients as close as possible to control of their disease.

Expert panelists share strategies and considerations for selecting optimal treatment pathways for patients with lupus nephritis.

Video Series

Considerations for LN Treatment Selection

 There are a lot of drugs being used to treat patients with lupus nephritis. For example, going back to my analogy about what lupus is, these angry cells are turning, and they spill out of the bloodstream and get into the kidneys, causing lupus nephritis. I want to give drugs that dampen the immune system. I use another analogy that [being] young and healthy balance out the scale, but with lupus nephritis, the scale is tilted on the negative side. Those angry cells are attacking the kidneys. I want to see if I can get it back to as balanced as I can. I don’t want to go too low because we’re going to see some adverse effects. That’s why we talk about our drugs as more like immunosuppressor drugs.

One of the hallmark drugs we use are corticosteroids—mostly prednisone or methylprednisolone. Those drugs are great, but it’s a double-edged sword. They work very quickly. They can get some patients into significant control. But we can’t keep patients on them long term, because with long-term corticosteroids, I’ve got to get back to that balance. I don’t want a young, 30-year-old woman to get cataracts or diabetes or have osteoporosis of her bones. Those are features that we worry and think about regarding what’s good and the bad for some of these treatments.

In addition to corticosteroids, we use other immunosuppressive drugs. Mycophenolate mofetil is one of the hallmarks, along with cyclophosphamide. All of those drugs were borrowed from our oncology counterparts to dampen the immune system. Those are potent drugs, but we don’t want to give too much and turn the immune system too low, because then we see increased risk of certain types of infections and of cancers.

For example, cyclophosphamide is used, and a study is coming out from the NIH [National Institutes of Health] and Europe showing that it works for patients with lupus nephritis, but even after 1 dose of that medication, I have to tell the patient, “I need to monitor you on a regular basis to make sure you don’t go on to get bladder cancer coming from the medication.” Mycophenolate is a great drug. I usually prefer it at my practice. It doesn’t have all the other adverse effects, but it’s still an immunosuppressive drug. I want to make sure patients aren’t going to get bowel infections, pneumonia, and other types of illnesses that are triggered by that.

Then we talk about a class of drugs called the calcineurin inhibitors. These drugs work in a number of ways. We’re learning that some of these newer agents are targeting the immune cells, such as the T cells, and they’re stabilizing the part of the cells that anchor the kidneys together, making that dam intact: the podocytes. The landscape has changed. The days of treating people willy-nilly are gone. We have targets in mind. I talked earlier about the goals we set with our patients with lupus. They want to reduce their pain, fatigue, and swelling of the legs. I say, “I want to get the protein in your urine down by 50% in 6 months.” There’s a ratio in which we look at the protein and the urine vs the creatinine. I want to make sure that number goes down to 0.5 mg/dL or less.

There are certain features and targets that we use. With the corticosteroids that we use as a bridge therapy, the No. 1 goal is to get the corticosteroid dose down to less than 7.5 mg. When I was doing my fellowship at Duke University, we talked about 10 or 15 mg of prednisone. That was a low dose. We’ve learned so much more [since then], including that 7.5 mg or more can cause more harm than good. Now I want to get my patients off if possible, or to a target of 2.5 or 5 mg. That means that the landscape in treating patients with lupus nephritis has changed, which is exciting for our patients who have active disease.

When you think about our different treatment options for lupus nephritis, I want drugs that are FDA approved. When you think about drugs that aren’t FDA approved, they’re experimental, and patients don’t come to my practice wanting to experiment . They want to get the best treatment options based on evidence-based medicine, and that’s what we do. I tell my colleagues, “That’s what we all should be doing.” Let’s start with evidence-based medicine to get these patients under control.

[We don’t want to] use drugs that we think have worked. We want to say, “We go to things that have been shown in randomized controlled clinical trials, and these are the ones that the FDA mandates.” This leads to getting data in the peer-reviewed journals. The rheumatology and nephrology journals are all out there to vet those [drugs]. There aren’t many FDA-approved drugs. We have corticosteroids and calcineurin inhibitors, such as voclosporin. These were vetted in clinical trials, which showed that when patients have been on the drug for 1 or 2 years—we now have long-term data—we can decrease the protein in the urine, preserve the glomerular filtration rate, and do that in the setting of low-dose corticosteroids. Many drugs are out there, and some of my colleagues are using them, but they aren’t FDA approved. My patients are demanding me to give the best medication supported by the best evidence.

Alvin Wells, MD, PhD, provides an overview of the lupus nephritis treatment landscape.

LN Treatment Landscape Overview

An increased risk for worse patient outcomes in 

 have been associated with non–Northern European White individuals and those from low socioeconomic backgrounds, said Liz Lightstone, MBBS, PhD, FRCP, professor of renal medicine for the Faculty of Medicine, Imperial College London.

How do race and sociodemographic factors impact patient outcomes and care management in lupus nephritis?

So, we know that being from a deprived background is likely to lead to a worse outcome. And that's really complex—it’s education level, it’s access to treatment, it’s speed with which you get your treatment. If you're in a job that you're only paid when you're there, and you need to go to clinic—it's a choice between do you earn or do you get your health care done. So, all those factors, I think, feed in hugely.


Everyone who is non–Northern European White has a risk of worse outcomes with lupus. I'm not quite sure why that is and what the genetic impacts are. In the Black population, it's related to the 

 gene, almost certainly giving them an extra bonus hit of doing badly if you've already got kidney disease, that's work known from a long time ago.

There's also issues about trust, involvement, and understanding of the need to be in trials. And I think we need to do a huge piece of work. I know particularly in the United States, there's enormous distrust in the African American community around trials. And I think it's our duty and our job to find ways of showing that we can be trusted and that it is hugely valuable to their communities for people to go in. And it just takes time. It takes time and effort to involve people. I treat, in West London, a very, very diverse community, and I have to say nearly everyone I've gotten into trials has been non-White, but it takes a lot of time and effort.

Liz Lightstone, MBBS, PhD, FRCP, professor of renal medicine for the Faculty of Medicine, Imperial College London, discussed the influence of genetics and background on the care management of lupus nephritis.

Population Health

Dr Liz Lightstone on Race and Sociodemographic Implications in Lupus Nephritis

 The goals of therapy for patients with lupus nephritis have changed over time. Based on the MAINTAIN trial in 2016, we know protein reduction is critical for long-term renal outcome. Therefore, prompt diagnosis, biopsies, and therapeutic interventions are important for these patients in focusing on reducing proteinuria, obtaining a bland urinalysis, and trying to get the urine PCR [protein-creatinine ratio] less than 700 mg/g, depending on what you read, or less than 500 mg/g, depending on the study.

We have lacked data in academic research for over 40 years regarding the management of lupus nephritis. The lack of data has left us with a status quo of partial remission—in essence, having patients with protein leakages greater than 1.5 g or above. We often relied on a 50% reduction, which we clearly know based on the data hasn’t been sufficient to treat these patients to a complete remission. Depending on the articles you read, complete remissions and partial remissions are varied. But overall, the consensus is that if we’re able to get a protein excretion less than 700 mg per day, those patients do quite well with less deterioration from a renal perspective in outcome.

We also know the European guidelines have been well defined and accepted by the US guidelines, where the reduction of urine PCR with the standard of therapy of blood pressure control, RAS blockade, etc, has led to the backbone of management of these patients along with the standard of care that has been set forward. Dr [Gerald] Appel, Dr [Gabriel] Contreras from the University of Miami, and other colleagues [showed the value of] MMF [mycophenolate mofetil]–Cytoxan therapy and steroid therapies, which were the standard of therapy for many years until 2020. We now have 2 medications with good outcomes that we’re able to add to the revolver and treat the complexity of these patients that we haven’t had in 40 years.

 I tell my patients with lupus nephritis that we need to set some goals. I sit down with them and ask, “What are your goals? What do you want to do?” They say, “Dr Wells, I don’t want to have pain or fatigue. I don’t want the swelling in my ankles to continue.” As a rheumatologist, I want to make sure your disease is under control, that you don’t get end-stage kidney disease and end up on dialysis. We try to put those features together. Even though we talk about kidney disease, some of the biggest things that drive patients into the clinic are swelling of their ankles, weight gain, and fatigue. These patients might go to bed at night and think they’re sleeping for 6 or 7 hours, but when they wake up, they feel like they’ve been hit by a truck. That’s because the immune system is turning like a machine and not able to shut off unless we use aggressive medications.

With patients with lupus and lupus nephritis, I say “Let’s talk about our goals.” Let’s see if I can minimize certain drugs, such as corticosteroids, which have some adverse effects we don’t like for long-term [use]. Let’s see if we can maximize and preserve their kidney function long term so that a 30-year-old woman who presents with lupus nephritis can have as close to a normal life expectancy as possible.

Alvin Wells, MD, PhD, and Jorge Larranaga, MD, highlight the goals of treatment for patients with lupus nephritis.

Patient Goals in Treatment of LN

 There are many issues involved in seeing patients with lupus disease. Many patients experience delay in care for multiple reasons, including socioeconomic status, insurance, young age, and not seeking attention until it’s too late. But there are some data from Medicaid years ago that say that 1 of 8 patients with lupus nephritis are seen in a hospital setting in a very critical state with rapidly progressive crescentic renal diseases. This has suggested that there’s poor, inadequate interactive collaborative management and transitions of patients’ care among physicians and hospitals.

Furthermore, the percentage of patients who have received immunosuppressive therapy after the diagnosis of lupus nephritis is quite impressive in the sense that 13% of patients get immunosuppressive therapy within 30 days of having a lupus nephritis diagnosis. Roughly 22% of the patients get immunosuppressive therapy at 90 days, and 34% get it 1 year after a lupus nephritis diagnosis. This is clearly unacceptable. These are data from the Medicaid trials. These patients need to be seen [and receive] intravenous [treatment] as urgently as possible. Otherwise, it’s ultimately about renal demise and patient survival.

 Many patients with lupus and lupus nephritis utilize a lot of aspects of our medical system. That young female patient with lupus nephritis has to be seen every 3 months by a rheumatologist. She has to get bloodwork. She has to get her urine tested. She’s going to be on several medications to treat her disease. Because of the disease and the medications patients are on, they can have other complications. Patients with lupus nephritis are at increased risk for infections. They can end up with cardiovascular disease. All of those features cost a lot in the medical system, and these patients need to be seen and followed closely.

At my practice, I tell my patients: “If you have a flare of your disease or other or new symptoms, don’t go to the emergency department. Call me. Because I know you and the drugs that you’re on. You know my staff, and we can treat almost everything that can trigger or be associated with a flare.” If a patient is retaining fluid or their blood pressure goes up, we can address that. When a patient is having a fever and a cough, it could be a sign of an infection. We can address that. Even though patients with lupus nephritis use a lot of health care resources, we can mitigate that and minimize how much they use by having them seen on a regular basis in a rheumatology clinic and by us if they have any acute or urgent needs.

If patients with lupus nephritis have disease progression—meaning they aren’t responding to therapy—they require a lot more utilization of health care resources. If you have a patient on multiple drugs to treat their lupus nephritis and they continue to progress—meaning they’re seeing more protein in their urine—there are certain markers in the bloodwork that are going up, and that correlates with some of their other symptoms as well. That patient is going to require more medications to get them under control.

When patients require more medications, we’re going to follow their laboratory values [more frequently than] every 3 or 4 months. I have some patients whom we test every month until we get them under control. Because as we worry about the balance of the benefits of the medicines, I also want to make sure there are no adverse effects of the medication. That’s why these patients have to be followed closely. One pearl I’ll put in a plug for is that even if your patients aren’t able to be seen physically in the clinic, they can take advantage of telemedicine. I can do a telephone call to address their acute or urgent needs. I can do a video visit to talk about different things as well. That’s something we do to keep these patients from using more health care resources.

Key opinion leaders discuss aspects driving care pathways for patients with lupus nephritis.