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Psoriasis treatment: “Off-label” medicines that work throughout the body

severe psoriasis on the bottom of feet
Severe psoriasis: On the bottom of the feet, psoriasis can be disabling, and sometimes FDA-approved psoriasis medicines fail to work.
Dermatologists sometimes prescribe a medicine that the US Food and Drug Administration (FDA) has not approved to treat psoriasis.

This practice (prescribing a medicine for an unapproved use) is called “off-label” use. It’s perfectly legal under a doctor’s supervision and can be quite helpful. In fact, doctors in all fields sometimes prescribe a medicine off-label.  

A dermatologist may prescribe an off-label medicine for a patient with severe psoriasis when:

  • FDA-approved medicines for psoriasis have failed to work

  • FDA-approved medicines for psoriasis have stopped working 

  • The patient has another medical condition, which makes many of the strong psoriasis medicines off limits

  • An off-label medicine could reduce the risk of possible side effects

Off-label medicines that a dermatologist may prescribe to treat severe psoriasis include the following. 

6-thioguanine (thigh-oh-gua-neen): No studies have looked at treating psoriasis with this medicine. However, there are reports of patients clearing or almost clearing while taking 6-thioguanine. In looking at these reports, researchers found that of 40 patients taking this medicine, many (78%) had complete or almost-complete clearing. Serious side effects are the most common reason for stopping this medicine. 

Azathioprine (as-ah-thigh-oh-preen): The largest study to look at treating psoriasis with this medicine enrolled 29 patients. More than half, 19 patients, had some clearing, and 13 patients saw 75% or greater clearing. Azathioprine works slowly, generally taking six to eight weeks to show results. The most common side effects are nausea, vomiting, and diarrhea. More-serious side effects are possible.

Psoriasis medications and pregnancy

Women who are pregnant, breastfeeding, or planning to become pregnant should avoid most of these off-label medicines for psoriasis. While taking azathioprine, men should avoid getting a woman pregnant.

Couple gardening

Fumaric (few-mare-ic) acid esters: This may be a treatment option for patients who have psoriasis and multiple sclerosis (MS). This medicine is FDA-approved to treat relapsing forms of MS in adults. 

It can also effectively treat severe plaque psoriasis, pustular psoriasis, and stubborn psoriasis on the scalp, nails, or both. Studies show that between 50% and 70% of patients have a 75% or greater clearing within 4 months. 

The most common side effects are nausea, vomiting, and abdominal pain. Flushing on the face and elsewhere are also common. Flushing tends to stop after you take the medicine for a while. More-serious side effects are possible.

Hydroxyurea (hi-drox-e-you-rhee-ah): For someone who is HIV-positive and has severe psoriasis, this may be an option for treating psoriasis. This medicine has been used for more than 30 years to treat psoriasis. It has successfully treated people with: 

  • Severe plaque psoriasis

  • Erythrodermic psoriasis, which can be life threatening

  • Generalized (appearing all over the body) pustular psoriasis

In one study of 85 patients, 60% of those receiving hydroxyurea had complete or almost-complete clearing of their psoriasis. 

Some patients with pustular psoriasis on their feet and hands who have not been helped by other treatments have been helped by taking both hydroxyurea and another medicine called acitretin. 

Possible side effects of hydroxyurea include hair loss and dark spots on the skin. For most patients, their hair re-grows and their dark spots fade when they stop taking hydroxyurea. More-serious side effects are possible, which limits the widespread use of this medication to treat psoriasis. 

Visit your doctor regularly

Keeping appointments for doctor’s visits and lab tests can help find side effects early.

woman getting her blood pressure taken in doctor's office

Leflunomide (le-flu-no-mide): Effective for only a handful of patients with psoriasis, leflunomide is FDA-approved to treat rheumatoid arthritis in adults. 

In one study, only 17% of patients with psoriasis had 75% or greater clearing after taking leflunomide for 24 weeks. The most common side effects include nausea, diarrhea, no appetite, weight loss, headaches, and dizziness. More-serious side effects are possible.

Mycophenolate mofetil (my-co-fen-oh-late mo-feh-til): FDA-approved to prevent the body from rejecting an organ after a transplant operation, this medicine greatly suppresses the patient’s immune system. It can be effective for some people who have psoriasis. A study of 23 patients found that the average reduction in psoriasis was 47% after taking the medicine for 12 weeks. Another study of 11 patients found that clearing ranged from 40% to 70%. 

To improve results, this medicine may be used along with cyclosporine. 

The most common side effect when taking it is diarrhea. Nausea, vomiting, and abdominal cramps are also common and usually go away in time. Some patients find it painful or difficult to urinate. Others may have an urgent need to go, need to go frequently, or both.

Sulfasalazine (sul-fa-sal-a-zeen): Containing an antibiotic and medicine that can reduce inflammation, this medicine is FDA approved to treat ulcerative colitis and rheumatoid arthritis. 

It can also be effective for some people who have psoriasis. In a study of 50 patients with moderate-to-severe psoriasis, some taking sulfasalazine saw a great reduction. One-fourth of these patients, however, had to stop taking it due to rashes and nausea. 

Other possible side effects include heartburn, vomiting, diarrhea, fever, and headache. 

Consult with your dermatologist

If an off-label medicine is an option for you, be sure your dermatologist knows all the medicines you take, including ones you buy without a prescription. This can prevent a serious side effect.

doctor writing prescription

Sulfasalazine may be an option for treating psoriasis if a patient needs to stop taking methotrexate. Sulfasalazine is less effective than methotrexate, but the possible side effects are also less serious. 

Tacrolimus (tack-row-lie-mus): Available as an ointment and in pill form, both are used off-label to treat psoriasis. 

In pill form, tacrolimus is FDA-approved to prevent the body from rejecting an organ after a transplant operation. Doctors first learned that tacrolimus could also successfully treat psoriasis when four patients with psoriasis had organ transplants. To learn more, a small study was run. The patients with moderate-to-severe psoriasis who took tacrolimus had about an 85% clearing in 9 weeks. 

Due to possible serious side effects and uncertainty about how much tacrolimus to prescribe, tacrolimus pills are seldom used to treat psoriasis. 

Work with a doctor who has experience prescribing these medicines

If you feel that one of these off-label medicines may be an option for treating your psoriasis, be sure to see a doctor who has experience treating psoriasis with the off-label medicine. It’s essential to know the risks and benefits of the medicine and who can take it.

Image 1: Image used with permission of the Journal of the American Academy of Dermatology. (J Am Acad Dermatol. 2011;65:137-74.)

Images 2-4: Getty Images

Hugh J, Van Voorhees AS, et al. “From the Medical Board of the National Psoriasis Foundation: The risk of cardiovascular disease in individuals with psoriasis and the potential impact of current therapies.” J Am Acad Dermatol. 2014;70:168-77.

Lebwohl M, Menter A, et al. “Combination therapy to treat moderate to severe psoriasis.” J Am Acad Dermatol. 2004;50:416-30.

Menon K, Van  Voorhees AS, et al. “Psoriasis in patients with HIV infection: From the Medical Board of the National Psoriasis Foundation.” J Am Acad Dermatol. 2010;62(2):291-9. 

Mentor A, Korman NJ, et al. “Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents.” J Am Acad Dermatol. 2009;61:451-85.

Mentor A, Korman NJ, et al. “Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions.” J Am Acad Dermatol. 2011;65:137-74.