Plaque Psoriasis "is a chronic, immune disease that appears on the skin," a condition that affects approximately 7.5 million Americans and 125 million people worldwide. Of the affected population, "approximately 20 percent have moderate-to-severe plaque psoriasis."
Now, Eli Lilly and Company has announced a breakthrough in the treatment of this disease. According to the company, in a Phase 3 clinical trial, patients who did not respond to treatment with etanercept showed significant improvement when treated with ixekizumab.
"Despite the availability of existing treatment options, there are many patients living with moderate-to-severe plaque psoriasis who have not responded to previous treatments and are still looking for an alternative," said Kim Papp, M.D., lead author and president, Probity Medical Research, Inc. "In this study, ixekizumab demonstrated high levels of clearance for all patients. We saw high levels of improvement in biologic-experienced patients, and we saw high levels of improvement in those who have not been treated with a biologic. These results provide further evidence of a robust clinical data profile that, if approved, supports the use of ixekizumab in patients with moderate-to-severe plaque psoriasis."
The results of the trial were presented at the Annual Meeting of the American Academy of Dermatology (AAD) held in Washington, D.C. between March 4-8, and have been published in the journal JAMA Dermatology.
"Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines," the study reads. Ixekizumab is Eli Lily and Company's "investigational medicine for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis."
Approximately 2,500 patients with moderate-to-severe plaque psoriasis across 19 countries were evaluated as part of the study. During the study, patients were administered either placebo, etanercept (50 mg twice a week) or ixekizumab (80 mg every two or four weeks) for 12 weeks, following a 160-mg starting dose.
"Studies have shown that clinical improvement observed early during psoriasis treatment can help predict clinical response at later times," said Craig Leonardi, M.D., lead study author and clinical professor of dermatology at St. Louis University School of Medicine. "In this analysis of ixekizumab, early results were seen in patients with moderate-to-severe plaque psoriasis, an extensive and difficult-to-treat disease. According to patients and their dermatologists, rapid clearing of psoriasis plaques is one of the most important attributes for treatment success."
The clearing up of the skin also led to significant improvement in the patients' mental health and work productivity.
"Psoriasis is a serious, systemic disease that can have a significant impact on a patient's overall health and quality of life, including work productivity and overall activity levels,"said April Armstrong, M.D., MPH, corresponding study author and associate dean of clinical research at Keck School of Medicine of University of Southern California. "The results presented at AAD and detailed in 'JAMA Dermatology' further reinforce published data supporting ixekizumab as a potential treatment for moderate-to-severe plaque psoriasis. If approved, ixekizumab may provide dermatologists with a new option to address both skin symptoms and health-related outcomes for patients, including work-related activities."
