Meeting News

Long-term ixekizumab appears effective, safe in severe psoriasis

Three-year treatment with ixekizumab demonstrated high, and sustained, levels of skin clearance in patients with moderate to severe plaque psoriasis, according to findings from the UNCOVER-3 trial presented at the American Academy of Dermatology Annual Meeting.

Craig Leonardi, MD, an assistant professor at St. Louis University School of Medicine, and colleagues randomized 1,346 patients into four treatment groups to assess the long-term efficacy and safety of ixekizumab (Taltz, Eli Lilly).

During the 12-week induction period, patients received either 80 mg of ixekizumab subcutaneously every 2 weeks (n = 385), 80 mg of ixekizumab subcutaneously every 4 weeks (n = 386) following an initial dose of 160 mg of ixekizumab, 50 mg of etanercept (Enbrel, Amgen) twice a week (n = 382) or placebo (n = 193).

At week 12 of the study, patients began receiving 80 mg of ixekizumab every 4 weeks and entered a long-term extension period. Investigators were permitted to adjust dosing levels to 80 mg of ixekizumab every 2 weeks but could only do so after the first 60 weeks of treatment.

Researchers measured efficacy by the number of patients who achieved a 75%, 90% or 100% improvement from baseline, according to the Psoriasis Area and Severity Index (PASI).

Efficacy data for the intent-to-treat population were summarized using an as-observed, multiple imputation, and a modified non-responder imputation approach for missing data.

Seventy-seven percent of the patients completed 3 years of efficacy assessment.

A PASI score of 75 was achieved by 97% of patients within the as-observed population (n = 301) who received either ixekizumab every 2 or 4 weeks. Additionally, 87% reported a PASI of 90 and 64% reported a PASI of 100.

Of patients considered to have multiple imputations (n = 385), 91% reported a PASI of 75; 87% reported a PASI of 90, and 54% reported a PASI of 100.

Among patients considered to be modified non-responder imputations (n = 385), 84% reported a PASI of 75. Additionally, 72% reported a PASI of 90, and 52% reported a PASI of 100.

One-hundred and eighty-two patients had their ixekizumab dosing increased to 80 mg every 2 weeks after 60 weeks of treatment.

Eighty-seven percent of patients (n = 1,274) experienced at least one treatment-emergent adverse event.

The most common adverse event that occurred across the patient population was a viral upper respiratory tract infection (27.5%).

The safety profile, according to study data, was consistent with previous findings and there were no new safety concerns. - by Marley Ghizzone

Reference:

Leonardi C, et al. Abstract 6581. Presented at: AAD Annual Meeting; Feb. 16-20, 2018; San Diego.

Disclosures: Leonardi reports serving in the speaker bureau of AbbVie, Celgene and Leo Pharma and consulting for AbbVie, Amgen, Dermira, Eli Lilly and Company, Janssen, Leo Pharma, Pfizer, Sandoz and UCB Pharma. He reports having a conflict with AbbVie, Actavis, Amgen, Celgene, Cermira, Coherus, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel and Wyeth. Please see the study for all other authors’ relevant financial disclosures.

Three-year treatment with ixekizumab demonstrated high, and sustained, levels of skin clearance in patients with moderate to severe plaque psoriasis, according to findings from the UNCOVER-3 trial presented at the American Academy of Dermatology Annual Meeting.

Craig Leonardi, MD, an assistant professor at St. Louis University School of Medicine, and colleagues randomized 1,346 patients into four treatment groups to assess the long-term efficacy and safety of ixekizumab (Taltz, Eli Lilly).

During the 12-week induction period, patients received either 80 mg of ixekizumab subcutaneously every 2 weeks (n = 385), 80 mg of ixekizumab subcutaneously every 4 weeks (n = 386) following an initial dose of 160 mg of ixekizumab, 50 mg of etanercept (Enbrel, Amgen) twice a week (n = 382) or placebo (n = 193).

At week 12 of the study, patients began receiving 80 mg of ixekizumab every 4 weeks and entered a long-term extension period. Investigators were permitted to adjust dosing levels to 80 mg of ixekizumab every 2 weeks but could only do so after the first 60 weeks of treatment.

Researchers measured efficacy by the number of patients who achieved a 75%, 90% or 100% improvement from baseline, according to the Psoriasis Area and Severity Index (PASI).

Efficacy data for the intent-to-treat population were summarized using an as-observed, multiple imputation, and a modified non-responder imputation approach for missing data.

Seventy-seven percent of the patients completed 3 years of efficacy assessment.

A PASI score of 75 was achieved by 97% of patients within the as-observed population (n = 301) who received either ixekizumab every 2 or 4 weeks. Additionally, 87% reported a PASI of 90 and 64% reported a PASI of 100.

Of patients considered to have multiple imputations (n = 385), 91% reported a PASI of 75; 87% reported a PASI of 90, and 54% reported a PASI of 100.

Among patients considered to be modified non-responder imputations (n = 385), 84% reported a PASI of 75. Additionally, 72% reported a PASI of 90, and 52% reported a PASI of 100.

One-hundred and eighty-two patients had their ixekizumab dosing increased to 80 mg every 2 weeks after 60 weeks of treatment.

Eighty-seven percent of patients (n = 1,274) experienced at least one treatment-emergent adverse event.

The most common adverse event that occurred across the patient population was a viral upper respiratory tract infection (27.5%).

The safety profile, according to study data, was consistent with previous findings and there were no new safety concerns. - by Marley Ghizzone

Reference:

Leonardi C, et al. Abstract 6581. Presented at: AAD Annual Meeting; Feb. 16-20, 2018; San Diego.

Disclosures: Leonardi reports serving in the speaker bureau of AbbVie, Celgene and Leo Pharma and consulting for AbbVie, Amgen, Dermira, Eli Lilly and Company, Janssen, Leo Pharma, Pfizer, Sandoz and UCB Pharma. He reports having a conflict with AbbVie, Actavis, Amgen, Celgene, Cermira, Coherus, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel and Wyeth. Please see the study for all other authors’ relevant financial disclosures.