Brodalumab Approved for Psoriasis

The U.S. Food and Drug Administration has approved brodalumab (Siliq) for the treatment of adults and moderate-to-severe plaque psoriasis.

Brodalumab, which is administered as an injection, is a monoclonal antibody that neutralizes IL-17 receptor type A - an important cytokine in psoriatic arthritis. Plaque psoriasis typically does not respond to topical medications used for psoriasis, but biologics, like brodalumab, have generally performed well in clinical trials.

Approximately 17 percent of all psoriasis patients will develop moderate-to-severe plaque psoriasis. Psoriasis is increasingly becoming associated with the development of stroke, heart failure, obesity, hypertension and diabetes. But the severe form of psoriasis is in itself considered an independent risk factor for cardiovascular mortality and psychiatric disorders (depression, anxiety, and suicidal tendency from physical and mental distress), wrote researchers in a review published in January 2017 in Skin Therapy Letter.

"By targeting IL-17RA, brodalumab has proven to be exceptionally efficacious with improvement of PASI 75 in over 80 percent, and approximately 70 percent of those patients achieved PASI 90 on brodalumab 210 mg by week 12 in three large phase three clinical trials,” wrote Stephen K. Tyring, M.D., Ph.D., of the University of Texas, and colleagues in the review.

Patients with psoriasis often struggle to maintain an acceptable quality of life, researchers wrote noting that a PASI 90 response is necessary to achieve a Dermatology Quality of Life Index (DLQI) of zero or one. “Indeed, the new class of IL-17 antagonists has eminently shifted the expectation of treatment response, such that PASI 90 may be regarded as the new standard. Based on efficacy alone, brodalumab and other IL-17 class biologics could become first-line therapy for moderate-to severe plaque psoriasis. Safety considerations of depression and suicidality, however, could hamper the use of brodalumab in favor of the other IL-17 biologics secukinumab and ixekizumab,” the researchers wrote. In it’s approval of brodalumab for plaque psoriasis, which was proven effective in three randomized, placebo-controlled clinical trials of 4,373 adults, the FDA expressed

concerns

of suicidality saying that brodalumab should be prescribed with very specific patient guidelines. In addition to IL-17, biologics that target IL-23 and TNFa, have proven to be effective in plaque psoriasis and/or psoriatic arthritis patients.  

Biologic Drugs for Plaque Psoriasis and/Psoriatic Arthritis

Ixekizumab (Taltz). FDA-approved for plaque psoriasis 

Ustekinumab (Stelara). FDA-approved for plaque psoriasis and psoriatic arthritis

Golimumab (Simponi). FDA-approved for psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis

Infliximab (Remicade). FDA-approved for psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis and Crohn's disease

Adalimumab (Humira). FDA-approved for treating psoriasis, psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis

Etanercept (Enbrel). FDA-approved for treating psoriasis in patients 4 years and older, psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis

Secukinumab (Cosentyx). FDA-approved for treating plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis

Certolizumab pegol (Cimzia). FDA-approved for psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis and Crohn's disease.

Additional reading on Rheumatology Network:  “Induction Period for Switching Biologics in Psoriasis Recommended”

References:

Yun Tong, MD; Andrew J. Peranteau, MD; Zeena Nawas, MD; Stephen K. Tyring, MD, PhD. "A Review of Brodalumab, an IL-17 Receptor Antagonist, for Moderate-to-Severe Plaque Psoriasis," Skin Therapy Letter. January 2017. 

"FDA approves new psoriasis drug." FDA news release. Feb. 15, 2017.

"Biologic Drugs: Fact Sheets." National Psoriasis Foundation/USA.