EULAR Report: Ixekizumab Approved for Axial Spondyloarthritis

Eli Lilly announced this week that Taltz (ixekizumab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA).

Ixekizumab is currently approved to treat psoriatic arthritis, ankylosing spondylitis and patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

And, this week during the European Congress of Rheumatology (EULAR) annual meeting, which is being held virtually from Germany this year, the company is reporting results from the 52-week SPIRIT phase 3b/4 trial for psoriatic arthritis (PsA). The trial compares ixekizumab with adalimumab (Humira) in biologic naive patients with active PsA disease.

At 52 weeks, PsA patients receiving ixekizumab showed improvements across multiple endpoints, with or without methotrexate or other csDMARDs. And, more of these patients achieved Minimal Disease Activity (MDA) compared to those treated with adalimumab monotherapy (49% versus 33%). For those treated with methotrexate in addition to ixekizumab or adalimumab, the response rates were 47% vs 47%, respectively, and for those receiving concomitant csDMARD therapy, it was 47% vs 44%.

Those achieving the primary endpoint of ACR50 and PASI 100 at week 52 in all three subgroups were as follows:

• Monotherapy: ixekizumab 38%, adalimumab 19%

• Concomitant methotrexate: ixekizumab 39%, adalimumab 30%

• Concomitant csDMARDS: ixekizumab 40%, adalimumab 29%

A greater proportion of patients treated with ixekizumab versus adalimumab achieved PASI 100 when used as mono-therapy (66% vs 35%), in combination with methotrexate (63% vs 44%), or in combination with csDMARDs (64% vs 44%) and the proportion of patients achieving ACR50 was comparable between ixekizumab and adalimumab, regardless of monotherapy (51% vs 42%), concomitant MTX (48% vs 56%), or concomitant csDMARD use (49% vs 53%).

"In this subgroup analysis of the SPIRIT-H2H study, ixekizumab showed greater improvement than adalimumab across multiple PsA endpoints when taken as monotherapy, and at least comparable efficacy when used in combination with methotrexate or other csDMARDs," said Josef Smolen, M.D., emeritus professor of medicine at the Medical University of Vienna, Austria and lead author of the abstract. "Head-to-head studies provide important insights for physicians when making treatment decisions. The results of this analysis reinforce the efficacy of ixekizumab, even as monotherapy, for patients with PsA who have had an inadequate response to csDMARDs."

The observed safety profile for Taltz in the SPIRIT-H2H study was consistent with that reported for ixekizumab in patients with moderate to severe plaque psoriasis (PsO) and PsA.