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Patient Education for Biologic Therapy of Psoriasis and Psoriatic Arthritis

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Author: 
Cheryl J. Gustafson, MD, and Steven R. Feldman, MD, PhD
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Properly educating patients about the benefits and risks of biologic therapy can lead to significant improvements in the symptoms of psoriasis and patient satisfaction.

Editor's Note: Please see the PDF posted on this page for Figure 2.

The treatment of psoriasis has undergone revolutionary change with the recent implementation of biologic agents. Unlike traditional systemic medications that affect the immune system and other organs, biologics are designed to target specific aspects of the immune system, avoiding other end organ toxicities. Some biologic agents block T-cell receptors, while others block signaling proteins, such as tumor necrosis factor-alpha (TNF-α) or interleukins 12 and 23. In addition to relative safety, the mechanism of action of these medications has expanded our ability to control psoriasis considerably.   

Biologic agents offer new hope to psoriasis patients who have either experienced harmful side effects from, or have not responded to, other psoriasis treatments. Although biologic agents are FDA-approved as monontherapy for psoriasis, concomitant use with other therapeutic modalities — such as topical agents, methotrexate and phototherapy — is associated with enhanced efficacy. Additionally, using a biologic agent in combination with insufficiently effective non-biologic treatments may permit dose reduction or discontinuation of the non-biologic agent, thereby potentially reducing adverse effects and simplifying treatment regimens.

While biologics provide new levels of efficacy and safety for the management of moderate-to-severe psoriasis, they also raise new patient education issues. Patients may have questions about the effectiveness of biologics (which raises issues of how we measure efficacy), the safety of biologic agents (which raises critically important issues about how safety information is obtained and communicated), the cost of the medication (which depends on a host of factors), and how to properly administer biologic therapy. Even before biologic treatments became widely used, psoriasis patients often demonstrated a poor understanding of their disease process and treatment regimens. Psoriasis patients too frequently report dissatisfaction with their medical care.1 Such dissatisfaction is primarily in regard to poor physician-patient communication rather than healthcare providers’ competence regarding the medical management of psoriasis.2

The purpose of this article is to provide practical pearls that will help physicians better meet patients’ educational needs regarding biologic treatment of psoriasis. The topic will be presented in two parts. Part I will focus on patient education regarding efficacy and safety of biologic agents for psoriasis. Part II, which will be published in a subsequent issue of The Dermatologist, will discuss educating patients about the costs and proper administration of biologic therapy.

Efficacy Of Biologic Therapy

For patients to make an informed decision regarding treatment, they need to thoroughly understand the potential benefits of biologic therapy. Describing the efficacy of biologics in absolute terms can be difficult. Patients generally have no experience regarding PASI scores, the primary measure used to evaluate efficacy in clinical trials. Hence, relative differences in efficacy may be easier to communicate.

In a recent observational study, clinical improvement and treatment satisfaction were evaluated among patients on biologics compared to other treatment options for severe plaque psoriasis.3 Compared to other psoriasis treatments, biologics were associated with significantly greater clinical improvement, as disease severity declined from 70% to 15% with biologic therapy. The following clinical improvements were observed for other psoriasis treatments: topicals, 22% to 10%; phototherapy, 20% to 11%; conventional systemic agents, 49% to 15% (all P≤0.03). Patient satisfaction was significantly greater for biologic therapy (59%) compared to topicals (45%), phototherapy (34%) or conventional systemics (42%) (all P<0.001). Additionally, dermatologists also reported greater satisfaction with biologics (60%) compared to other psoriasis therapies: topicals (35%), phototherapy (26%) or conventional systemics (42%) (all P<0.001).3

At the time this article was written, there was very limited information from clinical trials directly comparing the efficacy of the different biologic agents available for psoriasis. One clinical trial compared adalimumab and methotrexate and found adalimumab to be considerably more effective; another compared ustekinumab to etanercept and found ustekinumab to be more effective. Several meta-analyses have been performed to generate estimates regarding the comparative effectiveness of the various biologic agents; the probability of response and relative risk with biologic therapy versus placebo were determined via statistical analysis of data from twenty randomized controlled trials.4 Of the available biologics, infliximab was found to have the highest predicted mean probability of response at PASI levels 50 (93%), 75 (80%) and 90 (54%), followed by ustekinumab 90 mg at 90%, 74% and 46%, respectively, and then ustekinumab 45 mg, adalimumab and etanercept.

Although these findings suggest a ranking of biologic treatments that could be of potential use, it is important to note the data evaluated were from short-term randomized trials. Therefore, response to treatment over such short periods of time may not be representative of long-term efficacy of biologic therapy. When giving patients information on the comparative efficacy, it may be helpful to let them know that the long-term efficacy of the different biologics is not so well defined.

Although biologics are an effective treatment for moderate to severe psoriasis and psoriatic arthritis, treatment efficacy can be reduced if patients develop anti-drug antibodies. Protein-based medications can induce the formation of anti-drug antibodies. These antibodies bind to the protein molecules of the drug, thereby neutralizing the effects of the medication on the immune system. Of the available biologics, infliximab is the most immunogenic, as it is a murine-human chimeric protein.5 Concomitant use of infliximab with methotrexate is associated with reduced formation of anti-drug antibodies.6,7,8 In addition, higher and more regular doses of infliximab are less immunogenic than lower, intermittent (as needed) doses. However, no randomized clinical trials have been performed, to date, to evaluate the long-term efficacy of methotrexate in combination with infliximab versus infliximab monotherapy for psoriasis.

Patients should be educated about the possibility of developing neutralizing antibodies. They should also be instructed to contact their physician if their psoriasis worsens and/or psoriatic arthritis so they can be clinically re-evaluated to determine if their treatment regimen needs to be changed.
 
Risks And Potential Side Effects  

Understanding risk is an essential requirement for patients to make informed risk/benefit decisions. It is critical that we counsel patients of the short- and long-term risks and side effects of biologic therapy. Determining safety risks is more difficult than determining efficacy, because the sample size needed to quantify relatively rare risks is much, much larger than the sample size needed to pin down efficacy. We can say that the risks of infection and malignancy are small, yet the exact numbers are hard to quantify. Communicating this to patients is all the more problematic.

One of the primary areas of concern is opportunistic infection, as biologics block certain aspects of the immune system. Patients who are considered appropriate candidates for biologic therapy should be informed that there is likely to be an increased risk of infection with any drug that downregulates immune function and about the importance of contacting their physician immediately if they develop any sign or symptom of infection, such as fever, chills, flu-like symptoms, cough or sore throat. Likewise, if patients acquire a significant open wound, they should contact their doctor for further evaluation to determine if biologic therapy should be continued or withheld.

The most common side effects associated with biologic therapy include upper respiratory infections and flu-like symptoms. In the majority of instances, these side effects are mild; therefore, discontinuation of biologic therapy is usually not necessary. Injection site reactions are also a common side effect of biologics, as these medications have to be injected subcutaneously or administered via infusion.

In addition to these common side effects, patients should be educated about other, potentially serious, complications of biologic therapy. Areas of concern include: malignancy/lymphoma, congestive heart failure and demyelinating disease.9 Psoriasis patients have a double to triple relative risk of developing lymphoma compared to non-psoriasis patients. The exact reason for this increased risk remains unknown; however, it is postulated that it is due to a combination of factors, such as inflammation from the disease itself, effects of medications and possible concurrent infections with Epstein-Barr virus.

The benefits and risks of prescribed medications are often presented to patients WITH statistics, which can be confusing. Hearing that a biologic agent is highly effective but can double or triple the risk of a serious adverse event can have a significant impact on patients’ and physicians’ clinical decisions. However, when baseline risk of serious adverse events is very low, tripling the risk of an adverse event may not carry much significance. Thus, it may be worthwhile to use illustrations and graphs as tools to educate patients about the health risks associated with biologic therapy.

The perceived risks often overshadow the demonstrated benefits. For instance, TNF-α inhibitors have high efficacy for the treatment of moderate-to-severe psoriasis. On average, 1.5 to 2 patients need to be treated to see one patient achieve marked reduction in disease severity.10 In a recent study, the risk of serious adverse events associated with TNFα inhibitors — including tuberculosis, lymphoma and demyelinating disease — was compared to the risks patients take on a regular basis, such as being in a car accident. The risks of serious adverse events from the medication were comparable to the risks patients take on a regular basis. In a separate study, the risk of these potentially serious adverse events from biologic therapy was compared to the lifetime risk of more common ailments, such as heart disease, stroke and cancer.11 Patients on biologic therapy had a much greater risk of acquiring a common ailment compared to sustaining a potentially serious adverse event from biologic therapy.

Biologics in PracticeTo help demonstrate this information to patients, risks of biologic therapy can be stratified in a graphical manner and compared to more common risks, such as car accidents (see Figure 1). This may enable patients to visualize and better understand medication risks and make more informed decisions regarding the treatment of their disease.

Figure 1: Graphical Illustration of Lifetime Risk3

Editor's Note: Please click on the image to see a full-size version of the graph.

Discussion

Patient education is a key component for both patient satisfaction and treatment success. Though psoriasis is a chronic disease, patients may not have an understanding of their disease process. In a qualitative study, communication issues among dermatologists and psoriasis patients were evaluated.12 Although physicians emphasized the need for patient education regarding psoriasis (eg, pathology, medical management, associated co-morbidities), some physicians reported that patients are not able to fully understand the complex nature of the disease. Since patients differ in their level of knowledge of psoriasis, as well as the degree to which they want to learn more about their disease and treatment, physicians indicated they usually only provide this information if requested. Additionally, physicians felt this information might be too confusing for patients to understand, but patients indicated they would like physicians to provide more detailed verbal and written information, particularly about the following issues: co-morbid conditions associated with psoriasis, disease course/progression, triggers for flares and treatment options.

Patients should be empowered to ask about their medical problem and treatments. The National Patient Safety Foundation introduced Ask Me 3, which is a patient education program implemented with the goal of improving communication between patients and healthcare providers.13 Patients are encouraged to understand three major questions:

 (1) What is my main problem?
 (2) What do I need to do?
 (3) Why is it important for me to do this?

In addition to these questions, physicians can address patients’ individual concerns and questions about their disease.

Unfortunately, there is only limited time to educate patients during outpatient clinic visits. Hence, it is difficult to cover every issue associated with psoriasis. It may be helpful if three to five minutes of the visit are spent on educational information. This can be difficult, especially during visits in which considerable time is spent on history taking and other aspects of care. In addition to providing verbal counseling to patients about biologic therapy and other medications for psoriasis, physicians can provide written materials to provide further information on the topics addressed in the patient education checklist (see Figure 2).

Additional resources, such as brochures and handouts, may help make the process more efficient. An invaluable resource is the National Psoriasis Foundation (NPF). The NPF is a non-profit, voluntary health agency that is dedicated to providing psoriasis patients with useful, educational resources. In addition, the NPF offers a variety of support networks for patients, including online communities and local group chapters. Membership to the NPF is free and patients should be encouraged to join. The American Academy of Dermatology also provides helpful educational resources for psoriasis patients.

One study revealed that patients are counseled at a surprisingly poor level about their medications.14 Many patients feel they receive inadequate education regarding prescription medications, such as treatment expectations, side effects and proper usage. In regard to psoriasis, as healthcare providers are well aware, this chronic disease requires long-term maintenance therapy with topical and/or systemic medications. However, patients often report using their medications only when they feel it is necessary, such as during the initial treatment period and flares.12 One step to improve patient adherence to prescription medications is to provide proper education regarding long-term usage of psoriasis therapies. It is likely that treatment outcomes will subsequently improve with increased adherence.

Practical pearls for patient education regarding proper administration and use of biologic therapy will be discussed in Part II of this article.

Dr. Gustafson is with the Center for Dermatology Research and the department of dermatology at Wake Forest University School of Medicine in Winston-Salem, NC.

Dr. Feldman is with the Center for Dermatology Research and the Departments of Dermatology, Pathology and Public Health Sciences at Wake Forest University School of Medicine.

Disclosure: The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories, L.P.