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Biologic medications for Psoriasis

Comparing effectiveness, safety, side effects, and price of biologic medications

Published: August 2014

At-a-glance

Psoriasis is a condition that causes red, thick, scaly patches on the skin. In some cases, psoriasis can also cause swelling and pain in the joints and spine, a condition known as psoriatic arthritis. Drugs that are put on the skin or those in pill form can help relieve symptoms of psoriasis and psoriatic arthritis, but they don’t work for everyone. In those cases, injectable medications called biologics—technically known as immunomodulator therapies—may be another choice. The biologic drugs do not cure psoriasis or arthritis due to psoriasis, but they can relieve symptoms and might help prevent joint damage from getting worse.

But the biologics can cause serious side effects that in rare cases can  even be life-threatening. The drugs are also are relatively new, so not much is known about their long-term safety. Because of those issues, biologics were used for many years only in people who had tried other therapies. Those therapies include:

  • Creams, salves, lotions, sprays, and gels that you put directly on the skin, such as hydrocortisone, betamethasone, calcipotriene (Dovonex and generics), clobetasol, halobetasol, and tazarotene (Tazorac).
  • Ultraviolet phototherapy or light therapy given at a doctor’s office. Used when large parts of the body are affected. 

But some doctors now use biologics first, especially in people who have severe psoriasis and those who have joint pain in addition to skin problems.

Other drugs often used to treat psoriasis include acitretin (Soriatane and generics), cyclosporine (Gengraf, Neoral, and generics), and methotrexate (Rheumatrex and generics). Those therapies have been used for a long time, and their advantages and disadvantages are well-studied and understood. But experts disagree on whether they should still be tried before biologics. 

If you try one of those therapies but do not get enough relief, then your doctor is likely to recommend a biologic. If you have severe psoriasis or psoriasis with joint pain, your doctor may recommend trying a biologic first.

There are six biologic drugs approved by the FDA to treat moderate to severe psoriasis. Four of them are also approved for arthritis due to psoriasis. All of them are expensive—none are available as a generic version. Without insurance, the price ranges from more than $2,000 to $6,000 per month. If you have insurance, your out-of-pocket cost may be less, depending on your coverage.

If you need a biologic to treat psoriasis or psoriatic arthritis, considering the evidence for effectiveness and safety, as well as cost, we recommend the following as Consumer Reports Best Buy Drugs.

  • Adalimumab (Humira)
  • Etanercept (Enbrel)

Studies show that for most people, these medications help relieve symptoms of psoriasis and arthritis due to psoriasis. And, they may have lower rates of side effects than some other biologics, such as infliximab (Remicade). Also an important: People in several studies were less likely to stop taking these two medications due to problems with side effects, compared to other biologics.

Although rare, serious or potentially life-threatening side effects from all biologic drugs can occur, including bacterial infections such as tuberculosis, pneumonia, or staph and fungal infections.

Minor side effects, such as pain and skin reactions where the drugs are injected, can also happen but usually do not require stopping or changing drugs.

Background

Psoriasis develops when the immune system turns against the body and attacks the skin and sometimes the joints. This process is called autoimmunity.  

Psoriasis causes red, thick, scaly patches on the skin called plaque-type psoriasis, and it is the most common type. The plaques can occur anywhere but often appear on knees, elbows, scalp, hands, feet, and lower back.

Psoriasis lesions can itch, sting, burn, or simply hurt. In some cases, they can also cause people intense anxiety. Some people may avoid social situations because they are worried about the appearance of their skin. People with psoriasis also have an increased risk of developing depression and anxiety.

Arthritis due to psoriasis can cause swelling, stiffness, and pain in the joints, which can be disabling. In some cases, this type of psoriasis can cause pits and other problems in toenails or fingernails.

Psoriasis symptoms often come and go. It's usually difficult to predict when flare-ups will occur, but having an infection or dry skin, experiencing stress, or taking certain medications can cause a flare-up.

More than 5 million adults in the U.S. suffer from psoriasis, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Children can also develop the ailment, but it occurs mostly in adults. It occurs about equally in men and women.

How severe your psoriasis is—how much of your body is affected by the psoriasis plaques—will be an important factor in helping you and your doctor determine which treatment might be best to try. For example, in very mild cases, there may be only a few lesions on the skin and topical creams or gels may be helpful.

But in moderate to severe psoriasis more than five to 10 percent of a person’s skin is affected. (To give you an idea of how much that is, the surface of one of your palms, including your fingers, represents about 1 percent of your entire skin surface.) Because the discomfort and itching can be so bad that it prevents a person from carrying out daily activities and reduces her quality of life, other drugs may be used, including a biologic.

There are other types of psoriasis, including guttate psoriasis—which causes small droplike lesions on the upper back—and pustular psoriasis, which produces lesions filled with pus. But the biologic drugs have not been studied in those types of psoriasis so we do not cover them in this analysis.

What is a biologic drug?

Biologics work by suppressing the human body's immune system. This helps stop or reduce the symptoms of psoriasis. Here are the six biologics we evaluate.

Table 1. Biologic drugs used to treat psoriasis

Generic Name

Brand Name FDA-Approved for Plaque Psoriasis? FDA-Approved for Psoriatic Arthritis?
Adalimumab Humira Yes Yes
Certolizumab Cimzia No Yes
Etanercept Enbrel Yes Yes
Golimumab Simponi No Yes
Infliximab Remicade Yes Yes
Ustekinumab Stelara Yes Yes

All of the biologics are given by injection. As Table 2 shows, one of them (Remciade) is given through a vein in your arm (intravenously), while the others are injected under the skin (subcutaneously).

How often you have to take a biologic will depend on which drug you take. Some are given once a week or every other week, some once a month or every three months, and others have a more varied schedule. Discuss with your doctor whether you feel comfortable injecting yourself or whether you prefer an intravenous infusion at your doctor’s office.

Table 2. How and when to take a biologic drug

Drug name How the drug is given How often
Adalimumab (Humira) Under the skin

Psoriasis: Two injections the first week, followed by another injection the second week.  Every other week after.

Psoriatic arthritis: Every other week.

Certolizumab (Cimzia) Under the skin Every other week.
Etanercept (Enbrel) Under the skin

Psoriasis: Twice weekly for 3 months, followed by once weekly.

Psoriatic arthritis: Once weekly.

Golimumab (Simponi) Under the skin Monthly.
Infliximab (Remicade) Vein in arm Given in weeks 0, 2, and 6, then every 8 weeks.
Ustekinumab (Stelara) Under the skin Two injections separated by 4 weeks; repeat treatment every 12 weeks.

Some of the biologics have multiple uses and are also approved for treating other diseases such as ankylosing spondylitis, Crohn’s disease, rheumatoid arthritis, ulcerative colitis, and other autoimmune diseases.

Who needs this medication?

The biologics do not cure psoriasis or arthritis caused by psoriasis, but they can relieve symptoms and may help prevent further joint damage.

Some medications such as creams, salves, lotions, sprays, or gels are safer and less expensive than the biologics. Or, if a large part of the body is affected, ultraviolet phototherapy or light therapy may be used. 

Some people might not get enough relief with those treatments or they might have joint pain that requires other medications. Other options for treating psoriasis include: acitretin (Soriatane and generics), cyclosporine (Gengraf, Neoral, and generics), and methotrexate (Rheumatrex, Otrexup and generics). These options also cause serious side effects, and doctors disagree about whether it is better to use one of them before trying a biologic.

Another option is apremilast (Otezla). This is a new type of medication that was approved by the FDA for treating psoriatic arthritis in early 2014, shortly before this report was being prepared for publication. Unlike biologics, Otezla does not suppress the immune system. Since it is brand new, it’s long-term safety has not been established. If your doctor recommends any of these drugs, you should ask about the advantages and disadvantages compared with a biologic.

Your doctor should not prescribe a biologic if:

  • You have an infection.
  • You are intensely fearful of injections.

Your doctor might decide not to prescribe a biologic if:

  • You have had tuberculosis in the past.
  • You have had other infections.
  • You have cancer.
  • You have or had heart failure.
  • You have certain neurologic disorders.
  • You are pregnant or breastfeeding.

Comparing effectiveness

Studies of biologics do not clearly show that one drug works better than the others to relieve symptoms of psoriasis or arthritis due to psoriasis. When used to treat moderate to severe psoriasis, four of the drugs—infliximab (Remicade), etanercept (Enbrel), ustekinumab (Stelara), and adalimumab (Humira)—usually work within weeks. And all reduce skin lesions in more than half of patients. For those with arthritis due to psoriasis, studies show biologics reduce joint pain and inflammation in most people who try one.

How well do the biologics work to relieve psoriasis symptoms?

Four of the six biologics we evaluated are FDA-approved to treat moderate to severe plaque psoriasis: adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade), and ustekinumab (Stelara). They have been studied in people who had 10 percent or more of their body surface area affected by psoriasis.

In nearly all of the studies our analysis evaluated, more than half of people who received a biologic experienced a substantial improvement—a 75 percent reduction in the size and severity of their plaques after taking a biologic for 12 to 16 weeks. People experienced less itching, redness, scaling, and lessening of the thickness of their plaques and of how much of their skin surface was affected.

The only head-to-head-study between two biologics compared Stelara and Enbrel. Depending on the dose they were given, after 12 weeks of therapy, between 68 percent and 74 percent of people who received Stelara had a major improvement in their skin lesions, versus 57 percent of those who received Enbrel. 

How well do the biologic drugs work to relieve arthritis caused by psoriasis?

All six biologic drugs included in our analysis—adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and ustekinumab (Stelara)—are FDA-approved to treat psoriatic arthritis. The biologic drugs reduce joint pain and inflammation and improve the quality of life in up to 80 percent of people with this condition. 

There are no head-to-head trials of biologic drugs to treat arthritis caused by psoriasis. Other studies that attempted to compare them indirectly had mixed results, but most found no difference in effectiveness among Humira, Enbrel, and Remicade. Simponi was approved after these studies were done. In the only major study of Simponi, about half of people who received it had at least a 50 percent improvement in joint pain, swelling, and function.

Table 3. Comparison of biologics

Note: All biologics increase the risk of infection, so it is not listed below. The first five drugs—adalimumab, etanercept, golimumab, and infliximab—can also cause congestive heart failure, lupuslike syndrome, and multiple sclerosis.

Biologic

Advantages

Disadvantages

Adalimumab (Humira)
  • Self-injectable
  • Well-known safety profile
  • Possible allergic reactions to latex.*
Certolizumab (Cimzia)
  • Self-injectable
  • Less frequent administration compared to adalimumab
  • Higher rates of serious adverse events.
  • Not FDA-approved for plaque psoriasis.
Etanercept (Enbrel)
  • Self-injectable
  • Well-known safety profile
  • Possible allergic reactions to latex.*
  • For psoriasis, requires twice weekly injections for 3 months, followed by once weekly.
  • For psoriatic arthritis, requires weekly injection.
Golimumab (Simponi)
  • Self-injectable
  • Less frequent dosing
  • Limited safety experience. Has only been available in U.S. since 2009.
  • Not FDA-approved for plaque psoriasis.
  • Possible allergic reactions to latex.*
Infliximab (Remicade)
  • Well-known safety profile
  • One analysis suggested it works faster than other biologics
  • May induce remissions that last several months
  • Inconvenient—requires clinic visits for infusions.
  • Risk of infusion reactions.
  • May lose effectiveness over time.
  • Risk of blood and liver toxicity.
Ustekinumab (Stelara)
  • Self-injectable
  • Least frequent dosing—every 3 months
  • Not associated with demyelinating diseases, or lupus-like syndrome
  • Limited safety experience.

* The needle capsule for self-injection has latex in it.

How safe are the drugs?

Most of what is known about side effects of the biologics comes from trials of people with rheumatoid arthritis, Crohn’s 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.

The mild side effects associated with these medications include:

  •     Headache
  •     Skin reaction where the drug is injected
  •     Respiratory infection
  •     Urinary tract infection 

Serious side effects include:

  •     Allergic reactions
  •     Liver damage
  •     Cancer
  •     Serious infections: tuberculosis, pneumonia, staph, and certain fungal infections

Here’s what we know about specific kinds of side effects and each drug.

For biologics that are injected under the skin (subcutaneously)—adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), and ustekinumab (Stelara)—people commonly experience skin rashes, itching, and pain where the drug is injected.

People also sometimes experience reactions to biologic drugs injected into a vein (infusion), such as infliximab (Remicade), due to infusion reactions. These reactions can include dizziness, chills, itching, headache, and fever. In about 1 percent of people, these infusion reactions can be severe or lead to convulsions. Rarely, it has been reported that people have died after receiving a biologic injected into their vein.

About three percent to four percent of people who take a biologic drug have an infection of some kind over the course of a year. Most of these are skin or lung infections (bronchitis or pneumonia). The risk of getting an infection after receiving a biologic is about 20 percent higher than the risk with methotrexate, a drug that many people try before a biologic drug. These risks are highest during the first six months of treatment.

 

There are differences in the biologic drugs in the risk of certain infections they pose. For example, a British study found the risk of tuberculosis was three to four times higher for people who took adalimumab (Humira) and infliximab (Remicade) compared with etanercept (Enbrel). But the actual risk is a fairly low number—about one in every 10,000 to 20,000 people who take a biologic.

 

If you have signs of an infection while taking a biologic, call or see your doctor right away. These include having the chills, a cough, diarrhea, feeling tired, a fever, muscle aches, and weight loss. 

All six of the biologics we evaluated have a warning on their drug label that they might increase the risk of certain cancers, including cancers of the breast and colon, lymphoma (a type of blood cancer), and certain types of skin cancers. In some cases, people have died from the cancer. 

 

But large, recent studies of people who took biologics for a variety of conditions have found no overall increased risk of developing cancers that can spread through the body (malignant), compared with people with who had the same diseases but who did not take biologics.

People have developed congestive heart failure, autoimmune ailments, such as lupus and multiple sclerosis, and serious liver reactions after starting a biologic. Most of the people improved after stopping treatment, which is an indicator that the biologic drug was the cause.

 

Ustekinumab (Stelara) has been associated with a single case of a brain condition called reversible posterior leukencephalopathy syndrome, which can be fatal but is usually reversible if caught early. The person who developed the ailment completely recovered after ustekinumab was stopped.

 

Although infliximab (Remicade) clears severe psoriasis faster than other biologics, it has a higher rate of withdrawal due to side effects than other biologics, so it is not one of our top picks. The main reasons people stop taking it are because they have skin or allergic reactions due to intravenous administration.

 

Long-term risks of the older biologics have not been identified yet. The first biologic—infliximab (Remicade)—has been on the market since 1998, and many experts think that long-term risks would have been detected by now.

 

For the newer biologic drugs, serious problems can take five years or more to recognize, so at present, there is less certainity.  

To reduce the risk of side effects, let your doctor know if you have:

•   chronic obstructive pulmonary disease (COPD)

•   congestive heart failure

•   diabetes

•   an infection or history of infections

•   tuberculosis or a positive skin test for tuberculosis

•   viral hepatitis

•   multiple sclerosis

Also notify your doctor if you have been around a person with chicken pox, shingles, or tuberculosis, or if you are scheduled to receive a vaccine or have surgery.

The risk of biologics to unborn babies is unknown. Women of child-bearing age should use contraception while on biologics. If you are planning to become pregnant, talk with your doctor about when to stop using contraception and biologics. The labeling of biologics advises these medications not be used by pregnant women unless necessary.

Drug Interactions

Biologics are often prescribed together with other medications, such as methotrexate, pain medications, or corticosteroids, and do not seem to interact with most drugs. But it’s important to note that there is little research on this issue. You should not take two or more biologics in combination. Studies show that when two or more biologics are taken at the same time, there is a substantially higher rate of serious adverse events compared to taking one of the drugs alone. 

Because biologics affect your immune system, it is recommended that you should not receive "live" vaccines, such as the yellow fever vaccine or FluMist, while you are on a biologic. But in some situations, a live vaccine may be necessary (for example, rubella immunization in women of childbearing age). You should discuss the possible risks and benefits of immunizations with your doctor. Other vaccines, such as flu vaccines that don't contain the live virus, are safe and can be administered with biologic medications. Discuss with your doctor any vaccines you plan to receive and read the package insert of the biologic you are taking—which can be found here.

Age, Race, and Sex Differences

People older than 65 and various ethnic groups have been underrepresented in most studies of biologics. Still, the existing evidence does not indicate that any biologic is more or less effective than the others in older people, any particular race or sex, or in patients who have other diseases.

Our 'Best Buy' picks

The main difference between these medications comes down to your choice of the type of injection you prefer and the potential side effects they can cause. Your choice of biologic drug will also depend on how severe your psoriasis is and whether you have psoriasis plaques on your skin or arthritis from psoriasis.

Also, the cost of these drugs, how much your insurance will cover, and how much you will pay out-of-pocket will all factor into deciding which biologic therapy is best for your situation. Biologics are expensive. They range in monthly cost from more than $2,000 to more than $6,000 if you are not covered by insurance. Taking into account the evidence for effectiveness and safety, as well as cost, if you need a biologic drug to treat psoriasis or psoriatic arthritis, we recommend the following as Consumer Reports Best Buy Drugs.

  • Adalimumab (Humira)
  • Etanercept (Enbrel)

Studies show that these medications are effective for relieving psoriasis and psoriatic arthritis symptoms in most people, and they also may have lower rates of side effects than some other biologics, such as infliximab (Remicade). People in several studies were less likely to stop taking these two medications due to problems with side effects compared to other biologics.

Our analysis shows that adalimumab (Humira) costs nearly $3,200 per month depending on the dose. The monthly price tag for etanercept (Enbrel) is slightly more, ranging from $3,417 to $3,439, depending on how the medication is given. You could incur additional expenses, such as administration and office visit fees, so check with your insurance to find out how much you will have to pay out-of-pocket.

If those drugs don’t relieve your symptoms or you can’t tolerate the side effects, consider trying ustekinumab (Stelara). It was more effective than Enbrel for relieving psoriasis in one 12-week trial (though it's not known if it continues to work better than Enbrel beyond that time). Other studies suggest too that Stelara helps relieve symptoms for longer than 12 weeks.

Stelara isn't one of our Best Buys because it has a comparatively shorter track record compared to Humira and Enbrel, since it hasn't been on the market as long. Plus, at the highest dose (90 mg, recommended for people weighing more than 220 pounds), Stelara is the most expensive biologic at more than $6,000 per month. At the lowest dose, though, it is less expensive than either of our two Best Buys, at $3,148.

Many biologic manufacturers offer programs that provide the medication free or for a small co-pay of $5 or $10, for a limited time, such as 6 months or a year. Depending on your insurance coverage, these may be worth checking out. Be sure to read the fine print. Often you must meet certain criteria to qualify, such as having insurance, and you’re usually not eligible if you use Medicare, Medicaid, or other federal insurance. You can find information about the programs by visiting the websites for the various medications. The easiest way to find them is to do a Google search for the brand name of the medication.

How we selected

Our evaluation is based in part on an independent scientific review of the studies and research literature on biologic therapies conducted by a team of physicians and researchers at the Oregon Health & Science University Evidence-Based Practice Center. This analysis reviewed more than 163 studies, including 70 controlled clinical trials, 31 studies that performed a cross-cutting analysis of multiple other studies, 51 observational studies, and 11 studies of other design. This effort was conducted as part of the Drug Effectiveness Review Project, or DERP. DERP is a first-of-its-kind, multistate initiative to evaluate the comparative effectiveness and safety of hundreds of prescription drugs.


A synopsis of DERP’s analysis of the biologic drugs forms the basis for this report. An additional literature search was conducted to capture the most recent published studies available evaluating biologic therapies. A consultant to Consumer Reports Best Buy Drugs is also a member of the Oregon-based research team, which has no financial interest in any pharmaceutical company or product. The full DERP review of the biologic drugs is available here. (Note that this is a long and technical document written for physicians and other medical researchers.)


The monthly costs we cite were obtained from a health-care information company that tracks the sales of prescription drugs in the U.S. Prices for a drug can vary quite widely. All the prices in this report are national averages based on sales in retail outlets. They reflect the cash price paid for a month’s supply of each drug in June 2014.


Consumer Reports selected the Best Buy Drugs using the following criteria. The drug had to:


-Be approved by the FDA to treat psoriasis or psoriatic arthritis or both.


-Be as effective as or more effective than other biologics when prescribed appropriately.


-Have a safety record equal to or better than other biologics when prescribed appropriately.


The Consumers Reports Best Buy Drugs methodology is described in more detail in the Methods section at www.CRBestBuyDrugs.org.


References

  1. Burmester GRPanaccione RGordon KBMcIlraith MJLacerda AP. Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. Ann Rheum Dis. 2013 Apr;72(4):517-24. doi: 10.1136/annrheumdis-2011-201244. Epub 2012 May 5.
  2. Curtis JR, Patkar N, Xie A, et al. Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. Arthritis Rheum 2007; 56:1125–33.
  3. Donahue KE, Jonas D, Hansen RA, Roubey R, et al. Drug Therapy for Rheumatoid Arthritis in Adults: An Update. Comparative Effectiveness Review No. 55. AHRQ Publication No. 12-EHC025-EF. Rockville, MD: Agency for Healthcare Research and Quality. April 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
  4. Giezen TJ, Aukje K. Mantel-Teeuwisse, et al. Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union. JAMA. 2008;300(16):1887-1896. doi:10.1001/jama.300.16.1887.
  5. Kylie J. Thaler, Gerald Gartlehner, Christina Kien,  et al.  Drug Class Review: Targeted Immune Modulators. Final Update 3 Report.  Portland (OR): Oregon Health & Science University; 2012 Mar. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0049852/ [Also: Posey, R, Roberta Wines, Cynthia Feltner. Drug Class Review: Targeted Immune Modulators. Preliminary Scan Report #1 April 2013 [Revised August 2013]]. 
  6. Novosad, S.A. and K. L. Winthrop. Beyond Tumor Necrosis Factor Inhibition: The Expanding Pipeline of Biologic Therapies for Inflammatory Diseases and Their Associated Infectious Sequelae.  Clinical Infectious Diseases 2014;58(11):1587–98
  7. Posey, R, Roberta Wines, Cynthia Feltner. Drug Class Review: Targeted Immune Modulators. Preliminary Scan Report #1 April 2013 [Revised August 2013]. 
  8. Singh JA, Wells GA, Christensen R,  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.
Editor's Note:

These materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).



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