Promising new psoriasis drug wins FDA approval

| Melissa Leavitt

A new psoriasis drug that can keep patients feeling good inside and out has been approved by the U.S. Food and Drug Administration (FDA).

Taltz (ixekizumab), a biologic drug manufactured by the drug maker Eli Lilly, won FDA approval for the treatment of moderate-to-severe plaque psoriasis.

Clinical trial results have shown that Taltz can improve psoriasis by at least 75 percent after three months in more than 80 percent of people taking the drug, delivering completely clear skin to up to about 35 percent of patients in the same period of time. 

New data on the safety and effectiveness of Taltz made headlines at the American Academy of Dermatology (AAD) meeting in Washington, D.C., earlier this month. According to the data, Taltz may not only get rid of plaques, but it could keep patients clear long-term and improve their quality of life.

In a presentation at AAD, Dr. Andrew Blauvelt, a clinical investigator for the Taltz trials and president of the Oregon Medical Research Center, reported that Taltz stayed effective for more than a year, with more than half of patients in a Phase III trial having clear skin 60 weeks after starting the drug, which was an increase over the number of patients who were clear after three months. Blauvelt also reported that there were no unexpected side effects associated with long-term use of the drug that didn’t come up in the first few months of treatment. 

According to previous data, the most common side effects experienced by patients taking Taltz for three months included the common cold and upper respiratory tract infection.

Other data presented at the meeting offered insight into how Taltz affects specific aspects of patients’ skin and well-being. Here are some highlights:

•    Taltz can offer significant improvement in fingernail psoriasis. After 60 weeks of treatment, researchers reported, up to half of patients on Taltz had completely clear nails.
•    The drug may also improve patients’ sex lives. After three months of treatment, skin-related sexual difficulties improved for up to 81 percent of patients on Taltz, researchers reported. 
•    Taltz can deliver relief for scalp psoriasis. Up to about 75 percent of patients who had scalp psoriasis at the start of treatment had no scalp psoriasis remaining after three months of treatment, according to trial results.
•    Quality-of-life may improve in many patients on Taltz. A trial found that after 60 weeks of treatment, about two-thirds of patients reported that psoriasis did not have any effect on their quality of life.
•    Taltz may be a good alternative for patients who have not seen improvement on other biologics. In a study analyzing how well Taltz worked in patients who had already failed to get results on Enbrel (etanercept), another biologic currently on the market, almost 84 percent of those who switched to Taltz saw 75 percent improvement after three months. Data from the same trial showed that more than 20 percent had completely clear skin in the same amount of time. This suggests that patients who have not improved on Enbrel “have just as good a chance to respond to [Taltz],” Blauvelt said in an interview with the National Psoriasis Foundation.

Taltz targets a cytokine, or pro-inflammatory protein, known as interleukin-17

 

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