Ixekizumab improved function, other parameters in treatment of PsA

MADRID — Improvements in arthritis outcomes, physical function and psoriasis were reported for treatment with ixekizumab among patients with active psoriatic arthritis, according to findings presented at the EULAR Annual Congress.

Peter Nash, MD, a rheumatologist at the University of Queensland in Brisbane, Australia, conducted the 24-week, double-blind, placebo-controlled phase 3 study in a cohort of 336 patients with inadequate response or intolerance to prior therapy. Overall, 118 patients received placebo; 122 patients were treated with 80 mg ixekizumab (Eli Lilly) every 4 weeks; and 123 patients received that dose of the study drug every 2 weeks. Patients in the ixekizumab arms received a 160-mg starting dose.

The primary endpoint was ACR20 at 24 weeks. Secondary endpoints included ACR50, ACR70, health assessment questionnaire disability index (HAQ-DI) and minimal disease activity (MDA) at 24 weeks.

“There is a long-term extension out to 3 years in this study population,” Nash said.

ACR20 results at 24 weeks showed 19.5% of the placebo group reached this endpoint compared with 53% for the monthly treatment group and 48% for the group treated every 2 weeks. For ACR50 at 20 weeks, the rates were 5% for placebo; 35% for the monthly treatment group; and 33% for the group treated every 2 weeks. The ACR70 response was 0% for placebo compared with 22.1% for patients treated every 4 weeks and 12.2% for those treated every 2 weeks.

“Significant responses at the ACR20 level were seen at a week,” Nash said. “ACR50 was seen at about 4 weeks [and] ACR70 at about 7 weeks.”

The change from baseline for HAQ-DI was -0.2 in the placebo group, was -0.6 in the monthly group and was -0.4 in the group treated every 2 weeks. Response rates were 17%, 43% and 40% for placebo, monthly treatment and with treatment every 2 weeks, respectively.

The MDA response was 3% for placebo, 28% for patients treated every 4 weeks and 24% for those treated every 2 weeks.

“Enthesitis was a different story,” Nash reported. “There was no difference between the fortnightly and monthly doses.”

Regarding dactylitis at 24 weeks, 21% of patients in the placebo group reported this outcome compared with 75% and 50% for those treated for 4 weeks and 2 weeks with ixekizumab, respectively.

The adverse event profile indicated rates of 2.5% for the monthly treatment group and 6.5% for the group treated every 2 weeks, with injection site reactions occurring in 11.5% of those in the 4-week group and 23.6% of those treated every 2 weeks.

“Ixekizumab has improved signs and symptoms of PsA, with improvements in physical function and no unexpected safety outcomes,” Nash concluded. — by Rob Volansky

Reference:

Nash P, et al. Abstract #OP0201. Presented at: EULAR Annual Congress; June 14-17, 2017; Madrid.

Disclosure: Nash reports receiving grant or research support from AbbVie, Amgen, BMG, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi and UCB; consulting for AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi and USB; and being on the speakers bureau for AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi and UCB.