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When Not to Use Biologics for Psoriasis

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

More often, individual patient and disease characteristics influence treatment decisions. As many as 30% of patients with psoriasis develop psoriatic arthritis, and the condition becomes severe in up to 30% of cases. For those patients, methotrexate remains widely used, either as initial therapy or in combination with a biologic or other systemic therapy. The drug decreases inflammation but does not prevent x-ray progression of arthritis, said Cohen. Cyclosporine can be helpful when used with methotrexate or etanercept (Enbrel). Acitretin (Soriatane) has moderate efficacy in combination therapy.

Apremilast (Otezla) has two advantages — an oral medication that has two indications: patients with moderate-severe psoriasis who are candidates for phototherapy or systemic medication and adults with psoriatic arthritis. The drug works after failure of biologic therapy and has particular efficacy for scalp and nail psoriasis, said Cohen.

“No long-term safety issues after 3 years of follow-up, no routine labs for safety monitoring — patients love that,” he said.

Tofacitinib (Xeljanz) has an indication for adults with psoriatic arthritis (after failure of disease-modifying drugs), but no approved indication for psoriasis. Clinical trials of the drug focused on improvement in arthritis status (American College of Rheumatology criteria) but some studies also documented improvement in the Psoriasis Area and Severity Index, said Cohen. Tofacitinib cannot be used in combination with another immunosuppressant.

For patients with psoriasis complicated by inflammatory bowel disease, apremilast has been used, with no reports of adverse effects on psoriasis control. Methotrexate outperformed placebo in randomized trials. Cyclosporine has been shown to induce remissions in refractory Crohn’s disease.

Patients with psoriasis have an increased risk of lymphoma, but little data have accumulated to provide guidance about solid tumors, said Cohen. The general rule is not to use biologic agents, particularly if a patient is less than 5 years out from diagnosis. Methotrexate is a good option, as is cyclosporine, at least in the short term. However, long-term use in transplant patients has been associated with an increased risk of malignancy.

Acitretin probably is the best option for patients with psoriasis and a history of malignancy, Cohen continued, as the drug was shown to prevent or delay progression of nonmelanoma skin cancer in transplant patients. Apremilast has limited data to support its use in patients with malignancy, but no safety signals have emerged.

“Talk to your oncologist,” he said. “They’re a lot more liberal than us dermatologists. You talk to them and they’ll say, ‘Of course you can write that [prescription].'”

With respect to infections, acute episodes should be treated first, then the psoriasis, said Cohen. For patients with chronic infection, methotrexate, apremilast, and acitretin are options, but not cyclosporine because of its immunosuppressive properties. Methotrexate is contraindicated for patients with hepatitis B or C. Cyclosporine should not be used by a patient with hepatitis B, but data regarding hepatitis C are mixed. No data have emerged for apremilast and hepatitis, but it “should be OK.” Acitretin also should be acceptable but requires monitoring with liver function tests.

Patients with a history of tuberculosis should be screened before, during, and after treatment, said Cohen. Apremilast and acitretin are safe to use, and methotrexate and cyclosporine can be used only after patients have received TB prophylaxis.

Special Populations

Obese patients “love” apremilast because they often lose weight, as much as 10-15% in some cases, Cohen said. Cyclosporine and acitretin are riskier, and methotrexate should be avoided because of a risk of fatty liver disease.

Studies have shown that older patients on biologic therapy have low adherence rates and high discontinuation rates, reaching 50% during the first 12 months of therapy. At the opposite end of the age spectrum, pediatric patients have fewer approved options. Methotrexate, cyclosporine, and acitretin are not approved for use in pediatric patients but are nonetheless considered safe, said Cohen. Phototherapy is a good option because of its safety. Apremilast is not approved for use in pediatric populations, but “probably is safe.”

“There are so many options today, what are you going to do?” Cohen said in conclusion. “Talk to your patients; let them know what’s available. Consider comorbidities, and look at the different patient populations. Talk to your patients about the cost, because it’s a lot of money to spend.”

When he started clinical practice, hydroxyurea was a mainstay of treatment for psoriasis, he said, explaining that methotrexate and cyclosporine were his personal favorites for years. With the advent of biologic therapy, “sometimes we need to step back and pause,” he said. “There are still a lot of great [nonbiologic] drugs that you should be using.”

Cohen disclosed relationships with AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharmaceuticals, and UCB.