If you treat psoriasis on a regular basis, then you may be familiar with statistics from the National Psoriasis Foundation indicating that just over half (57 percent) of patients with severe psoriasis are receiving topical therapy exclusively. The Foundation also found that the average patient with psoriasis sees two to three dermatologists before they acquire treatment with which they are satisfied. In addition, approximately 20 percent of dermatologists are responsible for 99 percent of prescriptions for biologic agents.
These numbers should prompt serious reflection from dermatologists about the current state of psoriasis treatment and how we as clinicians can improve care for our patients. But the message here is simple: Psoriasis is not being treated aggressively enough in this country. A variety of factors likely contribute to this problem, ranging from concerns about the safety of biologic agents, insurance barriers, malpractice worries, or even perhaps situations in which clinicians do not wish to treat patients with severe psoriasis.
To further probe these issues, I recently posed a series of questions to some of my colleagues, seeking their impressions of the state of psoriasis care, with a particular focus on biologics and how they should figure in the treatment of moderate to severe psoriasis. Ahead, I will share some of the feedback I received and attempt to synthesize the differing viewpoints and perspectives expressed on issues ranging from questions of psoriasis being undertreated, to the viability of long-term use of biologics. In light of your clinical experience, surveying of the data, and discussion with colleagues, would you say psoriasis is undertreated? According to Steven R. Feldman, MD, PhD, Professor of Dermatology, Pathology, and Public Sciences at Wake Forest University, personal experiences can be very misleading, as we're not likely to see our colleagues' well-treated patients. Nevertheless, he notes that the data from the National Psoriasis Foundation makes him believe that under-treatment is common. While topical therapy appears to be over-utilized, other perhaps effective approaches appear to be under-utilized. According to Gerald G. Krueger, MD, Professor of Dermatology at the University of Utah, anything less than clear or near clear status as a goal for treatment is not acceptable, which is why topical therapy simply is not enough for some patients. “This should be a goal for all of us, as until we do, even for those who have less disease, we put them at risk for shortened life span and less than full success at home and outside the home,” says Dr. Krueger.
There are many possible reasons for psoriasis patients receiving inadequate care. Brian R. Keegan, MD, PhD, a dermatologist who practices at Windsor Dermatology in New Jersey, says that, “Patients are generally more concerned about chronic medications and their cost, safety and efficacy.” In addition, some patients may be resigned to their condition, due to the chronic nature of their disease. Arnold C. Toback, MD, Clinical Assistant Professor of Dermatology and Internal Medicine at Columbia University, notes that many patients seem to seek a level of symbiosis with psoriasis. “They have it, but it doesn't rule them, and they have kept a balance with it,” says Dr. Toback. But the effect psoriasis can have on patients' quality of life can be profound.
Data indicate that psoriatic patients get less sleep than non-psoriatics and have more anxiety.1,2 In addition, psoriasis has been shown to affect how patients pursue particular career paths or make life-altering decisions.3 It is crucial that clinicians recognize this, rather than facilitate the notion that patients should accept their condition. According to Abby Van Voorhees, MD, Assistant Professor of Dermatology and director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania, some patients are told by practitioners to accept their disease rather than treat it, and they become subsequently discouraged from receiving the best and most extensive treatment. “Ensuring that patients get to see doctors who will to treat them with the appropriate prescription medications is key,” says Dr. Van Voorhees.
What role should biologic agents play in the treatment of patients with moderate to severe psoriasis?
According to Dr. Krueger, all treatment options for psoriasis need to be considered in order to clear the skin and maintain results. Dr. Van Voorhees notes that biologics are just a few of the options for treatment of psoriasis. “I consider that there are about a dozen therapies, each with unique advantages and possible risks, and each needs to be considered for the unique patient,” says Dr. Van Voorhees. Biologics offer unique and effective treatment in the most extensive and difficult cases, according to Dr. Toback. Dr. Feldman generally advocates use of biologic agents after phototherapy (including an oral retinoid if not contraindicated), while Dr. Keegan suggests that biologics should be first-line agents for patient with moderate to severe psoriasis, due to improved patient compliance and current safety profile.
What is your impression of the growing pool of data on long-term safety and efficacy of both newer and established agents?
While efficacy has been documented fairly well with TNF inhibitors such as etenercept (Enbrel, Amgen) and adalimumab (Humira, Abbott) and the newer IL 12/23 inhibitor, ustekinumab (Stelara, Centocor), clinicians have some concerns regarding safety. According to Dr. Keegan, current safety data for the established biologics is quite robust. However, in light of the unexpected adverse event of progressive multifocal leukoencephalopathy that led Genentech to withdraw efalizumab (Raptiva) from the market, physicians such as Dr. Keegan are still concerned about emerging rare events. Most physicians are aware of the rare potential for particular adverse events, including lymphomas, renal failure, liver damage, and infection, associated with TNF inhibitors, but it's important that patients are informed about them. Says Dr. Van Voorhees, “The long term risks I am most concerned about include infection risks associated with the TNF inhibitors and cardiovascular risks of the IL 12/23 compounds.” Dr. Van Voorhees adds that clinicians need to be vigilant about the possible risk of malignancy, as well. According to Dr. Feldman, while there is also some concern about potential unknown longterm effects of IL-23 inhibitors, these are unlikely based on the experiences of individuals living with genetic IL-23 deficiencies.
Although there are still questions and concerns about biologic agents, Dr. Krueger observes that progress is being made in terms of both how they are utilized and understood clinically. Current perspectives about use of biologics range greatly, however. “Many feel that we have enough data to think that what we now have, in the terms of safety data, all we need to treat, to clear, and maintain,” says Dr. Krueger. However, he adds, “Many of our colleagues and many of our patients think that we need more data.” For some this will not happen in our generation, Dr. Krueger notes. Placed in context, however, the current safety and efficacy data is encouraging, while the longer-term data is of greater quality than what we are typically used to for most long-use dermatologic drugs.
According to Dr. Toback, while biologics have great risk in the small percentage of patients who have significant side effects, they are most safe when used by physicians with the greatest experience: “The patient-doctor relationship gives the canvas upon which these agents are used.” Those who are experienced at treating psoriasis are probably utilizing them in an appropriate way, but given that so few dermatologists actively prescribe biologics, there is a question as to whether these agents should receive somewhat higher consideration across the spectrum of dermatologists.
There appears to be some disparity among dermatologists between those who make psoriasis a focus of treatment versus those who do not. In the latter group, biologics are likely not considered for a variety of reasons; among which would certainly be safety and experience. But other issues may perhaps cloud the biologic picture and otherwise discourage clinicians from considering them.
To what extent does the potential for malpractice weigh in your decision to prescribe a biologic agent?
“Malpractice does not figure at all into my decision to prescribe biologics, nor do I see it playing a significant role in the continued development and use of biologics for psoriasis, at least not in my practice,” notes Dr. Feldman. While Dr. Krueger and Dr. Van Voorhees echo these sentiments, other clinicians report some concern of malpractice, but not necessarily attached to biologic agents themselves. Dr. Toback, who does not prescribe biologics regularly, notes that the potential threat of malpractice would to some extent temper his use of them if he did. “Our specialty is not used to day-to-day higher risk procedures,” says Dr. Toback. Therefore, he suggests a need to account for medicolegal implications in teaching and instructing patients. Says Dr. Keegan, “We expose ourselves to potential malpractice every time we see a patient. We can be sued for anything that we do or fail to do. That being said, I attempt to inform my patients of the risks, benefits and potential side effects of their treatments regardless of biologics vs. conventional systemic,” observes Dr. Keegan.
Although there are more variables involved with use of biologic agents, which would warrant greater consideration and discussion with patients, the lack of a tangible connection seems to suggest that malpractice may be more a problem of perception than reality with biologics.
Do you regard insurance reimbursement for biologics to be a barrier to quality care for patients with severe psoriasis?
According to responses, opinions vary greatly on the significance of insurance reimbursement for biologic therapy in the treatment of psoriasis. Insurance can be a major roadblock in the eyes of some clinicians, while not playing much of a role for others. For example, Dr. Feldman observes that some insurance companies may be too generous with reimbursement, as some do not require a trial of a home light unit before covering biologics—something Dr. Feldman would advocate were he in the position of insurance companies. But according to Dr. Van Voorhees, insurance reimbursement is a “huge issue, since access is getting tighter, which makes fewer dermatologists willing to prescribe these medications.”
With the widening gap between practitioners who prescribe biologics versus those who do not, patient access to the appropriate care on a national level may be affected. For practices that specialize in psoriasis treatment (such as my own), clinicians and staff better understand the documentation necessary for prescribing a biologic agent, as they deal with it on a regular basis. Problems are encountered frequently in some practices when it comes to securing approvals, but with some effort they tend to get them approved. This is customary for practices that focus on psoriasis treatment. For a general dermatology practice, these problems can cause many frustrations, and, understandably, many clinicians may not want to deal with them.
A Disconnect in Treatment
There still seems to be some disconnect in the treatment of patients with moderate-severe psoriasis. I think most dermatologists recognize the burden of the disease. The question is why more clinicians don't treat severe psoriatic patients, or at the very least refer them to dermatologists that are interested in treating psoriasis. This may stem from economic factors, which may be as influential as not having the time or personnel to secure the proper approvals. Whether biologics are perceived to be too expensive or too much of a burden, they are an essential component in psoriasis care for moderate to severe cases.
It is possible that some practitioners may not want to educate themselves about the different biologic agents, because the data seem to be overwhelming. In fact, the data on these agents is extensive and continues to show the efficacy and safety of these agents. As with any pharmacological agent, there is some level of risk when using biologics, but when used properly, these risks can be minimized greatly and patients are at a much greater likelihood to achieve clearance or near clearance. It is understandable if treating psoriasis is not the focus of a particular practice. But in these cases, physicians should be willing to refer to other local dermatologists who do treat psoriasis extensively.
Our patients deserve the best treatments available. And although there may be numerous barriers that sometimes stand in the way of delivering optimal care, there are few things as satisfying to a clinician than seeing the smiles that shine on patients' faces when they achieve clearance and relief of their psoriasis.
Dr. Bagel is on the speaker's bureau for Abbott Labs, Amgen, Centocor, Galderma and Leo Pharma.
Jerry Bagel, MD is Clinical Associate Professor of Dermatology, College of Physicians and Surgeons of Columbia University, New York. He is Director of Psoriasis Treatment Center of Central New Jersey.
- 2011 AAD Meeting, New Orleans. P 3341
- 2011 AAD Meeting, New Orleans. P 3315
- Warren RB, Kleyn CE, Gulliver WP. Cumulative life course impairment in psoriasis: patient perception of disease-related impairment throughout the life course. Br J Dermatol. 2011 May;164 Suppl 1:1-14.