lxekizumab Performance in TNF Nonresponders Phase 3 Trial Save

Ixekizumab performs well in TNF nonresponders phase 3 trial.

With more IL17 inhibitors becoming available for treatment of seronegative spondyloarthropathies the question of efficacy and safety in different clinical scenarios arises.

The phase 3 PsA SPIRIT-P2 trial involving 363 patients with PsA who failed or could not tolerate 1-2 TNFi randomized patients into 3 groups: PBO, IXE 80 mg q 2 weeks and IXE 80 mg q 4 weeks.

Acr 20 was assessed in 24 weeks as a primary end point. 16 week escape was allowed.

Best response was observed in arthritis and dactylitis domain in both IXE groups with ACR20 65 [53.3%], 59 [48%] vs. 23 [19.5%]; Q4W, Q2W, placebo, respectively. At the same, rates of enthesitis resolution were not significantly different compared to placebo. 

In terms of safety, serious AE and oral candidiasis were numerically higher with Q2W vs placebo. No deaths or cases of inflammatory bowel disease, uveitis, TB reactivation, or grade ≥3 neutropenia were reported.

The study concluded that IXE improves arthritis, skin psoriasis and physical function with no unexpected safety findings in patients with active PsA and prior IR or intolerance to TNF-inhibitor(s).

The safety profile of IXE was comparable to safety findings from SPIRIT-P1 trial.