Biologic shows high levels of clearance for psoriasis in phase 3 trial

By John Murphy, MDLinx
Published March 9, 2016

Key Takeaways

The drug ixekizumab cleared plaque psoriasis in the majority of patients after 60 weeks of treatment, according to late-breaking research presented at the 2016 American Academy of Dermatology meeting on March 5, 2016, in Washington, DC.

“Izekizumab treatment led to high clinical response rates and sustained efficacy in most patients,” said dermatologist Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, in Portland, OR. “Over 50% of ixekizumab-treated patients achieved complete resolution of psoriatic plaques at week 60. The safety profile for ixekizumab looked like that which was observed throughout the 12-week induction period.”

Dr. Blauvelt presented results from UNCOVER-3, a phase 3 clinical trial that evaluated the 60-week efficacy and safety of ixekizumab injection (a biologic, interleukin 17A inhibitor with high binding affinity) in patients with moderate-to-severe plaque psoriasis. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.

For this trial, patients with psoriasis were randomized into one of four groups: an induction period to placebo; etanercept 50 mg twice weekly; ixekizumab 80 mg every 4 weeks; or ixekizumab 80 mg every 2 weeks. After 12 weeks, all patients entered into open-label treatment with ixekizumab every 4 weeks.

Researchers assessed disease severity using the Psoriasis Area Severity Index (PASI) and static Physician Global Assessment (sPGA). At week 60, the PASI 100 response rate was 57%, PASI 90 was 78%, and PASI 75 was 87%. On sPGA 0/1 assessment, nearly 4 out of 5 patients (79%) had complete clearance or mild severity.

In addition, the long-term safety and tolerability profile mirrored that of the induction period, in which serious adverse events occurred in less than 2% of subjects in each group.

The researchers concluded that ixekizumab therapy over 60 weeks was highly efficacious and well tolerated in treating plaque psoriasis.

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