Ixekizumab improves psoriatic arthritis patient-reported outcomes

May 29, 2018|Psoriatic Arthritis ICYMI

REPORTING FROM RHEUMATOLOGY 2018

LIVERPOOL, ENGLAND – In biologic-experienced patients with psoriatic arthritis, the interleukin-17 inhibitor ixekizumab not only met the primary efficacy endpoint of a pivotal phase 3 trial, but also improved multiple patient-reported outcomes in doing so.

Newly-released results from the Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P2) showed that patients who received active treatment exhibited significantly better changes in physical function, quality of life, itch score, and work productivity compared with those given placebo.

Changes in Health Assessment Questionnaire Disability Index (HAQ-DI) scores from baseline to week 24 were a respective –0.4 and –0.6 for 80 mg of ixekizumab given either every 2 weeks or every 4 weeks and –0.2 for placebo (P less than or equal to .001). The minimal clinically important difference (MCID) in HAQ-DI is 0.351, said SPIRIT-P2 investigator Helena Marzo-Ortega, MD, who presented the findings at the British Society for Rheumatology annual conference.

Patients treated with ixekizumab 80 mg every 2 or 4 weeks more often achieved the MCID by week 24, reaching 40% for 80 mg every 2 weeks and 43% for every 4 weeks, compared with 17% for placebo.

A total of 363 patients who met CASPAR (Classification Criteria for Psoriatic Arthritis) criteria were randomized into the SPIRIT-P2 trial. Patients could be included only if they had at least three tender and three swollen joints, active skin lesions, or a documented history of skin psoriasis, and had received prior treatment with a tumor necrosis factor inhibitor (TNFi).

“The population of patients studied is representative of the patients we see in our clinics,” said Dr. Marzo-Ortega, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust, England. The mean age was 52 years, a similar percentage of men and women were seen, and the majority (53%-58%) were inadequate responders to one TNFi. One-third had not responded to two TNFis, and 8%-10% had an intolerance.

The primary endpoint results, which have been previously presented and published (Lancet. 2017;389[10086]:2317-27), showed that a significantly (P less than .0001) higher percentage of patients treated with either of the two regimens of ixekizumab achieved a 20% response level on American College of Rheumatology criteria (ACR20) at 24 weeks. Indeed, 48% of 123 patients given 80 mg of ixekizumab every 2 weeks and 53% of 122 given 80 mg every 4 weeks achieved an ACR20 versus 20% of 118 placebo-treated patients. Also, on two key secondary endpoints at 24 weeks, an ACR50 response was achieved by a respective 33%, 35%, and 5% of patients, and an ACR70 by 12%, 22%, and 0%, she said.