The Importance of Minimizing the Communication Gap

by Joan T. Merrill, MD

Dr. Joan T. Merrill, Medical Director

Several years ago the Lupus Foundation of America collaborated with Lupus Europe and the biopharmaceutical company UCB on a survey of people with lupus. In the United States, 531 patients participated. Most (93%) were women, 86% were between 20–50 years old, more than half were married and almost as many had children. If you were to take a poll of patients in my clinic, this would pretty well describe them.

So how did 531 people with lupus think they were doing? 69.2% said that they have 3 or more flares each year. The most common problems reported included fatigue, arthritis, muscle pain and skin rashes. More than half of the participants reported depression. When asked about current medications, only 44% said that they were satisfied and 45% reported that their treatments impair daily activities or work.

But when I ask my patients how they are doing, most will say pretty well. Maybe they will report some symptoms, but will often blame the weather or stress, making it easy for me to assume that that nothing important happened. But in a busy clinic, that may be exactly what I want to believe. So most of the time, the medical visits with my patients are pleasant and fairly routine. And if you look at the medical literature, you are unlikely to see reports of more than one or two mild-moderate flares/year per patient.

Well, we know that the patients disagree about that. In fact, several studies of lupus have found that patients opinions on how they are doing are completely mismatched with those of the doctors. Doctors who work on clinical research express frustration that patients have trouble differentiating chronic damage or depression from lupus flares, and the disconnect between doctors and patients opinions is often attributed to this. But are we certain about who is making which mistake?

Most clinical trials in lupus find that only 40-50% of patients meet the cutoffs we (the doctors) set to define improvement. What do we think is happening to the other 50-60%? Are doctors missing lupus flares because we are not as good as we think we are at recognizing what is lupus and what is “other?” Another poll of patients with lupus was performed by the pharmaceutical company GlaxoSmithKline. This survey found a three way breakdown of communications, with patients minimizing their symptoms both to their doctors and their families. This can’t be helping the doctors to recognize flares. What can be done about this?

It might be difficult to make doctors listen better or to convince patients to risk the emotional discomfort of complaining. But what if there was an efficient written tool to accurately track symptoms and responses to treatments, both from the doctors and the patients perspectives? This might be set-up to clearly distinguish lupus problems from non-lupus problems and supplement information that is lost during intermittent, time-limited clinic visits. The Lupus Foundation of America is dedicated to solving the cruel mystery of lupus and developing tools for patients and doctors to improve communication. We welcome input about what you think and what type of tools would help ensure successful communication with your doctor. Leave your comment below with your ideas!

Guest Column: Back to School with Sodium Girl

Jessica Goldman

By Jessica Goldman

As a kid, August meant two things: rushing to finish my summer reading list (ugh) and back to school shopping (yes!). And when I say shopping, I don’t mean buying jeans or the coolest new light up high tops. I’m talking supplies: multi-colored pens, neon colored notebooks, crisp lined paper, maybe even a protractor and a calculator. Or three. Yes, I was a total nerd.

But now, as an adult, I realize my enthusiasm for back to school shopping resulted from more than a love for paper goods and writing utensils. It came from the delight in creativity (remember those colored pens?) and the commitment to have fun while making preparations for the year ahead.

Which brings me to this big point -- to live a full life with a chronic illness, at any age, requires a lot of energy, forethought, and yes, preparation. And going back to school is no exception to the rule. So as you or your kids get ready for pre-K to college, it’s important to approach your medical and health needs with the same zeal as those neon notebooks; to involve your young students in the process; and above all, to make it fun.

Parent Teacher Student Meeting

You don’t have to wait until Halloween to meet with school staff. Teachers usually return a week or so before the first day to set up classrooms and prepare for the year ahead. So whether you call the office or stop by to set up a meeting, make sure to get some one-on-one time before the first bell rings.

And of course, don’t feel limited to the homeroom teacher. Invite anyone who needs to be aware of your child’s needs (like the PE teacher, the school nurse, head of the cafeteria). And remember to make it fun! Bring cookies and milk, tea and sandwiches, or perhaps something special for the homeroom. Simple gestures like this help create a positive working relationship for the months and years to come.

Show and Tell

Before you can ask for help, it is essential to know what you need. So make a date with your child or teen to talk about the challenges of school (whether it is a special diet, the need to leave early for doctors appointments, or telling the other kids about their condition). And most importantly, figure out ways (together!) to overcome each one.

For younger kids, a big poster board and stickers help to literally map out this “big picture” approach and strategies. Or for a more involved crafts project, write your own story book about living with lupus that can be read to the class.

As for teens and young adults, give them the reins as much as possible. Such as helping them write notes to their teachers, creating special protocol sheets for different health circumstances, or organizing medical info folders for the essential staff. Need more artsy inspiration? Check out these food allergy tattoos.

It’s just one of many creative solutions that make taking care of medical challenges easy and fun.

Meet, Play, Love

The classmates in your child’s life are just as important as the school staff. And getting to be like the other kids -- participating in play dates and sleepovers -- is a huge part of staying healthy and happy. So it is important to get other parents involved, so that both you and your child have the support and confidence you need.

But these conversations don’t have to be dull. Again, THINK FUN. Invite everyone over for an afternoon, and while the kids pretend to be dinosaurs or space warriors, break the ice with the moms and dads by serving up lemonade and treats. Then let them know the kinds of things your child would need during a playdate or sleepover, gauge their comfort with these requests, invite their own suggestions, and of course always express your appreciation for their support. Because when you welcome others into your world with enthusiasm, they’ll be excited to play along.

As for teens and college students, make use of social networks! Encourage them to use Facebook and Twitter to find peers (beyond their classroom) with the same health needs. The exchange of online support will not only help them feel a part of greater community but will also generate new ideas on how to live a full, healthy life.

For more special diet, low-sodium advice, recipes, and adventures, visit www.SodiumGirl.com. And pick up a copy of Sodium Girl’s Limitless Low-Sodium Cookbook from Amazon, Barnes & Noble, or anywhere books are sold.

The Power of Sharing Your Personal Story

Kim Cantor

by Kimberly Cantor, Senior Director of Advocacy and Government Relations

A personal story is powerful – to those who tell it and to those who hear it. On June 24 and 25, lupus activists from across the country will meet in Washington, DC for the National Lupus Advocacy Summit, where lupus activists will unite to tell their stories to help solve the cruel mystery of lupus.

The Lupus Foundation of America’s legislative successes would not be possible without the power of lupus activists across the country who work tirelessly to make their voices heard both locally as well as on a national level. For example, their compelling and personal stories have helped:

• Secure more than $27 million for the National Lupus Patient Registry and lupus epidemiological studies at the Center for Disease Control and Prevention (CDC);
• Illustrate the clear impact lupus has had on those who serve in the military by keeping lupus listed as a disease area eligible for research funding under the Peer Reviewed Medicare Research Program (PRMRP) at the Department of Defense resulting in more than $12 million in lupus research to-date; and,
• Encourage 48 bi-partisan members of the United States House of Representatives to join the first-ever Congressional Lupus Caucus led by Representatives Tom Rooney (R-FL), William Keating (D-MA), Ileana Ros-Lehtinen (R-FL), and Jim Moran (D-VA). 
• Increase funding for health professional education, which led to the creation of The Lupus Initiative
• Co-found the Ad Council's first national lupus awareness campaign on lupus along with U.S. Department of Health and Human Services' Office on Women’s Health (OWH)

However, there is still so much to be done. Lupus is one of the cruelest, most mysterious diseases on earth, yet research on lupus remains underfunded compared to its scope and devastation. Together, we can change this. During the first day of the Advocacy Summit, activists will receive training on basic advocacy principles and the Foundation’s legislative priorities. Day 2, activists will travel to Capitol Hill and meet with their Members of Congress to tell their lupus story, using their story to educate Congress on the Foundation’s legislative priorities, why these priorities are important to people with lupus and to raise awareness of the disease.

Sharing your story and engaging in advocacy is powerful and empowering. We encourage you to become a lupus activist and to engage with your Members of Congress through e-mails, phones call and in-district visits. Plus, there is still time to join the Foundation on June 24 and 25 for the National Lupus Advocacy Summit. Remember: just one story can and does make the difference.

Developing Clinical Trials for Lupus

By Dr. Joan T. Merrill

Dr. Joan Merrill

Clinical trials for lupus have been challenging. The main reason for this is that no two patients are exactly alike, not as people, not in terms of how the symptoms come and go, and not in the fine details of how the immune system disorder plays out. This means that no one treatment works for everybody and for those who might potentially benefit from a given treatment no one dose works for everybody.

When new treatments are tested in clinical trials, the FDA and the drug companies know about these issues, but the challenge is to come up with a simple protocol that can be tested on all kinds of different patients around the world and can answer two simple questions. Is the treatment reasonably safe and does it work better if you do give it than if you don’t give it? If these two conditions are met, the regulatory agencies can consider approving it for use in the clinic.

Think about this question, though: Does a treatment work better if you do give it than if you didn’t give it? To answer this question you just need more people to get better in a group who get the drug than in a group that receives placebo (or dummy treatment). So to answer this question it doesn’t matter if up to half the people participating in a clinical trial were never going to benefit from this treatment in the first place. In fact less than half of the people around the world who took Benlysta in the large international Phase III trials actually met the criteria for improvement. Still it did well enough to be approved, now, in a growing number of countries worldwide.

Here are the important questions that have not been answered by that simple question: Which patients are more likely to benefit from Benlysta? How can the dose be optimized for an individual patient? How can we tell, in patients for whom it is not working whether it will never work for them (in which case it should be stopped) or whether it might be of significant benefit if the amount of dose, timing of the dose, or combinations with other medications could be optimally adjusted? The answers to all of these things needs to be worked out and the fact that the FDA has approved Benlysta at only one dose to be given only at rigid monthly intervals is not helping matters.

But even if doctors in clinic were given more flexibility to practice the art of medicine in treating patients with new expensive biologics, it would be difficult to address these important questions about how best to treat individual patients using information from the clinical trials. Remember that a wide range of patients from all over the world, with disparate individual differences in their immune system were treated with Benlysta while still taking various additional lupus treatments, all of which are already at work changing the immune system of each of these patients in different ways. This superimposes a whole lot of treatment influences onto what we already know are different background immune disorders in the patients. In trying to figure out who is more likely to get benefit from Benlysta or how best to treat those individuals it will be difficult to sort all of this out.

How will we sort all of this out? I want to tell you about our recent study that a large team of doctors and scientists have recently completed as a collaboration between the Oklahoma Medical Research Foundation and Pfizer Pharmaceuticals. The name of the study is BOLD which stands for Biomarkers of Lupus Disease. Biomarkers are detailed bits of biological information that can be picked up from a simple blood test which can be used to sort out very complex questions about individual differences that perturb the balance of the immune system. Some biomarkers that are active in some patients might suggest a disorder that Benlysta could fix. Others might suggest that different types of treatments would be better. Importantly, it has been hard to figure out in any previous studies what the impact of all the various lupus treatments are on these biomarkers which might really confuse a doctor if they were trying to pick out a treatment to either add on or switch a patient to. The BOLD study was designed to begin looking at this very question. Patients who agreed to be in the study were considered qualified to participate if they had active disease, but at the start of the study they could be on various background treatments. A blood sample was taken. After that, unlike most clinical trials, the strong background immune suppressants were stopped. Everyone received a short course of steroids. More blood was sampled when the participants were better. The steroid was allowed to wear off. The patients were followed closely with serial blood donations and they were instructed to return to clinic within three days if their symptoms came back. When a “flare” visit occurred, blood was drawn once more and then the patient was immediately treated.

Before this, almost everything known about biomarkers in lupus has been based on random samples of blood from biologically diverse patients on a cacophony of background medications. Now there is a freezer full of samples donated by patients where we can address biologic diversity by comparing the same patient with active disease on azathioprine (or the other immune suppressants) to themselves when they flare up without that treatment on board. This is how we can learn what the real impact of these agents on lupus is and how some of them, when they are allowed to be used during trials, could be interfering with certain drugs we are trying to study. In the past two years some preliminary data from the BOLD study has already been presented at the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) meetings. Now that the study is completed, the full reports will be out in the next year.

It is well known that lupus patients can be sorted into two major groups, those with inflammation that seems strongly influenced by interferon alpha and those with a much lower interferon influence. The preliminary abstracts that have already been released from the BOLD study are suggesting that many other factors that distinguish one patient from another, including the impact of immune suppressants, might be better understood by appreciating that they have different impacts on the interferon low and high groups. A better understanding of how to sort lupus into biologically meaningful subsets, and the biologic influence of background treatments on each of these groups may help to better design and interpret clinical trials as well as to inform better and more precise medical care for individual people in the future...not just for 50% of the people.