Newly Approved Treatment for Psoriasis in Ixekizuma

March 23, 2016

Ixekizumab, one of three anti-IL-17 agents for moderate-to-severe plaque psoriasis, has been approved by the FDA for plaque psoriasis - a disease that goes untreated for most patients.

The U.S. Food and Drug Administration has approved ixekizumab (Taltz/Eli Lilly) for adults with moderate-to-severe plaque psoriasis. In an announcement issued on Wednesday, the FDA stated that ixekizumab performed well in clinical trials. It achieved greater clinical response than placebos in three randomized, placebo-controlled clinical trials with a total of 3,866 participants. Ixekizumab binds to the IL-17A protein that causes inflammation. By binding to IL-17A, ixekizumab stops the inflammatory response associated with plaque psoriasis.[[{"type":"media","view_mode":"media_crop","fid":"47055","attributes":{"alt":"©LipowskiMilan/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_2650698834138","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5511","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"©LipowskiMilan/Shutterstock.com","typeof":"foaf:Image"}}]] Ixekizumab, which is administered as an injection, is intended for patients who are candidates for systemic therapy, phototherapy or a combination of both.  It has been approved with a medication guide for patients to learn more about the risks of infection or allergic reactions. Serious allergic reactions and inflammatory bowel disease have been reported with ixekizumab. Plaque psoriasis is the most common form of psoriasis.  Ixekizumab is one of three anti-IL-17 agents for moderate-to-severe plaque psoriasis. The others include secukinumab and brodalumab, but they all seem to have comparable safety profiles, according to a review published this month in the Journal of Drugs in Dermatology. The authors of the review found that the number of patients whose condition improved by 75 percent after 12 weeks was comparable:  83 percent of patients receiving secukinumab; 89 percent receiving ixekizumab; and, 85 percent receiving brodalumab. “The anti-IL-17 agents demonstrated a rapid and robust clinical improvement accompanied by a favorable short-term safety profile. The results of the phase III trials continue to reinforce the theory that the IL-17 pathway is an essential target in psoriasis treatment,” wrote John Koo M.D., of the University of California at San Francisco, and colleagues. Previously, IL-12, IL-22 and IL-23 were considered the primary pathways for drug development in psoriasis. “IL- 17 contributes to the activation and recruitment of neutrophils and the stimulation of psoriasis angiogenesis. The findings of elevated levels of IL-17 in psoriatic lesions and in the serum of patients with psoriasis further support the role of IL-17 in the pathophysiology of psoriasis,” the authors wrote. New treatments for psoriasis are needed because most patients continue to go untreated, the authors wrote.  

 

References:

FDA approves new psoriasis drug Taltz

, U.S. FDA news release issued on March 22, 2016. Benjamin Farahnik BA, Kourosh Beroukhim BS, et al.

"Anti-IL-17 Agents for Psoriasis: A Review of Phase III Data,"

J Drugs Dermatol. 2016;15(3):311-316.