Comorbidities Special Populations Idiosyncrasies Influence Decisions
byCharles Bankhead, Senior Editor, MedPage Today March 6, 2019
WASHINGTON — Knowing when not to use a biological agent to treat psoriasis can help optimize outcomes for many patients, a psoriasis specialist said here.
Reasons for considering alternatives to biological therapy vary from valid clinical issues to demographic considerations to personal preferences and idiosyncrasies. At one time, patients’ aversion to needles made adherence to injectable therapies problematic, although that issue has subsided, Russell Cohen, MD, of Mount Sinai Health System in New York City, said during a forum on biologic therapy at the American Academy of Dermatology meeting.
In contrast, direct-to-consumer advertising has emerged as a major influence on patients’ perceptions about therapies, contributing to opposition to biologic therapy that lacks a scientific base but nonetheless makes sense to the patient.
“I had a patient who came in just yesterday 72 years old, total-body psoriasis,” said Cohen. “He had seen many dermatologists, and nothing made it better. He said, ‘I’ve heard that you’re the guy, you’re the biologic guy.’ We talked about everything and he was all ready to do it. I brought in my biologic coordinator, and I said, ‘OK, let’s do it.'”
“He said, ‘I can’t.’ I asked why not, and he said ‘Because my mother said they’re dangerous.’ His 97-year-old mother told him not to take a biologic.”
Comorbid Conditions
Special Populations
Disclosures
Primary Source
How Safe Are The Drugs
Most of what is known about side effects of the biologics comes from trials of people with rheumatoid arthritis, Crohns disease, or other ailments. The risk of experiencing a side effect for people with psoriasis appears to be less because combination therapy with methotrexate and other medications that suppress the immune system were not used in psoriasis clinical trials.
The risk of experiencing side effects is an important factor to consider when choosing to take a biologic drug.
C Data Abstraction And Data Management
Two reviewers will use a standardized data extraction tool to independently extract data disagreements will be resolved through discussion. The following data will be collected from each unique study: author identification, year of publication, funding source, study design characteristics and methodological quality criteria, study population , patient baseline characteristics , intervention and comparator regimen in detail , use of concurrent standard medical therapies, data needed to assess intermediate and final health outcomes and harms, outcome definition, and data reported for subgroups of interest defined in KQ 3. Authors will be contacted for clarification or to provide additional data when necessary.
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Observational Cohort Study Finds Less Risk Of Serious Infection In Patients Taking Newer Targeted Systemic Medications For Psoriasis
- Date:
- Beth Israel Deaconess Medical Center
- Summary:
- Dermatologists found a decreased risk of infection in patients with psoriasis using some of the newer, more targeted medications compared to those taking methotrexate, a drug widely used since the 1960s as a first line treatment for moderate-to-severe psoriasis.
A common chronic skin condition affecting 125 million people worldwide, psoriasis is an autoimmune disease, a class of disorders in which the immune system attacks the body’s own healthy cells. In recent years, new medications — known as biologics — that inhibit the overactive immune system by targeting specific inflammatory pathways, have revolutionized the treatment of psoriasis and other autoimmune diseases. However, until now, few studies have documented the comparative safety of these various biologics.
“In addition to being potentially more effective than methotrexate, some of the newer targeted treatments for psoriasis may also be safer for patients in terms of risk of infection,” said Dommasch, who is also Instructor of Dermatology, Harvard Medical School. “Doctors and patients may want to consider the risks of infection when choosing a systemic treatment for patients with moderate to severe psoriasis.”
“This information should be considered when prescribing therapies for individual patients,” said Dommasch. “This study demonstrates how researchers can use ‘big data’ to help compare the safety of different medications for patients with psoriasis.”
Youd Prefer To Take Fewer Doses
Many psoriasis treatments have to be taken daily to be effective. It can be hard to remember to take your medication on time, especially if youre busy or you travel often. Biologics, on the other hand, are usually taken less frequently.
Some biologics have to be injected once per week, but others, like ustekinumab , need to be injected only once every 12 weeks after the first 2 doses.
You can also give yourself most biologics at home after being trained by a medical professional.
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Methotrexate Raises Risk Of Serious Infections More Than Newer Biologics
Patients with plaque psoriasis taking apremilast, etanercept, and ustekinumab had a lower rate of serious infections than those who took methotrexate.
Erica Dommasch, MD, MPH
Patients with moderate to severe psoriasis receiving a handful of the newer biologic drugsapremilast, etanercept, and ustekinumabhad a lower rate of serious infections compared to patients who received methotrexate.
The study also included patients who received the systemic biologics acitretin, adalimumab, and infliximab, who did not have a significant difference in the rate of overall serious infections compared to those who received methotrexate.
Lead author Erica Dommasch, MD, MPH, a dermatologist at Beth Israel Deaconess Medical Center and instructor of dermatology at Harvard Medical School, highlighted the clinical implications of the study results.
“Doctors and patients may want to consider the risks of infection when choosing a systemic treatment for patients with moderate to severe psoriasis,” said Dommasch.
The observational cohort study used claims data from 31,595 patients in Optum Clinformatics Data Mart and 76,112 patients in Truven MarketScan from 2003 through 2015. These patients were diagnosed with psoriasis and were new users of acitretin, adalimumab, apremilast, etanercept, infliximab, methotrexate, and ustekinumab.
The study, Risk of Serious Infection in Patients Receiving Systemic Medications for the Treatment of Psoriasis, was published in JAMA Dermatology.
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Tips For Overcoming Your Hesitation
Biologics arent new. The first biologic for psoriasis was approved in 2003. Over the last couple decades, researchers have gathered quite a bit of evidence to support the safety and effectiveness of these medications.
You may be hesitant to talk with your doctor about biologics because youve heard theyre stronger drugs. Or perhaps youre worried theyre too expensive.
Its true that biologics are considered a more aggressive treatment option. They also have a high price point. But theyre more targeted drugs, which means they work very well. And they tend to have fewer side effects than other psoriasis treatments.
Still, you shouldnt take a biologic if:
- your immune system is significantly compromised
- you have an active infection
- you recently received a live vaccine such as shingles, MMR , or flu mist
- youre pregnant or nursing
If youre afraid of needles, ask your doctor about a new treatment for psoriasis known as apremilast . Otezla is taken as a pill twice per day. It isnt considered a biologic. Rather, its in a new class of drugs known as PDE4 inhibitors. Otezla is FDA-approved to treat moderate to severe plaque psoriasis when phototherapy or systemic therapy is appropriate.
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What If Methotrexate Isnt Working For My Psoriatic Arthritis
If methotrexate doesnt work for you or if youre having side effects, your doctor may try prescribing another DMARD or a biologic therapy, according to the NPF. The dose of methotrexate may be increased over two to three months if its tolerated but not effective at a lower dose, Ostrowski says. If that doesnt work, other options would be to try another traditional DMARD or switch to a newer biologic DMARD, such as a TNF inhibitor.
What Steps Should Someone Take If A Biologic Is Ineffective Or Stops Working
Many people experience benefits from biologics for several years. But in some cases, the response lessens over time.
This may result from the persons body developing antibodies against the medication, neutralizing its effect. In some cases, a particular class of biologics may not be effective at all.
While psoriasis on any two people may look the same, various genetic mutations can cause the condition. Depending on the particular type of mutation, or genotype, a person may respond better to a certain class of biologic.
Currently, medical professionals have yet to identify all of the genetic mutations that cause psoriasis, and they have no way of predicting which drug will lead to the best response.
However, many of these medications have been evaluated both in people new to biologics and those who have previously used other types. So, we do have some guidance when making decisions for our patients.
If an individual does not respond to a biologic after several weeks of continuous use, or if someone is no longer responding to one, the dermatologist may change the medication to another in the same class or to one in a different class.
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What To Discuss With Your Dermatologist
You should tell your dermatologist if you:
-
Have any side effects while taking the biologic
-
Stop taking the biologic
-
Have questions, including how to take the biologic
-
Become pregnant
Biologics and vaccines
Before you get a flu shot or vaccinated against any disease, call your dermatologist. You should NOT get some vaccines while taking a biologic.
Related AAD resources
Cordoro KM. Management of childhood psoriasis. Adv Dermatol. 2008 24:125-69.
Feldman SR. Treatment of psoriasis. UpToDate 2015 Jul, Wolters Kluwer Health. Last accessed November 2015.
Kim WB, Marinas JEC, et al. Adverse events resulting in withdrawal of biologic therapy for psoriasis in real-world clinical practice: A Canadian multicenter retrospective study. J Am Acad Dermatol 2015 73:237-41.
Motaparthi K, Stanisic V, et al. From the Medical Board of the National Psoriasis Foundation: Recommendations for screening for hepatitis B infection prior to initiating antietumor necrosis factor-alfa inhibitors or other immunosuppressive agents in patients with psoriasis. J Am Acad Dermatol. 2014 Jan 70:178-86.
Singh JA, Wells GA, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD008794. DOI: 10.1002/14651858.CD008794.pub2.
All content solely developed by the American Academy of Dermatology
The American Academy of Dermatology gratefully acknowledges the support from Amgen and .
A Comparison Of Psoriasis Severity In Children Treated With Methotrexate Vs Biologic Agents
- JAMA Dermatology
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Your Psoriasis Is Mild But Really Bothers You
Biologics are typically reserved for those with moderate to severe psoriasis, but they could be an option if your psoriasis is greatly affecting your quality of life.
Even if your psoriasis is considered mild, you may have painful plaques on the soles of your feet, your palms, your face, or your genitals. The pain may prevent you from doing your usual activities. In these cases, a switch to a biologic may be justified.
Major Cardiovascular Events Risk In Plaque Psoriasis Similar Between Biologics And Methotrexate
There were no significant differences among 3 biologic therapies and methotrexate used to treat chronic plaque psoriasis and the risk for major cardiovascular events , according to results published in the Journal of the European Academy of Dermatology and Venereology.
This cohort study examining the comparative risk for major CVEs was conducted using the British Association of Dermatologists Biologics and Immunomodulators Register. For the main analysis, data from adults with chronic plaque psoriasis receiving ustekinumab were compared with those of patients taking a tumor necrosis factor inhibitor as the reference group. For the secondary analyses, data from patients receiving first-line adalimumab were compared with data from patients taking ustekinumab, etanercept, or methotrexate. Patients were observed from the date of receiving therapy to first major CVE or the earliest date of change of treatment, end of recorded data in the register, death, or end of the study follow-up . Investigators examined the risk for major CVE occurrence once during treatment as well as within a 90-day window following the last dose.
âOverall, we found no difference in the risk of major CVEs between etanercept, adalimumab, and ustekinumab in adult patients with moderate-severe plaque psoriasis following short-to-medium term exposure,â researchers wrote. Future studies are needed to assess longer-term impact.
Reference
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First Data For Ustekinumab
There certainly doesnt appear to be any added benefit from using methotrexate on a group level in patients getting ustekinumab and TNF inhibitors, Dr. Siebert said. Weve looked at everything, he emphasized, and none of the single domains or composite measures were improved by the addition of methotrexate. I think we knew that for TNF inhibitors, but the key thing is weve never known that for ustekinumab, and this is the first study to show that.
Indeed, the findings match up with those from the SEAM-PsA study in which patients who were treated with the TNFi etanercept as monotherapy did much better than those given the TNFi in combination with methotrexate or methotrexate alone. While not a randomized trial, PsABio now shows that the same is true for ustekinumab.
Obviously, there are some clear differences between a clinical trial and an observational study such as PsABio. For one thing, there was no randomization and patients taking methotrexate were presumably doing so for good reason, Dr. Siebert said. Secondly, there was no methotrexate-only arm.
What Is Methotrexate And How Does It Work
A medication in the class of antimetabolites, methotrexate works by blocking a cells ability to continue to replicate and make copies of itself. In psoriasis, an overactive immune system allows skin cells to have an abnormally fast growth cycle, which results in the symptoms of painful scales and plaques on the skin. Methotrexate suppresses inflammation and decreases the overproduction of skin cells.
Methotrexate is also used to treat rheumatoid arthritis and some cancers, although in those cases, it is typically given in much higher doses than it would be when treating psoriasis.
Methotrexate can be given orally in pill or liquid form, by subcutaneous injection under the skin, or through intravenous infusion. For psoriasis treatment, methotrexate is most often prescribed by dermatologists in pill form or as an injection, usually given once a week. When taking methotrexate, folic acid levels in the body may be depleted, and often, a folic acid supplement is recommended.
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How Well Do Biologics Work
Biologics don’t cure psoriasis, but theyâre effective. Some people see clearer skin within a few weeks.
These drugs may be the best option if your symptoms are moderate to severe. Biologics work better than conventional drugs like methotrexate, acitretin , and cyclosporine . And their targeted actions can mean fewer side effects.
Some biologics work better the longer you’re on them, or if you pair them with another psoriasis treatment. But not everyone sees big benefits. Others canât tolerate the side effects, which can include a skin reaction to the shot, diarrhea, and headaches.
B Searching For The Evidence
A systematic literature search using the strategy detailed in Appendix A will be conducted in MEDLINE® and the Cochrane Central Register of Controlled Trials. Language restrictions will not be applied. A manual search of references from included clinical trials and systematic reviews will be conducted. A grey literature search for meeting abstracts will be conducted in Web of Science, limiting search results to meeting proceedings. For agents with an FDA-approved indication for the treatment of psoriasis, a search for completed trials with posted results will be conducted on ClinicalTrials.gov and a search of FDA regulatory documents will be conducted. Data from these two sources will be used to supplement published manuscripts when the trials can be matched. The Scientific Resource Center of the Agency for Healthcare Research and Quality Effective Health Care Program will contact the manufacturers of identified interventions and comparators for scientific information packets. The same inclusion/exclusion criteria previously described will be applied to packets that are received. The literature search will be updated concurrently with the peer review process, and the same inclusion and exclusion criteria will be applied as described previously. Relevant literature will be incorporated into the review.
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Talk With Others Who Understand
MyPsoriasisTeam is the social network for people with psoriasis and psoriatic arthritis and their loved ones. On MyPsoriasisTeam, more than 91,000 members come together to ask questions, give advice, and share their stories with others who understand life with psoriasis and psoriatic arthritis.
Are you living with psoriasis and have been treated with methotrexate? Share your experience in the comments below, or start a conversation by posting on your Activities page.
What Are The Potential Side Effects Of Biologics And How Can Someone Manage Them
The main side effects that biologics can cause include infections and malignancies.
While reducing inflammation in the skin is good for psoriasis, blocking the immune system which defends the body from infections and combats cancerous cells can potentially lead to adverse effects.
If the immune system does not protect the body from infections and cannot recognize and fight off abnormal cells as well as usual, a person may have a greater risk of infections and malignancies.
Besides these risks, TNF blockers have been associated with the development of multiple sclerosis, or MS.
Also, IL-17 blockers have an additional warning about a potential increased risk of inflammatory bowel disease, or IBD.
While the potential adverse effects may be worrisome, they are extremely rare. With regular follow-up visits to a dermatologist, these drugs are safe to use.
The dermatologist will examine the persons skin, assess their medical history for any potentially concerning symptoms, and perform blood monitoring.
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