National Psoriasis Foundation

New clinical trial tests Humira as a nail psoriasis treatment

By Melissa Leavitt

A familiar drug is going to be put to the test as a new therapy for a tough-to-treat form of psoriasis. Humira (adalimumab), a biologic medication, is already used to treat plaque psoriasis and psoriatic arthritis. Now a new clinical trial will test whether Humira is an effective treatment for nail psoriasis, too. 

Nail psoriasis can cause discoloration, grooves, or pitting on the fingernail or toenail. Even though approximately 50 percent of people with psoriasis worldwide have this condition, treatment options are limited. 

"Nail psoriasis can be difficult to treat because the location of the inflammation is not on the surface of the skin," said Dr. Phoebe Rich, clinical adjunct professor of dermatology at Oregon Health & Science University. "This can make drug delivery difficult."

Topical treatments do not penetrate far enough, and injections into the nail can be uncomfortable and are not always effective, she noted.

"People who have nail psoriasis are really limited. It affects quality of life in an enormous way," Rich said. "It can interfere with their careers, and it can limit their ability to do the things they love to do," such as gardening and other hobbies.

AbbVie, the company that manufactures Humira, announced the launch of the trial late last month. According to Rich, Humira is not currently indicated as a treatment for patients who only have nail psoriasis—which means that insurance companies typically will not cover the use of Humira for nail psoriasis alone. In some instances, people who have severe psoriasis along with nail involvement have found that biologics can clear nail psoriasis symptoms. This trial will help determine whether Humira can be indicated for nail psoriasis specifically, which could offer a new, cost-effective treatment option for these patients. 

"This is one of the first times a company is really stepping up to the plate for these patients, helping them get the treatment they deserve," Rich said.

The double-blind, placebo-controlled trial will study 200 people with moderate to severe chronic plaque psoriasis with nail involvement. Participants must have at least one fingernail with psoriasis, and cannot have been treated previously with Humira. 

At the end of the 26-week study, researchers will compare the symptoms of patients taking Humira with those taking the placebo. The study will measure the percentage of patients who receive a "clear" or "minimal" assessment of their fingernail psoriasis, as well as the number of patients who experience a 75 percent reduction in severity.

This clinical trial is currently recruiting participants. More than 30 sites worldwide will participate in the study, including several locations in the United States. Data collection is expected to be complete in February 2015, with the study wrapping up in 2016. Learn more about the clinical trial >>> 


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